chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This retrospective pregnancy case was reported in a literature article and described the occurrence of spontaneous abortion in a female subject who received Hepatitis B vaccine. The subject received Hepatitis B vaccine during the first trimester of pregnancy. The subject's last menstrual period was unknown and estimated date of delivery was unknown. On an unknown date, less than a year after receiving Hepatitis B vaccine, the subject developed spontaneous abortion. Serious criteria included GSK medically significant. Additional event(s) included exposure during pregnancy. The outcome of spontaneous abortion was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy ended in a spontaneous abortion at less than 22 weeks gestation with no apparent congenital anomaly present. The investigator considered that there was a reasonable possibility that the spontaneous abortion may have been caused by Hepatitis B vaccine. Additional information was provided. This retrospective pregnancy case was reported in a literature article and described the occurrence of spontaneous abortion (SAB) in a pregnant female of unspecified age who was vaccinated with unspecified recombinant hepatitis B virus (HBV) vaccine (manufacturer unknown) during 1st trimester of pregnancy. The patient was part of the study that evaluated on HBV vaccination in pregnancy and impact on pregnancy outcomes. Database was searched in Jan 2018 using the search terms: Hepatitis B vaccine, pregnancy, major congenital malformations (MCMs), preterm birth, spontaneous abortion (SAB), and foetal/neonatal death. The search identified 1 randomized controlled trial (RCT), 5 prospective cohort studies, and 1 Vaccine Adverse Event Reporting System (VAERS) study. 5 of 7 studies were conducted in the 1980's-90's. No information on patient's medical or family history or concomitant medication was provided. On an unspecified date during 1st trimester of pregnancy, the patient received unspecified recombinant HBV vaccine (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, the RCT and 2 cohort studies examined recombinant HBV vaccines in 284 pregnant women. Vaccination occurred in the 1st trimester in the cohort studies and 3rd trimester in the RCT]. The age of vaccination was not provided. On an unspecified date, an unknown period after the vaccination, the patient had spontaneous abortion. Treatment was unknown. The authors did not comment on the relationship between the event of spontaneous abortion and unspecified HBV vaccine. The authors concluded "The majority of the prospective studies identified are old, have limited sample sizes, and inappropriate exposure windows. The VAERS study is recent but has limitations (recall bias, inconsistent data, lack of denominator data) due to the spontaneous/voluntary nature of the reporting of adverse events. While the data from these limited studies are reassuring, more research is needed".
Rapid hearth beat for 3 hours (120-130) the morning after the injection after a morning walk Pain and redness at injection site 4 days Muscle pain 3 days Tiredness 4 days Headache 3 days Shivering 2 days Fever 4 days
Within 5 minutes of receiving injection, while he was sitting in the 15 minute waiting area, patient had difficulty breathing. He started coughing. RPH injected him with dose of Epi Pen 0.3 mg & patient threw up after. We immediately called 911 and they came within minutes. Medics checked his vitals and all were within normal range.
This is a spontaneous report from a Pfizer-sponsored program via a Regulatory Authority Support Program from a contactable other healthcare professional, physician and consumer, patient. A 57-years-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number was not reported), an unspecified route of administration on an unspecified date as dose 3 (booster), single for covid-19 immunisation. Medical history included ongoing breast cancer. The concomitant medications were not reported. On an unknown date the patient experienced white blood cell count was slightly down prior to starting ibrance. patient had corona booster prior to blood work being done, Off label use and Booster. It was reported that initial: ibrance 125 mg daily times 21 days off 7 days with faslodex. patient reports white blood cell count was slightly down prior to starting ibrance. patient had corona booster prior to blood work being done. patient is dissolving her ibrance per ibrance instructions due to having a stricture of esophagus. Doctor of medicine aware. The patient underwent lab tests included white blood cell count that was slightly down on an unknown date. Case was from a Marketing program but suspect product was not part of the RA, marketing/stimulate classification and will be maintained for tracking purposes.The outcome of the event white blood cell count was slightly down prior to starting ibrance  was unknown.
