chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 25-JUL-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 0.5 ml (lot # K011492, expiration date 31-JAN-2017. No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 24,34 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 176, 48 and R; 47 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
tested as follow up to known exposure, tested positive on binax rapid antigen test asymptomatic has had 2 doses of Moderna- refuses booster doses
Fever; lathargic; stomach ache; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 01Apr2021 at 15:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient medical history included common variable immunodeficiency and rheumatoid arthritis. The patient had latex allergy and sulfonamide allergy. The patient previously had drug allergy while taking Percocet (MANUFACTURER UNKNOWN) and oxycontin (MANUFACTURER UNKNOWN). Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), ethinylestradiol, levonorgestrel (AMETHIA), immunoglobulin human normal (HIZENTRA) and methylprednisolone (MANUFACTURER UNKNOWN) started on an unknown date for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG207) via an unspecified route of administration in the arm left on 11Mar2021 at 18:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Apr2021 at 08:00 the patient experienced fever, lethargy and stomach ache. On 03Mar2021, the patient underwent nasal swab test for COVID-19 and the result was negative. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any therapeutic measures for the adverse events. The clinical outcome of the events fever, lethargic and stomach ache were not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Developed COVID after first dose of vaccine.  Pt arrived to vaccine clinic on 03/13 for her second dose. Had symptoms consistent with COVID since 3/10- sore throat, fevers, body aches, diarrhea, congested. Tested positive for COVID 3/14. Received bamlanivimab on 3/15. Was referred to ED 2 hours after monoclonal infusion after presyncopal episode. Cardiac workup done and was negative.   Admitted for monitoring received IV hydration and supportive care (no supplemental O2)
Day after the vaccine she had a seizure or mini stroke that lasted between 35 minutes and 1 hour.  She is currently being tested.  This was her second seizure if it was a seizure.  The other one occurred almost a month previously.  She saw a Dr.  who said it could possibly be a side effect of the vaccine.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On an unspecified date, patients were vaccinated with improperly stored VAQTA (dose, route of administration, lot#, expiration date and indication were not reported). No adverse effects were reported). This is one of several reports received from the same reporter. Additional information has been requested.
Patient (age 56) was accidentally given Fluzone HD while not indicated for it.  The pharmacy contacted the patient to communicate that an error had occurred. The only issue the patient described was that of a dry mouth at the time of call on October 19th, 2022 but feeling fine, otherwise.
This case was reported by a consumer via call center representative and described the occurrence of nausea in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th December 2021, the patient received the 1st dose of Shingrix (intramuscular). On 10th December 2021, 1 days after receiving Shingrix, the patient experienced nausea, dizziness, malaise and lethargy. On an unknown date, the outcome of the nausea, dizziness, malaise and lethargy were recovering/resolving.   It was unknown if the reporter considered the nausea, dizziness, malaise and lethargy to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The patient had the dose of Shingrix vaccination in his right arm.  The next day experienced nausea, dizzy, malaise, lethargy, these were better but persisted.  The reporter was given medical disclaimer and was referred to health care professional (HCP). The reporter was offered (product information) PI, provided medical information phone number for HCP reference. The reporter did not consent to follow-up.
Patient's arm was initially sore, but has not gotten any better. She states that her arm has become increasingly sore with aching  pain radiating up to her shoulder. The arm hurts continually and feels weak. She states that it hurts to lift her arm. This has been continual since the vaccine in May.  Patient called the pharmacy July 8, 2021 to report and see what she should do. She was advised to see her primary care physician.
Screaming in pain 24/7, paused breathing for weeks afterwards, not eating, head to toe severe rash that never went away. Blood in stool, projectile vomiting, slept for weeks.
Area to left arm warm, red, swollen, painful to touch. Suggested to follow up with MD.
Area below right deltoid became very red, warm to touch and edematous. This lasted X 2 days. Onset was 1 day, post vax.
