chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a certified medical assistant concerning a 72 year old female with osteoporosis and drug hypersensitivity to amoxicillin and a history of migraine and fibromyalgia who on 16-APR-2007 was vaccinated with Pneumovax 23 (lot # 655501/1035F) 0.5 ml IM in the left upper arm.  Concomitant therapy included AMBIEN, amitriptyline hydrochloride (MSD), CAFERGOT, fluoxetine and alendronate sodium (MSD).  On 18-APR-2007, the patient developed cellulitis that was a couple of inches below the injection site (injection site not involved).  The area was warm to the touch and "very slightly" raised.  The affected area was from mid bicep to just below the elbow.  Medical attention was sought.  The patient was told to take TYLENOL and BENADRYL.  The patient was concerned about infection and was referred to urgent care where the physician gave the patient cephalexin 500 mg four times daily for 7 days.  The physician felt that the cellulitis did not require an antibiotic but gave it as a precaution.  At the time of reporting, the patient was recovering.  No further information was available at the time of reporting.  The reporter felt that the cellulitis was serious (Other Important Medical Event).  Additional information has been requested.
Information has been received from a medical assistant referring to a 4 years old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported)(Incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
EXTREME NIGHT SWEATS (OCCURRED DURING DAY ALSO) HEART PALPITATIONS
Episcleritis/scleritis OD (red, irritated eye-no discharge); occurred 12 hrs a/ fever, chills which lasted approx 6 hrs;
Rash on upper back both shoulders and both arms. Vaccine was given 11/14/18 reported by MD on 12/11/18.
pharmacist at a Medical Center that she utilizes refused to give her another Moderna; shingles; itching from the shingles; bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), PRURITUS (itching from the shingles), VACCINATION COMPLICATION (bad reaction) and OFF LABEL USE (pharmacist at a Medical Center that she utilizes refused to give her another Moderna) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included High cholesterol and Chickenpox (in childhood). Previously administered products included for an unreported indication: SHINGRIX in 2017. Concurrent medical conditions included Leukaemia in 1990 and Blood pressure high. Concomitant products included ACYCLOVIR [ACICLOVIR] for Shingles, ACETYLSALICYLIC ACID (ASPIRINE) and RUXOLITINIB PHOSPHATE (JAKAFI) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced HERPES ZOSTER (shingles), PRURITUS (itching from the shingles) and VACCINATION COMPLICATION (bad reaction). On an unknown date, the patient experienced OFF LABEL USE (pharmacist at a Medical Center that she utilizes refused to give her another Moderna). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Shingles, at a dose of 1 dosage form. In March 2021, HERPES ZOSTER (shingles) had resolved. At the time of the report, PRURITUS (itching from the shingles) had not resolved, VACCINATION COMPLICATION (bad reaction) outcome was unknown and OFF LABEL USE (pharmacist at a Medical Center that she utilizes refused to give her another Moderna) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Hematologist believed that the medication Jakafi made her prone to developing shingles, and not the Moderna vaccine. Patient received the J&J (Jansen) vaccination on 03 Mar 2021, intramuscular injection into the right arm., She stated  that took unknown blood pressure medications and unknown cholesterol medication daily.
Patient has currently not had any adverse events, he however was given the vaccine too early. His dose of Prevnar 13 was on 9/11/2020 so Pneumovax 23 was not due until after 9/11/2021.  It was given on 8/20/2021
patient asked to receive the Moderna vaccine first dose. The patient's date of birth was mistaken for 18 yrs old but the actual age was 17. No adverse effects were reported by patient.
Injection side became very red and swollen, hot to the touch within the first 4 hours. Continued to get red and swollen. Managed with Tylenol. swelling reduced on day 5 however on day 7 the site is now red again and hot to the touch.   other side effects during the first 4-5 days included SEVERE headache, SEVERE fatigue, foggy thoughts and cognitive issues.
sz p/100-101 fever started lastingx 30 sec then limp w/postictal period
This spontaneous report was received from a licensed vocational nurse regarding an approximately 64 years old female patient. The patient's current conditions included anaemia, Diabetes, hypertension and hyperlipidaemia with no drug reactions or allergies. On an unknown date in the end of August 2012, the patient was vaccinated subcutaneously with a dose if ZOSTAVAX (lot# and dose not reported). No concomitant medications were reported. After administration of ZOSTAVAX at the end of August 2012, the patient developed a stiff neck. The patient stated that the pain was initially a "9 out of 10" in severity but at the time of the office visit on 15-OCT-2012, the pain had decreased in severity to "3 out of 10". The pain was worse with neck movement. The nurse stated that a carotid doppler was ordered due to a carotid bruit but no treatment was prescribed. The patient sought medical attention(office visit). No treatment was given for adverse events. The outcome of stiff neck and carotid bruit was unknown. Additional information has been requested.
