chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Beginning 6 hours after her second dose of Pfizer COVID-19 vaccine she had severe headache, body aches, myalgia, shaking.  Symptoms did not improve after the 48-hour mark and continued until the time of this report 8 days later.  She has a history of fibromyalgia which has been very well controlled and this feels to her like her fibromyalgia has been reactivated by the vaccine.  She also reports some swelling below the jaw on the left and physical exam confirms submandibular gland enlargement. . She had emergency room visit on 3/29/2021.
Nausea for a week since second dose, sometimes accompanied by vomiting and diarrhea. Prescribed Ondansetron for nausea.
Patient states 30 minutes after injection she started feeling very nauseous, shakey, and hot. One hour later she started vomiting with fever (fever not measured with thermometer) and feeling very tired. Symptoms lasted for the rest of the day (4-18-08). Patient woke next morning feeling better but her allergies were acting up.
950am student in nurses office or immunization clinic. Rec'd 5 vaccines - after several min of sitting looking @ stickers leaned to (L) an fell out of chair = 24 inches hit (L) knee an elbow, eyes open - no sign of injury - sat after an assisted back to chair, water offered, cool cloth applied to neck - no LOC denied pain anywhere assisted to nurses bed to rest - mom called 10:22 arrived informed what to watch for encouraged food/liquids. BP checked 86/62 HR 64. @ 1025 home with mom
At times of exercise, extreme shortness of breath and increased heart rate, beginning soon after the 2nd Dose and occurring for roughly 6 to 8 weeks.
FEVER AND ELEVATED BLOOD GLUCOSE READINGS. 488 THAT NIGHT, 308 THE NEXT MORNING AND IN THE 200'S TODAY. I TOLD HER TO CONTACT HER DR. I CALLED MD'S OFFICE AND THEY SAID THEY WOULD CALL BACK.
Patient complained of headache, diarrhea, a swollen gland and elevated blood pressure.
Noticeable Hair Loss after 1st dose resulting in member shaving his head. Significant Hair Loss following 2nd dose resulting in loss of most of Member's hair on face and body.
Initial information received on 25-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3 years old male patient who experienced gave PENTACEL today which expired, while he received vaccine PENTACEL. The patients past medical history, medical treatment, vaccination and family history were not provided. On 25-Jun-2018, the patient received a expire dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5401AA, Exp date 24 Jun 2018. It was a case of an actual medication error due to expired vaccine used. It was not known whether the patient experienced any adverse events or not. 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.
Patient developed a red and itchy rash on her left posterior arm, shoulder felt achy, and she may have had a low grade fever. The itchy rash resolved 1 week later, but shoulder pain worsened to the point that she had difficulty raising her arm over her head, fixing her hair, etc. I saw her yesterday in clinic and pain is improved, but she continues to feel pain with abduction and flexion of shoulder > 90 degrees.
This initial spontaneous report was received from the father of a 17 year old female patient. Pertinent medical history and drug reactions/allergies were unknown by the reporter. No information was provided regarding concomitant medications. On 21-FEB-2018, the patient received GARDASIL 9 for "routine vaccination" (dose and route unknown; lot # M035486; expiration date 05-JUN-2019). That same day, she also received BEXSERO (route and dose unknown; lot # 166801; expiration date unknown). On 24-FEB-2018 (reported as three days later), the patient felt sick, the left side of her body felt weak, and she had loss of motion and balance. On an unspecified date, the patient was taken back to see her physician, who sent the patient home, thinking she had low iron. The patient did not improve after three more days, so she was taken back to see the physician, who then sent the patient to the hospital. The patient underwent computed tomography (CT) scans, magnetic resonance imaging (MRI), a spinal tap twice, and was given high doses of steroids. The patient was hospitalized for six days (dates not specified). The father reported that the diagnosis was either multiple sclerosis or acute disseminated encephalomyelitis (ADEM). The patient was "100% recovered" at the time of the report. The father did not rate causality. He was requesting compensation for his daughter's hospital and neurologist's bill. Upon internal review, multiple sclerosis and acute disseminated encephalomyelitis were considered medically significant. Additional information has been requested.
