chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FACIAL IS SWELLING; SLURRY WORDS; DIZZINESS; SWOLLEN TONGUE; HARD TO TALK; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 23 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known medical history. The patient had no known drug allergies at the time of reporting. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 about 1 hour and 30 minutes ago (as reported) on for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the patient experienced facial is swelling. On 05-APR-2021, the patient experienced slurry words. On 05-APR-2021, the patient experienced dizziness. On 05-APR-2021, the patient experienced swollen tongue. On 05-APR-2021, the patient experienced hard to talk. On 05-APR-2021, the patient experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from facial is swelling, slurry words, dizziness, soreness at injection site, swollen tongue, and hard to talk. This report was non-serious.
On Aug 27th at 430 AM woke up to racing heart beat of 117.  Arm pain from Aug 25th-28th Cant sleep at night 27th and 29th woke up with racing heart beat and chills on 29th. Low grade fever 28-29th Muscle pains and aches  from 26th -29th Headache from 27-29th due to lack of sleep and Stress about side effects.
Swollen lips, chills, unable to move/lift arm. Pt didn't seek medical attention.
Neck pain and tightness; Shoulder pain; Bicep pain; Neck tightness; Chills; Fever; Aches; Sweats; Headache; Lack of energy; This case was reported by a consumer and described the occurrence of chills in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 20th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 20th November 2020, less than a day after receiving Shingrix, the patient experienced chills, fever, pain, sweating, headache and loss of energy. On 21st November 2020, the patient experienced neck pain, shoulder pain, muscle pain and neck tightness. On 22nd November 2020, the outcome of the chills, fever, pain, sweating, headache and loss of energy were recovered/resolved. On an unknown date, the outcome of the neck pain, shoulder pain, muscle pain and neck tightness were not recovered/not resolved.   It was unknown if the reporter considered the chills, fever, pain, sweating, headache, loss of energy, neck pain, shoulder pain, muscle pain and neck tightness to be related to Shingrix.  Additional details were provided as follows: The patinet received 2nd dose of Shingrix in left arm.  After receiving 2nd dose of Shingrix, the patient experienced chills, fever, aches, sweats, headache, lack of energy, neck pain and tightness, and shoulder and bicep pain. The patient states he sought medical treatment for the neck, shoulder and bicep pain, was prescribed medication, and that it has not helped. The patient states that neck pain and tightness, and shoulder and bicep pain symptoms have grown more painful over time and are still on going. The customer does not have vaccine information for this adverse event. The reporter consent to follow up.
Pentacel and Quadracel were both administered to patient.; ActHib was reconstituted with Quadracel, and Pentacel (DTap and IPV) was given separately.; Initial information received on 19-Aug-2019 regarding an unsolicited non-valid non-serious case received from a nurse.   This case concerns a 04-month old female patient who received DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE [QUADRACEL] and DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL)   Patients medical history and concomitant therapy not reported.  It was of potential medication error due to Inappropriate reconstitution technique and Extra dose administered.  It was unknown whether adverse event was experirnced.  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.  List of documents held by sender: none.
0800 6/13/06 swelling and redness left arm at site, 6/14/06 severe pain, swelling to approx 3 inch diameter, 6/15/06 severe pain, swelling, fever, ice pack and Tylenol, 6/16/06 same adverse reaction, visit Dr, ice and Tylenol #3 for 2 weeks. 8/28/06 final swelling gone.
-routine administration of vaccine, patient went to sit in observation area, experienced what may have been seizure lasting less than 5 seconds. she quickly recovered/responded to the sound of my voice. gave water and ice pack. observed for approximately 30 minutes. patient was emotionally upset. after calming down she felt she was ok to leave the facility.
Very sore arm at injection site almost immediately following vaccination. Soreness of muscles generally throughout my body the next day; even soreness of skin, akin to having the flu. Headache. "Wooziness."  Mild stomach upset. General malaise. Worst of the symptoms occurred beginning the morning of the day after vaccination and lasted approximately 2 days.
Pt recv vax pm 8/20/98; on 10/30/98 pt exp bruising; dx=ITP
Patient received 6 months to 4 years dose instead of 5 to 11.
PATIENT WAS FEELING NAUSEATED, CHILL, SWEATING, LIGHTHEADEDNESS, AND EAR RINGING AFTER VACCINATION. WE GAVE HER A BOTTLE OF WATER AND A SWEATER FOR THE CHILL WHILE WAITING FOR EMS. SHE FELT BETTER ABOUT 25 MINUTES LATER. EMS CHECKED HER BLOOD PRESSURE AND BLOOD SUGAR WHICH WERE NORMAL. SHE STATED SHE HAS HISTORY OF PASSING OUT AFTER VACCINATIONS AFEW YEAR AGO. SHE STAYED FOR ANOTHER HALF AN HOURS AT PHARMACY. ADVISED HER TO DISCUSS WITH HER FAMILY DOCTOR ABOUT THE 2ND DOSE COVID-19
Symptoms began 03/18/2023; fever, cough, SOB, chest pain, fatigue, chills, congestion, head ache,  muscle aches, poor appetite.
