chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid positive; Covid positive; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect via a contactable consumer (patient). This reporter reported similar events for 2 patients (reporter and reporter's husband). This is 1st of 2 reports reported for the reporter. A female patient of an unspecified age received first dose of BNT162B2 via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient and her husband both had vaccine on Friday and they discovered that they both were Covid positive on Monday. Patient did not have symptoms but her husband did, the question was whether they should still get the second shot. Events outcome was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021049698 Same reporter, same drug, different patient
Information has been received from a physician concerning a 14 year old female with a history of anxiety with such procedures as blood drawing and vaccinations and no known drug allergies who on 05-DEC-2007 was vaccinated IM with her first dose of GARDASIL (lot# 659437/1266U).  There was no concomitant medication.  Subsequently the patient had fainted several times.  She also vomited, urinated and had terrible sweating.  An ambulance was called into the office, but she wasn't taken to a hospital because she recovered at the site.  The patient had sought medical attention with her physician.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/14/2008. The patient had experienced a syncopal episode that was on-going, multiple episodes lasting for greater than 30 minutes. Her blood pressure and heart rate were normal. No further information is expected.
slightly sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 16-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any medications within two weeks of COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021, the patient experienced slightly sore arm. No therapeutic measures were taken as a result of the event. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event slightly sore arm was recovered on unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Severe hives and rash all over body that did not go away for 4 full weeks of prescription steroids. Also began having panic attacks / full blown anxiety, which has never been my nature and within the year was diagnosed with Sjogrens, Lupus and Raynauds Syndrome.
Twitching Deltoid Muscle Injection Site (Visible); Itching Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Twitching Deltoid Muscle Injection Site (Visible)) and VACCINATION SITE PRURITUS (Itching Injection Site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced MUSCLE TWITCHING (Twitching Deltoid Muscle Injection Site (Visible)) and VACCINATION SITE PRURITUS (Itching Injection Site). On 31-Mar-2021, VACCINATION SITE PRURITUS (Itching Injection Site) had resolved. At the time of the report, MUSCLE TWITCHING (Twitching Deltoid Muscle Injection Site (Visible)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up received and it contains No New Information
Patient left clinic and mother came back in saying he complained his stomach hurt and he threw up.  Skin is bright pink and child is scratching. Vital signs 98.1-119-20, BP 96/60, O2 Sat 96%. Seen by MD. Benadryl given and referral to Allergy/Immunology.
Pain, Redness, soreness, swelling at injection site, Headaches, muscle aches, shivering, fatigue,, dizziness and weakness
None. Vaccine was given after the FDA recommendation to discontinue sent out on 08/31/2022. No adverse reactions were experienced.
ZOSTAVAX administered SQ right arm on 7/7/14. Pt noticed "hard, red rash" surrounding inj site 7/8/14. Denied fever, pain. No itching. Rash about the size of a dollar bill.
within 1 minute of receiving vaccine.  Patient was flushed, turning red, and sweating.  She reported trouble breathing.  Followed Protocol, had epipen on hand.  Patient requested 911 be called.
PATIENT SHAKING SLIGHTLY.  COMPLAINED OF FEELING LIGHTHEADED.  PATIENT DRANK WATER AND STATED FEELING BETTER.
1 days p/vax pt devel fever of 103.4 7 area of redness DTP inj site measuring 0.75 inch by 2 inches;reporter (pt grandma) indicated that DTP was given subcutaneous;Tri-immunol recommended to be administered IM;also devel swelling @ site;
June 11th, I came down with a severe cough, it was so bad that I felt like my ribs were going to break. It kept me up all night and I was hacking and hacking. I had to lock myself away from everyone. I called my doctor. He told me to use inhalers he had formerly prescribed for when I had COVID-19 (to help me with my lungs), Albuterol Sulfate, Breo Ellipta 200 mcgs. That saved me for the night, and I started getting better. It was pneumonia and it lasted two or three weeks. I was weak from being in bed. And was dizzy and achy. I had problems with food, it still is difficult for me to eat food since having COVID-19. It grosses me out to eat foods that I used to like. I do get dizziness a number of times and I get really tired when I try to go work in the yard. I thought I was having a heart attack. I became a little anti-social, I still have no desire to go mingle with people. I try to work on my RV but I just want to sleep a lot. I do get a deep cough every once in a while. I got my flu shot last week, over a week ago in October 2021 (about the middle).
pt recv vax 9FEB96 & pt devel a fever of 102;seen by MD on 14FEB96 & noted to have congestion, beffy red cropharynx & a rash;strep test was negative & pt recv DPH;pt had viral illness & not a vax rxn;
This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 20th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 ug. On 20th March 2018, 4 hrs after receiving SHINGRIX, the patient experienced feeling cold, nausea, somnolence and headache. On an unknown date, the outcome of the feeling cold, nausea, somnolence and headache were recovered/resolved. It was unknown if the reporter considered the feeling cold, nausea, somnolence and headache to be related to SHINGRIX. Additional information was reported as follows: About 4 to 5 hours after the vaccination, the patient was freezing cold, nauseous, had a headache and could not stay awake. She could not get out of her bed for about 20 hours. The patient had denied to contact her physician.
