chrisvoncsefalvay/vaers-outcomes huggingface dataset:
did notget the second shot of the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did notget the second shot of the Moderna COVID-19 vaccine) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did notget the second shot of the Moderna COVID-19 vaccine). The patient was treated with PREDNISONE ongoing from 10-Apr-2021 for Platelet count, at a dose of 1 dosage form. At the time of the report, PRODUCT DOSE OMISSION ISSUE (did notget the second shot of the Moderna COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Platelet count decreased: 12000 (Low) 12000. On an unknown date, Platelet count: 322,000 (Inconclusive) 322,000.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.
forty three children were administered varicella virus vaccine from a shipment that was stored out of the refrigerator for 5 days; This spontaneous report has been received from unspecified reporter via company representative concerning a children of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. The reporter stated that the patient was vaccinated from a shipment that was stored out of the refrigerator for 5 days.   This is one of 45 case reported by the same reporter.
An administration error was discovered. The patient indicated she needed a third dose of Moderna due to immunosuppression from diabetes on her consent form and a full third dose was administered. Diabetes is not a qualifier for moderate-severe immunosuppression warranting a third dose of 0.5ml, so she should have only received a booster of 0.25ml. Patient was contacted upon discovery of administration error and she stated she did not have any adverse effects from her dose.
Information has been received from an advanced practice registered nurse for GARDAIL, a Pregnancy Registry product, concerning a 23 year old female patient with a history of loop electrosurgical excision procedures, Papanicolaou smear abnormal and cervical intraepithelial neoplasia II (CIN2) and no drug reactions/allergies who on 22-DEC-2011, was vaccinated intramuscularly with a first dose of GARDASIL (Lot number: 006642 is an invalid lot number for GARDASIL, expiration date: 30-SEP-2012, dose and route not reported). There was no concomitant medication. It was reported that on 22-DEC-2011, the patient went to the office for annual exam and cervical smear (Pap smear) visit and during the visit was given GARDASIL. Automatically, the patient was given a pregnancy test and learned after she was given the shot that she was actually pregnant. Cervical biopsy was performed. The patient's last menstrual period (LMP) was on 23-NOV-2011, according this, Estimated Delivery Date (EDD) would be on 29-AUG-2012. Follow up information was received from the same advanced practice registered nurse that EDD was 01-SEP-2012. Pregnancy outcome: normal infant, no congenital anomaly. Additional information is not expected.
This spontaneous report was received from a Licensed Practical Nurse (LPN) referring to an unspecified 18 year old patient. The patient's medical history included vaccination with the first and second doses of GARDASIL 9 on 05-JUN-2018 and 17-JUL-218, respectively. No other information was provided regarding the patient's concurrent conditions, drug reaction/allergies or concomitant medications. On an unknown date, the patient was vaccinated with RECOMBIVAX HB for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The Nurse reported that there might had been an administration error with RECOMBIVAX HB. No adverse effects were reported.
A report has been received from a Health Professional concerning a 4 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 17-Dec-2013. The patient reported that they gave three expired doses of FLUMIST QUADRIVALENT which started on 17-Dec-2013. The outcome of the event of gave expired doses of FLUMIST is unknown. The report was considered to be non-serious.
Dizziness, Myalgia, Arthralgia, Fever & NauseaVomiting Narrative: Per supervisor report: "Please note that employee...called-out today for an authorized absence secondary to side effects from the COVID-19 vaccination received yesterday, 1/20/21, around 3pm. Her symptoms include severe muscle and joint pain, chills, nausea, dizziness and fever of 101.3."
Local soreness, redness, hardness and swelling muscle doning, chills, leg swelling, arm swelling itching and hives. Starting 9/18/08 Lasted 48 hrs
Vaccine administered was exposed to a low temperature and not supported for administration. Patient has not reported any reactions. Revaccination plan to be initiated.
There was no adverse reaction.  I am filing this VAERS to report an administration error.    It was noticed by this writer when performing the vaccine count this morning that an extra green top vial remained unopened in box.  The box contained 5  green vials and only 4 blue vials.  The pt listed is the only pt recorded as receiving Pentacel since the last reconciliation which was one week prior.   It is presumed that the patient only received the liquid component (Dtap and IPV).  The MA who gave the vaccine does not acknowledge making this error.  The pt's mother was informed that the pt did not receive the complete vaccine and has scheduled an appointment to return to receive the correct vaccine.  The doctor and nurse manager have been notified.
