chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash at injection site; Rash at injection site, which itched and spread; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EN6200) via an unspecified route of administration in the left arm on 23Mar2021 at 13:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had a history of allergy to sulfa drugs. Concomitant medications included escitalopram oxalate (LEXAPRO), nortriptyline hydrochloride (PAMELOR), metformin hydrochloride (GLUCOPHAGE), atenolol (TENORMIN) and others, all from an unknown date for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200), via an unspecified route of administration in the right arm on 02Mar2021 at 13:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021, 5 days after second shot of Pfizer, the patient experienced rash at injection site, which itched and spread, was continuing as 5 days at the time of reporting. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcomes of the vaccination site rash and itchy were recovering.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a registered nurse refers to multiple, different unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medication were not reported. On an unknown dates, the patients were vaccinated with improperly stored (-14 degrees Celsius (C), for 2 hours and 48 minutes) VARIVAX (Merck) injection, lot # L029466, expiry date 06-AUG-2017, (dose and frequency not reported). Vaccine had previous temperature excursion (-14 C) for 32.5 hours, because of data logger. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.
3 days after administration of vaccine. Pt had tight sided upper back pain which then radiated to her shoulder, neck + head. Also developed erythema at site. Treated with antibiotic and Ibuprofen. On 6/29/09, back pain still present, other sx's better.
61 years old was administered FLUZONE HIGH-DOSE QUADRIVALENT , no AE; 61 years old was administered FLUZONE HIGH-DOSE QUADRIVALENT , no AE; Initial information received on 10-Sep-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 61 years old patient (gender unknown) who was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE  (lot number and expiration date not reported) (PTs: Product administered to patient of inappropriate age and overdose) via unknown route in unknown administration site as prophylactic vaccination on an unspecified date.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to Inappropriate age at vaccine administration (same day latency).  It was also a case of overdose (same day latency) .  No adverse event reported at the time of reporting.  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.  There will be no information on the batch number for this case.
Patient was admitted 5/24/21 ~2-3 weeks after his 2nd dose of pfizer vaccine. Stated that he had had shortness of breath and chest pain that started a few days after vaccine that never really got better. He was found to have pericardial effusion and pleural effusion of unclear etiology. Did not have evidence of myocarditis on  EKG or imaging, but findings suspicious for pericarditis.
Much Swelling at base of skull on right side. Very painful to touch the swelling and to move Extreme fatigue.  Dizziness- on going without relief.  Headache/migraine.  Stiff neck.  Extreme tenderness at site of injection and whole soldier, and feels very hot to the touch. Lowered heart rate after injection and dropped blood pressure.  Lightheaded every time I move my head.  Some nausea.   Runny nose same night as injection and in the morning.  Overall pain and achy. Can?t really walk around due to pain in body, head, and the dizziness.
Information has been received from a certified medical assistant concerning a 20 year old female patient with reactive airways disease and no known drug/allergies who on 10-AUG-2009 and 09-OCT-2009 was vaccinated IM with the first and second doses of GARDASIL (lot # 0670Y). Concomitant therapy included oral hormonal contraceptives (unspecified) and unspecified inhaler. On 09-OCT-2009, the patient fainted in the physician's office after receiving her second dose of vaccine. There were no laboratory diagnostic studies performed. At the time of the report, the patient was recovering. Follow-up information has been received from a health professional concerning a 20 year old female patient with a history of fainting who on 09-OCT-2009 was vaccinated with the second doses of GARDASIL (lot# 0670Y) in the right gluteus. After the vaccination, the patient said she felt like she was going to pass out. The reporter said that as she looked up, she saw the patient go down. They all got the patient up in a wheelchair and called her mother. When waiting for the mother, they gave the patient a bagel and some orange juice. The patient said she hadn't had anything to eat yet. When her mother got there, they were advised to go to the emergency room (ER) for follow up. Medical attention was not sought. Additional information has been requested.
Lhermitte's Reaction when bending neck; Nervousness feeling entire body like a caffeine feeling; pins and needles; This spontaneous case was reported by a consumer and describes the occurrence of LHERMITTE'S SIGN (Lhermitte's Reaction when bending neck), NERVOUSNESS (Nervousness feeling entire body like a caffeine feeling) and PARAESTHESIA (pins and needles) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Q11Q21A and Q35L21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Anxiety. Concomitant products included HYDROXYZINE HYDROCHLORIDE (HYDROXIZINE) for Anxiety, VITAMIN B COMPLEX for an unknown indication.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced PARAESTHESIA (pins and needles). On 18-Jul-2021, the patient experienced LHERMITTE'S SIGN (Lhermitte's Reaction when bending neck) and NERVOUSNESS (Nervousness feeling entire body like a caffeine feeling). At the time of the report, LHERMITTE'S SIGN (Lhermitte's Reaction when bending neck) and NERVOUSNESS (Nervousness feeling entire body like a caffeine feeling) had not resolved and PARAESTHESIA (pins and needles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jul-2021, SARS-CoV-2 test: positive (Positive) Infinity biologix TAQPATH SARS-CoV-2 Assay RT-PCR based. On an unknown date, Magnetic resonance imaging: normal (normal) normal. On an unknown date, Magnetic resonance imaging head: normal (normal) normal. On an unknown date, Magnetic resonance imaging neck: normal (normal) normal.         Patient took MRI thorax which showed spinal fluid was normal. Patient stated that knees, limbs felt weak and during shower while bending the neck resulted in vibration that passes down to hands. Treatment medication was not reported.   This case was linked to MOD-2021-313186 (E2B Linked Report). This case was linked to MOD-2021-313186 (Patient Link).; Sender's Comments:  MOD-2021-313186:
Had soreness that lasted 8 days and redness that at injection point and surrounding area is still red.