2/12/20 visit: On her right thigh there is a 1 inch red Firm patch.No warmth.She does have about 10 red spots on her abdomen and chest that ranged from 2 mm to 10 mm also several on her back they are nontender.  Discussed lukewarm baths Aquaphor. She does have a local reaction on her thigh from the immunizations she could use a little hydrocortisone 1% over-the-counter for this. 2/14/20 Visit: Patient is here today with mom and dad with a rash. She saw healthcare provider on 02/12/2020 and was told to use hydrocortisone with aquaphor. The rash has spread since and has not gotten any better. She's been sweating a lot but she also has a tooth coming in. Given timing and nature of rash likely varicella vaccine reaction. Rash appears similar to varicella without vesicle formation, discussed with parents this may occur. Also on differential is viral xanthem however currently patient has had rash x 1 week and is afebrile with no other associated symptoms. Also has local site reaction on R thigh with erythema. Discussed with parents. Presenting for re-check rash. Discontinued antibiotics still with diffuse papular rash. Had received varicella injection 01/31/2020 and started having symptoms on 2/2/2020 with papular rash which started near injection site with localized erythema and spread down leg and to body. No associated fever, parents have notice some itching of lesions.
The week after taking first Moderna vaccine June 16, I woke up with my left elbow itchy, swollen and painful. Later on, my elbow swelled up about 3 inches. I had trouble putting my clothes, tying my hair, washing dishes, and any movement that bend my elbow. I had trouble sleeping as my elbow was stiff and painful. I did not injure my left elbow/arm or did very strenuous activity prior to the adverse event, June 16. My left arm was sore and painful for few days on June 9 from the first vaccine shot and I was better by June 13. As of July 1, my elbow still itches, swelled around 2 inches, and hurts. The pain is not extreme as June 16 but pain still lingers when I touch it. I have been icing my left elbow everyday.
Chills, body, body aches, headache, blurry vision all 1-8-21 then nx day 1-9-21 loss of  balance, confusion,   Night of 1-11-21 loss of vision for several hours,  could not see to dial the phone for help, no one else at home, stayed up most of night, could see in am still slightly blurry, made emergency appt  with eye doctor. eye doctor stated no permanent vision damage.
Started heavy, prolonged periods approx. 1 month post vaccine which progressed to heavy continuous period in December.  Soaking tampon and pad every hour at times.  Fatigued, SOB with physical activity Saw Dr. on Jan 10, 2022, lab work done, started on low dose estrogen birth control Repeat visit and lab work in March.  Started on 25 mcg Levothyroxine.  Last period  was in March and none since.  Will repeat lab work this week.
1) Event: Administration Error - Patient received  correct vaccine with expiration date of 01/23/2022 2) Treatment of Adverse Drug Reaction: NONE 3) Outcome   - As per manufacturing company (Merck), the  potency of the vaccine was backed and supported by internal data when evaluating the vaccine expiration date of 01/23/2022 and administration date of 02/17/2022.
Initial information received on 13-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a six months old male patient who was vaccinated with a 0.5 ml third dose of expired vaccine ACT-HIB (lot UI822AAA and Exp. Date 05Jan2019 for box) (ACTHIB lot UI822AA and Exp. Date 02Jun2019 for vial) via intramuscular route in the right deltoid on 12-Feb-2019. The patient's medical history not reported and concomitant medications included DAPTACEL; IPOL; PREVNAR 13; and HEPATITIS B VACCINE all received on 12-Feb-2019 for Immunization. It was an actual medication error case due to expired vaccine used. It was reported that, patient received a ACTHIB with an expired diluent. It was unknown whether the patient experienced any adverse event. 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. List of documents held by sender: none.
Expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 4977T, expiry date 5th September 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th September 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 19th September 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-SEP-2022 Reporter's comment: The nurse reported that a dose of Pediarix given to the patient and it was already expired. The reporter consented to follow up. Additional Supportive Information: The use of Pediarix dose, which was already expired on 5th September 2022, which led to expired vaccine used.
