chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Product storage error; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066421A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2022 at 1:44 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Moderna Vaccine pulled from freezer on 16-Dec-2021. BUD Date of 15-Jan-2022 printed in red and tapped to the top of the boxes. On 26-Jan-2022, staff brought it to attention that it was still in the fridge and expired-5 doses were given at that point. On 27-Jan-2022, remaining county sites checked. All other clinics found to have same error of not noticing the BUD date. Moderna contacted and report filed. BUD date added to the daily COVID usage and wastage report. On 31-Jan-2022, Moderna responded revaccination not required. No treatment medication was reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 2, single (Lot number: Eng198) at the age of 52 years, in right arm for COVID-19 immunisation; COVID-19 vaccine MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE), on 18Dec2021 as dose 3 (booster), single (Lot number: T60h21a), in right arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Pt recvd #3 DTP & IPV 27AUG91 & mom describes sore rt arm & temp @ 8PM 105 orally; Pt given APAP q3-4 hrs; Temp came down to 102 only p/alcohol sponge bath; Also exp uncontrollable crying for several hrs;
SEVERE HEADACHE BEGINNING APPROXIMATELY 18 HOURS AFTER INJECTION AND LASTING APPROXIMATELY 10 HOURS.
This is a spontaneous report from a contactable nurse. A 7-month-old female patient of an unspecified ethnicity received third single dose of PREVNAR 13 (lot L04916, expiry date 31Jul2016, NDC# 00005197101) on an unspecified date in Apr2015. The patient medical history was not reported. Concomitant medication included MOTRIN as needed. On an unknown date in Apr2015, two days after vaccination, the patient experienced an abscess at the site which required hospitalization from 26Apr2015. Since unknown date in 2015 she was also positive for MRSA. The patient underwent an unspecified lab work with unknown result. Therapeutic measures were taken as a result of the abscess at the site (it had to be drained, surgery was done and she was put on antibiotics). The patient recovered on unknown date from abscess at the site. Outcome of 'positive for MRSA' was not provided. Nurse did not believe the adverse events were because of the vaccine.
Elevated fever, and prolonged hysterical crying for 3-4 days after receipt of 4 month vaccines (DTaP/Hep B/IPV, Hib, PREVNAR, Rotavirus). She slept intermittently, after wearing herself out. Fevers were as high as 103, although responded to TYLENOL. She did fine with 2 month vaccines. No local reaction. No emesis, hypo responsiveness, limpness, collapse, cough, rigors, diarrhea, or hypotonic/clonic movements. She has no history of neurologic illness or event. Fever, unspecified, other Symptoms and Signs involv ner sysm. Subsequently did well with 6 month vaccines. DTaP given as solitary vaccine with premedication.
Complained of pain at site & tingling in fingers of right hand.  Site edematous, firm, & warm to touch.  Some edema top of right thumb.  Had difficulty gripping. This information was provided by school nurse.
Early morning  day following 2nd  shot.  EXTREME/VIOLENT shaking/chills for 2 hours....very concerning---upset stomach =slight temperature.  General sickness. Extremely sore arm/shoulder at injection location.  2nd day was bet ter. 3rd day most symptoms gone gone with exception of shoulder pain.  In the last few weeks pror to this date the pain in the shoulder has increased SUBSTANTIALLY and migrated in the the lower area of the shoulder.  It is now difficult to LIFT my arm and have use of it do the the pain and decreased ability to use it. Having had major joint surgeries in the past I know what pain and lack of function can be.   This is something different and becoming worse quickly.
Pt had shaking of arms and head x 2 seconds. Pt has no recollection of the incident.
Patient began exhibiting signs of stroke within 24 hours of receiving COVID vaccine.  Patient was administered COVID Pfizer vaccine at around 12 noon on 6/15/21.  On 6/16/21 at approximately 10 a.m. patient started having difficulty swallowing.  On 6/17/21 Patient's spouse noticed her speech was choppy, she had one sided facial drooping, tongue shift from midline, and difficulty walking (left side affected).  Patient was taken to local hospital by her spouse and admitted to Shasta  Regional Hospital in Redding , CA.  She was diagnosed as having a brain stem stroke.  She was hospitalized for 6 days and then transferred to a rehabilitation facility.  She was there for 7 days and then went back to a private residence.
