chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine exposure during pregnancy with no reported adverse event; Initial information received on 15-Sep-2021 regarding an unsolicited valid non-serious case from an other health professional and physician.  This case involves a 28 years old female pregnant patient who was exposed to vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE]. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported event occurred at 30 weeks of gestation period (exposure during pregnancy).  The date of last menstrual period was reported as 14-Feb-2021.  The estimated delivery due date was 08-Nov-2021.  The information on patient's previous pregnancy was unknown.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 15-Sep-2021, the patient received a dose of suspect FLUZONE (lot 4T7325GA and expiration date: 30-Jun-2022) via intramuscular route in an unknown administration site for prophylactic vaccination.  It was a case of vaccine exposure during pregnancy (same day latency).  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were laboratory data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, patient had no adverse event and the outcome was unknown for the reported event.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.
Patient had immediate swelling and induration in the area fluzone high-dose was given. Patient immediatly went to her dr. shingrix was given with no immediate adverse events.
arm sore 10 mins p/shot, numbness began in neck & spread down lt side-some dizziness-tingling-pt was told to see MD according to pts husbant-did not see a MD;
I went home after dose and a couple hours later I started getting nauseous and my heart was racing and I didn't feel good. I felt fever, withdrawn and feverish. No fever, only feverish. I couldn't sleep, I was agitated and I felt like I had a really bad flu but since my heart was racing I called cardiology on Friday and he put me on heart monitor because my heart was racing. He kept me on it for 4 days to track to see how my heart was doing and he also said that I had inflammation that was due to the vaccine. For a couple days I was very nauseous, and I had palpitations and fluttering in heart. This is still ongoing. I've just been feeling very nauseous for a week and run down and feeling tired. I've also had headaches and I'm concerned about that. It's on and off like a pressure.
Developed chest pain/pressure evening of 2/3/22. Came to Health clinic 2/4/22. ECG mild diffuse PR depression and CRP elevation at 23.4 mg/L; otherwise normal Chest Xray, CBC, CMP, TSH, Sed Rate, Troponin, CPK, D-Dimer, Influenza/COVID negative. Cardiology consulted they diagnosed pericarditis after review.  Started ibuprofen and colchicine; Echo and Cardiology consult pending.
Armpit on injection side was visibly swollen (almost like edema) and pain in armpit while running. When raising arm there was a "zing" to my fingers, almost like impingement on a nerve. 3 days later swelling has subsided somewhat but lymph node pain remains. Lymph nodes on neck and breast seem normal.
Injection site left arm soreness; Injection site left arm soreness more intense, also in shoulder of same side  starting; Injection site left arm soreness more intense, also in shoulder of same side  starting; This is a spontaneous report from a contactable consumer. A 50-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8734 and expiration date not reported) via an unspecified route of administration, administered in Arm Left on 31Mar2021 10:30 as SINGLE DOSE for COVID-19 immunization. Medical history included asthma and possible osteoarthritis still awaiting formal diagnosis once able to return to doctor visits from on an unknown date. The patient's had allergies to sulpha drugs, azithromycin (not had either in a very long time, many years) also allergies to animal dander and sun exposure from an unknown date. Concomitant medications included fluticasone propionate (FLONASE) daily, ascorbic acid (+) boswellia serrata resin (+) chondroitin sulfate (+) collagen (+) glucosamine hydrochloride, hyaluronic acid (+) manganese sulfate (+) methylsulfonylmethane sodium (+) sodium borate (OSTEO BI-FLEX) taken daily, cyanocobalamin (NATURE MADE B12 VITAMIN), Vitamins supplements (one a day Vita Craves and Flaxseed & Tumeric supplements). The patient received first dose of BNT162B2 (Lot/Batch# EN6202 and expiration date not reported) via an unknown route in left arm as SINGLE DOSE on 10Mar2021 at 10:30 AM for COVID-19 immunization and then patient had injection site left arm soreness on 10Mar2021 and resolved on 12Mar2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There are no other vaccines in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. On 31Mar2021 at 11.30, after second dose, the patient experienced injection site left arm soreness more intense, also in shoulder of same side starting. The patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from all events on 02Apr2021.   No follow-up attempts are needed. No further information is expected.
