chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 30-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA001345: US-009507513-2207USA004679: US-009507513-2207USA004690: US-009507513-2207USA004691: US-009507513-2207USA004695: US-009507513-2207USA004697: US-009507513-2207USA004698: US-009507513-2207USA004700: US-009507513-2207USA004707: US-009507513-2207USA004709: US-009507513-2207USA004710: US-009507513-2207USA004712: US-009507513-2207USA004714: US-009507513-2207USA004715:
Consistently High fever of around 102.5, headache, body/joint pain and fatigue, chills and stomach cramps.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 23Feb2021 at 15:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 24Sep2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "Ledderhose" (unspecified if ongoing), notes: Ledderhose; "Dupuytrens" (unspecified if ongoing), notes: Dupuytrens; "known allergies: just fragrances" (unspecified if ongoing), notes: known allergies: just fragrances. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) negative, notes: rebound lasted 6 days til testing negative again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache, Fever, NauseaVomiting, Chills, pain at the injection site Narrative:
Bells Palsy 2/27/02. Treated at hospital. 60 day follow up states pt has recovered.
Patient got her covid 19 vaccine. 5 minutes after her shot she said her throat was hot. BP was 135/90. Pulse 75. No signs of distress. I gave her 50mg of benadryl. Patient stayed for 30 minutes. All symptoms were resolved by when she left.
Pt reported  headache, nausea, joint aches, and fatigue after 2nd dose of Shingrix which she did not experience after the 1st dose. Symptoms lasted approx 24 hours and resolved on their own.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 81-year-old male patient received BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Lot number: EK9231), in left arm, on 25Jan2021 as dose 2, single (Lot number: EL8982), in left arm, on 08Nov2021 as dose 3 (booster), single (Lot number: 30155BA), in right arm and on 11Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "recurrent sinuisitis" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LATANOPROST OPTIC; FINASTERIDE; ATORVASTATIN, start date: 25Apr2022, stop date: 26Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 28Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 28Apr2022, outcome "recovering", and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: RADT antigen test became positive. Other medication in 2weeks was reported as Yes. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Age group: Elderly (65+ Years).  No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events, COVID 19, Drug Ineffective and BNT162B2 is considered possible.
PM 6/11/08 experienced flu like symptoms, temperature 100.  "Area from the top of her left shoulder to approximately 2 1/4" became swollen, red, warm to touch.  Unable to lift her left arm more than 90 degrees.  Symptoms became worse thru 6/12/08.  Patient applied cool compresses and ermida cream to area.  Patient called our office on 6/18/08 to report reaction.  Patient examined by doctor.  Slight swelling, no heat to area, area light pink in color.  Patient able to lift arm without pain or discomfort.
January 11, 2021 I woke at 11:30pm with a severe headache and fever (temp 101.4).  I was tested for COVID on January 12, 2021. My results were positive for COVID on January 14, 2021.  I had bronchitis type symptoms, cough, sneezing, chills.  My treatment was antibiotics, cough suppressant, inhaler and steroids.  I was ill for roughly six days.  I made a full recovery.
Numbness in feet; Tingling in feet; Unable to walk; Swelling in knees; Swelling in feet when over exerted; Acute and debilitating joint pain in fingers, wrists, elbows, knees, feets; Extreme fatigue; Had a flare up of her arthritis; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Had a flare up of her arthritis), HYPOAESTHESIA (Numbness in feet), PARAESTHESIA (Tingling in feet), GAIT INABILITY (Unable to walk) and JOINT SWELLING (Swelling in knees) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis, Celiac disease and Sulfonamide allergy (Allergy to sulfa drugs).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced ARTHRITIS (Had a flare up of her arthritis). 12-Apr-2021, the patient experienced ARTHRALGIA (Acute and debilitating joint pain in fingers, wrists, elbows, knees, feets) and FATIGUE (Extreme fatigue). On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in feet), PARAESTHESIA (Tingling in feet), GAIT INABILITY (Unable to walk), JOINT SWELLING (Swelling in knees) and PERIPHERAL SWELLING (Swelling in feet when over exerted). At the time of the report, ARTHRITIS (Had a flare up of her arthritis), HYPOAESTHESIA (Numbness in feet), PARAESTHESIA (Tingling in feet), GAIT INABILITY (Unable to walk), JOINT SWELLING (Swelling in knees), PERIPHERAL SWELLING (Swelling in feet when over exerted) and FATIGUE (Extreme fatigue) outcome was unknown and ARTHRALGIA (Acute and debilitating joint pain in fingers, wrists, elbows, knees, feets) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included various supplements and digestive enzymes. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-May-2021: Added patient demographics, relevant medical history, concomitant medications. New events (extreme fatigue, joint pain, numbness in feet, tingling in feet, swelling in knees) were added. The outcome of the event (joint pain) changed (from unknown to not resolved). On 25-Jul-2021: No new information was received.
