chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired Tenivac was gievn to the patient, no AE; Initial information was received on 05-Jan-2021 regarding an unsolicited valid non-serious case received from an other health professional, nurse via Global Medical Information (GMI) (Reference number- 00416851) in the United States.  This case involves a female patient of an unknown age who received an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6101AA, expiration date- 23-Oct-2020, strength-standard) once via unknown route in unknown administration site for prophylactic vaccination on 29-Dec-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy or vaccination done.  It was a case of an actual medication error due to expired vaccine used (latency-same day).  At the time of report no adverse event was reported.  Reporter wanted to know if vaccine needed to be re-administered and if so how long they should wait to give it.  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 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.
After the 1st dose I had a low fever, body aches, fatigue, and chills which lasted for 24 hours. After the 2nd dose I had a low fever, fatigue, severe body aches - specifically in my joints, chills and nausea for the first 24 hours. Then I developed swollen lymph nodes under my left arm which I still have over 48 hours after the vaccination. I am also still fatigued over 48 hours after the vaccination.
Muscle aches and pain in arm going from shoulder to wrist. Extremely painful. Went to Doctor and sent to PT for therapy. Pain is still there for over a year now. I feel like it's getting worse not better, still have tremors in left hand.
Patient received 0.25ml of Moderna bivalent vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine).    No concomitant drug information was provided.  It was reported that 196 patients had received 0.25 ml of Bivalent Moderna vaccine.   It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received age group, narrative updated.
Placed in the fridge on 11-Jan-2022 and administered on 02-MAR-2022; Patient administered expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered expired moderna vaccine) and PRODUCT STORAGE ERROR (Placed in the fridge on 11-Jan-2022 and administered on 02-MAR-2022) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 008C21A and 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered expired moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Placed in the fridge on 11-Jan-2022 and administered on 02-MAR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered expired moderna vaccine) and PRODUCT STORAGE ERROR (Placed in the fridge on 11-Jan-2022 and administered on 02-MAR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  A pharmacist, the vaccine coordinator in their facility reported that they inadvertently administered expired dose of the Moderna Covid-19 vaccine.  Date the vial was initially stored in the refrigerator was on 11-Jan-2022, which means that all doses administered more than 30 days after 01-Jan-2022 were not in accordance   The vial did not undergo any temperature excursions.  They identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage.  No treatment drugs were reported
Description: Hx obtained Jun 07: 3 yr old female for evaluation of adverse vaccine reaction.  She received above mentioned vaccines July 2006.  Both legs became swollen, had fever to 101 for 4 days, warmness over vaccine sites.  She has sensitive skin and gets large local reactions to mosquito bites.  Both legs swollen about equally down to the knee, resolved over the course of 1 week.  Developed her first day and progressed for 2-3 days.  No specific treatment per dad.  Had small bump at site of each shot, without drainage.  No blisters or pustules.  No trouble breathing, vomiting, diarrhea.  With prior reactions had smaller areas of swelling.  Symptom: Fever.  Start: 07/11/2006.  End: 07/14/2006.  Symptom: Edema at injection site 50-120mm.  Start: 07/11/2006.  End: 07/18/2006.  Comment: bil thigh to knee.
patient is 17 years old and was given moderna vaccines which is approved for use by 18 years and older
In mid-December after my 3rd dose I discovered a lump in my left armpit. I waited a couple of weeks to see if it would go away and it didn't. I called my OB/GYN but not sure the date. The doctor did feel the lump so they sent me to do Ultrasound and Mammogram. I want to say it was around January 2, 2022. Results were enlarged lymph node but nothing malformed. I was advised if it got larger to come back for a follow-up. As of right now, it has gotten smaller.
Fever 103.5 x 3 days; inconsolable, stopped eating (but will breastfeed), stopped crawling, swelling/pain at injection site (PREVNAR site).
Pt was treated for Henoch Scholein Purpura 10 days after the vaccine was given lasting over 1 month.
03-13-2018: Left arm pain, swelling, hot injection site, muscle pain and limited mobility shoulder to elbow, left arm, 03-13-2018: MOTRIN, ice and heat 03-14-2018: Same as above and vomiting. 03-14-2018: Appointment with MD.
