chrisvoncsefalvay/vaers-outcomes huggingface dataset:
prolapsed bladder or uterus; prolapsed bladder or uterus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "covid-19". The following information was reported: CYSTOCELE (non-serious), UTERINE PROLAPSE (non-serious), outcome "unknown" and all described as "prolapsed bladder or uterus". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Pharmacist on duty gave that dose to a patient; left the already drawn-up vaccine dose outside in room temperature 75 degrees F for about 18 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (left the already drawn-up vaccine dose outside in room temperature 75 degrees F for about 18 hours) and EXPIRED PRODUCT ADMINISTERED (Pharmacist on duty gave that dose to a patient) 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 02-Jun-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (left the already drawn-up vaccine dose outside in room temperature 75 degrees F for about 18 hours). On 03-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist on duty gave that dose to a patient). On 02-Jun-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (left the already drawn-up vaccine dose outside in room temperature 75 degrees F for about 18 hours) had resolved. On 03-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Pharmacist on duty gave that dose to a patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Treatment of COVID-19; (17Sep2022) Negative, notes: negative test 4 days ago. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.
Pt complained of joint pain, about 1 week, post vax, with diffuse pain, including knees, shoulders and hips. Complained of numbness and pain to hands and soles of feet about 3 weeks, post vax.
8hr post fax-chills, dizziness, t102 lasting approx 6hr;vomited x1;body aches & pains;better by 3rd day;
feeling shingles outbreak coming/Feeling like shingles-; This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd May 2022, the patient received Shingrix. In May 2022, less than a week after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was not recovered/not resolved.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-MAY-2022 Reporter's Comment: Pharmacist reported that a patient received a dose of Shingrix vaccine last sunday and was feeling like an outbreak was coming (clarified, felt like a shingles outbreak was coming). The reporter did not consent to follow-up.
ECHOCARDIOGRAM ABNORMAL; Coronary artery dilatation; Kawasaki's disease; Information has been downloaded from regulatory authority (US-PFIZER INC-2012090348).   This spontaneous report was received from an other health professional concerning a 12 month old male patient. His concurrent conditions included respiratory tract infection and candida nappy rash. No concomitant therapy was reported.      On 25-FEB-2011, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (bath/lot# 1510Z, 1 dosage form, intramuscular), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (batch/lot# 0811Z, 1 dosage form, subcutaneous), varicella virus vaccine live (Oka/Merck) (VARIVAX) (batch/lot# 1044Z, 1 dosage form, subcutaneous), pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) (batch/lot# E84462, 1 dosage form, intramuscular) and Hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (MRC-5), tetanus toxoid (PENTACEL) (batch/lot# C3747AB, 1 dosage form, intramuscular) for immunisation.    On 05-MAR-2011, the patient experienced Kawasaki's disease. On 18-MAR-2011, the patient experienced coronary artery dilatation. On an unknown date, the patient experienced echocardiogram abnormal. All the events caused hospitalization. The outcome of all the events was reported as resolved.  Action taken with suspect drugs was not applicable.   The causality between the events and suspect drugs was not reported.
fatigue; fever; body ache; chills; headache; injection site soreness and swelling; injection site soreness and swelling; This is a spontaneous report from a contactable consumer (the patient). A 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EJ1685), via an unspecified route of administration in the left arm on 18Dec2020 10:15 (at the age of 22-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 18Dec2020 at 20:30, the patient experienced fatigue, fever, body ache, chills, headache, injection site soreness and swelling. The patient did not receive any treatment for the events. The clinical outcome of fatigue, fever, body ache, chills, headache, injection site soreness and swelling, was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Febrile seizure, within 24 hours, post vax. Occurred on 1/5/01. Of note: pt's sister was ill at the time with viral gastroenteritis.
is like feeling the need to cough, it's like there's air bellow her throat and it will come out in sort of a half cough; throat is also, like the inside of her throat is a; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (is like feeling the need to cough, it's like there's air bellow her throat and it will come out in sort of a half cough) and OROPHARYNGEAL DISCOMFORT (throat is also, like the inside of her throat is a) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021 at 9:04 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (is like feeling the need to cough, it's like there's air bellow her throat and it will come out in sort of a half cough) and OROPHARYNGEAL DISCOMFORT (throat is also, like the inside of her throat is a). At the time of the report, COUGH (is like feeling the need to cough, it's like there's air bellow her throat and it will come out in sort of a half cough) and OROPHARYNGEAL DISCOMFORT (throat is also, like the inside of her throat is a) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated something regarding the inside of the throat which is unclear. Concomitant medications were not provided. Treatment information was not provided.
55 y/o female, with no past medical history, who presents with Right arm tingling post vaccination. Patient states that this is her first dose in the two-dose series. Patient denies previous vaccination reactions. Patient received her vaccination to the Right arm. Patient states that she also feels anxious and nervous. Patient denies sore throat, difficulty swallowing, chest pain or difficulty breathing. NP and Paramedics at patient side. Patient provided with a bottle of water and legs were elevated. Within 3 minutes patient stated that tingling resolved. Patient noted to be hypertensive (172/104) with all other vital signs normal. Patient denies medical history of hypertension. Patient moved to the partitioned off area and placed on cot. Patient vitals monitored every 5 mins for 1 hour. Patient became normotensive and stated that symptoms had resolved. Patient discharged home in stable condition.
