chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Broke out in Hives two days later on face, hands and arms; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on 24Jul2021 at 12:00 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Jul2021, two days after the vaccine, the patient broke out in hives on face, hands and arms. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event hives on face, hands and arms was recovering at the time of this report.
I started having very severe headaches, about twice a day and 12hrs apart, some months after receiving the vaccine. I went to the neurologist for some MRI scans. She prescribed me Amitriptyline to aid with the cluster headaches in the meantime as we wait for the results to come in.
Youth was ordered to receive Bexsero series and Hep B vaccination was administered. PCP Dr. contacted and updated with current info. No new orders received. No ASE noted upon assessment. VSS/WNL. Patient condition remains stable will continue to monitor.
Pt started to notice numbness in foot 1 to 2 days after vaccination then numbness moved up to waist in 2 days time - pt. went to ER was hospitalized with spinal inflammation.
PATIENT WAS GIVEN THE JANSSEN COVID VACCINE. ABOUT 5-10 MINS LATER, PATIENT REPORTED HAVING SOME DIZZINESS WITH SOME CHEST PAIN. BENADRYL WAS PROMPTLY GIVEN @1202PM. THEN AT 1209PM, PATIENT BP WAS TAKING, IT WAS HIGH AT 160s/90s. PATIENT STATED THAT HE DOES HAVE HBP  IN WHICH HE DOES TAKE MEDICINE FOR. HE ALSO STATED THAT, AT THAT PRESSURE, IT WAS NORMAL FOR HIM. PATIENT WAS MONITORED TILL AROUND 1245PM, HE STATED THAT HE WAS FEELING BETTER AND HIS WIFE HAS TAKEN HIM HOME. A FOLLOW UP PHONE CALL WAS CALLED AROUND 105PM. AT THAT TIME PATIENT WAS A HOME AND SAID THAT HIS SYMPTOMS HAS SUBSIDE BUT JUST FEELS SLEEPNESS FROM THE BENADRYL.
Have been extremely tired. Finally went to the doctor and had various bloodwork done. NP said heart is skipping beats. Currently seeing a cardiologist and have various tests scheduled. No results as of today's date.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium
Fever (up to 100.5) for 24 hours after. Sore arm, sore and swollen lymph node in right armpit and clavicle. Nausea. Weakness and extreme tiredness. Chills. Muscle aches. Headache.
Patient received the shot and had no immediate symptoms, but developed a very sore upper arm/shoulder that did not resolve. He described 10/10 pain when lifting his arm. He did not report thise to us until nearly a month after the vaccine, when he was picking up a steroid dose pack for the pain. He said the steroid resolved his pain completely when we checked in with him about a week after he picked up the steroid.
My cycle was accelerated by a week, 22 days. Usually 28/29 days.  For the cycle that began on 6/28/21 pregnancy resulted. Was suspected blighted ovum on 8/18/21, confirmed on 8/25/21.
Family consisting of mom and two sons scheduled to get seasonal immunization at the pharmacy on 11-16-23.  13 year old male had appointments for two shots - one spikevax and one fluzone quad immunization.    following second immunization patient briefly passed out and had a brief seizure event.  the event only lasted about 10 seconds.  mom stated that patient has history of passing out at sight of blood but never with immunizations.  patient regained consciousness after about 10 seconds , white in facial color and lips slightly blue.   patient stated felt a little nausea upon sitting up.  patient was offered water and started to regain color and decreased nausea symptom.   patient  remained in immunization room for another 30 minutes and then left with mom and brother for some electrolyte drink and to go home.  mom was  going to follow up with doctor in the morning.
Sudden onset of urticarial bleed at site of injection within 1 min of injection.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, drug allergies and concomitant medications were not reported. On unspecified dates, the patients were administered GARDASIL 9 (Lot# L043213, expiration date:28-AUG-2017, dose, frequency and route were not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was asked pre-screening questions, no contra-indications to vaccine. while vaccinating patient, needle got disconnected from syringe causing most of the vaccine to leak out. Patient was vaccinated with a new dose  vaccine, 2-inches away from the site, team lead was made aware. Patient did not c/o of any discomfort.
Narrative: Patient reported anxiety after administration of 1st dose of Pfizer COVID vaccination. Patient required no intervention and was able to be released without issue.
