chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rapid heart rate; Loss of appetite; fever 101 Fahrenheit; Muscle pain/body ache; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heart rate), DECREASED APPETITE (Loss of appetite), PYREXIA (fever 101 Fahrenheit), MYALGIA (Muscle pain/body ache) and FATIGUE (Feeling tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Also had covid-19 in june 2020) in May 2020. Concurrent medical conditions included Hypertension and Cholesterol.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced HEART RATE INCREASED (Rapid heart rate), DECREASED APPETITE (Loss of appetite), PYREXIA (fever 101 Fahrenheit), MYALGIA (Muscle pain/body ache) and FATIGUE (Feeling tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (Rapid heart rate), DECREASED APPETITE (Loss of appetite), PYREXIA (fever 101 Fahrenheit), MYALGIA (Muscle pain/body ache) and FATIGUE (Feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were provided as blood pressure pills, cholesterol pills, blood thinner medicine.
ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIA 1/19/2023  &  1/26/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "afib" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (16Dec2022) Negative, notes: positive RAT on 19Dec (previously negative on 16Dec); (19Dec2022) Positive, notes: positive RAT on 19Dec (previously negative on 16Dec). Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient taken anti-viral drug paxlovid from 11Dec2022 to 16Dec2022 via oral route for treatment of COVID-19. The patient experienced rebound covid with fever and positive RAT on 19Dec (previously negative on 16Dec) and patient recovering from rebound covid. Patient did not have any known drug allergies. The other medication received in 2 weeks was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective and covid-19 with the suspect drug BNT162b2, BNT162b2 omi ba.4-5 cannot be excluded. The case will be reassessed once new information is available.
Initially c/o numbness in L arm when leaving clinic. In parents car, appeared to have seizure, was not incontinent, was nauseated. Above seizure barely observed by staff and was soon cognizant. Taken home. No further problems.
3 days later after receiving COVID-19 shot in his upper arm patient gradually started having dysphagia ?out of nowhere? which progressively worsened for the next 3 days.  He presented about 6 days later to emergency with complaints that he was not able to eat or drink for the past 4 days.  Also reported associated voice changes, trismus and right ear pain.  He denied any previous similar episodes.  He denied fever and chills, difficulty breathing.  He was admitted for inpatient treatment of Angioedema to ICU for airway observation and treated with intravenous epinephrine, steroids, antihistamines and on the same.  After 3 days he was discharged home in stable condition.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jan2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Feb2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 09Oct2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 01Apr2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing); "acid reflux" (unspecified if ongoing). Concomitant medication(s) (received in 2 weeks) included: LOSARTAN, start date: Sep2016; METOPROLOL, start date: Sep2008; PANTOPRAZOLE, start date: Sep2006; ROSUVASTATIN, start date: Nov2019; CHLORPHENIRAMINE [CHLORPHENAMINE], start date: Feb1982. Past drug history included: Metranidazole, reaction(s): "Known allergies: Metronidazole". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; negative, notes: after having tested negative for 7 days. Therapeutic measures were taken as a result of vaccination failure, covid-19. She received Paxloid for COVID 19 treatment on 01Oct2022 and stopped on 06Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
In December 2020 and January 2020 I received Moderna vaccines and had no adverse reaction. For my booster I took Pfizer in October 2022. November I began having menstrual irregularity and by early December developed severe menorrhagia. Bleeding continues and I have undergone hysteroscopy. With D&C and IUD placement. Pathology came back unremarkable. Now bleeding into 7th week.
