chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient passed out about 5 minutes after receiving flu vaccination. She was waiting outside the vaccination room with her dad and her sister and reported to have just fell down and passed out just for a few seconds and then regained consciousness immediately.  I was still in the vaccination room giving shots to her other family members at the time she passed out. She said she felt ok afterwards, but I could tell she was a little nervous from what just happened to her. I recommended that she take a seat for at least 15 minutes and have some water. I told the family to please contact me/ her doctor if there was anything abnormal that occurred once they returned home.
Patient became unresponsive (fainted) and had appeared to be having involuntary body movement.  When she came to, she felt dizzy, was sweating and experienced blurred vision. Had no recollection of her fainting and that she had been speaking, but not making any sense.
Chronic Cough, loss of voice, wheezing in lungs, easily SOB, sinus issues, runny nose. CXR unremarkable. Went to urgent care multiple times with no medications/ treatments successful. Referred to pulmonologist and was put on breathing treatments, inhaler and steroids and antibiotics. Treatment successful and began to improve. Received second vaccine on 11/18/21 and all of the above re-occuring and is still on going and pt being treated by pulmonologist.
Abdominal pain, Headaches, chest pain, loss of appetite, confusion, elevated liver enzymes 1/8-1/15/21
Medivaced on 9 Nov 2007, with coronary artery disease symptoms. Diagnosed with myocarditis due to small pox vaccine and sent for further treatment. Currently being treated for pericarditis and cardiomyopathy due to heart damage by the military.  01/31/08 MR received for several F/U OVs in Nov and Dec 2007 for past episode of pericarditis/myocarditis for which pt was hospitalized.  Pt developed exertional chest pain and SOB.  Pain increased with deep breathing. Pt reports chest fluttering, night sweats, and fevers.  03/05/2008 Hospital records received for DOS 12/7-8/2007 with DX: Shortness of Breath.  Cardiomyopathy. Secondary Dx:  Borderline HTN. Pt referred to ER for further eval of orthopnea, paroxysmal nocturnal dyspnea, fatigue, pedal edema and abdominal bloating.  Pt developed sx of exertional dyspnea, nausea, chest discomfort and diaphoresis in October 2007 while overseas. Pt had cardiac catheterization overseas. Pt currently showing Class 3 heart failure sx. Meds adjusted during hospitalization and to be f/u as outpt.. 1/20/2010 Congestive Heart failure.
Fever (101) headache, shaking, body aches, nausea, vomiting, diarrhea lasting three days.
This EE was fully vaccinated on 12/23/2020 and 01/13/2021.
Left clinic and went to store. Fifteen minutes later noticed "whelps all over". Reports head, feet, fingers and hands started itching; fingers swelling. Took Benadryl 25mg "po" stat. Went home a gave self epi-pen injection - responding quickly per patient.
Patient has a rash started in high chest area and has spread over last few days to lower abdomen Advised to consult physician
1 week after 3rd dose, pt developed shingles rash/herpes zoster to left forehead (same place she has had shingles in the past)
Positive for COVID; Positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Oct2021 as dose 3 (booster), single (Lot number: Fh8020) at the age of 23 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 08Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Possible tuberculosis" (unspecified if ongoing), notes: was treated for 6months. Concomitant medication(s) included: AZITHROMYCIN, start date: 16Jun2022, stop date: 20Jun2022; BENZONATATE, start date: 15Jun2022, stop date: 21Jun2022. Past drug history included: Ceclor, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "Positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The patient received treatment of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Drug ineffective", "COVID-19" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
No adverse events reported by patient's mother besides body aches and headache for a day or two after vaccination
A non-serious, spontaneous report of accidental exposure while administering drug and "got sick" has been received from a company representative concerning an adult female nurse subsequent to FLUMIST administration. Medical history and concomitant medications were not reported. The patient administered FLUMIST to other people several times over the past two years. The patient reported that if she did not wear a mask while administering FLUMIST, she would "get sick". She believed she became ill due to close proximity to patients during FLUMIST administration. No additional information was available. The company representative reported that the nurse believed she became sick due to exposure to FLUMIST (related). The outcome of the events was not reported.
45 minutes after receiving immunizations, broke out with large hives, progressing to all parts of body.  No shortness of breath.  Some Asthma, wheezing.  Treated with oral prednisone and Syrtec with swedess.