pt recv vax; devel an inc in biliary function & exp a tender liver; sx slowly resolving;
March 25 - loss of taste - March 30 - shortness of breath - resp failure - March 31 - transferred to ER - intubated for three days. Transferred to hospital - March 5 - transferred to Rehab - 4/15; released to home 4/24.
tested positive for a COVID 19 infection; tested positive for a COVID 19 infection; Loss of smell; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on an unspecified date (Lot Number: EP6955) as dose 2, single, via an unspecified route of administration, administered in left arm on 01Mar2021 (Lot Number: EL3248) as dose 1, single for COVID-19 immunisation. Patient 's age at vaccination was 40-year-old. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. No concomitant medication was received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously took cefaclor (CECLOR) and experienced allergy to CECLOR. The patient experienced loss of smell on 23Sep2021. On the evening of 23Sep2021, he tested positive for a COVID 19 infection. The events did not result in emergency room visit or physician office visit. No treatment was received for the events. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included PCR (polymerase chain reaction): negative (Nasal Swab) on 18Sep2021, polymerase chain reaction: positive (nasal swab) on 23Sep2021. The outcome of the event loss of smell was not recovered, outcome of event tested positive for a COVID 19 infection was recovered with lasting effects on an unspecified date.
patient that received an expired dose of GARDASIL 9.; This spontaneous report was received from a pharmacist (also reported as a "physician"), via a company representative, referring to a 22-year-old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On an unknown date, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, route of administration, anatomical location, lot # ad expiration date were not reported). No additional adverse event (AE) details were provided.
Extreme fatigue coming on suddenly after vigorous exercise (first time exercising since booster).  Some chills.  Vomited once.  Did not seek medical attention.  Symptoms lasted 24 hours.
Pt states area of injection became red and swollen. Used cold compress and 1 Advil. Next day and today remains red, swollen and hard per pt.
APPROXIMATELY 24 HOURS POST VACCINATION, MOM NOTED A "RASH" ON BABY'S CHEST.  OF NOTE, MOM STATES BABY TO BE "CRANKY" AND WITH TACTILE TEMPERATURE ON THE DAY OF VACCINATION.  MOM DOES NOT REPORT ANY OF THE FOLLOWING:  COUGHING, WHEEZING, EYELID EDEMA, NOR LIP SWELLING.  RASH IS PAPULAR, NONPURITIC, AND CONFINED TO TORSO ONLY.
Reporting administration error as per Agency. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only incude manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from then.  No adverse reaction reported from the patient at the time of the vaccination and no adverse reaction Reported since given vaccine.
generalized tonic-clonic sz w/fever 102 5 hrs p/vax;
No additional AE's; PROQUAD that underwent a tempreature excursion was administered; This spontaneous report as received from a medical assistant, referring to a patient of unknown age and gender.The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 27-MAY-2021, the patient was vaccinated with an incorrect stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine liverecombinant Human albumin (rHA)(PROQUAD) lot# T035393, expiration date 14-APR-2022, for prophylaxis (strength, dose, route and frequency were not reported).       The temperature excursion was of -58 Fahrenheit degrees (°F) to 5 (°F) (15.2°F), during 2 hours 15 minutes 0 seconds. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
Patient received the vaccine at 11:00 AM. At 12:00 PM reports to school nurse that he felt "sick". Temp 102 degrees F, skin warm and dry, alert and oriented x 3. RR=28, pulse=120. Denies difficulty breathing or swallowing. No localized reaction at injection site. No hives. Complains of headache. Has a history of peanut allergies.
Menactra and Adacel given 4/1508. Slight T-100 on 4/16. Slight headache. 4/17/08 Redness injection site - pain with movement of arm. Redness about 10cm in diameter. No fluctuance at site
Reddening of the skin from her deltoid all the way down to her elbow in patchy areas. Mild redness over the biceps muscle. Face flushed. Symptoms started 1/28/10. TYLENOL to be given as needed for fever.
