chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2013US015423, is an initial spontaneous report received from a medical assistant on 18 Jul 2013: This case refers to an 11 years old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: X12025 and expiry date: Jan 2015), intramuscularly without being reconstituted with Men A component on 08 Jul 2013. No adverse reaction was reported following this administration error.
administered with vaccine from a vial punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine from a vial punctured for more than 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022 at 8:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine from a vial punctured for more than 12 hours). On 21-Jan-2022, EXPIRED PRODUCT ADMINISTERED (administered with vaccine from a vial punctured for more than 12 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment Drug details were reported. The vial was 1st punctured on 20Jan2022 at 11:53am. The 1st dose vial was exposed to room temperature for greater than 24 hours-21 hrs.      This case was linked to MOD-2022-458007 (Patient Link).
Information has been received from a physician concerning a female with a history of breast cancer who was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Subsequently the patient experienced palpitation, flushing, weakness and over the course of several months the patient had lost 30 lbs. On an unspecified date, the patient was sent to emergency room but specified reason was unknown. At the time of report, the patient was recovering. Additional information has been requested.
after giving patient the vaccine, he sat at the waiting for a few minutes.  then he starts to faint.  and he was experiencing a little twitching of his extremities and lost conscience for a minute and regain it back. He was laying on the floor. rolled on to his side and then remained in the position and until the 911 crews came in.
Chest pain, fluttering heart, chest tightness that lasted 4-5 days
Hospitalized (10.25.21);  COVID-19 positive;  Fully Vaccinated Discharge Provider: MD Primary Care Provider: MD Admission Date: 10/25/2021 Discharge Date: 10/28/21 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Sepsis  Shock    HOSPITAL COURSE: Patient is a 60 year old woman with PMHx of uncontrolled Dm1, gastroparesis, HTN, HLD, hypothyroidism, GERD. She is fully vaccinated against COVID-19 with Pfizer (last dose 4/20/21). For approximately 1 week prior to her hospitalization, she had not been feeling well, with nausea, vomiting, lethargy, and abdominal pain. She attributed her symptoms to gastroparesis. It seems she frequently becomes quite symptomatic from her gastroparesis, and her husband will sometimes crush up diazepam and promethazine for her when she gets that way. Her PO intake had been quite poor over the past few days. She was brought to the ED on 10/25/21 after being found by her husband, "cold, grey, gurgling, and looking like death" with a blood sugar as low as 23. EMS was called, she was given D10 and also found to be hypoxic to 83% on room air. In the emergency department she was found to be hypothermic to 33 C, hypotensive with BP's of 70's/40's. She was given 2 L IV fluids without improvement in BP's, and so was started on norepinephrine and admitted to MICU for further management. CT chest/abd/pelv was negative for obvious infectious source, she was started on zosyn empirically. She was found to be positive for COVID-19. Overnight she did become hypoxic to 88% and was placed on 1L nasal cannula, but her O2 saturations improved once she was awake. She was quickly weaned off of pressors. On 10/26 she remained hemodynamically stable to transfer out of the ICU. She developed hyperglycemia for which she was placed on endotool. Her nausea and vomiting had resolved. Her zosyn was discontinued and she was monitored. Pt was transitioned off of endotool by DGMS and was deemed stable for discharge on her pre-hospital DM regimen
2 mo old infant was hospitalized for apnea approx 48hrs after immunization, admitted to ICU and placed on a monitor.  IV bicarbonate & oxygen administered.  Infant reamins in ICU at the time of this report.
BP 150/98. HR 96. Chest tight Throat felt tight at first now continues with chest tightness. Pt felt like chest is getting better after few minutes History of possible vasovagal reaction after getting shot
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Breast cancer treatment 04May2023; "known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR, start date: 01Aug2021; LETROZOLE, start date: 10Aug2023. Vaccination history included: bnt162b2 (DOSE 1, SINGLE), administration date: 26Mar2021, for COVID-19 immunisation; bnt162b2 (DOSE 2, SINGLE), administration date: 19Apr2021, for COVID-19 immunisation; moderna (DOSE 3 (BOOSTER), SINGLE), administration date: 22Nov2021, for COVID-19 immunisation; moderna (DOSE 4 (BOOSTER), SINGLE), administration date: 20May2022, for COVID-19 immunisation; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Vaccine location: Right arm), administration date: 13Oct2022, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (Oct2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 21Oct2023 to 25Oct2023. Also, the patient had COVID 19 Treatment from 19Oct2023 to 24Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350864 same patient, different drug, different event;
Low fever, severe body aches, chills, fatigue, weakness, some nausea.
