chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heartburn; A spontaneous report was received from a echocardiographer concerning a patient who may have received the Moderna's Covid-19 vaccine (mRNA-1273) and developed heartburn.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Lot # not provided) on (date of vaccine not provided) for prophylaxis of COVID-19 infection.   The echocardiographer reported hearing someone say they had heartburn and asking if anyone else had heartburn at the facility. The reporter was unsure if this patient did or did not receive the vaccine.  Treatment for the event was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, heartburn, was considered unknown.   The reporter did not provide an assessment of the event, heartburn.; Reporter's Comments: Very limited information regarding these event has been provided at this time.  Further information has been requested.
pt was given Tdap vs. TD per pt preference. Pt dose not have any allergies to this vaccine. Miscommunication with pt for clarification and was attempting to accommodate for pt appointment time in lab. Pt has had tdap vaccine in the past with no adverse reactions. No adverse reactions at end of pt visit.
PT states chest pain, body aches, and fatigue began the next day after receiving 2nd dose of Covid vaccine.
Patient admitted to hospital with ascending polyneuropathy consistent with Guillain Barre Syndrome. Symptoms worsened, given IVIG and he was transferred to tertiary care center for plasmapheresis. Symptoms began one hour after vaccine. He had URI 2 weeks prior to symptoms.   1/3/2005  Hospital d/c summary of 12/8-12/9/2004 states GBS, urinary retention & weakness.  Neuro consult done.  Pt had recent URI.  Admitted to ICU & tx w/IVIG initially.  Transferred to higher level of care.  2/02/2005 Hospital d/c summary of 12/9-12/15/2004 FINAL DX: GBS, Miller Fisher variant Records states pt experienced numbness of hands & feet within 2 hrs of vaccination on 12/7, weakness, difficulty walking, urinary retention, ataxia & constipation. Neuro consult & LP done.  Exam revealed marked ataxia.  Transferred to inptient rehab.  Follow up 03/01/05: The patient has not recovered from the events, has presistant ataxia and gait instability and neuropathic pain. As per annual follow up 01/04/2006 Some improvement, peripheral neuropathy of hands and feet. Trouble with gait and urinary retention. Some neuropathic pain.
Left Arm became painful,swollen, hot to the touch,with a large round rash at site of vaccination.& is itchy
Right axillary is sore, tender. Very painful. Numbness in right leg like it is asleep
I had Soreness on the arm the same day of vaccination, redness, achy in the muscle area on my arm. I think the injection was administrated to high in my arm.  The within the next 24-48 hours I had a headache and was tired. About the 4th-5th day I had tingling, prickly feeling across right shoulder, down both arms down to my fingers and down  my legs down to my toes. This lasted about 5-10 minutes. Then on the 16th it happened again but this time it was my whole body the torso area and my limbs. I also had weakness, I felt like I needed to hold onto to someone to be able to stand. I had an unstable feeling while standing. The headache has occurred on and off since time of vaccination  about 4-5 times.  I  went doctor on Tuesday 2/16/2021, I did not see my doctor this time I see a different  it was a lady doctor.  She wasn't aware of this being one of the side effects and just to monitor myself and return if the symptoms worsen. She thought it was safe to get the 2nd dose. I have a virtual visit scheduled with Dr. on 2/23/2023
Patient "Ballooned up" on side of injection to the point he was unable to walk or put weight on that side
On 12/07/2021, client requested to receive the Pfizer booster. The Pfizer booster, 0.3 ml, was administered. When the vaccinating team entered the Covid-19 booster vaccination in. It was discovered the booster was given 137 days early. Booster was due 04/23/2022. Client was observed for 15 minutes following the injection.
11/16/2018 Severe muscle aches, fever, cold sweats. 11/27/18 Severe pain in right shoulder, arm and hand as well as joints. Severe back pain, numbness and tingling on right side of body as well as loss of feeling. Symptoms continues through December that also included muscle weakness in legs, could not stand longer than 35 minutes. Symptoms migrated to left leg, including pain, muscle weakness, numbness and loss of feeling. Cold burning feeling on toes that has now included both feet up to my ankles. Now January, still experiencing pain, numbness and loss of feeling in legs as well as leg weakness. Cannot stand longer than 4o minutes, now walking with cane due to leg muscle weakness. Not sleeping due to leg cramping and numbness, tingling sensations.