pt to clinic 23MAY96 lt thigh sl warm & sl swollen;guarding lt thigh;tx warm soaks QID;Ibuprofen given;mom stated 26MAY96 pt had jerking movements, loss of consciousness & vomiting;tx avoid pertussis in future;
ACUTE DVT OF LEFT FEMORAL VEIN 4/23/2023 DM 2 W CKD STAGE 3A (GFR 45-59) HYPOTENSION 5/3/2023 DM 2 W CKD STAGE 3A (GFR 45-59) ACUTE DVT OF LEFT FEMORAL VEIN 4/23/2023 BPH W URINARY RETENTION HYPOTENSION 5/3/2023 BPH W URINARY RETENTION
Disclaimer:  Dates/descriptions are approximate.  This is a follow-up to my initial report filed back in April.    - Immediately after shot: heart rate spike to 180, dizziness, sweating, weakness and pain in hands ? sent to ER for monitoring; - 0-2 months after: Rapid heart rate for first two weeks; pain in extremities and limbs that ?traveled? upwards to hips, spine, and head; burning in mouth; severe headache and facial pressure; burning on scalp: tingling, burning, and numbness in various places on body; tongue pain and burning; feeling of ?manual? breathing; sudden flushing and HR spikes; deep pain?described as bone pain. Two more ER visits, multiple primary care visits, Rheumatology and Electrophysiology visits.  Bedridden for first two months;  medical leave required.  Labwork, X-rays, MRIs ordered.  Rheumatological / autoimmune cause ruled out.  - 2-4 months after: Bedridden; same symptoms plus ongoing muscle spasms and tremors; continuing, severe pain in spine, shoulders, knees.  Unable to tolerate physical therapy.  Additional doctor visits including Neurology visits.   Pain in chest and feeling of pressure on throat.  - 4-6 months out:  Continuing symptoms.  Able to get out of bed for longer periods of the day, but extreme muscle / exertional fatigue from activit.  Rapid HR continues, even at rest.  Dizziness and ?tunnel vision? upon standing.  Cardiology and Electrophysiology appointments; POTS suspected.  More Neurology visits?EMG/nerve conduction study, autonomic testing, and biopsies for small fiber neuropathy.   Echocardiogram, holter monitor.  Insignificant findings.  - 6-8 months :  Continued symptoms, but improving.  Rapid HR, dizziness, muscle fatigue/pain/weakness, unexplained rashes, tongue/mouth burning.  Continuing bone pain sensation.   Diagnosed with mast cell disorder by Allergist/Immunologist; advised that symptoms were a reaction to the vaccine.  Neuro treating heart issues as POTS.
This case was reported by a nurse via call center representative and described the occurrence of fever in a child male patient who received KINRIX (batch number 53NB2, expiry date 10th November 2018) for prophylaxis. Concomitant products included PROQUAD. On an unknown date, the patient received KINRIX. On an unknown date, several hours after receiving KINRIX, the patient experienced fever and pain in arm. The patient was treated with ADVIL and TYLENOL. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the pain in arm was unknown. It was unknown if the reporter considered the fever and pain in arm to be related to KINRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed high fevers within hours after receiving the KINRIX vaccine. In addition to the fever the patient also experienced sore in arm. The health care professional recommended TYLENOL or ADVIL for the fever. This case has been linked with US2018112030 and US2018112033 reported by same reporter.
Patient was dizzy, lightheadedness, flushed, warm, and nauseated. This occurred about 15 to 20 minutes after receiving the vaccination.
The patient received a Pfizer vaccine on 12/12/2022 and it was a 12+ vaccine and should have been a 5-11 vaccine. Patients MD, and MA that administered the vaccine were contacted and education is given. The patient's Mother was contacted to report.
5/13/07 Woke up with body ache and joint pain shoulders, ribs, hips and back and forearm pain significant lethargy, sleepiness, difficulty staying audile except for attempts to keep warm or cool off due to chills and excessive heart episodes. No temperature taking Tylenol for bodyaches - x 2 days, better 3rd day but weak.
Mom called and stated that the patient woke up this AM and her gums and lips looked swollen and she had a "mottled" rash on her lower back. Mom gave a dose of Benadryl and the symptoms resolved. She did not have pictures of the findings and she was clear at the time of call to the office.
