chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 33-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  There were no power outages that would have impacted the Moderna vaccine. However, the facility was unable to download the digital data logger and needed to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022.  No adverse reactions were reported by the patient.  No treatment medication was provided.
Area where vaccine was given started to feel a little achy and itchy.  A 6cm x 4cm red area of skin was noted at the site of the injection.
(4-26-10) pt presents with 2 day h/o rash. 2 wks prior had 1 year shots. 4 days ago had fever.
patient received expired quadracel with no adverse event reported; Initial information received on 18-Aug-2021 regarding an unsolicited valid  non-serious case received from a consumer/ Non-Healthcare Professional via other health professional.  This case involves a patient with unknown demographics who received expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Aug-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number not reported, expiry date 13-Aug-2021 via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired product administered (latency same day).  At the 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 by the regulatory authority. 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.  There will be no information available on the batch number for this case.
Woke up to use restroom. Was shivering before I returned to bed.  Shortly I noticed nausea that was intensifying. After a few minutes, I went to sit next to the toilet. I had dry heaves but did not vomit. I broke out in a sweat that soaked through my night clothes. I returned to bed but could not get comfortable due to what felt like a fever. Vaccine site too sore to sleep on that side. I did ice it after returning home to try to prevent the intense soreness that I had after round 1.  The soreness was the only AE I had after round 1.  I took acetaminophen around 4 or 5 and dozed some.
Soreness in right arm area of flu shot yesterday.  Soreness comes and goes to this day when I move arm 01/14/2014.
4/30 morning: Hot, red and swollen welt at injection area, approx 1" in diameter, 1/4" puff. Painful to touch.  4/30 evening: double the size, approx 2" in diameter, 1/4" puffy, hot, red and painful for fabric to touch on or around area. 5/1 morning:  larger, approx 2.5" and a white line around the red welt.  Not as swollen, but still red, hot and painful.  Some itching starting.  5/2 morning: Same size at approx 2.5", lot of itching, swelling going down but redness still there with a white line around the perimeter.  5/2 evening: lot of itching, swelling going down but still red and white line around. 5/3 morning: same size approx 2.5", red starting to recede to darker pink,  white line still there, itching. 5/4 morning: same size, dark pink turning to dark skin tone, white line around it is gone. 5/5 morning: dark circle itches when touched, no white line.
Immediately following vaccination left foot went numb & both hands became numb. About 6 hours following vaccination legs felt heavy for 2 weeks following. Vaccination arm was sore & swollen for 3 weeks following vaccination, and is still having intermittent swelling in various places like deltoid, forearm, wrist, hand, & most recently the labrum. Swelling & pain come and go.
This spontaneous report as received from a nurse via employee refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced injection site rash. The outcome of the event and the relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected due to lack of the reporter's contact details.
Within 5 minutes of shot, pt appeared dizzy, began to fall, lowered to ground by father at 11:15 am. 1122 am still dizzy. Continuing to monitor. 1128 am walked to bathroom with assistance. 1120 walked to family care with assistance, safely. Take water. Stated "I feel better. Just tired." Able to ambulate independently. Advised father to call MD or ED of any further concerns. Verbalized understanding (ED). 1315 spoke to someone she's fine ate soup. Denies recommended seek medical help for concerns or questions - verbalized ok.
