chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Saddle pulmonary embolus; This literature-non-study case was reported in a literature article and describes the occurrence of PULMONARY EMBOLISM (Saddle pulmonary embolus) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE: Emergency room imaging findings in patients presenting after COVID-19 vaccination. Imaging Sci. 2022;12     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PULMONARY EMBOLISM (Saddle pulmonary embolus) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (Saddle pulmonary embolus) 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 considered PULMONARY EMBOLISM (Saddle pulmonary embolus) to be related.    Concomitant and treatment medications were not reported.  This study was carried out on vaccinated patients who underwent imaging studies in the ER between December 2020 and August 2021.  Chest pain, cough, shortness of breath and headache are the most common presenting symptoms in the ER after COVID-19 vaccination.  Company comment-This literature-non-study case concerns a 30 year old female patient with no medical history reported, who experienced the unexpected serious (medically significant) AESI of Pulmonary embolism (reported as Saddle pulmonary embolus) that occurred 4 days after first dose of mRNA-1273 vaccination. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the event was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.   This case was linked to US-MODERNATX, INC.-MOD-2022-629822 (E2B Linked Report).; Sender's Comments: This literature-non-study case concerns a 30 year old female patient with no medical history reported, who experienced the unexpected serious (medically significant) AESI of Pulmonary embolism (reported as Saddle pulmonary embolus) that occurred 4 days after first dose of mRNA-1273 vaccination. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the event was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information. US-MODERNATX, INC.-MOD-2022-629822:Patient 2 (82-year-old man)
Pt called complaining of inability to raise arm without pain. Recommended 2nd dose of ASPIRIN and follow up with PCP if no improvement 9/29/09. (Right arm).
Information has been received from a medical assistant concerning a female (age not reported) who on an unspecified date "within the last several months, no exact date given" was vaccinated with PNEUMOVAX (lot # unknown) injection.  On an unspecified date, the patient had the onset of a few symptoms after receiving PNEUMOVAX.  The patient suffered soreness at the injection site on the first day and for the next several days, up to three days after the patient experienced soreness at the injection site, malaise and difficulty lifting her arm.  Patient was not aware of any additional medications at this time.  At the time of reporting it was not reported if the patient had recovered.  Additional information is not expected.
Severe back pain. Cannot walk. Extreme difficlty standing, sitting, moving.  Spent most of first 3 days on the floor.
Developed Immune thrombocytopenic purpura (ITP) - Blood Platelet count dropped to 5000
During observation after patient received 2nd dose Pfizer vaccine, patient complained about chest pain, BP 173/81. Patient described chest pain before receiving vaccination when being evaluated in observation. Taken to ED and admitted to hospital. Noted to have ischemia on stress test with multivessel disease. Patient discharged from hospital.
positive for COVID-19 after 1st dose; positive for COVID-19 after 1st dose; This is a spontaneous report from a contactable nurse.  A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The nurse was inquiring about receiving the second dose of vaccine after testing positive for COVID-19 after 1st dose. Outcome of the event was unknown.  Information on Lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  Further information like confirmative virus genome /nucleic acid detection needed for meaningful medical assessment.
Patient became flushed and said she felt hot and that her stomach felt tight. She was given a cool compress (water bottle) and stayed in the pharmacy area 30 minutes and did not require further treatment.
Patient developed 3 - 5 vesicular lesions on torso 2/8/14.
Cough; shivering; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (shivering), PYREXIA (fever) and COUGH (Cough) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product LENVATINIB MESILATE (LENVIMA) for Liver carcinoma.    No Medical History information was reported.   On 30-Jul-2021, the patient started LENVATINIB MESILATE (LENVIMA) (Oral) 8 milligram once a day. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (shivering), PYREXIA (fever) and COUGH (Cough). At the time of the report, CHILLS (shivering), PYREXIA (fever) and COUGH (Cough) had resolved. Unknown          Patient started drug therapy of Lenvima for lung cancer due to which patient experienced adverse events stated as increase in blood pressure- improved; constipation/stomach bloating - on and off since last report.  In follow-up New report stated occasional "knot in the middle of chest/6 out of 10 pain level/at times, after a meal", stomatitis, on and off lower back pain, abdominal pain (affecting night sleep)- MD aware and it was advised patient to miss one dose and take Lenvima in the morning (night sleep- improved).  Patient recently also had Flu Vaccine.  Patient was prescribed with magic mouthwash for relief of stomatitis.  Treatment product information was not provided. Concomitant product use was not provided.
