chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 16th of June 2021, I was at the employee health to receive my first dose of covid vaccine, the nurse administer me the first dose on my right arm and told me to go sit at the waiting area and gave me timer for 15mins. At exactly 5mins into it, I began to feel tightness, palpitation and pain in my left chest , then I stood up to alert the nurse for help and my vision went blurry and dizziness, so I was about to fall, and the nurse grabbed me and took me to a room and she check my blood pressure and alerted the physician on duty and I was wheeled to the emergency room for further evaluation. at the emergency room they did EKG 12 lead, XR chest PA and lateral , and some labs.
p/recv vax pt exp axillary soreness extending to tricep; redness @ inj site w/swelling
CONTINUING DISCOMFORT IN THE INTERIOR OF THE LEFT SHOULDER WITH WEAKNESS OF SHOULDER WHEN STRESSED.
5 1/2 in. x 5 in. Red, hot, swollen area
varicella- Information has been received from a company representative concerning an unknown number of patients who were vaccinated with one dose of varicella virus vaccine live (unknown site) the reporter stated that a nurse practitioner informed him that the office recently has been seeing more breakthrough cases of chicken pox with the varicella virus vaccine live.  an unspecified number of patient sought unspecified medical attention.
Pt had heavy feeling in her feet followed by a choking feeling in her throat. Also noted tingling in hands and feet.
Woke up he felt he could not move, ¨i though i was going to die ¨; freezing; could not move, ¨i though i was going to die; pain in the arm of the injection; chills; fever up to 101F; very bad headache; lost of appetite,; This spontaneous case was reported by a consumer and describes the occurrence of Immobility(Woke up he felt he could not move) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Appetite lost on 17-Mar-2021, Headache on 18-Mar-2021, Chills on 18-Mar-2021, Freezing phenomenon on 18-Mar-2021, Fever on 18-Mar-2021, Pain in arm of the injection on 18-Mar-2021 and Movements reduced on 18-Mar-2021.  Concomitant products included Blood pressure medication, Cholesterol medication, Thyroid medication, Liver medication and Methadone.   On 17-Mar-2021, the patient received their first of two planned doses of mRNA-1273 (Moderna COVID-19 Vaccine batch #: 047A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 18-Mar-2021, the patient experienced Woke up he felt he could not move, HEADACHE (very bad headache), CHILLS (chills), FEELING COLD (freezing), PYREXIA (fever up to 101F), VACCINATION SITE PAIN (pain in the arm of the injection), MOBILITY DECREASED (could not move, ¨I though I was going to die) and DECREASED APPETITE ( lost of appetite). Treatment information was not provided.   At the time of the report, (Woke up he felt he could not move) is gone,  loss of appetite is coming back on 19-Mar-2021. The outcome of the events headache, chills, freezing, fever up to 101F, pain in arm of the injection, and woke up he felt he could not move was unknown. The outcome of the event appetite loss was resolved. Action taken with mRNA-1273 in response to the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-052642:Crosslinked case
C/o flat erythematic rash to area on arm just below vaccine site for 24 hours then it went away. 48 hours later blisters to left & right calf area 17cm above Achilles tendon.
DAYS: 1-2: SORENESS IN RIGHT ARM 3-5: SEVERE PAIN IN RIGHT ARM RADIATING THROUGH CHEST, STERNUM SENSITIVE TO TOUCH 6-14: SLOW DECREASE IN PAIN, SORENESS IN SHOULDER AND RIGHT PECTORAL MUSCLE THROUGHOUT
The patient was scheduled for her 2nd Pfizer vaccine today at 8:10 am. I administered the vaccine in the patients left deltoid. After I asked the patient to wait 15 minutes in our waiting area in case of any adverse reaction. I went to talk to the patient to document the lot number and todays date on her COVID card. When I read the documentation of the first vaccination I noticed the date read 3/30/2022. Then did I realize I had administered the 2nd vaccine earlier than the recommended 28 days in between vaccinations.
