chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flared up her autoimmune disorder; Inflammation for a couple of weeks after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (flared up her autoimmune disorder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Polymyalgia rheumatica (She is an immunocompromised patient who has Polymyalgia Rheumatica). Concomitant products included PREDNISONE ACETATE (PREDNISONE [PREDNISONE ACETATE]) for Polymyalgia rheumatica.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (flared up her autoimmune disorder) (seriousness criterion medically significant) and INFLAMMATION (Inflammation for a couple of weeks after the second dose). At the time of the report, AUTOIMMUNE DISORDER (flared up her autoimmune disorder) and INFLAMMATION (Inflammation for a couple of weeks after the second dose) outcome was unknown.            Treatment medication was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
SUSPECTED CVA; BRADYCARDIA; FACIAL DROOP; SLURRED SPEECH; WEAKNESS; DYSARTHRIA; ALTERED MENTAL STATUS;   HYPERTENSION;HYPOKALEMIA; ISCHEMIC CARDIOMYOPATHY; LEFT BRANCH BUNDLE BLOCK; RHEUMATOID ARTHRITIS; RIGHT SIDED WEAKNESS; TYPE 2 DIABETES MELLITUS WITH DIABETIC NEUROPATHY STARTED ON 7/4/21 AND PATIENT WAS HOSPITALIZED UNTIL 7/8/21.  CARDIAC ARREST; ACUTE ENCEPHALOPATHY; ALTERED MENTAL STATUS STARTED ON 7/9/21 AND PATIENT WAS HOSPITALIZED UNTIL 7/12/21.
Site of the injection became sore; each day it got worse; went to a Dr. and was diagnosed with cellulitis and put on an antibiotic; continued to be more and more painful.
10-11JUN started coughing, not feeling good 14JUN93 went to MD was told had inflamed bronchitis; 17JUN93 called back cough worse; seen by MD & was told was poss pertussis; 1JUL93 culture was called by lab as pos;
This spontaneous report as received on 02-MAR-2017 from a female healthcare worker (Not further specified if a healthcare professional), refers to 10 patients (age and gender not reported) who received unspecified doses in VARIVAX (Lot number M033905, expiration date 20-JUL-2018) immunization series that were improperly stored.  The site and route of VARIVAX administration were not reported.  The vaccinations occurred between 22-FEB-2017 and 01-MAR-2017. The vaccines were exposed to temperature of 18.5F (Fahrenheit) for a time frame of 5.3 hours.  There were no previous temperature excursions reported. The temperature excursion was recorded by a data logger. The patients' pertinent medical history, concomitant medications and drug allergies were not reported. It was further specified that on 27-FEB-2017, this patient (age and gender not reported) received administration of VARIVAX. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA001788:
was diagnosed with Bell's palsy; they diagnosed her with "a result of the Moderna vaccine"; extreme pain just below her left eye where the cheek bone is; it hurt to blink; severe pain in both nostril for 5 days; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (was diagnosed with Bell's palsy), NASAL DISCOMFORT (severe pain in her left nostril for 5 days), FACIAL PAIN (extreme pain just below her left eye where the cheek bone is), EYE PAIN (it hurt to blink), VACCINATION COMPLICATION (they diagnosed her with "a result of the Moderna vaccine") and NASAL DISCOMFORT (she had pain in her right nostril) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced FACIAL PAIN (extreme pain just below her left eye where the cheek bone is) (seriousness criterion hospitalization) and EYE PAIN (it hurt to blink) (seriousness criterion hospitalization). On an unknown date, the patient experienced BELL'S PALSY (was diagnosed with Bell's palsy) (seriousness criteria hospitalization and medically significant), NASAL DISCOMFORT (severe pain in her left nostril for 5 days) (seriousness criterion hospitalization), VACCINATION COMPLICATION (they diagnosed her with "a result of the Moderna vaccine") (seriousness criterion hospitalization) and NASAL DISCOMFORT (she had pain in her right nostril) (seriousness criterion hospitalization). The patient was hospitalized from 13-May-2021 to 15-May-2021 due to BELL'S PALSY, EYE PAIN, FACIAL PAIN, NASAL DISCOMFORT, NASAL DISCOMFORT and VACCINATION COMPLICATION. The patient was treated with PREDNISONE for Bell's palsy, at a dose of 60 mg. At the time of the report, BELL'S PALSY (was diagnosed with Bell's palsy), FACIAL PAIN (extreme pain just below her left eye where the cheek bone is), EYE PAIN (it hurt to blink), VACCINATION COMPLICATION (they diagnosed her with "a result of the Moderna vaccine") and NASAL DISCOMFORT (she had pain in her right nostril) outcome was unknown and NASAL DISCOMFORT (severe pain in her left nostril for 5 days) had resolved.            Concomitant medications were not provided by the reporter.  Laboratory tests the patient underwent included, several tests, a scan, EKG, cardiac ultrasound, MRI, and  bloodwork but results were unknown.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information has been requested
Moderna COVID-19 Vaccine EUA.  Received vaccine at 2:30. By 7:00 pm started with headache, chills and slight fever and very fatigued. Went to  bed. At 2::00 am decided to take an ibuprofen. By 6:00 am fever broke and went into a sweet. By 8:00 am next morning felt much better. Just slight headache and tiredness
Pt had Hep A given on left deltoid on 3/15/03. No reaction on 2nd day. Follow up nausea and vomiting and some pain. On 3/18/03 pt was seen here at the office with indurated 1.5 petechia and ecchyoma 2" x 2.5 with no colic.
