chrisvoncsefalvay/vaers-outcomes huggingface dataset:
full blown covid symptoms; feeling crappy; worn out; terrible chills; body aches over her entire body; headache; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (full blown covid symptoms) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in September 2020.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (full blown covid symptoms) (seriousness criterion medically significant), MALAISE (feeling crappy), FATIGUE (worn out), CHILLS (terrible chills), MYALGIA (body aches over her entire body) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SUSPECTED COVID-19 (full blown covid symptoms), MALAISE (feeling crappy), FATIGUE (worn out), CHILLS (terrible chills), MYALGIA (body aches over her entire body) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Company Comment 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 23-Jul-2021: Non Significant FU-Patient denies to provide contact information and denied for further FU; 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.
Ears popped simultaneously.  Had ear muff feeling for days, ringing and hissing in ears.  Saw primary who put me on a low dose of prednisone then ent.  The ear muffs went away and the hissing went away.  The ringing went away as well and all that remained was that everything sounded different in my left ear.  My hearing was checked and I have slightly diminished hearing in my left ear.  They said there was no way to tell if it was from the vaccine or if it was like that before.  That I should still get the 2nd vaccine and see them immediately if it comes back.   I got the 2nd vaccine and nothing immediately.  Still uncomfortable in my left ear, feel like pressure sometime, very very slight ringing here and there.  But nothing I can?t live with.   It?s been 2 months since I got the 2nd.  There was no immediate reaction.  But now, now it is awful!! Out of nowhere the ringing is constant, the pressure, the ear muff. It?s all back.  And it awful.  I can?t live like this.
unable to draw up 0.5 mL of Fluzone (multi-dose vial) while administering it to a nine years old patient they cannot administer the whole product into the skin because they feel pressure when they press down/No AE; unable to draw up 0.5 mL of Fluzone (multi-dose vial) while administering it to a nine years old patient they cannot administer the whole product into the skin because they feel pressure when they press down/No AE; Initial information received on 18-Sep-2019 and additional information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a nine years old patient (gender unknown).  In this case it was reported that they were unable to draw up 0.5 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (multi-dose vial) while administering it to the patient, they cannot administer the whole product into the skin because they feel pressure when they press down lot number: UJ237AB, expiry date: 30-Jun-2020 via unknown route in unknown administration site on an unknown date.  It was a case of vaccine underdose and liquid product flow abnormal.  It was unknown whether patient experienced any adverse event following vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
soreness of arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness of arm of injection) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included HYDROCHLOROTHIAZIDE, CARVEDILOL, SIMVASTATIN and ESCITALOPRAM for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness of arm of injection). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form three times a day. At the time of the report, VACCINATION SITE PAIN (soreness of arm of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-042638 (Patient Link).
Have been sick to stomach; Headache; Nausea; Throwing up; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 05Apr2021 at 13:15 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Patient had medical history (unspecified). The patient previously received iodine and experienced allergy. The patient received medication (unspecified) within two weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the 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 four weeks prior to the vaccination. On 05Apr2021 at 13:30, the patient experienced sick to stomach, headache, nausea and throwing up. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events sick to stomach, headache, nausea and throwing up was not resolved.   No follow-up attempts are needed. No further information is expected.
Patient had a large visible bruise around the injection site and had noticeably red skin below the bruised area. She reported stiffness, soreness in the shoulder and a runny nose.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: patient called store on Saturday August 21 to tell me she had a reaction to the shot. She said it was hot, red and swollen
At 36 hrs after vaccine I started with fever 101 and severe headache. After 3 days later I was diagnosed with positive Covid pneumonia.
Medical Assistant gave Meningococcal (Menactra) per verbal order for PCP. Order was actually supposed to be Meningococcal B (Bexsero). MA misunderstood as she had never known of any other meningococcal vaccine. She called to Immunization Agency and spoke with someone there who said that it was fine. No contraindication.  Pt received a 3rd dose of the Menactra. No adverse event occurred.