Approximately 12 hours after my daughter received her vaccines she was moving her arms up and down and then simply fainted. She fell forward against my back, and fell to the floor face down. I tried to wake her up and she twitched her head and stayed down for about 30 seconds. Then she woke up sat her on the floor. She was pale, I gave her apple juice we got her to bed. She only complained of her lip hurting which had a small cut.
This spontaneous report as received from a physician refers to multiple patients of unknown age. On an unknown date, unknown number of patients were possibly vaccinated with PNEUMOVAX23. Concomitant medications were not reported. ON an unknown date, multiple patients received improperly stored PNEUMOVAX23 and no adverse effect were reported,. PNEUMOVAX23 ws exposed under the recommended condition from 17-OCT-2013 to 21-OCT-2013. Additional information is not expected.
SHE SPEAKS VERY LITTLE ENGLISH, WE USED A TRANSLATER TO HELP COMMUNICATE. AFTER RECEIVING THE VACCINE SHE FELT DIZZY AND LIGHT HEADED. ON SITE EMS RESPONDED. VITALS ARE BELOW. SHE DID TEST POSITIVE FOR COVID APRIL 2020. 25MG DIPHENHYDRAMINE ORALLY GIVEN. SHE WAS MONITORED AND FELT BETTER AND RELEASED TO HOME. NOTE: THE NAME I TYPED OUT WAS HOW IT WAS ON HER DOCUMENT.
Blistering at injection site; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration on 28Apr2021 at 14:30 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included occasional ibuprofen (MANUFACTURER UNKNOWN) and calcium supplement (MANUFACTURER UNKNOWN) both for an unknown indication on an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) on the arm left via an unspecified route of administration on 07Apr2021 at 15:30 (at the age of 56-year-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 vaccination. On 29Apr2021 at 10:00 the patient experienced blistering at injection site. The clinical outcome of the event blistering at injection site was unknown at the time of the report.  No follow-up attempts are needed. No further information is expected.
Caller says he is not taking the next dose; Heart racing; This is a spontaneous report from a contactable consumer (patient himself). A 62-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6202; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left (at age of 62-years-old) on 15Mar2021 11:45 as single dose for COVID-19 immunization. Medical history included high blood pressure. Concomitant medications included olmesartan taken for blood pressure measurement, clopidogrel taken for blood viscosity increased, acetylsalicylic acid (ASPIRIN (E.C.)) taken for blood viscosity increased, start and stop date were not reported. Patient's Medical History (including any illness at time of vaccination) was not reported. Patient did not have family History. Patient did not have prior Vaccinations (within 4 weeks). There was no any history of all previous immunization with the Pfizer vaccine considered as suspect was reported. It was reported that, the consumer calling regarding the Pfizer COVID 19 shot. He got the shot yesterday and last night it had his heart racing and he did not think he can get the next shot. Clarified he received the first dose of the Pfizer COVID 19 vaccine on 15Mar2021 at 11:45 AM in the left arm. On same day at the night when he laid down at 10:00 PM he noticed his heart racing and it lasted at least three hours. He didn't go to sleep until about 04:00 AM. Stated that, he asked the nurse at the vaccination clinic since he has a stent would it be okay, and she said yes but he didn't look at the paper because it said you could have heart racing. Reports today he was fine and has recovered but added he did not know if it will race again when he lays down. Confirmed that, he was scheduled to receive the next dose on 06Apr2021. The adverse events did not require emrgency room visit or physician office visit. There was not any relevant test. The outcome of heart racing was resolved on 16Mar2021 while it was unknown for event caller says he is not taking the next dose.  No follow-up attempts are possible. No further information is expected.
Patient experienced severe vomiting  2-3 hours after receiving vaccination.  Patient had to go to ER to control her nausea . This was a 2nd shot  and  patient experienced similar reaction  (severe nausea and vomiting) as she did to the first one.
Two days after varicella injection mom reported child hot with rash all over body. Took him to ER later in day for lip swelling. Given Benadryl and sent home, In am child woke up with swelling of eyelids, hands and genitals. Rash gone Dr said difficulty breathing to Return to ER. Back to ER and treated with Benadryl and steroids.
