chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reporting waking up every morning with nose bleeds on the right side/nose bleed/ it only gushes from her right nostril, only the right one; This is a spontaneous report from a contactable consumer (patient).  This 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not provided), via an unspecified route of administration, on 02Mar2021 at 11:30 (at the age of 57-year-old) at single dose for COVID-19 immunisation. Relevant medical history included Graves' disease from 2016 (5 years ago) and went in remission. The patient not had any other recent vaccinations or started any new medications. She said she was not on any medications, all she did take were supplements which she had been on the same ones for years. The patient was waking up every morning with nose bleeds on the right side. Also reported having her vaccine shot on the right side and asking was this normal. It really has just happened since she got the shot. She said she was not sure if there was a correlation, but she thought she would mention it. The patient had no treatment for the nosebleeds, she had stopped them when it happened. She said it was not a little nosebleed, and it only gushed from her right nostril, only the right one, and she got it to stop after a few minutes. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Developed local erythema within 2 min. after immunization - enlarged somewhat overnight. Sie type 1 reaction, immediate, IgE mediated immun. reaction.
I received the FluMist early in the day on Nov 4, 2008.  That evening, approximately between 6PM-8PM, I began feeling really dizzy.  The room was not spinning, but internally I felt like I was spinning.  I thought I was going to faint.  I laid down on the couch, prayed, and fell asleep (I'm not sure if I naturally fell asleep or fainted).  I have been internally spinning/dizzy and physically off balance every day since then.  I am dizzy 24hrs, 7 days a week, 365 days a year.  It has been over two years now and no one can tell me what is wrong. During my visit with the doctor immediately following the onset of dizziness, it was discovered that I am anemic.  I had never been told that I was anemic before.  I'm not sure if I always was anemic and my doctors just failed to inform me.  Nevertheless, over the past few months (August 2010-present Feb 2011), my overall health has been rapidly declining.  The main complaints, among many, are dizziness, fatigue, migraines, brain fog and malaise.  I am not on any treatments currently because no one knows how to help me.  I've had two brain MRIs, an echocariogram, balance testing, hearing tests, physical therapy, and blood work.
itching; dry skin; allergy; This is a spontaneous report from a contactable consumer via Regulatory Authority. An elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 06Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, consumer experienced dry skin and itching/itchy, allergy. Consumer has recently changed soaps. Consumer said its subsiding. Patient has dry skin anyways. Was this from soap or injection? Consumer stated that she was a little itchy. At first she was not. However, now she was. She did not have any spots or anything. Her skin was dry. She was trying to see if this was due to possibly changing soaps as well. Normally she does not. Stated she used some at her brother's house and then she bought some where she is now. She did not use any of the soap at all yesterday. Consumer asked if she should get 2nd dose? She was just trying to see if these are side effects or could be from the vaccine. The outcome of event itching was recovering, for dry skin not recovered and for allergy was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I got covid but took both pfizer vaccines in March; I got covid but took both pfizer vaccines in March; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Mar2021 as dose 1, single for covid-19 immunisation and dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. On an unspecified date the patient experienced i got covid but took both pfizer vaccines in March. The outcome of the event was unknown. Information on the lot/batch number has been requested.
Red, warm area approx. 6 inches below where vaccine administered (Band-Aid still in place).
AE: patient experienced blurred vision and ringing in the ears Treatment: No medical treatment were given. Patient was observed for 15 minutes. Outcome: Patient was discharged home with the help of mother.
Red spot; Swollen  spot; Hot spot; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red spot), SWELLING (Swollen  spot) and FEELING HOT (Hot spot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced RASH MACULAR (Red spot), SWELLING (Swollen  spot) and FEELING HOT (Hot spot). At the time of the report, RASH MACULAR (Red spot), SWELLING (Swollen  spot) and FEELING HOT (Hot spot) was resolving.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: In Telephone Contact Report (TCR) has no new information.
medication error due to use of invalid vaccine since it was reconstituted with wrong diluent with no reported adverse event; Initial information received on 03-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old female patient who was administered an invalid vaccine since it was reconstituted with wrong diluent with no reported adverse event while receiving vaccine hib (prp/t) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (Pediarix); pneumococcal vaccine conj 7V (CRM197) (PREVNAR); and Rotavirus vaccine.  On 02-May-2022, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE (lot UJ588AAA, expiry date: 24-Oct-2022) via intramuscular route in the left thigh for immunization.  On 02-MAY-2022 the patient was administered an invalid vaccine since it was reconstituted with wrong diluent with no reported adverse event (product preparation error).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 the 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.