very uncomfortable; dermatitis; Redness; Itchy; Body rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DERMATITIS (dermatitis), FEELING ABNORMAL (very uncomfortable), ERYTHEMA (Redness), PRURITUS (Itchy) and RASH (Body rash) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety and Allergy to chemicals (sulphur). Concomitant products included LORAZEPAM (ATIVAN) for Anxiety.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021 at 1:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021 at 9:00 AM, the patient experienced ERYTHEMA (Redness) and PRURITUS (Itchy). 08-Apr-2021 at 9:00 AM, the patient experienced RASH (Body rash). On 10-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DERMATITIS (dermatitis). On an unknown date, the patient experienced FEELING ABNORMAL (very uncomfortable). The patient was treated with CLOBETASOL PROPIONATE from 10-Apr-2021 to 20-Apr-2021 for Rash, at a dose of .05 percent twice a day. On 15-Apr-2021, ERYTHEMA (Redness), PRURITUS (Itchy) and RASH (Body rash) had resolved. On 20-Apr-2021, DERMATITIS (dermatitis) had resolved. At the time of the report, FEELING ABNORMAL (very uncomfortable) outcome was unknown.            Patient reported  body rash was described as new spots appearing each day. Treatment was also provided with the use of ice packs.   This case was linked to MOD-2021-146319 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Updated patient demographics[DOB]. Added allergy[Sulphur] .Updated treatment medicine dose. Added new Event [Dermatitis].
Post operative wound abscess. Patient underwent irrigation and excisional debridement right lower extremity with application of incisional wound VAC. Patient received DVT prophylaxis with the use of Eliquis, early mobilization, and SCDs.  Discharged home. Hospital admission within 6 weeks of receiving the COVID vaccine.
Frequent involuntary painless muscle spasms throughout body, particularly in the foot; Pain at injection site; Myalgia/ Muscle soreness in upper body; This is a spontaneous report from a non-contactable consumer, the patient. A 15-year-old patient of unspecified gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Jun2021 at 14:00 as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Jun2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On an unknown date in Jun2021, the patient experienced frequent involuntary painless muscle spasms throughout body, particularly in the foot, pain at injection site, myalgia and muscle soreness in upper body. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcomes of event painless muscle spasms throughout body, particularly in the foot, pain at injection site, myalgia and muscle soreness in upper body were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Returned from away on Wednesday 7/27/22, I felt fine. On Saturday 7/30/22 I started coughing (dry hacking cough -on occasion). On Sunday 7/31/22 I was also coughing (dry hacking cough - on occasion but a little more frequent) I took an at-home covid test on 7/31/22 but it was negative. On Monday 8/1/22 still coughing, I took another at-home covid test - it was positive. On  Tuesday 8/2/22 I had a telehealth meeting with my Primary Care Physician,  I was prescribed a 5-day regiment of Merck's  Lagevrio 200mg. My coughing symptoms improved overnight and improved by next morning. Saturday 8/6/22 my symptoms are very mild, but I still tested positive. It is Tuesday 8/9/22 and I still have mild coughing on occasion.
Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Mild rash developed at injection site immediately after administration, improved while pt was under observation. No shortness of breath, itchiness, or dizziness noted. Pt was provided Benadryl to take at home in case rash worstened or developed any SOB/chest tightness
Muscle aches, headache, chills, sore throat, fatigue, sore arm at injection site - lasting 24 hours
PATIENT WENT TO ER ADMISSION,  DIED SHORTLY  AFTER ADMISSION ABOUT 6:30 P.M.  9/26/06 Received provisional autopsy report which states: COD, pending;underlying COD consolidation of bilateral lungs suggestive of pneumonia; polyp of cecum with ball valve effect & ulceration of cecum; & manner of death pending. Pathologic diagnoses: cocaine baby by hx; respiratory deficiency & fever by hx; renomegaly bilateral; & hepatomegaly w/steatosis of liver. 8/15/08 Received final autopsy report which states COD as changes compatible with viral pneumonitis.
Severe muscle aches; Chills; Face flushing; This case was reported by a consumer and described the occurrence of myalgia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myalgia, chills and facial flushing. On an unknown date, the outcome of the myalgia, chills and facial flushing were unknown.   It was unknown if the reporter considered the myalgia, chills and facial flushing to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix  and had severe muscle aches, chills and face flushing.
Approximately three days of my first Moderna dose, I began to have difficulty rinsing and spitting from my mouth after brushing my teeth.  There is a some what dull pain above the left side of my top lip.  I do not get full pressure when spitting and the left side of my mouth does not seem to move when I spit.  It almost feels like it was shot up with Novacaine. I went swimming on March 14 and when I blew air out of my mouth  none came out of the left side.
