chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When she was given the shot, part of it escaped the syringe and ran down her arm; When she was given the shot, part of it escaped the syringe and ran down her arm; When she was given the shot, part of it escaped the syringe and ran down her arm; A spontaneous report was received from a consumer who was also a 76-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and when she was given the shot, part of it escaped the syringe and ran down her arm/ device connection issue and underdose.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 26 Jan 2021, the patient presented to the pharmacy for their first of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 26 Jan 2021, during vaccination, part of it escaped the syringe and ran down her arm. The patient was concerned by how much vaccine escaped the needle and reported that it was "like a gush". She did not experience any symptoms. No treatment information was provided.   Action taken with mRNA-1273 in response to the event(s) was not reported.   The event, when she was given the shot part of it escaped the syringe and ran down her arm, was considered resolved.; Reporter's Comments: This report refers to a case of Device connection issue and Underdose for mRNA-1273, (Lot number: 007M20A) with no associated adverse events.
Headache, Myalgia, Fever, fatigue, chills, injection site pain Narrative:
Rash-on torso; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Lot Number: EW0158), dose 2 intramuscularly, administered in Arm Left on 09Apr2021 12:43 as a single dose for COVID-19 immunization. Medical history included ongoing high cholesterol. There was none relevant test. The patient previously took first dose of bnt162b2 (lot number: GP6955) via intramuscular on 18Mar2021 10:40 am, in left arm for COVID-19 immunization. 2nd day after shot on 19Mar2021, the patient developed sore arm, non-serious, with recovered outcome, no treatment received for it. After the first shot, side effect "just a sore arm" which did not affect daily activities." Prior vaccination: None. Concomitant medication included pravastatin taken for high cholesterol from an unspecified start date and ongoing; estradiol (ESTRADIOL TRANSDERMAL) taken for an unspecified indication from an unspecified start date and ongoing. The patient experienced rash-on torso on 10Apr2021 after second shot, lasted 3 days. This is a non-serious event, without any treatment for it. The outcome of event was recovered on 13Apr2021.    No follow-up attempts are needed. No further information is expected.
Pt states that she began feeling ill the next day and was in so much pain she went to the hospital. She states she was experiencing severe pain, swelling, and redness at the injection site. At the hospital she states she was given a steroid shot and lidocaine. She states the CC was site of injection pain (severe)
Pt's rt shoulder found with large reddened area. Warm and tender to touch at the injection site. Size of reddened area is 8cm x 7cm. Ice pack placed on area. Kpad ordered by physician.
103 fever, tachycardia, myalgias, severe arm pain,arm bruising, headaches, lethargy. all symptoms lasted about 2.5 days. worst being 24-36 hours after pneumococcal vaccination
Myalgia, Arthralgia,  Fatigue, Chills Narrative:  Other Relevant History:
Day 1: Pins & Needles hands and feet; Day 2: Slight fever, tingling continues; Day 3-14: Tingling, muscle twitches, cramping, crawling sensation, stabbing pains, soreness in legs/feet/toes; Day 15- Present: Twitching continues but not as severe, mostly legs/feet but sometimes back/arms.
Patient was inadvertently administered an expired dose of Daptacel/No AE; Initial information was received on 03-Jun-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 5 year old female patient who received expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT (IPV) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) for Immunisation.  On 03-Jun-2020, the patient received a fifth 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5366AA, expiry date- 07-Feb-2020) via unknown route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  Patient was inadvertently administered an expired dose of Daptacel in the left thigh.  At the time of report, no adverse event 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 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.
This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 68-year-old female patient who received Shingrix for prophylaxis. On 16th December 2018, the patient received the 1st dose of Shingrix (intramuscular). In December 2018, less than a week after receiving Shingrix, the patient experienced upset stomach, chills, headache and joint pain. On an unknown date, the outcome of the upset stomach, chills, headache and joint pain were not recovered/not resolved. It was unknown if the reporter considered the upset stomach, chills, headache and joint pain to be related to Shingrix. Additional information was provided as follows: The patient received Shingrix in the left arm. The caller reports that the events was improving but have not resolved yet. The reporter did not consent to follow-up.