The evening of receiving my vaccine, I had some itching but didn't think much of it. By the next day, I had hives. I still didn't think a lot of it and treated myself with BENADRYL. The hives continued to get worse though and when I woke up the next morning they had spread to my mouth and eyelids. I went into a local urgent care clinic. They performed a Strep test which was negative and just advised that I continue taking BENADRYL for treatment of symptoms. I had recently traveled by plane out of state, and she thought I may have contacted something that I was having an allergic reaction to. She advised that if I have difficulty breathing to go to the emergency room but did not prescribe any additional medication. I also developed a ring of rash around the injection site. I treated it with BENADRYL cream and other over the counter treatments, but it lasted for around 2 months. When I spoke with my primary care physician about the events that occurred, she was concerned that I may have been having a reaction to the vaccine. She advised that if I receive another dose of the vaccine, that I should do so under treatment and supervision in her office.
The first intradermal attempt did not result in a wheel. No physical adverse event occured. A second attmept was administered by an expert, and was successful.
The day of vaccine I was tired after. I developed a headache and extreme fatigue. Around week 2-3 my fatigue has not resolved, I am struggling to do my daily activities I am so tired. I have mild joint pain that started around week 2-3. I am concerned about getting the second shot and making my symptoms worse.
patient received an Adacel dose during her third trimester of pregnancy; Initial information received on 30-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 19 years old female patient who was received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number, expiry date, dose, route of administration were unknown) in left shoulder on 30-Jul-2019, while she was pregnant (third trimester).  The date of last menstrual period was not reported.  The estimated due date is 02-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was case of vaccine exposure during pregnancy. The patient was pregnant (third trimester) when she received vaccine.  It was unknown whether patient experienced any adverse reaction after the injection.  Pregnancy outcome was unknown at the time of report.  Information on the batch number was requested.  List of documents held by sender- none.
pt recv vax;devel red & swollen arm; employee felt there was a problem w/ the lot of vax;
Pt. unsure if adverse reaction began the evening she received vaccine or the next day.  C/O pain, edema, redness, and fever in right arm - approximately 3 inches below vaccination site.  Underside of arm also warm, red, hives.  2 Tylenol taken with some relief.
intense migraine, cluster headaches, major gi upset to where ometprasole dose had to be 4x, and carafate was added. Migraine required treatment with steroidds.
Metallic taste in mouth  started on 9/15/2021 and still present,  hands and feet  numb and cold sensation feels like I have bengay on them  all the time started on 9/18/2021 and still at the present  and also now up in my calfs and my forearms. Im also itching some on my collar bone and legs.
temp @ 6PM 102.9 APAP was given; temp down @ 8PM 101.0; 930PM temp rose to 103.5 resulted in sz lasting 1 to 2 mins w/staring spell approx 30 to 40 mins APAP was given & temp went down 02 was given;APAP was given the next 24 to 48 hrs;
Janssen Primary Dose and Pfizer Booster 9mins post vaccination pt had a near syncopal event.  Pt also developed dizziness, tingling in extremities, and a rash on her chest and neck. VITALS: 1900: 99% SPO2 78 HR  17 RESPIRATION BP 138/80 1925: 99% SPO2 66 HR 14 RESPIRATION BP 130/78  Pt was given 50mg PO benadryl @19:05 Pt stable and released from the vaccination site.  Pt reported reaction to PCP immediately after leaving vaccination site .  No further action taken at that time.
pt recv vax & it was reported that the nurse had blood return in the syringe & pt devel bruising around the site of inj;
Administered after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a child male patient who received DTPa-IPV (Kinrix) (batch number 25ZH4, expiry date 27-OCT-2024) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced incorrect storage of drug (Verbatim: Administered after temperature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-MAR-2023 The reporter reported that the Kinrix vaccine exposed to -24.6 degree F and was administered to a patient. The reporter asked how to proceed with the patient vaccination. The reporter consented to follow up. The reporter reported that the Kinrix vaccine exposed to -24.6 degree F was administered to a patient, which led to incorrect storage of vaccine.