My arm was sore and beginning to turn red the day of the 2nd vaccine. The first vaccine I experienced Covid Arm after 5-6 days, so I surprised it was happening this fast. The next morning, I was achy, itching and had congestion, so I took 1/2 a benedryl and 3 motrin. I rested all saturday and my temperature went up to 100.3. The temperature went down before bed, the rash began to spread on my face around my temples and eyebrows and a little on my eyes. I noticed the rash on my neck and stomach later that evening, so I took another benedryl before bed, this time 1 pill. I woke up Sunday morning, itchy and the rash is still on my neck and stomach, more in a uniform red coloring. My arm also is red and hot to touch. Saturday the flu like symptoms were worse than Sunday. My temperature now is 99.5. I am not having difficulty breathing, just itchy and drowsy.
jabbed her or inserted the needle, blood spewed out of her arm/ She was bleeding bleeding bleeding; she didn't know if the medicine from the vaccine actually had a chance to go into her arm, and into the tissues it was supposed to; This is a spontaneous report from a contactable consumer (the patient). A 64-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EW153), via an unspecified route of administration in the right arm on 18Apr2021 (at the age of 64-years-old) as a single dose for COVID-19 immunization. The patient had no medical history and no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number ER8330 or ER8730), via an unspecified route of administration in the left arm on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient received the second COVID shot and as soon as they jabbed her or inserted the needle, blood spewed out of her arm. She was bleeding, bleeding, bleeding. She was concerned, because she didn't know if the medicine from the vaccine actually had a chance to go into her arm, and into the tissues it was supposed to. Her arm was bleeding as soon as the needle went in. She wanted to know if there was a way to know if she got the medicine. The outcome of the events was unknown.
pt recvd 1 dose of Engerix-B & on 22JUL92 exp redness @ inject site, hot to touch; also pain in lower lt back;
20MAR96 5PM started low grade temp elevation & APAP given;21MAR96 9AM went to ER t106 R;tx alternated APAP & motrin
Patient's left arm was very sore, red, hot to the touch,w/ a rash (size of tennis ball). Right arm had a small rash and was warm to the touch but not swollen. After 2 doses of benadryl, patient is feeling better.
Patient described having "extremely sore arm" lasting more than a couple of days. Pt stated that he is having increased pain and it is spreading to his neck/shoulder area.
Information has been received from a licensed practical nurse concerning that two patients developed localized reactions after received PNEUMOVAX. The nurse provided information concerning a 73 year old male with coronary artery disease, diabetes, hypertension and atrial fibrillation who received a dose of PNEUMOVAX in 2005. On 26-NOV-2008 the patient was vaccinated with a 0.5 mL dose of PNEUMOVAX (lot # 658074/0803U), intramuscularly in the left arm. Concomitant therapy included ezetimibe, tablet (dose, duration and indication not reported), hydrochlorothiazide, ACTOS, insulin and potassium (unspecified). On 28-NOV-2008 the patient returned to the office because his arm was red, swollen and painful. He was treated with antibiotics and TYLENOL. The patient returned on 01-DEC-2008 and was found to be improved. The patient sought medical attention through an office visit. Follow up information received on 26-DEC-2008 stated that the patient had swelling, pain and warmth of lower arm (forearm) that looked like cellulitis. Patient was put on antibiotics for the cellulitis. This is one of 2 reports from the same source. Additional information is not expected.
Diarrhea; Feels like I have asthma/using inhaler more than I should; Night sweats; Chills; Soreness of left shoulder; Fever; Headache; Nausea; Loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), DIARRHOEA (Diarrhea), ASTHMA (Feels like I have asthma/using inhaler more than I should), NIGHT SWEATS (Night sweats) and CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A,) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included SALBUTAMOL (ALBUTEROL HFA) and GABAPENTIN for an unknown indication.    On 01-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced DECREASED APPETITE (Loss of appetite), CHILLS (Chills), ARTHRALGIA (Soreness of left shoulder), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea). On 02-May-2021, the patient experienced DIARRHOEA (Diarrhea), ASTHMA (Feels like I have asthma/using inhaler more than I should) and NIGHT SWEATS (Night sweats). On 02-May-2021, DIARRHOEA (Diarrhea), NIGHT SWEATS (Night sweats), CHILLS (Chills), ARTHRALGIA (Soreness of left shoulder), HEADACHE (Headache) and NAUSEA (Nausea) had resolved. At the time of the report, DECREASED APPETITE (Loss of appetite), ASTHMA (Feels like I have asthma/using inhaler more than I should) and PYREXIA (Fever) outcome was unknown.            No laboratory details were  provided. Treatment medication included Aspirin 81 mg.  Action taken with mRNA-1273 in response to the events was not applicable.
