chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT CAME TO PHARMACY ON 09/11/19 TO GET FLUZONE HD ADMINISTERED. SHE CAME IN ON 09/18/19 CLAIMING SHE WAS BLEEDING AT THE INJECTION SITE THE EVENING OF 09/11/19 ONLY AND THAT HER ARM WAS HURTING  ALOT SINCE AND WAS LEFT WITH A BRUISE AROUND THE INJECTION SITE WHICH COULD STILL BE SEEN AS OF 09/18/19 WHEN SHE CAME TO THE PHARMACY.  I, PHARMACIST WHO SHE HAD CONTACTED ON 09/18/19 COULD SEE THE BRUISE AND ASKED IF SHE WAS TAKING ANY BLOOD THINNERS WHICH COULD POTENTIALLY LEAD TO BLEEDING AT THE INJECTION SITE BUT SHE REPLIED NO.  SHE CLAIMED SHE NEVER TOOK ANY MEDICATION SINCE APPLYING THE VACCINE AND THERE WAS NO ALLERGIC REACTION OR AT LEAST FROM WHAT I COULD SEE ON 09/18/19, BUT I DID SEE A BRUISE AROUND THE INJECTION SITE. IN MY OPINION I BELIEVE THIS IS NOT A TRUE ADVERSE EVENT BUT I AM FILLING THE FORM AS A LIABILITY PRECAUTION AND ALSO BECAUSE I WAS ADVISED BY MY MARKET HEALTH AND WELLNESS DIRECTOR TO DO SO, AGAIN, FOR LIABILITY PRECAUTION.
The patient stated she had pain the same day of the shot, then halfway through the following say her arm swelled up and was heavily bruised . Pt also reports being very dizzy, very tired, and nauseous.
Hospitalized (10.30.21 - still hospitalized / admitted);  COVID-19 positive (10.30.21);  fully vaccinated  CHIEF COMPLAINT:  Fall History of Present Illness Patient is a 87 y.o. female , vaccinated with moderna feb 2021 Past medical history as noted below Resides at (PRIVACY) over the past 1-2 years Lives with her husband Uses a walker at baseline Comes in after having sustained a fall Claims to have been in her normal state of health prior States that she was doing her hair in the bathroom when she felt lightheaded She grabbed on to the towel bar but still fell Denies any head trauma Contact staff contacted EMS On arrival was found to be febrile, hypoxic CT head obtained and negative.  Chest x-ray showing COVID COVID test positive Patient's code status was do not resuscitate prior but during our conversation, opted for a full code States that she needs to be alive for her husband Acute hypoxia COVID-19 Continue remdesivir for now, symptoms only on day of admission Continue supplemental oxygen, wean as tolerated Continue Tylenol Continue melatonin Vaccinated with Moderna in February
Patient developed 3" red circle around injection site. On 5/29 was diagnosed with shingles infection
COVID 19; COVID 19; Dose 1: Moderna/Dose: 2: Moderna/Dose 3: Pfizer/Dose 4: Pfizer; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Jan2023 as dose 4 (booster), single (Lot number: GJ3276) at the age of 61 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Aug2022 as dose 3 (booster), single (Lot number: FP7139) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Dec2020 as dose 1, single (Lot number: o39K20A) and on 22Jan2021 as dose 2, single (Lot number: o28L20A) for covid-19 immunisation. The patient's relevant medical history included: "obesity (BMI 32)" (unspecified if ongoing); "obesity (BMI 32)" (unspecified if ongoing); "A1C 5.8" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE; MONTELUKAST. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Aug2022, outcome "unknown", described as "Dose 1: Moderna/Dose: 2: Moderna/Dose 3: Pfizer/Dose 4: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Feb2023, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Feb2023) Positive, notes: confirmed by PCR next day. Therapeutic measures were taken as a result of drug ineffective, covid-19 included PAXLOVID (COVID 19 Treatment) from 09Feb2023 to 13Feb2023.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Itchy; Rash; Chitlains; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), RASH PRURITIC (Rash) and SKIN DISORDER (Chitlains) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (Unspecified, has unusual reactions).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchy), RASH PRURITIC (Rash) and SKIN DISORDER (Chitlains). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash pruritic, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchy) and RASH PRURITIC (Rash) had not resolved and SKIN DISORDER (Chitlains) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient reported an additional treatment was a topical steroid cream on an unknown start date. She also received a lowdose steroid injection as treatment for her adverse events from her dermatologist on an unknown start date.
