chrisvoncsefalvay/vaers-outcomes huggingface dataset:
has not yet received the fourth dose; Dose 1: 11/3/2021, Dose 2: 3/11/2022, Dose 3: 4/19/2022; Dose 1: 11/3/2021, Dose 2: 3/11/2022, Dose 3: 4/19/2022; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (1st dose received on 3rd November 2021). Concurrent medical conditions included peritoneal dialysis.   On 19th April 2022, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 11th March 2022, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 11th March 2022, not applicable after receiving Engerix B and Engerix B Pre-Filled Syringe Device and unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. In April 2022, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long, drug dose administration interval too long and incomplete course of vaccination were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-Jun-2022 Reporter's Comments: Nurse reported that a patient who was on peritoneal dialysis had an interruption in their Engerix-B dosing schedule.  The patient has not yet received the fourth dose.  Health care professional (HCP) declined follow-up from Safety.  No additional information was provided. Additional Supportive Information: The patient received 1st dose on 3rd November 2021, 2nd dose on 11th March 2022 and 3rd dose on 19th April 2022, later than the recommended standard schedule for both 2nd and 3rd dose, which led to lengthening of the vaccination schedule. Till the time of reporting, the patient did not receive 4th dose of Engerix B, which led to incomplete course of vaccination.
generalized erythema a 4-6 hrs after vax;tx Epi & DPH
NUMBNESS TO RIGHT SIDE; SWELLING OF RIGHT INDEX FINGER; EXTREME PAIN; This spontaneous report received from a patient via a company representative concerned a 54 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of report.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced numbness to right side, swelling of right index finger, and extreme pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the numbness to right side, swelling of right index finger and extreme pain was not reported. This report was non-serious.
Stopped breathing while asleep - 2 sep. occasions. Numbness in hands/arms, feet/lets scalp - random other places. Blurred vision occas., extreme headaches, reduced thought processes, short term memory loss. Motor skills decreased.  3/7/08 Reviewed PCP medical records of 11/6/2007-1/14/2008 which reveal patient experienced numbness & tingling of arms & legs x 2 weeks prior to 11/6 visit with trouble sleeping.  Also had fatigue, joint stiffness, muscle pain & muscle weakness. Referred to neuro for NCS.   PCP FINAL DX: suspect Guillian Barre syndrome resulting from immunization but difficult to prove. NEURO FINAL DX: possible post immune encephalopathy w/underlying neuropathy in patient w/(+) West Nile titers all occuring approx 1 wk s/p hepatitis & sleep deprivation seconday to meds.  Seen by neuro 11/8/2007 & NCS revealed mod to severe bilat CTS, worse on right.  Returned to PCP on 11/14 anxious w/same complaints. Referred for labs & MRI, all WNL.  Referred to 2nd neuro & seen on 11/26.  EMG/NCS at that visit revealed evidence of an underlying ensory motor polyneuropathy, demyelinative greater than axonal in nature.  Referred for additional lab studies for West Nile & spinal MRI.  Returned to PCP 12/4/07 for labs & 12/10 for med changes & LP.  Returned to PCP 12/17 w/right side weakness, forgetful, impaired memory & concentration, back & muscle pain, numbness of hands, insomnia, anxiety/depression.  Referred to neuro for neuro-psych testing.  Seen by neuro 12/20 for underlying encephalopathy.  Neuropathy of feet improved but still having intermittent confusion.  Referred for neuro-psych testing & additional MRI scans.  Returned to PCP 1/14/2008 very frustrated as no improvement & unable to perform work duties.  Referred to Clinic.
Patient received 2nd dose and was waiting outside of the pharmacy for their 15 minutes. About 10 minutes after the vaccine was given, the patient fell over and seemed to be having a seizure (hands curled back/rigid body, eyes rolled back in head). Patient came to a few minutes later and was confused as to what had happened.
Chest pains 24 hours after vaccine was given. Chest pains and shortness of breath on exertion every day since second vaccine in August. Completed Cardiac work up and now in pulmonologist care.
