chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt diagnosed with venous thrombosis in August 2021; unclear if due to IBD or the vaccine at the time of diagnosis
Information has been received from a nurse concerning a 13 year old female patient who on 10-DEC-2008 was vaccinated with her third dose of GARDASIL. The patient since 10-DEC-2008 had rosacea on the face that was worse in the evening. On 10-DEC-2008 later evening the patient had a bad headache, flushed face and achy joints. The patient had visited physician's office for medical attention. Follow-up information has been received from the nurse that the patient was vaccinated with her first dose of GARDASIL (lot # 659962/1740U) on 30-MAY-2008. The patient was vaccinated with her second dose of GARDASIL (lot # 659964/1978U) on 05-AUG-2008. The patient was vaccinated with her third dose of GARDASIL (lot # 660616/0570X) on 10-DEC-2008. The nurse stated that no labs were performed. A physician may ask if there was any correlation of rosacesa and GARDASIL. Additional information has been requested.
Information has been received from a physician referring to a 30 year old female patient with HIV positive. On 20-APR-2015 the patient was vaccinated with PNEUMOVAX 23, 0.5 mL/one time dose, lot # K022886, expiration date: 09-JUN-2016, intramuscularly. Concomitant therapies included NORVIR, sulfamethoxazole, BACTRIM, azithromycin, emtricitabine, TRUVADA and ZOLOFT. The physician reported that following the administration of PNEUMOVAX 23 on 20-APR-2015 the patient experienced chills, and a fever of 101 F on 23-APR-2015. The outcome of the events was unknown. The patient had called the physician's office. Additional information has been requested.
Rash at the site of injection. The doctor described it as a cellulitis rash.  Started small and is now from elbow to shoulder.
Sniffles; Ill feeling/ ILL; Sickness/ Sick; Arthritis/ ARTHIRITIS IN WRIST/ANKLES/KNEES; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Sniffles), MALAISE (Ill feeling/ ILL), ILLNESS (Sickness/ Sick) and ARTHRITIS (Arthritis/ ARTHIRITIS IN WRIST/ANKLES/KNEES) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Sniffles), MALAISE (Ill feeling/ ILL), ILLNESS (Sickness/ Sick) and ARTHRITIS (Arthritis/ ARTHIRITIS IN WRIST/ANKLES/KNEES). At the time of the report, RHINORRHOEA (Sniffles) and ILLNESS (Sickness/ Sick) outcome was unknown and MALAISE (Ill feeling/ ILL) and ARTHRITIS (Arthritis/ ARTHIRITIS IN WRIST/ANKLES/KNEES) had resolved.      This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Concomitant medication was not provided.  No information regarding treatment medication was provided.
THE DAY ATER RECEIVING VACCINE, CHILD COMPLAINED OF ITCHING RIGHT ARM, MOTHER NOTED REDNESS, SLIGHT SWEELING AT SITE OF INJECTION THAT WAS WARM TO TOUCH
High fever, body aches, chills (rigors), sweats and heart racing. Pt was sick for 3 months and still has recurring symptoms.
He c/o of dizziness and diaphoretic, sat down in hallway floor,  placed pt on a stretcher, BP 97/57 ,Hr 48. waited 2 minites,He continued to be diaphoretic, called EMS/ 911, refused treatmen.t 12:40 repeat BP 119/64, HR 84 o2 sat 97% .  Refused additional treatment and walked out of building.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II, lot # reported as L011528, expiration date 03-APR-2017 (strength, dose, route of administration and albumin status were not provided). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Oct2021 as dose 2, single (Lot number: Ep7533) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ENSKYCE, start date: 08May2022, stop date: 14May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19".  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a medical assistant, and refers to a 75 year old patient of unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. On 30-NOV-2017, the patient was vaccinated with improperly stored ZOSTAVAX (lot # N012615 with an expiration date in 16-MAR-2018), for prophylaxis, that underwent a temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit during a time frame of 1 hour. Furthermore, it was also reported that an additional previous temperature excursion was registered from 15 degrees Fahrenheit to 46 degrees Fahrenheit during a time frame of 14 hours and 30 minutes. The vaccine was reconstituted with MERCK STERILE DILUENT. It was unknown if MERCK STERILE DILUENT was properly stored. Digital data logger was involved. No adverse effects were reported. This is one of three cases received from the same source. Sender's Comments: US-009507513-1803USA002223: US-009507513-1807USA010667.
Patient complained of itching and pain at the site of injection. Mother viewed the site on 12/7/17 and saw redness with some swelling. She administered 12.5 mg of BENADRYL per instructions from an RN that she spoke with at office as well as drawing a circle around the edges of the swelling and redness. Patient was evaluated by Dr. on 12/8/17 which she reported increased redness at 3cm in width with blanching and 2 cm induration at the injection site and "not significantly warm". Patient reported pain in the area when not active.
Pt show a fainting look after I gave her FLULAVAL vaccine. Prior to that, I gave her BOOSTRIX vaccine, 5 minutes prior, she start looking pale, so I call for help, and have her sips of water.
This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. On an unknown date, the unspecified number of patients were vaccinated with RECOMBIVAX HB (lot#, expiry not reported) off schedule. No adverse symptoms reported. Additional information has been requested.