After receiving the booster shot, around 11:00am on Saturday, Sept. 24th, that evening Sept. 25th around 12:30am I had shaking severely, throw-up and diarrhea. And was very tired.  I slept pretty much the rest of the day on the 25th.  I feel fine today, September 26th
Itching reported by patient at site of varicella vaccine approximately 10 minutes after injection - ice pack was applied, itching & redness.
Stomach ache; nausea; slight stuffy nose; soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 9 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Nov2021 18:30 (Lot number: FK5612) at the age of 9 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing). Concomitant medication(s) included: XYZAL taken for hypersensitivity (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Left shoulder, Route of administration: Intramuscular, Vaccine Administration Time: 06:30PM), administration date: 09Nov2021, when the patient was 9 years old, for COVID-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 01Dec2021 13:00, outcome "recovered" (02Dec2021), described as "Stomach ache"; NAUSEA (non-serious) with onset 01Dec2021 08:00, outcome "recovering", described as "nausea"; NASAL CONGESTION (non-serious) with onset 01Dec2021 08:00, outcome "recovering", described as "slight stuffy nose"; INJECTION SITE PAIN (non-serious) with onset 01Dec2021 08:00, outcome "recovering", described as "soreness at injection site". Therapeutic measures were not taken as a result of abdominal pain upper, nausea, nasal congestion, injection site pain.  Additional information: Patient did not receive any other vaccine in four weeks, did not have covid prior vaccination and not tested covid post vaccination. Patient did not have any prior vaccination within 4 weeks. Patient did not have any known allergies. The patient received (ongoing) immunotherapy injection for allergy shot on 24Nov2021 as concomitant medication.  No follow-up attempts are possible. No further information is expected.
Pt called to report itching and redness at the injection site. Pt informed to use hydrocortisone cream and oral benadryl. If it doesn't resolve then she should follow up with primary care doctor.
Left leg with 75cm redness and swelling for two days. Instructed to give Benadryl and apply cool towels to leg for 48 hours.
Erythema, pain extending from shoulder past elbow, shoulder pain, fevers, chills. Rx AUGMENTIN/ADVIL
Swollen and painful supra clavicular lymph node left side.; Swollen and painful supra clavicular lymph node left side.; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 04Feb2021 at a single dose for COVID-19 immunization. Medical history included lupus and allergies to latex. Patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient experienced Swollen and painful supra clavicular lymph node left side on 10Feb2021. The patient underwent lab tests and procedures which included nasal swab: negative on 04Nov2020. Outcome of the event was not recovered. Patient was not diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This case was reported by a health professional and described the occurrence of injection site cellulitis in a 4 yr old male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The pt has no pre-existing medical conditions. On 07Feb05, the pt received the fifth dose of Infanrix in the left leg (lot DTPA620B9). On 07Feb05, the pt also received injections of measles, mumps and rubella virus vaccine (MMR II) and inactivated poliomyelitis virus vaccine (IPOL). The health professional stated that the MMR II and IPOL injections were administered in separate areas from the site of the Infanrix administration. At an unspecified time following the fifth dose of Infanrix, on 07Feb05 the pt experienced swelling and redness at the injection site of Infanrix. The pt was seen in an ER and was diagnosed with injection site cellulitis. The pt was treated with hydroxyzine hydrochloride (Atarax). The outcome of the injection site cellulitis was not reported. The vaccine provider considered the injection site cellulitis to be possibly related to this lot of Infanrix.