Numbness in right hand, can't move control fingers 8 days later. Feels burning, down back of arm, down the hand.
pt recv vax 21OCT97 4 to 5hr p/vax pt exp photophobia, h/a, stiff neck, generalized myalgia;also the pt has a rash on face that extends across nose, is palpable but does not itch;
continued dizziness and weakness; continued dizziness and weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (continued dizziness and weakness) and DIZZINESS (continued dizziness and weakness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (continued dizziness and weakness) and DIZZINESS (continued dizziness and weakness). At the time of the report, ASTHENIA (continued dizziness and weakness) and DIZZINESS (continued dizziness and weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
After leaving pharmacy, patient felt signs of anaphylactic reaction and drove herself to the ER. Patient received Prednisone at ER and has since recovered.
COLD; SHAKING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced cold, and shaking. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold, and shaking. This report was non-serious.
Developed Myocarditis that lasted 12 hours.  Went to  hospital in  for treatment.
Arm being a different size since receiving the vaccine, has no idea if it is associated with the inoculation, it is very odd; It looks like her muscle is bigger, from the elbow to shoulder, her arm is like an inch bigger on the left side than the right side, it does not hurt or anything, it has not changed; It looks weird; Swelling at the injection site; Headache; Tired for the day; A little nausea; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm being a different size since receiving the vaccine, has no idea if it is associated with the inoculation, it is very odd), MUSCLE SWELLING (It looks like her muscle is bigger, from the elbow to shoulder, her arm is like an inch bigger on the left side than the right side, it does not hurt or anything, it has not changed), FEELING ABNORMAL (It looks weird), VACCINATION SITE SWELLING (Swelling at the injection site) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Depression. Concomitant products included BUPROPION for Antidepressant therapy, AMLODIPINE and VALSARTAN for Hypertension, VITAMIN D NOS and VITAMINS NOS for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm being a different size since receiving the vaccine, has no idea if it is associated with the inoculation, it is very odd), MUSCLE SWELLING (It looks like her muscle is bigger, from the elbow to shoulder, her arm is like an inch bigger on the left side than the right side, it does not hurt or anything, it has not changed), FEELING ABNORMAL (It looks weird), VACCINATION SITE SWELLING (Swelling at the injection site), HEADACHE (Headache), FATIGUE (Tired for the day) and NAUSEA (A little nausea). At the time of the report, PERIPHERAL SWELLING (Arm being a different size since receiving the vaccine, has no idea if it is associated with the inoculation, it is very odd), MUSCLE SWELLING (It looks like her muscle is bigger, from the elbow to shoulder, her arm is like an inch bigger on the left side than the right side, it does not hurt or anything, it has not changed), FEELING ABNORMAL (It looks weird), VACCINATION SITE SWELLING (Swelling at the injection site), HEADACHE (Headache), FATIGUE (Tired for the day) and NAUSEA (A little nausea) outcome was unknown.            She stated her muscle is different size from the site of vaccination elbow to shoulder and her left side inch bigger than right. Patient stated she didn't took any medications. Patient stated she just had a pneumonia shot about 2 weeks ago,
NO sleep; Arm hurts at site of vaccination.; Aches in shoulders, neck, back, legs, both arms and left hip; Aches in shoulders, neck, back, legs, both arms and left hip; Aches in shoulders, neck, back, legs, both arms and left hip; Aches in shoulders, neck, back, legs, both arms and left hip; Aches in shoulders, neck, back, legs, both arms and left hip; Chills; Probably low grade fever, but I'm too tired and lazy to take my temperature; lazy to take my temperature; Probably low grade fever, but I'm too tired and lazy to take my temperature; This is a spontaneous report from a contactable consumer (reporter's mother). A 70-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6203)), via an unspecified route of administration, administered in Arm Left on 03Mar2021 13:30 at the age of 70-year-old as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: E19266), via an unspecified route of administration, administered in Arm Left on 13Feb2021 at the age of 70-year-old as dose 1, single for covid-19 immunisation. On 04Mar2021 03:00 patient had no sleep, arm hurts at site of vaccination, aches in shoulders, neck, back, legs, both arms and left hip. chills. probably low grade fever. Patient was tired and lazy to take body temperature, no headache yet. Patient took Tylenol in response to the events. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected
On 3/25/2021 Patient lost complete hearing in left ear.  On 3/29/21 she went to an ENT doctor to have this checked. Doctor thinks this could be related to the vaccine.  She had an MRI and is scheduled for a CT scan next week. So far none of then hearing has come back.