Three weeks after the vaccine, I started experiencing pain on the left side of my face, randomly, mainly in the jaw area.  Location varied, including middle of lower jaw, left side of my chin, upper or lower teeth, upper jaw, jaw joint right in front of my ear.  The pain got progressively worse over the course of a week, and then started improving and was quite rare a couple weeks later.  At first, I thought it was a TMJ issue, maybe stress related, not related to the vaccine, but then the same thing happened three weeks after dose #2 (lot number 023CZIA received on 5/4/2021).  The recurrence wasn't as acute, but also got progressively worse over the first week and has been improving since then.  (see next page)It has not yet completely dissipated.  I should note that sometimes it's more of a tingling sensation than pain, very similar to how it feels when the nerve recovers after dental work.    On a separate note, there was also considerable arm pain after both injections.  Dose number one was fairly acute for the first day, and then more of an ache on day 2 when it felt more like a normal flu shot ache.   Pain was not sufficiently severe to interfere with activities.  Dose number 2 was much more acute pain, but it started a few hours after the shot.  Pain was severe to the point of not being able to do my normal exercise routine, and trying to raise my arm above the shoulder was too painful.  The second day the pain remained as did the limitations. By day 3, my arm had recovered.
A spontaneous report was received from a consumer concerning a 17-year-old female patient who was the pediatric patient received vaccine and the patient experienced light headache.   The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (LOT# 037K20A) on 07-Jan-2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient's mother reported that her 17-year-old daughter received the Moderna vaccine on 07-Jan-2021.  She stated that the provider of the clinic where her daughter was vaccinated was unaware of the patient's age.  She also stated that since the clinic had become aware of the patient's age, the second dose of the vaccine would not be administered to the patient unless she was enrolled in the clinical trial.  Additionally, the patient's mother reported that following the vaccine, the only side effect experienced by the patient was a headache.    No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The event pediatric patient received vaccine was considered resolved.  The outcome of the event light headache was not reported.   The reporter did not provide a causality assessment of the events pediatric patient received vaccine and a light headache.; Reporter's Comments: This case concerns a 17 year old, female patient, who experienced non-serious unexpected events of product administered to patient of inappropriate age and a non-serious expected event of headache. There were no reported AEs associated with this case of product administered to patient of inappropriate age for mRNA-1273 (lot # 037K20A). The event of headache occurred on an unspecified date after mRNA-1273 (lot # 037K20A) administration. The treatment details were not provided. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
arm sore, collarbone swollen, dysphagia, adenopathy cervical;
RUNNING NOSE LIKE ALLERGY OFF AND ON, ON DAILY BASIS. BASEBALL SIZE BRUISE FOR 2 WEEKS. CONSTANT RIGHT SHOULDER PAIN WHEN ARM IS LIFTED AND WEAKNESS IN ARM. WORSENED JOINT PAIN AND SWELLING.
The individual was given a Pfizer Bivalent Booster instead of a Pfizer 5-11 yo Booster.  When I called the parent to inform her, the child had not had any adverse side effects as of 9/17/22 @ 1045am.
Right when she got the vaccine she felt acute pretty severe discomfort. She did not really look but noted later where they put the Band-Aid that the vaccine was given way too high. Since that time she is had moderate to severe discomfort in the acromial area and subacromial area as well as radiation of pain to the clavicle and really limited range of motion with her arm. Patient  went to urgent care on 1/30/21 with possible bursitis-like reaction to vaccine that was injected close   to the acromium subacromial area. Treated with anti-inflamatory therapy (Toradol)
Pt. was given GARDASIL vaccine by medical asst. Pt. is 26.5 weeks pregnant. No adverse reaction. Dr aware. Pt. called to return to office.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had COVID 19 Treatment from 15Jun2023 to 19Jun2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300232346 Same patient, different drug and different AE;
I have my birth control arm implant in my left arm. I asked the medical assistant if it will affect it. I was told it won't. I had a very sore arm that felt like it was going to fall off both times. Then the 2nd one suddenly had me start my period the same day a couple hours later. I am currently still on my period flow. The birth control was inserted way back in June of 2021. My body had adjusted to it finally in August. It was normally on the 20th of the month that it starts. With the 2nd vaccine it just started my period. My period is actually a heavier flow, too. I will be arranging an appointment with my doctor to discuss it. With both vaccines it felt like something travel in my body.
