chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First dose more than 35 days before second dose; first dose was 0.25 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (first dose was 0.25 ml) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose more than 35 days before second dose) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904 and 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 27-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 02-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (first dose was 0.25 ml). On 27-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose more than 35 days before second dose). On 02-Nov-2021, ACCIDENTAL UNDERDOSE (first dose was 0.25 ml) had resolved. On 27-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose more than 35 days before second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment medications was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Dec-2021: Non Significant follow up included reporter's email address.
Redness, swelling and pain to area around injection.  Dx Cellulitis at office visit on 03/07/2016.  Antibiotics given.
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 02-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
The patient experienced arm pain lasting all night. The patient has a headache and aches all over.  The patient had a previous reaction in 1993 to flu vaccine. The patient has received the vaccine yearly since then with no ill effects.
Immediately experienced racing heart and severe dry mouth. My KARDIA 6-lead EKG stated "Possible AFib" and heart rate was 145-155. Blood pressure became elevated much higher than baseline (Normal is 90/60). Paramedics came to evaluate and performed numerous 12-lead EKG's and noted multiple Premature Ventricular Contractions and transported me to the hospital where I was observed and consulted on from ED Physician. Later was evaluated by electrophysiology cardiologist with echocardiogram and EKG. Multiple physicians have advised not to get second vaccine.
Client arrived with father for first dose Pfizer vaccine.  While sitting in medical monitoring the patient began to exhibit what appeared to be a vasovagal response.  Vital signs BP 90/65, HR 60, RR 16.  Patient appeared weak, nauseous, and diaphoretic with an immediate onset.  Patient stated she did not eat and was given a snack of chips and water by charge nurse.  Cool compress applied to cooling areas on patient's body.  Charge nurse ambulated patient and patient began to converse with nurse stating, " I feel better now."  Patient appears in no apparent distress and answers appropriately.  Charge nurse instructed patient and caregiver patient's father to seek medical attention immediately if new symptoms arise or previous symptoms reoccur.  Approximately 1 hr 15min later caregiver patients father returned to vaccine site and stated his daughter is feeling much better.  Caregiver indicated daughter is eating and resting at present.  Charge nurse instructed caregiver to provide fluids throughout the day and to monitor for any symptoms.  Caregiver instructed to seek medical attention immediately if symptoms reoccur.
On 01/25/2001 the patient developed chicken pox from head to foot. Unspecified medical attention was sought. In follow up the physician reported that she felt fairly comfortable that this child's rash was probably wild-type varicella. Additional information has been requested.
SORE ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 17-DEC-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 17-DEC-2021, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Devel soreness in deltoid area day after vax. Area of numbess, area of tinea versicolor ___ and ___ to site of inject.
Pt presented to the Medical Clinic on 6/18/07 with c/o reddened warm swollen R arm following vaccinations on 6/14/07. Exam noted a 15 by 15cm demarcated area of induration and warmth to the right lateral upper arm. Diagnoses as possible cellulitis and orders were given for Ibuprofen, Benadryl, and Augmentin. Follow up on 6/18/07 noted improvement in symptoms.
No other AE or PQC reported; a temperature excursion happened/unsure if ROT ATEQ and VAQTA had been administered since the excursion occurred; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 05-NOV-2021, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced temperature excursion. On 09-NOV-2021, the patient was vaccinated with the improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (1 time dose, lot # 1742078, expiration date 06-JUL-2022; strength and dose were not reported) orally for prophylaxis (product storage error). Current temperature excursion was 47.1 Fahrenheit degrees for 36 minutes. There was no previous temperature excursion. No other adverse event (AE) or product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA000877: US-009507513-2112USA000883: US-009507513-2111USA005243: US-009507513-2112USA000879:
1:17 Patient was in the observation area post vaccination on her left arm 1st dose of Pfizer, suddenly complained of drowsiness, weakness. Patient reported no food since this morning.  Patient  was attended by the Clinical Team.  Vital signs were taken as follows : BP 154/114, HR 129, RR 18, oxygen saturation 97%. Temp 98.2.  No palpitation or chest pain  noted. 911 was called and came and evaluated the patient.  Blood sugar was 118. Patient was advised to  have a further evaluation in the hospital or urgent care. Patient was with the family,  Issues were not resolved but declined to be brought in the hospital.
