chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy skin on several parts of my body; This case was reported by a consumer via call center representative and described the occurrence of itchy skin in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced itchy skin. On an unknown date, the outcome of the itchy skin was unknown.   It was unknown if the reporter considered the itchy skin to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but was selected as adult as per vaccine indication.  The patient received Shingrix vaccine and had itchy skin on several parts of the body (not hives) and asked that this was a common side effect.
Child has a history of milk protein intolerance/bloody stools - had improved on neutramigen but stools still guaiac (+) - 1 day after 2 month vaccines (rotavirus not given) child developed grossly blood stools which have not resolved - stool cx and c diff sent at that time were negative.
The sound attenuates in both loadness and pitch from day to day/Sound in my head that does not go away; Disorientation; loss of memory; inability to focus; It iterferes with sleep and ability to complete complicated tasks.; It iterferes with sleep and ability to complete complicated tasks.; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 27Mar2021 13:00 (Batch/Lot Number: ER2613) as dose 1, single for covid-19 immunisation. Medical history included fibromyalgia, acid reflux, osteoarthritis, attention deficit disorder and allergy. Concomitant medication not reported. On 30Mar2021 at 12:00, the patient experienced disorientation, loss of memory, inability to focus started day after first immunization and has continued. The sound attenuates in both loudness and pitch from day to day.  It interferes with sleep and ability to complete complicated tasks. The sound in her head that does not go away and about 5 days after the first covid-19 immunization, booster caused sound to be loader. He patient underwent CT Scan and MRI, but results were not provided. The patient received pain management medication. The outcome of the events was not recovered.
warm at injection site; flu-like symptoms; respiratory issues; sore arm; red at injection site; tender  at injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm at injection site), INFLUENZA LIKE ILLNESS (flu-like symptoms), RESPIRATORY DISORDER (respiratory issues), MYALGIA (sore arm) and VACCINATION SITE ERYTHEMA (red at injection site) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm at injection site), INFLUENZA LIKE ILLNESS (flu-like symptoms), RESPIRATORY DISORDER (respiratory issues), MYALGIA (sore arm), VACCINATION SITE ERYTHEMA (red at injection site) and VACCINATION SITE PAIN (tender  at injection site.). At the time of the report, VACCINATION SITE WARMTH (warm at injection site), INFLUENZA LIKE ILLNESS (flu-like symptoms), RESPIRATORY DISORDER (respiratory issues), MYALGIA (sore arm), VACCINATION SITE ERYTHEMA (red at injection site) and VACCINATION SITE PAIN (tender  at injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received contains no new information.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 03-FEB-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ lot #L000569, expiration date: 13-JUL-2016 or lot # L022447, expiration date 26-FEB-2017 and with a dose of improperly stored dose of RECOMBIVAX HB lot # L025738, expiration date: 14-AUG-2017 or lot # L029631, expiration date: 14-AUG-2017. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 60 year old female patient. On 07-JUN-2013 the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # J001010, expiry date 24-APR-2014) subcutaneous to the "upper arm". Approximately on 07-JUN-2013, the patient experienced "redness, 10 cm by 5cm, in an oval shape" at the injection site and the redness has lasted "about 7 days now (14-JUN-2013)". There were no lesions or vesicles with the redness. Warm compress was given as a treatment. The patient had sought medical attention via contact pharmacy. The outcome of the patient's adverse events was reported as not recovered/not resolved. This is one of several reports from the same source. Additional information has been requested.
it's feeling the mucus on his system; This spontaneous case was reported by a consumer and describes the occurrence of SECRETION DISCHARGE (it's feeling the mucus on his system) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SECRETION DISCHARGE (it's feeling the mucus on his system). At the time of the report, SECRETION DISCHARGE (it's feeling the mucus on his system) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.