My arm hurt for 1 day and then 2 days of eye lid swelling which dosent go away. Pain around swelling.
info was recv by pharm concerning pt who was vax sometime in 1995 & pt failed to seroconvert. pt was given booster vax & seroconverted, pharm rpt pt recently had titers checked & was seronegative again. addl in for req
9/30/16 pt. felt chill and feverish. 10/1/16 took oral Typhoid #2 capsule. 10/2/16 cramping in stomach 9 in 0-10 pain scale, last for about 5 sec. 25-30 time in that day, felt like having diarrhea, but just passed some gas 10/3/16 felt fine, took oral typhoid #3. 10/4/16. Same reaction like 10/2/16. Pt. took some PEPTO BISMOL.
Diarrhea- started around 1am, on and off for 12 hours.  Fatigue-from  9am-10pm  Muscle soreness-at vaccintion site on left arm, both shoulders, upper back, neck. Lasted all day while awake.
Patient described welps down her arm, migraine like pain in head and neck and neck that was not migraine per patient. Local redness and pain redness down arm, lasting 3 days then resolving. Symptoms began about 30 min after shot.
Pt received 2nd dose of MENACTRA along with a PPD placement on 8/28/18 approx 15.05pm. About 7 minutes after injection pt c/o feeling lightheaded, turned pale and blacked out. Pt did not fall, was sitting in chair. I immediately laid her down and took her vital signs which were normal. Pt had high level of anxiety prior to vaccine, also stated after the fact she had not eaten anything that day.
Fever 105.4 then 104.6 and 104.0 got the night of shot until 4 days after with chills, headache really bad and weakness fatigue,  body and joints aches, no appetite,  nauseous essential, saw spots
Violently ill; Low blood pressure; Went into high hypertension; Had really strong reactions; Fever; Chills; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (Violently ill), HYPOTENSION (Low blood pressure), HYPERTENSION (Went into high hypertension), IMMUNISATION REACTION (Had really strong reactions) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced ILLNESS (Violently ill), HYPOTENSION (Low blood pressure), HYPERTENSION (Went into high hypertension), IMMUNISATION REACTION (Had really strong reactions), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, ILLNESS (Violently ill), HYPOTENSION (Low blood pressure), HYPERTENSION (Went into high hypertension), IMMUNISATION REACTION (Had really strong reactions), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Blood pressure measurement: Got low blood pressure and Went into high hypertension.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Patient started treatment on 22-Sep-2022 with Moderna Bivalent COVID-19 vaccine dose 5 for COVID-19 immunization. It was reported the patient was violently ill, got low blood pressure and he went into high hypertension, had fevers, chills, testing his kidney, and had really strong reactions  The lab data also reported, unspecified testing of kidney.  No treatment information was provided.
Patient  states her arm started feeling  uncomfortable as soon as she received the shot.  Stated she had more soreness than usual and was not able to utilize her arm for 'awhile' as she previously had when she had received a flu vaccine.  Patient had not specifically seen the Dr for the arm/shoulder issue, but says she may have mentioned it during a regular office visit.  However, she was not specifically being treated for it.  Patient  says she was already in physical therapy for other issues and her physical therapist believe it is her radial nerve that is the culprit, although she has no issues utilizing  her hand, wrist or elbow.  Patient  states as of mid-December her arm is feeling  better and is self resolving.
At approximately 3:00am on 10/04/16, patient awoke with her chest feeling heavy. She felt that her heart was beating heavily. She went back to sleep then awoke again shaking and feeling cold, heart still felt like it was beating fast/strong. She again fell back to sleep. She awoke at 6:00 AM(when she normally would prepare for work) but felt very tired and weak, her chest still felt heavy. She had recently (7/30/16) suffered a stroke so she was worried that something serious was happening. Her right arm at the site where she had received the PREVNAR 13 vaccine was red and raised. She measured her blood pressure and found it to be 144/102 (her usual reading would be 135/75), her heart rate was 113 (her usual was appx 70). She took her blood pressure medication and a low dose aspirin. She called 911. The EMT found her to have a low grade fever (100.3). She was given an EKG. She was told that she was having PVC's at the rate of 1 every 5 seconds. Her blood work and stress test were normal. She had an elevated WBC which was expected due to her fever. Doctor diagnosed her to have had an adverse reaction to her PREVNAR 13 vaccine. Over time, (2-3 hours) she felt better and her symptoms went away. She was discharged.
