chrisvoncsefalvay/vaers-outcomes huggingface dataset:
surgery; This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (surgery) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SURGERY (surgery). At the time of the report, SURGERY (surgery) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       On an unknown date, SARS-CoV-2 test was Negative.  No concomitant medications were provided.   No treatment medications were provided.
pt recvd 3 doses of Hep B vax & was found to be nonresponder;
Pain, redness, fever, enlarged lymph node in armpit, red streaks going up the arm from site of infection.
After Covid booster noticed lump right side of back. Upon exam, soft non tender mass right upper back lateral to scapula
Itching  around injection site after getting vaccine, hives around injection site x3 weeks after vaccine.
headaches, nausea, chills, fever 99.4*F, body aches
Information has been received from a pharmacist referring to unspecified patients of unknown age and gender. Information regarding the patients' medical history, concurrent medication were not provided. On unknown dates the patients were vaccinated with doses of improperly stored (at 24 Fahrenheit for 24 hours) ZOSTAVAX (lot # L040442 with expiration date 15-JAN-2017; lot # L046900 with expiration date 23-FEB-2017; dose and route unknown). There were no temperature excursions previously. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Pt recv vax on 9/24/98; on same day pt exp seizure (rigid, eyes rolled up, drooling) ; 9/25/98 pt exp seizure again; pt seen by neurologist.
Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 08Jan2021; Mild fever; Nausea; Headache; Pain in the muscles and joints; Pain in the muscles and joints; This is a spontaneous report from a contactable consumer reporting for her sister. A 40-years-old female patient  received the second dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 08Jan2021 at single dose for COVID 19 immunization via an unspecified route of administration from 21Dec2020 to 21Dec2020 at SINGLE DOSE for an unspecified indication .  The patient medical history and concomitant medications were not reported.  The patient received the first dose of the vaccine on 21Dec2020. On 08Jan2021 about 12 hours after the administration of the vaccine, the patient experienced mild fever, nausea, headache, pain in the muscles and joints. The outcome of all the reported events was recovering. The patient received the second dose before the day 21.  Information on the lot/batch number has been requested.
86 y/o F Presented to immunizations clinic for routine vaccination check-up.  Patient was inquiring about her immunization record being up to date. Pt showed due for PCV13. Administrator miss took vaccination name and accidently administered PPSV23. Pt stated that that same night she began to has sx of severe arm pain with increased swelling, redness and very warm to the touch. Pt describes swelling and redness around 6in long and wide. Pt had not taken any Rx to help with pain or swelling. Stated sx were worse the following day except for the pain. Pt has no additional sx, such as headaches, chest pain, difficulty breathing,  blurred vision or seizures. Patient was advised to treat w/ cold compress and take pain relief meds prn. Also informed pt to go to ER/seek medical attention if sx worsen or there is no relief by 16 Aug 2019. Pt acknowledged and had no further concerns.
HYPOXIA 11/18/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Approximately on an unknown date in 2011 (reported as 2 years ago), the patient who was vaccinated with a first dose of GARDASIL may have received a second dose approximately on an unknown date in 2013 (reported as recently) (Lot number, expiry date, route and dose were not reported). No adverse effect reported was unknown. Additional information has been requested.
received an expired Quadracel on 14-Nov-2019/no ae; Initial information received on 09-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is a linked case of 2020SA010010, 2020SA010007, 2020SA010008 by the same reporter.  This case involves female patient of 3 year 11 months who received an expired vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] on 14-Nov-2019 (expired product administered) (lot C5325BA, via unknown route at an unknown administration site).  It was a case of actual medication error due to Expired vaccine used.  It was unknown whether adverse event was experienced or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
On day 9 after the vaccine, I started to get itching and a slight rash on my right arm at the injection site.  It is also red and slightly hard at the site.  The symptoms are relatively mild.  I looked up the reaction and they said it is called COVID arm.
Patient reported that the day after vaccination she felt "loopy and out of it" and that all the joints in her body were aching. She also reported low grade fever and chills. The joint pain lasted approximately 24 hours then subsided.