ACUTE NON ST ELEVATION MI 11/1/2021 COVID-19 PNEUMONIA  ACUTE NON ST ELEVATION MI 11/1/2021 DYSPNEA ON EXERTION
pt recvd vax & exp urticaria over body (back, chest, face & neck) & pruritus;pt has been treated w/daily pred;this medicine has now been discontinued & is being treated w/seldane;urticaria appears from time to time;tx ATB
Patient reports achiness, weakness, dizziness, rapid heart rate, chills and shallow breathing 4 1/2 hrs after receiving flu shot. 22 hours after shot symptoms improving, but not gone.
headache and fever persisted for 4 days after vaccination. NSAIDs helped some but still had symptoms
Arm became very sore and tender to touch and hives around shot site. Took Benadryl and applied ice. On 12/6/99, saw the doctor. Rx'd for Atarax. Missing informtion is unavailable.
lt arm swelled down to elbow, turned red & feverish, painful to touch, script for zyrtec, diprolene topical cream;
Soreness at injection site could not lift my arm, flu like symptoms for a week, fever, chills, shortness of breath, I was  gasping for air.
Patient developed cranial nerve 7 palsy, facial numbness, and non descript visual changes.  Was treated with prednisone for Bell's palsy.   Also developed joint pain
Abnormal Pap- LISL, then 8/16/2010 IBS, 10/15/2010 Migraines with visual, 11/19/2010 varicose veins with Greater Saphenous vein litigation, 11/10/2011 Genital and anal HSVI and HPV with Anal condoloma removal surgery (ongoing), 9/17/2012 Interstitial Cystitis Onset (ongoing), 07/2013 Fibromyaliga Dx (ongoing).
Patient hospitalized for leukocytosis and peripheral artery disease within 6 weeks of receiving COVID vaccination.
Breakthrough case admission after 3rd vaccine 2/5/21 Pfizer Lot# El9261 2/26/21 Pfizer Lot# EM9810 12/5/21 Pfizer Lot# FJ8757
After initial shot I had similar typical reaction as to shot #2 - sore arm, flu like symptoms lasting less than 48 hours, and a very swollen underarm lymph node on the injection side which subsided after a couple days. Approximately 10 days later I became extremely itchy randomly throughout my body.  I took Benadryl that evening assuming the issue was the changing weather. However, the next day the issue continued, also accompanied by random raised welts that would appear quickly and disappear after about a half hour. Any scratching, even lightly, will result in Dermatographia ?skin writing.? This issue has continued consistently (and sporadically across my body) since then - 14 days and counting.
Neuropathy of both hands and feet. Burning and pin prick sensations that were significant enough to cause early release from school and one-day absence. The neuropathy continues, one week post vaccine.
vial was initially stored in the refrigerator on 03Oct2022 and administered on 07Nov2022; No adverse event; received doses after its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses after its beyond use date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 03Oct2022 and administered on 07Nov2022) and NO ADVERSE EVENT (No adverse event) in a 42-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030g22b) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 03Oct2022 and administered on 07Nov2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received doses after its beyond use date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 03Oct2022 and administered on 07Nov2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (received doses after its beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 03Oct2022 and administered on 07Nov2022).    No concomitant medications were reported.  Individual vials or unbroken cartons: in the box. Vial size was 2.5ml. Vial did not undergo any temperature excursions.   Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-673091, US-MODERNATX, INC.-MOD-2022-673093 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2022: Live Follow-up: Significant information accepted: Patient information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673093:Same reporter case US-MODERNATX, INC.-MOD-2022-673091:Same reporter case
Patient felt shaky, developed headache, she said her bp was slightly elevated after about 30 minutes.
Within 1/2 hour, post vax, pt developed crying and was unable to console. Pt was seen by MD and he felt reaction was to vaccine. Physical exam was not performed per mother. Tylenol with codeine was Rx'd and mother was told to watch for respiratory distress.
The patient had a black out within 10 minutes of taking vaccine for both doses. The black out lasted for about 2 minutes. In the first case, the patient fell on the carpet since he was standing. Paramedics attended, observed for 15 minutes and declared that he was doing alright and we took him to a physical examination after that and found everything was normal. After the second shot ensured the patient was sitting on the chair after the shot and he experienced a black out and recovered. In both instances, he complained of heart pain.