Rash on back and stomach started on 1/22/03 rash did spread to face on 1/23/03. No fever, no SOB, no swollen glands. Mom reports child doing OK and acting normal.
Unspecific adverse event; This case was reported by a lawyer and described the occurrence of adverse event in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced adverse event. The action taken with Shingrix was unknown. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  The initial information was received on 31 March 2021 via medical record (case is now medically confirmed). As per pharmacy record, On 20 June 2018, patient ingested shingrix vial kit.
no additional AE have been reported at the time of call.; Nurse practitioner reports an AE for MMRII and VARIVAX. Caller states a 3 year-old patient was inadvertently administered 2 doses of MMRII and 2 doses of VARIVAX concomitantly on 9/28/2022. Caller states no additional AE have been reported at the tim; This spontaneous report was received from a Nurse Practitioner, referring to a 3-year-old female patient. Information regarding medical history, concurrent conditions and concomitant medication was not provided.  On 28-SEP-2022, the patient was inadvertently administered 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # U022316, expiration date: 15-JUL-2023, 0 .5 milliliter for prophylaxis (dosage information and route of administration not informed), and 2 doses of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 mL, Lot Number: W012164, expiration date: 12-APR-2024, for prophylaxis(dosage information and route of administration not informed); concomitantly, diluted with sterile diluent, product quantity 4, 0.5 mL (Accidental overdose). No additional adverse event had been reported at the time of call.
High pitch crying uncontrollably. Fever of 102. Then seizure. Lasting 5 seconds. Same occurred three more times with a fever at 102, 101.9, 99.9 and 100 degree temperatures. Each one lasted 3-7 seconds. Eyes rolled and eye lids fluttered. Last seizure around 6:45am eyes remained open without blinking and no eye movement. Body started stiff as a board then convulsed.
The minute I got the vaccine, I felt weird. My sinuses started to bother me immediately. Since then, I have had severe body aches, fevers, and just feeling very unwell and fatigued and chronic sore throats and sinus headaches. It has been 2 months now and it is not going away. I feel disabled and I do not function at the level I did before the vaccine. I hope I recover  but I just don't know if I will. It is dragging on and I am not improving.
felt a little dizzy for a day or two; arm felt sore, warm, and was a little red at injection site; flu-like symptoms of warm then cold; flu-like symptoms of warm then cold/chilled; headache; tired; flu-like symptoms of body aches; arm little red at injection site; arm swollen at injection site; arm felt sore, warm, and was a little red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt a little dizzy for a day or two), VACCINATION SITE WARMTH (arm felt sore, warm, and was a little red at injection site), FEELING HOT (flu-like symptoms of warm then cold), FEELING COLD (flu-like symptoms of warm then cold/chilled) and HEADACHE (headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroiditis (Hashimoto Thyroiditis), Migraine headache, High cholesterol, Vitiligo and Dairy intolerance (Dairy sensitivity). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication, ROSUVASTATIN CALCIUM (CRESTOR).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE WARMTH (arm felt sore, warm, and was a little red at injection site), FEELING HOT (flu-like symptoms of warm then cold), FEELING COLD (flu-like symptoms of warm then cold/chilled), HEADACHE (headache), FATIGUE (tired), MYALGIA (flu-like symptoms of body aches), VACCINATION SITE ERYTHEMA (arm little red at injection site), VACCINATION SITE SWELLING (arm swollen at injection site) and VACCINATION SITE PAIN (arm felt sore, warm, and was a little red at injection site). On 30-Mar-2021, the patient experienced DIZZINESS (felt a little dizzy for a day or two). At the time of the report, DIZZINESS (felt a little dizzy for a day or two), VACCINATION SITE WARMTH (arm felt sore, warm, and was a little red at injection site), FEELING HOT (flu-like symptoms of warm then cold), FEELING COLD (flu-like symptoms of warm then cold/chilled), HEADACHE (headache), FATIGUE (tired), MYALGIA (flu-like symptoms of body aches), VACCINATION SITE ERYTHEMA (arm little red at injection site), VACCINATION SITE SWELLING (arm swollen at injection site) and VACCINATION SITE PAIN (arm felt sore, warm, and was a little red at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Body temperature: 99.6 f High.         Other Concomitant medicines included Multivitamin, Calcium + D3, Vit C, Vit E, fish oil, M Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-028110, MOD-2021-028110 (Patient Link).
