chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen lymph nodes under left arm; This is a spontaneous report from a contactable non-Health care professional. A 49-year-old patient (gender unspecified) received BNT162B2 (BNT162B2), Lot/batch no: En6207, via an unspecified route of administration in the left arm on 14Mar2021 at 08:00 (at the age of 49-years-old) as second dose, single for COVID-19 immunization. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included omeprazole + sodium bicarbonate (ZEGERID) and melatonin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient's past drug history included BNT162B2 (BNT162B2), Lot/batch no: El9266), first dose, single via an unspecified route of administration in the Left arm on 20Feb2021 at 16:00 for COVID-19 immunization. On 15Mar2021 at 07:00 the patient experienced Swollen lymph nodes under left arm. The patient did not receive treatment for the event. The patient was recovering from the event at the time of this report. No follow-up attempts are needed. No further information is expected.
I developed a red rash all over my back. It was not itchy. When my body doesn't like something, it usually reacts through my skin - either through hives or a rash. The rash lasted about 2 days then went away.  Ever since I got this vaccine, my menstrual cycle has not been the same. They have become irregular. I experience fatigue, headache and cramps the first few days. In between periods, I experience cramping.
This spontaneous report as received on 03-DEC-2014 from a consumer refers to a 40 year old female patient with multiple sclerosis, fibromyalgia, reactive arthritis and no known drug allergies. On 11-NOV-2014 the patient was vaccinated with PNEUMOVAX 23. Concomitant therapies included COPAXONE, ibuprofen and HYDROCORTONE. On 17-NOV-2014, 7 days after onset of therapy the patient experienced coughing and bronchial spasms. On an unspecified date the patient sought medical attention at an urgent care facility and received unspecified lab tests. The patient was treated with azithromycin. The outcome of coughing and bronchial spasms is unknown. Additional information has been requested.
Nausea, Headache, Weakness, Shortness of breathing, elevated heart rate, light-headed. Just felt bad (Still having some of these problems)
Approximately one week after Dose #2 of Pfizer COVID-19 vaccine, I developed a large Arthus reaction at the injection site.  At the same time, I developed large hives on the arms and legs with intense itching.  This was fairly consistent with a Type III Hypersensitivity Immune Reaction.  I had the hives for approx 36 hours.  they did improve with Benadryl and Zyrtec.  I would not have reported this except I was asked to report it by the people who were doing the vaccine monitoring by the CDC.
blepharospasm- ataxia of the eyelids; apraxia of the eyelid; This is a spontaneous report from a contactable consumer (patient's father). A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EWO185), via an unspecified route of administration on 14May2021 (at the age of 17-year-old) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: ER8737), on 03Apr2021 (at the age of 17-year-old) as single dose for COVID-19 immunization. The reporter stated that 1 to 2 weeks after the second dose his son began having a side effect diagnosed as blepharospasm- ataxia of the eyelids in May2021. Both eye lids were involved. He stated that it had not gotten any better since it began at the end of May. He stated that his son (patient) had to physically hold his eyelids open with his hands or apply pressure or physical stimulation to the side of the area to cause the muscle to stop contracting. He recently had Botox injected to cause the muscles to relax and provide some relief but he stated that this was temporary. He stated that they had been back and forth to the doctor and he had had a neurological work up which provided so answers. He had seen an optical surgeon as well. The reporter stated he had gone through all the doctors and neurologists and no one could make sense of it. He stated that it was unmanageable. The patient started process a month ago to get labs and went through doctor, his eyes would close and if he pushed his knuckle to side of head it would trigger them to open. The reporter stated that when looking at the CDC website he saw there were around 400 reports of this occurring. He would like to know if there was any data on this or anything that may be related to helpful to his sons case. The outcome of the events was not recovered.
(L) upper arm sore, red, swollen. No temp change. Improving slowly with ice and steroid taper.
Mom calls on 7/28/17 and reports that child is not acting right. States that child developed symptoms on 7/27/16 of a rash (neck, check, stomach, and back), decreased appetite, Diarrhea, Vomiting, fever (controlled by Tylenol), and excessive tiredness. Is drinking fluids.
Patient indicated on 1-31-13, that she had this reaction and would stop by to discuss. On 2-4-13, we called her and she said she felt tingling and numbness in her right arm shortly after she received the shot. She said she had limited degree of motion and still has this. Her family MD told her not much they could do, and she said she is getting better.
lump the size of a silver dollar at injection site; dizzy; No energy; itchiness at injection site; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (lump the size of a silver dollar at injection site), DIZZINESS (dizzy), ASTHENIA (No energy), INJECTION SITE PRURITUS (itchiness at injection site) and INJECTION SITE ERYTHEMA (redness at injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-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 INJECTION SITE MASS (lump the size of a silver dollar at injection site), DIZZINESS (dizzy), ASTHENIA (No energy), INJECTION SITE PRURITUS (itchiness at injection site) and INJECTION SITE ERYTHEMA (redness at injection site). The patient was treated with MAGNESIUM SULFATE (EPSOM SALT) for Injection site pruritus, at an unspecified dose and frequency. At the time of the report, INJECTION SITE MASS (lump the size of a silver dollar at injection site), DIZZINESS (dizzy), ASTHENIA (No energy), INJECTION SITE PRURITUS (itchiness at injection site) and INJECTION SITE ERYTHEMA (redness at injection site) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-179851 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up information received on 27-MAY 2021 contains event outcome details updated to recovered from unknown. Treatment information was updated.