Mouth sores/lesions along gum and causing throat pain on same side; Mouth sores/lesions along gum and causing throat pain on same side; Possible cold sore virus reactivated after 20+ years.; This is a spontaneous report from a contactable consumer (patient). A 56 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route, administered in Left Arm on 22Apr2021 at 15:00 (56-year-old at vaccination) as a Dose 2, single for COVID-19 immunization. Patient was non-pregnant at time of vaccination. The patient's medical history included known allergies: Penicillin, sulfur, mushrooms. There were no concomitant medications within two weeks of vaccination. Facility type vaccine was reported as Public Health Clinic. The patient had not received any other vaccine in four weeks prior to Covid vaccination. The patient was not diagnosed with Covid prior vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route, administered in Left Arm on 28Mar2021 (56-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. On 24Apr2021 at 15:00 (48 hours after 2nd vaccine), the patient had experienced mouth sores/lesions along gum and causing throat pain on same side, possible cold sore virus reactivated after 20 plus years. No treatment received for the events. On an unknown date in 2021, the patient underwent lab test and procedure which included sars-cov-2 test (Nasal swab): negative. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
On June 29, 2021, 47 days after the 2nd injection of Pfizer-BioNTech COVID-19 Vaccine EUA, a sever skin rash or hives occurred over the entire body and has persisted for a week now.   Sever swelling of facial tissues, especially the lips and cheeks has required treatment of Prednisone 40 MG per day to reduce swelling, this prescribed by order on July 1, 2021.  This has never occurred before in this individual and there has been no other known cause for this condition.  There are no known food allergies or other allergies know to cause such a reaction in the history of this patient and no event, insect sting, bite or unusual exposure to any allergen has been found to have occurred.
Described pain in the axilla of the arm that received the vaccination on going to bed. Woke early the next morning saying that his arm hurt worse. There was marked swelling in the axillary region. Swelling and pain increased over the rest of the day. We applied alternating hot and cold compresses to help with the swelling and discomfort. We brought him to immediate care after calling the pediatricians office and they said just bring him to immediate care. Immediate care didn't know what it was but said give him motrin and if it persisted longer than three days, call the pediatrician back. We continued to do alternating hot and cold compresses and the swelling and discomfort slowly resolved over the next three days.
Within 6 hours after vaccination administration, she developed fever of 100.3 F, diffuse joint pain, and swelling, soreness in left armpit.   Also developed left-sided posterior neck pain and left-sided neck muscle (trapezius) pain and stiffness that eventually lead to approx 2cm nodule in left armpit/left breast that was warm to touch but no reddness or streaking.  Symptoms completed resolved without treatment or intervention after 3 days.
Keeps getting hot and cold; Chills/Shivering really bad; Chills and fever back and forth; Slight headaches; Extremely tired; Chills and fever back and forth; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Keeps getting hot and cold), CHILLS (Chills/Shivering really bad), FATIGUE (Extremely tired), CHILLS (Chills and fever back and forth) and PYREXIA (Chills and fever back and forth) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ENALAPRIL for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced CHILLS (Chills and fever back and forth). On 23-Apr-2021, the patient experienced FATIGUE (Extremely tired). On an unknown date, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Keeps getting hot and cold), CHILLS (Chills/Shivering really bad), PYREXIA (Chills and fever back and forth) and HEADACHE (Slight headaches). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Keeps getting hot and cold), CHILLS (Chills/Shivering really bad), FATIGUE (Extremely tired), CHILLS (Chills and fever back and forth), PYREXIA (Chills and fever back and forth) and HEADACHE (Slight headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment include Tylenol. Concomitant product include vitamin supplementation.
Sores inside and outside of mouth; This is a spontaneous report from a contactable consumer or other non healthcare professional.  A 79-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number EL9264), via an unspecified route of administration, administered in Arm Right on 02Feb2021 as DOSE 1, SINGLE for covid-19 immunization (at Public health clinic). Medical history included diabetes mellitus from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, cardiac failure congestive from an unknown date and unknown if ongoing, cerebrovascular accident from an unknown date and unknown if ongoing, drug hypersensitivity for Sulfonamide allergy from an unknown date and unknown if ongoing. There were no concomitant medications. Patient didnot received other vaccinations within 4 weeks prior to vaccination. Patient didnot had Covid prior to vaccination. Patient was tested for Covid under post vaccination. On 05Feb2021, the patient experienced sores inside and outside of mouth. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 09Feb2021. Therapeutic measures were taken as a result of sores inside and outside of mouth. The outcome of the event stomatitis was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Patient received expired vaccine. Vaccine expiration date 9/30/2022. Vaccine administered on 10/6/2022. No adverse effects reported following the vaccine
Erythema, Edema, Warmth. Patient experienced nausea. No fever and no temperature.