ABOUT 1 WEEK AFTER RECEIVING SECOND MODERNA COVID VACCINE, PATIENT BEGAN EXPERIENCING INTENSE BURNING AND ITCHING AT INJECTION SITE. TREATED WITH BENADRYL AND HYDROCORTISONE CREAM. FINALLY SAW A DETERMOLOGIST ABOUT A MONTH LATER. NOW BEING TREATED WITH PRESCRIPTION STEROID CREAM. 4 MONTHS LATER, CONDITION CONTINUES, BUT HAS SPREAD DOWN TO WRIST, THE UPPER ARM NO LONGER BEING AFFECTED.
PATIENT RECEIVED A SUBCUTANEOUS INJECTION TO HER RIGHT ARM. NO ADVERSE EVENTS OCCURED. PATIENT WAS UNABLE TO RECEIVE AN INTRADERMAL INJECTION, THEREFORE A VACCINE WAS ADMINISTERED SUBCUTANEOUSLY.
Information has been received from a registered nurse, for the pregnancy registry for GARDASIL concerning a 17 year old female with no known drug reactions or allergies and no pertinent medical history who on 30-SEP-2009 was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL (Lot # 662518/0087) while pregnant. LMP: 15-MAR-2009. EDD: 20-Dec-2009. Concomitant therapy included prenatal vitamins (unspecified). No adverse effect was reported. The patient sought unspecified medical attention. Follow up information was received from a registered nurse, concerning a 17 year old female patient, with history of colposcopy (on 11-AUG-2009), allergies and vaginal yeast infection. Concomitant therapy included vitamins (unspecified), MONISTAT and CLARITIN. The patient EED was also reported as 10-JAN-2010. On 21-MAY-2009, an ultrasound of routine was performed and showed: Viable pregnancy. On 18-DEC-2009, the patient delivered a healthy normal baby (ID 50705) and had a complication during labor/delivery specifically Breech-C section. Upon internal review breech C-section was considered an other important medical event. No further information was available.
This spontaneous report was received from a healthcare worker (office manager), refers to an unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with doses of oral ROTATEQ, lot # L020861, expiry date 25-JAN-2017, (dose and frequency not reported), which were exposed to temperatures outside of the recommended range. No adverse effect has been reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information was provided. This is one of four reports received from the same reporter. Additional information has been requested.
Hives, redness @ injection site - (immediate) --> Hives developed after 5 mins. on chest - observed pt. for 30 mins. Advised BENADRYL PO @ home - no SOB, wheezing.
severe intractable headache from 12nn 12/23/2020 to 1500 12/24/2020 associated with photo sensitivity, nausea, generalized body malaise, pain & tenderness on injection site. Treated with Tylenol & neurofen tablets, rest in the night & whole morning.
WAS VACCINATED AT ABOUT 2 PM-BY 6 THE INJECTION SITE WAS SORE-BY 10 PM STARTED TO HAVE HEADACHE-WENT TO BED AND WAS AWAKENDED AT LEAST 20 X IN THE NIGHT WITH CHILLS & INCREASING INJECTION SITE PAIN-BY 5 AM I FELT LIKE I HAD THE FLU-ACHY, UPSET STOMACH, HEADACHE, MUSLE ACHES, CHILLS, LOW TEMP, EXHAUSTED, INCREASED INJECTION SITE PAIN TO POINT THAT I CANNOT GET ARM ABOVE MY BACK TO RAISE IT HIGHER THAN AN INCH
Rash started 1/2 hour after receiving H1N1 vaccine. In ER was given BENADRYL and 36mg PRELONE PO. Observed symptoms lessened went home with prescription for ORAPREDODT 15mg daily x 5 BENADRYL PRN
Fever, Severe chills lasted for 36 hours Got the Moderna ARM in 24 hours. Swelling of the injection site location and redness, lasted for 5 days,  discoloration of the skin as a patch even after 3 weeks
Patient states she started having severe side effects the next day after receiving her 2nd dose of Shingrix. She stared to have a fever, nerve pain radiated on her left side down to her buttocks and myalgia. In addition her injection arm felt heavy and her mobility has greatly decreased. She has taken tylenol 500mg which somewhat helped her symptoms. The fever has resolve about a day after symptom on set. Symptoms has been going on for a bout 3 days. I recommended the patient if her symptoms does not improve in another day to refer her to urgent care for further evaluation.