Itchiness occurred on right side of body for a couple of days after first dose.; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in right arm on 04Aug2021 as dose 1, single for COVID-19 immunization (at the age of 37-year-old). Medical history included ongoing asthmatic (Currently asthmatic). No known allergies. No other vaccines within 4 weeks prior to the COVID vaccine. The medications the patient received within 2 weeks of vaccination: Vitamins, ibuterol and anti-histamine. Concomitant medication included budesonide, formoterol fumarate (SYMBICORT). The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since the vaccination. On 04Aug2021, the patient experienced itchiness occurred on right side of body for a couple of days after first dose. It was reported that after second dose, rashes in addition to itchiness occurred at various locations throughout the body. Has been ongoing for a month. The height of the affects are usually in the morning and then taper off throughout the day. Have been taking antihistamine every now and then to help calm the rashes. No idea if this is an allergic reaction to vaccine but am certain these rashes and itchiness did not occur before getting vaccinated. No treatment received for the event. The clinical outcome of the event was not resolved. Follow-up attempts are completed. No further information is expected.
Initial report received from a consumer who is the patient's parent on 07 November 2013. A female patient (age and date of birth not provided), received FLUZONE, lot number UH910AC intramuscularly into the left deltoid on 06 October 2013. The patient had no illness at the time of vaccination and has no pre-existing allergies or medical conditions. Three hours after vaccination, the patient passed out and hit her nose. It is unknown how long patient was passed out. The patient had her nose x-rayed and had a fracture. The patient began putting on weight and gained 17 # (pounds) in 4 days. The patient's face was swollen. The patient developed pink eye on 18 October 2013 and had a severe headache and had nausea. The symptoms resolved on an unreported date. Further details are not available at the time of this report. Outcome was recovered. Documents held by sender: None.
Patient c/o itching ears, scratchy throat, some swelling under her eyes. No SOB, No respiratory distress. The patient was transported to  the ER for observation.
Headaches, ovarian cyst, I'm losing my right ovary due to cysts, heavy periods, backache, fatigue. I wrote all this in the wrong section. Cyst ruptured almost bled to death.
first day was extreme fatigue body aches. then the fatigue got worse and day 3 started with vertigo, dizziness, brain fog ,confusion, racing heart, and extreme exhaustion and headaches every day on and off.  Now on Day 9 and still having the same side effects
This spontaneous report was received from patient's father regarding his 12 years old son. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with 1st dose of GARDASIL 9, intramuscularly, dose; unknown. It was followed by 2nd dose in the series (intramuscularly, dose: unknown), on an unknown date 30 days after the 1st dose. Subsequently on an unknown date, the patient experienced unspecified adverse event. The outcome of the adverse event and causality was not reported. No product quality complaint (PQC) involved. Additional information has been requested.
Pain in armpit. No sense of lumps, but slight pain raising the arm and putting some pressure on the armpit.
pt recvd vax 13MAR95 & 3 days post vax exp hives,swelling o both arms,swollen knuckles,purple knuckles,& wheezing;sx got worse over the next several days;pt was seen in ER 19MAR95 w/hives,wheezing & swelling;treated erythromycin;
Patient is a 75 y.o. female who presented with fever, chills, congestion, SOB, HA, and productive cough for 10 days. In the ED she was hypoxic and provided supplemental oxygen. She was found to be COVID-19+ and CXR showed suspected RLL pneumonia with mild fluid overload, but she was clinically euvolemic. She had a leukocytosis as well. She was started on antibiotics for community acquired pneumonia as well as given IV steroids for acute exacerbation of her underlying COPD and COVID+ status. She was admitted to the hospitalist service for further management and evaluation. At admission she was switched to Decadron and prophylactic dose Lovenox. She was outside of the treatment window for remdesivir. Given her new oxygen requirement and risk of deterioration, treatment was intensified to IV steroids at approx. 1/mg/kg/day and full dose anticoagulation. Antibiotics for CAP coverage were continued with rocephin and doxycycline. She was mildly hyperglycemic d/t steroids and corrective insulin coverage was required. She was also started on IV Lasix 40 mg daily. Albuterol was also scheduled which helped her breathing and SOB as well. Over the course of her hospitalization, she was able to wean back to room air from low flow nasal cannula. Her steroids were weaned and her home dose of PO Lasix was provided on the morning of discharge. She was ultimately discharged home in stable and improved condition with antibiotics to finish CAP treatment as well as a prednisone taper as described above.