His vitals signs was stable after vaccine was administered, but the resident was expired in 85mins after given 1st dose of Covid Moderna vaccine.
Pt was feeling hot and was on verge of fainting. Had pt lie down in supine position and applied ice pack to foreheard and pt felt better
TENIVAC has been drawn into syringe for 25min in 70F; Initial information received on 07-Feb-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a patient with unknown demographics whos tenivac has been drawn into syringe for 25min in 70f while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot number not reported.  On an unknown date the patient tenivac has been drawn into syringe for 25min in 70f (product storage error) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (TENIVAC has been drawn into syringe for 25min in 70F).  At time of reporting, the outcome was Unknown for the event tenivac has been drawn into syringe for 25min in 70f.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
ADR- Chills, sweats, body aches, tachycardia with near syncope and a fall in the shower this am.
the day after vaccination, patient developed hives. Swelling and itching localized to left upper delt area. By time examined on 11/21/07. Decreased swelling. Decreased itching. Some hives still present
mild fever; severe body aches; joint pain; a lot of pain; This is a spontaneous report from a Pfizer-sponsored program Support and a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01May2021 as Dose 2, Single for covid-19 immunization. The patient received first dose of BNT162B2 on an unspecified date for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced mild fever, severe body aches, joint pain a lot of pain. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient was advised to take the second dose outside the window period; her left ear had fluids; Sinus infection; Headache; stuffy nose; ear infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection), HEADACHE (Headache), NASAL CONGESTION (stuffy nose), EAR INFECTION (ear infection) and OFF LABEL USE (Patient was advised to take the second dose outside the window period) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced SINUSITIS (Sinus infection), HEADACHE (Headache), NASAL CONGESTION (stuffy nose), EAR INFECTION (ear infection) and MIDDLE EAR EFFUSION (her left ear had fluids). On 28-Apr-2021, the patient experienced OFF LABEL USE (Patient was advised to take the second dose outside the window period). On 23-Apr-2021, SINUSITIS (Sinus infection) and HEADACHE (Headache) had resolved, NASAL CONGESTION (stuffy nose) and EAR INFECTION (ear infection) was resolving, MIDDLE EAR EFFUSION (her left ear had fluids) outcome was unknown. At the time of the report, OFF LABEL USE (Patient was advised to take the second dose outside the window period) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication were not reported  Patient was treated with unspecified antibiotics   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up document received. Added lab data and an event
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concomitant products included VALSARTAN, TAMSULOSIN, SIMVASTATIN, FINASTERIDE, TRIAMTERENE, APIXABAN (ELIQUIS), METOPROLOL, DIGOXIN and IPRATROPIUM BROMIDE for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow up 01: No new information received.
About 1 hour after the vaccine I had tingling and numbness in the left side of my face. It lasted about 30 minutes and came back intermittently for several days. The morning after I received the vaccine I had a noticeable ringing in my ears when I woke. It lessened and went away after several hours but has been present most mornings since and has lessened and then stopped as the day progressed. Today (5/28) was not present when I woke but suddenly started again about 5:00 pm.
Tinnitus of left ear - fairly severe.  Has not gotten better so am foregoing second shot.
Itchy rash in area below injection site - similar in appearance to hives, about 5" in diameter - persisting since initial date of onset.
numbness in left side fingers only then moved to all over left arm for 2 days. Diarreah 8 times for 2 days. That night developed fever & severe body aches & headache. Was on Tylenol & Advil for 6 days. worked on tues with numb hands & diarreah. took off work for 3 days (wed, thur, fri).
On 9/4/21, she was relaxing when she suddenly began to experience palpitations, lightheadedness, and fading vision. Her palpitations persisted until she arrived in the ED and was found to have a heart rates around 200 bpm and SVT on initial EKG. Valsalva was then performed and she converted to sinus rhythm. 10/29/2021 EP study + AVNRT ablation slow pathway modification
Patient came into the pharmacy today and showed us a raised red area at the injection site. Patient said it hurt but did not itch and it had a bruise as well. Patient did not seek medical treatment.
This non-valid spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 13-AUG-2018, the patients were inadvertently vaccinated with ROTATEQ, orally (dose, lot# and expiration date were not reported) after the product was stored in the shipping container longer than the carton allowed for. No adverse effects were reported. No product quality complaint (PQC) was reported. This is a non-valid case due to lack of patients' identifiers.
