chrisvoncsefalvay/vaers-outcomes huggingface dataset:
INCIDENT OCCURED ON 12/7/21 AT AROUND 6PM AT AN OFF SITE COVID CLINIC . THE INCIDENT WAS BROUGHT TO THE PHARMACIST'S ATTENTION LONG AFTER THE ICIDENT OCCURED AROUND 6:45PM BY THE PATIENT'S FATHER. I AM REPORTING FROM WHAT WAS TOLD TO ME BY THE PATIENT'S FATHER AND THE NURSE. THE PATIENT'S FATHER WAS HOLDING THE PATIENT WHILE HE WAS ABOUT TO GET HIS VACCINE, THE PATIENT SUDDENLY STARTED TO MOVE, AND THE NURSE WHO WAS ADMINISTERING THE VACCINE TO THE PATIENT SLIGHTLY HIT THE FATHER'S THUMB WITH THE NEEDLE, THEN INJECTED THE PATIENT WITH THE VACCINE. THE NURSE THEN CLEANED UP THE SITE OF HARM ON THE FATHER'S THUMB. THE FATHER STATED THAT HIS THUMB WAS FINE AND DID NOT HURT.
Anxiety/ stress/ brain fog/ nerves; COVID-19 diagnosis; Only got 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety/ stress/ brain fog/ nerves), COVID-19 (COVID-19 diagnosis) and INCOMPLETE COURSE OF VACCINATION (Only got 1st dose) in a 60-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 045221A) for COVID-19 vaccination.     The had no allergies.  Concurrent medical conditions included Vertigo.    On 09-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANXIETY (Anxiety/ stress/ brain fog/ nerves), COVID-19 (COVID-19 diagnosis) and INCOMPLETE COURSE OF VACCINATION (Only got 1st dose). At the time of the report, ANXIETY (Anxiety/ stress/ brain fog/ nerves) and COVID-19 (COVID-19 diagnosis) had not resolved and INCOMPLETE COURSE OF VACCINATION (Only got 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: covid diagnosis after 1st dose (Positive) COVID Diagnosis after 1st dose.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  It was unknown whether the patient received other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient did not received any further doses and only got first dose. Recent change in patient status was worsening.  Treatment medications included anxiety and stress medication.  Company comment-This spontaneous case concerns a 60-year-old male patient, with no relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 unspecified days after first dose of mRNA-1273 vaccine. COVID test done on an unknown date was positive. Patient experienced stress, nerves, brain fog and anxiety after first dose. No further doses were taken- Incomplete course of vaccination was noted. He consulted a physician for the same and was advised anxiety and stress medicine. The Symptoms have worsened and ongoing. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 60-year-old male patient, with no relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 unspecified days after first dose of mRNA-1273 vaccine. COVID test done on an unknown date was positive. Patient experienced stress, nerves, brain fog and anxiety after first dose. No further doses were taken- Incomplete course of vaccination was noted. He consulted a physician for the same and was advised anxiety and stress medicine. The Symptoms have worsened and ongoing. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Patient's husband called pharmacy and described redness, pain, and swelling that was spreading down the arm. I was not able to confirm visually, but I recommended they follow up with a physician visit since the reaction was of much concern.
Started that day with sore right arm, felt weird, following day it got worse, extremely tired no energy, slept all day, later in day had fever of 100, fever only lasted a couple hours, next day still felt tired but improving
Redness/swelling at injection sight. Soreness at injection sight. Dizzy, migraine, nauseous, fainting spell, and body aches.
Severe headache, within a couple of minute of vaccine. It turned to a dull headache in about 5 min; Eye sensitivity; "My" eyes feel as if I had them dilated at the dr's; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 30Mar2021 at 11:00 (at the age of 49-year-old), as a single dose for COVID-19 immunisation. Medical history included chronic migraine, allergy to sulfa and wheat. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), lamotrigine (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN), clonidine (MANUFACTURER UNKNOWN), erenumab (AIMOVIG), botulinum toxin type a (BOTOX), rizatriptan (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN) and unspecified epidural; all taken for unknown indication from unknown dates and unknown if ongoing. On 30Mar2021 at 12:00, the patient experienced severe headache, within a couple of minutes of vaccine. It turned to a dull headache in about 5 minutes and had continued for all day. The patient also experienced eye sensitivity and felt as if had eyes dilated at the doctors. This started about an hour after the vaccine and continued to feel that way about 9 hours later. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events severe headache, dull headache, eye sensitivity and eyes felt as if dilated was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Malaise, fever, headache, body aches, enervation...flu-like symptoms (minus cough) for ~48 hours starting late that 1st night.  Stayed in bed for much of those 48 hours.  Also, injection site pain, well-delineated erythema, heat, and induration around injection site lasted for 3-4 days.