Right shoulder after the 2nd shot started to swell up.; Arm pit is much more full and feels very sore.; Lymph nodes are swollen.; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on 08Apr2021 at 14:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included a known allergy to fentanyl (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm an unknown date as a single dose for COVID-19 immunisation. On 30Apr2021 at 12:00, the patient reported that his right shoulder started to swell up after the second dose, the arm pit was much fuller and felt very sore. The patients' father who was a medical professional said that the lymph nodes were swollen. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events right shoulder started to swell up, arm pit was much fuller and felt very sore and lymph nodes were swollen were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
First tested positive for COVID on 08May2022 Sunday; First tested positive for COVID on 08May2022 Sunday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6207), in right arm, on 06Apr2021 as dose 2, single (Lot number: ER8729), in left arm and on 19Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE; BUSPIRONE, stop date: 08May2022; LEVOTHYROXINE. The following information was reported: VACCINATION FAILURE (medically significant) with onset 08May2022, outcome "unknown", COVID-19 (medically significant) with onset 08May2022, outcome "recovered" (24May2022) and all described as "First tested positive for COVID on 08May2022 Sunday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Positive, notes: positive for COVID on 08May2022; (13May2022) Negative; (14May2022) Negative, notes: Tested negative each day 14May2022 - 20May2022; (20May2022) Negative, notes: Tested negative each day 14May2022 - 20May2022; (21May2022) Positive, notes: Tested positive on 21May2022; (22May2022) Positive, notes: Tested positive on 22May2022, 23May2022; (23May2022) Positive, notes: Tested positive on 22May2022, 23May2022; (24May2022) Negative, notes: tested negative today 24May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Report about covid treatment was Yes. If vaccine received and other medication in 2 weeks were reported as Yes. Anti-viral details product: COVID 19 treatment, brand: Pfizer, treatment start date: 09May2022, treatment stop date: 09May2022, indication: Treatment of COVID-19. Adverse event was Paxlovid Rebound- First tested positive for COVID on 08May2022 Sunday. Then I started Paxlovid on Monday 09May2022 and took all doses through Friday 13May2022. Tested negative on Friday 13May2022. Tested negative each day 14May2022-20May2022 Tested positive on 21May2022, largely asymptomatic. Tested positive on 22May2022, 23May2022, and then tested negative today 24May2022. Never really had any symptoms-thought they were allergies. Known allergies reported as No.
Fever of 102.2 began 27 hours after the shot.  Extremely sore arm, hurts to move it.   Headache. Dry eyes. Fatigue - extremely tired, took a 3 hour nap.  Cold - not chills, just cold in general.  Gave motrin, but fever is still at 102.0 nearly 3 hours later.
pt recvd vax;started getting cough & shortness of breath;sxs got worse;chest pains & bad ha;felt like had case of terrible flu or a bad heart condition;still felt ill next day;
Syncope on 10/29/2021 Rapid heartbeat 10/31/2021-to ER diagnosed with Atrial Fibrillation. Started on Eliquis. Discharged from hospital on 11/2/2021.
This case was reported by a healthcare professional (pharmacy technician) and described the occurrence of swollen all over in a 37-year-old female subject who was vaccinated with influenza vaccine unspecified (manufacturer unspecified). Concurrent medical conditions included penicillin allergy. In 2008, "about 5 years ago" the subject received a dose of influenza vaccine unspecified (unknown details). In 2008, 30 minutes after vaccination with influenza vaccine unspecified, the subject experienced swollen all over and rash all over. The subject was taken to the emergency room and subsequently discharged. The subject was not hospitalized. The healthcare professional considered the events were disabling. At the time of reporting the outcome of the events were unspecified. The reporter had limited information to provide at the time of reporting. Follow-up information was received on 29 April 2014 via pharmacy tech who reported the subject experienced the events in 2008 and resolved in 2008; dates not specified. The reporting pharmacy tech did not consider the events serious. Details regarding the flu vaccination were unknown as it was not administered at the reporting technician's pharmacy. No action was taken with the flu vaccine; it was unknown if it was reintroduced or if symptoms recurred. No other information was provided.
Noticed the arm the vaccine was administered is weaker and unexplained bruising has appeared on my arm and back... it does not hurt...The bruise on my arm went away as magically as it appeared. The bruise on my back is still showing.
Whole arm swelled, red hot. Cold packs and on March 5, 2015 started an out break of shingles inside the cranium behind left ear area. Causing screaming pain on facial and head nerves 5, 6 and 7. Being treated with prednisone, cyclovera and oxycodone for the next 2 weeks. Over vaccinated!
A report has been received from a physician concerning an adult, male patient (son of the physician). The patient drug history was not reproted. He had a well controlled asthma. In the fall of 2013 the patient received FLUMIST. He experienced several days of fever, chills, and aches and was clinically assessed to have flu in March-2013. Action taken with FLUMIST and outcome of flu was unknown. The report was considered to be non-serious.
Experienced COVID-19; Experienced COVID-19/Suspected COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Experienced COVID-19"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "Experienced COVID-19/Suspected COVID-19".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pale, flaccid difficult to arouse. Also was grunting with possible wheezing, lifeless