chrisvoncsefalvay/vaers-outcomes huggingface dataset:
throat tightness; bp is up; This is a spontaneous report from a non-contactable other HCP. A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EM9809) via unspecified route of administration, on an unspecified date as 1st dose single for COVID-19 immunisation. The patient's medical history included hypertension, a-fib, allergies and asthma. The patient's concomitant medications included allergy medications and hypertension medication. On an unspecified date during her 15-minute waiting period after the vaccination, the patient had experienced throat tightness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, hoarseness, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. She had taken her allergy medications along with her hypertension medication. The patient reported that she usually checks her home blood pressure and runs around 140s systolic. She stated that her blood pressure was up as she was anxious. She stated that she got like this prior to doctor appointments or visits. She had felt well and wished to go home. She was informed to monitor blood pressure at home and follow up in ED if throat symptoms worsen or do not improve. The patient received antihistamines as treatment. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
pt recv vax 22JUN95 & on 11FEB98 pt devel a few varicella lesions, w/no fever;
After a few weeks, my right ear started to have constant tinnitus as not subsided.  Note that I have Meniere's in my left ear, but this is the first time my right ear has had tinnitus for a sustained period of time.
The clinic wanted me to stay at the clinic for 30 minutes after the shot. I started to feel itching approximately 20 minutes after the shot. My face then became flushed & heart felt like it was racing.  The staff brought me to another area and checked my blood pressure as well as dispatched team for assistance.  They gave me benedryl since I opted not to use my epi pen.  I stayed until they had 3 readings of my blood pressure reducing.  Continued to take benedryl for 2 days after the appointment.
There was no adverse event the patient was given a high dose influenza vaccine instead of a regular influenza vaccine.
Red white rash; Arm was extremely swollen; Itchy; rash from shoulder down to elbow; Arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was extremely swollen), PRURITUS (Itchy), RASH ERYTHEMATOUS (Red white rash), PAIN IN EXTREMITY (Arm was hurting) and RASH (rash from shoulder down to elbow) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol. Concomitant products included LISINOPRIL and LEVOTHYROXINE for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was hurting). On 05-Feb-2021, the patient experienced PERIPHERAL SWELLING (Arm was extremely swollen), PRURITUS (Itchy) and RASH (rash from shoulder down to elbow). On an unknown date, the patient experienced RASH ERYTHEMATOUS (Red white rash). On 25-Jan-2021, PAIN IN EXTREMITY (Arm was hurting) had resolved. At the time of the report, PERIPHERAL SWELLING (Arm was extremely swollen), PRURITUS (Itchy), RASH ERYTHEMATOUS (Red white rash) and RASH (rash from shoulder down to elbow) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-033849 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-033849:Patient Wife case
Information has been received from a certified medical assistant CMA and a registered Nurse concerning an over 65 adult male with no pertinent medical history or allergies who on 10/20/05 was vaccinated IM with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649697/1038P). the day after the injection, on 10/21/05, the pt experienced swelling, redness, induration, warmth and pain at the injection site. The swelling was described as almost like cellulitis. Unspecified medical attention was sought. The pt was reported as recovering at the time of the report. No product quality complaint was involved. No additional information is expected.
vaccine was administered in gluteus instead of deltoid, NO AE; Initial information received on 13-Jan-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 56 years old female patient who was vaccinated with RABIES (HDC) VACCINE [IMOVAX RABIES] in the gluteus instead of deltoid muscle on an unspecified date.  Medical history included raccoon bite. Past medical treatment, vaccination and family history were not provided.  Concomitant vaccination included IMMUNOGLOBULIN HUMAN ANTI-RABIES (Imogam)  On an unspecified date, patient t was vaccinated with RABIES (HDC) VACCINE [IMOVAX RABIES] via unknown route in gluteus site instead of deltoid (day 3 and day 7 dose).    It was a case of actual medication error due to vaccine administered at inappropriate site.   At the time of report, no adverse event was reported.   Laboratory data was not provided.  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 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.  Information on the batch number was requested.
