chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Forearm elbow down to hand has been swollen/puffy; Diagnosed as left arm Cellulitis of unspecified cause for the left arm swelling; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Diagnosed as left arm Cellulitis of unspecified cause for the left arm swelling) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic and Pacemaker insertion (cardiac).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced PAIN (Sore arm). On 15-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CELLULITIS (Diagnosed as left arm Cellulitis of unspecified cause for the left arm swelling) (seriousness criterion medically significant). On an unknown date, the patient experienced PERIPHERAL SWELLING (Forearm elbow down to hand has been swollen/puffy). At the time of the report, CELLULITIS (Diagnosed as left arm Cellulitis of unspecified cause for the left arm swelling), PAIN (Sore arm) and PERIPHERAL SWELLING (Forearm elbow down to hand has been swollen/puffy) outcome was unknown.            No concomitant medications mentioned.  Treatment for the events included Clindamycin hydrochloride 300mg.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. The Urgent Care, diagnosed patient left upper arm swollen twice the size from elbow down to finger, as Cellulitis of Unspecified cause left upper limb. The Urgent Care prescribed Clindamycin HCL 300mg antibiotics every 6 hourly for 7 days and patient symptoms improving after starting the treatment, according to the patient.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Mentioned confirmation of visiting Urgent care and diagnosis from Urgent Care; Events updated. 2nd dose information mentioned; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sinus issue" (unspecified if ongoing), notes: Verbatim: she has had a sinus issue for over one month. The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hives and rash on left arm from wrist to elbow, left lymph on the left side of neck, swollen eyes both
Patient state pain and soreness was experienced on the site of administration of vaccine immediately after flu shot was given on 11-30-15. Patient did not return for treatment until 12-31-15. Until now, pt. cannot move the (L) arm because of pain. Pt referred to physical therapy.
Developed sharp,constant left sided CP which was relieved with sitting forward 3 days after his second dose of Moderna Covid-19 vaccine. No palpitations, edema or SOB.   Dx: Probable Myocarditis
This spontaneous report was received from a other health professional refers to a 4 year old male patient with unspecified preservative allergy, jello allergy, and neomycin allergy. The patient's medical history included Kawasaki's disease. On 08-MAR-2006, the patient was vaccinated with a dose of M-M-R II (lot# 649509/0773P), 0.5 ml, subcutaneously. Concomitant therapies included IPOL (Manufactured by PMC per the caller) and INFANRIX (Manufactured by GlaxoSmithKline). On 08-MAR-2006, the patient became flushed, developed sneezing and watery eyes after receiving M-M-R II. No treatment was given and the symptoms resolved within an hour of the onset of symptoms on 08-MAR-2006. On 20-MAR-2006, the patient was vaccinated with VARIVAX (Merck) and experienced wheezing and hives (see related case 1307USA002101). Laboratory diagnostic tests performed was none. Patient sought medical attention as adverse events occurred in the doctor's office. The outcome of became flushed, sneezing and watery eyes was reported as recovered. This is 1 of 2 reports regarding the same patient. Additional information is not expected.
Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported No treatment medication was reported
COVID BREAKTHROUGH CASE************** Around May 13, 2022 I set up a video appointment I was having symptoms of allergies or so I thought. Sore throat; Thirsty; Chills; Lightheaded; Earache; Cough; Lots of Fluid buildup. On May 17, 2022 tested positive for Covid 19 with an at home test. Mostly like a allergies. I thought it was due to the high pollen count, but it was COVID. After the video visit my doctor order my prescriptions. Paxlovid I took medication as prescribed. Zithromax 250mg; methylprednisolone 4mg; I could take ibuprofen; Eliquis 5mg. These were the only medications that I was allowed to take because some interact with one another in many different ways.
right arm hurt when she moved or put it in the air; sweats; massive headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right arm hurt when she moved or put it in the air), HYPERHIDROSIS (sweats), HEADACHE (massive headache) and FATIGUE (fatigue) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (right arm hurt when she moved or put it in the air), HYPERHIDROSIS (sweats), HEADACHE (massive headache) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (right arm hurt when she moved or put it in the air), HYPERHIDROSIS (sweats), HEADACHE (massive headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-283888 (Patient Link).