Vertigo; Diarrhea; Throwing Up; Chills; Nausea; No appetite
I got the 1st COVID vaccine 1/28, 9 days later I had a red rash come up on my arm in the same area with the injection, reported it. So now I tested positive for COVID on 12/7- received antibodies injection on 12/8 and 7 days later I start having cramping in the arm and area with injection site, no redness, reported it also, yesterday I had a red area come up hot to touch in the same spot as the cramping now I can hardly even use my arm without pain. I actually have a picture documentation from 2/6 and 12/13
Vaccinated and wears a mask, he got COVID, it was mild; Vaccinated and wears a mask, he got COVID, it was mild; This is a spontaneous report from a contactable consumer.   A 24-years-old male patient received BNT162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose (at the age of 24 years old) for COVID-19 immunization. The dose number received was not specified.  The patient's medical history and concomitant medications were not reported.  This patient who worked in a pharmacy, was vaccinated and wore a mask, and he got COVID on an unspecified date. It was mild. The outcome of the event "got COVID" was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
diagnosed with acute metabolic encephalopathy, myelitis with acute ascending lower extremity weakness, fever chills tremors headache, West Nile virus IgM positive, in serum and CSF, status post Plex treatment as CSF not indicative of GBS. Afib with RVR.
Per patient, he started to have headache, muscle ache and low grade fever on 12/25/2020, which he thought was a common reaction to the vaccine.  He then started to have runny nose, coughing and fatigue on 12/26/2020.
Reason for Appointment  1. INFECTION IN ARM AFTER VACCINE  History of Present Illness  General:  Pt initiated and verbally consents to phone visit, pt without capability of televisit in lieu of clinic visit to limit exposure/contact during COVID19 pandemic. The pt and myself are present for today's visit.  68 y/o male presents today with c/o arm infection after vaccination. Pt had his second Moderna COVID-19 vaccine on 03/11/2021. He noted a sore arm after vaccinatino, but had no serious reactions or side effets immediately following vaccination. 2 days after vaccination, he noticed a small streak of blood from his injection site on his pillow. He covered the area with a bandaid. When later removing the bandaid, he noticed the area was red and there was some clear fluid on the bandaid. He cleaned the area with some peroxide and used some antibiotic ointment on it. The next day he noticed that in addition to the area being red, there was now an area of white pus approximately the size of a dime at the injection site. Pt notes that he called the Health Department to report the issue, they told him to contact his PCP which is why this appointment was scheduled. Pt did request an in-person appointment, but was told that he would have to schedule a phone visit with me. Today, the pt reports that there is still an area of pus about the size of a dime at the injection site. The surrounding area of redness is reducing. He notes that the pain in his arm also seems improved today. Pt denies fever, chills, lightheadedness/dizziness, N/ V, palpitations.  Vital Signs  WI 188, Ht 5 ft 6 in, BMI 30.34 Index, Ht-cm 167.64 cm, Wt-kg 85.28 kg.  Examination  General Examination:  GENERAL APPEARANCE: alert, in no distress.  LUNGS: Speaks in full sentences, no respiratory distress, no audible stridor or wheezing.  NEUROLOGIC: alert and oriented.  PSYCH: alert, oriented x4, cognitive function intact, speech clear.  Assessments  1. Adverse effect of other vaccines and biological substances, initial encounter - (Primary)  2. Infection following immunization, initial encounter - Treatment  I. Adverse effect of other vaccines and biological substances, initial encounter  Notes: From pt's history, this sounds like a mild superficial skin infection. Pt may benefit form I&D. I attempted to schedule the pt with a provider in our office today, but there is no availablility. He has been advised to go tot an urgent care or to the ER for treatment. Pt is to f/u with me next week. I will be requesting that my staff file a VAERS for this patient.  2. Others  Notes: 30 minutes spent on this phone visit.  Follow Up  1 Week (Reason: Injection site infection)
Reporting that client received the Moderna COVID-19 vaccine series after a dose of J&J. This came to my attention from a data discrepancy that inquired confirm the Moderna doses. The client received J&J at another location on 4/7/21 (lot: 202A21A). The client attested on 5/11/21 that it would be their 1st COVID-19 vaccination and was therefore vaccination with Moderna on 5/12/21 (lot: 032B21A) and the Moderna 2nd dose on 6/9/21 (lot: 047A21A).