pt recvd vax;4 hrs later,became SOB w/ itchy eyes;seen in ER;expiratory wheezes;sclera & eyelids injected;hx cig smoking;tx proventil x 3,decason,IV,DPH,prednisone;p/ aerosol tx lung & whezzes clear;dx hypersensitive rxn to flu vax;
Patient is here today for COVID-19 immunization per federal guidelines/written order./ See immunization activity for details. Patient was observed post-immunization For 30 minutes due to a previous history of a previous reaction of lightheadedness. .   Immediate assessment of patient -patient reports lighheadedness - no SOB, swelling, or wheezing noted. Vitals taken - O2 Sats 99%, pulse 88, B/P 164/103. Pulse strong and regular. No abnormal breath sounds noted. Dr. presented to room. Standing order not initiated due to patient fell out of criteria for use. Patient states she was feeling better after eating granola bar. After 20 minutes, attempted slow movement from sitting to standing and tolerated well. Continued to monitor blood pressure every 5 minutes. See blood pressure readings. COVID-19 MRNA Vaccine allergen not added to patient allergies. Patient reports lightheadedness with all immunizations. VAERS reporting not submitted per Dr. Patient remained in office for 50 minutes. Symptoms resolved. Walked with patient to her car. No distress noted. Instructed patient to call for any concerns from the vaccine today.    COVID-19 post-vaccination Patient Instructions added to After Visit Summary for patient to review in her MyChart account.
This spontaneous report was received from a 71 year old female consumer, reporting on herself, with allergy to FLAGYL, allergy to codeine and allergy to sulfa. On 11-JUN-2008, the patient was vaccinated with a dose of ZOSTAVAX (dose and frequency reported as 1 DF) (route, lot number and expiration date were not reported) in the left arm. Patient was not on concomitant therapies at the time of the report. The patient reported that after receiving ZOSTAVAX vaccine, on 14-JUN-2008, she experienced 3 days later pain in left arm, pains in the stomach, injection site was red and painful and also a headache. Also has experienced some shingles blistering on her right side of her vagina, in the crease by the leg, with little pain also some tiredness, lightheaded, off balance and stomach pain as well. At the time of the report the outcome was reported as not recovered. Patient received was prescribed a ointment for treatment of the shingles. No lab diagnostics studies were performed. Patient sought medical attention. Additional information has been requested.
Possible cellulitis -- clinic gave her antibiotics (cephalexin 500 mg QID X10 days) on 1/11/19.
My hair is thinning, just two weeks after my second dose and is continuing to thin until now; shingles up until now.; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (My hair is thinning, just two weeks after my second dose and is continuing to thin until now) and HERPES ZOSTER (shingles up until now.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 011M20A) for COVID-19 vaccination.     The patient's past medical history included Corneal transplant. Concurrent medical conditions included Shingles and Blurred vision.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced ALOPECIA (My hair is thinning, just two weeks after my second dose and is continuing to thin until now) and HERPES ZOSTER (shingles up until now.). At the time of the report, ALOPECIA (My hair is thinning, just two weeks after my second dose and is continuing to thin until now) and HERPES ZOSTER (shingles up until now.) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications were reported. No treatment information was reported.
Breakthrough case admission after 2 vaccines Moderna 1/14/21 Lot# 021L20A;  Moderna 2/11/21 Lot# 010M20A
soreness in the arm; taste of metal in their mouth; pain in the arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm), DYSGEUSIA (taste of metal in their mouth) and PAIN IN EXTREMITY (pain in the arm) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm), DYSGEUSIA (taste of metal in their mouth) and PAIN IN EXTREMITY (pain in the arm). On 13-Mar-2021, PAIN IN EXTREMITY (soreness in the arm), DYSGEUSIA (taste of metal in their mouth) and PAIN IN EXTREMITY (pain in the arm) had resolved. Not Provided      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.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Non significant follow up received on 12-APR-2021, no new information.