Second day (Tuesday 1/5/21) swelling and some soreness on inside of throat right side. Wednesday 1/6/21 swelling had spread significantly to inside the right side of mouth and tongue also affecting right jaw. By 3 Pm that day my tongue was numb and swollen on the right side as well as the right side of my mouth and jaw. I could only chew, eat, and swallow effectively on the left side of my mouth using the left side of my tongue to negotiate eating.  I could only this with small amounts of food. By that evening about 4 hours later I could eat , chew etc. pretty good but the swelling & discomfort remained but reduced to a functional level.  Today, Thursday 1/7/21, the soreness and discomfort remains inside throat, mouth, tongue and jaw all on the right side.
Tinnitus Worsened and my tinnitus is till worse than normal for me to this day.  Worsened tinnitus is primarily the right ear.  Left ear is currently normal.  I went to see PA  today and from her exam she indicated right ear drum looks normal.  Sinuses are somewhat swollen.  She wants me to use Afrin and Flonase for one week.  If that doesn't help, then low salt diet for one week.  If still no help, she will refer me to an ENT.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The physician reported that, on 04-NOV-2014, the patient was vaccinated with expired dose of ZOSTAVAX subcutaneous (dose unspecified), lot # J003359, expiration date: 21-JUN-2014. No adverse effect was reported. Additional information has been requested.
pain on the arm at the location of where the vaccine was administered; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received BNT162B2, administration date 15Mar2021 (Lot number: EN6204) 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: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "pain on the arm at the location of where the vaccine was administered".  Additional information: The patient reported that him and his wife got the covid vaccine yesterday. They were both good but had pain on the arm at the location of where the vaccine was administered. He stated that the pain was not bad, and just wanted to check to see if they can take Tylenol or Ibuprofen to relive the pain.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021300970 same reporter/drug/event, different patient
On 2/4/21,  after receiving the vaccine I was starting to feel a slight headache but more like pressure. I was also feeling a bit nauseous but I thought it was stress but I did took an ibuprofen.  Later I starter to feel very tired do I went to sleep like about 7pm and I took a Tylenol before doing so.   I kept on waking up in the middle of the night still feeling pressure pain in my head and like a tightness sensation with a slight pain on my chest.   I woke up at 5am to get ready to work and I was still not feeling well. I got out of the house and stoped at a gas station and when I got out of the car, I started to feel extremely dizzy while walking. Got to my work place and took my temperature and it was 99.1. After a while dizziness and pressure on chest kept on getting worst.   I had someone at work take my vitals and my temperature was 101.0,  BP was 144/95, BPM was 120,  SpO2 was 98%. My boss send me home. And now I?m having mid and back lower pain with a bit of chills
2" x 2" circular patch of erythema and edema with positive pruritus occurring 24 hours after injection. Treated with Benadryl.
Information has been received from a registered nurse (R.N.) concerning an 8 year old male with 1 sibling who on 29-JUN-2001 was vaccinated subcutaneously in the right deltoid with a first dose of MMR II (Lot #637433/0149L). On the same day he also received a first dose of secondary suspect VARIVAX (Lot #638490/1900K) subcutaneously in the left deltoid. There was no illness at time of vaccination. "Five days prior to onset", on 02-FEB-2009, the patient experienced sore throat and fever. He was seen by a physician and was placed on therapy with ZITHROMAX. On 07-FEB-2009 the patient "broke out in pimple like rash in various spots". It was reported that the patient was seen by the physician on 09-FEB-2009 and "some lesions are already drying". The outcome of the patient was not reported. Follow-up information was received on 20-MAR-2009 from the R.N. indicating that the patient's "pimple like rash in various spots" appeared to be "chicken pox lesions". On 16-FEB-2009 the patient was seen by a doctor and his rash had gone. This is one of several reports from the same source. Additional information is not expected.
