chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Double Vision), NERVOUS SYSTEM DISORDER (Neurological medical condition), VACCINATION COMPLICATION (adverse reaction to the booster shot), HEAD DISCOMFORT (when she tried to hold her head up, she felt the room going around) and IMPAIRED DRIVING ABILITY (could not drive a car for 5 days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Double vision and Cataract operation (Summer 2021) in 2021. Concurrent medical conditions included Diabetes and Hypothyroidism. Concomitant products included METFORMIN for Diabetes, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, INSULIN GLARGINE (LANTUS) for an unknown indication. On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, the patient experienced DIPLOPIA (Double Vision), NERVOUS SYSTEM DISORDER (Neurological medical condition), HEAD DISCOMFORT (when she tried to hold her head up, she felt the room going around), IMPAIRED DRIVING ABILITY (could not drive a car for 5 days), DIZZINESS (She was very Dizzy) and NAUSEA (Nauseous). On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse reaction to the booster shot). On 11-Nov-2021, HEAD DISCOMFORT (when she tried to hold her head up, she felt the room going around), IMPAIRED DRIVING ABILITY (could not drive a car for 5 days), DIZZINESS (She was very Dizzy) and NAUSEA (Nauseous) had resolved. At the time of the report, DIPLOPIA (Double Vision) had not resolved and NERVOUS SYSTEM DISORDER (Neurological medical condition) and VACCINATION COMPLICATION (adverse reaction to the booster shot) outcome was unknown.No treatment medications were reported. This case was linked to MOD-2021-404053, MOD-2021-404058 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Added the medical history (Cataract Surgery, Diabetes, Hypothyroidism, double vision),events (Dizzy, Nauseous, Double Vision, head discomfort,  impaired driving ability, Neurological disorder NOS), Concomitant medications (Metformin 1000mg BID, Synthroid, Lantus insulin.)
expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Patient developed abdominal pain, nausea, dark urine, and fever to 104 on 9/16/21. She was seen in an ER in where she was traveling, found to have a large spleen. Presumed mono and discharged home. She was feeling worse with persistent pain and fever, and was seen at the ER at Hospital, where she was evaluated and admitted from 9/18-9/22/21.
LOSS OF HEARING FOR A BIT; DIZZINESS, COULD NOT HOLD HEAD UP; VISUAL DISTURBANCE; SWEAT; SORE ARM; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On 25-MAR-2021, the subject experienced loss of hearing for a bit. On 25-MAR-2021, the subject experienced dizziness, could not hold head up. On 25-MAR-2021, the subject experienced visual disturbance. On 25-MAR-2021, the subject experienced sweat. On 25-MAR-2021, the subject experienced sore arm. On 25-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of hearing for a bit, dizziness, could not hold head up, visual disturbance, sweat, and nausea on 25-MAR-2021, and had not recovered from sore arm. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Information has been received from a nurse concerning a 15 year old female patient. No concurrent or historical conditions were reported. On 04-MAY-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (strength, route and dose unknown, lot # K008931 and expiration date 04-MAR-2017). No adverse effects reported. Additional information has been requested.
Instant HA within 2 minutes of administration of vaccine. Pressure behind left eye and trouble focusing. Lasting day of injection. HA continues to linger now 7 days post injection. Left neck and left inner ear pain still ongoing not as severe. Burning with injection. Left arm pain x 4 days. Chest tightening and heaviness for past 6 days. Has hx of sports induced asthma.
Extreme upper arm pain extending into armpit and left breast areas, chills, headache, body aches
PT PARENT REPORTED THAT ONE DAY AFTER VACCINE WAS GIVEN, AREA BECAME SORE, RED, WARM TO TOUCH, AND ITCHY.
on May 8th, 2021 reports red raised itchy rash on upper chest, face and ears.  Also reports face swelling and eye swelling..  States lasted about 72 hours.  States took over the counter benadryl tablets and used topical hydrocortisone cream to rash.
tingling in cheeks and nasolabial folds; This is a spontaneous report based on nformation received by Pfizer (manufacturer control number GL-040921-8926). A ncontactable consumer (patient) reported a female patient of unspecified age received dose 1 of COVID-19 vaccine (unspecified manufacturer) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization and hyaluronic acid, lidocaine (RESTYLANE L) at an unspecified dosage from an unknown date for an unknown indication. Medical history and concomitant medications were not reported. On an unspecified date after receiving one of the COVID-19 vaccines, the patient experienced tingling in cheeks and nasolabial folds. The action taken with hyaluronic acid, lidocaine in response to the event was unknown. The outcome of tingling was unknown.   No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Woke with sore throat, worsening throughout the day by 3 PM low grade temp, body aches, pain, runny nose.