Pt received flu shot and left clinic. He returned approximately 25 mins later to report hives on neck and headache but breathing ok. Pharmacist had stepped out for a few minutes. Pt just wanted to report incident and left. We contacted him 10-15 mins later and pt reported symptoms had improved and we recommended BENADRYL . Pt said he had some and would take at home.
Swelling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US022271_OS.  A 64 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "Swelling".  Additional Information: Patient reports that she had swelling about 2 weeks after having her second covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2014, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. Later in 2014, the patient sought subsequent treatment from the same physician for another episode of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.    Additional information has been requested.
Patient stated she was having an incredible pain she had never felt before. Someone came in from the parking lot and told a store manager. The store manager called an ambulance then came over to the pharmacy to let me know what was going on. Patient was in her car in the parking lot. I was giving other vaccinations so I sent my technician out with an Epipen. When we got out there, the ambulance was already there. I went out when she got back and spoke to the patient and the ambulance drivers. She was not having any problems at that point. They checked her over and I called later that night to check on her and she was doing great.
patient returned to pharmacy tonight at 9:30 pm complaining of swollen , red and painful right upper arm.   no rash or fever present.  recommended 50 mg benadryl and 500 mg acetaminophen with  cold compress
Pt had a clotting stroke in left frontal lobe of brain on 5/23/2022, he woke up in the am unable to speak, we went to the hospital and CT scan of brain and MRI of the brain confirmed a clot in left frontal lobe of brain.  He was placed on statin drug, high dose aspirin, and blood pressure medication, 6 weeks later pt. had a second clotting stroke in the cerebellum of the brain.  He was then started on Eliquis along with other medications mentioned above with the addition of Plavix after 6 weeks.  He was seen by multiple doctors who could not determine the cause of pt.'s strokes.  During this process he was also found to have irregularities with his heart which is ongoing and continues to see a cardiologist with decrease in heart function with unknown cause.
My daughter had excessive diarrhea, she was very lethargic, feverish, had a cough,  and she threw up.  We tested on Sunday for COVID-19 and she was negative but we tested her again on 10/05/2022 and it came back positive. We called a nurse and she encouraged Pedialyte and fluids, but no prescriptions. She would not really eat or drink, it took a while to get her rehydrated. She is doing better and we are testing  again tomorrow.
Two Doctors, at different locations, and Assistant, diagnosed Lichen Sclerosus  ET Atrophicus. At last appointment, Doctor 2 gave a verbal diagnosis of scleroderma as well. Photo images of scaring (scars) on lower trunk and at vaccination site are available through Assistant who took images when performing biopsies. Pneumonia vaccine in 2008 is only other vaccine I have been given since then! No one in my extended family ever had these diseases.
Patient reported watery eye tearing, nauseated and numbness of lips at 4:40 pm.  patient viltals signs were taken within normal limits, ice pack, legs elevated and encouraged to drink water. Patient continuesly feeling nauseated. EMS activated by staff. Patient denies chest pain, shortness of breath as evidence by normal vital signs. Patient was able to answered questions when asked, ANOX3.  Patient denies difficulty swallowing nor swelling of throat or lips. EMS arrived, patient verbalized feeling better and wanting to go home. Patient refused to go with EMS. Patient was educated and reinforced the importance for further monitoring but patient strongly refused. Patient left building in stable condition and denies early symptoms.