Soreness at injection site. Nausea. Stomachache. Headache. Ear pressure. Sudden nasal discharge. Prolonged weakness.
Redness and warm to touch on left upper arm approx. 6cm X 7cm area of redness and very tender. Will not allow compress to area.
Patient developed sweating, dizziness, cramps in hands, bradycardia (P=46x') and hypotension (68/33 mmHg).
Had strange itchy rash months before diagnosis, doctors recommended taking Claritan, did not diagnose.  Also had DM Type 1 symptoms months before diagnosis.
Tiredness; muscle and joint pain; muscle and joint pain; injection site pain; nausea; multiple swollen lymph nodes in the side of neck that are painful and the size of llama beans, nickels and dimes; multiple swollen lymph nodes in the side of neck that are painful and the size of llama beans, nickels and dimes; I fell like I have a bad flu; This is a spontaneous report from a contactable Nurse (patient). A 42-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: Ek5730, intramuscularly in left arm on 18Dec2020 10:30 AM at single dose for COVID-19 immunisation. Facility type vaccine was hospital. Medical history was none, no known allergies. The patient didn't have COVID prior vaccination. Concomitant medication in 2 weeks included ibuprofen, phentermine, paracetamol (TYLENOL), valacyclovir. The patient didn't have other vaccine in four weeks. The patient experienced tiredness, muscle and joint pain, injection site pain, nausea, multiple swollen lymph nodes in the side of neck that were painful and the size of llama beans, nickels and dimes. She felt like she had a bad flu. Adverse events start date was 02Jan2021 08:30 AM. It was unknown if treatment was received for the events. COVID was not tested post vaccination. Outcome of the events was recovering. The patient received the second dose of BNT162B2, lot number: Ek9231, intramuscularly in left arm on 08Jan2021, 06:15 PM.
When I got the vaccine, on 11/19/2022, i got a sore arm on the injection site, next day I had typical flu symptoms that disappeared on the next couple of days. I went on a trip on 12/9/2022, and I got a sore throat and muscle aches on 12/19/2022, I flew back home on 12/20/2022, I was talking over the counter cold medicine for the sore throat and it was feeling better but I sensed a low grade fever. On 12/20/2022, as soon as I arrived home, i took a home test for Covid and it was positive. 12/21/2022 I had a runny nose, a low grade fever, and itching of the throat and nose which caused me to sneeze or cough at random. I started taking Dayquil and Advil Severe.  12/22/2022, fever was gone. 12/23/2022 til today has been better  every day. My oxygen level saturation for some reason is lower today, but overall I feel better. Asyntomatic right now.
Left arm swelling, pain, redness following receipt of pneumococcal polysaccharide vaccine. Patient was hospitalized and treated for cellulitis. Patient was treated with antibiotics. According patient she received shot in the sae arm as a flu shot that she received a day earlier. Discharge Summary received on 12/22/2004 states pt experienced hypopotassemia, serum reaction, and agranulocytosis.
arm was swollen and very red; arm was swollen and very red; Left arm sore; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER6955) via an unspecified route of administration in the left arm on 11Mar2021 at 09:30 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient received medication(unspecified) within two weeks of vaccination. The patient had no known allergies. 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 02Apr2021(friday) at 08:00,the patient experienced left arm sore, the arm was swollen and was very red, it was about the size of 1/2 dollar.  On saturday, the same symptoms were present but it was the size of tennis ball and on Sunday same but size was very large about 5 inches long and wrapped about 1/2 of the arm. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events left arm sore, swollen and very red arm were resolved with sequelae on an unknown date in Apr2021. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER2613) via an unspecified route of administration in the left arm on 08Apr2021 at 09:30 as a single dose for COVID-19 immunisation.   No follow-up attempts are needed. No further information is expected.
Swelling in armpit after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling in armpit after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swelling in armpit after first dose). At the time of the report, VACCINATION SITE SWELLING (Swelling in armpit after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by reporter.  Treatment medication was not reported.