The pt complained of elevated temp, chills, pain at the deltoid radiating to the elbow of left arm and inability to move arm. Erythema from deltoid to mid upper extremity, hot, tight skin, finger edematous and painful to touch. Two small bumps on each side of injection site. No oozing or drainage. 80mm of erythema and swelling in length.
I was 34 weeks pregnant and I woke up in the middle of the night to what I thought was my water breaking, but was large amounts of blood. After going to the hospital they determined that my placenta had an abruption, and I was 1cm dilated. My abruption created a clot about 7cm. I was kept in the hospital for about a week. Things stabilized so I was sent home.   Around week 19 of my pregnancy- I had this same thing happen, a placenta abrupted that caused two clots about 5 cm. But after 8 weeks, I had passed both clots and was cleared from my doctor. During this time I was put on pelvic rest.  After my first COVID-19 vaccine (May2) - I noticed my bleeding had picked up some. Enough to need a liner, but not large amounts like week 19. After an ultrasound appointment- they didn?t see any new clots and just said I had a sensitive cervix. Again still on pelvic rest, taking it easy. It was unclear why the bleeding had started up, and the only new thing was the COVID-19 vaccine   I ended up delivering my baby at 35 weeks via a c-section. I don?t have any other history of bleeding issues or clots.
Patient developed pain in the left lower leg about 8 days post vaccine, progressively worsening over time, with associated swelling and spread of discomfort to the thigh. Presented to urgent care on 5/23/2021 and was felt to have findings suspicious for deep vein thrombosis. See item 19 for details on test results.
On December 16, 2022, I woke up with dyspepsia. By that afternoon, I had a barking cough. I ran a low-grade fever. I went into the walk-in clinic at the hospital. They tested me for RSV, COVID-19, and Influenza. The results were negative. They told me I had a cold. By Monday, my fever was about 101-degrees. I coughed and hurt for about a week. I went back to the walk-in clinic. They tested me for RSV, COVID-19, and Influenza again. The results showed I was positive for Influenza-A. Through all this, I had gastric upset, heaviness in my stomach, indigestion, and general GI distress. I also had a poor appetite. About 10 days later, I felt a bit better. I still had the gastric upset. On January 21, 2023, I flew to out of town. I still had gastric distress and poor appetite. I went on a cruise and finally felt a bit better. I ended up out of town and did not feel well the entire time. I had poor appetite and low energy. On the way home, I started feeling bad again. I had more stomach upset and vomiting. On February 14, 2023, I went back to the walk-in clinic. They diagnosed me with acid reflux. I was given Omeprazole. Two days later, I had diarrhea, leg pain, and headache. I went back to the walk-in clinic. I went off the Omeprazole. She thought I needed to stop eating gluten. I started talking probiotics and stopped eating gluten. Within two days, I was having 6-12 stools a day of diarrhea. Stool cultures were done. They results were negative. They also did an abdominal CT scan. They found two spots on my kidney. On March 13, 2023, I saw a urologist and was told we would just watch the spots. I have a follow-up for that in October. The next day, I had an appointment with the gastroenterologist who scheduled a colonoscopy and an endoscopy the next day. I was admitted overnight. I was still having diarrhea. The tests showed some inflammation in my duodenum and upper intestine and some flattened villi. The doctor said I probably have Celiac Disease. He did further bloodwork that was negative. Since that time, I've had diarrhea off and on, copious bloating and gas, and a very poor appetite. I've lost 25 pounds since this started. I was dairy free for three weeks. Nothing changed. I was eating gluten-free. Nothing changed. So, I'm eating both again. I have lots of weakness and tiredness. I have edema in my lower extremities.
