chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from nurse practitioner refers to an unknown number of patients of an unknown age and gender. Medical history was not reported. Since 01-APR-2014 the patients were vaccinated with GARDASIL (injection), (lot number, expiration date, route and dosage were not reported). That was improperly stored. No adverse events were reported. Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received Vaccine Booster (Dose 3) which had hindsight was expired past 10 weeks in refrigerator temperatures.  (11 days Past date Expired 4/11/22) Called Patient 5/13/22 not able to reach.
Narrative:  Patient received Janssen COVID 10 vaccine in June 2021. The patient tested positive for COVID 19 on 6 Sep 2022. The patient presented to the ED with diaphoresis, nausea, cough, sob, believes speech became slurred. The patient was admitted with COVID pneumonia and acute kidney injury. The patient was treated with remdesivir and dexamethasone. The patient was discharged in stable condition with a referral for kidney function on 10 September 2022. Reported per EUA.
Expired dose of FLUZONE HIGH DOSE QUADRIVALENT was administered with no reported adverse event; Initial information received on 26-Oct-2021 regarding an unsolicited valid non-serious case from a other healthcare professional and consumer or other nonprofessional via Global Media information (under the reference 00829446).  This case involves a 76-year-old female patient receiving expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Oct-2021, the patient received a0.7 mL total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [oral solution, Frequency: once, Dose: 0.7 mL, Strength: Fluzone HD, lot UJ443AB, expiry date: 30-Jun-2021] via intramuscular route in the left arm for prophylactic vaccination. It was a case of actual medication error due to expired vaccine use (latency same day)  The reporter reported " Caller clinical nurse manager reports administering expired FLUZONE HIGH DOSE QUADRIVALENT to two patients."  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Felt light headed. Passed out. Body became rigid. Lasted about 2 minutes.
Myocarditis, elevated heart rate, palpitations, weakness, low blood pressure, near syncopal episodes, treatment: prednisone
Missed dose; started on the other arm; soreness on the same site of the shot; Lot of tiredness; Swelling arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (started on the other arm), VACCINATION SITE PAIN (soreness on the same site of the shot), FATIGUE (Lot of tiredness), PERIPHERAL SWELLING (Swelling arm) and PRODUCT DOSE OMISSION ISSUE (Missed dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (soreness on the same site of the shot), FATIGUE (Lot of tiredness) and PERIPHERAL SWELLING (Swelling arm). In April 2021, the patient experienced PERIPHERAL SWELLING (started on the other arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, PERIPHERAL SWELLING (started on the other arm) had not resolved, VACCINATION SITE PAIN (soreness on the same site of the shot) and FATIGUE (Lot of tiredness) outcome was unknown and PERIPHERAL SWELLING (Swelling arm) and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Mammogram: normal (normal) Nothing came up and swelling was from the shot as it didn't involve lymph nodes.. In April 2021, Ultrasound scan: normal (normal) Nothing came up and swelling was from the shot as it didn't involve lymph nodes..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
On Tuesday, 8 hours after the shot, extreme body aches, soreness, and over all tiredness began.  Very weak and had issues climbing stairs and moving from a resting position.  This lasted through the night, all day Wednesday, and most of Thursday, finally tapering off on Friday.  Fever began Tuesday night about 10 hours after the shot and lasted about 12 hours until Wednesday afternoon.    Body Aches/soreness/weakness - ~54 hours total over 3 days. Fever - ~12 hours   Treatments - Rest, hydration, and two Advil twice a day.  As of today Tuesday November 9 I feel back to normal.
Systemic: Chills-Medium, Systemic: Hyperventilation-Mild, Additional Details: about 8 min after injection patient was nervous and was hyper ventalting, we deep deep breathing and that was better.  got her a water and then said she was cold all over then husband picked her up and they are not ansering phone to see how she is doing
Latissimus Dorsi Hematoma; This is a spontaneous report from a contactable physician. A 68-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 06Apr2021 (at the age of 68-years-old) as dose number unknown, single for COVID-19 immunization. Medical history included known allergies: NSAID, Sulfates. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 2 weeks of vaccination. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced latissimus dorsi hematoma on 09Apr2021. The event resulted in emergency and physician room visit. The patient did not receive any treatment. The clinical outcome for the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
patients who would like to know the amount of sodium in the Pfizer BioNTech COVID-19 vaccine because she is sensitive to it; This is a spontaneous report from a contactable other hcp. A 62-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, (Lot number and expiry was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. Medical history included allergy to metals, blood pressure measurement from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. patient who would like to know the amount of sodium in the Pfizer BioNTech covid-19 vaccine because she is sensitive to it (circumstance or information capable of leading to medication error). On an unspecified date outcome of the event was unknown.   Information on Lot/Batch information has been requested.
