chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Contracted COVID approximately 2 weeks prior to admission, only had mild respiratory symptoms with non productive cough and anosmia; Pt. was in usual state until morning of admission. Woke up with right arm weakness and right facial droop. In ED CTH  revealed atherosclerotic calcifications of ICS artery and verterbral artery. CTA of head/neck revealed high grade left  ICA stenosis>70% and right ICA stenosis 50% MRI brain revealed scattered acute infarct; MRA neck >90% right ICA stenosis and right ICA stenosis 60-70% started 8/3/21 on aspirin 325 mg daily, atorvastatin 40 mg daily, enoxaparin 40 mg daily, guafenesin prn, hydralazine 10 mg q6h as needed  8/5/2021 discharged home with anticipated left CEA 8/16/2021
Patient reported she received her Covid booster on 12/7/21. She was having chills and fever and was advised to go to the ER by her MD. The ER discovered she had an infection due to an abscess under her arm and admitted her to the hospital for IV antibiotics. Patient stated the infection is now cleared and her MD gave her the okay to resume her Humira. She stated she missed 1 or 2 doses due to this.
severe body pain/every movement painful; fever with chills for 2 days/feverish; Cannot lie down, shivering/fever with chills for 2 days; She was sweating a lot; Cannot even move around; cannot eat; This is a spontaneous report from a non-contactable pharmacist (patient).  An adult female patient (not pregnant) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on right arm on 21Jan2021 at single dose for covid-19 immunisation.  Medical history included Covid prior vaccination from an unknown date. Covid was not tested post vaccination. The patient's concomitant medications were not reported. Historical Vaccine included she received her first dose on 31Dec2020 for covid-19 immunization and gave her mild body ache and feverish for 2 days. The patient took second dose Pfizer vaccine. It was terrible. She stated the first dose gave her mild body ache and feverish for 2 days. On 21Jan2021, the second dose gave her severe body pain, fever with chills for 2 days. Today was the third day. She cannot even move around, cannot eat, every movement painful. She can not lie down, shivering. They told her to take Tylenol 24 hours. She woke up at 2 am last night feverish. She took Ibuprofen 400 mg. She was sweating a lot. She was taking lemon with tea. She was feeling much better. The outcome of the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pneumonia vaccine given about 2:30. Pain left arm woke her up at 12:00. Sharp pain injection site down. Throbbes from time to time. Pain on scale "1-10" is 920.
On the 01/03/2022, on 01/04/2022 numbing of the fact on left side. 01/05/2022 COVID positive Right over the teeth and strange feeling in teeth and following to feel like it was something in my throat like ants. I had the feeling of something crawling in throat, pain in upper teeth and stuffiness. Flushing of the face and an annoying cough, 99 fever for 24 hours and stated feeling heavy pressure in my nose. Body pains and headache loss of sense of smell after four days. Second day a COVID test from urgent care and it came back positive. 01/05/2022 COVID, 5th day numbness in hands and feet, oxygen level was low. Started to recover at the day 6th, extreme fatigue set in and is still ongoing. Lyme disease under control is controllable. Heart and Lung disease. Issue with forgetfulness. COVID strong COVID symptoms are going but not recovered. Joint pain, sleep and fatigue are ongoing issue. Digestive issue under control prior to COVID now is not under control. Anxiety level increase and increased.
Fever (102 degrees) multiple muscle aches, mild nausea was seen and released from ER 3/25/09 still has muscle aches & erythema around injection site today but no pain.  He feels much better.
Pain in top of head immediately. Numbness in both hands and dizziness immediately. The next day, extremely tired, confused, weak, runny nose, feverish. It lasted 10 days. The confusion lasted a few days longer.
patient developed ITP; This is a spontaneous report from a Pfizer-sponsored program via a contactable other health professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient developed Immune thrombocytopenic purpura (ITP). The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as relationship between  the suspect drug BNT162B2 and reported event immune thrombocytopenic purpura cannot be excluded until further information becomes available. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
shortness of breath with oxygen saturation of 84% low heart rate 42 low blood pressure 90/60
The 2nd dose of pfizer pediatric vaccine was given on 10/03/2022.  The information we perceived for the product at the time was: expiration date 10/31/2022 (12 months from manufactured date 10/2021) and Beyond use date is 10 weeks from fridge date or whatever closer date with expiration date (fridge date was 08/22/22). The recall information we obtained was on 10/12/2022 and the product was isolated right away.
