chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe chills; Fever; Fatigue; Body ache; This is a spontaneous report from a contactable consumer. This 41-year-old female consumer (patient) reported for herself.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Bicuspid aortic valve" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "Allergy: Bactrim". The following information was reported: CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Severe chills"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Body ache".  Additional information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Device Date: 12Nov2021  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient with 3 COVID vaccines who admitted and had COVID detected PCR found upon d/c planning.  Asymptomatic for COVID found during routine testing for facilty placement.  "86 year old patient with a history of paroxysmal atrial fibrillation, Parkinson's disease, and mild cognitive impairment presented with L sided weakness with suspected CVA involving the left parasagittal frontal lobe as visualized on CT Cerebral perfusion, showing critical hypoperfusion, with subsequent weakness in his right upper and right lower extremities. Suspect thromboembolic based on the location and distribution of the infarct. Neurology was consulted. It was deemed Eliquis failure, for which Neurology recommended transition to Xarelto, which the patient tolerated without complication. ASA was discontinued due to risk of bleed/hemorrhagic conversion while already on anticoagulation given his history of atrial fibrillation. The patient also demonstrated recurring agitation and confusion, and attempts at initiating pharmacotherapy were made with some success. By discharge, the patient was on a regimen of Seroquel 25 mg in the morning, Seroquel 50 mg in the early evening, and PRN haldol oral solution for breakthrough agitation. The morning dose to be administered at the discretion of the family, depending on striking a balance of agitation prevention and interactivity. The patient was found to be COVID positive on PCR screen, however he was asymptomatic. He was discharged home with family in stable condition."
Flu; Arm was sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd November 2019, the patient received the 1st dose of Shingrix. On 23rd November 2019, 1 days after receiving Shingrix, the patient experienced pain in arm. In January 2020, the patient experienced influenza. On an unknown date, the outcome of the pain in arm and influenza were recovered/resolved.   It was unknown if the reporter considered the pain in arm and influenza to be related to Shingrix.  Additional details were reported as follows: The patient did not remember which arm was injected but the arm was sore the following day and the soreness lasted approximately 5 days. The patient had flu in January 2020. The reporter did not consent to follow up. The outcome for events was reported as recovered/resolved with sequel however it was captured as recovered/resolved in the case.
After first dose her mental status become slightly altered and she leaned to the left a bit when standing up and walking.. From the day of second dose my sisters appetite decreased. She started sleeping more, got weaker to the point I had to bathe her, she had to start using a wheelchair. Mental status much more altered.  She was to weak to go to dialysis on Monday March 22 2021 hospice was called in Tuesday March 23 2021 and she passed away at approximately 4:00 P.M. March 24th 2021.
Gum pain; Terrible sensitivity to hot and cold/had to change from using electric brush and her toothpaste; Felt like her tooth will fall out; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL PAIN (Gum pain), HYPERAESTHESIA TEETH (Terrible sensitivity to hot and cold/had to change from using electric brush and her toothpaste) and LOOSE TOOTH (Felt like her tooth will fall out) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included Root canal infection. Previously administered products included for Product used for unknown indication: Super shingles shot in 2018, Pneumonia shot in September 2018 and Flu shot in September 2020. Concomitant products included ATORVASTATIN and LEVOTHYROXINE for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-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 GINGIVAL PAIN (Gum pain), HYPERAESTHESIA TEETH (Terrible sensitivity to hot and cold/had to change from using electric brush and her toothpaste) and LOOSE TOOTH (Felt like her tooth will fall out). At the time of the report, GINGIVAL PAIN (Gum pain), HYPERAESTHESIA TEETH (Terrible sensitivity to hot and cold/had to change from using electric brush and her toothpaste) and LOOSE TOOTH (Felt like her tooth will fall out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information was reported.   This case was linked to MOD-2021-233451 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: No New Information.
No sign or symptom of distress or adverse reactions immediately after and after 20 minutes of monitoring.
Positive exposure to husband on 3/11 Had had both Moderna Covid vaccines, 1st on 12/26/2020, 2nd on 1/22/2021 She had symptoms on 3/13 and tested positive with PCR test on 3/14. 3/15 had a telehealth visit with PCP for muscle aches and sinus pressure which continues at this time
This spontaneous report was received from a 72 year old female patient regarding herself. The patient's medical history and concurrent conditions were not reported. On 23-OCT-2014 the patient was vaccinated with ZOSTAVAX (lot # J012660; expiry date: 10-JAN-2015). The patient's concomitant medications included unspecified medications. The patient reported that she experienced an outbreak of psoriasis immediately (unspecified date in OCT-2014) after receiving ZOSTAVAX. No other symptoms were reported. The patient saw physician and treated with unspecified topical cortisone cream. Therapy with ZOSTAVAX was continued. The outcome and causality of the events were not reported. Additional information has been requested.
Patient receive Fluzone vaccine at 1:20pm , came up to counter complaining of intense itching and redness at site.