03/31/2023 I started having constipation, elevated blood pressure, ringing in ears. After reaching out to doctor I was diagnosed with essential hypertension. I was prescribed HCTZ, amlodipine and losartan.
I developed tinnitus about three weeks after the first injection of the Moderna vaccine into my left arm. I received the second dose in my right arm on April 15. The ringing in my ears has persisted since then. The four days leading up to the sudden onset of the tinnitus were the most stressful of my life, for non-vaccine related reasons. I wonder if the extreme anxiety may have played a role in the onset of tinnitus. The volume of the ringing can vary. It sometimes appears to be mainly in the left ear, but sometimes it's in both.
Patient has seen 15 doctors who were treating her for each condition. This had to stop and we had to get to the root of this problem. To cover just a snapshot of her treatment this last year, she has had an endoscopy and ultrasound and we started seeing a naturopathic doctor that did Electro- Dermal Scanning  and later saw another group of doctors at Medical Center that have put her on different supplements and year later, she is slowly improving BUT her high heart rate has gotten worse so we are seeing a cardiologist next week to make sure. She has done acupuncture, lymphatic massage, lymphatic dry brushing and lymphatic heat treatment, heat therapy, detox baths and saunas, chiropractic, SO MUCH BLOOD-WORK, homeopathic treatments, saliva panels, breath tests and urine tests.
hot flash; skin ache; hormonal balance if off; barely got good quality sleep; fatigue; muscle pain; joint pain; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flash), PAIN OF SKIN (skin ache), HORMONE LEVEL ABNORMAL (hormonal balance if off), INSOMNIA (barely got good quality sleep) and FATIGUE (fatigue) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic reaction to drug.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HOT FLUSH (hot flash), PAIN OF SKIN (skin ache), HORMONE LEVEL ABNORMAL (hormonal balance if off), INSOMNIA (barely got good quality sleep), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (low grade fever). At the time of the report, HOT FLUSH (hot flash), PAIN OF SKIN (skin ache), HORMONE LEVEL ABNORMAL (hormonal balance if off), INSOMNIA (barely got good quality sleep), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (low grade fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient stated genetis history of  teradoxic reaction. No concomitant medications reported. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
chills; fatigue; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (fatigue) and DIARRHOEA (diarrhea) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 027821A.) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 15-Apr-2021, the patient experienced CHILLS (chills), FATIGUE (fatigue) and DIARRHOEA (diarrhea). At the time of the report, CHILLS (chills), FATIGUE (fatigue) and DIARRHOEA (diarrhea) outcome was unknown.            No concomitant medication are taken. No treatment medication are taken.   This case was linked to US-MODERNATX, INC.-MOD-2021-079488 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079488:First dose  (Deleted from the system)
within 10 minutes, had trouble breathing and tingling hands.  got Benadryl shot and then had shakes throughout body. rising blood pressure. admitted to ER. After approximately 4 hours it subsided.
COVID Arm. Large 4 inch red reaction at the injection site.  Warm to the touch and slightly swollen
Fatigue, intolerance to exercise,  mild difficulty breathing while walking and speaking, cough and feeling of chest tightness (similar to congestion, but without any medical signs of it)
Information has been received from a registered nurse concerning a 4-year-old white female with no allergies or medical history who on 27-Jan-2003 between 13:00 and 14:00 was vaccinated with a first SC in the right thigh with MMR vaccine live (lot 641628/063M). Concomitant therapy at the same time included a third dose IM in the left thigh of diphtheria toxoid (+) pertussis acellular vaccine (+) tetanus toxoid (Tripedia) (HDTPA575A2), a third dose IM in the left thigh of inactivated poliovirus vaccine (IPOL) (HW0334-2) and a third dose IM in the right thigh of HIB conj vaccine (tet toxoid) (ACTHIB) (HUA715AA). There was no illness at the time of vaccination and no other concomitant medications. It was reported that, in February 2003, between 09:00 and 10:00, the child developed red dots over her entire body. This was 1.5 to 2 weeks after receiving the vaccines. The red dots started on the legs then moved to her stomach. Symptoms lasted one week and the patient recovered. There were no labs or diagnostic tests performed. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. The patient was vaccinated with GARDASIL first dose on 07-SEP-2010, second dose on 05-NOV-2010 and third dose on 16-MAR-2011 (concentration, route of administration lot# and expiration date were not reported). On 06-OCT-2017, the patient was vaccinated with a dose of GARDASIL 9 lot # M017983, expiration date 30-MAY-2018 (concentration and route of administration were not reported). No adverse effects were reported. The outcome of interchange of vaccine products and extra dose administered was unknown.