felt faint, laid down;BP 54/42, water & cookie given;watched & monitored until BP 102/76;vasovagal synd rxn;pt hungry, rushed & stressed;
Patient presents with a potential reaction to the COVID19 vaccine. I was called to the patient's vehicle just outside the vaccination area. The patient appeared to having a moderate to severe vasovagal episode without total syncope. There did appear to be slight pseudoseizure activity present, however, there was no LOC or loss of bowl or bladder tone. The patient was placed in a supine position and moved to the monitoring area. With positional changes and aggressive hydration, he rapidly improved to baseline. He did endorse that he has had similar episodes with blood draws, etc.  He was returned home with his mother as the driver and with preventative instructions for his second dose.
Case previously recorded as MA2009-4003. Initial case report received from a nurse via Novartis Pharma, on 11 Nov 2009. A 3-year-old patient was vaccinated with 0.25 mL of FLUVIRIN (batch no. 1009235P) i.m., on 10 Nov 2009. No adverse events was reported. Company assessment: not serious. Seriousness criterion: not serious. Causality: not applicable. Expectedness assessment according to agency: Administration to a child under 4-year-old is unexpected with FLUVIRIN. No change in benefit-risk-ratio. No measures necessary. Agency reference no.: NA09-007988.
invalid doses given after 12 hours from first puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (invalid doses given after 12 hours from first puncture) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy, Diabetes in 2015 and Hypertension in 2013. Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and CARBAMAZEPINE for Back pain, INSULIN GLARGINE (LANTUS XR) and METFORMIN for Diabetes mellitus, ARMODAFINIL for Sleep disorder NOS, LEVOTHYROXINE for Thyroid disorder NOS, GABAPENTIN and MORNIFLUMATE (FLOMAX [MORNIFLUMATE]).    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (invalid doses given after 12 hours from first puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (invalid doses given after 12 hours from first puncture) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Non-significant follow-up On 24-May-2021: Followup- patient information update
ABDOMINAL PAIN Headache E87.1 - Hypo-osmolality and hyponatremia
Information has been received from a medical assistant concerning an unknown number of females (age not reported) who on unspecified dates was vaccinated with Gardasil (lot#s unknown). On unspecified dates "a couple" of patients developed menstrual spotting after vaccination with Gardasil. Medical attention was sought. No other information was available. On unspecified dates the females had recovered. Attempts were being made to obtain additional identifying information to distinguish the unidentified patients mentioned in the report. Follow-up information was received from a medical assistant via telephone. The nurse reported that she could not provide any additional patient details. The nurse confirmed that there were 3 patients who reported menstrual spotting following vaccination with Gardasil. Additional information is not expected.
Sore Arm; Fever of 103; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 103), CHILLS (Chills) and ARTHRALGIA (Sore Arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Asthma.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced PYREXIA (Fever of 103) and CHILLS (Chills). On an unknown date, the patient experienced ARTHRALGIA (Sore Arm). At the time of the report, PYREXIA (Fever of 103), CHILLS (Chills) and ARTHRALGIA (Sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. Treatment included Tylenol   This case was linked to US-MODERNATX, INC.-MOD-2021-024565 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-024565:crosslink
Staring on Tuesday, July 27, I began to experience a tingling sensation and numbness in my left ring and pinky fingers
PATIENT AWOKE UNABLE TO MOVE. SHE CALLED AMBULANCE AND WAS TREATED AT HOSPITAL AND AT PRIMARY DOCTOR
20 mcg administered to 19 YO; Engerix-B adult administered to 19 YO; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B adult) (batch number f73dg, expiry date 3rd July 2023) for prophylaxis.   On 6th August 2022, the patient received the 1st dose of Engerix B adult 20 µg. On 6th August 2022, unknown after receiving Engerix B adult, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's Comment: The reporter reported a 19 year old was administered 20 mcg of Engerix-B.  The reporter consented to follow up via phone. Additional Supportive Information: The reporter reported a 19 year old was administered 20 mcg of Engerix-B, which led to overdose and inappropriate age at vaccine administration.
Information has been received from a nurse concerning a 16 month old male with watching head circumference and no drug allergy who on 25-FEB-2011 was vaccinated intramuscularly with a dose of 0.5ml PNEUMOVAX 23 instead of PREVNAR. Second suspect therapy included PEDVAXHIB injection on the same day (dose, route and lot # not reported). Concomitant therapy included vitamins with fluoride. The patient had received three doses of PREVENAR prior to receiving PNEUMOVAX 23. The patient developed a fever of 101F in the evening that the patient received PNEUMOVAX 23 and PEDVAXHIB. The patient did not seek medical attention. No lab diagnostics study was performed. At the time of reporting, the patient recovered from fever. Follow-up information has been received from an office manager who reported that the wrong drug administration was not due to product confusion. The office manager reported the nurse did not remember exactly how she gave the wrong vaccine, but she did remember that it was not due to product confusion. No further information is available.