Stroke Sudden fall around 1:15 PM on May 6, 2021.  Laceration on head and eyebrow as result of fall.  Lightheaded after fall.  Loss of feeling on left side.  Dystonia of left hand. Arrived at ER around 2:30 PM.  MRI  Diagnosis: Cerebrovascular accident due to embolism of right middle cerebral artery (HCC) Transferred to Another hospital around 5:00 PM.  Treated with blood thinners.   ICU for about 24 hours Numerous CT scans and MRI, ECG Normal function of left side restored.  Slight loss of sensation remains on left side.  Discharged from hospital and returned home.  5/9/21
While pt was being given Gardasil she passed out. Laid her down and elevated her feet--Upon arousing was nauseated and felt the need to have a BM.
Swelling to upper arm at injection sight began 1/23/2021;  as days went on the site became red,  warm/hot to touch and then itchy. Antibiotic treatment was assigned by Dr. on 2/6/2021.  Symptoms continue,but may be abating. I have taken 4 doses of the antibiotic., since 2/6/2021, and two so far 2/7/2021Still itchy, warm site, but lighter color: pink.
This spontaneous report as received from a Licensed Practical Nurse refers to a 51 years olds female patient. On an unspecified date the patient was vaccinated with a dose of live ZOSTAVAX (lot#: 0564AE, exp, date was unspecified). On 05-NOV-2012 the patient who was administered live ZOSTAVAX complained of "soreness, swelling, redness and it felt hot to the touch at the injection site." The patient was sent to the emergency room(ER) at an unspecified hospital for an unspecified duration. The outcome of the events was unknown. The relatedness the events was unknown for live ZOSTAVAX. Additional information is not expected.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unspecified gender and age. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On unknown dates, the unspecified number of improperly stored doses of GARDASIL 9 lot# reported as M004798, expiration date 31-OCT-2019 (dose, route of administration and anatomical location were not reported) were administered to the patients. The doses were stored in temperatures from 32 degrees Fahrenheit  to 25  degrees Fahrenheit  for 240 hours. No adverse effects have been reported. Data logger was not involved. There was no previous excursion reported. Product quality complaint was not involved.
Body aches; Chills; Headache; Painful skin; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced general body pain, chills, headache and skin pain. On an unknown date, the outcome of the general body pain, chills, headache and skin pain were recovered/resolved.   It was unknown if the reporter considered the general body pain, chills, headache and skin pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022178661   Additional Information: GSK Receipt Date: 29-NOV-2022 Reporter's Comments: The case was self reported by the patient. The patient received first dose of Shingrix a year ago and reported body aches, chills, a headache and painful skin. The reporter would call back with lot/expiration date of vaccine given as well as the date of the first Shingrix vaccine after checking her patient chart. The reporter consented to follow up.  Additional Supportive Information: For tolerance of 2nd dose, refer case US2022178661.; Sender's Comments:  US-GSK-US2022178661:Same reporter
severe itching; had some different allergies; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the first dose of BNT162B2 for COVID-19 immunisation on 28Dec2020, and the patient had no side effects. The patient got the second COVID shot (vaccine) and she had a reaction to it, she had some different allergies and she got severe itching on 16Jan2021, admitted into emergency room from 16Jan2021 to 16Jan2021. Seriousness of the events was hospitalization. The patient stayed at the site for a while because the itching didn't end they wanted the patient to go into an Emergency Room (ER) but they were able to get it under control and the patient was fine today. The patient received diphenhydramine hydrochloride (BENADRYL) and steroids for the events. The outcome of the events was unknown. The reporter considered that the events were related to BNT162B2.  Information on the lot/ batch number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, a causal relationship between events "reaction to it, she had some different allergies and she got severe itching" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. 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.
Atrial fibrillation; pericarditis; low grade myocarditis; he was still having chest discomfort.; pleuritic chest pain; This is a spontaneous report from a contactable physician. A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: not reported), via an unspecified route of administration on 12Jan2021 (at the age of 79-years-old) as dose 1, single, and via an unspecified route of administration on 02Feb2021 as dose 2, single for covid-19 immunization. Medical history included ongoing hyperlipidemia; ongoing Presume erectile dysfunction. Concomitant medications included rosuvastatin (ROSUVASTATIN) taken for hyperlipidemia; tadalafil (CIALIS) taken for erectile dysfunction. On 03Jun2021 the patient experienced atrial fibrillation. On Jun2021 the patient experienced pericarditis, low grade myocarditis. on 02Jun2021 the patient experienced pleuritic chest pain, on 10Jun2021 the patient experienced he was still having chest discomfort. The patient underwent lab tests and procedures which included C-reactive protein increased: 65.2 on 03Jun2021 upper limit of normal is less than 8 , C-reactive protein increased: 74 on 10Jun2021, C-reactive protein increased: 65.1 on 16Jun2021, sedimentation rate: 80 on an unspecified date, sedimentation rate: 25 on 10Jun2021, sedimentation rate: extremely high on 24Jun2021, troponin: elevated on 03Jun2021, troponin: normal on 10Jun2021 .Therapeutic measures were taken as a result of atrial fibrillation, pericarditis, low grade myocarditis , pleuritic chest pain, he was still having chest discomfort. Treatment included on 24Jun2021 primary/internist started patient on steroids which caller clarified as being Prednisone 20mg because he was not feeling well and a sedimentation rate came back quote: extremely high; Eliquis 5mg twice daily with the atrial fibrillation; When caller first met the patient, he started Motrin and Colchicine-which caller clarified as they gave him Mitigare which caller believes is the same thing as Colchicine: 0.6 twice daily. The outcome of events was not resolved.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the limited information currently available, the causal association between the event Pericarditis, myocarditis and the suspect drug cannot be excluded. Also, there is limited information in the case provided, the causal association between the event Atrial fibrilation, Chest pain, Chest discomfort and the suspect drug cannot be excluded.  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 RAs, Ethics Committees, and investigators, as appropriate.