Infection following vaccination. Arm developed increased redness, swelling and temperature. Treated with Bactrim.
became lethargic, hyporesponsive & poss difficulty breathing 24 hrs p/2nd sets of DTP/TOPV/HIB
Injection site is itchy; Red; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site is itchy) and VACCINATION SITE ERYTHEMA (Red) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Injection site is itchy) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, VACCINATION SITE PRURITUS (Injection site is itchy) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported . No treatment medication was reported .  AE submitted via Chatbot
Area of erythema 12cm x 10cm left bicep. Occurred after patient was grabbed by a class mate at area vaccinated.
Patient is bedbound at home after multiple strokes. He also has dysarthria at baselin. Was in usual state of health. Received vaccine at medical facility on 1/29/21. Caregiver reported that he subsequently had behavioral change the following day and stopped oral nutrition intake. He was subsequently admitted to Hospital on 2/6/2021 with encephalopathy and severe dehydration.
patient felt faint and nauseous.  Patient felt better after ice packs and lying down. Patient did not vomit or pass out.
26th  Tuesday- January 2021-Low back pain, spinning head 27th January 2021-Wednesday-Back continued to hurt 28th January 2021-Thurday-still having back pain 29th January 2021-back pain-can't get up-Through the 3 rd February 2021- Motrin does help-reminded to go to the ER if her symptoms get worse-she said she has a diabetic doctor's appointment on the 27th February-Need to call her PCM?   She called me today 4th February@1000 to give me the lot# -she feels better she says
Itchy red warm rash and swelling, noted just over a week after immunization at site of shot. Lasted 3 days. Improved with antihistamines.
Extreme swelling under the arm, with shooting pain across chest muscles starting about 11 hours  after dose administration and continuing through the next day. Advil 800mg every 4 hours only mildly relieves symptoms.
About a day after my fifth Covid shot, I developed diarrhea and stomach pain.  At first I thought it was related to something I ate, but it has persisted about six days and is constant.  I can eat but feel tired and have some mild to moderate stomach pain.  All bowel movements are diarrhea.  Injection site is raised and itchy like a mosquito bite.
Crying; parent unable to soothe child; t102.5 p/APAP w/in 1hr & 15min; 29MAY91 PC fr mom temp dec p/2nd dose of APAP;
Swollen hand and wrist in left side after second dose; Nose bleeds; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swollen hand and wrist in left side after second dose) and EPISTAXIS (Nose bleeds) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (Swollen hand and wrist in left side after second dose) and EPISTAXIS (Nose bleeds). At the time of the report, JOINT SWELLING (Swollen hand and wrist in left side after second dose) and EPISTAXIS (Nose bleeds) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-042884 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11-MAY-2021 , Patient detail received; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-042884:first dose
Patient received five doses of the Janssen vaccine instead of one dose. This was an administration error. Follow up was conducted with the patient and the patient had no sided effects or long term effects.
Had Janssen covid vaccine on 3/5/2021.  Recent exposure to a positive person, came to clinic for testing and was confirmed to be positive for COVID-19 by PCR test on 4/19/2021
2 days after feet and hands went numb, 4 days after I lost vision in my left eye I had extreme pain behind my eyes with pressure. Most of my body parts started to go numb and I had a squeezing pain around my rib cage. I also had vertigo. Had a hard time walking had pain in the back of my head.
diagnosed with COVID and symptomatic; diagnosed with COVID and symptomatic; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient diagnosed with COVID and symptomatic/got COVID-19 after first vaccination but before second one in recent weeks.  Event took place after use of product. The outcome of event was unknown.  Information about lot/batch number has been requested.