Received second dose of Moderna COVID 19 vaccine at 10AM Thursday 05/20.  T+12-18hrs: Feeling flushed. Slightly confused. Body aches build over the night. Wake up with mild/moderate pain in back, knees, arm. Groggy. Went to work on something with a friend at 10:00 AM (T+24Hrs), but had to return home because....  T+24hr: ....headache growing. Went home and found fever at 102°.  Slight chills, bit mainly just heat without sweating. Fever hit 103.2 at peak. Went through 10lbs ice to keep the fever in check. Headache from T24hr-T36HR feels like a spike through the top of frontal lobe to my left eye.  T+32hr: Headache still intense. Only back pain now. Appetite slowly increasing.  T+48hr (Saturday morning). Back pain persists, but mild. Headache gone. Have a relatively normal day.  T+60hrs (Sat. Afternoon): Back pain increasing. Stop all unnecessary lifting/moving.  T+68hrs (early Sunday morning): Go to ER with the back pain. Absolutely excruciating spasms from top of sacrum - roughly LI/12T. Lower back stiff as wood. Given shot or Toradol, dose/prescription to flexiril. I specifically request this plan because usually takes care of the spasms; basically, get me able to move and the pain/spasms will go away.   NOTE: I have a history of back issues in this area, but I have not had an episode in years and certainly never had an episode that works like this with no relief. From about 2017-2019, I r  T+70-78hrs: Feel normal.  T + 78-88hrs: lower back pain comes back with an absolute vengeance.  T+90hrs (early Monday morning): Return to ER. Back pain worse than Sunday morning. Receive toradol shot and prescription Prednisone. Back pain gone by around 10:30 AM. Decide to take prednisone Tuesday morning as its getting a bit late in the day by the time pharmacy fills the prescription.   T+90hrs: Back pain returns in similar fashion as Sunday afternoon. Still. Barely mobile.   T+96 hours: Wake up with lower back pain similar to Sunday/Monday morning. Took prednisone and flexiril this morning.   Please help me.
FLUIDS RUSHING TO HEAD; 2 DIFFERENT BLOOD PRESSURE READINGS ON TWO DIFFERENT ARMS LIKE 40 OR 50 POINTS; LEFT ARM WAS NUMB; METAL TASTE IN MOUTH; BLOOD PRESSURE 260/220; BLOOD PRESSURE WAS SUPER LOW LIKE 50/30; This spontaneous report received from a patient concerned a 36 year old female. The patient's weight was 145 pounds, and height was 64 inches. The patient's past medical history included: transient vertebrobasilar insufficiency (TVI) (in 2018). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022 expiry: unknown) dose was not reported, 1 total was administered on left arm on 20-SEP-2021 for covid-19 prophylaxis. Age at time of vaccination 36 years old. No concomitant medications were reported. On 20-SEP-2021, the patient experienced metal taste in mouth right almost instantaneously after vaccination. On an unspecified date in 2021, the patient's blood pressure was going up to 260/220 and experienced fluids rushing through head which patient felt scary. Patient stated, symptoms were coming and going. Last time patient was sitting at physician office and patient's blood pressure was super low like 50/30 and reported as it will do in like 30 seconds then it will go really high. Then it was 200/250. Patient asked if it could be mast cell. Patient continued reporting sometimes patient had 2 different blood pressure readings on two different arms like 40 or 50 points. Patient also reported when her blood pressure was super high whole left arm was numb patient had extremely different blood pressures on her arms, and patient felt like going to have a heart attack or stroke in the next year. Treatment medications included: cortisone shot right after the vaccine. Patient had multiple emergency room (ER) visits. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the metal taste in mouth, fluids rushing to head, left arm was numb, blood pressure 260/220, blood pressure was super low like 50/30 and 2 different blood pressure readings on two different arms like 40 or 50 points was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20230962553.; Sender's Comments: V0: 20230952401-blood pressure 260/220, blood pressure was super low like 50/30. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
No additional AE reported; Nurse reported that a dose of VARIVAX was administered to a patient after its labeled expiry date.; This spontaneous report as received from a nurse referring to a 13-month-old patient of unknown gender.      The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 08-SEP-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose (strength, frequency, and route of administration were not provided) lot # T029532 and expiration date 01-SEP-2022 (expired product administered), as prophylaxis. The varicella virus vaccine live (oka/merck) (VARIVAX) had not experienced any temperature excursions. No additional adverse event (AE) reported, no product quality complaint involved.