woke up in the middle of the night with right side numbness, and drooping face. Was rushed to the ER. Stroke team diagnosed and began treatment of stroke. Had multiple tests run to include arterial ultrasounds, internal echo cardio, and CT and MRI of the brain. Confirmed left side of brain stroke but causes are still unknown. all tests and bloodwork came back normal and within range of an above average healthy adult.
Unable to sleep, 1 day after vaccine began to have body aches and weakness. Fever of 101, headaches. Took Aleve.
dehydrated; lost a pound; worst panic attack; panic attack; pain at injection site, especially when lifting arm; nausea; moderate headache; fatigued, slight fatigue; couldn't sleep; severe panic attack; loss of appetite; sleepy, sleepy through next 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of PANIC ATTACK (severe panic attack), DECREASED APPETITE (loss of appetite), SOMNOLENCE (sleepy, sleepy through next 24 hours), DEHYDRATION (dehydrated) and WEIGHT DECREASED (lost a pound) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Panic disorder, Anxiety, Emetophobia and Obsessive-compulsive disorder. Concomitant products included LAMOTRIGINE (LAMICTAL), LORAZEPAM (ATIVAN), ONDANSETRON (ZOFRAN [ONDANSETRON]), BETANIDINE SULFATE (REGULIN [BETANIDINE SULFATE]), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), DIHYDROERGOCRISTINE, LOMIFYLLINE (ANTIVERT [DIHYDROERGOCRISTINE;LOMIFYLLINE]) and PROMETHAZINE (PHENERGAN [PROMETHAZINE]) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PANIC ATTACK (severe panic attack), DECREASED APPETITE (loss of appetite), SOMNOLENCE (sleepy, sleepy through next 24 hours), INSOMNIA (couldn't sleep), VACCINATION SITE PAIN (pain at injection site, especially when lifting arm), NAUSEA (nausea), HEADACHE (moderate headache) and FATIGUE (fatigued, slight fatigue). On 13-Mar-2021, the patient experienced PANIC ATTACK (panic attack). On 14-Mar-2021, the patient experienced PANIC REACTION (worst panic attack). On 15-Mar-2021, the patient experienced DEHYDRATION (dehydrated) and WEIGHT DECREASED (lost a pound). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. On 15-Mar-2021, DECREASED APPETITE (loss of appetite) had resolved. At the time of the report, PANIC ATTACK (severe panic attack), SOMNOLENCE (sleepy, sleepy through next 24 hours), DEHYDRATION (dehydrated), WEIGHT DECREASED (lost a pound), INSOMNIA (couldn't sleep), PANIC ATTACK (panic attack), PANIC REACTION (worst panic attack), VACCINATION SITE PAIN (pain at injection site, especially when lifting arm), NAUSEA (nausea), HEADACHE (moderate headache) and FATIGUE (fatigued, slight fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Zofran and Fenergan is also given as treatment medication.
intense itching (keeps awake @ noc);3hr p/vax took zyrtec & DPH;no swelling @ site;
Saturday patient started having swelling, redness and inflammation of the left arm with difficulty raising arm. patient stated that it got better by Monday. Patient applied cold compress 15-20 minutes about 4 times a day.