Patient reported "chills" the day following the vaccination. Additionally, patient stated she was experiencing redness on her left arm that appeared in a circular fashion that has lasted since the date of vaccination on 2/12. Patient was advised to consult PCP when she presented to the pharmacy on 2/14.
Sore arm was only is; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose received on an unknown date, for tolerance refer case US2022AMR083269).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient received Shingles vaccine and experienced sore arm. The patient stated that it was worth the price and side effect was not that bad. Fortunately, the patient's insurance paid part of the cost.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR083269:Same reporter
have elevated TSH levels in the more recent labs, they all have gotten the Pfizer covid vaccine also/TSH level is markedly increased; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; levothyroxine sodium (SYNTHROID), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD THYROID STIMULATING HORMONE INCREASED (non-serious), outcome "unknown", described as "have elevated TSH levels in the more recent labs, they all have gotten the Pfizer covid vaccine also/TSH level is markedly increased". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for levothyroxine sodium was unknown.   Additional information: Additional Information: Patient took Synthroid and had elevated TSH levels in the more recent labs. Patient was not having any symptoms but TSH level were very elevated. As per patient, it could be reaction from covid vaccine /reagents as he did the research internationally. His doctor thought he was not taking Synthroid. It was reported that patient was well.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
sore left upper arm; sluggish feeling; tired; a little bit achy all over; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8734) via an unspecified route of administration in the left arm on 07Apr2021 at 14:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and allergies. Concomitant medications included loratadine (CLARITIN), budesonide (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN, strength: 125 mcg) for unknown indication and on unknown date within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 Within 4-6 hours of vaccination, the patient experienced sluggish feeling, tired and a little bit achy all over. On 08Apr2021 at 18:15 within 16 hours the next morning, the patient experienced sore left upper arm.  No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events sluggish feeling, tired, a little bit achy all over and sore left upper arm was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Large area of erythema and warmth beneath the injection site, severe, bone-penetrating pain from shoulder to tips of fingers.
Patient syringe was done and the needle was not correctly on the barrel, vaccine spilled instead of coming out of the needle. Nurse decided to administer another dose, since patient did not receive a full dose
Suspected vaccination failure; Shingles; Hurt badly; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster and pain. On an unknown date, the outcome of the vaccination failure, herpes zoster and pain were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles anyway. The patient stated that, he/she had never hurt as badly. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Im breastfeeding.   I experienced pain tenderness, breast felt hot and I produced more milk.
1. Hordeolum externum of right lower eyelid - amoxicillin-clavulanate (AUGMENTIN) 875-125 mg per tablet; Take 1 tablet by mouth 2 (two) times a day for 10 days.  Dispense: 20 tablet; Refill: 0   2. Periorbital cellulitis of right eye - amoxicillin-clavulanate (AUGMENTIN) 875-125 mg per tablet; Take 1 tablet by mouth 2 (two) times a day for 10 days.  Dispense: 20 tablet; Refill: 0     -Rest -Hydration -Avoid eye rubbing -Warm compress -Advised to start Polytrim and oral antibiotics to cover for potential periorbital cellulitis -Advised follow-up tomorrow. -ER precautions explained
Around 7 pm I started feeling really anxious. I checked my HR on my smart watch and it said that around 12pm my HR was 157bpm which was right after getting the vaccine when I started walking home. My  resting HR is usually 47-52bpm. I am a very active person. I have been waking up in the middle of the night multiple times in night sweats and it feels like my heart is contracting very hard. I notice that my HR jumps up right when I start to be more active, but more than normal. On the 11th my average walking HR was 140. Today at work my HR was 134 at the highest around 9am and the lowest was 56bpm around 7am when I was getting ready for work. Additionally to the increased HR I have SOB when I walk and talk. I did have a sore arm as well the first day, but nothing more than any other injection I have had before.