Per mom, shots given at 09:30 and pt had chills by 10:30 and was given Tylenol. Pt's temperature was 102F at 13:00 and was given Tylenol. Temperature increased at 16:30, not taken but felt hot, so was given Tylenol. Pt slept until 18:30 and then he awoke and wanted only to be held. He had a seizure at 19:00 and went to ER. Watched at ER and given antipyretics and sent home. Tylenol and ibuprofen at 02:00. He is doing fine today on 12/5/00.
On 11/22/2022 in the night around 8:00AM. My son had cough, runny nose, and fever. We gave him TYLENOL and MOTRIN to reduce his fever. After few days of the fever we took him to the pediatrics office. He diagnosed him with double ear infections. They prescribed him with antibiotics. He is recovering but not 100% better yet. He still has the lingering cough and runny nose. His fever and ear infection is resolved.
No adverse reaction noted however she lied on her pre Covid questionnaire and she also stated this would be her 5th shot in series.  upon looking at card that was verified that she had received 4 and this would be her 5th however when i went to enter her information into the electronic charting system, it was noted that patient had already received bivalent and 5th shot which made this the 6th shot. Patient was asked specifically if they had ever received the Bivalent, and denied this
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L028279, expiration date 28-OCT-2016 (strength, dose and route of administration were not provided. No adverse effects were reported. Additional information has been requested.
Patient awoke day after immunizations feeling weak, nauseated, chest pressure/heaviness, SOB and low-grade fever. Patient seen in clinic, was stable with normal exam and recommended to rest at home.
Angioedema.  Did not respond to diphenhydramine.  Resolved with prednisone.  Patient has recovered.
patient was given an expired 0.5 ml dose of Daptacel vaccine/No AE; Initial information was received on 04-May-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a one year old female patient who received an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  The caller stated that 0.5 ml of Daptacel was given IM to a patient and it was allready expired.  At the time of report, no adverse event reported.  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.  There was no information available on the lot number.
nerve issues in her left arm, which include pain and constant tingling from shoulder to hand; nerve issues in her left arm, which include pain and constant tingling from shoulder to hand/fingertips feel spikey, for lack of a better term, like maybe needle pricks; her hands itch; nerve issues in her left arm, which include pain and constant tingling from shoulder to hand; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on an unspecified date of 2021 (earlier this year) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date of 2021, patient experienced nerve issues in her left arm, which include pain and constant tingling from shoulder to hand, her hands itch, and her fingertips feel spikey, for lack of a better term, like maybe needle pricks. Patient was wondering if this was reported before in anyone who took the COVID vaccine and was there anything she can do for relief. The outcome of all the events was unknown.  Information on the Lot/batch number has been requested.
The patient said that each time she got the covid vaccine she got a rash around injection site. She stated that the rash was less so after each dose in the series.
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 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021 at 3:23 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 3:23 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 38.17.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021.18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  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 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
hives, rash.  I have had hives and rash starting about 12 hours after injection.  Hives have been present for over 2 weeks now even while on steroids and other antihistamines.  I have had a visit to the ED, allergist, and about to make a second visit to ED.
Arm was sore for three days. Patient denies any swelling or redness. On the third day in the morning patient noted redness and swelling at the injection site. Denies fever, but states injection site was hot to touch. Patient called clinic and was advised to go to the walk in clinic. Patient was seen at the walk in clinic on 9/26/19. Antibiotics and Motrin were prescribed. Dx of cellulitis was made. patient states she completed antibiotic therapy. Patient states it took 3-4 days following start of  antibiotics for the swelling and redness to go down. Currently patient feels a lump under the skin at the injection site. Patient states it felt like her arm was asleep starting on the third day after injection. Patient states are still feels weak.