Patient stated he felt ? dizzy and nauseated? Patient provided water and stated symptoms resolved Patient refused medical transport and signed AMA form
Transposition of the great vessels; This spontaneous case was reported by an other health care professional and describes the occurrence of TRANSPOSITION OF THE GREAT VESSELS (Transposition of the great vessels) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030M20A) for COVID-19 prophylaxis.    MEDICAL HISTORY (Parent): The mother's past medical history included Miscarriage (approximately 4-5 weeks pregnant) on 30-Apr-2021 and Maternal exposure before pregnancy. Concurrent medical conditions included Asthma.    No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2022, the patient experienced TRANSPOSITION OF THE GREAT VESSELS (Transposition of the great vessels) (seriousness criteria hospitalization, medically significant and congenital anomaly). The patient was treated with Surgery for Transposition of the great vessels. At the time of the report, TRANSPOSITION OF THE GREAT VESSELS (Transposition of the great vessels) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Prenatal screening test: Showed no defect.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that prenatal visits showed no defect. Patient had a surgery on 30-Aug-2022 to correct the defect and patient was still in the hospital.  Company comment: This spontaneous case concerns male patient of unknown age with no medical history reported, who experienced the unexpected, serious (hospitalization, congenital anomaly, and medically significant) event of transposition of the great vessels. The patient was born approximately 1 year and 6 months after his mother was exposed to the first dose of mRNA-1273. Prenatal screening and visits did not show the congenital defect. The patient had surgery 6 days after date of birth. Outcome was unknown but patient was still hospitalized at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.      See case  for details regarding the child case.; Sender's Comments: This spontaneous case concerns male patient of unknown age with no medical history reported, who experienced the unexpected, serious (hospitalization, congenital anomaly, and medically significant) event of transposition of the great vessels. The patient was born approximately 1 year and 6 months after his mother was exposed to the first dose of mRNA-1273. Prenatal screening and visits did not show the congenital defect. The patient had surgery 6 days after date of birth. Outcome was unknown but patient was still hospitalized at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Minimal side effects day of/after injection (01/20/21): headache, chills. No further side effects until 01/27/21: dull headache began; swelling, itching, redness, firmness around injection site lasting until 01/28; eye swelling evening of 01/28. Swelling brought under control with benadryl, but dull headache persists until today 02/03.
This spontaneous report was received from a medical assistant and refers to a 2 year old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 17-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042267, expiration date 27-OCT-2017; site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
Chills, Fever (100-101.2), 5/10 Headaches, DRY Mouth, sore throat, body aches, L eye conjunctivitis (not bacterial, not viral), malaise.
Information has been received from a pharmacist concerning a patient who on 10-DEC-2007 was vaccinated with a dose of ZOSTAVAX and later that day developed a rash on her neck.  The patient did not have any other symptoms.  No further information was available.  The outcome was reported as not recovered.  There was no product quality complaint.  Additional information has been requested.
101.4 fever, chills, achy, bad headache from 12:30am-4:00pm April 6th from 4:00pm no more fever but bad headache and very dizzy.  April 7th woke up with hives all over torso and still had headache and very tired.  April 8th hives gone but still had headache.  April 9th felt well again.
I have had a metallic taste in my mouth since mid to late March and I began developing neuropathies in my hands and feet at the same time. They would come and go, but now do not go. I lost weight without trying but because nothing tastes good.
Initial report received from a healthcare professional on 01 October 2014. A female patient whose age, medical history and concomitant medications were not reported, had received a dose of Flu vaccine (manufacturer: unknown, batch number, expiration date, dose in series, route and site of vaccination was not reported, on an unspecified date. On an unspecified date, the patient reported that following flu vaccine she experienced a metallic taste in her mouth. At the time of this report, the patient had not recovered from the event. Laboratory investigations and corrective treatments were not reported. Documents held by sender: none.
I had COVID in early September, very short lived at 48 hours symptom free except cough. I had the latest recommended booster on 29 September. The next day 100 degree temp, mild body/head ache, cough worsened, elevated HR to 100-115. After 48 hours symptoms gone except for cough, which is lessining as of t his report.
Patient dropped in at the drive through flu clinic as he was getting registered I took his completed consent form for the flu vaccine. took a look at his age written on the form to me looked like 69 so gave the patient a high dose vaccine. When entering the vaccine later in the day noticed he was only 64 years of age.
rash, presumed erythema multiforme, typical target lesions with no other trigger.