I awoke with sever head and body aches all over.  Nest day 9/25/2015 had a increase heartbeat and slightly higher than normal blood pressure.  Also had hot flashes followed by cold chills.  Still feeling lethargic.
Urticarial rash, fever 102, vomiting, developed about 4-5 hours after vaccines, Treated with Benadryl Q 4 hours.
This is a spontaneous report from a contactable physician, reporting for himself. This report was received via a sales representative.  An approximately 65-year-old male patient received PREVNAR 13 on an unspecified date at 0.5ml single dose intramuscularly in arm for preventive care.  The patient medical history was not reported.  Concomitant vaccine included influenza vaccine administered at the same time in the same arm.  The patient received the vaccines in a pharmacy. The patient developed Pneumococcal Pneumonia and was hospitalized on an unspecified date with outcome of unknown. The patient also experienced prolonged arm pain for 4 months, with outcome not recovered. Sender's Comments: Based on the information provided in the case, a lack of efficacy with PREVENAR 13 in this patient cannot be excluded. Further information like serotyping results is needed for a full medical assessment.
This spontaneous report was received from a license practical nurse referring to a 27 month old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. In approximately March 2018, (also reported as "2 months ago") the patient was inadvertently vaccinated with PROQUAD lot number N019250 and expiration date of 20-DEC-2018 and a dose of VARIVAX lot number M049126 and expiration date of 15-DEC-2018 both for prophylaxis (dose, route of administration, lot number and expiration date were not reported).
my left arm hurt; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (my left arm hurt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (my left arm hurt). At the time of the report, PAIN IN EXTREMITY (my left arm hurt) outcome was unknown.        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.
Three weeks after the first Vaccine, I developed numbness in both feet between the big toe and the next one.  This numbness/Cold feeling/Tingling slowly started spreading up my legs and seemed to settle the thigh area for a short time which even caused my clothes that touched it to generate a strange sensation (Almost like a hyper sensitivity) and it was a constant feeling.  Then the feeling/numbness started affecting my calves and shin areas to a greater degree where they both feel like I have some fatigue and after walking or using them for a short time I feel like I have been running a marathon.  At this point the skin around my ankle would come and go with becoming numb to the touch.  As the numbness continued to spread further up to my waist area It eventually started to affect my abs, back and around the right and left outside edges of my chest.  They have strange sensations and occasionally I can feel them as numb or some sort of sensory deprivation with the exception of my chest area which was sensitive to the touch (Pain).  Continuing further I now have the same tingling/cold issues with both of my arms and there have been instances where both of my shoulders feel weak along with the numb behavior.  This has all been going on over the past 6 months and is still continuing.  I have been to multiple Urgent Care facilities, Doctor Visits, Whole barrage of tests: MRI's, Cat Scans, EMG's, Blood Work, Spinal Tap, etc.  And so far all tests have come back normal.  Jan 14 -- Trip to Urgent Care for numbness -- They said that I got too cold / did an X-Ray of my back.. Everything looked fine they said.  Jan 25th -- Trip back to Urgent Care, numbness getting worse.   Around Jan 28th -- MRI of lower Lumbar area.  Nothing found  Feb 17 -- Initial Consult Dr. Neurologist -- Orders Complete Bloodwork and does basic nerve tests   Feb 12th -- Bloodwork done Health  -- All normal  Feb 22 -- Office Visit Dr. Neurologist -- Electromyogram of both legs.  All normal  Feb 24 -- MRI Lumbar Spine -- nothing that could cause the issues noted.  March 10 -- Office Visit  March 22 -- MRI Brain with and without contrast -- nothing that could cause the issues noted.  April 16 -- Office Visit  May 3 -- MRI - Neck area --nothing that could cause the issues noted.  May 17 -- Office Visit -- Electromyogram (EMG) of arms and hands -- all Normal.  May 21 -- ER visit -- Bowel issues, tiredness, fatigue ?  Cat Scan performed.. All tests normal and released  May 26 -- Gastro visit to make sure the numbness had not affected bowel control  May 28 -- Dr. -- Changed Neurologists --- Scheduled Spinal Tap  (Suspected MS even though nothing was showing up in all tests)  June 3 -- Spinal Tap -- Everything normal not showing any signs of MS or any other disease.  June 10 -- Spinal Headaches (received Blood Patch)  June 18 -- Office Visit -- Doctor suggested could be Covid Vaccine related but sending to Medical Center and giving medicine in case it is Lyme disease
Within hours post vax, the employee developed a large injection site reaction characterized by redness and swelling. The reporter indicated that 13 employees were vaccinated; 8 experienced this event.