Per patient- "I received my second shot on March 11, 2021 at approximately 9:15 a.m. I felt fine all day. I woke up at 2:30 a.m. 9m. (March 12) with severe shaking chills and feeling very weak. After getting the heating pad I went back to bed. I spent the rest of the day on the couch. Late afternoon I discovered I had a rash across my stomach, my arm pits were both red, and I had a rash from my right arm pit down to my elbow. There was no discomfort with any of them - just color. I still have faint lines of the rash on the area going down my right arm.  Not concerned, just thought it should be in my medical records."
pt recv vax & devel t102, fussy-no prolonged crying; 15AUG95 t102.2-100.5; 16AUG clinic notified; mom called MD- pt taken to MD; appetite poor; 17AUG mom called temp down, pt beginning to nurse nl-taking fluid
Developed extreme weakness, fatigue (couldn't keep her eyes open), dizziness and vomiting one hour after receiving Menactra and Varivax #1. Symptoms lasted for 2-3 days finally prompting her to go the emergency room for evaluation. There had blood work and was given one pill for vomiting which then stopped.
Narrative:  80yo male patient with the following PAST MEDICAL HISTORY: DVT seizure disorder after head trauma overseas - was on carbamazepine HTN DM HLD CAD s/p cabg chron's disease psoriasis t cell lymphoma treated with light treatment pyoderma gangrenosum atrial flutter - s/p ablation 6/2012 PE 4/2009 OSA balance problems/vertigo - extensive workup outside - vestibular ankylosing spondylitis cervical spine fracture s/p surgery after fall hx of left foot drop secondary to dm wing died in rehab facility on 11/25/2021. Pt had received covid vaccines on 1/13/2021 & 2/10/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
I registered and attended the Covid vaccinations at a facility in the spring of 2021. I also responded to all of the texts received by V-safe. On at least one response date (unknown) I included that I was experiencing ringing  and  high pitched hissing in the ears. It did not get worse until the beginning of 2022. I have experienced ringing in both ears increasingly since Early 2022. I saw my specialist at the end of February 2022 due to the fact that I was having hearing difficulty in the workplace with people wearing masks and the increasing tinnitus in both ears. I thought this was very odd to experience ringing in my right ear considering its nearly deaf and I Haven't had any issues with it since I was a young child.
Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date the patient was vaccinated with doses of improperly stored ROTATEQ orally (lot# K011948, expiration date 07-JUN-2016, lot# K024700, expiration date 30-JUL-2016, lot# was reported as L001316, expiration date 11-OCT-2016, strength and dose unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
During the 15min observation time, pt c/o feeling nauseated and started vomiting. Pt noted to be pale and skin was cool and clammy. RN provided pt with small sips of juice and proceeded to check vital signs. Initially, RN was not able to obtain BP and pulse was in 120s. RN laid pt down and elevated both legs in effort to improve cardiac perfusion. After a few minutes, BP was obtained and pulse was all within range. Paramedics arrived on scene to evaluate and pt's vitals were stable. RN and paramedic later determined that it was not an anaphylactic reaction but more of a vasovagal response to the injection. Mother declined to have pt be transported to nearby hospital for further evaluation. Pt stated he felt a lot better and was no longer experiencing symptoms.
About 8 days after the shot, my stomach started to have weird pains.  Those lasted from Thursday April 15 through Sunday April 18.  Starting Monday morning April 19 I began to experience intense diarrhea for all of Monday.  It has continued, although less intensely, Tuesday April 20 and Wed April 21.
VACCINE RELATED INJURY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination(dose series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine related injury. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine related injury was not reported. This report was non-serious.
Information has been received from a physician concerning to a retired physician who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number not reported). The reporting physician mentioned that on an unspecified date the patient believed he had developed a case of shingles after receiving ZOSTAVAX (Merck). At the time of the report, the patient's outcome was unknown. This is one of two reports received from the same source. Additional information has been requested.