chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient called pharmacy on 9/11/2020 to report that two days after receiving her flu vaccination from our facility she felt acutely ill with difficulty breathing and had to be admitted to the hospital where she still remains.
Approximately 2 weeks ago, I started having a constant ringing/noise in my ears.  It has become very annoying!!  It's constant.
Vaccubes given at 3:45 pm.  Rash appeared at 4:05. Vital signs remained stable.  No edema or respiratory distress.  Benadryl given .15ml (7.5mg)IM.  Referral written for ER visit 4:45.  Left clinic 5:00 pm.  Reached mother by phone on 8/15/08.  Mother stated she did not take pateitn to ER as instructed by reported baby doing well.  Mother to follow-up with Pediatrician.
Patient complains of excessive swelling and redness at injectio site, site all is hardened and feels hot to the touch.
Employee alleges she developed linear papular rash distal to injection site (left deltoid) and proximally up to the shoulder region.
Swelling in right knee; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 25Mar2021 at 11:30 as a single dose (at the age of 43-years-old) for COVID-19 immunisation. The medical history of the patient was reported as none. The patient had no known allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 10:00, the patient experienced swelling in right knee. The patient did not receive any treatment for the reported event. The event 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 swelling in right knee was recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Severe insomnia; muscle spasms in legs; chills; Headache; Arm pain for a few days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2021 at 10:00 as dose 1, single (Lot number: EW0153) at the age of 47 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypogonadism", start date: 21Oct2017 (ongoing); "Seasonal depression", start date: Feb2021 (unspecified if ongoing), notes: winter and into spring. Well controlled by April; "depression", start date: 08May2009 (ongoing); "hypertension", start date: 27Oct2016 (ongoing); "GERD", start date: 21Dec2011 (ongoing). The patient's family history included: "GERD", start date: 21Dec2011 (ongoing), notes: Mother: GERD; "Hypertension", start date: 27Oct2016 (ongoing), notes: Father: Hypertension, Depression; "Depression", start date: 08May2009 (ongoing), notes: Father: Hypertension, Depression. Concomitant medication(s) included: BUPROPION oral taken for depression, start date: 08May2009 (ongoing); LISINOPRIL oral taken for hypertension, start date: 27Oct2016 (ongoing); OMEPRAZOLE oral taken for gastrooesophageal reflux disease, start date: 21Dec2011 (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Apr2021, outcome "recovered" (Apr2021), described as "Arm pain for a few days"; HEADACHE (non-serious) with onset 06Apr2021, outcome "unknown"; INSOMNIA (non-serious) with onset 11Apr2021, outcome "recovered" (12Apr2021), described as "Severe insomnia"; CHILLS (non-serious) with onset 11Apr2021, outcome "recovered" (12Apr2021); MUSCLE SPASMS (non-serious) with onset 11Apr2021, outcome "recovered" (12Apr2021), described as "muscle spasms in legs". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that before onset in Feb2021, physical wl primary care doctor, normal bloodwork, healthy for his age. Seasonal depression, winter and into spring. Well controlled by April. On 06Apr2021 first COVID vaccine left arm. Headache. Arm pain for a few days. On 11Apr2021 severe insomnia, muscle spasms in legs, chills. Resolved by next day.