Received Moderna Dose #2 on 1/25/21, immediately after injection, metallic taste in mouth, but no other compaints at that time. Waited 15 minutes felt fine, took public transport home. At 1am on 1/26/21 woke up to use the bathroom and came back to bed with severe chills and fever of 99.4, sweating profusely, nausea, unable to lift right arm above shoulder, and severe headache. Continued with chills for 2 hours, retook temp after chills subsided and resulted at 101.7. Headache so severe could barely lift head off pillow. Took 600mg Motrin and pushed fluids. Continued with profuse sweating until 11:30 am, temp at that point 100.3. No further symptoms except nausea. Later on in the evening (about 6:30pm) of 1/26/21, noted loss of taste, but still had sense of smell. As of today 1/27/21 still with no sense of taste, feeling of lethargy, but normal temp of 98.6 (taken at 7pm).
Pain in right leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in right leg) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Pain in right leg). At the time of the report, PAIN IN EXTREMITY (Pain in right leg) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, X-ray: normal (normal) normal. On 07-Mar-2021, Blood test: normal (normal) normal. On 07-Mar-2021, X-ray: normal (normal) Normal.         The patient was hospitalized twice for less than 24 hours. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
This spontaneous report as received from a current 83 year old female patient refers to herself. The patient was allergic to anti-biotics. There was no pertinent medical history. On an unknown date the patient was vaccinated with ZOSTAVAX (0.05 ml single dose, lot# and expiration date were unknown) intramuscularly. There were no concomitant therapies. On an unknown date (reported as over a year ago) the patient developed shingles after receiving ZOSTAVAX and as a result of shingles she developed neuralgia. Over the counter medication was given for the adverse events. Blood work was performed and result was not provided. The patient did not seek for medical attention. The outcome of the events was reported as recovering/resolving. Additional information has been requested.
PAIN, INFLAMMATION, REDNESS LASTING 3-5 DAYS CURRENTLY AT DAY 5 SYMPTOMS ARE RESOLVING
This prospective literature marketed report has been received from the author of a literature article. Objective of this report was to assess availability and use of measles-mumps-rubella (MMR) vaccination documentation for people vaccinated elsewhere. 1500 records were selected from 14 places from March 2013 through July 2015 to determine whether vaccination records were available at post health assessment and integrated into the Advisory Committee on Immunization Practices schedule. Number of doses, dosing interval, and contraindications were assessed. Twelve of 14 (85.7%) places provided data on 1118 (7 4.5%) people. Records for 972 (86.9%) people were available, most from the Centers for Disease Control and Prevention's Electronic Disease Notification system (66.9%). Most people (829; 85.3%) were assessed appropriately for M-M-R II vaccination; 37 (3.8%) should have received the vaccine but did not; 106 (10.9%) did not need the vaccine but were vaccinated. Author reported that out of 106 patients who did not require vaccination, 1 patient was pregnant and on an unknown date was vaccinated with M-M-R II (inappropriate schedule of drug administration and exposure during pregnancy). Her LMP and EDD were unknown. Patients pregnancy outcome was not reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Finger numbness; Underarm pain; Chest pain; Swollen lymph nodes; Feverish after 2 weeks; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW1076) via an unspecified route of administration in the left arm on 01May2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis. Concomitant medications included vitamins (MANUFACTURER UNKNOWN), fexofenadine hydrochloride (ALLEGRA) and diphenhydramine, paracetamol, phenylpropanolamine hydrochloride (BENADRYL); all from an unknown dates, for an unknown indications, unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP5733) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01May2021 the patient experienced finger numbness, underarm pain, chest pain, swollen lymph nodes and feverish. It was unknown whether any therapeutic measures were taken as a result of the reported events. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events of finger numbness, underarm pain, chest pain, swollen lymph nodes and feverish were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with GARDASIL (route, dose, and lot # were not reported) that was improperly stored. No adverse symptoms reported. The outcome of patients received improperly stored GARDASIL was unknown.This is one of several reports from the same source. Additional information has been requested.