Brain aneurysm; Anaphylactic reaction; Collapsed; BP sky rocketed; Shortness of breath; A spontaneous report was received from a consumer concerning a 69-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced blood pressure skyrocketed, shortness of breath, loss of consciousness, massive anaphylactic reaction, and brain aneurysm.    The patient's medical history, as provided by the reporter, included high blood pressure and arthritis. Products known to have been used by the patient, within two weeks prior to the event, included an antihypertensive.   On 04 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  Twenty-two minutes later she had a massive anaphylactic reaction. She experienced shortness of breath, blood pressure skyrocketed, and loss of consciousness. She was taken to the emergency room. The patient had a brain aneurysm and never recovered. No treatment information was provided.   The patient died on 04 Jan 2021. The cause of death was reported as brain aneurysm. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns a 69-year-old, female patient with a medical history of hypertension, who experienced fatal, serious, unexpected events of Anaphylactic reaction, hypertension, dyspnea, loss of consciousness and brain aneurysm. The events occurred 22 minutes after the first dose of mRNA-1273 was administered. No treatment information was provided. The patient never recovered and died. The cause of death was reported as brain aneurysm. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Additional information has been requested.; Reported Cause(s) of Death: Brain aneurysm
Arm was swollen; Hot; Rash around the injection site; Rash also pushed down to her elbow; Sore; Sore arm; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Arm was swollen), FEELING HOT (Hot), VACCINATION SITE RASH (Rash around the injection site) and RASH (Rash also pushed down to her elbow) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 10-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen), FEELING HOT (Hot), VACCINATION SITE RASH (Rash around the injection site), RASH (Rash also pushed down to her elbow) and PAIN (Sore). The patient was treated with CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) on 11-Mar-2021 for Rash, at a dose of 10 mg and CORTISONE (topical) for Rash, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved and PERIPHERAL SWELLING (Arm was swollen), FEELING HOT (Hot), VACCINATION SITE RASH (Rash around the injection site), RASH (Rash also pushed down to her elbow) and PAIN (Sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Reportedly, patient sent a picture to her MD to see if she needed any aggressive treatment.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB strength: 2.5mcg/0.5 ml (dose, route of administration and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Hives; This is a spontaneous report from a contactable consumer (huband). A 62-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number and Expiration date was not reported) via an unspecified route of administration in left arm on 25Feb2021 (at the age of 62 years old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took historical vaccine on first dose of BNT162B2 on 04Feb2021 for covid-19 immunisation. On 26Feb2021 the patient experienced, After her second dose last Thursday, the hives came back, they are causing her no discomfort, he just wanted to report it. Patient started treating hives with calamine lotion late night 28Feb2021. Caller states it is not serious. The patient received treatment for the event hives with calamine lotion. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This is a spontaneous report received from a non-contactable consumer via a Pfizer-sponsored program. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. Medical history included ongoing blood pressure (BP) increase (BP was already going up). The patient's concomitant medications were not reported. It was reported that the patient received first dose of COVID vaccine and then his blood pressure went up for a day or two on an unspecified date. The patient's BP was already going up as he keeps track of it and thinks it's a coincidence but was just checking if this can happen. The outcome of the event was unknown.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
The pt experienced irritability and fussiness at night was up several time. Won't sleep lying down.
Little weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Little weak) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced ASTHENIA (Little weak). At the time of the report, ASTHENIA (Little weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Patient (a primary care patient) called our center c/o body aches, soreness, headaches x 5 days after receiving second Pfizer vaccine on 6/21 (from a provider in the community) . Patient also reported constant chest tightness that started yesterday. Per patient, chest tightness feels similar to when he had bronchitis as a child. Pain is tolerable and does not radiate anywhere else, patient stated it is located at the sternum. Denies difficulty breathing. Patient does not sound in distress. Patient denies fever, swelling of face, rash.  Patient reported he has not taken any OTC medication to relieve his symptoms.  I consulted with MD, was concerned of his chest pain and the possibility of myocarditis from the vaccine.  Patient was highly recommended to seek ER ASAP due to his constant chest pain for more than 24 hours.  Patient verbally agrees to go to hospital now. I encouraged him for me to call EMS but patient stated he is well enough to have someone drive him and will call a service.
Noc p/DTP/OPV/HIB got fever t103 ax, screamed; could only be comforted w/ice on legs for few min; both legs swelled up size of silver dollar & were reddened;