pt recvd vax & several hrs post vax exp a red rash from ankles to thighs;
This spontaneous report was received from a nurse practitioner refers to a 14-year-old male patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were unknown. On 12-OCT-2017 the patient was vaccinated with doses of improperly stored GARDASIL 9 (dose, units and frequency were unknown) (lot # N007931 and expiration date 17-NOV-2019). The temperature excursion was at 9 C to 25 C (10 C) [C (degree centigrade)] for 1 hour. No adverse effects were reported. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was reported. This is one of several reports received from the same reporter (1710USA002936,1805USA004664, 1805USA004665, 1805USA004666 and 1805USA004667).
Low grade fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (Low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Low grade fever). At the time of the report, PYREXIA (Low grade fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details not provided. concomitant products details not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-092475 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092475:
Was sick; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 05-Dec-2020.  This case involves an unidentifiable patient who was sick (illness) while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient was sick (illness) following the administration of INFLUENZA VACCINE.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Fever, chills, headache, body aches, nausea/vomiting, restlessness
Tolerated first every flu shot well, no problems after 15-20 min.  After 2 hours returns, violently shivering, c/o feeling cold, breathing regularly but states his breathing felt "wrong." Extremely anxious, fingers of both hands extremely blanched, but hands above knuckles normal. Warm and diaphoretic on hands and arms. Went to nurses office where (I was told later) his BP was fine, O2 sat was in 80's until he breathed deeply and it "shot up to 95". Color returned to proximal fingers and seemed calmer when wife arrived, went to ED via 911 call by nurse.
Janssen COVID-19 Vaccine EUA I was vaccinated on Tuesday, 4/6--on Wednesday, I had the typical side effects of a sore arm, fatigue and muscle aches. On Thursday, 4/8, my arm was less sore and my fatigue and muscle aches were almost gone, however, I woke up with chest congestion and a cough. No fever but the coughs were painful--it almost felt like I had bronchitis. Nothing dire--I can breathe fine, no fever, I don't feel sick, but I just have this deep cough. When I looked up the side effects, I didn't see cough or chest congestion so I thought I would report it. Today is Friday, 4/9 and my cough seems to be getting better, although it's still there and I don't feel 100% yet.
Information has been received from a physician referring to a 16 years old male patient. On an unknown date the patient was vaccinated with a first dose in the series of GARDASIL 9 (dose, frequency and lot# were not reported). No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Began to feel tired and sore around 1530, chilled and feverish around 1730. Took temp at that time at 99.2° F. Muscle aches, joint pain, chills, tired and unable to move from couch, and dizzy. At 1830 temp up to 101.7° F, took 1000mg Acetaminophen. At 1840 temp up to 102.6°F before coming back down. It is now 2050, with 99.0° F with muscle and joint pain.
This spontaneous report as received from a healthcare worker refers to a 7 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 05-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally (incorrect product storage). The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
On 01-21-2021 at 3am, I experienced heart palpitations. I had a 24 hour holter monitoring it showed 79PAC's, and had 26pvc at a cardiologist office. I was experiencing chest palpitations all day and had to put me on heart medicine.   I am still having abnormal activity to my heart, not yet recovered.
allergic reaction; eyes swollen shut; eye itching; lips swollen; nose did not stop running; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (allergic reaction), EYE SWELLING (eyes swollen shut), EYE PRURITUS (eye itching), LIP SWELLING (lips swollen) and RHINORRHEA (nose did not stop running) in a 63-year-old female patient who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (unknown route) at an unspecified dose. On an unknown date, the patient experienced ALLERGY TO VACCINE (allergic reaction), EYE SWELLING (eyes swollen shut), EYE PRURITUS (eye itching), LIP SWELLING (lips swollen) and RHINORRHEA (nose did not stop running). At the time of the report, ALLERGY TO VACCINE (allergic reaction) outcome was unknown and EYE SWELLING (eyes swollen shut), EYE PRURITUS (eye itching), LIP SWELLING (lips swollen) and RHINORRHEA (nose did not stop running) had resolved. Not Provided          Treatment medication included prednisone for allergic reaction.   This case was linked to US-MODERNATX, INC.-MOD-2021-089104 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089104:cross link
Had a severe migraine headache for 1 day.  But this didn?t occur until June, 2021.  On Sept. 1, 2021 admitted to E.R. with a PE in left lung 2mm.