On 24-Jan-2011, pt. was brought into her PCP office for a routine/annual check-up by her mother. It was determined by Dr., that a chicken pox and tetanus/diphtheria booster was needed on this visit. RN performed injections (2) on pt.'s left deltoid. After vaccination, Dr. reentered room to explain the wrong vaccination was given; GARDASIL instead of tetanus/diphtheria. No education or informed consent had been provided to mother prior to vaccination. Medication error due to (per MD) similar generic trade names. "ADACEL" vs. HPV vaccine (GARDASIL).
prolonged period of swollen, sore muscles lasting more than normal 1-2 days causing enough discomfort not to perform normal activities, ie, gym and sleeping on first two nights was greatly interrupted due to hot, swollen, painful left arm. This was second dose of Bexsero, same thing happened with first dose. lasting over a week.
He was exposed 9/18/2021. Tested positive 9/25/2021. Symptoms began 9/22 nasal congestion, cough, diarrhea, loss of taste and small, fatigue. Worse the first 3 days, symptoms lasted 2 weeks. Didn't feel good for 6-8 weeks. Continued to test 10/7 positive, 10/14- negative. All test were at Pharmacy and PCR test.
While waiting the 15 minutes after the vaccine, I began to feel dizzy, I thought it was just because I was nervous.  After the 15 minutes, I went outside and tood off my mask to get some fresh air.  I went back to work and was still feeling dizzy.  I drank water, ate some food and sat for a bit.  At about 1pm, I was still feeling dizzy but also started feeling off, as if I were intoxicated or like how you feel when you just wake up from having anesthesia, sluggish.  I then went home and slept for about 5 hours and now I feel much better.  Will someone let me know if it is recommended I still get the second dose next month?
Fever, rash, small bumps reddened and white all over arms, legs, chest, etc. Joint pain (severe), headache, facial, neck swelling, eye swelling and nausea. MD stated "classic" drug or serum sickness/reaction". Symptoms for 2 weeks. Treated with Benadryl and Tylenol. Also worsening in asthma symptoms, increase in asthma meds. MD suspicious of thimersol allergy. No history of egg allergy.
Child was screaming for > 6-8 hours. Parents describe child lethargic and "acting out-of-it" for 1 week after vaccines. Was "shaking" for first day but no real seizure noted. Fever for 2 days after vaccines.
RAISED WHELP Arm Swollen and RED patch in a 4"diameter was given subcutaneous.
Presented to ER on 7/15/06 with c/o smallpox vaccination site reaction. Area to upper L arm about the size of a silver dollar with smallpox lesions on the left upper arm. No other lesions present to the rest of the body. Temp 101. Plan: Change dressing, follow up on Monday, If rash spreads come in sooner.
Very sore arm within 6 hours of receiving vaccination. Could not lift arm overheard or sleep on that arm as it was too painful. When I woke up the next morning, my arm was still sore (for both doses) but as the day went on the pain slowly went away.
swelling and redness around the injection site; swelling and redness around the injection site; expired vaccine administered; temperature excursion; This spontaneous report was received from a pharmacist referring to a 66-years-old male patient. The patient's medical history, drug allergies, previous drug reactions, concurrent conditions, and concomitant medications were not reported.  On 18-MAY-2020, the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) underwent a temperature excursion (product storage error) reported with a maximum temperature achieved above 47 Fahrenheit degrees "(82 F)" for a timeframe of 15 hours.  On 24-JUL-2020, the patient was vaccinated by a trained pharmacist with the improperly stored vaccine of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscular injection in the right arm, frequency reported as once (dose not reported, lot # R011632 which was confirmed to be valid for pneumococcal vaccine, polyvalent (23-valent) and expiration date reported and validated as 02-FEB-2020) for prophylaxis (expired product administered). On the same day, the patient was vaccinated with diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL) intramuscular injection in the left arm (dose not reported, lot number C5661AA and with an expiration date reported as 08-AUG-2020) for an indication not provided.  On 25-JUL-2020, the patient experienced swelling and redness around the injection site (vaccination site swelling and vaccination site erythema) that lasted 3 or 4 days, therefore, on an unspecified date in July 2020, the patient recovered from the events. No product quality complaint was reported.  The reporter considered the events vaccination site swelling and vaccination site erythema to be attributable to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and to the administration of the expired vaccine. The causal relationship between diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL) and the events was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R011632; expirationdate: 02-FEB-2020; deviceage and unit: 0 ; operatorofdevice: Pharmacist; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
LAYED PATIENT DOWN ON COT, ELEVATED HER LEGS, TOOK VITALS  AND CONTINUED TO MONITOR HER . PATIENT WAS RESPONSIVE AND AWARE OF THE SITUATION. VITAL SIGNS WERE STABLE , B/P- 131/71, HR: 104, RR- 20 , O2- 98% ON ROOM AIR.  911 WAS CALLED, ONCE THEY ARRIVED THEY RETOOK THE PATIENTS VITALS AND DECIDED THAT IT WAS NECESSARY TO TAKE HER TO THE LOCAL HOSPITAL DUE TO LOW BLOOD PRESSURE OF 78/42. AT THIS TIME, PATIENT WAS STILL RESPONDING  TO COMMANDS AND ALERT AND ORIENTED  X 4.
Headache, Myalgia, Arthralgia, Fever, Diarrhea,  NauseaVomiting, injection site pain Narrative:
Severe neck and arm pain started about 30 minutes after vaccination was given. Often times it is a tingle from the neck to my elbow and the pain lasts 24 hours a day.
Narrative: Pneumonia, morbid obese, dehydration, UTIs/p cystoscopy, weakness, decreased appetite. SOB, remdesivir and dex. d/c to home. PFizer #2
a little headache; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (a little headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Cancer.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced HEADACHE (a little headache). On 19-Jan-2021, HEADACHE (a little headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable. treatment information was not reported.   This case was linked to MOD-2021-046018 (Patient Link).
No additional AE details; patient received a late second dose of GARDASIL 9; This spontaneous report was received from a registered nurse and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-JUN-2022, the patient received a late second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose: 0.5 milliliter, lot # T036442, expiration date: 09-APR-2023; strength and route were unknown) for prophylaxis.  Dose was scheduled for 31-MAR-2022 but was not administered until 16-JUN-2022 (Inappropriate schedule of product administration). No additional AE details or product quality compliant (PQC).
On Friday, 6/19/21, client received her second dose of Pfizer Covid-19 vaccine (LOT #: EW0187, exp: on 8/2021) at 1:31 pm on her left deltoid. During assessment questions, client denied any underlying medical conditions or allergic reactions and was to be a 15 minute observation. At 1:45 pm, while waiting in Observation Area, client stated to EMTs, she is feeling "very anxious" and has had several anxiety attacks in the past. She does not take any medications for this condition. At 1:47pm, client was seated with anti-gravity and vitals were started and taken every 5 minutes. Client was also given a bottle of water. At 1:47pm, BP: 146/77, HR: 114, O2 sat: 99%. At 1:52pm, BP: 142/78, HR: 88, O2 sat: 98%. At 1:57pm, BP: 132/65, HR: 88, O2 sat: 98%. Client's pulse was strong and bounding at the radial. BP was read on right arm for first two readings. At 2:02 pm, BP: 118/73, HR: 82, O2: 99%. At this time, client told EMT this was her second dose of Pfizer Covid vaccine and experienced no anxiety the first time. Client states it was a busier day for her and her family and also had her coffee "extra strong" this morning. At 2:07 pm, BP: 120/70, HR: 81, O2: 98%. At 2:12, BP: 125/80, HR: 82, O2: 98%. At 2:17 pm, BP: 124/74, HR: 75, O2: 97%. At this time, client stated to EMTs that she was feeling much better. No further interventions needed. Client was educated by EMT on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on v-safe. Client left vaccination site with a steady gait at approximately 2:30pm.
Redness, heat, swelling, itching left arm middle of upper arm 03/10/2006.
I then discovered I was severely anemic; Getting COVID After the Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (I then discovered I was severely anemic) and COVID-19 (Getting COVID After the Vaccine) 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 ANAEMIA (I then discovered I was severely anemic) and COVID-19 (Getting COVID After the Vaccine). At the time of the report, ANAEMIA (I then discovered I was severely anemic) and COVID-19 (Getting COVID After the Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received and does not contain any new information