Received vaccine on 2/23. On 2/24 arm became swollen and red and spread beyond injection site to approx 4 inches in diameter. There was slight itching, and pain. On 2/28 became nauseated in shower and felt extreme weakness requiring assistance to get to bed to lie down. Thought she would pass out. Lasted 3 hours and then was recovered.
Mom called 10-19. Face, chest, shoulders red itchy. Given BENADRYL (children's) by mom. Denied difficulty breathing swallowing & was at school.
Several hours after vaccine (FLUMIST) patient had itching and rashes all over the body.
One day after receiving the first dose of the injectable flu vaccine, the patient developed red bumps. There were three larger bumps near the injection site and smaller bumps over the body. The baby was 'grumpy' for two days but no fever and no itching. The bumps disappeared in three days. The mother did not bring the baby to clinic for evaluation, thus all symptoms were reported by the mother.
My vaginal atrophy became more pronounced and stopped responding to estriol treatment. Severe inflammation and pain increased over time. In early April I observed the skin on my vulva had turned white and thick and there were several ulcerated areas. I saw a gynecologist on 4/6/2021 who prescribed clobetasol ointment. I am visiting NY from  my home in San Diego), so I will look for a doctor once I return home in early May.
r arm cellulitus requiring hospital admission for 1 1/2 days. r arm swelling beginning 48 hrs after administration, DTap and Var given in r arm.  L arm with MMR and IPV had no reaction.  no fever or discharge.  Pateint had swelling and induration from the top of the shoulder to below the elbow about 22 cm total 2/9/09 Received hospital medical records of 2/4-2/6/2009. FINAL DX: right upper arm cellulitis Records reveal patient experienced RUE swelling, induration, redness, pain, decreased movement, right axillary lymphadenopatny x 1 day.  Tx w/IV antibiotic.
Patient admitted to the hospital 7/21/21 through the ED and tested positive for Covid19 via rapid molecular test. Patient states he was vaccinated "months ago" and received one dose. He complained of fever, diarrhea, and fatigue. His Chest XR consistent with patchy airspace opacities. He was found to have orthostatic hypotension and hyponatremia attributed to dehydration.
ENDOMETRIOSIS; FIBROIDS; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: There was no reported medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. Non-company suspect drugs included: adalimumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced endometriosis, and fibroids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the endometriosis and fibroids was not reported. This report was non-serious. This case, involving the same patient is linked to 20220908814.
Pfizer was administered as a 3rd dose for an immunocompromised patient who got Moderna for her first two doses. No adverse reaction 2 hours after the dose was administered when patient was consulted. Referred her to reporting on V-Safe.
Fever, shaking of limbs, vomiting, slightly cyanotic, tachycardia, sent to ER. child was examined and released.
This spontaneous case, initially received from other non-health professional on 26-Oct-2018, concerns a 59-year-old female patient. On 16-Oct-2018, the FLUCELVAX QIVc had underwent temperature excursion. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019) which underwent temperature excursion. The patient did not experience any adverse events after vaccination. The reporter assessed this case as non-serious. This case 201805015 was cross-linked to the case: 201805002 reported by the same reporter. Follow-up report received on 13-Nov-2018: The reporter refused to provide the patient's initials. The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The narrative and case comment were amended accordingly.
Resident was fully vaccinated.  Tested positive for covid on 7/2/2021.  Had two subsequent covid tests which were negative.  Did pass away on 7/24/2021 but not from covid.
CHILLS; SORE ARM; FEVER; HEADACHE; EXHAUSTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, headache, exhaustion and sore arm was not reported. This report was non-serious.
Patient recevied 0.5ml dose instead of 0.25ml dose.  No adverse affects per patient.
Pt recv vax on 9/29/98; on 10/20/98 pt exp pain/ muscle spasm at vax site; tx=Ibuprofen
Generalized fatigue, body aches, chills and localized tenderness and pain at injection site.
SkinRash, Rash Numerous 1-2 MM ERTHEMATOUS PAPULES TO CHEST ABDOMEN RIGHT FLANK Narrative.
BREAKTHROUGH COVID: FULLY VACCINATED COVID POSITIVE, INCEDENTAL FINDING. PATIENT WAS ADMITTED D/T NEUTROPENIC FEVER D/T PROTEUS BACTEREMIA IN THE SETTING OF COMPLICATED UTI WITH OBSTRUCTIVE UROPATHY UNCOMPLICATED CYSTOSCOPY, UTEROSCOPY, LASER LITHO, AND STENT PLACEMENT COMPLETED ABX PER ID TEAM, UPPER EGD WITH REACTIVE GASTRITIS Atrial fibrillation with RVR (HCC),PROGRESSED TO SEPSIS.  Venous thromboemblism,  Neutropenic fever, Severe protein-calorie malnutrition, Pancytopenia, Ureteral calculus, Urinary tract infection due to Proteus. COVID 19 was not treated during admission.
Approximately 3 hours after vaccination, I was talking on phone when I felt a sharp pain to my L upper chest which lasted for around 2-3 seconds.  Pain became more diffused and dull. I immediately took 650 mg ASA just in case.  That same evening I felt an unusual feeling in same area of chest; not a sharp pain,  It was perceived as unusual to me.  On 5/20 when I laid down to sleep in late evening, I took a breath in and again felt an unusual feeling to L chest area.  I took 325mg ASA.  I notified my PCP who instructed me to call my cardiologist for f/u.  I will be doing this tomorrow via patient portal.
She had received Pfizer covid vaccine doses 4/17/21, 5/10/21 and 7/12/22 and then received the Modern Covid 19 Bivalent booster 9/25/22.  Five days after (9/30/22,) she experienced a first episode of supraventricular tachycardia (HR 150,) and that recurred 10/4/22 leading to an emergency department visit..   ED evaluation include ECG, that was normal (SVT resolved by that time), normal CXR, normal labs including TSH.  She continues to experience a vague SOB feeling, but no additional episodes of tachycardia as of 10/5/22.
Had swelling of uvula about 2-3 minutes after shot (not enough to prevent me from breathing or show signs of respiratory distress), was fine after taking antihistamine 30 minutes later when making it home. The next day I woke up with a swollen lymph node in my armpit (felt like someone punched me really hard and felt almost like it was bruised) It's now 1/25/2021 and almost completely back to normal (I'm a slow healer).
Pt reports limited range of motion in arm starting approximately 2 weeks following vaccine administration, physical therapy ordered by physician - left arm.
Transverse sinus thrombosis in the brain with severe headaches, nausea, dizziness, and blurred vision. Patient report headaches began within a week of receiving vaccine. She reports a electrical tingling sensation on the top of her head, which began on Tuesday 4/20/2021.
L/thigh approx. 4 x 3.5 cm long- reddened area where shot was given, vomiting, fever of 102. With Motrin, reduced to 96. On antibiotics for AOM.  Mom informed to call office if erythema region enlarging.
recvd MMR #2 on 10OCT92 approx 3 wks post vax; pt sent home from school w/fever 103;
Client stated "In 24 hours of receiving vaccine, my arm was in pain, mainly the shoulder and top of my arm. There was pain and stiffness". Client saw PCP. She was placed on steroids which helped but when the steroids were stopped symptoms returned. Client returns to PCP on 10/6/17 with possible X-rays to be taken. 10/12/17 Client reported X-ray taken. Results negative. Client given orthopedic referral.
I had reached menopause (confirmed through blood test) and starting menstruating two days after my first COVID vaccine.  I started menstruating again the day after my 2nd shot (given on 4/21/21).  I just started bleeding heavily again this morning (5/20/21).