Pt recv vax on 12/18/98; on 12/20/98 pt exp red cellulitis area of right thigh; tx=Keflex, Tylenol, warm compresses; dx=otitis media
This spontaneous report as received from a certified medical assistant refers to a female of unknown age. Her medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was in the office to receive her scheduled dose (unspecified if the 2nd or the 3rd dose in the series) of GARDASIL 9 (lot # M024261, expiration date 30-JUL-2018, 0.5 ml, intramuscularly), but she "refused to receive the dose, because it would have been 3 vaccines during this visit to the office". As a result, the patient missed the dose of GARDASIL 9. No adverse effects were noted. Additional information has been requested.
Rash over both arms neck and upper back,  chest pain pressure and burning, shortness of breath, fluctuations of blood pressure  , abnormal heart rhythm ie PVCs
This spontaneous prospective pregnancy report was received from a registered nurse regarding a 21 year old female patient. There was no information about concurrent condition. Historically on 17-MAY-2007 and 13-SEP-2007 patient was administered with GARDASIL. On 03-JUN-2015, the patient was vaccinated with GARDASIL 9 lot # L001312, expiration date- 24-FEB-2017, dose 1. No concurrent medication was reported. The patient became pregnant. The Last Menstrual Period (LMP) and Estimated date of delivery (EDD) was not known. The pregnancy outcome was unknown. On 03-JUN-2015, the patient had a positive urine pregnancy test (exposure during pregnancy). No adverse event was reported. On 03-JUN-2015, laboratory tests PAP smear, STD testing, Lipid screening and Complete Blood Count was done and results were unkonwn. No intervention was done to prevent serious criteria. No Product quality complaint was involved. The outcome of positive urine pregnancy test was unknown. Additional information has been requested.
After the vaccination, patient reacted in a couple of minutes. She had stressed breathing, body started to drop and she started to sweat. Patient seemed to have loss consciousness for about a minute so we helped her lie down on the floor.
Right arm where injection was given became stiff and sore. Saw PCP and was told that inflammation was present. Was given Prednisone for inflammation and Hydrocodone for pain. Took medication for next 2 weeks. Health was worse. Went back to PCP on 09/26/2011 and was given antibiotic took blood cultures and had lost 10 lbs at this point. Went back to PCP 09/28/2011 lost 4 more lbs. heard heart murmur, had echo sent to PMC for catherization and TEE. Found Mitro Valve problems, came home 09/30/11. Saw Dr. on 10/18/11, had blood cultures, went back on 10/26/11 had TEE again. Found mitro valve needs to be replaced but will wait until health is better. Its 11/06/11 and health is beginning to deteriorate again. See PCP on 11/8/11.
There are no adverse reactions but the PA gave 6 month vaccines instead of 12 month vaccines. We will catch the child up on MMR and Varicella at his 15 month appointment.
This is a spontaneous report from a contactable consumer who reported for herself. A 67-year-old female patient received PREVNAR 13, via an unspecified route of administration at 0.5 ml, single on 06Aug2016 for immunisation. Medical history included sinus problems , allergy certain times of the year, coughing, shortness of breath, difficulty breathing and phlegm and mucus that she had to spit out. She received unspecified treatment for coughing and for phlegm and mucus.  Concomitant medications were not reported.  On 13Aug2016  her left arm swelled up like baseball under skin at the injection site and arm was hot to the touch (injection site was hot to touch); on an unspecified date redness at the injection site occurred.Therapeutic measures taken as a result of arm hot to the touch included diphenhydramine hydrochloride (BENADRYL) cream. The outcome of left arm swelled up like baseball under skin at the injection site was recovered on an unknown date; arm hot to the touch / injection site was hot to touch recovered on 15Aug2016 or 16Aug2016;outcome of redness at the injection site was unknown. She was recently tested for allergies and she took triamcinolone acetonide (NASACORT) every day.The physician advised her not to take the shingles vaccine, but she will be doing the diphtheria vaccine, pertussis vaccine,tetanus vaccine (DTAP) and flu shot. Follow-up (14Oct2016):  Follow-up attempts are completed.  No further information is expected. Follow-up (18Oct2016): New information for a  from a contactable consumer includes: outcome, events updated (coughing and phlegm /mucus and difficulty breathing removed) medical history.Follow-up attempts are completed. No further information is expected.