It was reported that a 59 year old female received Fluzone SV 98-99 USP on Sep 29.1998. Reportedly sometime after the vaccination the pt experienced a fever and a swollen, red arm. From additional information received on Nov 16, 1998 it was reported that the pt also experienced chills after receiving the vaccination.
Systemic: Seizure-Mild, Additional Details: Minor seizure lasted only briefly. Patient seemed unconcerned afterwards and informed pharmacy staff that he goes through this outcome after getting any type of vaccine.
temporary loss of muscular function in left arm, chills, fatigue, lightheadedness/dizziness, severe night sweats
Difficulty breathing - 5:30 - 7:00pm, vomiting 8:30-9:00pm, headache- 2days, achyness - pm, pain in hips - pm - 12hrs, coughing - pm, dizziness  24 hrs next day, chills pm.
It started in both collar bones, they were so sore, when I would go to sleep, they felt like they were going to break. I went to the doctor and had some blood work done, which came back normal. Then I went to another doctor and by that time it went to my right shoulder, then to my hips, then to my left knee, and now my left shoulder. I am unable to sleep most nights because I am in so much pain. I am unable to do my landscaping business because of the pain. I also drive a school bus and it is difficult to sit down and drive and stand up. Even my personal vehicle is very difficult to drive. I have done heat therapy on my right shoulder. I am seeing a chiropractor now. Basically I have been living on Advil and Tylenol since I got the vaccine. If I do not take it, I am in horrendous amount of pain that I cannot stand it. I had x-rays done on my hips and shoulders and it showed some arthritis but nothing major that would explain this much pain. They sent me to a rheumatologist and they looked at my blood work and did some exams and said everything looks fine. I am doing an Ondamed treatment also, it's a pulsating electromagnetic frequency. On 03/10/2021 they gave me a prescription for meloxicam 15mg tablets. My doctor wants to send me to another rheumatologist and orthopedic surgeon but I refused because there is no point on seeing another doctor if they are going to tell me the same thing.
patient loss partial consciousness, had low blood pressure and she was less responsive when asked any question. She had normal breathing and blood sugar. She complained about some degree of loss of consciousness and control of her body. Paramedics were called, she refuse to call ambulance and after about 30 min she was conscious and went home with her daughter.
Pain in left arm,  that comes and goes...  Ibuprophen does not help to ease it...
Information has been received from a physician concerning a 17 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL and no reaction was noted.  On an unspecified date the patient received  a second dose of GARDASIL and developed hives, "4 hours after the second dose was given".  The patient did not seek medical attention.  Additional information has been requested.
Pt report on 11/14/01: "dizzy, warm, dehydrated" shortly after shot x 2 1/2 hrs; then (same day @ 8pm): so dizzy couldn't stand, nausea times 1 hr. Pt report on 11/15/01: dizzy today times 2 hrs also had previous episode of dizziness 3 mos prior. Had appt to see MD, but did not. Pt report on 11/21/01: "6 bumps under skin" noted 11/15/01 @ injection site; pruritic, never vesicular. Dizziness times 4-5 hrs.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site warmth (the injection spot is warm), vaccination site swelling (the injection spot is swollen), vaccination site erythema (the injection spot is red) and vaccination site pain (the injection spot is very sore) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site warmth (the injection spot is warm), vaccination site swelling (the injection spot is swollen), vaccination site erythema (the injection spot is red) and vaccination site pain (the injection spot is very sore). At the time of the report, vaccination site warmth (the injection spot is warm), vaccination site swelling (the injection spot is swollen), vaccination site erythema (the injection spot is red) and vaccination site pain (the injection spot is very sore) outcome: unknown. No concomitant medication or treatment information reported. Reporter did not allow further contact.
Tightness in  chest about 5 hours after the shot. Over the following few days the condition escalated to breathlessness and moderate intermittent chest pain (I have no previous history of respiratory issues.  I couldn't run or walk up stairs or a slight grade without getting out of breath. I sought medical attention on 4/27/2021. The Dr. heard wheezing and chest sounds for which he prescribed Flovet. I have never taken an inhaler before this time.  Concurrent with the shortness of breath, I had a urinary infection.  I have not had one in at least 30 years.  I was prescribed Sulfamethoxazole, and took two rounds. I had a second positiveurinalysis, and prescribed Ciprofloxacin HCLon 04/29/2021.