pt recvd DTP/OPV/HIB 245PM on 9JUN92 onset fever 102 2/continual crying 8PM reported to ER; approx 9PM dx DTP rxn;tx APAP, tepid bath, fluids; 10JUN92 onset diarrhea-fever 101;
This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events on three patients. This is the first of three reports. A patient of an unspecified age and gender received PREVNAR 13, (lot N97935, exp. date 12Jan2017, NDC number 0005-1971-01) on the right deltoid muscle at single dose on 12Sep2016 for immunization. Relevant medical history and concomitant medication were not specified. On an unknown date the patient experienced warm, red and swollen at administration site and they turned red like cellulitis. The outcome of the events was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016586404 same reporter, same events, different patients. US-PFIZER INC-2016586398 same reporter, same events, different patients.
Vertigo; Pressure in the head; This is a spontaneous report from a non-contactable consumer, the patient. A 16-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E200173) via an unspecified route of administration in the left arm on 01May2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient did not have any 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. On 04May2021 at 06:30, the patient experienced vertigo and pressure in the head. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 04May2021, the patient underwent SARS-CoV-2 test via nasal swab and the result was negative. The clinical outcome of the events vertigo and pressure in the head were not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Severe fever, vomiting, diarrhea, body aches and shakes, headache, exhaustion, dehydration, disorientation.  Diarrhea  continues for 6 days, culminating in ER admittance with IV drip ,
Administered a Covid-19 vaccine and after 2 minutes of administration the patient fainted falling off his chair.  Once the father notified me and I arrived to check on the patient he was conscious, breathing normally and stood right back up to sit back down on his designated seat.  His father explained that this does occur when he receives vaccinations.  After 20 minutes the patient did leave the pharmacy with no complications.  We called 911 but they did not arrive since the patient was able to get off the ground with no complications.  Patient recieved the shot at 12:47pm and fainted on 12:49pm.  No treatment was administered
0.5ml administered as a third dose.  Patient  was contacted for a well-being check. reports body aches, fatigue. Patient agrees to continue with Tylenol as needed.
eyes were also red; Swelling of the face also in the mouth area, mainly on the right side; Swelling of the face also in the mouth area, mainly on the right side; This is a spontaneous report from a contactable consumer (patient's wife). A 71-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9262, Expiration Date was not reported), via an unspecified route of administration on 26Jan2021 as single dose (at the age of 71-years-old), for COVID-19 immunisation. Medical history included ongoing high blood pressure  (it has been a while since he was diagnosed with this), ongoing high cholesterol  (it has been a while since he was diagnosed with this), type II diabetes mellitus from 2020 and ongoing. The patient's concomitant medications included bunch of unspecified medications but does not had them on hand at the time of report. On 29Jan2021, it had been 3 days, this morning his face was swelled up also in the mouth area, and mainly one side of the face. The entire face was swelled but more on the right side than the left including the mouth area. Like someone popped him in the mouth and knock up the side of head on the jaw area and patient eyes were also red on an unspecified date. The swelling had gone down a little. Patient had received no treatment, but she was getting ready to get Benadryl. The patient was enquiring about Benadryl okay to take or how long it lasts. The outcome of the events was recovering for swelling of the face also in the mouth area, mainly on the right side and unknown for eye were also red.  Follow-up attempts are completed. No further information is expected.
Information has been received from a health care facility concerning and an unidentified patient who in approximately July 2000, was vaccinated with a dose of varicella virus vaccine live. Subsequently, in July of 2000, the patient developed a questionable varicella like rash. The patient sought unspecified medical attention. It was reported that 2 other children in the same health care facility experienced a similar experience following exposure to varicella virus vaccine live. A lot check query was requested by the health care facility. Additional information has been requested.