chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller presented information that she was potentially given only half of a booster dose by a pharmacy; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Caller presented information that she was potentially given only half of a booster dose by a pharmacy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Caller presented information that she was potentially given only half of a booster dose by a pharmacy). On 09-Nov-2021, ACCIDENTAL UNDERDOSE (Caller presented information that she was potentially given only half of a booster dose by a pharmacy) had resolved.            No concomitant medications were provided.  No treatment medications were provided.
Reactivation of Shinlges, sharp, stabbing, burning pain that started  11/2/2022 over left side of mid back and extending laterally to the left side/flank following the T6 dermatome, started on Valtrex 1g tid for 7 days, lesions appeared 11/5/2022, resolution of lesions on 11/8/2022. No lasting side effects.
On 02/21/2001 the patient developed a log grade fever, diarrhea, and a rash with papulovesicular lesions (20 total) on his trunk, neck, extremities and face. FOLLOW-UP information indicated that the patient recovered. No additional is expected.
Patient passed out 7 minutes after vaccine was administered. Mother yelled out from room for help, upon entering room patient was sitting on floor by mothers feet and kept saying she was ok. Mom says patient was sitting on the exam table and got up to show her something on her phone and when she stood up and walked over to mom to sit down she dropped her cellular phone and mom thought patient went to pick it up but she fell forward and hit the front of her head on the wall. Mom reports pt. hadn't eaten breakfast or drank anything that morning.
Pneumonia vaccine given 11/06/2001. Next day pt experienced red and swollen arm. Two days after shot went to MD given "5 pills".
ABOUT A MINUTE AFTER GETTING THE VACCINE I FELT DIZZY AND FAINTED. I DO NOT KNOW HOW LONG I WAS UNCONSCIOUS. I HAD HARD TIME TALKING AND BREATHING. FELT BETTER AFTER 5 MINUTES BUT WAS WEAK, HOT AND SWEATING, LIGHTHEADED, AND CONFUSED. COUPLE HOURS LATER I HAD CHILLS AND DID NOT SLEEP ALL NIGHT. NEXT DAY HAD TERRIBLE HEADACHE, VOMITED, LOSS OF APPETITE AND GOT IREGGULAR MENSTRUAL PERIOD. FELT VERY WEAK ALL DAY AND CONFUSED. BODY ACHING.
cold symptoms; Metallic taste in mouth; cough; congestion; sore throat; tight chest; headache; fatigue; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (cold symptoms), DYSGEUSIA (Metallic taste in mouth), COUGH (cough), NASAL CONGESTION (congestion) and OROPHARYNGEAL PAIN (sore throat) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039f21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Prolactinoma, Hypogonadism, Drug allergy (clindamyacin) and Lactose intolerant. Concomitant products included CABERGOLINE from 01-Mar-2022 to an unknown date, FEXOFENADINE from 01-Jan-2022 to an unknown date, TESTOSTERONE CIPIONATE (TESTOSTERONE CYPIONATE) from 06-Apr-2022 to an unknown date and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) from 01-Mar-2022 to an unknown date for an unknown indication.   On 15-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2022, the patient experienced DYSGEUSIA (Metallic taste in mouth), COUGH (cough), NASAL CONGESTION (congestion), OROPHARYNGEAL PAIN (sore throat), CHEST DISCOMFORT (tight chest), HEADACHE (headache) and FATIGUE (fatigue). On 25-May-2022, the patient experienced NASOPHARYNGITIS (cold symptoms). At the time of the report, NASOPHARYNGITIS (cold symptoms) had not resolved and DYSGEUSIA (Metallic taste in mouth), COUGH (cough), NASAL CONGESTION (congestion), OROPHARYNGEAL PAIN (sore throat), CHEST DISCOMFORT (tight chest), HEADACHE (headache) and FATIGUE (fatigue) was resolving.            Vaccine Administration Time of suspect drug was reported as 12:00 PM.  It was reported that patient experienced metallic taste in mouth during course of treatment,faded in intensity by the end. 3 days after finishing meds, he developed a cough. 4 days after, it went to full blown symptoms cough, As of today (day 6) he still had fairly significant cold symptoms with cough and tight chest, and congestion. Headache had eased.  No treatment medication were reported.