Received Flu vaccine on (Lt) deltoid and noted reddened area & induration on 10/5/10 also received TDAP 10/4/10 and noted sm reddened area with induration.
chills/shivering; fatigue; malaise; myalgia; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, fatigue, malaise and myalgia. On an unknown date, the outcome of the chills, fatigue, malaise and myalgia were unknown.   It was unknown if the reporter considered the chills, fatigue, malaise and myalgia to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingrix and experinced chills, fatigue, shivering, malaise and myalgia. The reporter asked should not had the second dose in 2 months.
Chest pain began 4 days after primary smallpox vaccine.  Service Member meets criteria for "Suspect" pericarditis according to CDC guidelines.  Definition:  Typical chest pain (i.e. made worse by supine position, improved when leaning forward), no evidence for alternative likely of such chest pain, occurring within 30 days of vaccination.  No other objective findings.  Symptoms: Chest Pain, Dyspnea.  Pericarditis, post vaccinia  2/23/09 MR received with vax rec from reporter.  Pt presented 12/20/08 with c/o chest pain, dypnea on exertion, cough, fever and palpitations.  Initially dx with URI but continued to have intermittant CP and tachycardia. Assessment:  Pericarditis, acute.  Adverse drug effect of SP vaccine. Tx with Motrin.
Case number PHHY2011US33861 is an initial spontaneous report from a pharmacist received on 05 Apr 2011: This patient was vaccinated with MENVEO (batch number: unknown) on an unspecified date. The patient inadvertently only administered with the CWY 135 liquid conjugate component of MENVEO and did not received MenA conjugate component. No adverse reaction had occurred.
Information has been received from a father referring to a 18 year old female patient with seasonal allergy. Concomitant therapy included mometasone furoate (NASONEX). On 02-JUL-2017 the patient was vaccinated with a dose of GARDASIL 9 (dose, frequency, lot# and expiration date unspecified) intramuscularly to prevent human papillomavirus (HPV). On an unknown date in July 2017 (reported as "a few days later"), the patient experienced influenza like symptoms. The patient did not sought for medical attention. No treatment was given for the event and no lab diagnostics /studies performed. The outcome of the event was reported as recovered/resolved in 2017. Causality was not reported.
suspected vaccination failure/both doses and still got shingles; shingles/Mild case but still excruciating; Mild case but still excruciating; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received both the doses and still got shingles. Patient stated that stress was powerful thing. It was a mild case but still excruciating. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details found.
This is a spontaneous report from a contactable nurse via Pfizer sales representative, who reported similar events for two patients. This is the second of two reports. A male patient who was in his late 60's received  a single dose of  PREVNAR 13, on an unspecified date in arm because he was getting a cochlear implant.  The patient medical history and concomitant medications were not reported. On an unspecified date the patient's arm became red, hot, and hard. The adverse events took 2 to 3 weeks for the patient to completely recover.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2016547356 Same reporter/drug/event, different patient.
Dizziness and shaking fainted - Physician called to evaluate the patient. Patient transferred to gurney from chair.  Vitals checked BP:95/60 Pulse: 70 o2:99%   After few minutes patient responds and stoked she fells better now.  Patient stated she usually fainted whenever any blood was done on her.  Patient had sips of water and said she is normal now.  Suggest her to stay for more 30 minutes for evaluation. BP: 98/65 Pulse: 74 Advice her to consult her primary physician about adverse reaction. Patient left for home with husband.   #21 Went home
significant swelling and injection site reaction??? at back of tricep (not in deltoid).  discussed with administering rph and he stated he gave IM in the deltoid though.  originally I had suspected a SC administration due to area of reaction as was below deltoid and towards posterior aspect of arm.
