chrisvoncsefalvay/vaers-outcomes huggingface dataset:
increased blood pressure; reddening of the skin all over her body; This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: US-AMGEN-USASL2021027233). This case was split from master case #2021218108 to capture a 46-year-old female patient taking BNT162B2 and experienced increased blood pressure and skin red.  This non-serious solicited report (USASL2021027233) was reported on 18/FEB/2021 by a consumer from a commercial program (PSP00086) and involves a 46 years old   female patient who experienced increased blood pressure/blood pressure has continued to be elevated 180/100 [PT: blood pressure increased], migraines [PT: migraine] while receiving Enbrel, Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis, increased blood pressure, reddening of the skin all over her body. It was further mentioned that on 08/JAN/2021, the patient had a Covid vaccine and had a reaction to it immediately that including increased blood pressure and reddening of the skin all over her body. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel, Single Dose Prefilled Autoinjector on 28/JAN/2021. On 28/JAN/2021, the patient's blood pressure has continued to be elevated 180/100, even with Enbrel medication. Additionally, on an unknown date in JAN/2021, the patient had migraines and possible fibromyalgia. No treatment information was received. The outcome of the event blood pressure increased was reported as not recovered/not resolved. The outcome of the event migraine was reported as unknown. Action taken with Enbrel, Single Dose Prefilled Autoinjector was continued for the event blood pressure increased. Action taken with Enbrel, Single Dose Prefilled Autoinjector was reported as unknown for the event migraine. The causal relationship between the events blood pressure increased, migraine and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested.  Follow-up (08Mar2021): The following information was received: Narrative states, It was further mentioned that on 08/JAN/2021, the patient had a Covid vaccine and had a reaction to it immediately that including increased blood pressure and reddening of the skin all over her body. Kindly confirm Covid vaccine is co-suspect or concomitant. Response: As per the information in the case: 08/JAN/2021, the patient had a Covid vaccine. The patient began Enbrel, Single Dose Prefilled Autoinjector on 28/JAN/2021. Therefore, the Covid vaccine which was prior to Enbrel start is neither considered as co-suspect nor concomitant medication. The company is performing due diligence, and should further information be received, the case will be updated accordingly.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Exaggerated immune response and rigors; Exaggerated immune response and rigors; Fever and night sweats; Fever and night sweats; Sustained tachycardia between 100-105; This is a spontaneous report from a Pfizer sponsored program. A contactable 31-year-old male physician reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EH9899) via an unspecified route of administration in the right deltoid on 19Dec2020 at 10:30 at single dose for COVID-19 immunisation. Vaccination facility type: hospital. Relevant medical history included COVID-19 (recently had COVID prior to receiving the COVID-19 Vaccine). There were no concomitant medications. Five minutes after the COVID-19 Vaccine, on 19Dec2020, the patient experienced sustained tachycardia between 100-105 that lasted about 40 minutes and then dissipated by itself; the patient recovered from tachycardia on 19Dec2020. Early morning on 20Dec2020 at 03:30, he had an exaggerated immune response and rigors, which lasted about 30minutes to 40minutes, followed by fever and night sweats, which continued for 30 minutes and then it was all over. Reactions were spontaneously over. The patient recovered from the events exaggerated immune response and rigors, fever and night sweats on 20Dec2020. The physician believed that it was a hyper immune response. Recently, he had COVID prior to receiving the COVID-19 Vaccine and he wanted to know whether he should have waited after experiencing COVID to have received the first dosage of the COVID-19 Vaccine.  The physician considered the reported events related to the COVID-19 Vaccine.; Sender's Comments: Based on available information, a possible contributory role of the subject product cannot be excluded for the tachycardia and other  reported events due to temporal relationship. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline and during subject drug therapy, echocardiogram, electrolytes, chemistry panel, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  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.
pain in the administration site; a strong headache; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient took his first dose of BNT162B2 for covid-19 immunization on an unspecified date. The patient was experiencing pain in the administration site, and a strong headache that has been fading away. The action taken in response to the events for BNT162B2 was not applicable. The outcome of event "strong headache" was recovering, the another event "pain in the administration site" was unknown.   Information about Lot/Batch number has been requested.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 20Oct2021 at 17:00 as dose 3 (booster),single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Mar2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "gerd" (unspecified if ongoing); "high blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Feb1996, stop date: 26May2022; LOSARTAN, start date: Sep2021 (ongoing); PANTOPRAZOLE, start date: Aug2007 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: anti viral details: product of COVID 19 treatment, brand was Paxlovid, treatment start date was on 27May2022, treatment stop date was on 31May2022. The first BNT162B2 was at 01:00 pm on unspecified date, the second BNT162B2 was at 03:00 pm on unspecified date.  The lot number for BNT162b2, was not provided and will be requested during follow up.