symptoms lasting 4 days of stomach upset, sore arm, headache, shivering, mild fever, For stomach treatment, took Gas-x and IBGuard. for sore arm, mild fever, headache took Advil
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 38-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Sep-2022 at 2:19 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 17-Sep-2022 at 2:19 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        No concomitant product reported by the reporter. Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid. Bivalent vaccines stored in the refrigerator that underwent several temperature excursions in August 2022. Refrigeration excursions were identified, state vaccine was housed in the units. There were excursions noted. Manufactures were notified and the state department was made aware of the situation.  No adverse reactions were reported for any of the patients at the time of the report. No treatment medication reported by the reporter.
patient gotten the flu; Initial information received on 12-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient).  This case involves a 60 years old patient gender not reported who gotten the flu (influenza), while he/she received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (batch number and expiry date) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date, a month ago patient was told that the patient was around someone who had Coronavirus disease (COVID) due to which the patient had to do mandatory two week quarantine and had to do test. Tested negative and never had any symptoms.  It was not reported if the patient received a corrective treatment.  Event outcome was unknown, at the time of reporting.  There will be no information regarding the batch number for the case.
I had a miscarriage beginning on 2/18/21. The EDD of this pregnancy was 9/3/2021. I had another miscarriage on 6/1/21 . The EDD of this pregnancy was 1/10/22. Both miscarriages were incomplete and required D&Cs.
11/21/21 note by ED Dr. :"Patient with history of CAD status post stent x2 greater than 5 years ago, and roughly QOD aspirin (81mg EC), history of bronchitis here with complaint of syncope x2 today. Patient states that he first developed cough, congestion, fever, decreased appetite and fatigue on Wednesday 11/17. Patient's entire family has tested positive for Covid and patient states that he initially tested negative x2 via rapid test in urgent care, had one positive test, followed by another negative rapid test. He suspects that he has Covid as a test yesterday was positive, however he remains unsure given that he has received mixed test results. He is vaccinated x2 for Covid, though family is unvaccinated. Patient states that his appetite has been poor and yesterday he ate a small amount, but today his appetite was again poor and he has not eaten or drink anything today. In that context he states that he was feeling weak and lightheaded and sustained a momentary syncopal episode in which he fell to the floor, x2 today. Patient has had a dull headache throughout his Covid illness but denies striking his head or having worsening of headache post syncope. He denies vomiting or diarrhea. He denies any chest pain but does report occasional wheezing and shortness of breath associated with his largely dry cough. No leg pain or swelling. No prior history of DVT/PE. Otherwise well". Patient is admitted to Medical Center on 11/21/21 and is currently inpatient.
pt recv vax & 11AM mom returned to hlth dept & said pt vomited about 15min ago then became pale & limp;pt was pale, lethargic & diaphoretic;pt was seen to local ER where Phenergan suppository given & pt perked up & was released p/1-1 1/2hr;
Initial report was received 31 May 2012 from a health care professional which involved a cluster of approximately 17 patients (six elderly patients, two adolescent patients and approximately nine unidentified patients) who tested PCR positive for influenza A/H3 since January. This case captures information for two adolescent patients. The six elderly patients have been captured in case number 2012-05658 and the remaining unidentified patients (approximately nine) have been captured in case number 2012-05660. A cluster of two adolescent patients had received FLUZONE, lot number UT499AA (route, site and dates of administration not reported), and an unspecified amount of time later, the patients tested PCR positive for influenza A/H3 at the state laboratory. Outcomes were not reported. No additional information was provided at the time of the report. Documents held by sender: None.
