chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Numerous outbreaks of cold sores that the patient had never experienced before; This is a spontaneous report from a contactable other healthcare professional, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EL3249) via an unspecified route of administration in the left arm on 03Feb2021 at 15:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin and cold sores on unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the left arm on 14Jan2021 at 12:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 05Apr2021 at 12:00, the patient experienced numerous outbreaks of cold sores that the patient had never experienced before. The patient usually got cold sore once a year. But for the past 3 weeks the patient reported to have had 4-5. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  Therapeutic measures were not taken as results of events. The clinical outcome of the event numerous outbreaks of cold sores that the patient had never experienced before was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Muscle aches, muscle pains, hand shakes, muscle tension, fatigue, weakness, started 9/16 continues to have fatigue, dizziness, lightheaded
redness, swelling & 2 tender nodules @ site;redden area about the size of orange, 7 1/2cm;
Client received Flu shot at work. States she had a back ache a week to week and 1/2 after she received the vaccine states back felt worse than usual. Client states she took ALEVE - went to work and felt good on Oct 8, 2011. On Oct 9, 2010 she got up at 5:00AM to go to the bathroom and her left leg was numb and tingly. She states her right leg also became numb and tingly - 1 hour later she was unable to walk and went to the ER by ambulance. Client states the ER doctor thought it was GUILLAIN-BARRE. Client was hospitalized for 3 weeks. She had 3 MRI's and Cat scan and ultrasound of her leg. Her neurologist said it was transverse myelitis from the flu shot. She is still using a walker now and has a lot of pain. Her right leg is still numb. Client states she can't stand long without hurting. States the (R side of her) abdomen and buttox is numb, her groin area is painful. She states her skin is sensitive to hot and cold and she is in therapy. She states she is very unsteady and unbalanced. She states she had a catheter for 1 month now that is out - states her bowel is effected.
Initially I experienced pain and soreness at injection sites with difficulty using the arm which received the vaccine. I also had headaches, brain fog, confusion, fatigue, increased tinnitus. I was in good health with excellent blood work and a perfect BMI of 20; and a perfect Blood pressure (120/80) even two weeks after the last day of experiencing any symptoms from a prior COVID infection. I exercise 5 days a week, I am vegan, I am 5 ft 4.5 inches tall & weigh 120.  I never had high blood pressure in my entire life. After the 2nd Pfizer vaccine on 9/22/2021, I noticed an increase in brain fog and extreme forgetfulness (though intermittently experienced it was very disturbing as I hold 2 doctoral degrees). I also started to experience more headaches and a slow but steady increase in joint pain in my fingers; then more joint pain where I had not had it before (elbows, back of my knees, shoulders and cervical & lumbar spine). By December of 2021, I had extreme swings in high blood pressure (ranging from 148/87 to 207/101, and I have not stabilized since December 2021. I was treated with Lisinopril 5 mg every day in December 2021, but required an increase to  10 mg and by Jan 2022, increase to 40 mg; headaches, dizziness, vision problems, muscle aches, joint pain
Child was seen 2 days after immunization. He had an area 12 cm x 19 cm of erythema, swelling, increased temperature on left thigh. He had received BENADRYL at home. He was alert, playful and in NAD. No further treatment ws necessary.
Tingling sensation; Numbness in left foot; moved into right foot and left leg; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation), HYPOAESTHESIA (Numbness in left foot) and MOVEMENT DISORDER (moved into right foot and left leg) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation in 2015 and Cardiac ablation in June 2016. Concurrent medical conditions included Food allergy (Gluten). Concomitant products included PROTANDIM for Antioxidant therapy, CALCIUM, MAGNESIUM, GLUCOSAMINE, MYROXYLON BALSAMUM SYRUP, TERPIN (TERPINE), COLECALCIFEROL (D3), ASCORBIC ACID (C VITAMIN) and VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced MOVEMENT DISORDER (moved into right foot and left leg). On 07-May-2021, the patient experienced PARAESTHESIA (Tingling sensation) and HYPOAESTHESIA (Numbness in left foot). At the time of the report, PARAESTHESIA (Tingling sensation) and MOVEMENT DISORDER (moved into right foot and left leg) had not resolved and HYPOAESTHESIA (Numbness in left foot) outcome was unknown. Not Provided          No treatment medications were provided.   This case was linked to MOD-2021-023882 (Patient Link).
