chrisvoncsefalvay/vaers-outcomes huggingface dataset:
24 yo male hx pericarditis x1 in 2003, x2 in 2004. Received SPV Jan 20, 2005 as primary vaccinee. Reports sensation of severe 10/10 stabbing/ pressure like CP thay radiated to bilat arms - simialr to prior episodes of pericarditis but more severe. Sx started approx 2 weeks after vaccinationo. Sx worse with laying back and improved leaning forward. +Pleuritic. First documentation is ED day 83 post receipt where he was diagnosed with pericarditis and given NSAID with immediate relief. . In follow up he had recurrent bouts of CP requiring narcotics - sx resolved after 4 weeks. Has had  continue recurrent episode's through 2013. Sinnce then and been prescribed nsaid +/- colchicine. Labwork  to include cardiac enzymes from  FEB 15,16 & 24 2005 were found but no accompanying notes.
1st dose: extreme arm pain, mild body aches 2nd dose: flu-like symptoms including headache, body aches, fever, fatigue, swollen, hot arm at the injection site, and rash on arm of the injection site
Vertigo began 5 days after pfizer dose 1.  This is ongoing two weeks later.
A few minutes after receiving vaccine patient said he did not feel well. He was very pale, cool to the touch, clammy on his face. He felt nauseous and weak, Dad held him up as he spit in the toilet. He was quiet and not himself, when questioned said his stomach hurt, he didn't feel well, and eventually stated he felt like "there wasn't a big space to take a breath." I called 911 and we put a cool cloth on his head and had him rest on the bench with his dad, monitored his breathing which was normal, but he was still pale. After a few minutes he got some color back in his face and was more responsive, even smiling occasionally. Rescue squad assessed him and said his heart rate was elevated but otherwise he was fine.
102 fever; Feels tired; chills; body was aching; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (body was aching), PYREXIA (102 fever), FATIGUE (Feels tired) and PAIN IN EXTREMITY (Sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 05-Apr-2021, the patient experienced CHILLS (chills) and MYALGIA (body was aching). On 06-Apr-2021, the patient experienced PYREXIA (102 fever) and FATIGUE (Feels tired). At the time of the report, CHILLS (chills), MYALGIA (body was aching), PYREXIA (102 fever), FATIGUE (Feels tired) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
Swelling right eyelid and cheek bone area.  Prescription provided 8-23-08 by Dr. 21 tablets famciclovir 500mg.
10 minutes after injection, heart rate escalated to 125 BPM.  Since second injection, heart rate, despite medication,  has consistently been high (95--110 BPM) and BP has been slightly elevated.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2011, the patient's healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 01-SEP-2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
When given the second vaccine the lab tech injected the  vaccine into my bursa which caused major muscle and use issues. Within a couple months of the last vaccine I began encountering extensive skin rash and itching and neurological issues following that. I have experienced respiratory both sinus and chest infections and I?ll was since then and these are still occurring presently. Skin and neurological issues are excessive and have been to several specialists and nothing has been revealed as to the cause. The only link is this was all onset after vaccinations. My RA level had spiked several months after the onset of symptoms as well.
Intense whole body and joint aches. I had tested positive for COVID-19 in November 2020. I experienced the same intense body aches with that.
Patient experienced hallucinations. Husband reports patient has been acting strangely since receiving vaccine. Husband came back one month approximately after vaccine administration to tell us this about wife.
Developed swelling and urticarial rash on the whole thigh where Flu shot was administered. No other symptoms. Rash fading spontaneously. Last year, he also had the same reaction.
Information has been received from a registered nurse concerning a 14 year old patient who on an unknown date was vaccinated with a dose of GARDASIL injection (dose, route and lot number not provided). The nurse reported that after receiving GARDASIL injection, the patient experienced nausea, vomiting and elevated temperature (date unspecified). The patient was seen in the emergency room. At the time of the report the patient's outcome was unknown. This is one of three reports received from the same source. No further information is available.
Acute kidney failure, unspecified Proteus (mirabilis) (morganii) as the cause of diseases classified elsewhere
10 minutes after pt got the Pfizer COVID-19 vaccine she reported feeling light headed and dizzy.  Pt was offered some soda to treat suspected hypoglycemia.  After drinking some pt stated they felt chest tightness and SOB. EMS was called.  About 5 minutes after calling EMS pt said she felt better (no SOB and no chest tightness).  When EMS arrived pts BP and O2 sat where within normal limits.  Pt denied additional care from EMS. Pt declined EMS offer to transport to hospital.  Pt exited the pharmacy about 5 minutes after EMS left.
covid vaccine breakthrough case  dose 1 Moderna 1/21/21 029L20A dose 2 Moderna 2/18/21 013M20A
Fever; Chills; This is a spontaneous report from a contactable nurse (reporting for herself). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 18Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication included amlodipine (AMLODIPINE). The patient stated, "I think I am having the side effects, I am having some fever and chills and I had it early yesterday morning." No treatment was received for the events.The outcome of the events was unknown.
