chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Watery and bloody vaginal discharge, two weeks ahead of my menstrual cycle; Watery and bloody vaginal discharge, two weeks ahead of my menstrual cycle; This is a spontaneous report from a contactable pharmacist (patient). A 37-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0167), via an unspecified route of administration, administered in Arm Left on 27Apr2021 (at the age of 37-year-old) as dose 1, single for covid-19 immunisation. Medical history included depression from an unknown date and unknown if ongoing Depression, hyperlipidemia (both controlled) , hyperlipidaemia from an unknown date and unknown if ongoing Depression, hyperlipidemia (both controlled). Concomitant medications included fluoxetine taken for an unspecified indication, start and stop date were not reported; atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Apr2021, the patient experienced watery and bloody vaginal discharge, two weeks ahead of my menstrual cycle. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date, if covid prior vaccination Yes. No treatment was taken as a result of events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
A non-serious spontaneous report of "administration of expired product" was received from a registered nurse concerning a six-year-old male subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The product expired on 19-Jan-2010. On 01-Feb-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Vaccine site appeared higher on the left arm than the location of previous vaccines. More painful injection than previous flu vaccines. Soreness of the arm increased over the course of the day and by evening the arm was painful to lift. Started taking ibuprofen daily with a heating pad on the injection site at bedtime, after 4 days the arm cannot be lifted higher than the chest and impossible to lift overhead. The shoulder joint continues to be very painful and a popping sound in the joint can be heard when trying to move the arm.
Chills, shortly followed by shivering and chattering. The shivering is so intense it essentially renders the patient in a state of involuntary writhing; muscles across the body, even if not in movement, may be tensed to the point of pain. Muscles affected lie in the legs, arms, and torso. An observer might mistake the event for a seizure, though the patient is fully conscious for the duration. The episode lasts only a few minutes; such an episode has only occurred once.
low grade fever 99.9 for 12 hours muscle/body aches for 12 hours tired for 12 hours+ headache for 12 hours
blood clot in one of his leg; leg became red; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 23Apr2021 (at the age of 73 years old) (Lot Number: EW0169, unknown expiration) as 1st dose, single for COVID-19 immunization.  Medical history and concomitant medications were reported as none.  The patient received his first dose of COVID-19 vaccine on 23Apr2021. In the night of 24Apr2021, his leg became red and he spoke to his doctor. The experienced a blood clot in one of his leg on 25Apr2021. The patient received Eliquis for the events to be taken for 45 days. He would like to consult if he should receive the second dose after the side effect from the first dose. Patient would like to know if there have been reports of blood clots after receiving the COVID-19 vaccine. The patient is scheduled to receive his second dose on 14May2021. The patient underwent lab tests and procedures which included blood test and ultrasound on leg: unknown results on 26Apr2021. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
diarrhea which occurred the next day; This case was reported by a nurse via call center representative and described the occurrence of diarrhea in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th October 2019, the patient received the 1st dose of Shingrix. On 27th October 2019, 1 days after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was recovered/resolved.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were received as follows: The reporter stated that the patient experienced diarrhea the next day after vaccination. The event resolved one to one and one half days later. For tolerance to 2nd dose, refer case US2020AMR027635.
10/03/2017: I received the shingles vaccine along with the flu vaccine in my left arm at my primary care office. 10/04/2017: I noticed a red patch covering about one inch at the injection site of the shingles vaccine. 10/05/2017: The red patch was now raised, had increased to about two inches, indurated, hot to touch, pain and tingling that spread to wrist, blistering present. Phoned physician office and was seen by nurse who believed it to be a reaction to the shingles vaccine. Was advised to watch and report any adverse changes. 10/6/2017: Lesion was about three inches across. Phoned primary care office, spoke with nurse and was advised to continue watching and to seek emergency care if breathing became an issue. 10/10/2017: Noticed a red, indurated, raised, painful to touch lesion on the lateral side of right knee about one inch in diameter. Showed my husband and we believed it to perhaps be a spider bite. 11/01/2017: Traveled to see family. Daughter (age 32 and had chicken pox at age five) informed us she is seven weeks pregnant with first child. 11/02/2017: Notice new lesion on medial side of right knee with same symptoms of the lateral knee lesion (which now looks like a bruise) but is less than one inch in diameter. 11/14/2017: See a physician and he notes that he believes the knee lesions to be a side effect of the shingles vaccine. If lesion is still present in two weeks a cortisone injection may be warranted. 11/21/2017: A new lesion is on right arm, halfway between elbow and wrist on the lateral side. Symptoms consistent with knee lesions and is a little over one inch in diameter. I have been experiencing generalized joint pain that I thought was related to the change in temperatures as the season goes from autumn to winter. I have also noticed an increase in headaches. I have been taking ibuprofen as needed for pain and do not require anything stronger. Mediations: Atenolol 25 mg daily for high blood pressure, Fluticasone Propionate nasal spray as needed, BENADRYL as needed. Allergies: Latex, sulfa drugs, gluten and dairy intolerant.