25 y/o USAF AD female developed facial skin lesions onset approximately 9 days following receipt primary SPV & AVA#2 given on 12/8/2009. Pt first noticed redness over her nose & cheeks, followed by tingling grouped papular eruptions around upper & lower lip borders; by next day, a few more isolated eruptions appeared on forehead, right cheek & left outer ear. No oral lesions or painful swallowing; by day 10, papules increased around lips. Lesions remained tingly, otherwise non............. covering SPV site until after day 5 or so when she noted a vesicle at site; pt denied scratching/rubbing site & has kept it covered since. She was well day of vaccination but reported a fever blister left lower lip that lasted 3 days & just resolved the day before vaccination. She had childhood history VZ; no prior vaccine-related reactions. Immunization record indicated positive titers to MMR, VZV, & HBV. Initial medical evaluation by PCM was on 12/17/2009 at which time pt was afebrile & other than skin lesions, was well-appearing. She was evaluated by derm on 12/18/2009, at which time lesions were as follows: multiple grouped papules distributed around upper & lower lips borders, some on erythematous bases, some mildly coalesced; 2-2 papules above upper lip, 1 on left outer ear; 1 one vesicle on right cheek; 2 papules on forehead; shiny macular plaque across nose & both cheeks; SPV site appeared c/w robust take reaction with reported mild tenderness left axillary area. No other cutaneous findings. Preliminary diagnosis was possible autoinoculation; Valtrex was prescribed. Symptoms: Lesions, papule, Lesions, macule, Lesions, Vesicle.
Pfizer-BioNTech COVID-19 Vaccine EUA On the evening of 1/19/21 I noticed my arm in the area of my vaccine was sore to the touch.   As the evening progressed,  my shoulder joint became sore and got worse throughout the evening and became very sore to lift my arm.  This morning it is still very sore, and now my neck feels ?stiff? and also it?s tender to move.
Onset approx 45 min after injection--swollen eyelids and face, moderate throat constriction and hoarseness, severe fatigue, headache, brain fog for first 20 hrs, then intermittent eyelid and face swelling, hoarseness, fatigue and brain fog for the next 3 days, followed by mast cell activation symptoms of fatigue, puritis, and mild racing heart in the evening for the last two days.   For the past 3 years I have been medication free and virtually symptom free.  The symptoms of the last few days are consistent with those I had during the years when my MCAD  was active.  I am concerned that the vaccine has reactivated the hyper-sensitivity of my mast cells.
Wed. 05-04-11 (+) 4mm x 4mm red, raised, vesicular firm bumps to (L) arm x3 - (R) cheek x1 - (L) ear x1 - Occiput x1 3mm x 3mm circular, pink sl. raised bump on abdm. Rash post varicella vaccination on 4-4-11.
Chills, and symptoms of a head cold and dry cough at the beginning.  The next day I had body aches almost like the flu.  The following night I had night sweats.  Throughout, I had general fatigue and like a head cold. I still have night sweats.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Vomiting-Mild, Additional Details: 911 was called.  Evaluated and all vitals were good.  Rescue felt it was a panic attack. Mom told to follow up with ER visit- rescue offered to call ambulance but mom denied.  Patient left feeling better.
Swollen eyelid. A non-serious spontaneous report of swollen left eyelid has been received from a physician concerning a four year old male subsequent to FLUMIST. 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. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 01-Oct-2009. The patient received a total of one dose of FLUMIST before the onset of the event given on 01-Oct-2009. On 01-Oct-2009, when the patient went outside, his eyelid was swollen. The outcome of the event of swollen left eyelid was unknown.
loss of taste & smell, nasal congestion, got tested for COVID-19 on  1/04/2021 and it was Positive
04/20 right arm red swollen, warm to touch, fever, 4/22/05 decreased redness, decreased swelling no fever.