On 4-4-02 right arm swollen, red, hot. Mom applied ice to area and gave Tylenol. Seen at clinic 4-5-02; redness measured 4" long x 3" wide, swollen, hot. Nurse practitioner recommended Tylenol, Benadryl and ice
Information has been received from a physician concerning a 25 month old male patient with a history of wheezes who was vaccinated with three doses of ROTATEQ orally on 02-MAR-2009 (lot # 663217/1472X), 05-MAY-2009 (lot # 663711/0107Y) and 20-JUL-2009 (lot # 663682/0015Y) respectively. There was no concomitant medication. On 03-FEB-2011 the patient had symptoms diarrhea (not bloody stool) and some vomiting; stool was tested and found to be positive for rotavirus. The patient was hospitalized overnight. The patient was given fluid for the adverse event. The physician didn't think the patient was born pre-maturely. In February 2011, the patient had recovered. No further information is available.
This spontaneous report was received from a registered nurse and refers to a multiple unspecified number of patients of an unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies. The reported stated that improperly stored doses (incorrect product storage) of GARDASIL 9, lot number M004116, expiration date 12-OCT-2017 (dose, route, and anatomical location were not reported), were administered to the multiple unspecified number of patients on unspecified dates, for prophylaxis. The vaccines were exposed to a range of temperature of more than 8 degrees Celsius but less than 25 degrees Celsius for 1 hour and 30 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA007055: US-009507513-1702USA007056.
Had Shingles twice. Also had the vaccine twice\ suspected vaccination failure; had shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles vaccine twice and had the shingles twice. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Patient felt Chronic Pain . Onsite EMS was called vitals were taken BP 142/85  99% O2 room air HR 75. Patient refused evaluation/care. Left aginst medical advice.
The patient came into the office on 6-17-03 complaining of a rash all over the body and having slight diarrhea beginning on 6-16-03.  Doctor explained to mom the nature of the problem and prescribed Zyrtec syrup 1/2 tsp. by mouth this a.m., then 3/4 tsp by mouth tonight, then 1 tsp. by mouth every night as needed.  The mom was instructed to call if signs and symptoms were to change.
Got vaccine in left arm. Next day felt numbness and random pain in arm where shot was given. Numbness, tiredness and slight pain randomly in left thumb and palm around thumb. All since 9/3/2021 and today is 11/6/21
This spontaneous report as received from a pharmacist refers to a 67 years old female patient. The patient's medical history included bursitis in her elbow. The patient was vaccinated with a 0.5 ml dose of PNEUMOVAX23 (route, dose and lot # not reported) on 15-OCT-2012. No other co-suspects were reported. Concomitant medications included an unspecified tri-valent influenza virus vaccine in the opposite arm. Afterwards, the patient complained that she was unable to lift the arm that she had gotten the PNEUMOVAX23 in. The patient said it was similar to the bursitis she used to have in her elbow. The patient sought unspecified medical attention. There were no labs/diagnostics studies performed. Treatment with ice and heat was given for the events. The outcome of the events was reported as recovering. The relationship between the events and PNEUMOVAX23 was not reported. Additional information has been requested.
After 1st Anthrax shot, pt exp headaches & vomiting in the afternoon. After 2nd Anthrax shot, pt exp headaches, shooting back pain, & numbness in legs.
Diarrhea, fever, stomach pain for 7 days. She died on the seventh day.
Pain, stiffness, and weakness in the left shoulder the same arm as the injection site however no fever or visible swelling.  Was getting better after 3 days and then started getting worst on the 7th day after the shot.
Patient had initial soreness in arm, originally thought it was the normal soreness associated with a flu shot. Over the next few weeks has progressively gotten worse. According to patient PCP thought there was some swelling and bruising underneath in the arm muscle, but no bruising or obvious swelling could be observed by just looking at arm. Patient reported still being sore and having difficulty with arm towards end of work day and pain/soreness has affected her sleep.
Fatigue,severe muscle pains, headache,nausea,dizziness,drowsiness, loss of appetite. Increased heart rate,exhaustion,extreme pain at base of neck
Her arm around the injection site was warm to the touch; Her arm around the injection site was red; Her arm around the injection site was swollen; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of INJECTION SITE WARMTH (Her arm around the injection site was warm to the touch), INJECTION SITE ERYTHEMA (Her arm around the injection site was red) and INJECTION SITE SWELLING (Her arm around the injection site was swollen) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced INJECTION SITE WARMTH (Her arm around the injection site was warm to the touch), INJECTION SITE ERYTHEMA (Her arm around the injection site was red) and INJECTION SITE SWELLING (Her arm around the injection site was swollen). At the time of the report, INJECTION SITE WARMTH (Her arm around the injection site was warm to the touch), INJECTION SITE ERYTHEMA (Her arm around the injection site was red) and INJECTION SITE SWELLING (Her arm around the injection site was swollen) outcome was unknown.        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.   No concomitant medications were not reported. Treatment medication include steroid shot. The Physician told her the second shot could elicit a stronger response and the patient should pre medicate with Tylenol and plan to do no activities for 2 days post second injection.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: No specific follow-up information recorded.; Reporter's Comments: .; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Rash in spinal area suggestive of herpes zoster. Culture done at hospital on 2/24/2017. Pending results. Rash occurred 1 hour after injection.