got covid symptoms one week after her first dose/positive Covid 19 viral test on 22Mar2021; heart rate was accelerated at Covid 19 testing site; body ache; a little soreness on her left arm where the injection site is but then soreness in both arms; her right arm is also sore/sore in both arms; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in arm left on 13Mar2021 at 14:00 (at the age of 56-years-old) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she got COVID symptoms one week after her first dose of the Pfizer COVID 19 vaccine and wanted to know if you can get COVID from the vaccine. She wanted to know when does isolation start, from the day of symptoms or diagnosis, if she should get another COVID test done and how long does it take for symptoms to show up once you have been exposed. She got the Pfizer COVID 19 vaccine in the left arm and her right arm is also sore. She wanted to know if that was common. She had her first vaccine on the 13Mar2021 and ended up having Covid 19 virus symptoms on Saturday, 20Mar2021, a week after receiving her Covid 19 vaccine. She had a positive Covid 19 viral test on 22Mar2021. Was asking "Did this have anything to do with the vaccine?" She also had a little soreness on her left arm where the injection site is but then she was sore in both arms. When probing Covid 19 symptoms, she reported on Saturday, 20Mar2021, it was allergy like symptoms - a runny nose, sneezing, congestion, and chills. On Sunday, 21Mar2021, she woke up with more of a chill and a low-grade fever, congestion, body ache and headache. She took acetaminophen, dextromethorphan HBr, phenylephrine HCl (DAYQUIL) every 4 hours at 10:30AM/PM and 2:30AM/PM. She had no appetite, but she drank lots of fluids and ate chicken noodle soup all day. Her temperature at the pharmacy Covid testing site was 99.7F. Her heart rate was accelerated at the Covid 19 testing site, but they weren't concerned with it. Today (unspecified date) she's much better. Therapeutic measures were taken as a result of runny nose, sneezing and congestion. The outcome of the events 'got covid symptoms one week after her first dose/positive Covid 19 viral test on 22Mar2021', 'a little soreness on her left arm where the injection site is but then soreness in both arms', her right arm is also sore and heart rate was accelerated at Covid 19 testing site was unknown, while of the rest was recovering.
Uncontrollable vomiting and diarrhea simultaneously; chills, Sweats, shaking,headache Beginning at  Sunday,1:30AM, 04/11/2021 until 4:00 PM same day
Raise bump at injection site Appears infected red and hot to the touch Fever 100.5
I started feeling dizzy and my arm felt heavy after 20 minutes. That night my muscles started to ache. My muscles ached intensely for 2 days. The third day, today I have felt foggy and dizzy all day. I started sneezing and have a sore throat. I also have the COVID arm where my injection arm has become warm to the touch, swollen, sore, and red.
This spontaneous report as received from a registered nurse refers to an 11 year old male patient who was being prepped for a kidney transplant. On 23-JUL-2014 the patient was vaccinated with an expired dose of PNEUMOVAX vial lot # H018608, Exp date: 02-JUL-2014, (dose, frequency and route unspecified). No adverse effect reported. Additional information has been requested.
pt brought into MD office because mother found blood in the  diaper & pt exp diarrhea; had been exp diarrhea for 3 months; admit to hosp overnight & recovered;
Pt states immediately after getting the flu vaccine she felt like she was shaking, confused and pain from her neck up to her head. This lasted for about 5 minutes and symptoms never returned. -administered at pharmacy.
"I" had a significant increase in tinnitus after the first vaccine dose primarily in what seems like "my" right ear.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW6208) via an unspecified route of administration in the arm left on 21Mar2021 at 12:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The medical history included osteoporosis, minor tinnitus and allergies to penicillin and sulphates. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included multi vitamin (unspecified), calcium/vitamin d nos (MANUFACTURER UNKNOWN) and fish oil (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. On 22Mar2021 at 21:00, after the first vaccine dose, the patient had significant increase in tinnitus primarily in what seemed like the right ear. The patient had slight tinnitus prior to vaccine, but had experienced a significant increase that was impacted the patient's ability to sleep. On 06Apr2021, the patient underwent RT-PCR test via nasal swab and the result was negative. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event significant increase in tinnitus was not resolved at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm right on 11Apr2021 at 10:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are needed. No further information is expected.
Pt states her symptoms started approx. 4 hours after receving the vaccine (Left arm very sore).  Pt states she woke up the next morning and could not use her left arm.  she states she called her PCP and was seen.  Pt sates she was ordered a CT scan (results were normal). Pt states she is still experience pain in left shoulder as of 10/17/19.
I took the first shot March 14th Didn't get the second shot yet; 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 PRODUCT DOSE OMISSION ISSUE (I took the first shot March 14th Didn't get the second shot yet) 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 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I took the first shot March 14th Didn't get the second shot yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I took the first shot March 14th Didn't get the second shot yet) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received including Non-Significant follow up appended to AER. IRMS document attached.