Fatigue/I am still tired; My chin is like its frozen like I had been to the dentist and my right side of my lip is frozen; My chin is like its frozen like I had been to the dentist and my right side of my lip is frozen; This is a spontaneous report from a contactable consumer (patient herself). A 78-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6198) via an unspecified route of administration on 04Mar2021 as 2nd dose, single dose (at the age of 78-years-old) for COVID-19 immunization. Patient medical history included high blood pressure, mastocytosis and stage III kidney disease. To stabilize the high blood pressure she takes a bunch of other stuffs too. The concomitant medications included montelukast, aspirin [acetylsalicylic acid], fexofenadine hydrochloride (ALLEGRA). Patient reported that she takes Allegra with two Aspirin because that activates the Allegra. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9269 (as reported)) via an unspecified route of administration as 1st dose, single dose for COVID-19 immunization. About the lot number of first dose patient stated, she believes its FL, its EL9269. On an unspecified date in Mar2021, patient experienced fatigue, she was still tired, her chin was like its frozen like she had been to the dentist and her right side of her lip was frozen. Patient stated she had the usual symptoms, she had the second shot on 04Mar2021 and she was fatigue the 2nd day she guesses that was normal and the following day, she was still tired today. The other thing that she did not see that the usual thing was her chin was like its frozen like she had been to the dentist and my right side of my lip is frozen like she had been to dentist. She meant is that something that happens sometimes to different part of your body where the virus settle or the vaccination settles or maybe it will go away or (statement incomplete) she was wondering if you ever heard that before she meant you hear lots of things but (statement incomplete). Patient stated, in general are there drugs that cause a problem when you take them before you take the vaccine or may be there is not. She meant she takes a lot of things but and she took Aspirin she guessed she should not have taken that before she took it but. Patient did not receive any treatments for the adverse events. Lab work information included patient stated she had done just a routine physical on 05Feb2021 and she did have blood work done then. Patient further stated she had her chart for data care as her chart it might say on this. They checked her kidneys as sometimes she was considered stage III kidney disease, they check that, she did not know. The outcome of the event fatigue was not resolved while of other events was unknown.   No follow-up attempts are possible. No further information is expected.
As soon as injection was given IM to her right arm, it began to swell. An ice pack was applied a few minutes later.
1st night my heart felt like it was flipping out, my watch health monitor could not determine if it was afib, but was not sinus rhythm (undetermined).  Additionally it is showing Lower than average heart rate and I have the feeling of heaviness in my chest making it harder to breath.  I have shortness of breath from normal walking, normal activities.
Patient received Pneumovax 23 0.5 ml IM on 11/13/07. Patient reported fevers, chills, generalized body aches and fatigue through primary care telephone contact on 11/14/07. On 11/15/07 patient was seen in nurse triage with redness and pain in the upper left arm. Patient was given methylprednisolone 4mg dose pack for 7 days and cephalexin 250mg q6h for 10 days (for possible cellulitis).