couldn't sleep; head feels bad; irritable; sluggish and slow; hand feels weak; pain; muscle pain; dragging and tired; She felt like she was moving in slow motion all day/she did not usually feel like this; This case was reported by a consumer via call center representative and described the occurrence of sleeplessness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2019, the patient received Shingrix. On 4th November 2019, less than a day after receiving Shingrix, the patient experienced sleeplessness. In November 2019, the patient experienced headache, irritability, sluggishness, hands weakness of, pain, muscle pain, tiredness and dizziness. On an unknown date, the outcome of the sleeplessness, headache, irritability, sluggishness, hands weakness of, pain, muscle pain, tiredness and dizziness were unknown.   It was unknown if the reporter considered the sleeplessness, headache, irritability, sluggishness, hands weakness of, pain, muscle pain, tiredness and dizziness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and she could not sleep last night. Her head on the left side was not feeling that bad anymore but she received the vaccination on her left side. She was very irritable, sluggish and slow. She felt like she was moving in slow motion all day. Her entire left arm and hand feels weak to the bottom of her arm pit and was bothering her. She has pain, muscle pain and feels like she was dragging and tired. She was always on the go so she did not usually feel like this.  The reporter did not consent to follow up. The patient refused to provide any additional information and hung up.
started to smell things not present to others - initially I thought something was burning. occasionally it will make me a little nauseous. It was happening once or twice a day. I was given essential oils to smell twice a day for one minute for 12 weeks. I am in week 8. Now I rarely smell the smell. Also I now have a constant ringing in my head. sounds like a TV was left on after the broadcasting stopped.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 10Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), 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. Past drug history included: Bactrim, reaction(s): "Known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive, notes: COVID 19 Treatment. The patient received Paxlovid from 17Feb2023 to 22Feb2023 and experienced rebound symptoms 7 days after last dose of Paxlovid on 21Feb2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Not feeling herself; Patient is not tired but looks tired; Severe squeezing headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not feeling herself), HEADACHE (Severe squeezing headache) and FATIGUE (Patient is not tired but looks tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Osteoporosis. Concomitant products included IBUPROFEN from 20-Feb-2021 to 20-Feb-2021 for Headache, ALENDRONATE SODIUM (ALENDRONATE) for Osteoporosis, MULTIVITAMIN [VITAMINS NOS], MAGNESIUM, VITAMIN D3, FISH OIL and BIOTIN for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced HEADACHE (Severe squeezing headache). On 02-Mar-2021, the patient experienced FEELING ABNORMAL (Not feeling herself) and FATIGUE (Patient is not tired but looks tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Not feeling herself) and FATIGUE (Patient is not tired but looks tired) outcome was unknown and HEADACHE (Severe squeezing headache) had not resolved.            This case was linked to MOD-2021-032624 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up received on 3-5-2021, Patient demographics, medical history, concomitants updated
Information has been received from a physician concerning a 22 year old female with no pertinent medical history and no history of drug reaction/allergies who in January 2007, was vaccinated with a first dose of Gardasil (lot # not reported) 0.5 ml IM. Concomitant therapy included hormonal contraceptives (unspecified). In March 2007, the patient experienced left sided chest pain. Medical attention was sought. There was no radiation and treatment prescribed. In March 2007, the patient had an electrocardiogram, blood work and ultrasound performed; all results were negative. The patient was taking birth control but was discontinued in march 2007. The pain resolved on its own. When the patient was seen again by the physician at the end of April 2007, the pain had resolved completely. The physician restarted the birth control after the patient's visit in April, 2007. The patient was requesting the second dose of Gardasil. No additional information was available at the time of reporting. Additional information has been requested.
Sever headache and nausea 24 hours after shot. Then 5 days after shot sever abdominal pains on the right side. Was hospitalized and they found a blood clot in a vein leading from my ovary on the ride side. Treatment was Eliquis and further testing.
Breaking out in what appears to be shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Breaking out in what appears to be shingles) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced HERPES ZOSTER (Breaking out in what appears to be shingles). At the time of the report, HERPES ZOSTER (Breaking out in what appears to be shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.