1-2 days after injection L deltoid erythematous warm, mildly painful moving arm well 4 Feb Pt already on AUGMENTIN for OM
General malaise, some chills, redness at injection site 11cm x 8cm, site hand and warm to touch, no itch, no discharge, no fever, some nausea.
AT 1:40PM CLIENT C/O  SWELLING OF RIGHT NECK- ENLARGED AND TINGLING ON RIGHT SIDE OF FACE. THATS BECOMING WORSE SHORT OF BREATH. STATES SHE HASNT BEEN TAKING HER SYNTHROID MEDICATONS IN A LONG TIME, FOR HER THYROIDS.  RN NOTICED NECK ENLARGMENT TO THE RIGHT SIDE. NURSE IMMEDIATELY ASSESSED AIRWAY SPO2 @ 97% ON ROOM AIR. NURSE ADMINISTERED 1ML BENADRYL IM XS 1. NURSE STAYED WITH  CLIENT UNTIL SYMPTOMS RESOLVED, CLIENT STATES FEELING MUCH BETTER THANKING STAFF FOR SUPPORT THEN APPROXIMATELY 40 MIN LATER  CLIENT ATTEMPT TO STAND UP AND  FELT DIZZY AND HUSBAND LOWERED HER TO THE FLOOR.  ASSESSMENT BP 174/88 HR68  RR20 PUPILS EQUAL REACTANT TO LIGHT. HAND GRIP EQUAL NO SLURRED SPEECH NOTED A&0 XS 3. AMBULANCE CALLED AWAITING ARRIVAL BP NOW 220/130 AT 1;50PM
Incident Details: Per a clinic provider's email sent out on 9/1/22- "the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older. Any patients that are currently scheduled to receive a booster should wait until we have the bivalent booster on hand." The patient was seen in office on 9/2/22 and received a booster dose of the monovalent mRNA COVID-19 vaccine (Pfizer) by *** in error as patients are now only supposed to receive the bivalent booster per Drs. email. Patient was due for booster at the time they received it, however the bivalent booster was not yet stocked. Possible Cause: Possible cause of the incident is that an email was sent out regarding the discontinuation of monovalent Covid boosters until Private receives the bivalent booster doses. This was overlooked by management and staff, as previous changes to clinic processes is usually discussed in a meeting. Also "monovalent" and "bivalent" are new terms that have not previously been used when discussing booster vaccines.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history was not reported. On 10-FEB-2012, the patient was vaccinated with the first dose of ZOSTAVAX (lot #, expiration date, route and site of administration were not reported) and subsequently on 06-AUG-2015, the patient was vaccinated with the second dose of ZOSTAVAX (lot #, expiration date, route and site of administration were not reported). No adverse effect was reported. Additional information has been requested.
I started have runny nose and it got really severe; lots of coughing and mucus from the nose -  none from mouth. The runny nose stopped lasted for a week and the cough lasted for a month. I took Robitusin pills, syrup and I took Flonase; Vick's Vapor Rub; and used Tylenol and the most recent - asthma inhaler for the cough. I don't  have asthma but because the cough was so severe they had to give me the inhaler. The Robitusin did not help with the cough. I couldn't sleep - would have serious coughs for five minutes non-stop and had chest pains keeping me from sleep. I took COVID tests three days apart for the whole duration - it wasn't COVID it was just a cough. I am still coughing but not as much. For the cough, I have had a doctor visit.
Client called at 10:25 am to say the arm that received the flu vaccine felt like "extreme burning, hot coals" inside her arm. No redness, swelling, or itching at the site. Encouraged client to come back to the clinic for further evaluation. She declined. Given Immunization Coordinator's contact information.