Adrenaline feeling through whole body lasting approx. 2 weeks.; Had trouble sleeping; Menstrual period lighter than normal and lasted 15 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16May2021 12:30 (Lot number: 59267-1000-01) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: HORMONE LEVEL ABNORMAL (non-serious) with onset 19May2021 08:30, outcome "recovering", described as "Adrenaline feeling through whole body lasting approx. 2 weeks."; INSOMNIA (non-serious) with onset 19May2021 08:30, outcome "recovering", described as "Had trouble sleeping"; MENSTRUAL DISORDER (non-serious) with onset 19May2021 08:30, outcome "recovering", described as "Menstrual period lighter than normal and lasted 15 days". The events "adrenaline feeling through whole body lasting approx. 2 weeks.", "had trouble sleeping" and "menstrual period lighter than normal and lasted 15 days" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: investigation: (19May2021) unknown result. Therapeutic measures were not taken as a result of hormone level abnormal, insomnia, menstrual disorder.  Additional information: The patient did not receive other vaccine in four weeks. The patient received other medications (unspecified) in two weeks. The patient had not covid prior vaccination. The patient had not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Pt recv vax on 2/24/99; on 2/26/99 pt exp left thigh swollen, warm, red, bruised; tx=Motrin, Benadryl, ice
Patient is a 81 y.o. female patient of, CNP with history of COPD, chronic diastolic heart failure, coronary artery disease status post stent in 2011, hypothyroidism, hypertension, hyperlipidemia history of TIA presented to local Hospital with shortness of breath. She was diagnosed with COVID 19 infection. Acute hypoxic respiratory failure Acute exacerbation of COPD Secondary to COVID-19 infection Uses 2L NC at bedtime; requiring 2L continuously on admission Albuterol and Symbicort ordered Continue decadron as below Weaned to RA Wheezing markedly improved on exam Will continue decadron to complete 10d course at discharge   COVID-19 viral pneumonia Covid-19 Virus Infection Chest x-ray shows right lower lobe infiltrates.  Will need follow-up chest x-ray in 6 to 8 weeks to ensure resolution. Date of onset of symptoms: 2/28/23 Symptoms present on admission: shortness of breath, cough Date of covid positive test: 3/1/23 Vaccination status: not known Imaging: CXR: sows right lower lobe infiltrates Oxygen requirements on admission: 2 L NC Current oxygen requirements: RA Medical therapy: completed 4d of remdesivir while hospitalized; complete remaining course of dexamethasone Consultants following: none No indication to continue abx   Chronic systolic heart failure Essential hypertension Does not appear fluid overloaded.   Continue home Lasix, lisinopril, Imdur and coreg   Coronary artery disease Hyperlipidemia EKG shows sinus brady. Patient is asymptomatic Continue Plavix, statin History of pulmonary embolus History of stroke Continue apixaban
No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 2-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-DEC-2022, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, in left thigh, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009088: US-009507513-2301USA009112: US-009507513-2301USA009113: US-009507513-2301USA009927: US-009507513-2301USA010889:
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE NON ST ELEVATION MI 1/12/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
On January 31, 2021 I started to experience the following : Sweating. Headache. Rash on both lower legs. Night time lower leg cramping. On February 3, the rash was spreading upward on the legs. I saw the Emergency Room Doctor at the Medical Clinic. Prior to this visit the Sweating and Headaches had begun to subside. The Doctor prescribed Prednisone for the rash. I tried to email this to vaers,hhs.gov. but my email provider rejected your email address and would not send this, so this is why I am mailing this to you. I have tried to email you this thru 3 different email platforms and all reject this address you say to contact you at.  My second concern is: at the time of the first dose I was told that I was automatically scheduled for the second dose and that I would be contacted sometime in between the 28 day waiting period. My wife has read that I will have to re-register and be put on a waiting list just like the first dose. Please advise as to which is correct.     Lastly on behalf of myself and my family I would like to give you all a heartfelt thank you for your contributions to the COVID effort. You and your CDC family are my HEROES. God Bless you all and stay safe.
Within 30 minutes of vaccination itchiness of the scalp and neck; Within 24 hours of vaccination metallic taste in mouth that resolved 4 days after vaccination.; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 14Apr2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient was allergic to latex and peanuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and prenatal vitamins (MANUFACTURER UNKNOWN); both taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received doxycycline (MANUFACTURER UNKNOWN), hydrocodone (MANUFACTURER UNKNOWN) and vancomycin (MANUFACTURER UNKNOWN) and experienced drug allergy with all these medications. On an unknown date in Apr2021, within 30 minutes of vaccination, the patient experienced itchiness of the scalp and neck and within 24 hours of vaccination, the patient experienced metallic taste in mouth that resolved 4 days after the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 18Apr2021, the patient underwent COVID-19 test (nasal swab) and the result was unknown. The clinical outcome of the events itchiness of the scalp and neck and metallic taste in mouth were resolved on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.