flu shot in (L) arm on 10/24/07 and on 10/26/07 developed pain, developed warmth, redness 10x5.5 cm irregular shape area in left elbow. Received medication to relieve pain and observation. Stated she has never had any reaction previously to an flu shot.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05May2021 16:00 (Lot number: EW0167) at the age of 32 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Anemia" (unspecified if ongoing); "Known allergies: Soy, pollen, tree nuts, stone fruit" (unspecified if ongoing); "Known allergies: Soy, pollen, tree nuts, stone fruit" (unspecified if ongoing). Concomitant medication(s) included: Prozac; Nutrafol; Multivitamins [Vitamins NOS]; St John's Wort. Vaccination history included: Bnt162b2 (product: COVID 19, brand: Pfizer, lot number: EW0161, lot unknown: False, administration date: 14Apr2021, administration time: 04:00 PM, dose number: 1, vaccine location: Right arm. 1st dose felt a metallic taste in mouth), administration date: 14Apr2021, when the patient was 32 years old, for Covid-19 immunization, reaction(s): "taste disorder". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06May2021 23:45, outcome "recovered", described as "2nd shot had sour arm"; HEADACHE (non-serious) with onset 06May2021 23:45, outcome "recovered", described as "slight headache"; PAIN (non-serious) with onset 06May2021 23:45, outcome "recovered", described as "slight body ache"; DIZZINESS (non-serious) with onset 06May2021 23:45, outcome "recovered", described as "Very dizzy". Therapeutic measures were not taken as a result of pain in extremity, headache, pain, dizziness. Additional information: Facility type vaccine was Pharmacy or Drug Store. No other vaccine was taken in four weeks. The patient was very dizzy on the second day of 2nd dose of shot but went away after an hour or two. There was no Covid-19 prior vaccination. Covid-19 was not tested post vaccination. No follow-up attempts are possible. No further information is expected.
Hives in hands and back; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a female patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that, after vaccination with Engerix B, the patient had  hives in hands and back. The batch number and expiry date were not available since the first dose was not administered in the same facility where the reporter called. The reporter consented to follow up.
From 8/6/01 to 8/7/01, had a dull headache; took Tylenol Sinus & Allergy pills. On 8/8/01, had a feeling of pressure above right eye and a headache. On 8/9/01, had a loss of vision in eye; dx of optic neuritis; over the next 3 weeks, loss of colors, blurring, could not look at bright light and could not see some light (ex. car headlights); pain in eye, swelling. No treatment. From 10/01 to 11/01, began to return; reduction of pain, light flashes. In 12/01, sight is better but not the same (est. 85-90% normal). Also, in August, September and October 2001, had some memory difficulty. Annual follow up states patient has permanent deterioration of right optic nerve, right eye; continued visual problems in right the right eye.
Immediately felt dizzy; dizzy resolved with lying down but then recurred and persisted 2.5 hrs after injection.
Noticed a midly itchy rash that developed on my neck and spread to my face by mid morning on Wednesday September 1st. I took benedryl that evening and it had resolved a little by the next morning. I currently still have it on my neck and face - took my daily zyrtec. Also, did not have my regular menstrual cycle in August. It was due shortly after my first dose of Pfizer.
This spontaneous report as received from an unspecified healthcare worker refers to a 10 year old patient (patient # 3818) of an unknown gender. No information on patient's medial history, concurrent conditions or concomitant medications was provided. On 03-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, Lot# L000610 with expiration date 31-JAN-2017, current Procedural Terminology (CPT) 90651 (dose and route of administration were not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Red papules; few vesicles and about 10 lesions on trunk, back/ base.
Headache, Fever, Fatigue, Chills Narrative: Fever 103
could not sleep at all; fainted; felt worse fainted and almost felt passing out; multiple panics attacks during the day; sensitiveness to salty food; palpitations/heart palpitation 138 "bps"; heart raised really quick; felt difficulty breathing; This is a spontaneous report received via COVID-19 Vaccine Adverse Event Reporting System (COVAES). A conta sctable consumer (patient) reported a 39-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6207) via an unspecified route of administration on 26Mar2021 at 10:00 (at the age of 39-years-old) as aingle dose in the left arm  for COVID-19 immunization. Medical history included non-alcoholic steatohepatitis (NASH) and pre-diabetic. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included multivitamins. The patient did not have any allergies. On 26Mar2021, ten minutes after the vaccine (also reported as 10:15) the patient experienced heart raised really quick and felt difficulty breathing but calmed down and left the site. The next day (27Mar2021) she drank coffee like every morning but noticed palpitations, noticed sensitiveness to salty foods after ingestion felt palpitations but was not concerned as she thought it was a side effect. On 31Mar2021 she suddenly woke up at 05:00 with heart palpitations "138 bps." She thought it was going to go away but she felt worse, fainted, and almost "felt" passing out. Paramedics showed up and her heart rate was 115 but nothing serious, suspected panic attack. She never had before so she thought it was going to go away but she had multiple panic attacks during the day and night, could not sleep at all for 3 consecutive days. The patient visited a doctor as a result of the events. She was prescribed trazodone "one at night." The patient also saw a cardiologist for the palpitations and was treated with metoprolol 25 mg twice a day to control palpitations but the meds gave her intrusive thoughts and deep depression with suicidal thoughts. The outcomes of heart raised really quickly/palpitations, difficulty breathing, sensitiveness to salty foods, fainted, almost "felt" passing out, and panic attacks were recovering.    No follow-up attempts are possible. No further information is expected.