Bell's palsy; Information has been received from a lawyer and an elderly patient of unknown age and gender, regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In or about 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a healthcare provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX): Bell's palsy. The outcome of the event was unknown.   Upon internal review, Bell's palsy was determined to be medically significant.
?Covid arm? all of the sudden I have a large red raise lump about two inches round, at the site of the injection. It?s sore, red, and hard
3 days after the vaccine I developed hives on the back of my neck, scalp and face. I began taking Benadryl and the symptoms were relieved after 3 days.
he developed shortness of breath and weakness within 24 hours of vaccination. over next 72 hours, developed progressive symmetric proximal muscle weakness with labs/imaging c/w myositis. also had biochemical evidence of cell lysis (elevated uric acid, high K, low Ca, high phos). He received steroids 2/11 with near complete recovery in function by 2/12, but biochemical changes were already improving by time of steroid dosing.
heart complications; brain complications; Initial information received on 12-Jan-2021 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional.  This case involves patient (unknown demographics) who experienced serious heart complications (cardiac disorder) and brain complications (nervous system disorder), when received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.   It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 20-Sep-2020, the patient who do not expect to survive after development of serious heart complications (cardiac disorder) and brain complications (nervous system disorder) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.   These events were assessed as medically significant and life-threatening and was leading to disability.   The patient was hospitalized for these events.  It is unknown if the patient experienced any additional symptoms or events.   Medication details and reason for taking the medicine was not provided   It is unknown if there were lab data or results available  It was not reported if the patient received a corrective treatment.  On 24-Nov-2020, the patient recovered from both the events.; Sender's Comments: A patient (unknown demographics) presented with cardiac disorder and nervous system disorder following the vaccination with FLUZONE HIGH DOSE. Time to onset is unknown. Medical history, concomitant medication, precise final diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
Hypertension; tachycardia; Feels hot; heart rate is high; This is a spontaneous report from a contactable pharmacist. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular in left arm on 13Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient has no known allergies. Concomitant medication included simvastatin and acetylsalicylic acid (ASPIRIN (E.C.). The patient was not pregnant at time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced hypertension, tachycardia, feels hot and heart rate is high on 13Jan2021. The outcome of the events was recovering. The patient received treatment such as Amlodipine and lisinopril oral for the events.
About 4 hours later, I developed a nose bleed that lasted for about 4 hours.  I also had a severe back pain that lasted for about 8 hours.
Shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not provided. In 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not reported), as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and zoster-related conditions. Subsequent to vaccination, she was treated by a healthcare provider for shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome not herpes zoster was considered to be not recovered.
Patient received undiluted pediatric dose .2ml Patient did not report any adverse reactions. Patients were notified and scheduled in 8 weeks for full adult booster, per CDC guidelines.
First Covid 19 vaccination was Moderna (6 month to 5 yr dose)- given 6/27/22  Second Covid 19 vaccination Pfizer (6 month to 4 yr 11 month dose) was administered inadvertently given on 7/21/22 No adverse event
Patient had 1st dose Pfizer 6/11/2021 at 1:18pm. She stayed in observation area for 15 minutes with no reactions noted. Patient left and returned 10 minutes later with complaints of severe to left arm, chest and right foot. Patient also stated she had itching in throat with soreness, however declined shortness of breath/difficulty breathing. No swelling to throat noted, no wheezing present upon auscultation. Patient was administered 10mg of Cetrizine and vitals obtained (BP-138/94, HR-77, RR-18). Injection site assessed- slight warmth noted around site, however no further abnormalities noted. DON and Curative Medical Directors informed of event. Patient informed that 911 will be called as her symptoms could turn into anaphylaxis. Patient refused an ambulance and stated she would take herself to the hospital. Shortly after, patients mom came to site and advised patient to go to hospital via an ambulance. 911 was called as patient agreed, and within 10 minutes, ambulance arrived. During the wait for the ambulance, additional vitals were obtained (BP-154/80, HR-78, RR-16); (BP-118/72, HR 75, RR-16). Once ambulance arrived to site around 2:13pm, a review was done by EMS- they stated patients reaction was mild, however felt it wise patient be brought to hospital for further investigation/observation. Patient agreed and was taken by ambulance at 2:17pm. Patient remained alert and oriented during entire event. At no point did patient state difficulty breathing/shortness of breath.
left armpit swollen, lump is sensitive soft and warm to touch; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 06Apr2021 at 10:45 (at the age of 60-year-old) as a single dose for COVID-19immunisation. Medical history included cholesterol high and sulfonamide allergy. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) , GUMMY VI for unknown indication on an unknown date, magnesium (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), all for unknown indication, from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 12:00 the patient experienced left armpit swollen, lump is sensitive soft and warm to touch. It was unknown whether therapeutic measures were taken as a result of the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event left armpit swollen, lump is sensitive soft and warm to touch was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021  at left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced headache, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and tiredness was not reported. This report was non-serious.