COVID + 10/24/22 .  Vaccination status - Pfizer x2 BRIEF OVERVIEW: Discharge Provider: MD  Primary Care Physician at Discharge: MD  Admission Date: 10/24/2022  Discharge Date: 10/27/2022   Active Hospital Problems   Diagnosis Date Noted POA ? Influenza A 10/25/2022 Yes ? COVID 10/25/2022 Yes ? Autism 08/16/2016   DETAILS OF HOSPITAL STAY: Dehydration  Viral pneumonia  Hypoxia    HOSPITAL COURSE: Patient is a 9 y.o. male with PMHx autism spectrum disorder and HIE who was admitted on 10/24/2022 for acute hypoxic respiratory failure and moderate dehydration secondary to Covid-19 and Influenza A coinfection.    The patient presented on 10/24/2022 to hospital after 6 days of lethargy, fever, cough, and headache. He was tachypenic and hypoxic on arrival requiring 2L NC. He was also given two NS boluses for dehydration after failing a PO challenge. Film array was positive for both Influenza A and Covid-19. CXR revealed peribronchial thickening consistent with his viral illness. He was admitted to the hospitalist team for further care.    Patient was treated with Tamiflu and Decadron. After consultation with Infectious Disease, Remdesivir was also begun in the setting of Covid-19 positivity and hypoxia. The patient was supported with supplemental oxygen and maintenance IVF.    He was successfully able to be weaned from supplemental oxygen approximately 24hrs prior to discharge.    At the time of discharge, the patient was hemodynamically stable and on room air. His PO intake was increasing. He was discharged with a two day course of Tamiflu to complete a total of 5 days of treatment. All parental questions and concerns were addressed prior to discharge.    CONSULTS/RECOMMENDATIONS: Infectious Disease              - Use Remdesivir for the duration of admission
Felt stiff; sore; very tired on the 21st; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Felt stiff), PAIN (sore) and FATIGUE (very tired on the 21st) in an elderly 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.     The patient's past medical history included COVID-19 (second week of June, struggling with what seemed to be a very mild form of Long Covid.) in June 2022 and Fatigue.    On 20-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Sep-2022, the patient experienced MUSCULOSKELETAL STIFFNESS (Felt stiff), PAIN (sore) and FATIGUE (very tired on the 21st). At the time of the report, MUSCULOSKELETAL STIFFNESS (Felt stiff), PAIN (sore) and FATIGUE (very tired on the 21st) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: nothing was a miss, and the GP reckoned the same - symptoms came on after Covid..         The patient was over 70.  The patient had the booster on the afternoon.  No concomitant medication was reported.  Halfway through the morning of the 22nd, the patient suddenly felt loads better, as though the sun had come out. The patient was in a rehearsal. The patient was a musician and the whole mindset got changed; played better too. And since then it was as though never had a problem. Still on the go now after a 16 hour day.  No treatment medication was reported.
pt states awoke 2Am w/hard & fast heartbeat w/heaviness in chest x 6hr;pt described as same as when drink coffee but had no caffeine that day;s/s resolved when sat up;referred to MD;
New onset of severe night sweats and confirmed diagnosis of Essential Thrombocytosis with new CALR 5bp insertion gene mutation as evidenced by bloodwork and bone marrow biopsy. Earliest known evidence of significantly elevated platelet count was on 7/26/21, with count continuing to increase. Accompanied by concern of progression to myelofibrosis and/or thrombosis due to this new gene mutation following a two-dose COVID vaccination series and booster. Treatment at this time includes 81 mg aspirin daily with ongoing disease.
Our medical clinic is part of a program and one of our program refrigerators malfunctioned and created a too low temperature for vaccines to be viable. Patient received vaccination due to human error in not pulling the non-viable vaccines from refrigerator when it was reported that all non-viable vaccine were pulled correctly and transferred correctly. After speaking with all pharmaceutical companies regarding patient receiving non-viable vaccines, patient have been recalled and will receive vaccine as soon as possible. Age of patient at time of event: 4 years 7 months.
TROUBLE WALKING; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced trouble walking. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of trouble walking was not reported. This report was non-serious.
Some time after vaccination noticed trouble breathing and shortness of breath.  2 days later ( Tuesday, 1-18-2021)  still have difficulty breathing and heart beat is faster.  Woke up in the middle of the night on Sunday with a rapid heartbeat.
Lumpy  Injection site; Rash on the injection site; Itching Injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lumpy  Injection site), VACCINATION SITE RASH (Rash on the injection site) and VACCINATION SITE PRURITUS (Itching Injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced VACCINATION SITE MASS (Lumpy  Injection site), VACCINATION SITE RASH (Rash on the injection site) and VACCINATION SITE PRURITUS (Itching Injection site). At the time of the report, VACCINATION SITE MASS (Lumpy  Injection site), VACCINATION SITE RASH (Rash on the injection site) and VACCINATION SITE PRURITUS (Itching Injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided. Patient has not seen a doctor.
pt recvd vax; sore throat, achy bones;cont cough;early pneumonia, infected sinuses(both sides);seen MD; tx w/ guiatuss AC hydrocodone syrup,ceftin,biaxia,rhinocort nasal inhaler;chest x-ray,sinus x-ray;