Tinnitus, left greater than right ear. Patient had 24 hours of flulike symptoms after booster vaccine November 16, developed tinnitus within 24 hours of vaccine, and it has persisted until today
I started "spotting"./bleeding became a bit heavier; strong stabbing cramps.; I was not due for my next period until May 10th as I had just finished my last cycle the week prior; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0172), via an unspecified route of administration, administered in left arm on 24Apr2021 10:45 (at the age of 43-year-old) as dose 2, single dose for COVID-19 immunisation was public health clinic. Medical history included hashimoto's disease and hypothyroidism from unspecified date and unknown if ongoing. Concomitant medication received within 2 weeks of vaccination included levothyroxine and vitamins nos (DAILY VITAMINS). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8727), via an unspecified route of administration, administered in right arm on 18Mar2021 (at the age of 43-year-old) as single dose for COVID-19 immunisation. 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. Since the vaccination, the patient had not been tested for COVID-19. Patient received second dose on Saturday (24Apr2021 at 10:45) and on Sunday on 25Apr2021, afternoon she started "spotting". By Sunday evening (20:00), the bleeding became a bit heavier. She was not due for her next period until 10May2021 as she had just finished her last cycle the week prior. This was extremely unusual for her as she had always been very regular and never spot between periods. Today (Monday) on 26Apr2021, the bleeding continues to be moderate, however, she was now experiencing strong stabbing cramps (at the time of report). This was also highly unusual as my history of periods had been very moderate without much cramping. Menstrual changes were not listed as a possible side-effect of this vaccine and she saw that other women are reporting the same or similar issues. This was very clearly a side effect of the vaccine, at least for her. The patient did not receive treatment for the events. Outcome of the evets was not resolved.  Follow-up attempts completed. No further information expected.
Pt was given #1 intradermal however wheal was not created. #2 0.1 mL intradermal was provided again which created wheal. Pt left in no distress
within 5 minutes of receiving second Moderna vaccine, patient c/o itching to face.  no visible hives.
AFTER PT RECEIVED INITIAL DOSES OF VACCINE IN AUG 2021  STARTED HAVING INCREASED NEUROLOGICAL ISSUES, DECREASED MOBILITY TWITCHING/ JERKY MOVEMENT W/ FREQ FALLS.  AFTER RECEIVING HER BOOSTER 11/05/2021 PT BEGAN TO DECLINE AFTER 3 WKS. PLACED ON COMFORT CARE 12/2/2021 AND EXPIRED 12/03/2021
10 minutes after vaccination patient stated he felt faint and thought he would pass out. We sat patient down to monitor and took BP and pulse rate (120/59 and 60). After a few minutes, patient stated he was nauseated and still feeling dizzy. We continued to observe patient and after a few more minutes he stated he was starting to have intermittent chest pain. We then contacted 911 to request assistance. While waiting for EMS to arrive, patient stated the chest pain was becoming more constant. At this time we also observed patient was very pale, sweaty, and his skin was cold to the touch. EMS arrived quickly and took over patient care, stablilizing him and then transporting him to the hospital. We have not received an update on his condition at this time.
Patient was mistakenly given 0.3ml of undiluted Pediatric orange cap instead of adult dose. Manufacture has been contacted for guidance and the CDC vaccine hotline. Patient has been informed of error.
Pt received vaccine and left office. Father reported that when pt entered the car, he had a 3 second episode of rigidity and shaking. Returned to office and was cool and clammy.
FEVER TEMP UNKNOWN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-MAR-2021, the patient experienced fever temp unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever temp unknown. This report was non-serious.
Came to office 9/7/13 with 4.8 x 5.9 cm red, warm area of Rt deltoid area at injection site. She states she was hot/chills and achy - did not take temp - evening of 9/4, and swelling and redness at site as above. 9/6 swelling gone - temp 9/7 - 98.6.