Tenderness on the left arm where she got the injection; A spontaneous report was received from a consumer concerning a 78-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tenderness on the left arm where she got the injection.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an  unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number : Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 08-Jan-2021, the patient called to report that about a week ago she received the vaccine and experienced tenderness on the left arm where she got the injection. She stated her arm is better now. Treatment for the event included exercise and a hot compress.   Action taken with mRNA-1273 in response to the events was not reported.   The event, tenderness on the left arm where she got the injection, was reported as resolved on 08-Jan-2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
57 year-old male retiree with 5-year history of HTN, history of OSA, allergic rhinitis, and 1st degree heart block noted in 2010 who was in his usual state of health on 5 FEB 2014 when he received Tdap and Influenza vaccines on 5 FEB following a routine physical. When patient returned for a blood pressure check on 7 FEB, an irregular heart rate was noted. At the time, patient was asymptomatic and an ECG completed did not show significant changes from a 2010 ECG. Patient was referred for a 24-hour Holter which was completed on 19 FEB. During the course of the Holter, cessation of ventricular activity up to 6 seconds was noted and tracings were consistent with high degree AV block/Type 2 Mobitz. During these episodes of ventricular cessation, patient continued to be asymptomatic. After interpretation of Holter monitor recordings, patient was contacted and admitted to hospital. He was placed on telemetry where several non-conducted p-waves with ventricular pauses were observed, but patient remained asymptomatic. During his 6-day hospitalization, patient had normal echocardiogram and CT, Cardiac Angiography (except for dilation of the ascending aorta and minimal bilateral hilar and mediastinal lymphadenopathy), but had positive cardiac enzymes and cardiac MRI (see results below). During hospitalization, Infectious Disease was consulted for recommendations for viral myocarditis and recommended numerous viral serologies (see results below). Patient reported vague history of URI symptoms during the previous month). On 24 FEB, a pacemaker was implanted. When patient was discharged on 25 FEB, his discharge diagnosis included Arrhythmia likely related to myocarditis of unknown etiology. Patient has a history of vertigo during the past 3 years thought to be consistent with BPV. He denies history of syncope or loss of consciousness. He reports a history of lightheadedness and fogginess with standing up too quickly or after eating.
COVID arm - swelling / itching at injection site exactly one week after injection. This lasted exactly one week - from 3/19 to 3/26.  Migraine /nausea (3/23 &3/24)
she suffers from terrible anxiety/she has a terrible anxiety; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Terrible anxiety" (unspecified if ongoing), notes: Past Medical History: Terrible anxiety. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (First Booster; Unknown manufacturer), for Covid-19 Immunization. The following information was reported: ANXIETY (non-serious), outcome "unknown", described as "she suffers from terrible anxiety/she has a terrible anxiety".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
admitted to Medical Center, 4.19.2023 as a transfer from another Med Center expired 4.29.2023 no time of death noted at present positive 4.17.2023 from the Med Center, tested 4.20-positive
Mild numbness of upper and lower lips and the tip of my tongue starting about 30 minutes after and lasting only about 2hrs after the first vaccine, self resolved.  Left sided auricular, axillary, and cervical lymphadenopathy noticed about 1 week after the first vaccine.  Still present
Patient came back to the pharmacy on 11/30/14. Her upper post-lateral arm had a 2 inch raised, red welt, and surrounding redness that stretched 2 to 3 inches in all directions. Patient said it was hot and sore to the touch. The surrounding redness continued to spread so she went to her physician on 12/1/14 and received a Medrol dosepak and doxycycline.  The patient was contacted on 12/3/14 by the administering pharmacist. The patient said she was doing much better with most of the redness completely gone. She still had the middle red, raised welt, however.  She was in good spirits and felt fine otherwise.
A week after the vaccination I woke up at dawn with intense pain in the chest on the left side, I felt great pressure and pain, after that the pain persisted for approximately 2 days; A week after the vaccination I woke up at dawn with intense pain in the chest on the left side, I felt great pressure and pain, after that the pain persisted for approximately 2 days; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (Patient). A 22-year-old female patient (who was not pregnant at the time of vaccination), received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0185 and expiry dates were not provided), via an unspecified route of administration, administered in right arm on 12May2021, as a 2nd dose, single dose for COVID-19 immunisation. Medical history included COVID-19 prior vaccination from an unknown date and unknown if ongoing. The patient's concomitant medications in two weeks of COVID vaccination included contraceptives on 07Jun2021. Historical vaccine given to patient previously was dose 1 received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in right arm on 21Apr2021 at 12:00 as a single dose for COVID-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. It was reported that, one week after the vaccination at 03:00 on 17May2021 she woke up at dawn with an intense pain in her chest great pressure and pain, after that the pain persisted for about 2 days, but it was not diminished and went away, after that she kept getting sharp pains in her chest occasionally times more. The patient received both doses and experienced chest pain, on the side where her heart are located. Pressure is there. Wanted to ask if there are other people talking about the same experience of heart pressure. Asked if there was a website to search for this information. No product complaint was reported. It was reported as medical information request. The outcome of the events was recovered with sequelae.  Follow-up attempts are possible, additional information has been requested.
Pt arrived to vaccination clinic stating she had multiple allergies and after her shingles vaccination she had an allergic reaction.  3 RN's present in room during this time. Vaccination given and patient ambulated to observation location.  Within 30 seconds patient started complaining of feeling dizzy, SOB, and passed out.  Patient assisted to floor by 2 RN's while 3rd RN called RRT.   Patient not responded to verbal commands. Pt with pulse and respiratory effort. Patient began shaking in seizure like activity. Oxygen applied at 4 L NC. Unable to get B/P or SPO2 due to shaking.  Epi 0.3 mg administered SQ by RN.  Patient began to mumble words and laughed at husband.  RRT present and patient accompanied to stretcher and transferred to ER for evaluation. Report given to ED RN by Primary RN.