Less than 5 minutes after vaccine, nose drained, weird taste in mouth, tingle in nose and on tongue. Throat and tongue swelled, couldn?t speak. Dizzy and slurring speech. Was taken to ambulance outside, BP was 191/101. Given beta blockade. Confused and dizzy for next 2 hours in ER. Evaluated for stroke and given a 12-lead ECG. Given benedryl and prednisone.  Felt better after 3 1/2 hours. Continued steroids for 5 days and had to take benedryl every 4 hours for 3 days or swelling/itching/bad taste in mouth would return. Sore arm on day 3.
Facial rash within 24 hours of administration. Rash looks like a sun burn.
16may90 pt vax hepta B. pt devel nausea and diarrhea which cleared spontaneously in 3-4 day.
Redness and swelling from shoulder to halfway to the elbow. Area is warm and itchy.
Itchy rash at injection site on the muscle; Lost 5 pounds; Intestinal gas pains; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Lost 5 pounds), GASTROINTESTINAL PAIN (Intestinal gas pains) and RASH PRURITIC (Itchy rash at injection site on the muscle) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced WEIGHT DECREASED (Lost 5 pounds) and GASTROINTESTINAL PAIN (Intestinal gas pains). On 06-Feb-2021, the patient experienced RASH PRURITIC (Itchy rash at injection site on the muscle). At the time of the report, WEIGHT DECREASED (Lost 5 pounds), GASTROINTESTINAL PAIN (Intestinal gas pains) and RASH PRURITIC (Itchy rash at injection site on the muscle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Loss of hearing in my Left ear.  I have had recent hearing test that documented sudden loss and f/u appt with ENT doctor confirming loss.   He put me on high dose prednisone for the past week and no changes to date.
After giving vaccination, while he was waiting in line on pharmacy register, he felt dizzy/lightheaded, chill and was having cold sweats. He sat down on a chair about 30 minutes just to relax.  Before the shot, he was pretty nervous about getting vaccinated (needles) and his fiance told me that he hardly gets vaccinated in the past because he is afraid of needles. She was not sure if his reaction is because of his nervousness about the vaccine or if it is an allergic reaction. I told his fiance who was with him the whole time, to take him to the ER if he is having hard time breathing or if his dizziness gets prolonged.  I tried calling patient and her fiance  on 5/10/21 vaccination day, and 5/12/21 again and left message to follow up but no answer/ call back.
Pt recvd Td 23AUG91 & c/o feeling of tightness &/or crampy feeling along lower rib cage, same feeling in neck & shoulder area, feeling is emphasized upon taking a deep breath, unable to sleep; dx Pleuritic chest pleural pain & fever;
Three months after the vaccine, I started to get a blurry left eye and a week later I got a smaller one in my right eye. Within a week of noticing the blurry eye I went to the doctor and they found floaters in both eyes. The doctor said that it was nothing they can do and hopefully in time it would just go away.
PASSED AWAY ON HOSPICE SERVICES WITH COMFORT MAINTAINED ON 11/23/2021
Received Hep B and Flu for first time. Approx 20 minutes after, started itching on torso. Arrived home later pm discovered numerous hives, torso, back, legs, arms. No fever, no resp distress, no local reactions. Called health access took Benadryl, SXS relieved but have reappeared. Continues with Benadryl. Contact DR for advice direction for future IMS.
Moderna COVID-19 Vaccine EUA Joint pain mainly in the knees. It has been ongoing since the onset about 3 weeks after my first dose. I'm unable to run due to the pain and walking is mildly uncomfortable with walking up and down stairs being particularly painful. I have never experienced joint pain of any note prior to this onset and have never had issues that prevented me from being active.
MILD HEADACHE; 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: Unk) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-MAR-2021, the subject experienced mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild headache. This report was non-serious.
Pfizer vaccine administered after being stored at regular freezer temps longer than recommended. Doses determined invalid, client contacted and recommended repeat dose.