pt recv vax & w/in 1/2hr pt got rash all over;brought to office & in less than 45min had hives all over w/o face swelling w/o resp problems;pt given DPH & Epi & in 15min rash resolved;
HEAVY BLEEDING WATERY BROWN DISCHARGE; HEAVY BLEEDING WATERY BROWN DISCHARGE; PERIOD IS NOT EXPECTED TILL ANOTHER 2 WEEK; SKIN FEELS HOT TO THE TOUCH; CHILLS; HEAD IS CONSTANTLY HURTING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient did not have any medical history, patient had no known allergies, patient did not have any drug abuse/illicit drug use, patient has regular periods. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 03-APR-2021 03:00, the subject experienced heavy bleeding watery brown discharge. On 03-APR-2021 03:00, the subject experienced heavy bleeding watery brown discharge. On 03-APR-2021 03:00, the subject experienced period is not expected till another 2 week. On 03-APR-2021 03:00, the subject experienced skin feels hot to the touch. On 03-APR-2021 03:00, the subject experienced chills. On 03-APR-2021 03:00, the subject experienced head is constantly hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and the outcome of skin feels hot to the touch, head is constantly hurting, heavy bleeding watery brown discharge, period is not expected till another 2 week and heavy bleeding watery brown discharge was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
PATIENT AWOKE THIS MORNING WITH RASH ON FACE AND JAW, NO OTHER SYMPTOMS.  TOOK OTC BENADRYL THIS A.M. AND RASH IS DECREASING
Had both shots got shingles/suspected vaccination failure; got shingles; pain under skin is awful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had both shots got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got shingles) and skin pain (Verbatim: pain under skin is awful). The outcome of the vaccination failure was unknown and the outcome of the shingles and skin pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and skin pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and skin pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 12-MAR-2023 The case was received from the patient's wife interactive digital media. The patient had both Shingles shots and got shingles back in November. The patient stated that it was awful and the pain was awful and you could feel the pain under your skin. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Patient presented t ED on 01/11/2022 with complaints of malaise and shortness of breath.  Patient reported he had contact with COVID-19 a week prior hence is that time has been fatigue and progressively shortness of breath and fever.  Patient also endorse nausea and vomiting at that time.  Patient was admitted to the intensive care unit from emergency department due to his multiple comorbidities include lactic acidosis with AKI, troponinemia, on high-flow, and chest x-ray revealed patient had bilateral airspace disease, acute hypoxic respiratory failure likely secondary to COVID-19 pneumonia and altered mental status per on 02/01 patient was intubated and continues has positive COVID-19 without antibodies possibly due to immunosuppression status.  Patient was started on broad-spectrum antibiotic and at the time of discharge patient was recommended to continue on 3rd generation cephalosporin until 03/06/2022. Patient's hospital course was prolonged due to patient continued to require oxygen at very high setting.  Patient was initially admitted to ICU and was downgraded to regular floor in mid January of 2021. On 02/01/2022 critical Care was reconsulted due to patient being a febrile, heart rate up to 162 and respiratory up to 40. Patient was initially placed on high-flow nasal cannula at that time but was require intubation and mechanical ventilation on 02/02/2022.  On 02/03/2022 patient tested positive for COVID-19 again but was negative in the past.  COVID-19 spike antibody was positive.  Nuclear capsule antibody was negative.  Patient was placed back on isolation.  Patient was restarted on antibiotics with IV meropenem and Bactrim due to elevated CRP and procalcitonin patient was also started on steroid at that time.  Cardiology was consulted due to hypotension and tachycardia which revealed patient had normal LV function peer patient underwent tracheostomy on 02/12/2022.  Patient continued to require tracheostomy ventilation during the remaining course of hospitalization   Due to continue improvement in patient's respiratory status patient has reach medical stability to be discharged to Hospital.  At the time of discharge, patient was in guarded condition
In 48 hours I had developed a swollen left deltoid, became lethargic and had a headache. On approximately 11/11, I became increasingly lethargic, mentally foggy, inability to concentrate. This progressed  until 11/18 when I became unable to work or stay awake all day. Today, I was diagnosed with Hyperthyroidism as a likely result of Graves? Disease.   I currently am hypertensive, tachycardic, massive headache, lethargic, unable to sleep, uncontrollable sweating and temperature sensitivity, short of breath often at rest and always with minimal exertion.