Golf ball size knot on the right ankle, same side the shot was given; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 03May2021 at 14:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication included diazepam (DIAZEPAM) taken for an unknown indication from an unknown date. The patient had no past drug history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 03May2021 at 19:00, the patient experienced a golf ball size knot on the right ankle, the same side the shot was given on. The event resulted in emergency room/department or urgent care. The patient underwent an X-ray procedure on an unspecified date in May2021, the result of which was unknown. The clinical outcome of the event golf ball size knot on the right ankle was not resolved at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained.
pt recv vax & a small brown-colored lesion formed approx 1cm by 0.6cm;pt states had achy muscles & felt fatigued for about 5 days;
Intussusception diagnosed by ultrasound after patient presented with vomiting and bloody stools.  12/04/07 Reviewed vax record which confirms RO dose/lot as reported.  Faxed to CDC. 12/18/07 Reviewed hospital medical records which reveal patient experienced irritability, reduced oral intake, vomiting, abdominal pain & bloody stools.  Taken to ER 11/24/07.  Admitted for observation overnight.  Progressed well & d/c to home. FINAL DX: Intussusception, enema reduced.  Records faxed to CDC.
Pt was seen in ER last Aug.  Was given a DTAP (DAPTACEL) instead of a TDAP.  Came to our office today for a check up and we found the error.  According to CDC website, this is to be reported.
After having the vaccine, she felt not good but still able to stand up and move to other chair. After a couples of minutes, she turned pale, sweating, no difficulty breathing, closed her eyes but still answer to question and order. After  about 10 minutes, she's getting better . BP 80/45 (normal BP 85/55), normal HR. Emergency personnel confirmed her BP 80/45, normal HR and low BG 70
Injection sit lump; On/off headache; The swelling was a size of a lemon, itchy and rashy; The swelling was a size of a lemon, itchy and rashy; The swelling was a size of a lemon, itchy and rashy; This is a spontaneous report from a contactable consumer reporting for the mother. A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 21Apr2021, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced injection sit lump (non-serious) on an unspecified date with outcome of unknown, headache (non-serious) on an unspecified date with outcome of recovered, the swelling was a size of a lemon, itchy and rashy (non-serious) on an unspecified date with outcome of unknown. She had a little red lump around the injection site after receiving the vaccine. She basically went for a colonoscopy couple days later. They gave her anesthesia treatment. A day or 2 after she came back from the hospital. The injection sit lump started growing a bit in size. The swelling was a size of a lemon, itchy and rashy. Therapeutic measures were taken as a result of the swelling and included antihistamine. It helped and swelling got smaller. Since the day before report it grew again and its now bigger, rashy and itchy after she took her antihistamine medication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
unconsolable crying for 5-6hrs,rt thigh very swollen,red & hot;motrin given w/onset of pain;rxn not reported until client presented @ clinic for addtl immun 21FEB96;
Patient was inadvertently given the bivalent booster as her primary dose. Patient called asking to be schedule for the "Booster Clinic", our office was unaware this was her primary dose. No side effects or symptoms from this so far.
PATIENT RECEIVED MODERNA VACCINE INSTEAD OF PFIZER VACCINE BY NURSE.  ONCE THIS WAS MADE AWARE TO THIS NURSE, NURSE NOTIFIED COORDINATING NURSE. THIS NURSE CALLED PATIENT TO ADVISE, ALSO ADVISED SECOND DOSE MUST BE PFIZER.
Patient was administered varicella and MMR #1 upon receiving the MMR noticed a hive around the site of injection. No trouble breathing. Patient scratching site.