Spike cold agglutinins; AUTOIMMUNE RESPONSE; GI issues; Joint pain; Fatigue; Muscle pain; This spontaneous report received from a patient concerned a 74 year old female of unspecified race and ethnicity. Initial information was processed along with the additional information received on 28-OCT-2021. The patient's height, and weight were not reported. The patient's past medical history included: flu. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The patient confirmed that she received Covid-19 vaccine on 10-APR-2021.  On APR-2021, for the first few days, she had severe fatigue, muscle pain, joint pain and pretty severe GI issues. This went on for 3 months, not 3 days.  It also caused a spike in cold agglutinins, which is an autoimmune response. The only other time they did appear was when she had the flu 2 years ago.  Laboratory data (dates unspecified) included: Cold agglutinins (NR: not provided) Increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from GI issues, joint pain, fatigue, and muscle pain on JUL-2021, and the outcome of spike cold agglutinins and autoimmune response was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211053826-covid-19 vaccine ad26.cov2.s -Autoimmune response. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Information has been received from a certified nurse midwife concerning a 22 year old white female with an allergy to CECLOR (causes rash) who on 29-JUL-2008 was vaccinated with the first dose of GARDASIL. The patient was sitting in the office for observation as recommended. Approximately ten minutes after the injection, she noticed numbness in her tongue and an "itchy" feeling in her throat, that became more noticeable over the next five minutes. She never had progression or symptoms behind these and never experienced shortness of breath or inability to speak. She was given 60 mg of Allegra suspension (sample) and monitored for approximately one hour. Her symptoms totally resolved within 40 minutes after receiving Allegra. She was given x420/2.5 mg x 7 to take at home nightly. Concomitant therapy included hormonal contraceptives (unspecified). No further information is available.
Had the shot and still got them/ suspected vaccination failure; got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the shot and still got them/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 22-MAR-2023 This case was reported by patient's friend via interactive digital media. The reporter had friends who had the shot and still got them. so reporter asked was it worth the shot? This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
having headaches; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (having headaches) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (having headaches). At the time of the report, HEADACHE (having headaches) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant product use was reported. The patient reported that after receiving the booster, the patient was having headaches. No treatment information was provided. Reporter did not allow further contact
FLUBLOK QUAD given to a 17 year old male patient; indicated for 18 years and older. patient left facility in stable condition.
ADM IMMUNIZATION 10/13, CAME TO PHARMACY 10/16 OR 17 SEEKING ADVICE ON FACIAL RASH- COUNSELED ON ANTIHISTAMINE USE, S/S ANAPHYLAXIS, ETC, CAME BACK 10/18 MORE ADV RASH AND RX FOR PREDNISONE.
Received HPV Vaccine dose #3.  Did fine in office.  Fifteen minutes after leaving (while still in car) patient noticed that her hand was quite swollen and red.  No difficulty breathing, lip swelling or other swelling noted.  Patient "felt warm".  Swelling persisted for about an hour that night and swelled again the next day mainly after basketball practice.  Deltoid pain noted since shot.  No fever.  Stated "hard to turn neck at basketball practice".  Attendance at school not affected.
Start getting huge headache and ard breathing, pain in joints, and all over the body, running nose, glossy tear eyes, slow in the motions. Next day, couldn't go to work, called sick, high body temperature, sneezing, hard to breathe, pain all over the body. On Jan 2nd tried to visit a doctor, but everything close due to NY holidays. Was no any option just to go to E.R.
when he takes medication to get platelets up, after a few days he doesnt feel well and can hardly breathe; my platelets go way down; my red blood cells go way down; when he takes medication to get platelets up, after a few days he doesnt feel well and can hardly breathe; This is a spontaneous report from a contactable consumer (patient). A 87-years-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8720), via an unspecified route of administration on 04May2021 (at 87-years of age) as single dose for covid-19 immunisation. Patient received first dose of BNT162B2 (lot Number: EN6208, not sure it 8 or B as in boy) for Covid-19 immunization. Medical history included myelodysplastic syndrome (cancer patient and over a last 2-3 years). Concomitant medications included Dacogen, Zarxio, Procrit 40000 units/ml and Promacta 50 mg. It was reported that patient had no prior vaccination. The patient receive medication to get platelets up, after a few days he does not feel well and can hardly breathe, his platelets go way down and my red blood cells go way down. Patient stated that after taking of second dose of vaccination, patients doctor had a lot of trouble trying to control his blood characteristics, his platelets go way down and his red blood cells go way down. Patient stated that from past two weeks after 04May2021 that he could not control his red blood cells and platelets, it was both of these were blood products and if he could not get his platelets down, he would break to death. Patient added, three transfusions needed to get his platelets up. when patient took medication to get platelets up, after a few days he did not feel well and could hardly breathe. The patient underwent lab tests and procedures which included full blood count (CBC) which was good record on 06Jul2021 at 8 O'clock. All his blood as the result indicated a very good record graphical and numerical, platelet disorder and red blood cell abnormality go way down, transfusion: unknown results on 06Jul2021. Patient reported that he has been taking a lab test for the last two years every Saturday or Monday, every week for one time he had a very good record. Patient had not recovered from the events my platelets go way down and my red blood cells go way down while the outcome of event when he takes medication to get platelets up, after a few days he doesnt feel well and can hardly breathe was reported as unknown.  Follow-up attempts are completed. No further information is expected.