Pt complaining of redness at injection site with red mark. Redness and red spot subsided after a few days, but another smaller red mark appeared near inj. site. Pt also complaining of swollen lower lip. Pt mostly concerned about recurrence of red rash.
Approximately 5 minutes after receiving the Moderna vaccine patient became flushed and states that he "doesn't feel well". pt appears very anxious, pale, diaphoretic, and breathing fast.  blood pressure was 210/98. HR 99. Oxygen saturation was 99%. When attempting to calm patient he states he "needs help" and requests that I call the ambulance. The pt was an EMS worker and decided to call them off himself "because he felt better." He then decided that he "felt sick" again so EMS was dispatched again. While awaiting EMS arrival pt states his throat was "itchy and was beginning to bother him" diphenhydramine 25mg was given IM at 1129. EMS arrived at 1135 and pt was transported to local ER.
Rash at injection site, started about 48 hrs after and has spread to about 8 inch around site. Talked to his wife on 6/15/12 at 9:43am pt reaction is better and has not spread anymore.
Less than a day after my vaccine I awoke with severe menstrual cramps and extremely heavy bleeding (bleeding through a tampon every ½ hour to an hour) that lasted 8 days.  It then became a normal flow for a total duration of 3 weeks. I am pre-menopausal and have only had spotting every 2-3 month for the past year.  I have never experienced that heavy of a flow in my entire life, nor have I ever had a period for 3 weeks straight.  Since this was so unusual it caused me concern and I assumed the vaccine was the cause.  I began to research this as a side effect and learned that extremely heavy menstrual bleeding can cause anemia and other issues and it stated that you should seek a health care professional if it continues.  I was extremely tired and lethargic and decided to go to the Urgent care after 5 days of extremely heavy bleeding.  They tested my blood and made me a referral appointment for an ultrasound.  I had the exact same result 12-24 hours after the second round of Moderna vaccine.
Pt received her first dose of the Moderna COVID19 vaccination and while sitting in observation she reported feeling dizzy and very sweaty. Pt then developed a headache. BP 146/113, HR 75, O2Sat 98%. Not on any BP medications. EMS on site and evaluated the pt. Pt signed refusal for transport to the hospital. Pt was given ED precautions and advised to follow up with her PCP on her symptoms. Pt verbalized understanding.
both vaccinated siblings devel chickenpox (2wk apart) then 2wk p/last sibling devel them another sibling also became infected-this child not vaccinated;
Narrative: Pt received covid vaccines on 1/19/21 & 2/16/21. Pt died 5/24/21 in community hospice care. Pt had diagnosis of Leukocytosis of unknown origin, metastatic cancer and renal failure. Likely death is not related to covid vaccinations.
On 4/27 around 5pm my leg was itchy (right leg), I scratch it and didn't think any thing of it that evening I got into the shower and on my right leg when I got into the shower I had brusing but it was same 5in wide 7in long  and I took a picture of itt and sent a picture to my doctor through the online portal and let him know what was going. and it look like little spots of blood under my skin , 9:37 was when the picture was sent. 4/28 8:27am my doctor responding back and asked me some question and asked if it was any where else outside of my leg and asked if there was any bleeding or bleed in my urine and then asked if I had got my covid vaccine. I responded that it was only on my right leg and I didn't see any blood in urine or stool but that I had got my vaccine 4/11 she did call me around 10:15am and wanted to walk through some questions and asked about stomach pain and I had been having some pain and diherra and he also asked about vision changes and migrains and he said at that point because of the recent concerns with the vaccine he did want me to get checked out considering my history petechiae . He advised me to go to the er because of vaccine induced trombotic thromboctopenina (VITT) and he wanted to run some blood test and diagnostics. I arrived at the Medical center around 11am and I was seen by Dr  and explained everything that was going and he knew that they were concerd about VITT and they ran a CBC, and Estimated Glomerular Villtration Rate, Lypaz, Liver profile, collected urine and did a culture with an analysis and a pregnancy's test, Vitals were normal. the test came normal. All blood work came back normal, plateness was at 300, urine should a little bit of epidilla cells. They didn't feel like they needed to be concern about the VITT. I was discharged and then told to follow up with my family doctor and have had some communication, they asked that I followed up with a dermatologist and too look at genetics. 4/28 in the evening my left leg closer to my knee also started to itch it also developed a rash looking like strains but not as bad as what was on my right leg. but since then I have not had any more pop ups but I do still itch.