Fever 100.1, Chills, swelling, pain at injection site, headache, severe join pain. Symptoms started 12 hours after vaccine. Fever lasted 24 hrs, joint pain 24hrs, the remaining symptoms I am still dealing with.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 9:12 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:12 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 72.29.  Concomitant products were not provided.  On 31-Mar-2021, Excursion time was 8 AM, temp was 32 and at 9 AM temp was 32; total doses given for the day was 199, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 31-Mar-2021. 4 vial was moved to clinic. Vaccine BUD date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Following the first vaccine I began having heart palpitations, resulting in a visit to the cardiologist 2 weeks after.  I also had a UTI and subsequent yeast infection.  Palpitations began to dissipate just before the second vaccine.  Following the second dose they began again. The Echocardiogram and subsequent EKG's are all normal.  The cardiologist thought perhaps it is Inappropriate Sinus Tachycardia, since my heart is healthy, yet heart rate would randomly spike through out the day from simple movements.  As of this past Sunday, May 2, 2021, all my symptoms have completely gone away and remain gone.
Information has been received from a health professional concerning a 5 year old female with no allergies or medical conditions who on 6/28/99 was vaccinated SQ with a first dose of varicella virus vaccine live (lot # 630675/0424J). There was no concomitant medication. There was no illness at the time of vaccination. On 5/25/04, the patient experienced 10-15 lesions on the torso described as classic various stages. No diagnostic studies were done. Symptomatic treatment was provided. It was reported that the patient recovered. Additional information has been requested.
Initial information has been received from a pharmacist concerning a 74 year old male patient who on 17-APR-2012, was vaccinated with a dose of (Merck) (Lot # 671144/1269AA) that might have been exposed to a temperature excursion after the vaccine was transported back-and-forth between pharmacies packed in ice. The pharmacist stated that the patient did not receive any other vaccines on the same day that the ZOSTAVAX (Merck) was administered. The pharmacist also stated that the patient had not experienced any adverse events at that time. It was unknown if the patient sought medical attention. Follow-up information was received from pharmacist. On 17-APR-2012 at 11:30 AM, the patient was vaccinated with the second dose of ZOSTAVAX, subcutaneous (SC) (dose not reported) at pharmacy. No other co-suspects were reported. No concomitant medications were reported. No event occurred. This is one of several reports received from the same source. Additional information is not expected.
PER PATIENT SHE EXPERIENCED ANXIOUSNESS AND SLIGHT HEADACHE THAT RESOLVED BEFORE DISCHARGE.  VITALS MONITORED
Guillian-Barre syndrome. 11/20/09 and 11/23/09 DC summaries and hospital records received service dates 10/26/09 to 10/31/09. Assessment: Guillain-Barre. Presented with a 24-hour history of facial weakness and numbness on the left side of his face. Continued to have progressive weakness and difficulty with mobility both sides. IVIG. Some difficulty with swallowing. Patient noted to be drooling. Expiratory wheezing. Speech slurred. Unsteady gait. Iron difficiency anemia. Headache.   11/24/09 Flu questionnaire revealed additional PMH: COPD
INADVERTANTLY GAVE REGULAR DOSE INSTEAD OF HIGH DOSE- (WAS AVAILABLE) CLIENT NOTIFIED BY NURSE
Diarrhea, acid reflux, continuing from first shot. Headaches continuing from first shot. Kidney pain and difficulty urinating (first urination after awaking) 2 days after 2nd shot. Light-headedness.