Patient reported acute onset of nausea and vomiting approximately 3 hours after the injections.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 06-OCT-2017, the patient received an expired dose of VARIVAX injection, subcutaneously, one vial/ once (exact dose was not reported), lot # L034368 with expiration date on 08-SEP-2017. The VARIVAX was reconstituted with sterile diluent (lot # M020945 with expiration date on 05-DEC-2018). The pharmacist reported that both VARIVAX and sterile diluent were stored according to prescribing information. No adverse events were reported.
This spontaneous report as received from a Registered Nurse refers to an unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 11-FEB-2016, the unspecified patient was inadvertently administered a dose of PROQUAD (Merck) (lot # L041627, expiration date: 20-APR-2017, dose and route of administration were not reported) instead of an intended dose of M-M-R II, concomitantly with VARIVAX (Merck) (lot # L039092, expiration date: 06-OCT-2017, dose and route of administration were not reported). Nurse stated that PROQUAD was mistaken for M-M-R II because of the label "measles, mumps, rubella" was listed first before "varicella". No adverse effect was reported. No dose of M-M-R II was administered. Product quality complaint (PQC) was not involved. Additional information has been requested.
passed away from COVID (positive test on 24Apr2021); passed away from COVID (positive test on 24Apr2021); This is a spontaneous report from a contactable physician. A 37-years-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 37-years-old, via an unspecified route of administration on 20Mar2021 (Lot Number: EP7534, also reported as EPT534) as single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. Patient received first dose of bnt162b2 at the age of 37-years-old on 27Feb2021 (Lot Number: EN6205) for covid-19 immunisation. Patient with no comorbidities passed away from COVID (positive test on 24Apr2021) in the ICU on 09May2021. Autopsy is still pending. Patient's family members provided vaccination card and she would like to verify if the lot numbers are from Pfizer Covid-19 vaccine. Added that it is freighting as the patient developed fatal Covid a month after being fully vaccinated. Additionally, she would like to verify if it is possible to know where the vaccines were shipped or any other distribution or facility information she could get from these lots. Stated that the vaccination card has something written on a box from the right hand side. Reporter seriousness for Tested Positive for Covid was Hospitalization, Death. Cause of death: Autopsy Pending, they assume Covid. Autopsy performed, Autopsy details not available. Events outcome was fatal. The patient died on 09May2021.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on reported events cannot be excluded in a context of LOE.  The impact of this report on the benefit/risk profile of the Pfizer drug 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. ; Reported Cause(s) of Death: passed away from COVID (positive test on 24Apr2021)
Bell's palsy; This is a spontaneous report from a contactable healthcare professional (patient who was also reported as a consumer). A 66-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in the left arm on 28Jan2021 11:45 (Lot Number: EL3302) as a single dose for covid-19 immunisation. Medical history included aortic dissection, BP [blood pressure] (blood pressure abnormal), thyroid (thyroid disorder), heart (heart disorder) and cholesterol (blood cholesterol abnormal). The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication includes unspecified BP, heart, thyroid and cholesterol medication. The patient previously took and had allergies with codeine (includes upset stomach) and lisinopril (includes cough). The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine in a hospital. On 09Mar2021 07:15 AM, the patient had Bell's palsy. The event resulted in a doctor or other healthcare professional office/clinic visit and received treatment which includes prednisone (ORASONE) 20mg Oral and valacyclovir (VALTREX). The patient has not been tested for COVID-19 since vaccination. The outcome of the event was not recovered.; Sender's Comments: Based on available information, the event Bell's palsy most likely represents intercurrent medical condition and is unrelated to Bnt162b2 vaccine. Case will be re-assessed upon the additional information provided. 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.
This spontaneous report as received from a pharmacist via field employee refers to a patient of unknown age and gender. Information regarding the patient's current condition and medical history was not provided. On an unknown date (a while ago) the patient was vaccinated with ZOSTAVAX (vial, dose, lot number unspecified). On an unknown date the patient experienced shingles. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the event was reported as not recovered/resolved (recurring shingles). The causality assessment was not provided. This is one of the two reports from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Started menstrual cycle on June 4th with insanely heavy bleeding and large clots. Presented to the emergency room at Hospital for excessive blood loss, dizziness, near-syncope episodes. Was given fluids, and sent for a transvaginal ultrasound that was normal.  Hemoglobin was 10.8. The bleeding continued until 04/14/21.  Bleeding subsided for 5 days then consistent breakthrough bleeding started again on 6/15/21 straight up to another insanely heavy menstrual cycle on 6/30/21. Bleeding persisted for 10 days with abnormally heavy flow and large clots. Bleeding then subsided for only 2 days before starting up again and went straight to next cycle beginning on 7/24/21. I've  had several follow up blood tests and discussions with my functional medicine doctor (where it was confirmed that I was iron deficient/anemic) with abnormally large red blood cells lacking hemoglobin.