40 patients administered with vaccines that have undergone temperature excursion; 40 patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. A medical assistant reports that they had temperature excursions involving 4 Moderna Covid-19 vaccines inside the refrigerator on 28 Jan-30 Jan2022, 31Jan2022 and 04Feb2022. The impacted vaccines were administered to 40 patients on unspecified dates.No patients have reported any adverse events to date.The vial was thawed on 28 Jan 2022. The vials had Maximum or minimum temperatures reached,on 28 Jan 2022 temp range positive 34.7F to positive 41.2F, on 30 Jan 2022 temp range positive 34.7F to positive 41.2F which occurred approximately for 48 hours, on 31 Jan 2022 temp range positive 34.7F to positive 41.2F for 12 hours and on 04 Feb 2022 temp range positive 35.2F to positive 41.7F for 12 hours. No treatment drug details was reported.
ABOUT 15 HOURS AFTER INJECTION I HAD A EXTREME HEADACHE AROUND THE EYE AND NOSE AREA. I LAYED DOWN WITH A COLD PACK OVER MY EYES FOR ABOUT 2 HOURS.  I FINALLY DECIDED TO TAKE A COUPLE TYLENOL AND DISCOVERED IT WAS HARD FOR ME TO SWALLOW.  I TOOK A BENADRYL PILL AS WELL AND LAYED BACK DOWN.  MY THROAT BECAME LESS RESTRICTED SO  I JUST CONTINUED TO MONITOR MYSELF.  THE HEADACHE BECAME LESS SEVERE BUT CONTINUED FOR ANOTHER 24 HOURS OR MORE.  I CONTINUE TO BE TIRED BUT ALSO WORK LONG HOURS.  TODAY, 04/23/21, TWO WEEKS AFTER INJECTION, I WENT TO URGENT CARE TO HAVE A ANTIBODY TEST DONE.  BOTH THE IGG AND IMG CAME BACK NEGATIVE!
This case was reported by a physician via sales rep and described the occurrence of angioedema in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced angioedema (serious criteria GSK medically significant). On an unknown date, the outcome of the angioedema was unknown. It was unknown if the reporter considered the angioedema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter did not agree to follow up from GlaxoSmithKline.
The pt experienced redness, warmth, edema to left upper arm. Treated with cool compresses, Tylenol, and Benadryl.
Patient received the second dose with an interval of 49 days; This spontaneous case was reported by a nurse and describes the occurrence of OFF LABEL USE (Patient received the second dose with an interval of 49 days) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PREDNISONE, VALPROATE SEMISODIUM (DEPAKOTE) and BENZTROPINE [BENZATROPINE] for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced OFF LABEL USE (Patient received the second dose with an interval of 49 days). On 19-May-2021, OFF LABEL USE (Patient received the second dose with an interval of 49 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment information was not provided.
15 patients received dose from expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (15 patients received dose from expired vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.   In October 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (15 patients received dose from expired vial). In October 2021, EXPIRED PRODUCT ADMINISTERED (15 patients received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter reported Number of doses/vials: 20 doses (15-dose vial) Date the vial was initially stored in the refrigerator: 13Sep2021 Date(s) of administration of vaccine: 14-Oct-2021 through the 21-Oct-2021 included  No relevant concomitant medications were reported. No treatment information was provided.
patient with what appears to be shingles and muscle spasms 9 days after uneventful vaccine
This spontaneous report was received from a licensed practical nurse regarding a male patient of unknown age. There was no information on pertinent medical history and drug reactions or allergies. On an unknown date, the patient was vaccinated with GARDASIL strength reported as 120 Y (unspecified units) (dose, route, product lot# not reported) and immediately afterwards, he passed out, face first on the floor and cracked a bunch of teeth out. There was no product quality complaint involved. The outcome of the events was unknown. The causality was not reported. Additional information has been requested.