On 09/10/21 at 10:45 AM, patient was given first dose of Pfizer COVID-19 vaccine. Within 30 minutes, normal side effects were observed. Burning sensation at the injection site, and soreness in arm. That evening patient felt tired, and then slept for twelve hours which is unusual since she has two small children (father cared for children so she could rest). The morning of 09/11/21, patient experienced shortness of breath and pain in the lungs (COPD like symptoms), coughing, sever fatigue, headache and was lightheaded throughout the day. Lungs began to feel better by 10:50 AM, but lung pain and shortness of breath came back around 2 PM, which led patient to experience a panic attack. Severe fatigue returned that afternoon, and patient rested throughout the day. On 09/12/21 severe fatigue persisted, and patient rested and drank water to no avail. On 09/13/21 patient felt back to baseline and then at 9 PM that night experienced chest pain/pressure. On the morning of 09/15/21 patient woke up in a cold sweat and felt like there was pressure and pain around her heart. By 11 AM that morning patient experienced severe fatigue and had to take the day off of work to rest.  A severe pressure headache began at 11:19 AM, which intensified by 3:30. On the afternoon of 09/15/21, patient felt like heart was pounding out of chest. Patient called PCP, who said it was likely anxiety, and anti-anxiety medication should help. Patient followed doctor's orders, but anti-anxiety medication did not help. Patient visited urgent care on 09/16/21, where they performed a quick EKG which came back clear, and vitals looked good. As of 09/20/21 chest pain still comes and goes, and anti-anxiety medication does not help. It should be noted that though patient has experienced anxiety for years, chest pain has never been a symptom until after receiving the first dose of the vaccination.
heat rash; itchy rash consisting of small intact blisters all over his back, legs and arms; small intact blisters all over his back, legs and arms; This non-serious case was reported by a consumer via call center representative and described the occurrence of heat rash in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). In SEP-2023, between 1 and 2 months after receiving Shingrix, the patient experienced heat rash (Verbatim: heat rash), itchy rash (Verbatim: itchy rash consisting of small intact blisters all over his back, legs and arms) and blister (Verbatim: small intact blisters all over his back, legs and arms).  The patient was treated with ambiguous medication nos (Cortisone (Nos)). The outcome of the heat rash, itchy rash and blister were not resolved.   It was unknown if the reporter considered the heat rash, itchy rash and blister to be related to Shingrix.     It was unknown if the company considered the heat rash, itchy rash and blister to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-OCT-2023 The patient self-reported this case. He received his first Shingrix dose about 2 months ago from reporting.  About 3 weeks ago he developed an itchy rash consisting of small intact blisters all over his back, legs and arms.  The rash started while he was on vacation in a very hot area. He saw two doctors and was told it was a heat rash. He used a cortisone cream to treat the rash. The cream did not help.  Nothing else was reported. The reporter did not consent to follow-up.
flu like symptoms; sore throat; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced influenza-like symptoms and sore throat. On an unknown date, the outcome of the influenza-like symptoms and sore throat were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms and sore throat to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter asked how long do the flu like symptoms usually last. The patient received Shingrix and had sore throat and continued for 5 days. The reporter asked was this a side effect or a new problem.
left shoulder pain with limited mobility, having difficulty driving or lifting anything; left shoulder pain with limited mobility; bruising at the injection site; Initial information received on 23-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 31 years old female patient who experienced left shoulder pain with limited mobility, having difficulty driving or lifting anything, left shoulder pain with limited mobility and bruising at the injection site, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 08-Aug-2019, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious left shoulder pain with limited mobility, having difficulty driving or lifting anything (mobility decreased), left shoulder pain with limited mobility (musculoskeletal pain) and bruising at the injection site (vaccination site bruising) (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was bruising at the injection site, left shoulder pain with limited mobility and left shoulder pain with limited mobility, having difficulty driving or lifting anything.  It was not reported if the patient received a corrective treatment.  The patient was Not Recovered from the events.  Information on the batch number was requested.  Documents held by sender: none.