Severe itching, arm was swollen for one week, rash, high fever for two days, and chills
Received expired booster shot; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster shot) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A, 040A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster shot). On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received expired booster shot) had resolved.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-434042 (Patient Link).
38 y/o M with no PMHx syncopized 1 minute after receiving the vaccine. The episode lasted around 10 seconds and when he came to, he was able to offer a subjective. He states that before synopizing, he started to feel lightheaded and dizzy, stating that he was experiencing some blurry vision and muffled hearing. Denies HA, trauma, numbness, tingling or parasthesias, chest pain, chest tightness or heaviness, dyspnea, SOB, n/v or abd pain. Patient was immediately assessed by medics and PA on site.  Vitals @ 1706: HR: 48 bpm, BP: 109/60; RR: 18 -- EKG performed 3 lead : irregular rhythm, brady and prolonged QT -- > repeat @1711: HR: 56 bpm; BP: 104/70; RR: 16 put on 4 L O2 NC @ 1705 IVF through Left AC @ 1714
Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: not known if epipen or benadryl was given at urgent care-Severe
back surgery; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of back surgery in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced back surgery (Verbatim: back surgery).  The patient was treated with ambiguous medication nos (Cortisone (Nos)). The outcome of the back surgery was unknown.   It was unknown if the reporter considered the back surgery to be related to Shingrix.     It was unknown if the company considered the back surgery to be related to Shingrix.   Additional Information: GSK receipt date: 1-Sept-2023 Pharmacist reported that the patient got a back surgery after receiving the first dose of Shingrix and was taking cortisone for that reason.  The second dose was not administered at the time. The Vaccine Administration Facility was the same as Primary Reporter. Attempt to reach health care professional back to gather information about the vaccination date, patient's identifiers, etc but it was not possible.
Began with bilateral neuritis type symptoms both arms. Proceeded to "walking pneumonia", CHF polymyositis, mixed connective tissue disease, kidney failure & death. Tx- 2 inj of steroids, long term high dose steroids, immune suppression, dialysis & death.
feeling "Sort of dizzy"; arm is sore; just doesn't feel well; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on her left upper arm on 17Dec2020 13:25 at a single dose for covid-19 prevention. The patient's medical history included blood pressure abnormal. Concomitant medications included blood pressure medicine at night. The patient went to the hospital today where she works, to have a vaccine for COVID, and then she drove herself home. After she got home, she decided to rest a bit before her shift at work tonight, she laid down for a little while, and she started feeling sort of dizzy and her arm was sore. She just doesn't feel well. She does not feel like she needs to go to the hospital or anything, but she may need rest. Patient was wondering if these are known side effects of the product. She started feeling the side effects maybe 20 or 25 minutes after getting the vaccine and after she had left the hospital. She was just thinking at the time that it was okay and maybe she just needed rest. She takes blood pressure medicine at night, but she does not think that has anything to do with how she is feeling. Outcome of the events was unknown.
Patient received the vaccination on 1/7/10.  A few weeks later she started having pain in her arm.  The pain is radiating into her shoulder area.
The area is swollen with redness, soreness and itches sometime. It Underarm area sore. Yesterday I began rubbing alcohol on the area.  I hope this is common and will disappear soon.