Pt to ED 5/5 for syncopal episode via EMS. 5/6 new Hgb results reveal two point drop in levels,  hemoglobin is 6.5 at time. 5/7 pt denies any pain, is A&Ox4 remains on RA, COVID+. 5/10 no further signs of GI bleeding.  No complaints of nausea or vomiting.  Hemoglobin stable at 8.1. 5/11 pt C/O pain >10 in back and legs; Tylenol was given with little effect. Hgb dropped to 6.0, no signs of GI bleeding. 5/12 pt a&ox4, vss, room air, hgb up to 9.5, Protonix drip infusing. 5/13 pt A&Ox4 and showing no s/s of distress, complaining of leg pain, Norco ordered. 5/15 pt AOx4, vitals have been stable with no distress noted. 5/17 pt discharged.
patient developed pain from shoulder to elbow within 48 hours of injection. This has persisted and is continuing as of 11/20/2019
Did not feel good; Slept all day; Fever 101.4F to 101.6F; Joints ache; Tenderness at site of injection; Pain at site of injection; Legs ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Legs ache), MALAISE (Did not feel good), HYPERSOMNIA (Slept all day), PYREXIA (Fever 101.4F to 101.6F) and ARTHRALGIA (Joints ache) in a 75-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.     Concomitant products included METOPROLOL and HYDROCHLOROTHIAZIDE for an unknown indication.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Legs ache), PYREXIA (Fever 101.4F to 101.6F), ARTHRALGIA (Joints ache), VACCINATION SITE PAIN (Tenderness at site of injection) and VACCINATION SITE PAIN (Pain at site of injection). On 07-Mar-2021, the patient experienced MALAISE (Did not feel good) and HYPERSOMNIA (Slept all day). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site tenderness, Pain in extremity, Joint pain and Pyrexia, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Legs ache), MALAISE (Did not feel good), HYPERSOMNIA (Slept all day), PYREXIA (Fever 101.4F to 101.6F), ARTHRALGIA (Joints ache), VACCINATION SITE PAIN (Tenderness at site of injection) and VACCINATION SITE PAIN (Pain at site of injection) was resolving.            Concomitant medications also included eye vitamin.
She got her vaccine at a drive through area.  The next day she noticed that she had two boils on her face, one on her forehead near the hairline and one inside her nose.  A few days later she had a blood clot in her eye, blood over her left eye.  It went away and she did not go to a doctor as she felt there was nothing they could do.  Then she noticed that she had coughing, a lot of mucous and trouble breathing, and constantly clearly her throat.  A few months later she noticed that she has a racing heartbeat.  She didn't think about it until she went to the doctor and he informed her that she may have an enlarged heart.  They did an echocardiogram which showed that she had an enlarged valve.  They want her to do an MRI as she is allergic to the contrast material, and she wore the monitor.  That showed that it was not serious as sometimes it was short and sometimes it goes away.  It seems that is more at nighttime.  She notices that she is starting to have more racing heartbeat.  Her doctor gave her some medicine to take only when she really needed it and to do some exercises.  She has been having a lot of pain on her cheeks and her jaw, and she has not been paying much attention to other stuff.  Otherwise she is very healthy.  States that she got hacked, but was always on the go as a realtor.    She tries not to take the medicine if she does not need it, but she notices that her heart is running fast, speeding and then it goes away after about 15-20 times.  She feels her heart beating on her stomach and on her chest.  She also severe joint pain, and has had COVID twice with vomiting and dizziness.  She was traveling and had to check into a hotel for 3 days as she was too sick and dizzy to drive.    She also had a severe rash under her hairline, behind her neck, behind her ears, mini blisters in her head nonstop and could not sleep for a month as she itched nonstop.  She went to a dermatologist 3 times and her PCP 3 times to get medications.  It was then all over her body and back, and would go away and then come back.  She has a patch of blisters on her back, and sometimes on her elbows has a blister area.  Her skin gets real hot and when she lies down it is more irritated, and she continues to have that issue and is on 5-6 prescriptions to treat it.    She was getting better and then got the 2nd vaccine Moderna and still continues to have the rash.  She has brown spots all over her body, stomach, arms, legs, thighs.  All different sizes which happened about the same time as the rashes.
Fever, swelling of left arm from elbow to shoulder, redness, warmth. Pt also having chills, nausea & vomiting. Differential diagnosis included possible pneumonia. Pt discharged next day with Augmentin.
Day one: extreme malaise, fatigue and muscle soreness onset 4-5hrs from injection and lasted for 2 days. Day three: at midnight started itching and I had just dismissed it. Woke up at 6am itching in sleep on more place. Currently (0900 day 4) moderate hives presenting bilaterally on knees, elbows, sides, back, ear and eyes. Most of the hives present are fairly bilaterally. Applied benadryl tropical cream to spots and fighting the urge to itch.
Primary vaccination 02/14/2003.  Failed to show for "take/no take" assessment 7-10 days post.  Returned to medical attention 03/21/2003.  Initial c/s to derm incomplete.  Returned again to medical 04/01/2003.  Presumed to be mild exzema vaccination 2 hours to newly recognized eczema on right hand - Resolving- no treatment indicated at this time.
Information has been received from a physician concerning a 17 year old female with drug hypersensitivity and allergic reaction to AMOXICILLIN and  CODEINE who on 31-OCT-2008 was vaccinated with a first dose of GARDASIL vaccine. The patient received a second dose of GARDASIL vaccine (Lot #661046/0546X). There was no concomitant medication. 4 days after vaccination with the second dose of GARDASIL vaccine the patient developed persisting injection site pain lasting more than 5 days, the patient was vaccinated in the deltoid with a 1 inch needle. The patient was treated with hot compresses and anti inflammatory medication. After the first dose of GARDASIL vaccine she had pain, but it resolved in a few days. No laboratory studies performed. The patient sought medical attention through an office visit. At the time of this report the patient had not recovered. Follow up information received on 30-JAN-2009 stated that the patient had called back the physician with injection site pain 10 days after the GARDASIL vaccine was administered. No further information is available.
Headache cold/chills; Itchy (head, arms, legs); stomach ache; fatigue Narrative:
Pt pm complains of severe right arm pain and immobility with pain radiating to upper back on 11/5/04 one day after pneumococcal vaccination. The symptoms were constant and ended with shortness of breath. Triaged patient over the phone and advised to go ER .
Four years subsequent to receiving one dose of varicella virus vaccine live the pt developed chickenpox characterized by fever of 101 F with greater than 100 lesions. The pt was covered head to toe and also in his mucus membranes with chickenpox and some of the lesions had crusted.
redness in the arm; swelling in the arm; 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 ERYTHEMA (redness in the arm) and PERIPHERAL SWELLING (swelling in the arm) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness in the arm) and PERIPHERAL SWELLING (swelling in the arm). At the time of the report, ERYTHEMA (redness in the arm) and PERIPHERAL SWELLING (swelling in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (incorrect product storage) (lot numbers: L039660, Expiry date: 04-FEB-2018; lot numbers: M000442, Expiry date: 31-MAR-2018; lot numbers: M023718, Expiry date: 09-AUG-2018) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. On 07-OCT-2016, the vaccines were found to be subjected to a temperature excursion at 21.9C for 1 hour 56 minutes. It was reported that the call was due to a data logger. No Product Quality Complaint (PQC) was involved. This case is linked to case number 1610USA010371, 1610USA012625, 1610USA012627 and 1610USA012628 via same reporter link. Additional information has been requested.
patient was inadvertently administered an expired dose of Vaqta; This spontaneous report was received from a nurse concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 02-JUN-2020, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, inactivated (VAQTA), (dose, route and frequency not reported. Lot No. S021094 was reported and has been verified to be a valid lot number for Hepatitis A Vaccine, inactivated (VAQTA), expiration date reported and validated as 18-MAY-2020) for prophylaxis. No temperature excursion was reported. No additional adverse event information was provided.
A non-serious spontaneous report of generalized urticaria has been received from a physician concerning a four-year-old female, subsequent to FLUMIST use. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 15-Sep-2009. On 16-Sep-2009, about 24 hours after administration of FLUMIST the patient developed generalized urticaria. Outcome and causality were not reported. All follow-up attempts have been complete per company SOP.  No further information available. 10-Mar-2010.
Patient complained of dizziness after receiving her second dose of vaccine. According to patient, she had not had anything to eat prior to receiving the vaccine. Patient was received on the stretcher and made comfortable. A set of vital was collected on the patient and she was offered apple juice, water and gram crackers. Patient report relief from symptoms. she was discharged at 09:07AM
No more than an hour after receiving the first dose, I began to have chest pain, middle of the chest and maybe angled a bit to the right side.  More usual symptoms began to appear later that same day.. fatigue about 3 hours after shot, headaches about 5 hours after shot.  After the ?usual? symptoms subsided, the chest pain continued. May10, I went to immediate care, had a ekg which showed healthy results. May22, I was feeling much better, but had pressure applied to my chest by my partner? she inadvertently did this twice in a row. Over the next 1-2 hours, chest pain came rushing back and I began coughing a lot. Now May24, I am still having elevated chest pain and have been having a lot of heart palpitations over the past two days. I was scheduled to have the 2nd dose today, but am worried about what it will do to me.