It was reported that a female pt received a Rabies Imovax vaccination on 8/28/00. Reportedly, on 8/29/00, the pt complained of lymphadenopathy, a temperature of 102-103F, muscle aches and malaise. On 9/2/00, the pt developed facial swelling. Further information requested. From additional information received on 12/12/00, additional pt, responsible physician and lab data were received.
Hives occurred 11 days after booster. Now at 3 months. First started with itchy scalp and then dermatographia towards the end.
Muscle aches started about 12 hours after the injection.  First my legs and back but after another 12 hours it was mostly my legs.  Legs felt like the muscles were being pulled.  (It felt like the beginnings of the extreme reaction I had to ampicillin 2 decades earlier, though not nearly as severe.)  My arm swelled slightly, was warm at the injection site and ached about 12 hrs after the injection.  The leg aches lasted about 2 days, the arm ache lasted about 1 day and the slight arm swelling lasted about 6 days... Reason for my reporting:  I had an annual eye exam 4/14/21 where a retinal scan was done.  The optometrist saw some blood spots in my left eye and referred me to an ophthalmologist.  Ophthalmologist performed additional scans and tests including a Fluroescein angiography and determined I have BRVO (Branch Retinal Vein Occlusion) which is a series of blot clots in small vessels of the eye's main vein.  He did not say it could be a result of the vaccine but I have no risk factors associated with getting BRVO.  Since it is not affecting my vision yet, the doctor wants to monitor it in 3 months to make sure it has not worsened.  Since the Janssen vaccine was put on hold for causing other types of blot clots in women in my age group, I am wondering if the vaccine caused the blood clots in my eye.
pt recv vax;exp frontal HA during which had difficulty focusing eyes,cold & hot flashes; fever 99.1;aching joints in ankles & wrists;nausea & dizziness; mood swings, inc dysmenorrhea;
h/a, stuffy nose, w/o fever x 3 day post flu shot;
Received smallpox vaccine on 2/28/06, after receiving a briefing on the care of the vaccination site. Came into clinic on 3/6/06 for smallpox check.  Vaccine had taken (major reaction).  The patient returned to the clinic on 3/10/06 wondering if the vaccine site looked okay.  The vaccine site was normal, but at that time he stated that he had another bump on his chest.  Upon exam, it appeared that he may have had another smallpox site starting.  At that time, he stated that he had not been washing his hands after changing his bandages, and had been scratching at his chest, etc.  The patient was instructed at that point to continue taking care of the original site, and to treat the new bump as if he received smallpox there as well.  The patient was then taught again how to treat inoculation sites and given another pamphlet telling him what to do, and to follow up with the clinic after the weekend.  The patient returned on 3/14/06, the new site had begun to blister, at this time, the form was started, and patient was instructed to follow the proper course for the care of smallpox inoculation sites.
Diffuse vesicular rash, malaise, stomatitis and fever consistent with varicella.
Cause continuous pain in the top part of arm where shot was given, had an MRI done showing a tear in rotor cup
Heart arrhythmia, aches, joint pain, tooth pain, heart cramping, arm numbness, tingling
Pfizer-BioNTech COVID-19 Vaccine EUA arm pain beginning on 12/16 at injection site elevated temperature beginning 12/16 Fever (101.9) afternoon of 12/17 nausea afternoon of 12/17 Headache 12/17 muscle aches 12/17 chills 12/17 reduced appetite 12/17
Tenderness and induration-mother took baby to the doctor on 10/7/02, mother received instructions to apply hot and cold compresses to child's thigh.
high pitched cry-did not last for hr;no fever;had 2 days  p/vax;