Spoke with patient by phone. He described his symptoms after receiving the Twinrix vaccine on 05/30/2007. Will initiate VAERS. When he left the building something seemed wrong with his vision but there was no precise visual problem yet. When he got to work about 10 minute later the feeling that something was visually wrong was increased. Within a couple of minutes he started to see a parabola shape in the left eye. On the medial field of vision was a shimmering and glowing jagged line that formed the shape of a parabola. It was blurry inside the parabola which appeared gold when the left eye was closed. Later the parabola disappeared and was replaced by a jagged line around the field of vision and it was blurry outside the line. When this disappeared a jagged line appeared in the right eye that was almost horizontal and it was blurry around the jagged line. These visual disturbances occurred over a 60 to 90 minute period of time and have not returned. I recommended to him that he see his eye doctor to discuss as there might be a chance that this was not related to the vaccine. I did explain that there is record of visual disturbances as an adverse side effect of the vaccine. I instructed him to not get any more of this vaccine.
pt recv vax 16OCT95 & 17OCT95 pt devel an inj site rxn characterized by warmth & swelling;the rxn has resolved;this is one of two patients @ site who exp above rxn w/the same lot#;
Pfizer vaccine lot EL9262 administered  at 1:57. At 2:23 pm patient complained of shortness of breath. No wheezing or swelling noted. Benadryl 50 mg PO given. Patient declined all other interventions.  No further decompensation noted. Patient was discharged at 4 pm per her request in stable condition.
Patient call in complaining of a swollen tongue with a dry mouth/sore throat. She self-medicated with ibuprofen, APAP, salt water gargles, and BENADRYL.
Tested positive for Covid; lack of effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid) and DRUG INEFFECTIVE (lack of effect) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced COVID-19 (Tested positive for Covid) and DRUG INEFFECTIVE (lack of effect). At the time of the report, COVID-19 (Tested positive for Covid) had not resolved and DRUG INEFFECTIVE (lack of effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     Concomitant product use was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Upon internal review on 06-Aug-2021, an event (lack of effect) was added.
At times it was Throbbing to Pain level 10; Swollen fingers, hands/Swollen feet; Swollen wrists/Swollen ankles; Pain in Shoulders, Hips; Could not walk for several weeks; Loss of Bladder control; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 08:30 (Lot Number: EW0169  (EW969)) at age of 71-year-old as dose 2, single for COVID-19 immunisation. The patient is not pregnant at the time of the vaccination. Medical history included seasonal allergy. Concomitant medications included atorvastatin calcium (LIPITOR); fexofenadine hydrochloride (ALLEGRA); hydrochlorothiazide; multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took potassium chloride (KDUR) and experienced allergy, took bnt162b2 dose 1 on 01Apr2021 08:30 am (lot number=EL3302) in left arm at age of 71-year-old for COVID-19 immunisation. On 25Apr2021 16:00, the patient experienced swollen fingers, hands, (At times it was Throbbing to Pain level 10) wrists ,feet, ankles, pain in shoulders, hips, the patient could not walk for several weeks, lost of bladder control. The events resulted in doctor or other healthcare professional office/clinic visit. The case was reported as non-serious. The patient received treatment for the events included medication and pain medication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolving.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain, injection site erythema and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at the vaccination was not reported. The patient was mistakenly given dose of the SHINGRIX vaccine subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route. The patient also had quite a bit of pain and redness around the injection site but the pharmacist assured the patient that it happened because it was given subcutaneously. At the time of this report, the patient was asking if the patient needed a repeat dose of dose 1 or should just continue with dose 2 in 2-6 months.
Severe dizziness. Dry heaves. Cold sweats. Lasting about 3 hours.
The injection was first of all very high, too high, on my left arm. The nurse stated while giving the injection that I have a very hard muscle - I don't have hard muscles. My arm has lost mobility of motion, tingling in my hand, and I still feel pain at the injection site. I have taken ibuprofen, used ice and heat but pain has not gone away. Also feel burning at injection site and pain in neck area. This pain has affected my sleep and daily life.
pt recv vax 2MAR96 & 5MAR96 pt exp a rash all over body (even scalp);pt recv DPH;rash resolved;
Patient was given Kinrix instead of Pentacel at 2m WCC. Mother made aware at 4p when it was discovered. Child had no sx's of adverse reaction then or on 4/15 at 1045 when f/u call was made.
Headache, nausea, vomiting, fever, chills, loss of balance, blurred vision, numbness or tingling of legs, shoulder pain, stomach pain.
Covid Vaccine related ITP.......red pinpont rash on both legs, blood blisters on lips, tongue, gums and roof of mouth, blood streaks and bruises all over body, platelets dropped to 0 more than once. I was in Urgent Care, 2 ER's and hospitalized from March 14-24, 2021.  I was given 84 bottles of immunoglobulin intravenously and high potency steroids (90 mg., 80 mg.). This did not bring my platelets up so our daughter contacted the wife of the physician who passed from this after his vaccine who in turn gave our daughter the name of another physician who had seen and treated this after the Covid vaccine. He,together with my physicians, came up with an aggressive treatment plan for me. I was given one Vincristine treatment and injections of Nplates to jumpstart my body. This had never before been seen where I was located, as the Covid vaccine is so new. I was a perfectly healthy woman who only took vitamins and had not even had a cold all winter.  Everything else was ruled out.
Numbing, burning, pain, and weakness in both hands and arms. Started on 8/17, progressed on 8/19, numbing and pain was so bad, I went to the ER on 8/22. Left hand was wrapped. Taken off work.  Referred to Orthopedic specialist.  Recommended therapy. Taken off work.
Next day after vaccine was given, I had whole body aches and low grade temp of 100.8.  Off and on chills.  It felt like I had covid all over again  (I tested positive end of October).  Very sore L arm.