Widespread erythematous, pruritic rash and joint pain/fatigue developed 5 days post injection
pt seen in office on 30JUL & 1AUG97;1AUG97 T & h/a x 3d;pt had LP which was negative x/for 20WBC in CSF w/73% mono WBC's-pt observed in hosp x 2d;dx viral meningitis;
Two-month-old was found by family unresponsive in bed. Family stated pt had his first set of vaccines 7-10 days prior to event. Pt was coded, intubated and CPR was performed, but pt did not respond. Pt was taken to hospital in cardiac arrest. Pt also commonly slept in bed with other family members. COD as per autopsy report was SIDS.
Chronic coughing got worse; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Chronic coughing got worse) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056M21A, 020B21A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic cough. Concomitant products included PANTOPRAZOLE for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced COUGH (Chronic coughing got worse). The patient was treated with BENZONATATE (TESSALON PERLE) in 2022 for Cough aggravated, at an unspecified dose and frequency and HYDROXYCHLOROQUINE in 2022 at an unspecified dose and frequency. At the time of the report, COUGH (Chronic coughing got worse) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Antinuclear antibody: (Positive) Positive. In 2022, Blood test: (Negative) negative.         It was reported that after receiving the first booster dose on 06-Apr-2022, the patients chronic coughing got worse. For this reason the patient visited patients primary HCP, who prescribed the medicine, Tessalon Perles. This medication had not helped the patient. The patient then visited physicians office and was prescribed with oral steroids and this made the patient feel better. They did a specific antibody test and could find any positive.The HCP referred the patient to a rheumatologist and an immunologist. The doctor did another blood work test and it came back negative, after which they put the patient on an experimental drug, Hydroxychloroquine. The patient had already been 10 days with this treatment and saw no changes.   This case was linked to MOD-2022-612788 (Patient Link).
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL for prophylaxis (lot number K006960, expiration date 19-FEB-2017; dose and route of administration were not reported). Reporter was unsure whether GARDASIL or GARDASIL 9 (captured in case MARRS # 1701USA005205) was administrated. Administered doses of vaccines experienced the following temperature excursions: on 15-DEC-2016 of 11 degrees Celsius for 4 hours 13 minutes, on 16-DEC-2016 of 11 degrees Celsius for 9 hours 20 minutes, on 29-DEC-2016 of 11 degrees Celsius for 3 hours 37 minutes, a total  temperature excursion was 17 hours 10 minutes cumulative hours in more than 8 degrees Celsius and less than 25 degrees Celsius. Data logger was involved. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA001537: US-009507513-1701USA005207: US-009507513-1701USA005205.
Moderate pain at the injection site for two days. Developed a rash on at injection site 9 days after. Itching comes and goes and is not severe itching. Very mild.  The rash is about 3 inches by 2 inches in size.
REDNESS AT THE INJECTION SITE; TENDERNESS AT THE INJECTION SITE; SWELLING AT THE INJECTION SITE; 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, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced redness at the injection site. On 30-APR-2021, the subject experienced tenderness at the injection site. On 30-APR-2021, the subject experienced swelling at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from redness at the injection site, swelling at the injection site, and tenderness at the injection site. This report was non-serious.
Shingles: Blistery rash on lower right side, shooting nerve pain, skin sensitive all on right side.
