chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 2/6/2023 DUODENAL MASS ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 2/16/2023 DUODENAL MASS ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 2/6/2023 MALIGNANT NEUROENDOCRINE TUMOR, DUODENUM ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 2/16/2023 MALIGNANT NEUROENDOCRINE TUMOR, DUODENUM ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 2/6/2023 ABDOMINAL PAIN ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 2/16/2023 ABDOMINAL PAIN ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 2/6/2023 ESRD (END STAGE RENAL DISEASE) ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 2/16/2023 ESRD (END STAGE RENAL DISEASE)
With erythema at site of vaccine and ongoing urticaria for 6 days post vaccine. Reaction started 1 day post vaccine and then has progressed to urticaria.
I got the Gardasil vacine and the next morning I woke up with thousands of tiny warts on my lip.
Patient received ZOSTAVAX injection 10/16 in left arm. On 10/19 she returned to the pharmacy & her left elbow was red, warm & swollen. I gave her Diphenhydramine 25 mg & advised her to go to ER if swelling or redness persisted.
chills; slight fever; tiredness/Still a little tired; headache; some brain fog; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an unspecified route on unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date (12 hours after vaccination), the patient experienced chills, slight fever, tiredness and headache. This continued for about 36 hours and after that patient feeling better. Patient had still a little tired and some brain fog. Patient reported that no underlying medical conditions and general good health. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.  Follow-up (18Mar2021): This follow-up contains no new significant medical information.
Adverse Reaction or Side Effects Experienced: none; Pneumonia vaccine adminstered in October 2018 and October 2019; Information has been received from a lawyer via a Plaintiff Fact Sheet regarding a case in litigation concerning a patient of unknown age and gender. The patient's medical history included chicken pox. On an unspecified date in October 2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer inknown) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unspecified date in October 2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer inknown) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. Pt did not experienced any adverse reaction or side effects.   This is one of two reports for this patient (MARRS # 2009USA001240).; Sender's Comments:  US-009507513-2009USA001240:
The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023; She states that no adverse reactions have been reported by any patients; Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023).    Concomitant medications were not reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions.  Treatment information was not reported.  This case is reported for patient 48 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case
Within 10 minutes of receiving the vaccine I had a flushed/hot/sun burned looking face. Within 15 minutes I had hives on my chest in back. I had high blood pressure 180/120, facial puffiness and mild bottom lip swelling. I developed an onset of increased mucus in my throat causing me to clear my throat frequently. RN on site reported no throat swelling, but increased thickness due to mucus. I received a Benadryl injection on site within 30 minutes and almost immediately symptoms began to lessen. The next day I had mild bottom lip swelling, body itchiness, chest rash, headache and fatigue. Today (24 hours after vaccine) I have a headache, fatigue and body itchiness.
approx 1yr p/vax pt exp fever & blisters on chest area. rpt MD noted chickenpox on torso, 10-12 lesions. addl info requested
I have mostly watery stools and loss of bowel control on and off since I received my 1st COVID vaccine
Patient experienced mild symptoms after the first 2 shots; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient experienced mild symptoms after the first 2 shots) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient experienced mild symptoms after the first 2 shots). At the time of the report, VACCINATION COMPLICATION (Patient experienced mild symptoms after the first 2 shots) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had little issues with dairy products. Patient never tested positive for COVID.  Concomitant medications included medication for Cholesterol.  No treatment medications were reported.   This case was linked to MOD-2022-504212, MOD-2022-504199 (Patient Link).
PVCS FOR 15 MINUTES 8 HOURS AFTER AND THEN HAD 3 DAYS STRAIGHT ABOUT 2 WEEKS LATER
This case was reported by a healthcare professional to a sales representative and described the occurrence of injection site cellulitis in a child who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  The reporter stated that several children experienced injection site cellulitis following the administration of Infanrix; however, patient identifiers were not provided.  On an unspecified date in 2004, the patient received a dose of Infanrix.  At an unspecified time following the administration of Infanrix, on an unspecified date in 2004, the patient experienced swelling of the injected limb.  The child returned to the immunization clinic, where a diagnosis of injection site cellulitis was made.  The child was referred to the primary care physician for further treatment.  The reporter could not confirm that the child was seen by the primary physician or that any treatment was prescribed.  The outcome of the event is unknown.  The reporter also stated that they stopped using this lot number and switched over to a new lot number and have not seen any further occurrences of limb swelling.