Left arm never stopped hurting, injection site always red and whelty.  10 days later, inablitiy to move ankles, knuckles or knees beyond the smallest of bends.  Went to the ER on 4/27/2021.  I was given steroids 50mg for 5 days.  It worked perfectly.  I stopped taking it on   05/02/2021.  On 5/3/2021-5/6/2021 I had severe migraine, my stomach would only empty via vomiting. 2 times on 5/3/2020, 7 times on 5/4/21, 2 x on 5/5/2021.  I lost 9 lbs from 5/2-5/6/2021. When I vomited, the pain in my breast area felt like a vise grip tightening on my ribs and heart area.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 1:17 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 1:17 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 49.05.  Concomitant products were not provided.  On 13-Feb-2021, Excursion time was 09 AM, temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 9-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
My smelling sense has been off since about a week after my second dose.  Everything smells the same - onions, coffee, bowel movements.  It's a smell that's a bit hard to describe - somewhat of a burnt smell.  It now seems to be affecting my taste and I therefore have decreased appetite. Note: I did have a mild case of COVID in Feb 2021 (positive test)
Baseball sized warm and swollen injection site reaction post 48 hours. Told to take 2 BENADRYL. Patient already drew line around area and is watching for tracking or growth.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Lot number: EW0158), in right arm, on 05May2021 as dose 2, single (Lot number: EW0173), in right arm, on 09Nov2021 as dose 3 (booster), single (Lot number: FH8027), in right arm and on 21May2022 as dose 4 (booster), single (Lot number: PM9992) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Irritable bowel syndrome" (unspecified if ongoing); "tension headaches" (unspecified if ongoing); "Pacemaker implant due to bradycardia" (unspecified if ongoing), notes: Pacemaker implant due to bradycardia; "seasonal allergies" (unspecified if ongoing), notes: Seasonal allergies; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Known allergies: Latex" (unspecified if ongoing); "pacemaker implant due to bradycardia" (unspecified if ongoing), notes: pacemaker implant due to bradycardia. Concomitant medication(s) included: Cetirizine; Fluticasone; Azelastine; Magnesium Citrate; Metamucil [Plantago Ovata]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: within 12 hours of symptom onset and positive antigen test; (unspecified date) Positive, notes: COVID 19 Treatment; (28Aug2022) Positive, notes: Began testing daily on day 6-9, never testing negative; (29Aug2022) Positive, notes: Began testing daily on day 6-9, never testing negative; (30Aug2022) Positive, notes: Began testing daily on day 6-9, never testing negative; (31Aug2022) Positive, notes: Began testing daily on day 6-9, never testing negative. Therapeutic measures were taken as a result of covid-19. Clinical course: Began 5-day course of Paxlovid within 12 hours of symptom onset and positive antigen test. Symptoms were mild-to moderate headache, mild sore throat, slight sinus congestion and no post-nasal drip. Began testing daily on day 6-9, never testing negative. On Day 10, headache became worse and sinus congestion and post-nasal drip increased. On Day 11, symptoms included fever, chills, cough, body aches, significant sinus congestion and post-nasal drip, fatigue. Fever and chills resolved during Day 12 but returned that evening. Other medication in 2 weeks. Patient received Anti-viral treatment for COVID-19 with Paxlovid from 23Aug2022 to 27Aug2022.
a 26 years old female patient received a dose of Fluzone High Dose vaccine/No AE; a 26 years old female patient received a dose of Fluzone High Dose vaccine/No AE; Initial information received on 16-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer (medical assistant).  This case involves a 26 years old female patient who received a 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UT668110A via unknown route in the left arm on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of report no adverse event was reported.  Doctor visit and date 16Oct2019.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
This spontaneous report was received from a physician via field representative regarding a 15 years old male patient. The information on pertinent medical history and drug reactions or allergies was unknown. On 25-JUN-2014, the patient was vaccinated with GARDASIL (Product Lot #/Expiry date unknown) intramuscular injection, one single shot, intramuscularly. The concomitant medication was not reported. The physician reported that on 25-JUN-2014, after receiving GARDASIL the patient became dizzy, was unable to stand and his complexion turned pale. There was no product quality complaint involved. The outcome and causality of the events were unknown. Additional information has been requested.
pt reports a scratchy throat & tingly tongue immed following administration of vax, episode lasted 20 mins;
Information has been received from a physician concerning an infant patient who was vaccinated with unknown doses of Rotateq. It was reported that the patient did not complete the series of vaccination. The physician also reported that after receiving the vaccine the patient had developed rotavirus. A diagnostic laboratory test was undertaken which came back positive for rotavirus. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Pt DOB was misread at offsite clinic and pharmacist administered moderna vaccine to patient under the age of 18.
On June 26th he started having a pain in his spine and a sharp pain down his right arm . Stated that he cannot get comfortable when laying down, sleeping, or walking he feels very uncomfortable. This has been continuously going on since he got his second dose of the moderna. Was taking ibuprofen and has been trying different meds but none of them worked .
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccine was stored in the freezer and one to two vials were taken out and placed in the fridge each day as needed. No concomitant medicines were reported No treatment medicines were reported
> 100 erythematous macules with 5-10 with central vesicle.
This spontaneous case was received from a consumer on 03 September 2009. A 29-year-old female patient, with no reported medical history and no previous pregnancies, received an injection of ADACEL (lot not reported) on 13 August 2009. She was four weeks pregnant at the time of vaccination; date of last menstrual period was not reported. On 31 August 2009, 18 days post-vaccination, the patient had a miscarriage. No additional information was provided.
Patient received dose of Moderna on 9/6 . He had received a previous dose of Moderna 8/31/2021
Irregular heartbeat; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (Irregular heartbeat) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced HEART RATE IRREGULAR (Irregular heartbeat) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, HEART RATE IRREGULAR (Irregular heartbeat) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information was provided.  Treatment information was not provided.