Non-severe allergic reaction  Onset of small red hives within minutes, followed by itchy throat about 10 minutes later. Resolved with Benadryl administered on site.   Wheezing 2 hours later (possibly a panic attack due to stress over the situation, and not related). Resolved quickly.
Some chills, runny nose, sweating a lot during sleep, trouble sleeping.  Started night of vaccine, hasn?t stopped 2 days later
Approx 30min after vaccine she states her L arm begin to feel like it was falling asleep... the feeling has her fingers, face, cheeks an nose. She states she is not in any discomfort at this time. RN recommendation- To monitor symptoms, if they increase to seek medical attention via urgent care or ER. patient was agreeable. What happened as a result of the adverse event?No interventions RN called to f/u adverse reaction call- no answer.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63-year-old patient received BNT162b2 (BNT162B2), on 05Apr2022 at 16:39 as dose 4 (booster), single (Lot number: FP4554, Expiration Date: 30Jul2022) at the age of 63 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Lung Cancer", start date: Oct2019 (unspecified if ongoing); "R lower Lobectomy", start date: Feb2020 (unspecified if ongoing), notes: R lower Lobectomy; "Cholesterol" (unspecified if ongoing); "Rash-Herpes" (unspecified if ongoing); "Rash-Herpes" (unspecified if ongoing). Concomitant medication(s) included: FAMVIR [FAMCICLOVIR] oral taken for herpes zoster, rash, start date: 1999 (ongoing); REPATHA subcutaneous taken for blood cholesterol, start date: 2021 (ongoing). Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); unknown manufacturer), for COVID-19 Immunization. The following information was reported: EAR PAIN (non-serious) with onset Apr2022, outcome "not recovered"; PAIN IN JAW (non-serious) with onset Apr2022, outcome "not recovered", described as "Jaw pain"; TOOTHACHE (non-serious) with onset Apr2022, outcome "not recovered", described as "Teeth pain". The events "teeth pain", "ear pain" and "jaw pain" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of toothache, ear pain, pain in jaw. Additional information: The patient did not receive prior vaccinations within four weeks. The patient underwent physical therapy in May2022 for jaw pain and acupuncture in Jun2022 for ear pain. The patient reported that pain started in Apr2022 and was still in pain. It was also reported that the patient went to physical therapy for ear, jaw, teeth pain and went to Chiropractor for acupuncture. The patient received treatment with steroids for the events.
Erythema multiforme First reaction occurred within 1 week of HIB and flu vaccines in Jan. 2021 Second reaction occurred within 1 week of HIB and DTaP vaccines in August 2021
Patient developed rash on abdomen/trunk today. Rash is pruritic. Denies dyspnea, difficulty swallowing, rash at injection site. Denies new medications, products, etc. Pt took 2 BENADRYL at 2 hours ago pt called physician. Has appointment with physician this afternoon. Rash has spread to back since she first notice it this morning.
I have limited knowledge of this vaccine. The pharmacist no longers works at pharmacy and the vaccination was 2 months ago. Patient received the flu shot and some time later started to experience pain/tingling/numbness in her arm and fingers. Patient and her doctor believe the bone was knicked and a piece of the bone on the arm was scraped off.
Sudden onset severe tinnitus and pressure/plugged sensation in left ear, starting roughly 36 hours after injection. The pressure/plugged ear sensation went away after about a 3 days, but the tinnitus remains in that ear to this day. I thought this was possibly related to seasonal allergies, so I have not consulted medical advice yet, but I will mention during my yearly physical. As of now, the condition isn't quite debilitating as long as I try to keep my mind off it, but when the tinnitus is louder than the ambient noise (and is not getting any better), this becomes increasingly difficult.
Patient received TD on 03/12/2008.  Patient came back to the doctor's office on 03/14/08 with flu-like symptoms and redness, tenderness and a nodule at the TD injection site.  Her local reaction size was 1 1/2 X 2 inches.  Patient was told to contact the doctor's office if the reaction got worse.  Follow up information obtained on 04/29/08: Reporter of the event confirmed that the patient recovered.