Immediately after getting the vaccine I began to feel very strange with symptoms of light-headedness, dizziness, and lethargy. Around 3-4 hours later is when the real symptoms began. First, an extremely rapid heartbeat. My left arm began to feel numb. And I was seized by an episode of extraordinary fatigue. 6 hours after the shot, I was having muscle and joint pain to the point that I felt like I was being stabbed with knives - particularly in my tailbone, ankles, and shoulders. High fever followed, uncontrollable chills and shivering, intestinal pain, diarrhea, and intestinal cramps. The following day I had a headache and continuing extreme fatigue as well as pain in both arms.
The day after my second covid vaccine, I experienced fever, aches, headache, and chills.  I expected that and understand it is a normal response.  The other thing that has happened is I stopped having my menstrual cycles.  I have not had a period in 3 months.  My hormone levels show menopause.  There was never any sign or symptom of menopause before receiving the vaccine.
Myalgia, Rash, UrticariaPruritus, Malaise Narrative: Injection site redness, itchy, warm to touch, sore
sharp pain in her neck and shoulder; sharp pain in her neck and shoulder; arm was hurting/arm pain; This is a spontaneous report from a contactable consumer (patient's mother) via medical team. A 14-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 14May2021 (at the age of 14-years-old) as first dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sharp pain in her neck and shoulder and her arm was hurting/ arm pain on 17May2021 night. The reporter was concerned because the pain appeared after a few days and not within 24-48 hours. She asked is this could be an indication that the vaccine was placed in the wrong place like not in the muscle. She asked if this is normal or when the patient should have this checked. The reporter stated that her and her husband did not experience any side effects. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Pt recvd vax & went to MD w/rash,black & blue knot,swelling & tenderness @inj site. Tx w/Atarax & sx resolved
Chills; Fever; Hot Flushes; Fatigue; This spontaneous case was reported by a non-health professional and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), HOT FLUSH (Hot Flushes) and FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    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 and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (Fever), HOT FLUSH (Hot Flushes) and FATIGUE (Fatigue). At the time of the report, CHILLS (Chills), PYREXIA (Fever), HOT FLUSH (Hot Flushes) and FATIGUE (Fatigue) outcome was unknown. Not Provided          No concomitant and treatment medication reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Mild Bell's Palsy affecting right side of face. Mild assymetry noted, mild decreased muscle strength and tone, and slight right eye irritation. Symptoms with minimal progression by day 2. Started course of Prednisone on day 3 (12/28/20.) Currently symptoms persist but early in treatment course.
Joint pain, hives, mild swelling of fingers, mild wheezing per patient. Treated with antihistamine and albuterol inhaler.
Symptoms started 1/6/21 at 10 PM. Chills, body aches, no fever. Symptoms mild on 1/7/21 10am. Took Tylenol Xtra Strength.
I received my vaccine, left the pharmacy and went to produce. I checked out, went to my car and I started having a headache, I felt clammy, and I felt like I was getting sick. The next day I had a sore throat and I tested for COVID-19 and it was negative. I started treating myself like I had tested positive for COVID-19 and stayed hydrated. I didn't realize how much time had passed since I had received my vaccine and how long I had been sick. I finally contacted an urgent care clinic that came to my house. I was given a prescription for an inhaler. As of today, I continue to have a cough with congestion, and I feel fatigue.
I was woken up at approximately 2AM January 28th due to the fact that I had sweat through my clothes sheets and was shaking. I had severe muscle weakness, a severe headache, and fatigue that has limited my ability to do daily functions. Since 2AM 1500mg of tylenol have been ingested, but my fever holds at 100-101 degrees. Time of writing this document is 11:20AM January 28th.
diagnosis of COVID-19 from 9JUL2022-27JUL2022; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (diagnosis of COVID-19 from 9JUL2022-27JUL2022) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 008B21A and 013A21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu vaccine (had a similar reaction to flu vaccines in the past.). Past adverse reactions to the above products included Itching with Flu vaccine. Concurrent medical conditions included Allergy (Xyzal and Singulair for allergies). Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and MONTELUKAST SODIUM (SINGULAIR) for Allergy.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (diagnosis of COVID-19 from 9JUL2022-27JUL2022). On 27-Jul-2022, COVID-19 (diagnosis of COVID-19 from 9JUL2022-27JUL2022) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2022-655847 (Patient Link).