Syncopal episode x 2 DEC 16th 2007 occured @ 1030 PM lasting over a minute with lightheadedness in the shower. 01/02/08-records received for DOS 12/26/07-DX: Syncope. HX: Full syncope episode while in shower. Head eaten very little all day, during hot shower felt lightheaded and passed out.
immed local reaction rt lateral thigh; when seen 5d later, 4cm indurated & inflamed local rxn;
BODY ACHE; COLD CHILLS; QUEASY; HEADACHE; DIZZY; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid 19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.   No concomitant medications were reported. On 11-MAR-2021, the subject experienced dizzy. On 11-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced body ache. On 12-MAR-2021, the subject experienced cold chills. On 12-MAR-2021, the subject experienced queasy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the queasy, dizzy, cold chills, body ache and headache was not reported. This report was non-serious.
Diarrhea Started at 5:30pm and until I fell asleep at 11pm. Woke up next morning fine. Fatigue started on Tuesday and lasted until Friday (4 days)
Chief Complaint: Stroke Symptoms or Stroke Alert Difficulty moving left upper extremity, cough, shortness of breath, without wheezing .  Sepsis due to pneumonia from COVID-19.  Cause of death - Acute CVA and multifocal pneumonia due to COVID pneumonia
1hr p/vax pt noted body aches, back ache, low grade fever 99.4, sore throat, neck glands w/pressure sensation,malaise, phlegm sensation in throat;tx symptomatic & observation on going 26JUN96;
The pt experienced a 103 degree fever, anorexia, fatigue, headache, malaise, nausea, vomiting, pain, vertigo, abdominal cramps, diarrhea, arthralgia, chills, flu-like symptoms, flushing, itching chin, and pain at injection site.
Pt recvd 3 doses of Hep B vax; 3rd dose given 25JUL90; It was determined that pt was not immune to Hep B;
PATIENT STARTED RUNNING HIGH TEMPERATURE AT 9 P.M. LAST NIGHT, TODAY HEAD HURTS, LEFT LEG HURTS, CAN'T PUT WEIGHT ON IT, NAUSEA.
approximately 30 hours after injection I started having numbness/tingling across the right side of my face, including my gums and my taste altered (can taste, but nothing tastes "good" anymore).  Additionally, it felt like I had a lump at the back of my tongue making swallowing difficult.  I called a telehealth, no signs of stroke.  F/U with primary care provider, she ordered blood work, MRI and sent me to an ENT.  MRI showed no reason for the changes, a scope done by the ENT showed no anatomical changes, nothing in my bloodwork indicated any issues.
developed sudden red hot itchy rash w raised bumps at injection site.. did not know was pregnant at the time of vaccine , positive pregnancy test a week after injection, current estimayed due date September 15th
On my way home, about 30 minutes after the vaccine, my throat became tight and my lips and tongue were tingly. At 4 pm I took a Benadryl. At 7pm I took a second one and went to bed at 7:30. In the morning these symptoms were gone
Fever,  severe head ache, muscle and joint aches, redness and swelling in muscle beneath injection site for 36 hrs Swelling and itching in arm lasted 6 days with muscle fatigue so great that arm would. It support a hair dryer. Minor Muscle fatigue in arm continues with stiffness and some pain  17 days later.
patient became diaphoretic and disoriented at vaccination station, brought to EMS given H2O and allowed to rest. Monitored vital signs until WNL, discharged in no distress with wife @ 920am
Pt states passed out while driving his car at approximately 18:15 PM and went into a ditch then to ER at 19:50 PM.