Information has been received from a physician concerning a 9 month old male was vaccinated PO with his first, second and third doses (dates unavailable) of ROTATEQ. Subsequently the patient experienced a severe case of rotavirus and was hospitalized. Lab diagnostic studies included a culture taken in the hospital that confirmed rotavirus. The patient was treated with IV rehydration. Subsequently, the patient recovered. There was no product quality complaint. Rotavirus was considered an other important medical event by the physician. Additional information has been requested.
total body rash, swelling of nasal passages, swelling of throat-ER tx included IV Solumedrol 125mg;IV DPH;IV Pepcid;Epi;Tagamet, Pred;sx included local swelling, redness, itch @ site
Swelling and pain in arm, shoulder and neck. Pt vomited once. Pt seen by Emergency room physician
Received flu shot 10/26/16. Presented next day with C/O (L) shoulder pain and decreased ROM. Prescribed Naproxen, heating pad and arm exercises. F/U apt 11/1 - DX: bursitis - continue anti-inflammatories and exercises.
sore arm; fever; chills; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 at 15:30 as dose 1, single (Lot number: HF9275) at the age of 56 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHILLS (non-serious) with onset 13Oct2023 at 01:30, outcome "not recovered"; PYREXIA (non-serious) with onset 13Oct2023 at 01:30, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset 13Oct2023 at 01:30, outcome "not recovered"; PAIN IN EXTREMITY (non-serious) with onset 13Oct2023 at 01:30, outcome "not recovered", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, pyrexia, chills, headache.  Additional information: there was no other vaccine in four weeks, no other medications in two weeks. No covid prior vaccination, no covid tested post vaccination.
I got severe toe and leg cramps then it moved to my arms. It was so bad and made my toes/fingers spread in different directions. I have never had cramps other than pregnancy so It was very weird.  These cramp sessions would last for moments at a time. After the third dose the pain radiated from my elbow across my breast then under the muscle then back to my elbow. It was sharp thumbing burning.  My left hand and forearm became numb and then the numbness went to all fingers accept my pinky. I went to Dr because I thought I had a pinched nerve. Gabapentin was prescribed and it wasn't working so I took more and it caused some unwanted side effects and then he changed to Cymbalta  then I was given a MRI. Basically I was referred for a MRI they seen signs of MS and  stenosis however its evident I was in remission until I received the first dose.
PCR test came back positive.; PCR test came back positive.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 36 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single 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), COVID-19 (medically significant), outcome "unknown" and all described as "PCR test came back positive.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical course: The patient had the 2 shots of Pfizer Covid-19 vaccine. He attended an event on (city/state withheld) on Thursday, started feeling bad on Saturday, PCR test came back positive. And he is still feeling bad. Patient mother was trying to see if he could get the oral medication, PAXLOVID, made by Pfizer for his treatment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.
Chills, fever,  muscle aches, shakes. Very sore left arm and shoulder,   Like a bad case of the flu.
severe headache with nausea; severe headache with nausea; This is a spontaneous report from a contactable nurse (patient) who reported for herself that a 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899) via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization. Medical history included pulmonary sarcoidosis, thyroid, mild depression. Concomitant medication included famotidine, ibuprofen (DUEXIS). Nurse called in to report side effects, she got her shot on 17Dec2020 and she had a severe headache with nausea about 45 minutes after getting the shot. When probed if still experiencing the event, nurse stated, about 15 minutes it was gone on 17Dec2020.  She just took Ibuprofen (MOTRIN) for treatment. Outcome of severe headache with nausea was recovered on 17Dec2020.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events,headache with nausea, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
The patient reported numbness, tingling, and heaviness in vaccinated arm which travelled up neck, to eyelid and side of face. This prompted a visit to urgent care and urgent care sent the patient to the ED for stroke rule-out. The ED did not believe patient was experiencing a stroke and administered 10 mg of IM decadron. The patient's symptoms resided overnight but the next day developed red bumps all over upper palate of mouth. The patient went to her PCP which did not test for strep at this time. The red bumps developed into ulcers with white heads and the patient went back to the PCP which performed a rapid strep test which was negative. The PCP was concerned for mono due to lymph node swelling. The patient's palate has improved slightly but they still feel fatigued.