Received the injection at 10:30 Tuesday and had no reaction except for some fatigue. Woke up at 7:30 Wednesday with my injection sight swollen, big red round rash, that was itchy and hot to touch as well as hard.
Patient presents with history of noticing some tachycardia.  Symptoms started 5 to 7 minutes after he got the first Covid vaccine.  He has a history of A. fib.  He denies any chest pain.  Has also had TIA in the past.  EKG completed and no a-fib. HR 62 and BP 130/92.  Patient offered further evaluation at ER and refused.
6-8 hrs after vaccination, pt woke from nap and cried for 3 hours. Felt warm to touch. At 11PM on 1/8/19, had fever to 102.5 degrees was fussy and slept poorly all night. Woke frequently during night. On AM of 1/9/19, had fever 101.5. By afternoon, temp dropped to 99. Slept better on night of 1/9/19. Awoke on AM of 1/10/19, fever was gone and he was less fussy. No rash. Appetite was normal throughout. Was not treated with TYLENOL. No signs or symptoms of cold. Patient seen in office 1/18/19. Exam normal except for 2cm patch of seborrhea on scalp and his known cardiac. Excessive fussiness resolved by 1/12/19 according to mother.
24 hours after innoculation, chills, malaise, erythema at injection site, dizzy. Left deltoid pain 24 hours post injection on 11/02/2002. 11/03/2002 pain, chilled and miserable. 11/04/2002 site started to get red, slight dizziness. Took tylenol and slept.
Fever; chills; body ache; chest pain while breathing in; Dose number=1 27May2021/ Dose number=2 10Jun2021; Dose number=1 27May2021/ Dose number=2 10Jun2021; This is a spontaneous report from a contactable Other HCP (patient). A 41-years-old female non-pregnant the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection)via an unspecified route of administration, administered in Arm Left on 27May2021 at 03:00 PM (Batch/Lot number was not reported) as a Dose 1, Single and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection,Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 10Jun2021 at 14:00 (at the age of 41-years-old) as a Dose 2,Single for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history was not reported. Concomitant medication in two weeks included, birth control medications. Other vaccine received in four weeks was none. It was unknown whether the patient had covid prior vaccination. The patient was not tested for covid post vaccination. The patient had Dose number=1 27May2021/ Dose number=2 10Jun2021 (off label use and inappropriate schedule of product administration). On 11Jun2021 at 04:00, patient experienced fever, chills, body ache and chest pain while breathing in. Therapeutic measures were taken as a result of the events which included Anti-inflammatory medications. Events resulted in the Emergency room/department or urgent care. Outcome of off label use and inappropriate schedule of product administration were unknown whereas, rest of the events were recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This case was reported by a consumer via call center representative and described the occurrence of rash in a elderly female patient who received SHINGRIX for prophylaxis. On 26th December 2018, the patient received the 2nd dose of SHINGRIX. On 1st January 2019, 6 days after receiving SHINGRIX, the patient experienced rash, pruritus and burning sensation. On an unknown date, the outcome of the rash, pruritus and burning sensation were not recovered/not resolved. It was unknown if the reporter considered the rash, pruritus and burning sensation to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After vaccination, the patient experienced rash, itching and burning on the back. The patient planned to follow-up with her physician on an unknown date. The reporter was provided limited information. The patient disconnected the call while in conversation. The reporter gave consent to follow up.
Student received LAIV H1N1 vaccine at school at 1:10 pm. Complained of headache and nausea at 1:35 pm. Color pale, vital signs stable. No hives or wheezing. Student observed for 1 hour, mother contacted. Student to home with mother at 3:00 pm.
significant swelling and redness at injection site 6 days after receiving the second dose.; significant swelling and redness at injection site 6 days after receiving the second dose.; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 05Mar2021 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received first dose (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the left arm on 12Feb2021 at 10:15 (at the age of 71-year-old), as a single dose for COVID-19 immunisation. On 11Mar2021 at 10:00, 6 days after receiving the second dose, the patient developed significant swelling and redness at injection site. 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, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events significant swelling and redness at injection was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. Lost over sixty pounds and developed lesions on his throat and lungs following vaccination. He reportedly told his close friend of the family of the problems. He also told someone else who reportedly told him not to get involved with the vaccination issue in the military. (OMIC)
lymph node swelling under L arm that went into scapula region Narrative:  Employee will be going to see Urgent Care for his pain by his shoulder that is described as "tearing"  Other Relevant History:
WIthin hours of receiving HPV #2 on 6/19/19, patient developed peri-oral burning and itching and swelling. Since that time, she also developed a new dry, rough rash over upper eyelids and itching around eyes. Sxs did improve some with Benadryl but have continued to wax and wane. No vomiting, diarrhea, trouble breathing or mental status changes. She is also allergic to peanuts and has allergic rhinnitis.