My son received his 2nd COVID vaccine shot on 12/1/2021. He was diagnosed with type 1 diabetes on 2/14/2022. After he was diagnosed, in retrospect, it became clear that his diabetic symptoms started during the last week of December (four weeks after his vaccine). There is no way to know for sure, but it seems highly possible that the COVID vaccine triggered his type 1 diabetes to express itself.
Pt given vaccine & spoke a few words & 1-2 min later closed eyes & mildly jerked a couple of times & unresponsive.  Pt breathing without difficulty.  Skin cool & clammy.  After 10 seconds became responsive & answered nurse.  Once awakened child was oriented to person & place.  VS BP 92/52 HR 72 R 28.  Pt rested laying down.  Dr. examined child.  After 30 min child alert/smiling.  Skin warm & dry.  No complaints BP 90/52 P 76 R 24.  Oriented to person/place/time.
Thirty minutes after receiving vaccine began having spasms and discomfort in area of left scapula. Later in the day spasm and discomfort radiated to left neck. By the following day she began having difficulty moving head side to side. She reported this to Employee Health Monday morning 10/16/17 when she returned to work and was immediately referred to be evaluated by our Physician. She was diagnosed with cervicalgia and decreased neck range of motion secondary to muscle spasms. Today she states improved ROM. Has follow up scheduled for 10/23/17.
This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received BOOSTRIX (batch number HM4FY, expiry date 6th December 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Nurse at this time did not have any other information. 10 patients received BOOSTRIX that was exposed to temperature of 30.4F Two Lot Numbers 3P9CL exp 4/15/2016 HM4FY exp 12/6/2016. This case is one of the 10 cases reported by the same reporter for the same vaccine.
Patient complained of a shingles flare the day after receiving vaccine and also  described intensification of chronic pain, above and beyond normal, for the two days since her vaccine.
VOMITING; LIGHT-HEADED; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced vomiting, light-headed, headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, nausea, vomiting and light-headed was not reported. This report was non-serious.
I did not have an adverse reaction to the vaccine. I began having symptoms on 12/23/2022 of a sore jaw. On 12/24/2022 I had a stuffy head and a mild headache. On 12/25/2022, I started feeling worse and tested positive for COVID-19. I contacted my doctor and received a prescription for PAXLOVID. As of today, I have a sore throat, minor congestion and mild headache.
Pain at injection site; Pain in side of neck; severe headache; feeling flushed; aching in back; aching in legs; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old adult male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the left arm on 16Mar2021 at 11:45 AM, as a single dose for COVID-19 immunisation. Medical history was not reported. The patient reported that he did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications reported as none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: El3247), via an unspecified route of administration in the left arm on 23Feb2021 at 13:30 PM, as a single dose for COVID-19 immunisation. On 17Mar2021 at 02:00 AM, the patient experienced significant pain at injection site spreading up the side of his neck, severe headache, feeling flushed, aching in back and legs. No therapeutic measures were taken for the adverse events. The clinical outcome of pain at injection site, pain inside of neck, severe headache, feeling flushed, aching in back and legs were recovering at the time of this report.   No follow up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: patient's first name added in patient tab, patient's Country added and phone/email added in patient tab, Patient's age/unit added in patient tab, Patient's Race information and Ethnic group added in patient tab, duplicate Reported Indication of BNT162B2 removed, For Past Drug Event with BNT162B2 1st dose: Condition Type updated from Past Drug Event to Historical Vaccine; Age/Units captured as 57 years per vaccination date was 23FEB2021, duplicate Reported Indication of BNT162B2 removed, treatment received ticked as No.  Follow-up (02Jun2021) Amendment: This follow-up report is being submitted to amend previously reported information patient information and treatment information added.