MENVEO given in error 8/24/16. Patient had been given MENVEO 9/24/15. Patient has received 1 MENVEO at age 12 instead of age 16. Parent was made aware. Dr. is aware and spoke with patient's mother.
w/in 3-4 hrs, pt had violent shakes, no excessive fever but did get t101 ax; pt greatgrandma an RN did not believe shaking to be a sz;
PNEUMONIA. Information has been received form a registered nurse concerning a dialysis patient who on 20-OCT-2003 was vaccinated intramuscularly with a first dose of hepatitis B virus vaccine rHBsAg (yeast)(40mcg/ml) (lot 644028/1017M or 645647/0527N). Subsequently the patient presented to the clinic with a fever, low blood pressure and generally not feeling well. The patient had a positive blood culture for gram positive blood culture for gram positive cocci. It was noted that the patient also had other issues such as catheters or other frequent needle sticks so causality of the infection had not been determined. The patient received antibiotic therapy. The patient was later diagnosed with pneumonia and subsequently recovered. It was reported that these events were reported "prematurely and thought that the symptoms may have had something to do with the (hepatitis B virus vaccine rHBsAg (yeast)) vaccine that the patients received, since the symptoms of fever and generally not feeling well began within 48 hours of the vaccination." It was noted that the diagnosis was not caused by the hepatitis B virus vaccine rHBsAg (yeast). It was also reported that another patient had a similar experience (WEAES0311USA00987), however was hospitalized with an infected vascular catheter. It was also noted that these were two of fifteen patients who were vaccinated on the same day at the same facility. Additional information has been requested.
At approximately 15 minutes following vaccine administration, pt began audibly trying to clear throat and coughing. I checked on patient; He said his throat "felt funny". Pt denied problems breathing but kept trying to clear throat. Injection site was negative for swelling and redness. Pt states his throat felt itchy. Based on pt complaints, activated emergency protocol and instructed technician to contact EMS. Pt was alert and oriented x3, discussed administration of liquid diphenhydramine with pt. Pt stated he wasn't having problems breathing and felt he could safely swallow liquid diphenhydramine. Administered 25mg diphenhydramine at 15:28. EMS arrived at 15:32, provided report to paramedic, detailing medication given and amount. EMS evaluated patient, advised him all they could do was administer diphenhydramine which had already been given and transport to ER if he felt needed. EMS moved pt to their unit for further evaluation.
This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. No concurrent conditions or medical history were provided. The reporter stated that on 07-OCT-2014, improperly stored PNEUMOVAX 23 injection (lot# J004196, expiration date 06-DEC-2014) (strength, dose, route of administration were not reported) was administered to the patient. No concomitant medications were reported. No adverse effects were reported. The outcome was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Worsening of ME/CFS and dysautonomia/POTS symptoms (lightheadedness, post-exertional malaise, pre-syncope, fatigue, body aches, itchiness) Lowering of BP All have continued for 2 weeks post-vaccination and have not remitted back to baseline level yet
FELT REALLY/REALLY BAD AND FELT OUT OF SORT; SORENESS IN LEFT ARM; WEAKNESS; HEADACHE; RAPID HEART BEAT; INDIGESTION; DIZZINESS; ITCHING BEHIND NECK; MEDICINAL TASTE/SLIGHTLY SALTY TASTE/FELT TASTE OF VACCINE IN MOUTH; SORENESS UNDER LEFT ARMPIT; TO FEEL VACCINE GOING THROUGH HER BODY/FELT REALLY/REALLY BAD AND FELT OUT OF SORT; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included managed high blood pressure, non alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced rapid heart beat. On 15-MAR-2021, the subject experienced indigestion. On 15-MAR-2021, the subject experienced dizziness. On 15-MAR-2021, the subject experienced itching behind neck. On 15-MAR-2021, the subject experienced medicinal taste/slightly salty taste/felt taste of vaccine in mouth. On 15-MAR-2021, the subject experienced soreness under left armpit. On 15-MAR-2021, the subject experienced to feel vaccine going through her body/felt really/really bad and felt out of sort. On 15-MAR-2021, the subject experienced soreness in left arm. On 15-MAR-2021, the subject experienced weakness. On 15-MAR-2021, the subject experienced headache. On 18-MAR-2021, the subject experienced felt really/really bad and felt out of sort. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, had not recovered from weakness, soreness in left arm, medicinal taste/slightly salty taste/felt taste of vaccine in mouth, soreness under left armpit, and felt really/really bad and felt out of sort, and the outcome of indigestion, rapid heart beat, dizziness, itching behind neck and to feel vaccine going through her body/felt really/really bad and felt out of sort was not reported. This report was non-serious.; Sender's Comments: MAC not required as per standard procedure as case was assessed as non-serious.