I have a large (ping pong ball sized) lump, that I am thinking is a lymph node, in my collar bone area on the same side as my injection. My injection site has hurt more this time and I have had some pain radiate from the injection site into the shoulder bone area and seemingly to the lymph node area. It has ranged from tender to the touch to hard and painful. I tried using a heating pad on it last night and took 2 Aleve. The area remains sore, esp to the touch today, but I have not taken anything for it. I contacted the MESSA nurseline to talk with someone about it since it's still so intense today.
2 days following immun mom had in bed w/her; mom awoke & pt had stopped breathing; Pt taken to hosp & was pronounced DOA;
Pt with a diagnosis of chronic lymphocytic leukemia was administered ZOSTAVAX on 10/7/13 (contraindicated) Patient presented on 10/28/13 with a rash on legs, and again on 10/29/13 with a different rash to face. Patient instructed by primary care to hydrate, use cortisone cream and BENADRYL cream. Patient called heme/onc 10/30/2013 requesting meds for chicken pox and was prescribed acyclovir 800mg five times daily for 5 days. Patient reported to ER on 11/1/2013 with worsening rash. Was admitted with disseminated zoster and started on acyclovir 800mg IV QSH. He was discharged 11/4/2013.
Within 12 hours of receiving the second vaccine, I experienced flu-like symptoms (nausea, headache, body aches). They dissipated somewhat with Tylenol, but lasted roughly 48 hours. Additionally, since the first Moderna shot, I have had breakthrough menstrual bleeding. This is unusual given that I am taking oral birth control. The bleeding began roughly 10 days after the first shot, then I had a heavy menstrual cycle, and then the breakthrough bleeding began again roughly 10 days after my second shot. I called my OB/GYN about this, but they said their data was too limited to advise me on how long this is expected to last.
Vasovagal event with possible seizure. Pt felt faint immediately following Hep A vaccination (after previously tolerating Typhoid vaccination). Instead of just passing out, her entire body became tense and she grabbed my arms, her face turned red, eyes rolled back. No visible convulsions or nystagmus, and pt came to after 15 seconds. No loss of bladder or bowel control or post ictal state, but not typical vasovagal reaction, possible mild seizure. Pt recovered 100% by end of visit, was able to return to work. Vitals stable throughout, no fever.
Bad Headache, fatigue and body aches, some nausea starting the morning after vaccine and still fatigue and headache with body aches today, 9/16/2021
COVID 19 virus; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID 19 virus) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) 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) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced COVID-19 (COVID 19 virus) (seriousness criterion hospitalization). The patient was hospitalized from 28-Mar-2021 to 01-Apr-2021 due to COVID-19. At the time of the report, COVID-19 (COVID 19 virus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.  Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.
LARGE RED, ITCHY SKIN ERUPTIONS ON ARMS AND LEGS.  STARTED APPROX. 7 DAYS AFTER 1ST DOSE AND STILL SAME SIZE AND ITCHINESS AS OF 6/10/2021
1045-Pt received first dose of Moderna COVID vaccination LOT # 001A21A @ 1045 while in her vehicle.  Pt was being observed by EMT.  1055- Pt started feeling short of breath, chest pain, and rash was noted. Called 911 for emergency medical attention. Family notified.  Pt was brought into CHD and reported to DON.  Pt was flushed, with hives starting on neck and face. 1101-Epi 0.3mg given sq into left arm.    EMS arrived and took over care.   Flushing, redness, and hives decreasing.   Pt loaded onto stretcher  and taken to Hospital for further evaluation.  Report called to ER . , EMT.   Family followed pt and ambulance.
Pharmacist attempted to adminsiter vaccine in left arm, at the top of the shoulder, not in the thickest part of the deltoid, but syringe failed and vaccine spilled to the floor. The pharmacist adminstered a new dose in right arm, at the top of the shoulder, not in the thickest part of the deltoid. Patient came back to pharmacy next morning stating inability to sleep the night prior due to pain shooting down from both shoulders. She tried taking ibuprofen and found no relief and continues to have limited range of motion. Primary care provider Dr aware of incident and asking patient to be seen for evaluation.
Flu like Symptoms; Fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like Symptoms) and FATIGUE (Fatigue) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like Symptoms) and FATIGUE (Fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like Symptoms) and FATIGUE (Fatigue) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medication were not reported. Treatment medication were not reported.   Reporter did not allow further contact
Right after I got the vaccine they had us wait and sit for 15 minutes I grabbed some of the chips they had on the site. In less than 15 minutes I started to feel really dizzy and I had a flare of heat behind my neck. I called over one of the Dr.s and explained to him that I felt dizzy and if that was normal. He told me if I was dizzy that I needed to wait longer until the dizziness when away. I stayed longer because the dizziness went away. I was fine Friday and Saturday and Sunday I went to work and while I was working my head felt like it was spinning and spinning I felt like I was going to tip over. I left home that day thought I would just sleep it off and tried going into work the next day. Same thing was still feeling dizzy I got sent home . I proceeded and went to the urgent care on 5-31-21 where they told me that I had Vertigo . I have never had Vertigo in my life.  The only other time I had felt like this way was after the vaccine. So the Dr.said he's not for sure if it was the Vaccine but chances are if I've never had Vertigo than it probably was the Vaccine. I Went to the drs again this wed 6-2-21 they told me I had vertigo and again they said they don't know if its the vaccine but it possibly could be. Ive now had vertigo for 6 days and I need proof for my work that this Vertigo is being caused by the vaccine.