Pt. had fainting episodes with 1st dose of GARDASIL on 4/7/09. With this 2nd GARDASIL & within seconds pt. got pale, as she was laying down her eyes rolled back, got stiff & shook about 2-3 times. Resolved quickly. Physician came immediately & saw her recovered. Episodes of vomiting for 1 hr. Pt home. 9/22/09-records received for dates of service-6/26/09-8/13/09-neurology consult-evaluation for 2 episodes associated with Gardasil. Blacked out at time of injection-body stiffening and shaking eyes deviated upward. First event 4/7/09 C/O felt weird and ears heard rushing unable to see as black came into her vision. C/O being hot, lost consciousness and was limp. Confused regarding circumstances-no change in mental status. 2nd event 6/15/09-lost consciousness, stiffening and shaking of whole body, weak afterward, pale and greenish. Vomited. C/O abdominal pain and bothered by smells, dizzy and short of breath wi th stairs. Appetite decreased for 6 days. Follow-up visit 8/13/09-no further episodes of loss of consciousness or seizures. C/O vision will become black when changing from sitting to standing. C/O tired. Long history of being tired. Assessment: most likely represented convulsive syncope particulary given her history of other vasovagal presyncopal events.
Product administered to 16 year old; Fatigue, feeling wiped out; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Jun-2021 and was forwarded to Moderna on 17-Jun-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Product administered to 16 year old) and FATIGUE (Fatigue, feeling wiped out) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Product administered to 16 year old) and FATIGUE (Fatigue, feeling wiped out). On 29-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Product administered to 16 year old) had resolved. On 30-Apr-2021, FATIGUE (Fatigue, feeling wiped out) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered FATIGUE (Fatigue, feeling wiped out) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Product administered to 16 year old).    Patient reported no known allergies.  No information on concomitant medications was provided.  No information on treatment medications was provided.   This case was linked to MOD-2021-068994 (Patient Link).
he was frantic; Nauseous; Rash on his arm; Slight fever; This is a spontaneous report from a contactable consumer.  A 92-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single (age at vaccination 92 years) for covid-19 immunisation. Medical history of the patient since an unknown date was type II diabetic and that on the past month he had pneumonia and was supposed to be treating with a nebulizer for congestion and cough as he had a pulmonary infection. The patient's concomitant medications were not reported. The patient received vaccine yesterday and today, on an unspecified date he had felt nauseous, he was frantic, had a rash on his arm and had a slight fever of 100.3 degree F. Stated that he did not eat, he had calmed down and fever was gone. The patient underwent lab tests and procedures which included pyrexia as 100.3 °F on an unknown date. The outcome of the events was unknown for nausea and rash and for the rest was recovered on an unknown date.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Multiple ED visits/hospitalizations within 6 weeks of COVID vaccination.  6/2/2021 ED, 6/4/2021 ED to Hosp Admission, 6/12/2021 ED, 6/23/2021 hospital admission,
Had a migraine with all 3 shots / It occurs the one or two days after the shot; The patient received third/booster dose of BNT162b2; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date; received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date and also received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Nov2021 (at the age of 35-years-old); all as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had a migraine with all the three shots; on an unknown date after the first and the second shots and on 09Nov2021, after the third shot. It occurred one or two days after the shot. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included treatment with an unspecified medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event migraine after the first and the second shots was unknown; with the third shot the event was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
mom called stating pt vomited x 3;mom advised to omit formula, try pedialyte, mom noted knot in leg & redness-advised to bring pt to clinic;knot noted fifty cent piece size;21FEB96 no more n/v;slept better than has since birth
The patient is sick; considering administering second dose after 42 days; This spontaneous case was reported by a health care professional and describes the occurrence of ILLNESS (The patient is sick) and INTENTIONAL PRODUCT USE ISSUE (considering administering second dose after 42 days) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and AMLODIPINE for Blood pressure high and Heart disorder, ATORVASTATIN for Cholesterol blood excessive, ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (The patient is sick) and INTENTIONAL PRODUCT USE ISSUE (considering administering second dose after 42 days). At the time of the report, ILLNESS (The patient is sick) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (considering administering second dose after 42 days) had resolved.        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.   Concomitant medication also include Floraxatine.  No treatment information provided.
Headache; Flare ups of pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable other HCP and a contactable consumer (patient) reported that:  A 65-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 03Mar2021 (at the age of 65-years-old), as dose 1, single for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), oral route, daily, from 17Dec2020 (Batch/Lot number was not reported) to an unspecified date, at 11 mg (Tablet (30's), as reported), daily for rheumatoid arthritis. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced headache and flare ups of pain. Patient states received 1st dose of COVID vaccine 03Mar2021 and has had headaches on and off and flare ups of pain for the past 2-3 weeks and it has been better the past 2-3 days no headaches or pain. MD was aware. No description of severity (i.e. If hospitalized for event). Not any medications patient was using at or around the time of the adverse event and dates of therapy. (Exclude medications used to treat event.) No any relevant tests/laboratory data including dates. Outcome of the events was recovered on an unspecified date.  No follow-up attempts are needed. Information on Batch number, Lot number cannot be obtained.
Erythemetous macular papular rash 5 days post vaccination at vaccine site.