Seen in urgent care approx. 30 minutes after vaccination for diffuse muscle aches, nausea and dizziness, her BP was elevated. Treatment dugs:
Information has been received from a health professional concerning a 13 year old female patient who on 18-AUG-2008 was vaccinated intramuscularly with 0.5 mL PNEUMOVAX 23 vaccine (lot # 659010/1537U). There was no concomitant medication, no allergies and no pertinent medical history. On 19-Aug-2008 the patient developed a local reaction at injection site including pain, erythema, warmth, fever of about 102 degrees F, and tiredness. The patient sought unspecified medical attention. On an unspecified date, the patient recovered from local reaction at injection site including pain, erythema, warmth, fever of about 102 degrees F and tiredness. No other information was available. Additional information has been requested.
I26.99 ACUTE PULMONARY EMBOLISM 10/1/2022 LONG TERM METHOTREXATE THERAPY J96.00 ACUTE RESPIRATORY FAILURE 9/19/2022 LONG TERM METHOTREXATE THERAPY I26.99 ACUTE PULMONARY EMBOLISM 10/1/2022 CANCER METASTATIC TO VAGINA J96.00 ACUTE RESPIRATORY FAILURE 9/19/2022 CANCER METASTATIC TO VAGINA
Headaches going over 2 weeks without relief. Testicular pain for 1 week has subsided.
3/22/21 -- vaccine administered at approx 9:35am.  Soreness near the injection site in the arm began at approx 4pm.  Patient felt significant general fatigue beginning around 7:30pm, a sudden, overwhelming desire to sleep.  Around the same time, the patient's upper left arm/shoulder area progressed to being too sore to be able to move the limb independently.  Patient felt significant body aches (similar to what is commonly experienced with the flu) and chills by around 11pm and continued experiencing the drastic arm soreness.    3/23/21 -- by 1am, patient experienced mild nausea and also a big headache in addition to the symptoms previously listed.  By 7am, the arm soreness had improved significantly, the nausea/chills were gone, but the headache and body aches were still present and significant.  By noon, the headache was mostly gone, and the body aches had improved by 50%, and the arm soreness was almost gone.  By 5pm, the body aches and headache were finally gone.
Headache day 1. Aching sore body, severe back pain and fatigue for 7 days. Diarrhea and nausea on days 6 and 7 after vaccine.
Had an accident (concussion/head injury) and was in the hospital for 8 days; Had an accident (concussion/head injury) and was in the hospital for 8 days; This is a spontaneous report from a contactable nurse. An 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 20Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 26Jan2021, she had an accident (concussion/head injury) and was in the hospital for 8 days. She missed her second dose and is trying to get a second dose. Her local vaccination site is refusing to give her the second dose because it is out of the 6 week window. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.; Sender's Comments: Based on information provided, the events of concussion/head injury are accident but unrelated to bnt162b2. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Feverish feeling night sweats, starting day after vaccine. Day 3 got myalgias and headache. Myalgias passed and headache, severe, coming in waves, has persisted x last 2 days.
Pt. said as an outcome of flu shot she have severe diarrhea, vomiting and was splitting blood. Had to go to ER.
Pt. reports L arm numbness from elbow down to fingertips and cotton mouth while in observation after receiving vaccine. Shortly after she c/o of pain in L hand and L hand drawing up. Vital signs assessed and EMS called. Tingling went away briefly but came back 2 minutes later. Pt. is allergic to Trumpet and Morrell mushrooms(anaphylaxis), she carries an EpiPen. Pt. refused to go with EMS and stated she would seek treatment on her own. Pt was monitored for additional time and released. She stated she felt much better and denied any symptoms other than still experiencing a "claw hand" .
The patient started experiencing discomfort at the injection site several days after the vaccine was provided. The pain has remained intense and localized to her left deltoid region. At the time of the report there was no noticeable inflammation or redness at the injection site.
Pain in L/arm @ time of injection on 9/29/99.  Pain has persisted and arm continues to weaken.  Cannot lift anything with arm.  Saw a doctor and was advised to see a bone doctor.