No additional AEs were reported; Medical assistant is reporting that an expired GARDASIL 9 was given to a patient; This spontaneous report as revived from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history were not provided.  On 02-FEB-2022, the patient was vaccinated with one dose of expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe, lot # S011719, expiration date 04-DEC-2021 (route and site of administration were not reported) for prophylaxis (Expired product administered). No additional adverse events were reported (No adverse event).
I had no side effects with the first vaccine and non immediately following the 2nd shot. However, 4 days out I began having vertigo. When I lay down and when I wake up the room feels like it is spinning. When I stand up after lying down this also happens. If I get up to go to the restroom I am dizzy and and am unable to walk in a straight line.  However, once I am up for a little bit the dizziness subsides until I lay down again. This has been going on for approximately one week. I have not sought medical advice yet but will if it has not subsided by next week.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild
Red rash on entire face ( with a more prominent redness about size of a quarter on cheek bone )and small rash on opposite upper arm ( right arm ) and small rash on collar bone area . Was not itchy but tight. This Occurred about an hour or so after first shot. Called pharmacy and primary care physician and was told to take one  Benadryl. This took away the rashes within a half hour to an hour.
Very bad headache, loss of appetite, no energy, very sharp low back pains. all joints sore. was basically in bed all day the next day
5 days after vaccine i had a 3" round red spot at injection site.  Spot is sore and has heat.  This is the 14th day and site is still red, sore and has heat
Information has been received from a physician concerning a 13 month old male who on 05-MAY-2008 was vaccinated subcutaneous with his first dose of VARIVAX (Merck) (LOT# 659726/1772U) and MMR II. The patient developed chickenpox rash two weeks after vaccination. The rash appeared all over the body including near the injection site and he had fever. Subsequently, the patient recovered from symptoms. The patient sought medical attention by the physician. Additional information has been requested.
COVID vaccine was given to patient outside of its stability window (6 hrs after the vaccine was mixed). When this vaccine mistake was discovered, patient was contacted.  Pt was not having any adverse reaction to the vaccine. Patient will come back sometime next week to get re-vaccinated per Pfizer & CDC guidance.
Caller did not receive second Moderna Dose in the series (56 days since receiving first dose); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Caller did not receive second Moderna Dose in the series (56 days since receiving first dose)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blindness, one eye (Left eye) and Heart disorder (Heart issues).    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Caller did not receive second Moderna Dose in the series (56 days since receiving first dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Caller did not receive second Moderna Dose in the series (56 days since receiving first dose)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information were provided. No treatment information were provided.
patient was administered MENACTRA after the expiration date with no reported adverse event; Initial information received on 15-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was administered meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] after the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine, solution for injection (dose, frequency, batch lot number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination  On an unknown date it was reported that patient was administered menactra after the expiration date with no reported adverse event (expired product administered) (unknown latency).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event patient was administered menactra after the expiration date with no reported adverse event.   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 the guidelines. 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.
Patient reports an onset of shoulder pain 24-48 hours after vaccine administration. Patient reports progressive limitations of her range of motion of her left shoulder and increasing pain.
Three to four days after the injection I began to feel muscle and joint aches in my entire body along with fatigue. These symptoms grew in intensity and lasted about seven days, then suddenly diminished and then stopped.  Dates: (1) January 8, 2021: injection; (2)  January 11 - 13: beginning of symptoms; (3) January 16-17: lessening of symptoms; (4) January 18: disappearance of symptoms.   I also experienced soreness in my left arm at the site of the injection.  That began several hours after the injection and was much more intense than the soreness I usually experience with flu shots.  The soreness lasted about 24 hours, again much longer than my experience with flu shorts.  It then suddenly diminished and then stopped--same pattern as the aches and fatigue described above.
Redness and swelling at injection site - days later swollen ear and little red, itchy welt on back.
Body aches and temp of 102 for approximately 36 hours. Axillary lymph node swelled to size of a golfball within 2 days and was uncomfortable if pressure applied.  6 weeks after injection can still feel the lymph node but swelling has decreased to size of a grape.
The patients wife called me and said her husband was experiencing pain in his legs buttocks and feet. She said his feet hurt so bad he could not stand. I advised them to go to the ER and have him evaluated because we need to rule out serious adverse events such as Guillian Barre. I called back later in the evening and they decided not to go to the ER. his wife said he was getting better.
Elevated heart rate/pulse, hasn't gone below 90 (normal pulse runs from 40-70) - ongoing Body aches Chills  Headache Fatigue
Bilateral rash on both arms (wrist to elbow) and by ankle. Rash "feels warm", contains raised, small bumps that itch. Rash appears and disappears. Accompanied by joint aches and low grade fever (99.6 degrees F) (self-reported).
Initially after a day or so my Lymph node and surrounding tissue/area in left armpit/axilla swelled to a very large size and was very tender. After a while the Lymph node seemed to have shrunk by the inflammation/swelling and pain in the armpit/axilla remained.
Lab work (viral culture) (varicella) positive. Rash - OV 2/25/14.
On 8/30 came to clinic complaining of pain, swelling at injection site.  Induration is measured at 6cm by 10 cm.