Metallic Taste in Mouth, light headed at clinic. //BREAK// Severe joint pain in right hip, headache, body aches, chills, pain at injection site//BREAK// 48 hours later wrinkling of the skin on the inside wrist of the vaccine arm//two weeks later, heavy wrinkling on wrist of vaccine arm and continued illness
Patient came into the office to receive 1st COVID vaccine at 10:40, our office typically has never done pediatric patient COVID vaccines. I talked to my lead MA, she said we do them, I was still unsure. she then looked up dosage to make sure. She then still said yes to doing the vaccine. I administered Moderna with a red cape and a light blue border NDC: 80777-273-10 to patient. Patient did not have any reactions at the time. I then tried to input into vaccine system and was unable to, the system was saying that the vial is for 12+. I then started to report to my Supervisor, Health department, Moderna and VAERS.
10/12/21 pt had a positive COVID test; 11/3-12/7/21 pt had a hospitalization for melena; 12/18/21 pt to ED after being transferred from outside hospital (name unknown) due to hypotension, bilateral swelling and redness, concerning for possible cellulitis; INR from outside hospital was 6; started on Levophed; transferred to alternate hospital for further care; admitted to hospital; shock, hypotension, rule out sepsis, likely related to volume overload, pt has not missed HD; outside hospital called and stated blood cultures growing gram positive cocci; started on ABX; pt became progressively agitated and c/o diffuse all over pain; unable to localize; given low dose oxycodone with pain improvement; rapid progression of hypotension; treated with vasopressors; transitioned to comfort care; pt expired in the hospital
A volunteer at mass vaccination site inadvertently administered vaccine to a 16-year-old (ineligible to receive Moderna vaccine)
pt recvd flu vax & 5 mins later pt died; Wyeth is awaiting f/u info;
Hot, swollen, painful, and firm at injection site.  One week later, it's slightly firm, nearly back to normal.
chicken pox rash- arms, legs, scalp, chest and back. DX- 04/26/2005
blurred vision; fingers hurt; swelling; headache; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurred vision), PAIN IN EXTREMITY (fingers hurt), SWELLING (swelling), HEADACHE (headache) and ARTHRALGIA (joint pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (blurred vision), PAIN IN EXTREMITY (fingers hurt), SWELLING (swelling), HEADACHE (headache) and ARTHRALGIA (joint pain). At the time of the report, VISION BLURRED (blurred vision), PAIN IN EXTREMITY (fingers hurt), SWELLING (swelling), HEADACHE (headache) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Awoke the night with fever, chills, sweats, nauseated and achy.
Headache; nausea; diarrhea; weakness; fatigue; 99.5 temp; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL926), via unspecified route of administration in left arm on 18Feb2021at 08:30 as a single dose for COVID-19 immunization. The patient medical history included Hypertension, hyperlipidemia, acid reflux. The patient concomitant medication included fenofibrate, atorvastatin, atenolol, lisinopril. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient has allergic to cephalosporins. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Feb2021, the patient experienced headache, nausea, diarrhea, weakness, fatigue, 99.5 temp. The patient did not receive any treatment for the events. The outcome of the events Headache, nausea, diarrhea, weakness, fatigue, 99.5 temp was recovered.
Given 3 Doses of Heplisav-B; Initial Report Received on 21-Oct-2022, 27-Oct-2022, 03-Nov-2022,   This is a spontaneous report, received from a pharmacist regarding a 40-year-old female patient who received HEPLISAV-B for hepatitis B immunization.   There was no medical history reported.  Concomitant medications were not reported.  On an unknown date, dose 3 of HEPLISAV-B (Lot #938793, expiration date 07-Oct-2023, NDC # unknown), route not specified, was administered in the right deltoid for hepatitis B immunization.   The patient was given 3 doses of HEPLISAV-B. No adverse reactions were reported.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.