Patient fainted as she was walking out at exam, felt dizzy, pale, no loss of consciousness within 15 min after vaccination. Threw up chocolate later that am. BP & HR & breathing nml
patient has experienced neck, right arm, and shoulder blade pain ever since received 2 nd dose on 4/8/2021
This spontaneous report was received from a nurse regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with M-M-R II (lot #, expiration date, dose and route were not reported) for prophylaxis that were improperly stored (Incorrect product storage). The storage temperature was 9C and time frame was 1 hour. No adverse effects was reported. The outcome of incorrect product storage and no adverse event was unknown. This is one of the three reports received from the same reporter. Additional information has been requested.
improperly stored dose of GARDASIL 9 was administered; No adverse effect reported; This spontaneous report was received from a nurse, referring to patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications and previous drugs reactions or allergies were not provided.  On 28-AUG-2019, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) from a two doses series, as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; reported lot number 1614897, expiration date 20-SEP-2021, have been confirmed as valid) . No adverse effects were reported for the patient.  According to the reporter, the temperature excursion was 48.5 degrees Fahrenheit(°F) for a time frame of four hours and 15 minutes on an unspecified date (product storage error), without any previous temperature excursion; which was detected by a digital data logger, as the "no alarm went off".  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA012909: US-009507513-1908USA012939:
10 minutes post vax, the pt became lightheaded reportedly for 1 1/2 minutes. Pt plans - vaso-vagal, return home increase fluids and return for a follow up.
Child started the day around 7am with watery, smelly diarrhea.  At 8am child projectile vomited over 6 times.  Then 10 minutes later had watery smelly diarrhea and became lethargic.  Child remained lethargic for the following hours. The diarrhea continued through out the day.
Sudden, intense vertigo while lying in bed before going to sleep shortly before midnight on a Sunday night.  I felt as if my bed was spinning around at a fairly high speed.  The intensity decreased after about a minute.  I got out of bed.  Since I am diabetic, I checked my glucose level with my Freestyle Libre CGM.  My glucose level was approximately 130 mg/dl, but was on a rather steep downward slope.  I went downstairs and ate something.  My glucose never fell below 100 mg/dl, but I continued to have mild to moderate vertigo.  The vertigo continued the next day (Monday).  I saw my physician on Tuesday morning.
Syringe came undone after half of the dose was admininstered. Provider gave another half of a dose to finish recommended dosage. Providef informed patient of situation.
1 1/2" X 1 1/2" area of redness and swelling at injection site.  No itching.  Aware of it with movement.  Edges marked with pen by RN, advised to see MD if redness or swelling increased.
they have given a patient Tenivac IV instead of IM (with no reported adverse event); Initial information received on 17-Aug-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 30 years old male patient who was given diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] iv (intravenous) instead of im (intramuscularly) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of suspect diphtheria-2/ tetanus-5 adsorbed toxoids no preservative adult, suspension for injection (strength, batch number, expiry date not reported) via iv nos (intravenous not otherwise specified) route in unknown administration site for Prophylactic vaccination (immunization) instead of im with no reported adverse event (incorrect route of product administration) (same day latency).  Reportedly, The Tenivac was accidentally given by a nurse via IV push in place of Morphine as the syringes/labels looked very similar. Reporting to Quality due to this. HCP did not have the brand of the Morphine syringe available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (they have given a patient Tenivac IV instead of IM (with no reported adverse event)).  At time of reporting, the outcome was Unknown for the event they have given a patient tenivac iv instead of im (with no reported 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 the 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.
Date of Admission: 1/31/2022   Chief Complaint:  RLQ abdominal pain   Source of Information:  Patient, Available medical record and Mother   History of Present Illness:  This is a 26y.o. female past medical history indicated below the general sutures consult to evaluate for right lower quadrant pain. Patient reports that pain began abruptly around 12:30 AM earlier this morning which awoke her from sleep. Specimen to some nausea but denies any emesis, fever, chills or chest pain, shortness of breath. Patient procedure is not noticing changes in her bowel habits however when straining does cause her more abdominal pain. CT obtained demonstrated the appendix being mildly dilated up to 8 mm with periappendiceal inflammatory changes and appendiculis concerning for early acute uncomplicated appendicitis.   Past Medical History: Diagnosis Date ? Acne   ? Constipation   ? Diarrhea   ? Irritable bowel syndrome   ? Learning disability   ? Ovarian cyst   ? Seasonal allergies   ? Seizure disorder     absence seizures, not currently on meds, last seizure age 8. ? Seizures   ? Stomach pain
Patient had a syncopal episode which was eventually determined to be a probable seizure 5 days after receiving TDAP vaccine. He suspected the two were related. No recurrence of seizure since without treatment.