chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Female patient oriented in time, place and self. Patient is in area of observation after vaccination and reports having chest pain. Paramedic is needed, take her to the ambulance and vitals are taken P 104, BP 110/70, saturation 98 and dexto 108. We have the patient in observation for another 10 minutes and asked if she still has chest pain. She reports still having chest pain that come and goes. We advised patient to be transferred to emergency room and patient refuses. In the presence of her partner we advise again and patient refuses and her partner refers that if she continues to feel bad they will go to the emergency room. Patient decides to leave, she is oriented, alert and leaves with partner
A few minutes following vaccination, patient reported dizziness and ringing in the ears. We had her lower her head between her knees to increase blood flow. Checked blood pressure and it was 122/81.  She reported feeling better within minutes of having her head lowered. Did not require further treatment like lying on the ground or applying cold compresses to wrists and neck. We monitored her for 30 minutes instead of 15 minutes to make sure she was safe to go.
Headache, R CLAVICLE LYMPHADENOPATHY; ITCHING AT INJECTION SITE Narrative:
Severe pain and swelling in injection site, lack of mobility in arm that was injected, headache above both eyes, more pronounced above left eye for 4-5 days especially when looking up. General lethargy.
On 4/16/2021 went to the emergency room with high blood pressure that was noted as a "hypertensive emergency".  Was admitted into the hospital the next day where a CT scan confirmed that a blood clot in the brain occurred which led to a basal ganglia stroke.  After a 5 day stay in the hospital, patient is now in a full time rehab facility to attempt to recover her cognitive and speech skills, while also attempting to regain use of her right hand which is currently not functioning due to the stroke.
Had RSV vaccine on Sep.14 2023 pm . On Sep 22,2023 Smart Watch showed heart irregular rhythm  (atrial fib) twice and then again 2 times yesterday and thus far none today. Pretty much feel fine and curtailed exercise .Will get appt to see cardiology and also inform primary doctor
Became seriously ill  the night of shot. Chills, fever, vomiting?next day arm swelling and red traveling down and up and around arm, iced off an on for entire day and taking 12.5 Benadryl every 4hours. Feeling sore throat or lump like feeling in throat, Fatique. By 12/11/2022 AM Vision changing went to Emergency Room. When I arrived at ER Arm from shot injection red and swelling from top of arm to elbow around arm approaching  arm pit.  From top of arm to elbow completely covered with red and swelling except for a out a one inch width of skin running down the inside of arm almost a complete cuff from top of arm to elbow area.
Swelling - Near Injection Site; Red Dot - Near Injection Site; Itchy Sensation - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE ERYTHEMA (Red Dot - Near Injection Site) and VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE ERYTHEMA (Red Dot - Near Injection Site) and VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site). At the time of the report, VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE ERYTHEMA (Red Dot - Near Injection Site) and VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Began feeling nauseous, weak, fast heartbeat, sweating, headache, and very high fever.  Later developed redness all over arm where shots were administered, which were also painful and hot.  This lasted 3 days.
Shoulder began to feel irritated (itchy) could not see anything wrong. Just itchy under skin.
Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L 20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Severe throbbing pain for more than a month. It has been almost 2 months and there is still a dull ache. I can't lift left arm without severe pain and range of motion has been impaired.
Dizzy and hot flashes lasting for several weeks began 10/28/2021 Nausea and severe fatigue with slight fever (lasted about a week) 10/28/2021  Below unknown if related to vaccine for certain but all tests results that have come back so far are normal so  with recent report about covid-19 vaccine affecting women's menstrual cycle I felt it should be reported for record.  Abnormal uterine bleeding outside of menstrual cycle 12/19/2021 Heavier and longer menstrual cycle with severe cramping began on 11/8/2021
8 days after the vaccine, my left upper arm at the site of the injection began to feel itchy and uncomfortable. On day 9, a red circular, itchy rash appeared. This expanded on day 10 (today). It is sore, itchy, red, has bumps, and my lymph node under my left armpit may be enlarged. Shoulder is slightly uncomfortable.