Abdominal pain, nausea, diarrhea, headache, muscle aches, and fatigue1-2 days after vaccination prompting transport via EMS to ER from home. Had cardiac arrest while in the ER x2, subsequent anoxic brain injury and death following removal of ventilator support.
rash 2 days p/3rd dose in post exposure series;not seen @ the time;no in 4th dose & has rash characteristic of erythema multiforme;1AUG94 f/u no treatment was initiated;rash resolved over next 7-10days;
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion of +1.9C to +6.4 C) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion of +1.9C to +6.4 C) in an 88-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis. Previously administered products included for Drug use for unknown indication: Pfizer (1st dose) on 07-Jan-2021, Pfizer (2nd dose) on 28-Jan-2021 and Pfizer (3rd dose) on 05-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. On 15-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion of +1.9C to +6.4 C). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion of +1.9C to +6.4 C). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion of +1.9C to +6.4 C) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion of +1.9C to +6.4 C) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. 2 doses/vials were impacted (1 punctured and 1 not punctured). The vial moved from freezer to refrigerator on 08-Jun-2022 and 1 vial 15-Jun-2022. The vial was first punctured on 15-Jun-2022 at 9.15 AM. The vial was stored in portable fridge post puncture. The vial undergoes temperature excursions on +1.9C to +6.4 C. Excursion duration was 15 min.. All the vials were in the fridge quarantined. Visual inspection noting any vaccine state change included vial was thawed. No treatment medications were provided by the reporter.
Side effects in the first month: hypotension, light headed, felt faint, heart racing, shaking, fever, chills, fatigue, heavy feeling/pressure/pain/tight feeling in chest, difficulty breathing deep, swollen glands in armpits for longer, intense body pain  Side effects in 2-4 months after, these symptoms come and go: numb tongue, gastro pain, loose stools, heart racing (seems to be at bedtime), hypotension, feel like body underwater, elevated blood pressure, pressure in chest, tongue sores, tingling in calves, fatigue, feeling faint, eye redness, redness and itchy cheeks (with dry flaky skin), chest discomfort/pain/tightness, foggy thinking Current treatment plan is to raise low blood pressure.
"Moderna COVID-19 vaccine EUA" Patient received 0.5ml instead of 0.25ml COVID booster.
She was born a beautiful and perfectly healthy baby. She did receive her vitamin K shot being I had been on blood thinners for clotting. She suffered a bit from jaundice but at 4 days old she received her hep b. Her temp stayed lower than normal which they kept saying was normal being born at 36.5 weeks GA. At her 2 week check up she was found to be doing well and her temp had come up to 99.0 degrees. Well we took her home to have her temp spike within 8 hrs of her check up to 101.7. I thought it was my thermometer so I tried a bath, skin to skin and a tad bit of TYLENOL trying to help her. It came down to 99.8 which was better for me so we went to sleep for 3 hrs. When I retook it at 4am on December 14th, it was 101.4 so we took her to the ER. They did a lot of blood work and tried to get a lumbar puncture that ended as a failed try. They transferred us to another hospital where she started having respiratory issues and they ended up transferring us yet again. This time to another hospital's PICU. By the 15th she had crashed into a full cardiac/respiratory arrest which ended in her being intubated. They kept her intubated for 3.5 days until the morning of the 18th and they ended up bagging her within 5 minutes of extubated. Within the 7 days we were there, she was bagged 7 more times. Her last MRI showed her to have brain damage due to cerebral hypoxia, fluid on the brain, a collection on her spine as well as an abnormal 24 hr EEG.
Patient has a 30 x 17cm warm, erythematous area around injection site, (right deltoid).  Patient c/o 7/10 pain to site and c/o difficultly with ROM with RUE, probably due to pain.  Area also has generalized edema.  Patient was given 50mg benedryl IV and 250mg Naproxen PO BID for discomfort and edema.  Will follow up with him daily for next 3 days or PRN.