Pt administered 1st dose of Moderna Covid vaccine 1/30/21. Pt is 17 years old. Vaccine is currently approved for 18 and over. No adverse effect
This is in follow-up to report(s) previously submitted on 10/12/2007; 1/7/2008; 4/7/2008. Information has been received from a consumer concerning her 19 year old daughter with a sulfonamide and AUGMENTIN allergy, asthma and seasonal allergies and no pertinent medical history who on 02-FEB-2007 was vaccinated with a first dose of GARDASIL (lot# unknown) 0.5mL IM in the left deltoid.  There was no concomitant medication.  On approximately 02-FEB-2007 after the injection the patient developed a headache, injection site pain and felt lousy.  Medical attention was not sought.  On an unspecified date the patient recovered.  On 04-APR-2007 the patient was vaccinated with a second dose of GARDASIL (65376/0014U) 0.5mL IM in the left deltoid.  On approximately 04-APR-2007 after the injection the patient developed a headache, injection site pain and felt lousy. The patient also developed a "hives like rash." On an unspecified date the patient recovered.  On 13-JUN-2007 the patient was vaccinated with a third dose of GARDASIL (lot# 656850/0245U) 0.5mL IM in the left deltoid.  On approximately 13-JUN-2007 after the injection the patient developed a headache, injection site pain and felt lousy. The patient also developed a rash three times. The third rash started in November 2007 and was so severe that the patient missed 2 days of school and was admitted to the hospital. The patient treated intravenously with BENADRYL and cortisone. On an unspecified date the patient recovered from the headache, injection site pain, and feeling lousy. It was reported that the rash had gotten better but had not went away.  Additional information has been requested.  Follow-up information was received from a physician. It was reported that on an unspecified date the patient had a lump under the skin approximately 1 cm by 1 cm with the second or third injection for 2 to 3 months and was tender. Additional information is not expected. Follow-up information was received from the mother of the patient reporting that her daughter on 02-FEB-2007, experienced another rash on her hands and feet which was very painful. On an unspecified date, the patient recovered from the rash on her hands and foot. She said that her daughter had a lot of tests which all came back negative (Tests no reported). Additional information has been requested.
Left arm is swollen from upper shoulder area almost to elbow, red, and feverish.
Fainted after receiving her shot; disoriented for 10-15 seconds; vomited after that.  EMT called for transport to hospital.
Guillain-Barre Syndrome. Pt. admitted 11/4/11 to hospital.
Itchy red round rash about the size of a tennis ball. Hard and warm to the touch
sick; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20th October 2021, the patient received the 1st dose of Shingles vaccine. In October 2021, less than a week after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received first shot Wednesday.  The patient was very, very sick.  The patient would not get the second shot.
PPSV 23 WAS ADMINISTERED SOONER THAN RECOMENDED SCHEDULE LAST PPSV 23 WAS 10/11/2019
Patient received vaccines in office 8/30/17. Patient was found unresponsive by parents at home 8/31/17 and was unable to resuscitate and resulted in death.
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 60 year old female patient. No information was provided regarding medical history, concurrent conditions, concomitant medications, drug reactions or allergies. In May 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced Herpes zoster and she was treated by a physician for the event. The outcome of the event herpes zoster was not reported. The reporter considered the event of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Headache, increased fatigue, by the next morning was experiencing increased eye fatigue resulting in blurred vision. VA on exam today was 20/20 OD OS OU. PE unremarkable.
Vaccinated = 20 July. Stiff neck = 1 Aug. Body aches/stiffness, fever (102.5) = 2 Aug. Had blisters on stomach, back and face = 5 Aug. Valtrex prescribed by civ dr. for chicken pox.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FEELING HOT (felt a little warm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FEELING HOT (felt a little warm). At the time of the report, PAIN IN EXTREMITY (sore arm) and FEELING HOT (felt a little warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.    This case was linked to MOD-2021-018268 (Patient Link).   Reporter did not allow further contact
Stiff shoulder and neck on the side of the injection, light headache when standing, feels nauseous and warm on the face and neck the next day.
when gotten the shot, he/she get sicker than a dog; Initial information was received on 11-Nov-2020 regarding an unsolicited valid serious case received from a consumer (patient) via social media.   This case involves a patient (unknown demographics) who got sick (got sicker than a dog) (illness), after the patient received INFLUENZA VACCINE (shot).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (Unknown latency) the patient got sick (got sicker than a dog) (illness) everytime after getting the INFLUENZA VACCINE (shot).   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information available on batch number for this case.