A fully vaccinated individual has been diagnosed with COVID-19; A fully vaccinated individual has been diagnosed with COVID-19/mild cold; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (COMIRANTY; Formulation: Solution for injection; Lot number: was not reported, Expiration date: was not reported) as dose 1, single and then dose 2, single, both via an unspecified route of administration on an unspecified date for COVID-19 immunization. Medical history and concomitant medications were not reported. On 11Aug2021, a fully vaccinated individual has been diagnosed with COVID-19. They first experienced symptoms on 11Aug2021. It was reported that the person had mild symptoms for a couple of days (like a mild cold) and has now fully recovered while they wait for the quarantine period to complete. Manufacturer of vaccine was not disclosed. Lab test included covid test post vaccination resulted positive on 11Aug2021. The outcome of both events was recovered on an unspecified date in Aug2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Broke out around 18:00 with itching and rash. Dark red rash on body. Extremities and face looks like welts.
9/27 pt describes itching on arm that received hep B, left which began next day 9/28, then developed hives on legs 9/30/05. Dr advised pt to use Benadryl today 9/30/05. This was 3rd Hep b she received here. No other problems before.
Adult dose of Recombivax HB vaccine given too soon.  It was given at 4 weeks, rather than waiting the appropriate schedule of 4-6 months from the last Hepatitis B Recombivax HB adult dose.
no adverse event; when withdrawing the needle some came out and; when withdrawing the needle some came out and patient said it was a lot; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (when withdrawing the needle some came out and), ACCIDENTAL UNDERDOSE (when withdrawing the needle some came out and patient said it was a lot) and NO ADVERSE EVENT (no adverse event) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 21-Sep-2022, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (when withdrawing the needle some came out and) and ACCIDENTAL UNDERDOSE (when withdrawing the needle some came out and patient said it was a lot). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (when withdrawing the needle some came out and), ACCIDENTAL UNDERDOSE (when withdrawing the needle some came out and patient said it was a lot) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for WRONG TECHNIQUE IN DEVICE USAGE PROCESS (when withdrawing the needle some came out and) and ACCIDENTAL UNDERDOSE (when withdrawing the needle some came out and patient said it was a lot).    No concomitant medications were reported. Pharmacist seeking guidance because after administering the Moderna Bivalent vaccine, when withdrawing the needle some came out and patient said it was a lot, so there is no way of knowing how much the patient received.  No treatment medications were reported.
Documentation per Dr. is as follows:  "...mom and pt walked up to me to state she didn't feel well.  pt slumped backward and was caught by me and placed in a chair.  pt c/o tunnel vision and poor hearing.  pt did not eat breakfast , was nervous about shot, and c/o pain with injection.  she was nauseated and appeared pale.  her outer sweatshirt was removed and she was given cold water.  VSS.  no prior h/o vaccine reaction.  cold pack applied. pt's nausea persisted.  8 mg of zofran was administered after consulting with pt and mother.  symptoms resolved except she began to feel tired (expected with zofran).  monitored an additional 30 minutes without incident.  mom will take her home and monitor her today..."
SWELLING, KNOT, REDNESS, HOT TO TOUCH, PAIN IN SHOULDER JOINT, TENDER TO THE TOUCH - TREATED WITH ZYRTEC 10MG ORALLY
Patient's arm became developed mild pain, redness, and itching. Patient declined to be seen and opted for OTC medications (BNEADRYL and Hydrocortisone).
pt recv vax;approx 3 wk later, exp rash all over the neck & stomach;tx w/ dph & vit E;rash was mild & itchy;
Known Cerebral Palsy, 1 seizure periodically 12/08, sees Neurologist, EEG 12/08 abnormal, on KEPPRA, this episode = day after immunization mom called - found child slow to respond; incontinent, slow to talk. Neurologist notified increased KEPPRA 4.5 Bid. Sore, red arm, fever.
itchy; red; painful; The muscle is sore; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PAIN (painful) and MYALGIA (The muscle is sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hay fever and Shoulder fracture (Metal plate in her arm).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PAIN (painful) and MYALGIA (The muscle is sore). At the time of the report, PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PAIN (painful) and MYALGIA (The muscle is sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact