chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swollen lymph node in RT side of the neck; extreme discomfort; producing an earache; sore neck/shoulder x 3 days which began the day after the injection; sore neck/shoulder x 3 days which began the day after the injection; This is a spontaneous report from a contactable other hcp (patient). A 51-years-old (non-pregnant) female patient received BNT162B2 (BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EN6205, expiration date unspecified), dose 1 intramuscularly, administered in Arm Left on 04Mar2021 11:30 (at the age of 51-years-old) as SINGLE DOSE for covid-19 immunization at School or Student Health Clinic. The patient was not pregnant at the time of vaccination. Medical history included fibromyalgia, migraine, attention deficit hyperactivity disorder, drug hypersensitivity (sulfa allergy) with supplementation therapy from an unknown date. Concomitant medications included pregabalin (LYRICA), naproxen (NAPROXEN), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), cetirizine hydrochloride (CETRIZINE), vitamin b complex (VIT B COMPLEX), calcium (CALCIUM) tizanidine (TIZANIDINE); quetiapine fumarate (SEROQUEL) was taken for an unknown indication from an unknown start date at an unknown dose and magnesium (MAGNESIUM) taken for supplementation therapy, from unknown start date. The patient had not covid prior vaccination. The patient did not have any other vaccine in the past four weeks. On 05Mar2021 08:00AM, the patient experienced swollen lymph node in RT side of the neck, extreme discomfort, producing an earache and sore neck/shoulder for 3 days which began the day after the injection. The patient did not receive any treatment for events. The patient was not tested for covid post vaccination. The outcome of the events was reported as recovering at the time of report.   No follow-up attempts are possible. No further information is expected.
Initial report received from a nurse on 04 Mar 2011: This patient was vaccinated with only MenCWY liquid conjugate component of MENVEO (batch number not reported) intramuscularly without being reconstitutes with the MenA conjugate component on an unspecified date. No adverse events were noted following this administration error. The reporter stated that no addition details including batch number, date of vaccine administration and patient identifying information would be available.
Patient reports 8 inches of redness, swelling and itching. Patient states "I felt horrible for 2 days and could barely lift my arm,"
Initial information regarding an unsolicited valid non-serious case received from a nurse on 26-Sep-2018. This case involves a 45 years old female patient who was vaccinated with 0.25ml FLUZONE QUADRIVALENT (batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and family history were not reported. The patient did not receive any concomitant medications. It was an actual medication error due to vaccine underdose. It was reported that adult patient received a pediatric dose of FLUZONE QUADRIVALENT. The patient did not experience any adverse event. 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  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.
Clumps of vaginal  blood 3 days after vaccinations; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Right on 18Mar2021 as dose 1, single; dose 2 via an unspecified route of administration, administered in Arm Left on 15Apr2021 16:00 (Lot number: EW0161) as dose 2, single (both doses at the age of 31-year-old) for covid-19 immunization. Medical history was reported as none. Known allergies were reported as no. The patient concomitant medications were not reported. Patient did not receive other medications in two weeks. Patient did not have covid-19 prior vaccination and covid-19 was not tested post vaccination. On 04Apr2021 at 20:00, the patient experienced clumps of vaginal blood 3 days after vaccinations. Patient stated she had mirena iud and had not menstruated in 4 years. Patient did not receive any treatment for adverse event. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
3 doses of Kinrix, 6 doses of DTaP, 5 doses of IPV; Administered Infanrix instead of Kinrix; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a child male patient who received DTPa (Infanrix) (batch number NG5GF, expiry date 26th November 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included DTaP (received 2 doses of DTaP on an unknown date), Kinrix (received a dose of Kinrix on an unknown date) and IPV (received a dose of IPV on an unknown date).   On 20th May 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Kinrix, Kinrix Pre-Filled Syringe Device, the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 20th May 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and wrong vaccine administered 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: 12-Sept-2022 Reporter's comment: The nurse reported during quality check that they came across records that indicated a 6 year old child received extra dose of DTaP.   The patient is a 6 year old male who came in to clinic as a new patient and needed school immunizations, but the clinic did not had his prior vaccine record on file.  The doctor of medicine ordered DTaP, so the medical assist administered Infanrix, but the patient was supposed to have Kinrix.    The patient came back in later was given IVP separate.   During the call reporter stated that the patient has had 3 doses of Kinrix and ultimately had 6 doses of DTaP and 5 doses of IPV The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up. Additional supportive information: The patient had received 2 additional doses of Kinrix, which led to extra dose administered. The patient had received Infanrix instead of Kinrix, which led to wrong vaccine administered. This case was identified as duplicate of US2022131437. Case US2022131437 was deleted and all the future correspondence will be added in the present case US2022131418 which stands as a case of record for this subject.  As per reported information, it was not clear which schedule was followed for this patient and due to lack of information, the case was processed in worst approach and for the same further clarification was raised and also regarding facility type.
A serious spontaneous report of sixth nerve palsy has been received from a consumer concerning a four year-old male, subsequent to FLUMIST. The patient was reported to have no medical history and concomitant medications were not reported. The patient received FLUMIST in Sep-2010 intranasally. A week after administration of FLUMIST the parents of the child reported they noted some "eye problems" in their son with one eye crossed inward towards the nose. The child was seen by an ophthalmologist and diagnosed with sixth nerve palsy. There were no reports of head trauma; diabetes, viruses and a brain tumor were ruled out. It was reported that the child has since gained all movement back in his eye and the event resolved spontaneously. According to the parents, both they and the child's pediatrician feel the event was related to FLUMIST.
GI pain. Pt had appendicitis next day and appendix removed in hospital on 3/1. Pt was hospitalized the day after his vaccine for appendicitis. He had appendix removed.
Tinnitus; This is a spontaneous report from a contactable other healthcare professional (patient). A 30-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 29Jan2021 14:00 (Batch/Lot Number: EN5318), at the age of 30 years old, as dose 1, single for covid-19 immunisation.  Medical history included chronic migraine from an unknown date and unknown if ongoing. No known allergies. No COVID prior to vaccination and has not been tested for COVID post vaccination. Concomitant medications included cannabis (reported as medical marijuana) taken for an unspecified indication, start and stop date were not reported and sildenafil (VIAGRA) taken for an unspecified indication, start and stop date were not reported. On 16Feb2021 21:00, the patient experienced tinnitus. The event was further described as almost constant ringing in ears/white noise. Unknown if treatment was given. The event resulted in doctor or other healthcare professional office/clinic visit. The patient has not recovered from the event.  No follow-up attempts are needed. No further information is expected.
Per Agency, patient received two doses of Moderna COVID-19 vaccines on 5/27/2021 and 6/24/2021, respectively, and was subsequently admitted to our institution on 11/24/2021 and tested positive for COVID-19
at 15:30, mom called office: slight fever in morning, given 0.8ml Tylenol elixir at 7am. Now since 14:00 client crying, fever, shaking, increased respirations with retractions per questions. Answered by parent. Told mom to go to urgent care ASAP.
Injection site pain; Tiredness; Headache; Chills; Fever; Injection site swelling; Nausea; Feeling unwell; Swollen lymph nodes; Arm pain; Off label use; The patient received booster dose; This is a spontaneous report from a non-contactable consumer, the patient. A 74-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the arm right on 25Sep2021 at 17:30 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the arm left on 20Jan2021 at 19:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the arm right on 10Feb2021 at 19:45 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. On 26Sep2021 at 08:00, the patient experienced tiredness, headache, chills, fever, injection site swelling, nausea, feeling unwell, swollen lymph nodes, arm pain and injection site pain. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not tested for COVID-19. The clinical outcome of the event tiredness, headache, chills, fever, injection site swelling, nausea, feeling unwell, swollen lymph nodes, arm pain and injection site pain was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Pain at site of injection 12 minutes after vaccination,  No redness. Able to move arm without difficulty
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On an unknown date in 2011, the patient received the first dose in the series of three of GARDASIL (strength, dosing details, anatomical location, lot# and expiration date were unknown). On 06-JUL-2016, the patient was vaccinated with second dose in the series GARDASIL 9 (strength, dosing details, anatomical location, lot# and expiration date were unknown). No adverse effects were reported. The outcome of the events were unknown. No product quality complaint was involved. Additional information has been requested.
Chills, fever (99.7), some tenderness at injection site, throat feels little strange, ears ringing. Pt took BENADRYL and ibuprofen, then husband took her to urgent care clinic. They gave her shot (steroid I assume).
Patient's significant other called pharmacy to report that she had fluid on her elbow after having her 2nd VARIVAX vaccine. He reported that there was a swollen, tender, red area on her elbow and that she had a similar experience after her 1st dose of VARIVAX, but it resolved after a few days. She was unsure after the 1st dose if she had hit her elbow off something to cause the injury, so it was not reported. Now that the same symptoms are re-occurring after the 2nd dose, he wanted to report it to the pharmacy to see if it was normal. I informed him that it was not a listed side effect of the vaccine and sounded like elbow bursitis. He was able to confirm that she did receive the 2nd dose in the appropriate area, subQ on the side/back of the arm. Counseled pt to do RICE treatment and NSAID prn and it should resolve in a few days, call back if worsens or doesn't resolve.
Moderna COVID-19 Vaccine I had a headache, fever of 102, chilled, slept for 3 hours, woke up with fever still.  About an hour later the fever broke and I was fine.
Patient up to date on Moderna vaccinations who admitted to hospital with multiple complications including a detected COVID test who ultimately died.  Provider discharge note below:  "Reason for Admission: Communinty Acquired Pneumonia, COVID Positive, Complicated Urinary Tract Infection.    Hospital Course:  Patient received dual antibiotic therapy (ceftriaxone plus azithromycin) for Community Acquired Pneumonia and Complicated Urinary Tract Infection. It was later found that patient tested positive for COVID. Patient immunization status was asked, to which he reported he was vaccinated x2 and received a booster. Due to vaccination status, home Decadron PO daily was given, but Remdesivir was not given.   Despite said measures, patient continued to remain persistently hypertensive and intermittently tachypneic and tachycardic.  Nursing reported patient was refusing to eat starting day 3 of admission.  Patient also developed severe anemia with hemoglobin at 6.9 requiring 1 unit of red blood cell transfusion bringing level to 8.2 requiring no further unit administrations.  As time went on, patient continued to lose weight and eventually developed labored breathing at rest.  Code status was discussed with family, initially wanting to have patient remain on full code status.     The next morning, patient developed agonal breaths.  Family was soon consulted, who wished for patient to be resuscitated, but not intubated until they arrived at hospital. Dr. (Hematology/Oncology) who was managing patient's Multiple Myeloma outpatient spoke with family around noon.  At the end of the meeting, family wished to transition patient to comfort care. Later, in the afternoon, patient was refusing BiPAP and all medications.  Patient condition continued to decompensate until he developed asystole around 1517. Some time was given for family to be alone with patient. Exam was then performed declaring time of death 1531.    In retrospect, patient's disease process and condition decline leading to expiration began with becoming infected with possibly combined bacterial and COVID pneumonia with complicated urinary tract infection.  These infections were likely brought secondary to patient's immunocompromised state due to his ongoing multiple myeloma.  The combined pneumonia and urinary tract infection likely lead to sepsis which diverted blood away from vital organs leading to tissue hypoxia ultimately ending with cardiac arrest and patient death."
Rash on left side of back with bumps; Pain where the rash eventually appeared; Chills the day before the rash showed up; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 09Apr2021 at 14:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included heart condition- catecholaminergic polymorphic ventricular tachycardia (CPVT). The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included flecainide (MANUFACTURER UNKNOWN) and nadolol (MANUFACTURER UNKNOWN); both from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 12Mar2021 at 14:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021, the day before the rash showed up, the patient experienced chills. On 13Apr2021, the patient experienced rash on left side of back with bumps and pain where the rash eventually appeared. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, rash on left side of back with bumps and pain where the rash eventually appeared was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Lost his vaccine card would not give him a new one.  He got his vaccine, had burning sensation immediately after the needle was pulled out.  About 5-10 minutes later he started sweating, and seemed to have calmed down and felt OK.  He was observed for 30 minutes there and went for observation for another 30  minutes.  He went to another doctors office and at about 15:00 started feeling light headed and weak.  He drove back home, picked up some stuff at a grocery store, and outside the grocery store in 80 degree heat he felt the need to put on a jacket as he had the chills.  he went home, went to bed feeling bad, his shoulder was still burning where he got hte vaccin.e  He had a little bit of site pain, applied topical and the pain went away.  He woke up the next morning feeling really bad, felt like a major flu, his head felt like it was going to explode, but no problem with sinuses, no cough, no sneezing.  His eyes were watering from the pain, and chills on and off.  He had to change his sheets a couple of times due to sweating.  He then developed a fever of 99 degrees at about 18:00 that night, and about 19:00 he went to 102 when he checked it.  After that it went to 103, and about 15 minutes after that it was 104, and then higher at 104.+.  He took some vodka, honey and lemon juice and took an alcohol bath and the fever had not broken yet.  He called the clinic and they told him to call 9-1- 1 and to go to the ER.  He went to the ER at about 10:00, gave him fluids, did a chest x-ray and released him about midnight.  He apparently disoriented and tried to walk off and didn't remember this.  They took him back to the gate and called his son.  He went home, took another bath and woke up in sweat and was in bed for the entire weekend.  He got up Monday morning, 4/13/21 feeling a little bit better and went to see his doctor, who does not believe he was having any side effects and that the information that is being reported is true.   He is still feeling a little weak and still fatigued and on bedrest.  He was taking Advil besides his regular medicines every 6 hours with 500 mg of Tylenol for the intense pain as every joint in his body ached, and the worst headache he had ever had, as well as the high fevers.  His fever subsided on Saturday morning, and still had some sweats following that.  Did have hot/cold flashes on Saturday and Sunday.   He was given a COVID test in the ER and he was negative, but did not give him any other information regarding his lab work.
Patient passed away (Dead on Arrival on presentation to ER) on 02/03/2021
Swollen x 48 hours-entire leg 2x NL size fever up to 104.2 degrees x > 2 day after vaccine.
left butt cheeks; Left legs hurts; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL PAIN (left butt cheeks) and PAIN IN EXTREMITY (Left legs hurts) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced MUSCULOSKELETAL PAIN (left butt cheeks) and PAIN IN EXTREMITY (Left legs hurts). At the time of the report, MUSCULOSKELETAL PAIN (left butt cheeks) and PAIN IN EXTREMITY (Left legs hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Three days after shot #1, began to experience a constant ringing in the ears of medium discomfort (29-Mar-2021). As of the date of this report submission, it has not stopped. I am scheduled to see an ENT on Thursday, 1-Apr-2021.
Patient c/o of dizziness after receiving her booster shot. RN took vitals 98% spo2, HR 78, BP 136/80. Patient states that she went yesterday for Diabetic screening blood work due to a recent urine test that showed excess sugar. She has not other chronic conditions currently and is still waiting for the blood work results. She last ate half of a chorizo burrito around 10 am. @ 1425 RN gave her some water and patient reported that she was feeling better. RN provided education about Diabetic eating, maintaining blood sugars. Patient was feeling good when she left with her spouse at 1433.