Contact Dermatitis. Large raised, edematous area on upper arm approx. 6 cm in diameter.
This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. Approximately in 2016 (reported as couple days ago) the patient was vaccinated with ZOSTAVAX, 1 shot (lot# and expiry were not reported) subcutaneously. Approximately in 2016, the day after vaccination, the patient experienced shingles. The outbreak occurred on the same side as the injection site. The patient visited the doctor's office to seek medical attention. The outcome of shingles was reported as not recovered. The reporter did not provide the causality between the event and the suspect therapy. There were no product quality complaints (PQC) involved. Additional information has been requested.
ringing in their ears; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the Pfizer covid 19 vaccine and three days later got ringing in their ears and it went away. The patient recovered from the event on unspecified date.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
One prior pregnancy without complications, born 6/18/20. Subsequent pregnancy conceived 3/20/21, received Pfizer COVID-19 vaccine on 4/14/21 and 5/5/21. Marginal/velamentous insertion of umbilical cord. Spontaneous vaginal labor and delivery. Baby girl was born with "H-Type" TEF at 7 lbs 10.3 oz.
Had shot at 7:45am and around 3:45pm started having severe itching in mouth , ears and skin. Took oral zyrtec without relief. Was scratching myself raw and bleeding. Went to ER and got solumedrol 125 and 25mg IV Benadryl. Next day had wheezing and rash on chest. Went on prednisone oral taper and albuterol.
On 10/23: temp 101 F and body aches. On 10/24: 4" diameter red area on arm. On 10/26: All symptoms in remission.
pt had @ 3 days generalized aches including joints x 2 wk;rt knee filled w/fluid w/limited use x 1wk;glaring of eyes/redness 4 wk-@ 3wks weakness;wakened w/tingling,numbness fingers-lt hand & wrist w/pain/bilat hands,wrist & forearms
This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ERS235) via an unspecified route of administration on 24Apr2021 at 13:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included losartan (MANUFACTURER UNKNOWN) for an unknown indication from unknown date and unknown if ongoing. The patient did not receive other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 16:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 00:00, the patient experienced terrible head to toe body aches, swollen hands and joints, body aches to where patient felt like she was poisoned; jaw aches, muscles aching to where patient had to be in bed and could not walk or function without pain. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events terrible head to toe body aches, swollen hands and joints, body aches to where patient felt like she was poisoned, jaw aches, muscles aching to where patient had to be in bed and could not walk or function without pain was resolved with sequelae on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
blood clots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (002191).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (death, medically significant), outcome "fatal", described as "blood clots". The patient date of death was unknown. Reported cause of death: "blood clots".  Clinical course: The reporter was calling for Xeljanz refill. She mentioned she knows someone who's husband died from blood clots after received the Pfizer covid 19 vaccine booster shot. Another friend in (Withheld) also died from blood clots after receiving the covid vaccine. Agent does not have address to provide. Agent provided Xelsource number to caller.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201195438 same product and event, different patients;; Reported Cause(s) of Death: blood clots
Info has been received from a registered nurse concerning a 27 y.o. male employee w/a PCN allergy and a history of serum exposure to Hep B in his eye who was vax'd w/Hep B vax recombinant. There was no concomitant medication. Subsequently the PT developed an elevated serum alanine aminotransferase (ALT) of 530. The registered nurse reported that the PT had labwork done twice (dates unreported), and was negative for viral Hep B both times. The outcome of the PT's elevated ALT was unknown. It was reported that the PT sought unspecified medical attention. Add'l info has been requested.
heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart palpitations). At the time of the report, PALPITATIONS (heart palpitations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. No treatment was reported.