She received her first COVID vaccine on 2/24/2021 and her second COVID vaccine on 3/24/2021.  She had some arm soreness following the second shot.  On the morning of 3/26/2021, she awoke with fevers, chills, body aches, diaphoresis and shaking.  Her symptoms minimally improved with Tylenol.  She recorded her temperatures with the highest being 102.7 F this morning.  She reached out to her hematologist who recommended coming to the ED.  On admission she was noted to be pancytopenic with neutropenia ANC 100 and febrile 102.7F. CXR was clear, UA showed no pyuria, and CT chest/abd/pelvis was unremarkable.  She reports she did not develop diarrhea until she arrived at the hospital. C.diff testing was sent and returned positive.    Although fevers have been reported up to 7 days post COVID vaccination, I am not aware of reports of it causing pancytopenia. It is not clear if C.diff or other infectious etiology contributed to her pancytopenia or if her pancytopenia is a result of severe infection. Considering she did not have any recent insult that would have induced the C.diff infection (last chemo in Jan and no recent antibiotic use), no diarrhea prior to admission, and no CT evidence of significant colitis, I suspect her profound pancytopenia is what caused her C.diff to flare.   Unsure to what caused the pancytopenia, considering the vaccine.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Medium, Systemic: Exhaustion / Lethargy-Severe
SUBCONJUNCTIVAL HEMORRHAGE(RIGHT EYE, SAME SIDE AS SHOT)  BREAKTHROUGH BLEEDING
Chest tightness, spasmodic retrosternal pain. Occurred within 24 hours after first dose and 48 hours of second dose.
This spontaneous report as received from a consumer's friend refers to a patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On 21-OCT-2013 the patient was vaccinated with PNEUMOVAX 23 (lot, dose and route not reported). Concomitant medication was not reported. On 21-OCT-2013, the reporter stated that the patient received an overdosage of PNEUMOVAX 23 (also reported as received the large dose). The reporter also stated that she was unsure if the patient had experienced any adverse effects at this time. Additional information is not expected.
A few days after the 2nd modern vaccine began feeling nausea, general malaise, low energy.
Day after shot felt very tired  with headache and sore all over especially joints. Starting on the morning of the second day after swelling in glands around my underarm. The one between my underarm and breast is the size of about 2.5 golf balls placed side by side. Some swelling in face on same side and gland under cheek, near ear swollen. All very sore and uncomfortable.
Headache; Chills; This is a spontaneous report from a contactable consumer. A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an intramuscular route of administration in the left arm on 29Apr2021 at 09:00 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an intramuscular route of administration in the left arm on 06Apr2021 at 09:00  (at the age of 17-year-old) as a single dose for COVID-19 immunisation. On 29Apr2021 at 22:00, the patient experienced headache and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events headache and chills were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Cough; A little congestion in my throat; My head was stopped up a little bit; A spontaneous report was received from a consumer concerning himself a 73-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events cough, a little congestion in his throat/nasal congestion, his head was stopped up a little bit/headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 19 Jan 2021, the patient experienced the event(s) cough. a little congestion in his throat, his head was stopped up a little bit.  Treatment details included natural herb cough drops.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s) cough, congestion in throat and his head was stopped up a little bit were resolved on 27 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.