The Medical Assistant reported a temperature excursion for refrigerated vaccine.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 12-MAR-2021 , the patient was vaccinated with an improperly stored dose of hepatitis rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 1 (units not provided), per oral route (strength, dose #, frequency, and anatomical location were unknown) with lot # 1691301 and expiration date 12-DEC-2021 for prophylaxis.The patient was asyntomatic.  The administered dose of vaccine experience the temperature excursion on one of these dates, 22-FEB-2021, 25-FEB-2021, 02-MAR-2021, 05-MAR-2021, 09-MAR-2021, 15-MAR-2021, and 19-MAR-2021, of 35.6, 35.7, or 35.9  degrees Fahrenheit for 15 minutes; on 17-MAR-2021, the temperature excursion of 35.7 degrees Fahrenheit for 30 minutes;  on 18-MAR-2021 and 28-MAR-2021, of 35.2 and 35.9 degrees Fahrenheit for 45 minutes; on 25-MAR-2021, of 35.2 degrees Fahrenheit for 4 hours and 15 minutes; on 26-MAR-2021, of 35.4 degrees Fahrenheit for 2 hours and 45 minutes; or on 27-MAR-2021, of 35.9 degrees Fahrenheit 1 hour and 30 minutes.  There was no digital data logger involved, and no previous temperature excursion. The program did an audit, and they were unaware of the excursions.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA002850: US-009507513-2105USA003496: US-009507513-2105USA003497: US-009507513-2105USA003498: US-009507513-2105USA003499: US-009507513-2105USA003500: US-009507513-2105USA003501: US-009507513-2105USA003502: US-009507513-2105USA003503: US-009507513-2105USA003504: US-009507513-2105USA003505: US-009507513-2105USA003506: US-009507513-2105USA003507: US-009507513-2105USA003508: US-009507513-2105USA003509: US-009507513-2105USA003510: US-009507513-2105USA003511: US-009507513-2105USA003512: US-009507513-2105USA003513: US-009507513-2105USA003514: US-009507513-2105USA003515: US-009507513-2105USA003516: US-009507513-2105USA003517: US-009507513-2105USA003518: US-009507513-2105USA003519: US-009507513-2105USA003520: US-009507513-2105USA003521: US-009507513-2105USA003522: US-009507513-2105USA003523: US-009507513-2105USA003524: US-009507513-2105USA003525: US-009507513-2105USA003526: US-009507513-2105USA003527: US-009507513-2105USA003528: US-009507513-2105USA003529: US-009507513-2105USA003530: US-009507513-2105USA003531: US-009507513-2105USA003532: US-009507513-2105USA003533: US-009507513-2105USA003534: US-009507513-2105USA003535: US-009507513-2105USA003537: US-009507513-2105USA003538: US-009507513-2105USA003539: US-009507513-2105USA003540: US-009507513-2105USA003541: US-009507513-2105USA003542: US-009507513-2105USA003543:
The day after patient received vaccine she noticed soreness below injection site. The next day this soreness "4 inches" below injection site became red & swollen. It was also warm to the touch. On the 3rd day after injection, site still a little red but resolving.
This spontaneous report was received from a medical assistant, referring to an unspecified number of patients. Ages, genders, medical history or concurrent conditions were not reported. Since an unknown date, an unspecified number of improperly stored doses of GARDASIL 9 (lot # L020015, expiration date 16-AUG-2017) were administered to an unspecified number of patients. No adverse effects have been reported. The reporter stated that there was not product quality complaints involved. This is one of several cases from the same reporter. Additional information is not expected, because the reporter refused additional contact.
At around 9:25 am on Thursday, June 17th, 2021, a seventeen-year-old Foreign-speaking patient walked into the vaccination site. She was accompanied by two guardians, along with 14 other minors. The minors came in for their 2nd shot of Pfizer Covid-19 vaccines.  Patient signed all necessary consent forms and pre-vaccination checklist requirements with guardian and entered the vaccination section at around 9:30 am. The Pfizer vaccine was administered at 9:37 am.  Observation nurse reported that around 10:04 am the patient complained about having a severe headache. The observation nurse notified charge nurse that she needs assistance. The charge nurse immediately obtained a pulse oximetry reading of 99% and a pulse of 88. The charge nurse assessed if the patient is experiencing any symptoms of hives or redness, shortness of breath, or any difficulty breathing or swallowing. The patient stated to the observation nurse that she was having difficulty breathing.   At 10:06 am the charge nurse called 911. While the charge nurse was standing and speaking with the 911 operator, the patient started to faint and laid her head on charge nurse's stomach while she was sitting. The patient looked like she was sleeping and making some whimpering sounds for about 2 minutes.  At the same time, these events were taking place, observation nurse reported that another 17-year-old minor started complaining of a severe headache and ?seeing stars?.   First responder paramedics came on the scene at around 10:09 am and took over care of the patient. At that point charge nurse attended to another patient, 17-year-old minor. Patient was also exhibiting a reaction to the Pfizer Covid-19 vaccine.   First responder paramedics left with patient at around 10:15 am and she was taken to hospital for further observation.