10/17/2006 Received flu shot 10/16/06 woke up this am with left arm red and swollen, area the entire upper arm. No fever, site warm to touch, no glands swollen, no tenderness.
pt exp sore all over,bruising,paralyzed x 6mo;seeing MD;tired;red rash;dx as polio;3JAN96 pt states had flare up of polio type sx;
10/22/12 1015 (1) - Slight swelling, redness with size of 40 mm x 40 mm noted OCT-24/12 by Pt. BENADRYL .25 mg prescribed by PCP. (2) -  Pt. rechecked at clinic 10/24/12 - redness of 45 mm x 65 mm. Area slightly swollen, little hardness around the site, BENADRYL 25 mg, KEFLEX prescribed. (3) Oct-26/12 - Pt. checked by phone. No/report of/itching, swelling feels better, Pt did not take antibiotics anymore.
Shot 9:45am 10/18 Sat. Monday 10/20 am-onset of cold/flu symptoms. Pm-feeling worse. Tuesday-no food, drank one glass of water. Midday threw up immediately. Wed-midday-1 pc to as T. Thursday-feeling better but runny nose and sore throat and continue symptoms continue Friday, Sat, Sun, Mon-begin to feel better after six days. But nasal cong. continues.
Redness, swelling, and pain at injection site. Patient said that the swelling was bad enough to make the skin tight and extended to her shoulder and down to her elbow.
I was sitting down; I was talking to my daughter, and I was slurring your words and looked like I was having a stroke. She gave you water and could not take it in because I couldn?t control the left of your mouth and called 911 and went to the hospital by ambulance. In the stroke ward. Afib was escalating and got a intravenous drip Diltiazem. They determined a mini stroke with no lasting damage. I was there from 14 to 16 Sep22. I do have a whizzing in my chest as I slept three after I came home from the hospital. High Blood Pressure has been up and down for several.
Had a headache that quickly turned in to the chills and a fever of 103.  This lasted for about 4 hours and then she started to feel better.  Within 5 hours of the symptoms starting she felt completely better.
Moderna vaccine was administered outside of Facility- reported by patient  J96.00 ACUTE RESPIRATORY FAILURE 12/22/2021 ABNL CHEST CT SCAN J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/22/2021 ABNL CHEST CT SCAN J96.00 ACUTE RESPIRATORY FAILURE 12/22/2021 SHORTNESS OF BREATH J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/22/2021 SHORTNESS OF BREATH
This spontaneous report was received from a certified medical assistant, concerning an unknown number of patients of an unknown age and gender. Medical history and current conditions were not reported. On 29-JAN-2015, the patients were vaccinated with a dose of (Oka/Merck) VARIVAX (dose number, lot number and expiration date were not reported), 0.5 ml dose, subcutaneous,that was exposed to supported temperature excursions. No adverse effects reported. Co-suspect and concomitant therapies were not reported. Additional information has been requested. This is one (1) of four (4) reports from the same source.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot number L048464, expiration date: 08-AUG-2016 and lot number M003439, expiration date: 19-JAN-2018, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the VARIVAX with lot number L048464 and expiration date: 08-AUG-2016 underwent a temperature excursion of -11 degrees Celsius for an unknown amount of time that was less than 352 hours and 51 minutes, while the vaccine with lot number M003439 and expiration date: 19-JAN-2018 underwent a temperature excursion of -11 Celsius for 352 hours and 51 minutes. The temperature excursion was captured using digital data logger. No previous temperature excursion was reported. The primary reporter did not report any doses of VARIVAX lot L048464, expiration date: 08-AUG-2016 that were given after the expiration date. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter (linked with MARRS# 1609USA012656). Additional information has been requested.
Pt received FLUMIST on 10-8-08, but still tested positive for influenza A on 2-2-09.