Cluster of vesicles which resolved into an area of erythema over 3-4 days at the site of the varivax injection.
Felt they would passed out; Throat closing up; Really dizzy; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Felt they would passed out), THROAT TIGHTNESS (Throat closing up) and DIZZINESS (Really dizzy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced FEELING ABNORMAL (Felt they would passed out), THROAT TIGHTNESS (Throat closing up) and DIZZINESS (Really dizzy). On 16-Mar-2021, FEELING ABNORMAL (Felt they would passed out), THROAT TIGHTNESS (Throat closing up) and DIZZINESS (Really dizzy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Heart rate: 130 (High) Heart rate went up to 130.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient was told to lay down and given some water and carbohydrates. Patient felt better and left the facility after an hour. Concomitant medications were not reported.
Migraine; soreness in muscles; Continued discoloration (Schmaberg's) after second dose.; Constipation; tiredness; This is a spontaneous report from a non-contactable consumer reported for herself. A 30-years-old female patient received BNT162B2, via an unspecified route of administration on 26Apr2021 14:30 (Lot Number: EW0150), at the age of 30-years-old, as dose 2, single, for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included spironolactone taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The patient previously received 1st dose of BNT162B2 on 05Apr2021 at 02:45 PM (Lot number: EW0175) for COVID-19 immunization. Adverse event after 1st dose included enlarged lymph nodes both armpits 1 week after 1st vaccine. Lasted a few days. Painful to the touch. Schambergs disease: discoloration on both lower and upper legs shortly after 1st dose. Sore arm (where vaccine was administered). Upset stomach/constipation 2nd - 3rd week after 1st dose. The events after 2nd dose included: Migraine and increased soreness in muscles that were generally stiff due to non-vaccine related causes. Went away with 2 x Advil. Continued discoloration (Schmabergs) after second dose. Discoloration did not go away as of this writing (3.5 week post 2nd dose). Constipation & tiredness for 1-2 weeks. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of migraine and soreness in muscles which included 2 x Advil. No treatment was received for the other events. The patient was recovered with lasting effects. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Is weak; Is sick; Can't keep food down; Has no muscle strength; Having a reaction to the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Is weak), ILLNESS (Is sick), FEEDING DISORDER (Can't keep food down), MUSCLE STRENGTH ABNORMAL (Has no muscle strength) and IMMUNISATION REACTION (Having a reaction to the vaccine) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 017F21A, 038K20A and 026L20A) for COVID-19 vaccination.     patient had  not tested Positive to Covid-19test or diagnosis.  Concurrent medical conditions included Pollen allergy.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Is weak), ILLNESS (Is sick), FEEDING DISORDER (Can't keep food down), MUSCLE STRENGTH ABNORMAL (Has no muscle strength) and IMMUNISATION REACTION (Having a reaction to the vaccine). At the time of the report, ASTHENIA (Is weak), ILLNESS (Is sick), FEEDING DISORDER (Can't keep food down), MUSCLE STRENGTH ABNORMAL (Has no muscle strength) and IMMUNISATION REACTION (Having a reaction to the vaccine) outcome was unknown.            Concomitant blood pressure medication provided by the reporter. The caller was a consumed who stated that he is calling on behalf of his wife who is a 80 year old patient who was vaccinated 26 hours ago. Treatment information was not provided.   This case was linked to MOD-2022-584926 (Patient Link).
For 2 days after vaccine I had muscle soreness which resolved. On 1/26 I developed recurrence of local soreness just below vaccine site, followed by inflammation (circular red rash, swelling, heat, mild pain). It resolved within 48 hours with mild pruritis after that for a few days.
At the 14 day I had a severe head ache and hip pain on both sides for 3 days, at days 28 , 29, & 30 I was lethargic, both legs were severely swollen from my feet to mid calf, and I was nauseated and vomiting
10 min after shot i felt extreme warmth throughout my body, my face was flushed and warm. I was sweating and short of breath. My peripheral vision was cloudy. This lasted approx ten minutes.