Vomiting, body aches.  Vomiting from 3:00am until 7:00am.
I am post menopause.  I immediately started having symptoms of a period trying to start. Ovary throbbing, back ache, and sore nipples.. had these symptoms since the shot and yesterday I started a period for the first time in well over a year.
administration of Rotarix dose that was reconstituted with sterile water; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 7D7RY, expiry date 25-FEB-2024) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation (oral). On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced wrong solution used in drug reconstitution (Verbatim: administration of Rotarix dose that was reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution was 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: 15-AUG-2023 A nurse reported that administration of Rotarix dose that was reconstituted with sterile water instead of the accompanying diluent in the prefilled oral applicator, which led to wrong solution used in drug reconstitution. The reporter asked for guidance on this situation.  The reporter consented to follow up.
Patient wanted to report how she had a severe reaction to a pneumococcal vaccination. She ended getting a high fever, severe pain in the arm injected, with a severe inflamed rash that was all across half of her arm.
swollen lymph nodes under arm  patient is taking Aleve for symptoms, recommended HCF eval if sx persist
Fever to 104F, hyporesponsive; persisted and then fever decreased to 99/9F; resolved after 2-3 hours with acetaminophen.
Patient has history of a history of  idiopathic anaphylaxis and has allergies to many medications.   Patient had premedicated herself with Symbicort, Montelukast,  diphenhydramine 50 prior to coming in.  But 5 minutes after receiving the Covid vaccination she developed throat itching itching all over her skin/lungs, and chest tightness with intermittent coughing.  Code Blue was called, and patient was taken to the ER.  Patient received epinephrine, famotidine, benadryl and methylprednisone.  Patient was monitored in the ER and eventually discharged home.
Red mark at injection site /  2 inches long and 1 inch wide; Got chills; Body ache / Pain; Fever / had a temperature of 101.9 / 98.7 / 101.6 /  have not resolved; Extreme Fatigue /  have not resolved; Night sweats; 2 COVID tests in 2 different locations / waiting for the results; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number LN399, expiry date 9th October 2022) for prophylaxis.   The patient's past medical history included covid-19.   On 10th January 2021 16:30, the patient received the 1st dose of Shingrix. On 10th January 2021, 2 hrs after receiving Shingrix, the patient experienced chills. On 11th January 2021, the patient experienced injection site erythema. In January 2021, the patient experienced general body pain, fever, fatigue, night sweat and suspected covid-19. On an unknown date, the outcome of the injection site erythema, chills, general body pain, fever, fatigue, night sweat and suspected covid-19 were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, chills, general body pain, fever, fatigue, night sweat and suspected covid-19 to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. The patient had Covid 19 on 17th March 2020 until 20th 2020.  7 months after Covid, the patient still had antibodies for Coronavirus.  2 hours later after receiving Shingrix, the patient got chills. On the 2nd day, he had a red mark at the injection site that had a size of 2 inches long and 1 inch wide.  The patient also experienced body ache, pain, fever, fatigue, night sweats.  On the 4th day after the injection, at night, the patient's body temperature was 101.9-degree Celsius.  On 15th January 2021, the patient's body temperature was 98.7-degree Celsius in the morning and 101.6-degree Celsius in the evening.  The patient had extreme fatigue and fever symptoms that had not resolved. The reporter consented to follow up. The reporter provided consent to follow up but refused to provide healthcare professional information. The patient had done a 2 COVID tests in 2 different locations and was waiting for the results.
Initially, had an extremely inflamed area 10 cm in diameter; subsequently, devel an abscess 1 1/2cm in idameter in the lt buttocks @ site of inject; This has been aspirated on 2 occasions & may need excision;
Chills, body aches, nausea and headache since he got J&J vaccine on 12Apr2021. Denies fever, chest pain or difficult breathing.  Took some ibuprofen/tylenol @1700 yesterday with relief. CHIEF COMPLAINT & HPI: 23 yo M here with fever/chills/nausea/headache after getting his covid vaccine several days ago.  no rash/numbness/weakness/chest pain.  no abd pain.