Information has been received from an RN concerning a 67 year old Caucasian female pt who on 4/10/02 was vaccinated IM, in the left deltoid, with a dose pneumococcal vaccine 23 polyvalent (lot 641130/1161L). Subsequently, the pt experienced injection site pain, swelling, itching and redness and the site was hot to the touch. It was reported that the symptoms were almost like a cellulitis and went down to the elbow. The pt was afebrile. The nurse reported that the experiences were severe and Benadryl was needed to be given. It was also reported that the pt had previously received pneumococcal vaccine 23 polyvalent and did not have a problem. Unspecified medical attention was sought. Conflicting follow-up from the pt's physician, reported that the pt had received any previous doses of pneumococcal vaccine 23 polyvalent and that on 4/10/02, the pt experienced erythema, edema and pain. The pt was treated with over the counter Benadryl and warm compresses and subsequently, recovered. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is expected. The nurse also reported that 2 other female pts experienced injection site pain, swelling, itching, redness and warmth (WAES 0204USA01568 and 0204USA02063) and a 3rd pt experienced pain, swelling and redness (WAES 0204USA02065) following vaccination with pneumococcal vaccine 23 polyvalent.
Info has been received from a physician concerning an 18 month old male who on 4/18/05 was vaccinated with a SC, 0.5 ml dose, in the left thigh, of varicella virus vaccine live. Concomitant vaccine, administered on the same day, included DTAP. It was reported that on 4/27/05, the pt spiked a high fever and began to have seizures. The pt was transported via ambulance to the hospital this morning, on 4/28/05, at 05:00 AM. The fever on arrival at the ER was 103F. The pt experienced several additional seizures at the hospital. The report said the child presented with febrile seizures and lesions on his back. One of the lesions was oozing. A spinal tap was done and the CSF was normal. The pt remains hospitalized on IV fluids and acetaminophen. The pt's status was reported as not recovered. No product quality complaint was involved. No other info was provided. Additional info has been requested.
Very sore upper arm at and around injection site.  Chills Extremely tired night of vaccination only.  Mild/dull head ache  Stuffy nose
This spontaneous report has been received from the patient's cousin, concerning a 17 year old female patient. The patient's concurrent conditions and concomitant medications were unknown by reporter. Medical history included passing out on an unknown date. On 03-JUL-2018, the patient was vaccinated with the first of GARDASIL 9 0.5 ml, intramuscularly in the deltoid (frequency, lot number and expiration date were unknown by reporter) for prevention of human papillomavirus. On 03-JUL-2018, the patient passed out twice between medical office and her home. The patient sought medical attention and it was unknown by reporter if the patient received any treatment for the adverse event. There were none laboratories or studies performed. The outcome of syncope was reported as recovered. The causal relationship between the adverse event and the therapy was not assessed.
On the evening of vaccine mother notice increased swelling, redness and fever. On Wednesday fever was at 100.4 parent brought him into ED. They marked area and borders he was given medication, after leaving the ED mother notice redness had spread and they returned to the ED.He was given a different medication and admitted into the hospital. This information was obtained from Child's discharge summary.
Arm soreness immediately following vaccine on 1/14/21 which resolved.  Developed hard, red, itchy lump at injection site 1/21/21.
Left sided chest pain; Discomfort on the left chest; Shaking; Left side slight numbness; This is a spontaneous report from a contactable pharmacist, the patient. A 39-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 25Jun2021 at 12:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 25Jun2021 at 23:00, the patient experienced left sided chest pain, discomfort on the left chest, shaking and left side slight numbness. 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 not been tested for COVID-19. The clinical outcome of the events left sided chest pain, discomfort on the left chest, shaking and left side slight numbness was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna COVID-10 Vaccine EUA. 7 days after my first dose of the vaccine I developed a red rash around the injection site. The rash was approx. 4 inches long and 3 inches wide. Last night after I noticed the rash, I took allergy medication. Today it has improved somewhat, but has not gone away.
Symptoms, began last night (7/15/14): Rt. deltoid swelling, pain, tightness and warmth, per patient's mother. Applying ice pack and giving pain medication.
The day after his ablation (1/29/22) he started to develop a cough and increased shortness of breath as well as myalgias.  He denies any chest pain.  He does report feeling short of breath particularly with activity.