left arm swelling and soreness to deltoid/injection site started on 12/30/20 at 520 pm. Dizziness, chills, and fever 101 degrees Fahrenheit started at 1120 am on 12/31/20. Sore throat began on 12/31/20.
My deltoid will knot up (spasm) if I stretch or reach forward as to work on something or lift anything from an awkward position where that muscle needs to contract significantly.  I have to lower my arm and massage it to try to get it to relax again.  Symptoms developed within a week of the vax and are focused precisely at the injection site.  Pain and intensity of the spasm depends on how quickly I back off but if I am holding something I can drop and can't back of fast enough it gets fairly intense.
At 9:55 am patient reported numbness in the left arm, nausea, diminished pulse, hypotension, and back pain. Vitals taken every 5 minutes. Patient received 8L of  continuous O2 by face mask. Administered 50mg/mL IM Diphenhydramine to patient at 10:27.
pt experiencedsevere dizziness about 15 minutes after receiving the vaccine, she had one bout of vomiting about 20 minutes after the injection, her blood pressure about 30 minutes after injection was 92/70, her pulse was faint and her face lost all color, it took about 40 minutes after symptoms started before the color returned and she was able to communicate.
Possible exposure to covid; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPOSURE TO SARS-COV-2 (Possible exposure to covid) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Possible exposure to covid). At the time of the report, EXPOSURE TO SARS-COV-2 (Possible exposure to covid) outcome was unknown.        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 medication was reported. No treatment medication was reported.
Incarcerated and ischemic bowel due to massive thrombosis of portal vein and SMV; Incarcerated and ischemic bowel due to massive thrombosis of portal vein and SMV; This is a spontaneous report from a contactable consumer.   A 59-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 23Apr2021 (Batch/Lot Number: ER8736) as single dose at the age of 59-year-old for COVID-19 immunisation.   Medical history included pre-myelofibrosis aspirin on daily baby. No known allergies. Concomitant medication(s) included acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported. The patient received bnt162b2 (BNT162B2), dose 1 on 02Apr2021 (Batch/Lot Number: ER2613) as single dose at the age of 59-year-old for COVID-19 immunisation.  The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced incarcerated and ischemic bowel due to massive thrombosis of portal vein and SMV (hospitalization, disability, life threatening) on 09May2021 with outcome of recovering. The adverse events resulted in any Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was hospitalized for the events for 26 days.  The patient underwent lab tests and procedures which included Sars-cov-2 test: negative on 24May2021 Nasal Swab. The treatment received for the adverse event was emergency bowel resection. Since the vaccination, has the patient been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
complete kidney failure in DKA; can hardly breathe; coughing up blood; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 11Feb2021 (Batch/Lot Number: EL9267) as dose 1, single; dose 2 via an unspecified route of administration on 04Mar2021 (Batch/Lot Number: EN6200) as dose 2, single for Covid-19 immunization. Medical history included DKA (diabetic ketoacidosis). The patient's concomitant medications were not reported. The patient experienced complete kidney failure in DKA and can hardly breathe along with coughing up blood on an unspecified date. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Developed severe itchiness, redness, and swelling at site of vaccine. Also felt burning sensation in both my arms and my upper thoracic back. I took Benadryl which helped with the burning sensation, but the itchiness, redness, and swelling at site continues, and is worse today than yesterday. I plan to call my PCP today to report my symptoms.