Within 30 minutes post vax, the pt developed an injection site reaction characterized by itching and a 1 cm wheal, and paresthesia of the left arm. She was seen by the nurse and recovered within 4 hours without treatment. This is one of three employees from this facility who had an adverse experience following receipt of vax.
no adverse effect; patient received third dose in ROTATEQ series that was improperly stored; This spontaneous report was received from a registered nurse refers to a 6-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-OCT-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, dose 3 for prophylaxis with lot # 1658254 and expiry date 17-NOV-2020 (dose, route were not reported) (product storage error). The suspect product was stored at a temperature of 70 degree Fahrenheit (F) for a time frame of 5 days. There was no previous temperature excursion. The digital data logger was not involved. The patient did not experience any adverse effects.
patient was accidentally given a dose of Menactra with no reported adverse event; Initial information received on 29-Aug-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 5 years old male patient where patient was accidentally given a dose of meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine and diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine INACT 3V (MRC 5), tetanus vaccine toxoid (Quadracel) for Prophylactic vaccination.  On 26-Jul-2023, the patient received 0.5 ml dose of suspect meningococcal a-c-y-w135 (d conj) vaccine Solution for injection (lot: 7595AC) via intramuscular route in the right thigh (strength and expiration date: not provided) for Immunization (wrong product administered) (latency- same day).  Action taken- Not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
sever rash on arms, legs, back. several creams and lotions prescribed by various doctors.  no relief.
Rash at the injection site; Itching at the injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE PRURITUS (Itching at the injection site) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE PRURITUS (Itching at the injection site) and HEADACHE (headache). At the time of the report, VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE PRURITUS (Itching at the injection site) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
rapid HBR of 125 BPM; blood pressure of 145/82; Very uncomfortable; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the arm right on 26Mar2021 at 12:00(at the age of 62-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications included estradiol (ESTROGEN) and progesterone (MANUFACTURER UNKNOWN) for unknown indication and start date. Patient did not have any allergies to food, medications and other products. 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 vaccination. On 27Mar2021 at 13:00 the patient experienced rapid HBR of 125 BPM and blood pressure of 145/82. It was very uncomfortable and started afternoon the day after and continued until early Sunday a.m. On an unknown date, the patient underwent HBR and the result was 125 BPM. On an unknown date, the patient underwent blood pressure and the result was 145/82 (unknown unit). The patient did not receive any treatment for the reported events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events rapid HBR of 125 BPM, blood pressure of 145/82 and feeling abnormal were unknown.   No follow-up attempts are needed. No further information is expected.
On day 11, I have a rash that appears to be similar to "Covid Arm", seen with the Moderna vaccine. I have a round, raised, red, rash with irregular boarders. It is splotchey with patches of white. Currently it is roughly 2in wide and tall (marked to check for growth). It is excessively itchy, is tender to the touch, and is hot to the touch. Pain scale a 2-3 off a 1-10 adult scale. Overall feeling very tired and have an unproductive cough (could be allergies). Moderate headache.
Premature Ventricular Contractions up to a frequency of about 8 PVCs on 1 min for about 3-4 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 15:00 (Lot number: EW0161) at the age of 29 years as dose 1, single and administration date 03May2021 12:15 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VENTRICULAR EXTRASYSTOLES (non-serious) with onset Apr2021, outcome "not recovered", described as "Premature Ventricular Contractions up to a frequency of about 8 PVCs on 1 min for about 3-4 days". The event "premature ventricular contractions up to a frequency of about 8 pvcs on 1 min for about 3-4 days" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of ventricular extrasystoles.  Additional information: The patient had no known allergies. The patient reported that on after first dose, a week after the injection, the patient started Premature Ventricular Contractions up to a frequency of about 8 PVCs on 1 min for about 3-4 days. After that, PVCs frequency started going down to a frequency of about 8 PVCs in one day. After second dose, about 18h after the injection, started increased frequency of PVCs up to a frequency of about 8 PVCs per 1 minute again. The patient had no known allergies. 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 vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient had an asthma attack, headache, and dizziness an hour after. the second night she had swollen tongue and trouble breathing. pt did not seek medical attention. she is ok now
This spontaneous report as received from a medical assistant refers to a patient of 9 years old. No information about medical history, concurrent conditions and concomitant medications were reported. On 04-AUG-2014 the patient was inadvertently vaccinated with expired dose of RECOMBIVAX HB Lot# 1741AA, expiration date 27-JUN-2014, route intramuscular. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of several patient reports received from the same source. Additional information has been requested.
Patient experienced N/V after Influenza vaccination in Sept 2017. Patient did not have history of reaction to the Influenza vaccine. No further documentation provided.
Bad pain in my neck, shoulder, and spine. Currently undergoing 12-18 weeks of physical therapy. So far has done some good, but also hasn't really done to much to alleviate the pain.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On an unspecified date in 2012 the patient was vaccinated with the first dose of GARDASIL injection (dose, frequency, route and lot# were not reported). And in January 2015, the patient received the second dose of GARDASIL. The reported also reported that the patient was "currently" in the office on 17-MAR-2015, and would receive dose three of the GARDASIL series. No adverse effects were reported. Additional information has been requested.