Information has been received from a physician concerning a five year old male patient who on 9/26/2000, was vaccinated with varicella virus vaccine live (lot 632059/1452J). The physician reported that last week on 4/26/2005 the patient came into the office with a very mild breakthrough case of chicken pox. No treatment was given. There was no other information regarding the adverse experience. There was no product quality complaint reported. The reporter also mentioned that the patient's sister (0505USA03511) who was not vaccinated developed varicella illness on 4/27/2005. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/12/2006. Information has beenreceived from a physician concerning a five-year-old patient who on 26-SEP-2000, was vaccinated with VARIVAX (Merck) (Lot # 612059/1425J). There were no concomitant medicatins. The physician reported that last week on 26-APR-2005 the patient came into the office with a very mild breakthrough case of chicken pox. No treatment was given. There was no other information regarding the adverse experience. There was no product quality complaint reported. Follow up information received from the physician reported the patient did not undergo any lab/diagnostic tests. The only reported adverse reaction were the varicella lesions, a few lesions wirh no fever or puritis. The reporter also mentioned that the patient's sister (0505USA03511) who was not vaccinated developed varicella illness on 27-APR-2005. Additional information is not expected.
No additional AE; patient was administered expired PROQUAD; This spontaneous report was received from a registered medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug allergies were not provided.  On 18-MAR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD) 0.5 ml, lot # T028297 was confirmed to be valid, expiration date 16-FEB-2022 (expired product administered) (route of administration and injection site were not provided) for prophylaxis. No additional adverse events were reported.
mom states pt c/o pain in entire arm w/some numbness in fingers day p/vax; pt states pain went away on 2nd day p/inject x/for small area in wrist & elbow then pain felt only in elbow joints
Heavy period that lasted more than 3 weeks, periods have been heavy and take medication to stop period. More clotting and cramping.
Swelling, redness around injection site on left thigh began within 24 hours of vaccine administration.
Patient presented to the office with mild URI symptoms. Her lungs were clear on exam and she was breathing normally. She received the flu vaccine and 90 minutes later her mother described her as acting "delirious." At 10pm (5 1/2 hours after the flu vaccine), her parents noticed labored breathing. She was seen in the emergency room at 5:30am the following morning and per report had diffuse expiratory wheezes and tachypnea with O2 saturation in the mid 80's. She was given one Albuterol neb, followed by 2 back-to-back Albuterol and ATROVENT nebs. She was also given ORAPRED 13mg po, however she remained in respiratory distress with O2 saturation in the mid 80's so she was given methylprednisolone 15mg IV bolus, magnesium sulfate 600mg IV, and placed on continuous Albuterol via nebulizer. She was then transported via ambulance to Hospital and admitted to the ICU at approximately 8:30 am on 8/27/2009. Her chest x-ray showed right upper lobe atelectasis and she was started on Vancomycin, Azithromycin, and Ceftriaxone IV to cover for a possible pneumonia. The following day her respiratory status continued to improve and her chest x-ray showed resolution of the right upper lobe atelectasis so her antibiotics were discontinued and she was transferred out of the PICU to the medical floor. She was discharged from the hospital on 8/29/2009 on oral steroids and Albuterol every 4 hours. 11/20/09:  ED Records and Discharge summary received for dates of service:  8/27/09 to 8/29/09.  Dx: Status asthmaticus.  Assessment:  Presented with increased WOB x 1 day.  O2 sats in mid 80's.  Tachnypneic with diffuse expiratory wheezes.  Admitted to PICU and treated with continuous Albuterol initially, then spaced out to Q 2 hrs.  Started on steroid therapy and antibiotic therapy.  Antibiotics d/c'd since unlikely to be infectious.  IV Fluids administered.  Weaned to Albuterol tx. Q4h without need for O2.  Albuterol MDI and controller medications started.  To follow up with PMD and pediatric allergist.
Patient submitted a note that she told the pharmacist (which was me that gave her the vaccine) that she needed Benadryl, she DID NOT talk to me about this and I was not aware of any reaction the patient may have had, and she did not specify what kind of reaction she had. She needs to get her next shot at the doctors office for safety.
Fever, severe, fatigue, severe bodyaches, severe itchiness, pain at site of shot
Pt developed fever of 105 axillary on 5/24 at 17:45. Pt had 2 convulsions approximately 5 min apart. Mom gave Advil and tepid bath and then pt slept. MD saw pt next day and she still had fever. Treated with Tylenol and Advil. Pt had fever 5/25, none on 5/26, up to 101 on 5/27. Pt had no fever since 5/27.