Moderna booster vaccine given too early (in left deltoid). Second dose of Moderna was 11/10/2021.
1st shot mild fever, headache, body aches. 2nd shot approx 3 months later, severe headache, muscle aches and nausea. Fever at least 101. Diarrhea the morning after shot. Other symptoms lasted 24 hours. Couldn't take MOTRIN, too sick with nausea. Never had an adverse reaction to any other vaccine including original shingles vaccine shot over 6 years ago. No allergies or illness at time of these injections.
Fever chills through the night. ?Hangover? feeling next day. Fine by 3rd day.
Menstrual cycle/ Period was disrupted and was over 50 days long; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FH8030), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, LOT NUMBER: ER8727, Anatomical Location: left arm), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, LOT NUMBER: ER8729, Anatomical Location: left arm), for COVID-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "Menstrual cycle/ Period was disrupted and was over 50 days long". Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: The patient was not administered other vaccine in four weeks. The patient did not have covid prior vaccination. The patient was not tested COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Fever, swelling, severe rash and pain under left arm extending all the way up the neck to the forehead.  Was seen at urgent care on Friday, November 22nd.  The physician suggested a reaction to Meningococcal B, advised not to receive second dose.  Rash become more severe and was at it's worst on Saturday night.  Followed up with patient's mother on Monday, November 25th at 8:30 am.  She advised his fever broke late Saturday night and the rash had not gotten any worse and the patient was feeling much better.
Adverse Events 12 hours after vaccine injection: - Chills 5 hours,  - Mild Headache 8 hours, - Tiredness 36 hours - Whole body soreness 24 hours - Nausea 12 hours
shingles; he started feeling strange; This is a spontaneous report from a contactable consumer. A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9261), via an unspecified route of administration on the left arm, at the age of 71 years, on 20Jan2021 at 0.3 mL, single for covid-19 immunisation. Medical history included white blood cell count decreased from an unknown date and unknown if ongoing. The patient stated that his white blood cell count was usually on the low side and his doctor sends him to a hematologist to do whatever, then they say he was fine. Concomitant medication included an unspecified flu shot. The patient said that he had his first Pfizer COVID-19 shot 20Jan2021, and this coming Wednesday he was supposed to have his second shot, but unfortunately in the interim he found out he has shingles. He says he would like to know if he can get a second shot or would he need to hold off. He says that developed shingles 9 days later after getting first COVID-19 vaccine shot (31Jan2021), and he doesn't want to do something that will be a problem. He says that he was on an antiviral to treat the shingles. No further details provided about the antiviral. He says he didn't go see his doctor until last Wednesday, he thinks he has been suffering from shingles since 07Feb2021 or a little before that when he started feeling strange. The patient clarified he meant 31Jan2021 since he began dealing with this. The patient said when he was diagnosed with shingles they didn't do any tests, the doctor walked into the room and looked at him, though he didn't have a lot then, over the days it has gotten worse. Therapeutic measures were taken as a result of shingles (herpes zoster). The outcome of the events was unknown.
Shingles; chronic pain at injection site, L deltoid; Increased incidence and severity of acute Rheumatoid Arthritis flares; This is a spontaneous report from a contactable nurse. A 52-year-old female nurse (patient) reported for herself that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL1283) intramuscularly in left arm (deltoid) on 01Feb2021 at 12:45PM (at the age of 52-year-old) for COVID-19 immunisation. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899) intramuscularly in left arm on 08Jan2021 at 10:30AM (at the age of 52-year-old) at single dose for COVID-19 immunisation. Relevant medical history included depression, rheumatoid arthritis and endometriosis. The patient did not receive other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications included an unspecified anti-depressive drug. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient had chronic pain at injection site (left deltoid) since second shot and increased incidence and severity of acute rheumatoid arthritis flares on 02Feb2021, along with diagnosis of shingles in Mar2021. The events were serious as medically significant and disabling, and required emergency room and physician office visit. Antiviral for shingles were given. The events were resolving with sequelae at the time of report.; Sender's Comments: Based on the available information and the close drug event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events rheumatoid arthritis flares up, herpes zoster and vaccination site pain cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Five patients experienced local reactions, one pt went to ER due to large local reaction size of an orange, knot, Keflex prescribed, MD dx cellulitis, red, warm, tender to touch. Info on other 4 patients be need to be obtained. At this time, the pt that went to ER is identified as an adult female. Additional info to be provided at later time.
On Tuesday the 13th I developed a sore throat.  Wednesday the 14th - sore throat, fatigue, and itching eyes.  Thursday the 15th - fever/chills, fatigue, headache, runny nose.