Per providers notes:  "I was called to the waiting room ~30 minutes after patient received her immunizations and glucola test d/t patient feeling dizzy. She was then lowered to the ground and reported difficulty breathing along with tongue swelling. A BP was not detected w/ electronic or manual cuff. Pulse oximeter ranged from 70s to 90s. At this point, I administered an epi-pen in patient's left thigh and supplemental O2 was provided while awaiting for EMS. A glucola was 140s. FHT of 150 was detected with doppler after event. Details of events were communicated with FOB, Sterling. Patient going to ED via EMS and OB team notified. " Per event report provided by RN "I was called out to the waiting room for pt that was passing out. Pt had her Tdap, Flu injections, and her 50gm glucose test 30 mins prior so she was waiting out in the waiting room. I walked out pt was lowered to the floor with the assistance of 2 CMAs after they found her shaking and rocking in the chair in the waiting room and unable to walk to a exam room. I asked pt her name and starting rubbing her back to try and stimulate her into talking because she was in and out of consciousness. I asked staff to call for assistance and to tell someone to call 911 services. I assisted pt to her side and put a pillow under her head. We tried to get a blood pressure x2 unsuccessfully Pts pulse was 61 BPM and weak when I took it manually. Dr. then came out and I gave report to her from what I saw and interventions I did to keep her talking and conscious through incident. Dr. then did her assessment and pt stated "she couldn't breathe" and "feels like her tongue was swelling" very limited communication took place because of pt being so weak and unable to exert that much energy. At that time Dr.  asked for and Epi-Pen, oxygen and vital machine. Dr.  asked staff to try to get another blood pressure reading on pt with the machine and again was unsuccessful pt pulse ox ranged to 70s-90s. Dr. then administer the Epi-pen in pt's left thigh and administered O2 by oxygen re-breather mask. Pt's random glucose reading was 140s, FHT was detected with a handheld doppler of 150s while waiting for EMT services. EMT's were taking the Pt out of the building. Report was given by Dr. to EMT's and provided snapshot of Pt's information, and gave report to OB team at the ED."
Patient described tingling inflammation in the arm. The sensation was a localized reaction about 2 inches from the injection site.
ecchymosis inferior to injection site no hemarthrosis, full ROM, Neuro intact, 1/2 circumferencial,
Foul taste; Foul smell; Feeling horrible; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Foul taste), PAROSMIA (Foul smell) and MALAISE (Feeling horrible) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and DULAGLUTIDE (TRULICITY) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced TASTE DISORDER (Foul taste), PAROSMIA (Foul smell) and MALAISE (Feeling horrible). At the time of the report, TASTE DISORDER (Foul taste), PAROSMIA (Foul smell) and MALAISE (Feeling horrible) outcome was unknown. 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 information was not provided.
This spontaneous report was received from a consumer refers to her daughter of unknown age who was trying to get into School at the reporting time. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date (reported as some years ago), the patient was vaccinated with a first dose of M-M-R II (dose, route of administration, #lot and expiration date were unspecified). On an unknown date in November 2017, the patient was vaccinated with a second dose of M-M-R II (dose, route of administration, #lot and expiration date were unspecified). On an unknown date, the reporter stated that the patient failed to seroconvert to the vaccination because she showed a negative titer. Approximately on 06-AUG-2018, the patient was vaccinated with the third dose of M-M-R II (dose, route of administration, #lot and expiration date were unspecified). The outcome of antibody test negative was unknown. The relatedness between and the event and M-M-R II was not reported.
Patient inadvertently received a second dose of high-dose quad influenza vaccine within 28 days of her first annual dose.  At time of follow-up from pharmacy, patient was said to have body aches (including mild chest tightness) and a sore arm.  This information was given to us by the daughter and not able to be confirmed with the patient.
Provider ordered Infarix (DTaP). Medical Assistant administered Kinrix (DTaP-IPV). No adverse reactions noted.
pt had accident resulting in injury to foot;requested tetanus several hr p/vax began to have site swelling spreading to underarm;saw MD 2 days later then to ER same day for worsening condition & swelling in neck;
Patient was given a second booster based on updated recommendations. However, the provider misinterpreted the current recommendations and rather than giving the 0.25mL for the booster doses she administered 0.5mL
Severe joint pain whole body 4/23,4/24 Headache-still have Heart palpitations  4/23 Muscle pain  4/23,4/24 Dizziness -still have