"Very serious allergic rxn - wheezing, asthma symptoms, runny nose, difficulty breathing" 1 hr after flu shot.
Information has been received from a RN concerning a 5 y/o male with no medical history who on 03May1999, was vaccinated SQ in the right arm with the first dose of 0.5mL dose of dose of varicella virus vaccine live. Concomitant vaccinations on that same day included measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) and inactivated poliovirus vaccine. There was no illness at the time of vaccination. The RN reported that on 10Jul2003, the pt developed chickenpox characterized by a vesicular rash of 50-75 lesions mostly on his back and chest. It was noted that the pt's grandfather had shingles two weeks before he developed chickenpox. Unspecified medical attention was sought, but no treatment was required and no laboratory/diagnostic tests were performed. At the time of this report, the pt recovered from the chickenpox. Additional information has been requested.
pain in my arm; painful to move it/painful to raise it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in my arm) and PAIN (painful to move it/painful to raise it) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included PANTOPRAZOLE for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in my arm) and PAIN (painful to move it/painful to raise it). The patient was treated with TRAMADOL at an unspecified dose and frequency; GABAPENTIN at a dose of 100 mg three times a day; FLUOXETINE at a dose of in the morning and AMITRIPTYLINE at a dose of In the night. At the time of the report, PAIN IN EXTREMITY (pain in my arm) and PAIN (painful to move it/painful to raise it) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-323028 (Patient Link).
Client came into DOH 3/11/15 and rec'd 2 vaccines TDAP and pneumonia. Client stated next day 3/12/15 (R) arm was sore red and warm to touch. Client went to clinic today 3/13/15 and they told her to come back to DOH. Client stated that redness and warmth in (R) arm was spreading. Client rec'd both injections (R) deltoid. Redness and warmth starts from (R) shoulder area and goes down to just above elbow. Attempted to call clients MD but got answering service. Instructed client to go to ER for evaluation. Vital signs: Temp 101 degrees, pulse 84, Resp 16, B/P 132/79, Wgt-128. Client stated she would go to ER for evaluation. 3/16/15 Called client this am to f/u from Friday 3/13/15. Client stated she went to ER and they instructed her to take TYLENOL and put ice pack on (R) arm for 20 minutes at a time. Client stated she did this all day Saturday. Client stated that her arm is better today except for a little red mark.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a first 0.5 ml dose of VARIVAX (Merck) (therapy route and lot # not provided). The reporter stated that the patient came into her office" today", on 24-FEB-2011 who had developed chicken pox, even though the patient had been given VARIVAX (Merck) in the past. At the time of reporting, the patient's status was not provided. The patient sought unspecified medical attention. This is one of several reports received from the same source. Follow up information has been received from a medical assistant concerning the 4 year old male with asthma and rhinitis allergic and a history of respiratory syncytial virus infection and pneumonia who on 04-JAN-2008 was vaccinated with the first dose of VARIVAX (Merck) (lot# 658937/1560U) subcutaneously in the left thigh. On 02-JUL-2010 the patient was vaccinated with the second dose of VARIVAX (Merck) (lot # 665900/1604Y) in the right deltoid. On 04-JAN-2008, the patient was also received the third dose of (DAPTACEL) (Sanofi) (lot # C2800AA) in the left thigh, and the fourth dose of PREVNAR (lot # B47300H) in the right thigh, which was given elsewhere. Secondary suspect therapy included the second dose of MMR II (lot# 665803/1290Y) in the left deltoid on 02-JUL-2010. On 06-MAR-2011, the patient developed rash, no fever and multiple papules in different stages, over upper, lower extremities, lower abdomen and face and was diagnosed with varicella. The patient sought medical attention via doctor visit. OTC BENADRYL was given for treatment. At the time of reporting, the status of the patient was unknown. Additional information has been requested.