Injection site started itching a week after application, it is now red, hot, itchy, swollen and very tight/hard.
This spontaneous report as received from a healthcare worker refers to multiple unknown patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. Healthcare worker reported that before she became aware of the excursion, it is possible but unknown that on multiple unknown dates, the patient received improperly stored RECOMBIVAX HB (lot # M00442, expiry date: 31-MAR-2108; lot # M011838, expiry date: 09-AUG-2018; lot # M010212, expiry date: 21-JAN-2019; lot # M022077, expiry date: 10-MAR-2019; lot # M018654, expiry date: 31-MAY-2018 and lot # L044917, expiry date: 05-OCT-2108. She mentioned that it could not be ruled out that vaccine was or was not administered prior to her awareness. The vaccine was exposed to minimum 8.4C or maximum 14.5 C for 368 hours. A data logger was used to document the temperatures. There were no prior excursions. Reporter also mentioned that after she was aware, no vaccines were administered to the patients that were improperly stored. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Moderate, flu-like symptoms (general malaise, body aches, tiredness); moderate pain at injection site. Symptoms were managed with bed rest, acetaminophen, and lasted less than 24 hours.
left arm deltoid injection site with red circular rash with well defined border; There was general swelling (puffy/boggy) of upper arm centered around the injection site that extended under the rash 4 inches in diameter with diffuse/tapered border.; The injection site was very tender to palpation w/ pain raising or using arm.; This is a spontaneous report from contactable consumer (patient). A 13-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 03Jun2021 at 10:30 as 2nd dose, single dose for COVID-19 immunization. Medical history included appendectomy in Feb2019, otherwise healthy boy. Patient previously took Amoxicillin and experienced full body rash. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications the patient received within 2 weeks of vaccination. On 05Oct2020, patient had been tested for COVID-19 via Nasal Swab and resulted negative. Prior to vaccination, patient was not diagnosed with COVID-19. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration in left arm on 13May2021 at 09:15 AM as 1st dose, single dose for COVID-19 immunization. It was reported that, patient experienced on left arm deltoid injection site with red circular rash with well defined border that was not raised and about 2 inches in diameter. Does not itch. There was general swelling (puffy/boggy) of upper arm centered around the injection site that extended under the rash 4 inches in diameter with diffuse/tapered border. The injection site was very tender to palpation w/ pain raising or using arm. This was only a day following the 2nd injection (On 04Jun2021 at 14:00).  No treatment was received for the adverse events. Since the vaccination, the patient had been tested for COVID-19 via Nasal Swab. On 07Mar2021, patient tested COVID-19 and resulted negative. The device date was 05Jun2021. The outcome of the events was recovering.  Information about batch/ lot number has been requested.
Patient reports to clinic today with difficulty breathing, hives, complaint of muscle tenderness, and racy heart. Pt denies any history of these symptoms which started 9/15/09. Pt got vaccine 9/13/09. Pt symptom progressed 9/16/09 and she was seen in ER. Pt presents today bc she is not better.
Mother sent photo of left upper arm which showed a 6 inch by 3 inch area of redness and swelling..  Advised to give an antihistamine and apply ice to  area and monitor.  Follow up phone call on 5/8/20, mother reports area had greatly improved.  Informed that second dose will be given in future but with not other vaccine in same extremity.
Client reports nausea, abdominal pain, headache, difficulty concentrating, malaise 5 hours after receiving flu vaccine. No local reaction. Pt also reports fasting for 16 hours prior to receiving vaccine as part of diet routine. All symptoms resolved by midnight on 10/9/18.
Five minutes after receiving yellow fever injection, pt. experienced sudden onset of itching & urticaria @ injection site.  Redness also developed @ injection site.  Client remained alert & oriented.  Client denied respiratory problems.  Dr. notified & recommended Benadryl 50 mg IM be administered per office protocol.
Moderna COVID vaccines are approved for people age 18 and older.  PT is age 17.
I woke up in the night trembling so hard I was vibrating. I got sick and threw up twice. I felt beat up the next day.
Patient was Vaccinated with Moderna at age of 17 years instead of 18 years.  No adverse effects or symptoms