27AUG98 mom called to report child rt upper arm was red w/a raised area the size of a quarter;advised to apply ice to the area & use child APAP;later in the day raised area increased to the size of fifty cent piece;
At about 10 pm I began loosing feeling in my left arm. It starts at the injection site and the numbness and tingling runs down into my hand and finger tips. It's now 3 pm the next day and it's only getting worse as I use it.
pt called stated she got COVID vaccine on 1/16/21, she stated that at the time of receiving the vaccine she had immediate neurological reactions, such as dizziness, lightheadedness, loss of consciousness, she had someone come pick her up that day and since then she has not been able to get over the dizziness and lightheadedness. Per reasons why not to vaccinate recommended pt not get 2nd dose. Also recommenced pt go see PCP, she stated she is taking Dramamine and it is helping at this point she will make appt if symptoms worsen
This spontaneous report as received from a pharmacist refers to unknown number of patients. Pharmacist reported that ZOSTAVAX has been stored in their facility and temperatures had never been recorded. Some ZOSTAVAX was stored at an unknown temperature for an unknown period of time and administered to an unknown number of patients. Other ZOSTAVAX (Lot#J000853 with expiration of 23-APR-2014 & Lot# J000494 with an expiration of 14-APR-2014 was stored since about 30-APR-2013 at unknown temperatures. During this whole time period 20-30 patients were vaccinated. No adverse effect reported. Outcome was unknown. Additional information has been requested.
Adult dose of Hep-B (20mcg/1mL) 1mL syringe administered to child.
PAIN IN BACK; PAIN IN LEFT HIP AND SHOULDER; DRAGGING FOOT; This spontaneous report received from a patient concerned a 65 year old male. 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: 1805029, expiry: not reported) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced dragging foot. On 28-MAR-2021, the subject experienced pain in left hip and shoulder. On 28-MAR-2021, the subject experienced pain in back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in back, and pain in left hip and shoulder, and the outcome of dragging foot was not reported. This report was non-serious.
Information has been received from a certified medical assistant concerning a 6 month old male, with no medical history and no allergies, who was vaccinated with a first and second 2 ml oral dose of Rotateq (Lot# 654422/0607F and 656187/1237F) on 16-JAN-2007 and 19-MAR-2007, respectively. Concomitant therapy included Tylenol as needed. On 28-APR-2007 the patient was taken to the emergency room and was transported to another facility that was equipped to handle children. The patient was hospitalized and underwent surgery to correct intussusception. It was reported that a nurse mentioned that the child was seen on 21-MAY-2007 for a well check up and was still recovering at that time. It was noted that the patient was due for a third dose of Rotateq, but the physician decided not to complete the series. No product quality complaint was involved. No other information was provided. The patient's intussusception was considered to be an other important medical event by the reporter. Additional information has been requested. A lot check has been requested.  6/14/07 Received medical records via fax from CDC which reveal patient experienced abdominal pain w/bilious emesis x 1 day.  Seen at outlying ER where UGI films were neg & stool was + for occult blood.  Admitted 4/20-5/2/07.  Taken to OR for operative reduction of ileocolic IS & appendectomy.  Progressed well & d/c to home. FINAL DX: Intussusception. 6/14/07 Received medical records of ER visit via fax from CDC which reveals patient experienced congestion, bilious vomiting, fever & crampy intermittent abdominal pain w/difficulty sleeping.  Transferred to higher level of care.
Listlessness, paleness, vomitting, unresponsive, no eye contact. Lasted a few minutes, until EMS arrived. All his vitals were fine, but he was still unaware of surroundings. Then he slept for a couple of hours.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The healthcare worker reported that the patient received the first dose of GARDASIL (lot# unspecified) on 23-AUG-2012 the second dose of GARDASIL (lot# unspecified) on 25-FEB-2013 and the third dose of GARDASIL (lot# unspecified) on 30-APR-2013. No adverse event reported. The outcome of the patient was not reported. Additional information has been requested.