positive Covid-19 test yesterday; received the Shingrix vaccine underneath his arm in the tricep; dehydrated; dizzy; headache; was sweaty; stiff joints; had body aches in neck and shoulders; had body aches in the arms, neck and shoulders; had body aches in  shoulders; still has aches here and there; This case was reported by a consumer via call center representative and described the occurrence of dehydration in a 55-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included covid-19 virus test positive.   On 23rd October 2020, the patient received Influenza vaccine Quadrivalent unspecified season (intramuscular) and Shingrix. On 23rd October 2020, less than a day after receiving Influenza vaccine Quadrivalent unspecified season and Shingrix and less than a day after receiving Influenza vaccine Quadrivalent unspecified season and Shingrix, the patient experienced dehydration, dizziness, headache, sweating, stiff joint, neck pain, pain in arm, shoulder pain, general body pain and vaccine administered at inappropriate site. On 25th October 2020, the patient experienced coronavirus test positive. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the dehydration, dizziness, headache, sweating and stiff joint were recovered/resolved and the outcome of the neck pain, pain in arm, shoulder pain and general body pain were not recovered/not resolved and the outcome of the coronavirus test positive and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the dehydration, dizziness, headache, sweating, stiff joint, neck pain, pain in arm, shoulder pain, general body pain and coronavirus test positive to be related to Influenza vaccine Quadrivalent unspecified season and Shingrix.  Additional details were provided as follows: The patient received dose of flu vaccine in the left. The patient received dose of Shingrix underneath his arm in the tricep instead of deltoid region of the upper arm, which led to vaccine administered at inappropriate site. The reporter staated that, on the day of vaccination in the evening, the patient experienced body aches in the arms, neck and shoulders, stiff joints, was sweaty, headache, dizziness, and dehydration. The reporter stated, the patient kept drinking water and took Tylenol for these symptoms. The reporter stated that, the events had resolved except aches here and there. On 25th October 2020, the patient had positive Covid-19 test. The reporter did not consent to follow up. This was 1 of 2 linked cases reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020212948:same reporter
This spontaneous report as received from a physician via a company representative refers to a "young adult" male patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23. Lot number and expiration date were not reported. Dose and route reported "as directed". No co-suspect and concomitant therapies were reported. The physician reported that the patient developed a localized reaction at the injection site (reported as sight) that included significant pain (on an unknown date). The outcome of localized reaction at the injection site (sight) that included significant pain was reported as recovered (an unknown date). The patient sought medical attention. This is one of two reports from the same source (other case # 1407USA004383). Additional information has been requested.
I have experienced heart palpitations after my second shot that I received (4/7/2021, symptoms began 4/9/2021) and the same with my booster received on (11/1/2021).
Four hours after vaccine administration, the patient began experiencing body aches, headache, and chills typical of post-vaccine immune response. however, three hours later (7 hours after administration), she began having a burning sensation in her thoracic back, upper chest, shoulders, and upper arms with accompanying allodynia, the patient reports was up to 10/10 intensity. She went to an emergency room and was given acetaminophen, prednisone, diphenhydramine, and famotidine. Her symptoms did not significantly improve and was discharged. The burning sensation and allodynia did resolve overnight and have not reoccurred, but these symptoms are the adverse event I am reporting.
Patient noticed redness and swelling at injection, redness radiating down front of arm. Also had flu-like symptoms.
After getting a vaccine, patient was advised to sit for 15 more minutes. As soon as he left the immunizing room, he fainted for couple of seconds. Then regained consciousness but had shaky hands, SOB, and in tears. He was provided with water and asked he may take off the mask if breathing is difficult. Taking the mask ease the breathing a little, but still SOB. Gave him a brown paper bag  to breath into and as him to take deep breath in & out. He did that few times, then regained his normal breathing. Saw him looking down to his phone, which I told him to lift his head up to his eyelevel to decrease the dizziness. Was situated for about at least 30 minutes, then he said he was feeling better and he wants to leave as his friend is outside to pick him up and left.
Patient developed red rash that extended from the vaccination site down her arm to her elbow. The rash did not hurt or itch, but was firey red and inflamed. The Patient noticed the evening of the 18th, and came in on the morning of the 19th to show me. She then went to a previously scheduled Dr's appointment an hour later and had the Dr. look at it. She told me the Dr. was unsure what it was or why it happened, but prescribed her Keflex 500mg twice daily to be safe.
Rash that was red; Bump/pimple at injection site; Rash is round and raised; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Rash that was red), INJECTION SITE INDURATION (Bump/pimple at injection site) and VACCINATION SITE RASH (Rash is round and raised) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Rash that was red), INJECTION SITE INDURATION (Bump/pimple at injection site) and VACCINATION SITE RASH (Rash is round and raised). At the time of the report, RASH ERYTHEMATOUS (Rash that was red), INJECTION SITE INDURATION (Bump/pimple at injection site) and VACCINATION SITE RASH (Rash is round and raised) had resolved.            No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow-up information received on 26-JUN-2021. Updated outcome of all the events(From unknown to recovered/resolved),
tinnitus ringing of the ears; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation. The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "tinnitus ringing of the ears".  Additional information: The patient got tinnitus ringing of the ears ever since, which was reported like every time it is "quiet", it's up to her ears like crazy.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine had expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine had expired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine had expired). On 23-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine had expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow up received contains significant information, added patient demographic details and batch lot number.