At the injection site I experienced bruising, pain, tenderness and swelling hardness, warm to the touch, large redness rash, muscle and joint pain, nausea, vomiting and fatigue. Started on 12/5/2021. On December 7Th I went back to the doctors and got anabiotic?s due to the redness.
This spontaneous report as received from a nurse refers to patients of unknown age. Since July 2014, unspecified patients were vaccinated with improperly stored GARDASIL 120Y (lot#, expiration date, dose not reported). No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
GIVEN AN UNDILUTED PEDI PFIZER VACCINE. HAVE BEEN IN TOUCH WITH MOTHER AND ONLY COMPLAINT IS A SORE ARM THUS FAR. MOM WILL CONTINUE TO MONITOR AND GIVE TYLENOL OR IBUPROFEN AS NEEDED
Vaccine given to unknown amount of patient past 30-day BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given to unknown amount of patient past 30-day BUD) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given to unknown amount of patient past 30-day BUD). On 02-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given to unknown amount of patient past 30-day BUD) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patients experienced no adverse events and patients antibody numbers were in the 800-900 range after vaccination. No relevant concomitant medications were reported. No treatment information was provided.
Fever 103 3/27, stomach pain, vomiting, diarrhea, headache, chest pain, SOB Hospital 3/29, critically low potassium, D-Dimer elevated, chest CT clear, admitted 3/30 HIDA scan, gallbladder removed 3/31 woke with vision issues, seeing multiples of things, slanted hallways, can?t stay awake 4/1 CT and MRI of brain show venous blood clot  Started on blood thinners, stopped birth control (had only been on birth control about 5-6 months)
Diarrhea started two weeks after vaccination. Initially very large volume with increased frequency Evaluated patient July 2021, continued to have diarrhea but less volume and less frequent As of 10/2021- diarrhea improved, but still on antidiarrheal agent twice a day.
Information has been received from a physician and a patient's mother (physician) concerning her 32 day old breast-fed son who on 12-FEB-2008 was vaccinated PO with the first dose of Rotateq. On 11-JAN-2008 the patient's mother thought she saw blood in her son's stool. A hemoccult test was performed which was negative. On 14-FEB-2008 the patient experienced strands of blood in his stool and a positive hemoccult test. The patient was not hospitalized. There was no diagnosis at the time. The nurse mentioned that the patient would not be receiving his second dose of Rotateq until the other tests were done. At the time of this report, the patient did not have blood in his stool. There was no product quality complaint. Upon internal review, strands of blood in stool was determined to be an other important medical event. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 02-MAY-2014, a healthcare provider at a medical branch administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries and conditions (dose, route, and lot # not provided). On or about 17-NOV-2015, the patient was treated by a healthcare professional at the same medical branch for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages.  The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Rush of Metallic Taste in the Mouth; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSGEUSIA (Rush of Metallic Taste in the Mouth) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced DYSGEUSIA (Rush of Metallic Taste in the Mouth). At the time of the report, DYSGEUSIA (Rush of Metallic Taste in the Mouth) outcome was unknown. 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.   No concomitant medications reported. No treatment reported.
Pt recvd vax 9JUL93 & 2 to 3 hrs later exp apneic episode;
swelling in left nipple; tenderness in left nipple; This spontaneous case was reported by a consumer and describes the occurrence of NIPPLE SWELLING (swelling in left nipple) and TENDERNESS (tenderness in left nipple) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS) and LOSARTAN for an unknown indication.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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, the patient experienced NIPPLE SWELLING (swelling in left nipple) and TENDERNESS (tenderness in left nipple). At the time of the report, NIPPLE SWELLING (swelling in left nipple) and TENDERNESS (tenderness in left nipple) had not resolved.            Patient said the second dose of the vaccine was administered on 29-Mar-2021 or 30-Mar-2021. The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable No treatment drugs were reported
Information has been received from a registered nurse at a day school concerning two male children who, "in the past," were vaccinated with Varivax and have subsequently been diagnosed with chickenpox. Unspecified medical attention was sought. There was no product quality complaint. Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report. Additional information will be provided if available. No further information is available.
Upon awakening on 22JUL91 pt noted approx. 6 painful, raised, red lesions on lt side of chest; Area painful to touch; pt describes a shooting deep pain in chest; pt's husband MD dx as shingles on 25JUL91;