SYMPTOMS OF DISCOMFORT FROM DELTOID TO WRIST OF LEFT ARM FOR 2 DAYS, THEN THIS STOPPED.  REDNESS CONTINUED TO DEVELOP TO CIRCUMFERENCE OF BASEBALL AT INJECTION SITE. THAT AREA STILL WARM TO TOUCH AS OF 11-7-16.
This is a spontaneous report from a non-contactable consumer received via a Pfizer sales representative. A 16-year-old female patient received first dose of TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date after administration of first dose, the patient experienced sore arm. The outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Decreased tone LL extremity, (-) babinski, (-) grasp, decreased movement.
Pt got flu and pneumovax shot at 10:30am by 4:00 felt L arm heavy by 6pm felt hot L arm soreness, neck and shoulder were stiff, hurt in bed, got up at 1am and temp was 102 degrees. Took ASAT po helped after one hour ease sx's and at 5am went back to bed.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Agency consulted with the   Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question.   Healthcare is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Unable to Sleep-Severe, Additional Details: PATIENT STATED SYMPTOMS STARTED LATER THAT DAY OF THE VACCINATION. SYMPTOMS INCLUDED "NOT FEELING WELL, TINGLING SENSATION AND TOSSING AND TURNING WHEN TRYING TO SLEEP". PT ALSO COMPLAINED OF A SORE ARM BUT IT WAS GETTING BETTER. PT ON 01/26 COMPLAINED OF BODY ACHES WHICH SHE DID NOT PREVIOUSLY MENTION.
Received vaccine on 1/5, began having swelling in bilateral hands and lower extremities on 1/7, along with fatigue. On 1/8 she reports new swelling started in her face (eyes and cheeks). Swelling has not improved today and fatigue has worsened.
This initial spontaneous report was received from a female patient of unknown age referring to herself. She had no pertinent medical history or drugs reactions/allergies and was taking no concomitant medication. On 17-JAN-2007, the patient received her first dose of GARDASIL (lot # 0955F) because her mom recommended she take it at 17 years old (she did not specify whether she was 17 when she received it). The second dose was given on 12-MAR-2007 (lot # 0012U) and the third dose was given on 18-JUN-2007 (lot # 0525U). The expiration date for all three doses was unknown. In July 2007, the patient started to experience symptoms. She was unable to walk down the stairs and was diagnosed with psoriatic arthritis on 17-AUG-2007. She also experienced a "nerve reaction." She visited an orthopedic physician who informed her to see a rheumatologist. The patient was hospitalized for the nerve reaction for up to two days (dates not provided). The patient was treated with HUMIRA, CELEBREX, ENBREL, ORENCIA, REMICADE, methotrexate, and NEURONTIN. She mentioned that HUMIRA stopped working and that she experienced a "nerve reaction" after taking ENBREL. The following tests were performed (date and results not specified): magnetic resonance image (MRI), computed tomography (CT) scan, and unspecified blood work every other month. The events were not resolved at the time of reporting. Causality assessment was not provided. The patient wished to speak to the legal department regarding the adverse event she experienced after receiving GARDASIL. The patient mentioned that she used to work at a hospital and has seen multiple cases of people diagnosed with psoriatic and rheumatoid arthritis after receiving GARDASIL (case # 1811USA000122). Upon internal review, psoriatic arthritis was considered to be a medically significant event. The is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1811USA000122.
TRANSIENT CEREBRAL ISCHEMIA 5/30/2022 UTI (URINARY TRACT INFECTION) ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 5/30/2022 UTI (URINARY TRACT INFECTION) HYPOXIA 5/30/2022 UTI (URINARY TRACT INFECTION) TRANSIENT CEREBRAL ISCHEMIA 5/30/2022 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 5/30/2022 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY HYPOXIA 5/30/2022 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
feeling tired; like my body was cold; I had little fever; weak; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot Number: EW0162, Expiration date, NDC and UPC number was unknown) via an unspecified route of administration, administered in left arm on 21Apr2021 as dose 1, single (at the age of 45-years-old) for COVID-19 immunisation. Medical history included high blood pressure from unknown date to unknown if ongoing. The patient's concomitant medications included unspecified medications and like water pills for the high blood pressure. On 21Apr2021, when patient took the first shot, it was okay but on Apr2021, (22Apr2021 (the next day after) or 23Apr2021 (last night)), really bad, her body had little fever, just really like came down, like her body was cold, was weak and feeling little tired. Patient received no treatment for the events. The outcome of all the events was unknown.  No follow-up attempts are needed. No further information is expected.