Felt sick all  over, body aches, continued weight loss, dizziness, general malaise. She has impaired gait and memory issues since this injection. She now has trouble walking and balance since the injection.  She  moves very slow and can  no longerdrive. She wasavery active  person before this shot. She was a volunteer registered nurse at the free clinic in Glendale and no longer can ambulatedue to balance and edema issues in legs. She has just been diagnosed with Parkinson's Sydrome.  and Lymphedema. These symptoms started right after the booster. Symptoms have  now advanced into memory problems, speech problems, and ovarian cancer. Surgery for ovary removal just occured a few weeks  ago.
erythematous wheal with induration on left arm( Menquadfi) site, 4"X4"TDaP site also with mild erythema and induration .
Respiratory distress - Tachycardia, with periods of bradycardia, fever  observed at approx 3:09 pm - call to MD who gave order to send to ER for Eval and Treat
Pt receievd a first dose of Moderna on 30 March 2021. The week of 12 April, Moderna vaccine was seized from the clinic by the state for mishandling and deemed compromised.  Patients who received their COVID vaccine from the clinic were sent text messages by the state with instructions to  to get revaccinated.  This patient was instructed by the message to sign up for a vaccine clinic with a list of clinics offered this week.  Instructions were confusing.  Patient received a new dose of Moderna on 16 April, 16 days rather than 28 days from the compromised 1st dose.  Patient received his repeat dose sooner than 28 days.  Patient has not reported any adverse reactions.
RECEIVED VACCINE AT 06:00 PM.  18 HOURS LATER STARTED TO NOTICE LUMP AND SORENESS AROUND LEFT NIPPLE AREA.  GOT PROGRESSIVELY WORSE AND PAINTFUL AND HURT TO BREATHE DUE TO MUSCLE PAIN IN CHEST.  I WAS NOTIFITED AT 11:30 PM.  REDNESS AND FIRM RED NOED ABOUT 3CM IN DIAMETER.  IT HAD STREAKS OF RED INFLAMMATION UP TOWARD HIS ARMPTI WITH TENDERNESS. THE INJECTION SITE WAS NOT RED, INFLAMED OR SORE.  hE WAS GIVEN 25 MG OF BENADRYL PO AND IBUPROFEN 400 MG AND WAS CHECKED THROUGHOUT THE NIGHT. BENADRYL AND IBUPROFEN WERE CONTINUED EVERY 6 HOURS FOR 2 DAYS.  IT WAS CLEARED WITHIN 3 DAYS.
Stroke, two days later.  October 21, 2022.  Blurry vision and confusion.
On Nov 12, (9 days after injection) started having burning chest pain localized on left side of sternum.
This spontaneous report was received from a Licensed Practical Nurse (LPN) concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored M-M-R II (Lot # K004949 Expiration date: 04-APR-2016) (doses, routes and anatomical location of administration were not reported). No adverse effect was reported. This is one of two reports received from the same source. Additional information has been requested.
Large raised circular welt at injection area.  Approximately 2 inches in diameter.  Site is itchy, appears to be resemble a hive.  Appeared 8 days after injection.
Starting 04/18/2022, I had a slight sore throat and a lot of nasal congestion. I tested positive on the morning of 04/20/2022. I didn't have any treatment and my doctor didn't think I should take any medicine for it since it was such mild symptoms. To this day, I still have mild nasal congestion and a very dull headache, but no other symptoms.
Next day after the shot, I had upset stomach and diarrhea. That following Thursdays I became sluggish and drain. I went to the hospital tested positive for COVID. I didn't have a appetite and only wanted to sleep.