Terrible Itch; Rash on both legs, back upper arms; swelling in both legs; swelling top of feet; Swelling in both ankles/Swelling in both knees; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in both legs), PERIPHERAL SWELLING (swelling top of feet), JOINT SWELLING (Swelling in both ankles/Swelling in both knees), PRURITUS (Terrible Itch) and RASH (Rash on both legs, back upper arms) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, High cholesterol and Penicillin allergy (Joints swelled up.). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, LEVOTHYROXINE, AMLODIPINE and LOSARTAN POTASSIUM (TEMISARTAN) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling in both legs), PERIPHERAL SWELLING (swelling top of feet) and JOINT SWELLING (Swelling in both ankles/Swelling in both knees). On 10-May-2021, the patient experienced RASH (Rash on both legs, back upper arms). On an unknown date, the patient experienced PRURITUS (Terrible Itch). At the time of the report, PERIPHERAL SWELLING (swelling in both legs) and RASH (Rash on both legs, back upper arms) had resolved, PERIPHERAL SWELLING (swelling top of feet) and JOINT SWELLING (Swelling in both ankles/Swelling in both knees) was resolving and PRURITUS (Terrible Itch) outcome was unknown. Not Provided          Treatment medication included slept with feet on pillow for 6 nights and calamine lotion for rash.   This case was linked to US-MODERNATX, INC.-MOD-2021-077853 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up received on 17-May-2021 and updated patient address, demographics. Added concomitant products, New events were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077853:first dose vaccination
Migraine-like headache that didn't go away with acetaminophen (Ibuprofen taken 90 minutes later, and both together worked) followed by days of fluctuating temperature, from fever to hypothermia (95 degrees), woozy head verging on vertigo, nausea and decreased appetite, indigestion after eating, currently ongoing (after 3 days)
Moderna Covid-19 vaccine EUA. Rash, burning sensation, and itching begins at bottom of feet and then moves up to the upper torso. Have been taking Benadryl to provide relief from the burning and itching. Began approximately at 9 PM of Friday 3/5. If I do not take the Benadryl the rash, burning, and itching spreads from bottom of feet to the upper torso within 15 to 20 minutes.
Information was received from a registered nurse concerbing a patient who was vaccinated with a second dose of PPV.  It was reported that the patient received a second dose within 6 months of the first dose.  Subsequently the patient experienced "systemic reactions" (e.g. fever).  Unspecified medical attention was sought.  The patient's outcome was unknown.  No product quality complaint was involved.
Patient reported lingering pain in the left arm / shoulder post vaccination. She indicated she was going to physical therapy to help with the pain.
Pt recv vax on 10/14/97; on 10/15/97 pt exp red, warm, tender vax site
Patient had light-headedness and fatigue x 2 weeks post-vaccination, starting approximately 2-3days after vaccination and ongoing to date (from 6/15/21-7/2/21). No threat or bodily harm noted.
Her arm was swollen, red, purple red and unable to lift. Pt went to ER. She has a steroid shot and 4-5 days of steroid pills.
Medical assistant administered Oral Rotavirus with out any complications. Proceeded to next vaccine PENTACEL. Patient started crying. Proceeded with next vaccine Hepatitis B and immediately MA noticed patient was holding his breath, turning blue, body stiff and eyes rolling to patients right side.  MA picked up patient and his body fell limp in her arms and loss consciousness momentarily and then regained consciousness again. Dr. was called in to exam room to examine pt. He was kept 30 minutes post injection for observation. He was alert and playing. Following my face with his eyes and responsive to stimulation and interacted with mother and siblings. No reaction or redness to injection sight noted and breathing stable.
Patient received a COVID 19 12and up vaccine one day after Beyond use date ( date since being in fridge). Box expiration date is 06/30/2022.
Shot given on 10-10-07. That evening deltoid muscle was red with splotches. The next morning she had severe pain in shoulder which then progressively moved down to biceps muscle. 10-13-07 Came back to pharmacy with red, tender left biceps. We called her primary care MD and filled Keflex 500 mg # 28 - possible cellulitis versus local reaction. Spoke to husband on phone 10-17-07 - he says she is doing much better.