TOOK TWO DOSES IN A ROW; A spontaneous case report was received from a consumer on 22-Jul-2019 for two consumers.  Based on the information obtained from the consumer, two individual case safety reports PVX201907-000615 (PVX2019-1882; wife) and PVX201907-000616 (PVX2019-1883; husband) were created and cross-linked in the database.  This case describes a 60-year-old female consumer who "took two doses in a row" (PT: Inappropriate schedule of product administration), during therapy with Vivotif for an unknown indication.  Case report: The consumer took two doses of Vivotif in a row. The doses were taken on 18-Jul-2019, 20-Jul-2019, and 21-Jul-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable. US-PaxVax Berna GmbH-PVX201907-000616:
This spontaneous report as received from a medical assistant refers to a female patient of unknown age with no medical history and drugs allergies reported who on 01-AUG-2007, was vaccinated with dose 1 of GARDASIL (lot #, dose and route not reported). On 26-MAR-2012, was vaccinated with dose 2 GARDASIL (lot #, dose and route not provided). On 03-JAN-2013, was vaccinated with dose 3 GARDASIL (lot #, dose and route not provided). No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that there was no adverse symptoms reported. Additional information has been requested.
Painful shoulder felt like severe bruising.  ROM limited Rash on abdomen- occurring approximately 48 hours after vaccine.  Not sure if related.  Responded to topical Benadryl cream
Her injection spot became stiff the next day. She then stared feeling her lymph node were swelling so she started taking sinus medicine. Her arm started hurting but her ear is still bugging her. She went to the doctor and they told her to use nose drops and an antibiotic. She is still experiencing stuffed up feelings. They did take x  rays of her sinus and she did also see a dentist because her teeth hurt.
Her myeloperoxidase level went from 234 - 756; very sick; shaking; chills; A spontaneous report was received from a healthcare professional concerning a 48-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events very sick, shaking, chills, her myeloperoxidase level went from 234 - 756.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011J20A) via unknown route in the right arm for prophylaxis of COVID-19 infection. On 26 Jan 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 028L20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the event(s) very sick, shaking, chills. On 16 Feb 2021, the patient experienced the event(s) her myeloperoxidase level went from 234 - 756.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 28 Jan 2021 the outcome of event(s), very sick, shaking, chills was resolved. On23 Feb 2021 the outcome of event(s), her myeloperoxidase level went from 234 - 756 was resolved.
Patient has had seizures since 2009. Admitted to Epilelpsy Monitoring Unit for seizure characterization.
Redness around the shot site, swelling, tender to touch, hives, headache, nausea.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable Physician.  A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient tested positive for covid-19 infection on 11Jan2021 with outcome of unknown. The reported wanted to know how long the patient should wait before receiving the second dose.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Moderna COVID-19 Vaccine EUA Ache, Red, Hot to touch, Itching, Bumpy Skin
This spontaneous report as received from a registered nurse regarding unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with GARDASIL (Lot#K010215 and expiry: 15-MAY-2017; Lot# K008931 and expiry:  04-MAR-2017), route, strength and dose were not reported, which were improperly stored at 23 degrees Fahrenheit for 11 hours. The patients experienced no adverse events. There was no previous temperature excursions and the nurse called because of data logger. This is one of the several reports from the same reporter. Additional information has been requested.
On 5/29/1999, within 2 days, post vax, the infant developed vomiting and prolonged diarrhea. The pt sought medical attention and was dx'd with gastroenteritis. Subsequently, the pt recovered from gastroenteritis. No further information is available.
WHEN INJECTING THE PATIENT WITH THE COVID VACCINE THE SPRING IN THE  RETRACTABLE SYRINGE MALFUNCTIONED CAUSING A CRACK IN THE BEZEL WHICH CAUSED THE PATIENT TO RECEIVE LESS THAN THE FULL DOSE
Approximately 6 months after my 2nd dose I experienced the following symptoms: Fatigue, Shortness of breath, Massive centralized chest pain. I have no family history of having a heart attack but due to my existing health conditions such as (overweight and hypertension) it could be a contributing factor. I went to see my primary care physician and was advised to take a cardiology exercise.