Contracted a severe acute sinusitis; Was losing voice; sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2022 at 16:00 as dose 2, single (Lot number: FK9896) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Herpes" (unspecified if ongoing), notes: Herpes, asthma, migraines; "Asthma" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Sulfa" (unspecified if ongoing); "Tomatoes, Eggs" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. Past drug history included: Naproxen, reaction(s): "Known allergies: naproxen", notes: Sulfa, Naproxen, Tomatoes, Eggs. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FL3198, Location of injection: Arm Right, Vaccine Administration date: 12Jan2022, Vaccine Administration Time: 02:30 PM), administration date: 12Jan2022, when the patient was 43-year-old, for Covid-19 immunization.  The following information was reported: ACUTE SINUSITIS (medically significant) with onset 14Feb2022 at 12:00, outcome "recovered" (2022), described as "Contracted a severe acute sinusitis"; APHONIA (non-serious) with onset 14Feb2022 at 12:00, outcome "recovered" (2022), described as "Was losing voice"; OROPHARYNGEAL PAIN (non-serious) with onset 14Feb2022 at 12:00, outcome "recovered" (2022), described as "sore throat". The events "contracted a severe acute sinusitis", "was losing voice" and "sore throat" required physician office visit. The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (14Feb2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of acute sinusitis, aphonia, oropharyngeal pain. The patient AE treatment included: Antibiotics, allergy medicine and steroid shots. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. The patient had no fever.
This spontaneous report was received from a medical assistant referring to a patient of unspecified gender and age. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On 21-SEP-2017, an improperly stored dose of ROTATEQ 2 ml, once, lot number M045544, expiration date 23-JUN-2018 (route of administration and anatomical location were not reported) was administered to the patient. The dose was stored in temperature 33.8 degrees Fahrenheit for 20 minutes and in temperature 35.8 degrees Fahrenheit for 2 minutes. No previous temperature excursions were reported. No adverse effects have been reported. Data logger was involved. Product quality complaint was not involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA012899: US-009507513-1709USA012898: US-009507513-1709USA012896: US-009507513-1709USA011805:
Most arrhythmias and heart beat subsided; Most arrhythmias and heart beat subsided; Pain in arm kept her awake that night; This is a spontaneous report from a non-contactable consumer (patient).   A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced arrhythmia, heart rate abnormal and pain in arm. The events were described as "some side effects she had the first 5 minutes after the injection most arrhythmias and heart beat subsided within first 5 minutes of having the shot, they asked me to wait 15 minutes. The pain in arm kept her awake that night". The patient recovered from arrhythmia and heart rate abnormal on an unspecified date, while clinical outcome of pain in arm was unknown at time of this report.  No follow-up attempts are possible, information about lot number cannot be obtained.
Patient began feeling nauseated about 5 minutes after her dose.  She started feeling a little better at about 15 minutes post dose but still some nauseousness.
Flu-like symptom; Had ringing in her ears; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptom) and TINNITUS (Had ringing in her ears) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044BZIA and 040AZiA) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptom) and TINNITUS (Had ringing in her ears). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptom) and TINNITUS (Had ringing in her ears) outcome was unknown.            No concomitant medications were reported. The patient had not undergone any treatment.   Action taken with mRNA-1273 in response to the events were not applicable.
On 1/23 while exercising I noticed blotchy vision in my right eye that seemed to come on suddenly. On 2/3 I was diagnosed with a Branch Retinal Vein Occlusion.  I don't have any risk factors for this, and extensive lab work all came back negative. Although I don't know that the vaccine was the cause, I am suspicious that it may have been, and so am wary of taking a booster shot.
Pt presented to Urgent Care 5/5/16, c/o fever/chills and body aches since 5/4/16 PM. (L) deltoid noted redness, induration, pain and decreased ROM. Ceftriaxone 1 gm with Lidocaine IM XT, Cephalexin 500 mg QM x 10d.
Severe, continuous, ringing in right ear and diagnosis of "Tinnitus" in past two weeks.   Right knee pain with negative X-ray.
Death within 60 days of vaccination.  Tested positive for COVID-19 2/8/2021, admitted outpatient to Hospital 2/8-2/10 readmitted 2/13-2/14 with transfer to Medical Center in with death on 3/2/2021.
Pt felt ill like viral syndrome for one week, briefly fainted one day. Had weakness and chills.
Severe peripheral neuropathy c/w Guillain Barre syndrome and acute respiratory failure.