This is a spontaneous report from a contactable physician through a Pfizer sales representative. A 14 year-old male patient of unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date, at single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced induration, redness and low-grade fever, all on an unspecified date with outcome unknown. No follow up attempts are possible. No further information is expected.
Had headache, dizziness, nausea, starting 20 minutes after administration of Menactra and Hepatitis A vaccine.  Also developed neck stiffness the next day.
Moderna Covid vaccine was given at patient's workplace by Health Department on 10/12/2021.  Patient reported that this was her first Covid vaccine.  When patient's Covid vaccine information was being entered into system by Health Dept. nurse later that day, it was noticed that patient had already received the Pfizer Covid vaccine on 02/09/2021.  Health Department nurse contacted patient's supervisor at the nursing home to let her know about the incident.  Supervisor contacted patient and reported back to Health Department nurse that patient was not having any adverse reactions at the time which was within 24hrs of receiving the vaccine.
got theshot and ended up getting it again/suspected vaccination failure; ended up getting it again.; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter knew a patient who got the shingles shot and ended up getting the shingles again. The reporter also asked what did you tell about the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available. This case is one of 8 case, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR166325:Same reporter US-GLAXOSMITHKLINE-US2021AMR138446:Same reporter US-GLAXOSMITHKLINE-US2021AMR092424:Same reporter US-GLAXOSMITHKLINE-US2021AMR178106:Same reporter US-GLAXOSMITHKLINE-US2021AMR178222:Same reporter. US-GLAXOSMITHKLINE-US2021AMR178234:Same reporter. US-GLAXOSMITHKLINE-US2021AMR179350:Same reporter
pt recvd vax; rash 10 days p/ vax; fever went up to 105 R;
Information has been received from a literature article, referring to a 32-year-old man. The patient with recurrent idiopathic pericarditis was admitted with persistent hypotension. Workup revealed elevated ACTH, low DHEA-S, positive ACTH stimulation test and positive 21-hydroxylase antibody consistent with autoimmune Addison disease. Maintenance hydrocortisone, 20 mg in the morning and 5 mg at night, as well as fludrocortisone 0.05 mg daily, were started. He was counseled on the use of emergency dexamethasone injection pens. One month after discharge, he had normal sodium and potassium levels and a renin level of 3.0 ng/mL/h. During a follow-up primary care appointment, the patient was administered routine influenza virus vaccine (unspecified), Tdap and pneumococcal vaccine, polyvalent (23-valent) (manufacturer, dose, lot# and route unknown). Six hours after immunisations, the patient developed fever, myalgias, abdominal pain and vomiting that prevented intake of oral steroids. In the emergency department, vital signs revealed fever of 39.5 centigrade and hypotension of 88/54, with hyponatraemia and hyperkalaemia. Upon admission to the intensive care unit for adrenal crisis, he received 4 L of normal saline and stress-dose IV hydrocortisone for 24 h. The patient's gastrointestinal symptoms quickly resolved after steroid administration and his sodium and potassium normalised. He was discharged on his home steroid regimen and was instructed to triple his home steroid regimen with any future vaccinations. The author considered the event adrenal crisis to be related to influenza virus vaccine (unspecified), diphtheria toxoid, pertussis acellular vaccine (unspecified), Tdap and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). Upon internal review, the event adrenal crisis was determined to be medically significant.
Numbness and tingling on right side body then both legs below the knees with some weakness, headaches, generalized weakness, lethargy, abdominal pain and discomfort, abdominal swelling, both legs swelling.   All continued and worsened over months.
RASH ALL OVER BODY. TOOK 25MG BENADRYL AND RASH RESOLVED.
Patient went to two pharmacies in one day and received a Moderna COVID vaccination from both. Both pharmacies interviewed patient and he told both he had never received one.  When questioned once the incident had been discovered, the patient said he was aware he was not supposed to do it, but wanted to "try it out" since he was told the vaccine doesn't work very well. Patient did not show any obvious signs of distress at last viewing.