This case was reported by a other health professional via sales rep and described the occurrence of difficulty breathing in a patient who received BEXSERO. On 29th June 2016, the patient received BEXSERO. On 29th June 2016, 10 min after receiving BEXSERO, the patient experienced difficulty breathing (serious criteria other: as per reporter) and blurred vision. The patient was treated with BENADRYL. In June 2016, the outcome of the difficulty breathing and blurred vision were recovered/resolved. The reporter considered the difficulty breathing and blurred vision to be probably related to BEXSERO. Additional details were provided as follows: This case was reported by an office manager. The age at vaccination was not reported. The patient visited the emergency room. The sales representative was unable to provide full street address.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On 19-MAR-2013, the patient was vaccinated with a dose of MMR II (lot number and expiry date reported as H009784 and 15-MAY-2013 respectively, dose unspecified), subcutaneously that was exposed to a temperature excursion that was not supported (50 degrees Fahrenheit (F) for 12.5 hours). No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Rash under vaccine site on upper arm developed a few days following vaccine and lasted for about 10 days.  I also had the same reaction after the first vaccine, although the rash was delayed after a week following the first vaccine.
Pt. received 2nd dose of the Pfizer COVID19 vaccine on 1/28/21.  Pt. reports COVID symptom onset starting 5/6/21 and tested COVID positive via PCR swab on 5/7/21.
DAY 1 POST VACCINE PT HAD MODERATE-SEVERE SHORTNESS OF BREATH THAT WORSENED AROUND 1400.  PT WAS BROUGHT TO THE EMERGENCY ROOM BY HER DAUGHTER.
Shingles around her eye; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number ZJ432, expiry date 27th May 2022) for prophylaxis.   On 31st October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 4th November 2020, 4 days after receiving Shingrix, the patient experienced shingles. Shingrix was discontinued. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient developed shingles around her eye. The patient's doctor suggested to the patient not to receive a second Shingrix shot. The reporter did not consent to follow-up.
Nurse gave 5-1 BIV as primary series as current recommendation states 5-11 BIV for booster dose only. Patient observed for 15 min post exposure. Discharged WNL.
Rash in axilla appeared on 7/7/19.  No fever, chills or body aches.  Area is sore and not does not itch
Pt. called me 4-16-08 & stated she had no redness or any symptoms until one wk. after the injection when she started with a lump at the injection site.  She was seen at hosp. on 4-8-08 & cephalexin was prescribed.  Stated she started with vomiting that same day & contributed it to the med. (she D/C'd med).  On 4-11-08 vomiting was accompanied by diarrhea.  Went back to hosp. on 4-11-08.  Had I.V. infusion Toradol (for arm discomfort) & R.A. X-ray which was neg.  Pt. was unhappy when physician Dx her with viral condition & hadn't done labs/X-rays (which is why he most likely did an X-ray of her arm).  The physician told her to continue the cephalexin & did not give her an IV antibiotic.  The pt. D/C'd the cephalexin again on 4-11-08.  She states that on Sun. April 13th, her entire arm became edematous & was accompanied by a rash so she decided to start the cephalexin again & increased her food intake with same.  She called her PCP on Monday 4-14-08 (although she felt better in regard to n/v & arm) but the physician was not available.  She received a return call from PCP's answering service ??? today (4-16-08) & has an appointment scheduled for tomorrow 4-17-08.  I asked her why she didn't just see her PCP's coverage & she stated she doesn't like that physician.  I've asked this patient to call me with any questions.  I feel this situation had to have started with a minor local reaction which was not addressed & later when it progressed to a cellulitis, was not properly tended to (just my opinion from the history obtained).
Arm cold; Blood pressure of 208; 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 PERIPHERAL COLDNESS (Arm cold) and HYPERTENSION (Blood pressure of 208) 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 PERIPHERAL COLDNESS (Arm cold) and HYPERTENSION (Blood pressure of 208). At the time of the report, PERIPHERAL COLDNESS (Arm cold) and HYPERTENSION (Blood pressure of 208) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 208 (High) blood pressure of 208.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD21-023413, MOD21-024486 (E2B Linked Report).; Sender's Comments:  MOD21-023413: MOD21-024486:
headache; 99.8°F low grade fever; Pain at injection site; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PYREXIA (99.8°F low grade fever), VACCINATION SITE PAIN (Pain at injection site) and CHILLS (Chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced HEADACHE (headache), PYREXIA (99.8°F low grade fever), VACCINATION SITE PAIN (Pain at injection site) and CHILLS (Chills). At the time of the report, HEADACHE (headache), PYREXIA (99.8°F low grade fever), VACCINATION SITE PAIN (Pain at injection site) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Body temperature: (Low) Low grade fever 99.8 F.         This case was linked to MOD-2021-046584 (Patient Link).