Pt does not meet age requirement for Moderna vaccine. She should have received the Adult Pfizer.
PATIENT DESCRIBES, DIZZINESS, BODY ACHES, HEADACHE, AND A FEELING OF FLUSH. ALL SYMPTOMS STARTED ON OR ABOUT 3FEB03. NOTIFIED MEDICAL DEPARTMENT ON 4FEB03 AT 1030 CENTRAL TIME, ADVISED TO GO TO NEAREST EMERGENCY ROOM FOR FURTHER EVALUATION.
Stood up to go to the bathroom and could not put her right leg down; thought she was having a heart attack or a stroke or something; Fell on her right side; Cerebrovascular accident; Diarrhea; Nose running; Her calves were so sore, like having charley horse where her calf muscles were so tight it hurt; like having charley horse where her calf muscles were so tight it hurther calf muscles were so tight it hurt; her calf muscles were so tight it hurt; This is a spontaneous report from a contactable consumer. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 18Feb2021 (Batch/Lot Number: EN6201) as single dose for COVID-19 immunisation. Medical history included family history of glaucoma from 2019 (Her mother has Glaucoma); memory ain't that good (she puts everything on her calendar because her memory ain't that good); ongoing irregular heart beat since 2006 (periodically when she goes to the doctor they have her walk the treadmill and stuff like that); ongoing diabetes since 2011; and was allergic to Penicillin (as a kid she was bitten by a dog, she must have been about 12 years old, went to hospital they gave her a shot of penicillin, her head blew up, she looked like a monster, she went back they gave her Streptomycin). Concomitant medication(s) included brimonidine taken for glaucoma from 21Feb2021 to 01Mar2021; latanoprost taken for glaucoma; apixaban (ELIQUIS) taken for arrhythmia, and dyspnoea from 2019 and ongoing; and metoprolol taken for arrhythmia. The patient was administered with her first dose of COVID-19 vaccine on 18Feb2021. It went beautiful, she did not have any aftereffects or anything initially. On 01Mar2021, while in her own apartment she stood up to go to the bathroom and could not put her right leg down; she thought she was having a heart attack or a stroke or something and she fell on her right side. She went to the hospital where she was hospitalized overnight for observation and testing. MRI performed during that hospitalization had result of Cerebrovascular Accident-CVA. She also reported onset of diarrhea and nose running around 01Mar2021. When she went to the hospital on 01Mar2021 she was laying down, and when the doctor moved the blanket to test her legs her calves were so sore, like having charley horse where her calf muscles were so tight it hurt. The events were reported to have required a visit to the emergency room. They did not find anything else during hospitalization with testing. The only thing she can think of related to these events was the COVID-19 vaccine. She called to ask if she should or should not get the second dose of the COVID-19 vaccine as scheduled for 11Mar2021 relative to these events. She was scheduled for second dose on 11Mar2021, but she is scared because of events that occurred 01Mar2021. The outcome of the events diarrhea, "Nose running", "Her calves were so sore, like having charley horse where her calf muscles were so tight it hurt", "her calf muscles were so tight it hurt" was recovering, and for other events was unknown.
Information has been received from an investigator concerning a 2 month old male who was vaccinated PO with his first dose of ROTATEQ. This report was part of a post-marketing surveillance program. Seven days after vaccination the patient experienced ileocolic intussusception and was hospitalized for 2 days. Two days prior to admission the patient experienced crampy abdominal pain. Laboratory diagnostic studies included an ultrasonography which verified the ileocolic intussusception. A contrast enema failed to reduce the intussusception, however; it was reduced surgically. The patient was discharged from the hospital on day and the outcome was unknown. At this time, relationship of ileocolic intussusception to study therapy is unknown. Ileocolic intussusception was considered to be an other important medical event (surgery) by the reporter. Additional information has been requested.