Onset began with numbness and weakness in legs and eventual loss of function of legs- paralysis from waist down.
WITHIN 1 HOUR OF VACCINES, DEVELOPED EDEMA OF THE FACE AND VOMITED ONE TIME.
PATIENT FAINTED ABOUT 45 SECONDS AFTER ADMINISTRATION FOR 5-10 SECONDS. HE REGAINED CONCIOUSNESS AND RESTED FOR 20 MINUTES WITH PROGRESSING IMPROVEMENT. NO ISSUES AT TIME HE LEFT THE PHARMACY.
Information has been received from a licensed practical nurse (LPN) concerning a 4 month old patient who was vaccinated with the first and only dose of ROTATEQ. No adverse effect reported. A product quality complaint was not involved. Additional information has been requested.
Pt received vaccine at 0730 on 1/11/2021. She developed fever, chill, body aches and headache at midnight the same day. The following day shew had a fever a high as 103. She continued to feel fatigued, achy, headache, slightly nauseated and weak. Her symptoms improved over the course of the last 2 days. She is fever free today
Patient received a Pfizer vaccine dose, where the wrong amount of diluent was used to prepare the dose. Provider and patient were informed.  Provider recommended that patient receive repeat dose.
Soon after administration, patient got hot, sweaty, and had tunnel vision/ blurry vision. Checked blood pressure and was 54/40. Called EMS for support. Patient was light headed and shaky, would respond to questions and commands but a bit slow. Eyes seemed to be rolled back in head, but never lost consciousness. 2nd BP check was 94/62. EMS arrived at 11:25, patient began feeling a bit better at 11:30. paramedics arrived at 11:34. Patient moved to ambulance for observation until picked up to return home. Was not transported to the hospital. Checked in on patient at about 4:30 and was feeling well.
Patient experienced a severe fever and violent body tremors throughout the entire body, resulting in speech, movement, and breathing difficulties.
CLIENT RECEIVED MODERNA VACCINE, DOSE #1, AROUND 9:10 AM; CLIENT WAS VERY ANXIOUS ABOUT RECEIVING THE VACCINE. CLIENT HAS ALLERGIES TO OTC COLD AND ALLERGY MEDS WITH NO ANAPHALAXIS. REACTIONS INCLUDE ITCHING, DIAPHORESIS, SOB, FLUSHING.  CLIENT WAITED THE 15 MINUTES AND LEFT FACILITY WITH SPOUSE. RETURNED AT 9:35  WITH FEELINGS OF CHEST TIGHTNESS AND PAIN, SOB, FLUSHED, ITCHING ALL OVER. VITALS TAKEN (SPO2 -97%, HR-95-100, BP 140/88). LOCAL HCP CONTACTED AND REFERRED TO ER FOR EVALUTATION. CLIENT LEFT AGAIN WITH SPOUSE TO GO TO ER. 7/23- CALL TO CLIENT FOR INFO ABOUT OUTCOME NO RESPONSE.
Weakness; Increased Blood pressure 180/105; Increased Heart Rate 93 bpm; Dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA, HYPERTENSION, TACHYCARDIA, and DIZZINESS in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032 L20A and 013 M20A) for an unknown indication.     The patient's past medical history included Heart attack. Previously administered products included for an unreported indication: RANOLAZINE from March 2020 to March 2021. Concurrent medical conditions included Coronary artery disease since 02-Sep-2009 and Autonomic dysfunction (Frequent weakness, panic attacks) since July 2014. Concomitant products included LANSOPRAZOLE for Acid reflux, NITROSTAT for Chest pain, ATORVASTATIN for Cholesterol, ASPIRIN for Coronary artery disease.   On 29-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced ASTHENIA, HYPERTENSION, TACHYCARDIA, and DIZZINESS. On 24-Jan-2021, DIZZINESS had resolved. At the time of the report, ASTHENIA, HYPERTENSION, and TACHYCARDIA outcome was unknown. Not Provided.     DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Blood pressure measurement: 180/105 mmHg (High) 180/105. On 21-Jan-2021, Heart rate: 93 (normal) 93 beats per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Patient demographics, medical history updated, and suspect product information updated, concomitant drugs added.
Rash on Left Arm.  Skin was irritated. Rash went from deltoid to mid biceps.
Started to feel pain under left rib area on 8/25.  Pain progressively got worse.  Dr. Advised to go to urgent care.  Went to urgent care 8/30.  Diagnosed with shingles at urgent care.
Within one week - severe / constant headaches that would not go away with pain medicine. Within second week - heart palpitations / skipped beats sensation / increased heart rate; constant sinus drainage in the back of my throat (not a stuffy nose or head congestion); Severely lethargic.