Redness and Swelling (Cellulitis)of arm (right arm) at vaccine site. Treated with Keflex antibiotic and recommended warm soaks, and elevation of extremity as of 10/11/09.
little tired for a day after the second vaccine; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (little tired for a day after the second vaccine) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (little tired for a day after the second vaccine). At the time of the report, FATIGUE (little tired for a day after the second vaccine) had resolved. Not Provided          No Concomitant medications were reported. No Treatment information was reported.   Reporter did not allow further contact
Patient suffered an un-witnessed syncopal event. Found down. Came around quickly but was admitted to ship's ward for observation. Clinically, I do not feel the event was related to smallpox vaccination.
Member called regarding chest pain lasting less than 1/2 second, 1-2 times a day, for the past few days.
On 04Apr2021 she had a topical allergic reaction; The initial and follow up 1 case was missing the following minimum criteria: [specify criteria (no adverse event)]. Upon receipt of follow-up information on [26Apr2021], this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021465423.  A female patient received bnt162b2 (BNT162B2), administration date 21Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DERMATITIS ALLERGIC (non-serious) with onset 04Apr2021, outcome "unknown", described as "On 04Apr2021 she had a topical allergic reaction". Therapeutic measures were taken as a result of dermatitis allergic.  Additional information: A female patient age reported as 62 (unit not provided). Patient received the first dose of the Pfizer BioNtech Covid-19 vaccine on 21Mar2021,on 04Apr2021 she had a topical allergic reaction (she doesn't think it's related to the vaccine) to the formaldehyde in the paper mask she was wearing. Her doctor put her on oral steroids until 09Apr2021, her second dose was going to be that weekend and no-one could tell her if she should take it or not, she missed her second dose. She was still on topical steroids, she would like to know if it was safe for her to get the second dose of the vaccine. Reporter reschedule for second dose on 11Apr2021 possible reaction on steroids. Can she still get her second dose. She did not state what the reaction(s) were.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Updated the narrative and deleted the age from field and capture in narrative additional information.
15 month old child was inadvertently given the MMRV vaccine as well as the Varicella vaccine.
Patient called in to the nursing supervisor at approx 02:40. She was not on the schedule but was stating that she was having a reaction to the Covid vaccination she recieved the evening before. It was noted that while she was talking with the supervisors her speech was thick and she stated that her tongue felt swollen and larger than normal. She also stated that her significant other told her she sounded different too. She stated she had redness from her earlobe to her wrist on her R side, which is where she got the vaccination. She got it at appx 18:30 she had said, and when she got it during the observation period she was noted to have a very red and hot arm, but overall she felt fine. She also stated that she has had a covid infection recently. She stated she took 1 childrens dose of benadryl but was worried because she is breastfeeding. We advised her to call 911.  ***      1000am- #2 vaccine  given on 02/9/21 @ 610pm. felt ok for the first 15 minutes during the  waiting period; the site was examined by the Medical assistant & was very hot to touch & red about the size of a baseball. She was dismissed from the vaccine clinic.  She went home and around 7:30 pm felt swelling in her tongue & mouth. She disregarded this symptom and went to bed, she awoke @ 2:30 am and felt her tongue was more swollen & then called the nursing supervisor. Patient took Benadryl 50 mg at 0230am. NO response from the Benadryl. Went to the ER @ 0400 called 911, B/P was 155/88 & O2 sat 89%. She opted to go to the ER by private vehicle.  Went to ER. She was give IV fluids, Benadryl & monitoring.  Discharged from ER this am. Hx of allergy of bee stings. Stated this reaction was the same as  a bee sting reaction.  Discharged from the ER to take tylenol & Benadryl & monitor.  During this call she stated that her tongue is still a little swollen, speech is clear, Denied SOB. Temp 99.8 during this call.   Lymph nodes in her in neck are  swollen- she said  there is 1 area near her right collar bone the size of a golf ball. Currently nauseated, denied chest pain. She does not qualify for testing since she  had Covid on 01/8/21.  A VAERS report will be submitted today & I will add that ID # to this documentation. :PLAN Clear to work; yet verifying with physician if any additional instructions.
This is a 65 year-old male who presents with a history of reaction at site of SHINGRIX injection that he got on Tuesday. Reports the first day his arm just felt sore like when you get a tetanus shot. Last night his wife noticed he had red/warm area around injection site left upper arm and had f/c. He felt better on waking, but as the day has gone on his arm has become more painful and he felt warm again. Was advised by telehealth nurse to have evaluated in ED tonight.
Very sore area at injection site starting the evening of getting vaccine.  Next day range of motion in arm limited due to swelling and severe pain.   By mid-morning I began to feel fatigued, headache,  body aches, joint pain, chills, and slight nausea.  While getting ready for bed I noticed pain in armpit and swelling.  Next morning only experiencing pain, redness and swelling in upper R) arm and pain and swelling in R) armpit.  Still experiencing limited range of motion, hard to lift arm and hard to keep arm next to side due to swelling and pain.