Patient got the flu, her ears got stopped up, could not hear nothing but a buzzing.  Patient went to the doctor to see why and said she had a cold.  Medicine did not help.  Kept on going to the doctor's getting medicine for ears.  Patient went about 6 or 8 times then went to (ENT) about two times.  Second time went in the hospital. 7/28/08-records received for DOS 5/9/08-C/O ear infection since last fall, lost some hearing, on multiple antibiotics, chronic cough. Tubes in ears. No reaction from previous flu vaccine.
Fever was first day after, gone quickly.  Rash spreading all over body on 2/17 (4 days later), red, puffy and itchy.  Torso front and back, lower abdomen, neck, arms down to wrists.  Took some Benadryl at 7:40, hope it will call down and pass.
Within 24 hours, sudden onset of severe joint pain/arthritis, swelling in joints, hands and feet, arms, overall body, continues daily without relief to present.
pt recv vax; fever 104 started 1 day p/ vax;no oth sx; apap & ibuprofen given for fever;
Vision impaired went black then fuzzy then black. Felt faint and dizzy. Got really hot, went pale.  Headache began.
11/01/22 presents to ED for "weakness/debility". PMHx of "hypertension, dyslipidemia"
PT RECEIVED PNEUMOVAX 23 VACCINE ON 5/29, AND WALKED IN ON 5/31 C/O LEFT ARM PAIN, SWELLING, REDNESS, LETHARGY, WARM AND TENDER FOR TOUCH IN HIS LEFT ARM.  PATIENT WAS TREATED WITH CLINDAMYCIN 300 MG TID FOR 7 DAYS. SYMPTOMS RESOLVED.
Having bouts of vertigo 4 and 11 days after second pfizer vaccine.  Never had vertigo prior
BCG scar inflammation. Booster given in same arm (dominant arm) and redness, warmth, and pain from same.  Positive covid 19 rapid test on 8/1/22. Three days following booster. Severe body aches, fever, shakes, and fatigue.
Experienced sever chills for approximately 2 hours; sore arm; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative for a Pfizer sponsored program. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administration date 29Dec2020 (Lot number: EJ1686) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "gastric bypass surgery", start date: 2011 (unspecified if ongoing); "hernia repair", start date: 2018 (unspecified if ongoing); "very low iron stores requiring infusions" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Experienced sever chills for approximately 2 hours"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021295270 Same patient, different drug / event
I woke up 3-4 times during the night, after receiving my shot, with a dry cough.  My husband was worried because I don't do this.  I had taken a Claritin and Ibuprofen 800mg prior to going to bed.  By 0600 on 9/28, I did not experience anymore coughing episodes.
fatigue, burning in nose, myalgia, fever, chills, insomnia, palpitations
Information has been received from a registered nurse concerning her 11 year old daughter with no pertinent medical history and no drug reactions/allergies, who on 19-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). On 25-JUL-2008, she received the second dose of GARDASIL vaccine (yeast). Since the first dose of GARDASIL vaccine (yeast) was given, the patient had been experiencing nausea, weight loss and dizziness. Additional x-ray results were within normal limits. The nurse's daughter sought medical attention and visited her doctor's office. At time of reporting, the patient had not recovered. Additional information has been requested.  12/10/08 MR received from PCP. Seen 6/4/2008 with c/o 3 day hx of nausea. Last BM 3 days ago. Assessment:  constipation. Seen 7/31/08 with c/o nausea. Assessment:  Stomach function d/o. Rx:  Prilosec.