I noticed the night of the vaccine that the arm was already sore. The next day - about 14 hours after vaccine - 103.8 fever. I started Motrin. It would lower it to 102. Fever lasted until about early Monday morning. A general fatigue (extreme); headache; nausea; body aches; fogginess in the brain. I felt like I had the worst flu ever. I took Monday and Tuesday off and came back on Wednesday, the 10th. The fatigue is still lasting and so is the nausea. Terrible lingering. Anti-nausea med - Zofran - is being taken in the morning and then I eat something light for breakfast. It's hard to eat though because of nausea. I don't feel well or feel myself - I still have brain fog and fatigue and nausea. I just want to be in bed.
7/19/02 10:30pm "facial seizures," lasting 30 seconds continued x 6 until 7/20/02 6:00AM. Tx Tylenol-beginning at 11am 7/19-q 4h. Diostat rectal suppository.
Developed severe joint pain continued from time of second dose and went to Dr after approx 3 weeks and was stated on steroifs6 to calm down inflammation. Continued joint pain increased over the year. It never went back to pre vaccination level.  Started now on gabapentin
lt leg red & swollen-low grade fever;rash back, stomach, face, behind ears & arms;rash persists w/o fever;
About two minutes after being vaccinated patient states she felt nauseous, lightheaded, weakness, blurred vision. Told her brother who was sitting next to her that she "thought she was going to pass-out". Brother held her in chair and patient lost conscious for about three seconds but was supported by brother. I, , PA-C was alerted during the event and visually witnessed it and went to the patient who was regaining consciousness at that time still in her chair. I asked her how she was feeling and she said "okay". There was concern for possible anaphylaxis due to paling of skin and epinephrine was given in the left thigh without complications. No other signs of anaphylaxis were noted including no lip/tongue/mouth swelling; no wheezing; no hives. The patient was layed on the ground with her legs elevated which she states greatly improved her symptoms; and the patient was given orange juice to drink which she tolerated well. EMS arrived and evaluated the patient within about 10 minutes and the patient was feeling well at that time.  Patient never hit her head during the episode. Patient who was accompanied by mother decided not to go to the ED at this time for further evaluation as the patient states her symptoms felt similar to previous episodes of syncope. ED precautions were given to patient and patient to follow-up with PCP recommended.
Information has been received for the Pregnancy Registry for Gardasil from an 18 year old female consumer with Amoxicillin allergy who on 12-FEB-2008 was vaccinated with a first dose of Gardasil (route, site and lot # not reported).  There were no concomitant therapies.  Her last menstrual period was on 22-JAN-2008 and expected delivery date (EDC) being 28-OCT-2008.  She later found out that she had a miscarriage on 06-MAR-2008.  The consumer did not report if any laboratory tests were done.  No other information was available at this time.  Upon internal review "miscarriage" was determined to be an other important medical event.  Additional information has been requested.
father stated noted redness/fever lt upper arm in the afternoon p/vax given; pt c/o arm being sore-ref to MD;
Bruise at injection site with red rash noted 3-4 days, post vax. Rash in semi-lunar configuration on left thigh about 5cm in diameter.
Patient Presented with Red - warm Injection site reaction, complained of Discomfort and Limited Mobility, possible bursitis
Report 2001021437-1 describes cellulitis at the injection site of a five year old male who received Infanrix. Medical history, concurrent conditions, and concurrent medications were not specified. On 08/29/2001, the child received an injection of Infanrix. The reporter indicated that the child had received previous injections of Infanrix, but the number of previous injections was not provided. On 08/29/2001, an unspecified time post-immunization, the injection site became red, swollen and hot. The child was seen by the physician, who made a diagnosis of cellulitis and prescribed Benadryl every four hours. The cellulitis resolved on 09/01/2001. The reporter considered the cellulitis to be mild in intensity and related to Infanrix administration.
pt started having having arm pain and after the injection and then two weeks later moved to her other arm. had arm pain for about 5 weeks. Then started to move to her shoulders. Developed problems with swallowing and moved to her breast bone. She has back pain before but it got much worse. She fell on 11/30/2020 she stood up and just fell on her knees and hand. After that she couldn't get up from a lying position. or in and out of the car. She has to physically lift her legs up to the  in the car. Went to see immunologist, nurse practitioner, Neurologist, pediatrist, orthopedic. She is shaky in her  knees
severe joint pain lasting about 12 hours, short-lasting chills and shaking, low-grade fever, nausea, headache, muscle ache, fatigue
Information has been received on 27-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. 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. On or about 11-OCT-2011, the patient's healthcare provider at a physician's office administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 26-NOV-2016 the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, 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. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Bad back; Cannot go gor second dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Bad back) and PRODUCT DOSE OMISSION ISSUE (Cannot go gor second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 16-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Bad back) and PRODUCT DOSE OMISSION ISSUE (Cannot go gor second dose). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Bad back) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Cannot go gor second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Extreme headache starting around 5:00 pm day of vaccine.   General queasy feelings better much immediately after the vaccine by evening of day of vaccine, general flu like symptoms.  By the next morning, I felt fine.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 15-JAN-2018, the patient was administered with an expired dose of ZOSTAVAX (19400 PFU) (lot: N037656, expiry date: 29-NOV-2017) (expired product administered) subcutaneously. Concomitant medication included a sterile diluent. No adverse effects reported. Lot number N037656 is verified to be not valid for ZOSTAVAX.