killed this young man/he died of an enlarged heart (500+ grams); The initial case was missing the following minimum criteria: unidentified reporter. Upon receipt of follow-up information on 20Sep2021, this case now contains all required information to be valid.  This is a spontaneous report from Pfizer sponsored Program, via contactable consumers. A 16-year-old male patient received BNT162B2 via an unspecified route of administration on 19Apr2021 (Lot Number: ER8731; Expiration Date: Jul2021) (at 16-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient died in 24Apr2021. His father claimed he took the Pfizer vaccine five days before (24Apr2021) he died and that he died of an enlarged heart (500+grams) from Apr2021. It's not reported if autopsy performed.  Follow-up attempts are completed. No further information is expected. ; Reported Cause(s) of Death: died of an enlarged heart
Joint pain in both shoulders and knees; flu like symptoms; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 07Jan2021 and first dose on 19Dec2020 08:00 (lot number: EH9899) in left arm; both via at single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 19Dec2020 10:00, the patient experienced flu like symptoms and joint pain in both shoulders and knees that continued until second shot on 07Jan2021 that eventually subsided. The outcome of the events was recovered with lasting effects on unspecified date. No treatment given to the patient for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
fever, chills, diarrhea, then tinnitus on the 4th day post vaccine
pt recvd vax & next day had a 10 x 10 cm area of induration, erythema & edema below the needle site; dx cellulitis; treated w/Duracef for 5 days;
After my second dose vaccine I feel extremely exhausted, unable to really start get through a day without having to go to bed. My days have been extremely short. I am having hard time, fatigue and achiness are really bad. I also had a low grade fever after my vaccine. I still have the symptoms today.
Pregnant patient received both dose of vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received both dose of vaccine) in a 36-year-old female patient (gravida 6) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 025L20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage of pregnancy in January 2016, Miscarriage in July 2019 and Miscarriage in February 2020. Concurrent medical conditions included MS (Stable) since March 2016. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), FOLIC ACID and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 20-Jun-2020 and the estimated date of delivery was 27-Mar-2021. On 22-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received both dose of vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy.  On 22-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received both dose of vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Blood glucose: normal (normal) Normal. On an unknown date, Ultrasound scan: normal (normal) Normal.         The patient's date of positive pregnancy test was 15-Jul-2020 and estimated date of conception was 05-Jul-2020. No treatment information was provided by the reporter.; Reporter's Comments: This is a case of Vaccine exposure during pregnancy with no associated adverse events for this 36-year-old female. Patient will continue to be contacted for further monitoring of adverse events  during the pregnancy .
Child developed a headache for 3 weeks after a dose of Hepatitis B and had a seizure 3 weeks after shot. Has not been able to control hyperactivity with Adderall  15 mg Bid since.
104+ fever Day 1, 103 Fever Day 2 and Day 3, 102 Fever Day 4, 101 Fever Day 5. Extremely shaking from Hour 8 to 24 hour mark. Blinding headache and Tachycardia first 24 hours. Rest Heart Rate took at least 30 days to get back to 65bpm. 30 days! Felt shortness of breath and overall fatigue. Legit the most seriously sick I've ever been in my entire life. I tool Tylenol and Aleve to lower fever for that full 5 days and could barely move. I hydrated fully and constantly throughout. I am reporting because I am extremely pro vaccine - but also extremely hesitant to get a booster without drawing titres first to measure my level of antibodies after 8 months. I felt like I could have had an acute cardiac event for those first few days (I have bad genetics when it comes to cardiac markers and family history).  I had tachycardia within 8 hours after the 2nd dose/shot (and didn't realize it until weeks later and noticed on my wearable biometric device). And as I said, it took a full month for my heart to actually get back to its baseline after 2nd dose. I should note that I had really no side effects after the first dose at all. Just a slightly sore arm. But that second dose? I just didn't go to ER because I didn't think they would do more than give me Tylenol and IV.  I hydrated and took Tylenol (but wasn't entirely sure I was going to live, in complete seriousness). I've never been even close to that sick before in my life. So, super hesitant about these boosters. And want direction for patients like me who had severe (rare) side effects. I believe a booster could kill me.