Rash & urticaria pruritus. Cephalexin 500 mg QID.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 05-JAN-2016, it was reported that the patient received an improperly stored dose of M-M-R II, lot # L015282, exp date on 30-APR-2017. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Only 3 doses of MMR II were administered. The registered nurse also reported temperature excursion. High temperature excursion: Temperature: 14C Time frame: 11 hours. Low temperature excursion: Temperature: IC Time frame: 11 hours. This is one of several reports received from the same source. Additional information has been requested.
Erythematous, maculopapular rash on face, trunk, extremities. Also, an indurated, erythematous area at injection site right thigh.
Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium
COVID infection - fever, cough, myalgias, headache.  Received monoclonal antibodies on 4/19/22.  Acute symptoms have improved but continued exercise intolerance and daytime sleepiness.
accelerated heart beat; blood pressure also went up; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (accelerated heart beat) and HYPERTENSION (blood pressure also went up) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included DILTIAZEM HYDROCHLORIDE (CARDIZEM CD), DULAGLUTIDE (TRULICITY), EMPAGLIFLOZIN (JARDIANCE), METFORMIN, LOSARTAN and ROSUVASTATIN for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced HEART RATE INCREASED (accelerated heart beat) and HYPERTENSION (blood pressure also went up). At the time of the report, HEART RATE INCREASED (accelerated heart beat) and HYPERTENSION (blood pressure also went up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Blood pressure measurement: 130/80 (High) Normal 117/80. On 26-Jan-2021, Tachycardia: 99/120 (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not provided.
I started to have chest pains a few hours after the shot.  After a night's  sleep, they subsided. I was perfectly fine on Saturday then went to work out on Sunday morning.  I started having shortness of breath and a tight chest for most of Sunday
Severe erythema, burning and itching from inj site down the arm. (Also swelling) saw PA and received steroid shot and antibiotic on 9/23, and saw her again on 9/25 and was given a dif. antibiotic. 103 degrees oral temp on 23rd. Much improved on 9/25. 1st antibiotic- BACT SC - 2nd CLEOCIN 300.
Information has been received from a physician's office manager concerning a female who on 20-MAY-2008 was vaccinated intramuscularly with the first dose of GARDASIL vaccine (yeast). There was no concomitant medication. The patient felt dizzy afterwards, however that went away. On 22-JUL-2008 the patient was vaccinated intramuscularly with the second dose of GARDASIL vaccine (yeast) and has been dizzy ever since. Unspecified medical attention was sought. Additional information has been requested.
6/10/10 patient seen in office for ER follow-up from 6/9/10 for fever > 104 and diarrhea. CBC, UA, UC ordered and were NML. Home on Motrin prn and advised recheck if not better in 2-3d. In office 6/14 with continued fever > 104, diarrhea 6-8 x/day and rash. Stool samples obtained and positive Rotavirus detected 6/15/10.
About 45 seconds after administering the vaccine, the patient alerted me that she was going to pass out. She laid back into her chair and started to have a seizure. Her seizure lasted for about 45 seconds. When she came to she was confused about what happened and said she was very hot. Her heart rate increased and she was sweating. We called an ambulance and they arrived to the scene in about 2 minutes. They assessed her vitals and had her lay down while drinking water and eating a snack. The patient left about 20 minutes later in a wheelchair, but was cleared by the EMTs.
5 hours after second vaccine, developed, fever, hot and cold flashes, and nausea without vomiting. Symptoms lasted 24 hours. Called Ask a Nurse line.
Redness / erythema; pruritis; This case was reported by a pharmacist and described the occurrence of localized erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced localized erythema and localized itching. On an unknown date, the outcome of the localized erythema and localized itching were recovered/resolved.   It was unknown if the reporter considered the localized erythema and localized itching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and had a significant localized reactions of redness/ erythema and pruritus, which lasted for 1 week. The patient was concerned about receiving her 2nd dose. Per the package insert, these events did occur in 1% of patients receiving Shingrix, but wondering if there was any information to support that this may lead to a more significant and/or allergic response when the 2nd dose would be given.
I passed out about 45 minutes after the shot while driving my car to work.  There was no warning.  I left the road and woke up  in a horse pasture still with my foot on the accelerator about 10 seconds after passing out . I was not hurt.