This is a spontaneous report received from a contactable consumer (patient) via Pfizer-sponsored program support. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration in left arm on 09Feb2021 as single dose for COVID-19 immunization. Patient medical history and the patient concomitant medications were not reported. It was reported that, just patient got the 1st dose last week 09Feb2021 and she was reporting about the schedule for the second dose that is more than 3 weeks on 09Mar2021. The patient experienced an arm sore on her left arm where the vaccine was administered. The event was considered as a non-serious. The outcome of the event was reported as unknown. Information about lot/batch number has been requested.
The patient forgot she had already received a flu shot in November along with the covid booster. Patient showed up, filled out a consent form to get a flu vaccine. During counseling patient was asked whether she had received flu vaccine this year and response was no.
He has a sore arm after the injection; My husband had a breakthrough COVID-19 infection; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (My husband had a breakthrough COVID-19 infection) and VACCINATION SITE PAIN (He has a sore arm after the injection) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     Concurrent medical conditions included Kidney failure (stage 4 kidney failure). Concomitant products included ATORVASTATIN, GLIPIZIDE, ALLOPURINOL, CHLORTALIDONE (CHLORTHALIDONE), SODIUM BICARBONATE and IXEKIZUMAB (TALTZ) for an unknown indication.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Sep-2021, the patient experienced COVID-19 (My husband had a breakthrough COVID-19 infection). On an unknown date, the patient experienced VACCINATION SITE PAIN (He has a sore arm after the injection). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for No adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (My husband had a breakthrough COVID-19 infection) had resolved and VACCINATION SITE PAIN (He has a sore arm after the injection) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications provided by the reporter.  Company comment: This case concerns a 69-year-old male patient, with medical history of kidney failure, who experienced the non-serious, unexpected AESI event of Covid-19, 1 month after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient also suffered from injection site pain, on unknown date after the vaccine. The patient's age and history of kidney failure may have increased his risk of getting Covid-19 infection. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-416131 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Dec-2021: Reporter details and second dose date, events and treatment medication were updated; Sender's Comments: This case concerns a 69-year-old male patient, with medical history of kidney failure, who experienced the non-serious, unexpected AESI event of Covid-19, 1 month after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient also suffered from injection site pain, on unknown date after the vaccine. The patient's age and history of kidney failure may have increased his risk of getting Covid-19 infection. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Blood clot (DVT), lower left leg. Symptoms began Nov. 1, 2021 (6 months after the second Moderna vaccine dose).
Patient received annual flu shot. Patient was a little nervous about getting the flu shot. Patient stated that he did not see the needle. He stated that he felt a little prick. After getting the shot, he walked out of the immunization room stating that he felt okay. He walked around the store for a few minutes. After about 3 to 5 minutes, patient starting feeling faint. As patient was walking out of the store, he laid down on the floor. We called 911 and they arrived. They  assessed the patient and talked with him to see how he was feeling. Mom stated that they got the flu shot together every year and that this has never happened before. Afterwards, patient stated that he had not eaten anything. after being assessed, patient walked out of the store with mom to get food. Mom called back later that evening and stated that patient was doing great after he ate.
Approximately 10 to 12 days after my last vaccination I developed Deep Vein Thrombosis in my lower left leg. Utra sounc confirmed the presence of Thrombosis.
Myalgia, Fever, fatigue, facial flushing Narrative:  Facial flushing, fatigue, myalgia, fever to  100.9, arm soreness; resolved in 48 hours.
4 days after receiving the vaccine Patient became fussy, rapid respirations, fever, lethargic, sleeping a lot, running nose, and decreased appetite.  RVP negative and twin sister with no symptoms.
After 4 hours patient said he started having rash on his right arm. He reported it 2 days after and has welts still looks red and he said it is itchy. The other arm is starting to get red but no welts yet
It was reported that a female pt received third dose of Imovax ID vaccine on July 29, 1999. Reportedly 9-10 hours after the vaccination the pt experienced a red bumpy rash on chest and upper abdomen, also redness and itching at the injection site.