Headache, Myalgia, Arthralgia, Diarrhea, FATIGUE, SWOLLEN "KMOT" TO LEFT AXILLA AREA Narrative:
autoimmune disease that is not going away and screwed up her immune; itching so bad; blood cells are elevated because of infection in her body; rash that turned into lesions from her neck to her toes.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 09Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 68 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot: EN6207), administration date: 11Mar2021, when the patient was 68-year-old, for Covid-19 immunization; Bnt162b2 (Dose 2, Lot: EP7533), administration date: 2021, when the patient was 68 years old, for Covid-19 immunization. The patient received 3 doses of the Pfizer Covid-19 vaccine and after the third dose which was the booster shot and 2 weeks after the dose (Oct2021), she experienced a rash that turned into lesions from her neck to her toes, on top of her feet and was lingering for one year and she had been in pants and shirts all summer and she never had a problem before and she had pictures since Oct2021 and every month and she has seen 4 Dermatologists. She had been to the Emergency room and hospital and went to a university last month asking what to do and the vaccine made her have an autoimmune disease that was not going away and screwed up her immune and the booster did it to her and she was tortured with lesions all over her body, legs, thighs, arms, chest and everywhere. The patient described the rash as starting 2 weeks after booster as little dots all over her body and then came big rashes and then lesions and she has tried 500 different medications and not internally but externally.  When it first started she went to the Emergency Room because the itching so bad she was going out of her mind and thought she would have a nervous breakdown and they gave her intravenous prednisone and told her to see an infectious disease Doctor and they said they cannot do anything and then she went to Dermatologist 1, then Dermatologist 2, then Dermatologist 3, and Dermatologist 4. She had bloodwork and showed constantly her blood cells are elevated because of infection in her body. Her Dermatologist put her on dupilumab (DUPIXENT) and burning and shots and creams and she had been to 500 drugs stores and all over country and nothing was helping and this is the last resort. The patient received the following medications as treatment: doxycycline, hydroxyzine tablets for itching, mupirocin, prednisolone 5 times since Jan2022 and clobetasol. The outcome of "rash that turned into lesions from her neck to her toes" and "itching so bad" was not recovered while unknown for the other events.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201227099 same patient/product, different dose/events;
No additional AE; lnadvertenly administered expired vaccine; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concomitant medications or concurrent conditions was provided.  On 02-AUG-2021, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) 1 time dose, lot # T018670 was confirmed to be valid, expiration date 11-JUL-2021 (dose, route and site of administration were not reported) for prophylaxis. The vaccine had no temperature excursion. No additional adverse event was reported.
Numbness, itching, pain in left thumb beginning 12-16-15 date of high dosage flu vaccine. Nerve medications to no avail. Sleepless nights. Thumb could not touch anything. Office visit dates: 12/23/2015, 01/04/2016, 01/22/2016, 04/06/2016, 04/20/2016, Neuro 01/27/2016, Arterial Doppler Scan bil upper ext 04/15/2016.
Shingles 4/01. Typical dermatitis type rash on right chest wall.
The patients did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 2 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 20-NOV-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Annoying allergy, as of today I have body itching, mostly in the neck and ears and throat pain.
Diarrhea - multiple watery stools, fussy. Spitting up formula. Four day after vaccine x 5 days.
Are heart palpitations a side effect after the second dose of the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Are heart palpitations a side effect after the second dose of the vaccine) 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 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 PALPITATIONS (Are heart palpitations a side effect after the second dose of the vaccine). At the time of the report, PALPITATIONS (Are heart palpitations a side effect after the second dose of the vaccine) outcome was unknown.            No concomitant medication were provided.  No treatment medication were provided.
joint pain; This case was reported by a pharmacist via call center representative and described the occurrence of joint pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cancer in remission.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was recovered/resolved.   It was unknown if the reporter considered the joint pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Age was estimated to be over 55 years old since reporter did not have specific patient information. Patient was a cancer survivor and undergoing treatment.  After receiving Shingrix, the patient experienced joint pain. Pharmacist called to report about the safety profile for a second dose of Shingrix for a patient under treatment with estrogen blockers. The reporter consented to follow up.
No additional AE reported; Patient was administered improperly stored GARDASIL 9 on 09/30/2022.; This spontaneous report was received from a certified medical assistant and refers to patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided.   On 30-SEP-2022, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe, lot #1780878, expiration date: 02-DEC-2023 (exact dose, route of administration and administration site were not reported) for prophylaxis. On 19-SEP-2022, the dose of vaccine experienced the temperature excursion of 31.8 Fahrenheit degrees for 19 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) was reported (no adverse event).
Severe pounding headache,  fever, chills, body aches,  arm pain, redness, elevated blood pressure.