MENSTRUAL CYCLE DYSREGULATED; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced menstrual cycle dysregulated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of menstrual cycle dysregulated was not reported. This report was non-serious. This case, from the same reporter is linked to 20230247687.
covid; Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 69-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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 "covid"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "Covid". Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  Additional information: I was asked to go off Xeljanz a week before + a week after the TAVR Procedure. I was asked to go off Xeljanz a week after each vaccines. I was off Xeljanz for 2 weeks then I got covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
My daughter had her second hepB shot May 8,2018 and first Varicella shot May 21,2018. She started to notice hairloss the following week and found her first bald patch June 1, 2018. She was diagnosed with Alopecia at the dermatologist June 5, 2018. She had about 80% hair loss within a month and ended up shaving all her hair off.
No flu symptoms but experienced a lot of pain in the arm injection was given.  It has been two weeks since the injection and I have a hard lump under the injection site and it is still tender to the touch.  My parents received the injection the same day and neither of them have this issue.  I have not seen anyone about this yet as I don't know if this is serious or not, I just keep waiting for it to go away.
Initial pain and inflamation in left arm.  Shoulder muscle swelled as big as baseball.  Pain migrated to right shoulder a few days later. Minimal pain in both arms for next five weeks.   6 weeks after 2nd dose was administered on the night of April 18th, I woke with both shoulders severely aching and I had inflammation and pain all over my body. It is approx.5 weeks later since the pain became severe and I am presently trying to manage it with Tylenol and have no ides how to approach getting treatment.  My shoulders have extreme pain when I use my arms.  Body feels inflamed/sore constantly and restricts my daily activities.
Developed lassie varicella rash with lesions in various stage. Scattered lesion, most prominent on trunk, also on face and limbs. Active infection
On 4/1 at 12pm began have lightheadedness and very shaky. By 4/2 at 6am developed SOB, cough, and heart racing.
Woke up to full body shaking, fever between 100-102 for 3 days, full body joint and muscle pain, couldn?t close hands for 1 day and 2nd day post vaccine had very diminished hand grip strength. Hurt to move , lay down, but had a constant need to stretch. Also skin felt super sensitive with an almost burning sensation all over for 2 days
Initial report received from Healthcare professional on 10 OCTOBER 2014. A 63-year-old female patient, whose medical history and concomitant medications were not reported., had received a dose of FLUZONE QIV (batch number, expiry date, route, site of vaccination and dose number was not reported) on 07 OCTOBER 2014. The patient had experienced generalized rash over her body, generalized rash over her body that was slightly red, itchy and rash at injection site on 08 OCTOBER 2014. Lab investigations and corrective treatment were not reported. The patient illness at the time of vaccination, and pre-existing  diagnosed allergies and birth defects were not reported. At the time of this report the outcome of the event was not resolved. List of documents held by sender: none. Follow up information received from a healthcare professional on 20 JAN 2015. The patient had received a first dose of FLUZONE (batch number U196AC, via intramuscular route, anatomical side of administration was not reported) on 07-OCT-2014. There were no laboratory investigations reported.  List of documents held by sender: none.
INJECTION SITE REACTION W/SWELLING AND REDNESS. PT DID NOT CALL IN TO REPORT DISCOMFORT, AND ALSO APPLIED HEAT TO SITE OF REACTION INSTEAD OF ICE AND WORSENED THE REDNESS AND HARDNESS OF THE AREA. CAME TO PHARMACY THIS AM. AREA IS APPROXIMATELY 4 INCHES IN DIAMETER. RED AND HARD-TO-THE TOUCH IN THE CENTER. PT WAS GIVEN CLARITIN TO USE DAILY AND WAS ASKED TO SWITCH FROM TYLENOL ONLY TO IBUPROFEN TO HELP WITH THE REDNESS AND SWELLING. PT WAS ALSO ASKED TO APPLY ICE FOR DISCOMFORT. PT WAS ASKED TO CHECK BACK IN WITH PHARMACIST ON MONDAY.
KIDNEYS SHUT DOWN; This spontaneous report received from a consumer through social media via a company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, dose number in series was 1, 01 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  It was reported that, 10 days later after JnJ shot, his kidneys were shut down. Reportedly, he was on dialysis 3 days a week and was looking for kidney transplant (dose number in series was 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from kidneys shut down. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220107450-COVID-19 VACCINE AD26.COV2.S-kidneys shut down. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).