This spontaneous report as received from a consumer concerning a 76 year old female patient with penicillin allergy, hypertension, and diabetes mellitus. On 05-OCT-2015 the patient was vaccinated with PNEUMOVAX 23, 0.5 ml, in her left arm. Concomitant therapies included influenza. On 05-OCT-2015, the patient reported that four hours after receiving PNEUMOVAX 23, she experienced her left arm started to swell and was very sore at the injection site. The patient also reported that the swelling and tenderness goes all the way to her left shoulder. The patient did notify the physician's office and received treatment with diphenhydramine (no further details). The patient reported this exact same adverse reactions, soreness and swelling had happened to her 40 years ago after receiving an unspecified pneumococcal vaccine. The outcome of injection site pain and peripheral swelling was reported as not recovered/not resolved. Additional information has been requested.
rash developed after 1st dose; This spontaneous report has been received from a medical assistant referring to a 8 years old female patient. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 15-MAY-2015 the patient administered 1st dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #, expiration date and route were unknown) for prophylaxis.         On an unknown date in 2015 the patient experienced rash. The outcome and causality between rash and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) were unknown.  This is one of two reports received from the same reporter regarding the same patient.; Sender's Comments:  US-009507513-1907USA013489:same reporter
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 93-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Reporter stated that no treatment was given to patients.  Reporter also stated that the vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
Patient received mixed vaccines: 03/05/21 Pfizer Lot EN6205 04/18/21 Moderna Lot 038B21A 05/17/21 Moderna Lot 038B21A
Pt reports very painful injection. Pt states the injection site immediately felt sore.  Within 2 hours, she noticed a large hard knot, redness and heat at injection site. On 10/28/14, area remained red (3 inch area), hot, tender to touch and hard knot. By 10/30/14, reports redness (about 1 1/2-2 inch area), tenderness and heat had decreased but still present.
firm, red, warm area @ site of inj (rt thigh) @ 1 1/2" diameter-noted 14SEP95 1030AM; inj given 13SEP95; mom states area is lighter in color today but extends out more
Information has been received from a physician concerning a female who on 13-Mar-2008 was vaccinated with first dose of GARDASIL vaccine (yeast) ( lot# 655604/0052X) and developed warts on her knees and elbows. It was reported that on 20-May-2008 the patient vaccinated with second dose of GARDASIL vaccine (yeast) (lot# 659182/1757U) and developed warts on her hands and fingers. Unspecified medical attention was sought. The physician reported that the patient will not receive the 3rd dose of GARDASIL vaccine (yeast). The therapy with GARDASIL vaccine (yeast) was determined. At the time of this report the outcome of the events was unknown. No further information was provided. Additional information has been requested.
This was NOT an adverse event, patient received the WRONG vaccine.  She came in for the Shingrix vaccine and there was a break down in  our verification procedures at time of administration.  There were multiple people waiting for vaccines and the patient's name was called to be brought into the health room , a woman stood up entered room and was given the COVID vaccine.  We found out shortly after the vaccine was given that she was NOT the person whose name was called into the room. Patient was contacted about the mistake and she asked if this would count as her booster because she was due to get it.  I did reach out to her MD to verify her first vaccine dates and she was  currently eligible for her booster shot.  I had her come back into the pharmacy to have her sign the VAR and to update her CDC card accordingly.  I did NOT give her the vaccine that she had originally came in for (Shingrix) because her surgeon told her NEVER to get a vaccine in her right arm and I did not feel comfortable giving the Shingrix in the same arm that she had just had the Covid the day before.  I asked her to return 14 days later for her Shingrix.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medication history was provided.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Tightness in throat, trouble swallowing, unusual hoarseness,tingling feeling in mouth and throat, thick yellow discharge from eyes
Redness, swelling and tingling  in hands and feet bilaterally. Referred to PCP or urgent care.
Statement of Incident:  A partially used vial of Moderna was returned to the refrigerator instead of being discarded on 30 Dec 2020.  On 4 Jan 2021, the partially used vial was used to vaccinate at least six patients. On 5 Jan 2021, the Immunizations Team was discussing wasted vaccines and was reminded of the 6 hour expiration timeframe once a vial is punctured.  One of the members realized that they used the above mentioned open vial on 4 Jan 2021 well beyond the 6 hour timeframe. In addition, once a vial is punctured and brought to room temperature, placing the vial back into the refrigerator will invalidate the vial and make it unusable.  Mission Impact: A minimum of six patients received invalidated vaccine. Consultation with MILVAX concurred the doses given from this vial should be considered invalid and recommend that all patients who received vaccine from this vial be revaccinated. Corrective Action Required/Taken:  The Joint Base Medical Staff and the Medical Squadron Commander were notified to report the patient safety error.  The team identified ten patients who did or possible did receive the invalid vaccine.  After consulting with Risk Management, the Resolution Specialist and MILVAX, all ten patients were contacted, received full disclosures, and were recommended to receive repeat Dose 1 as soon as possible.  Eight patients were revaccinated on 6 Jan 2021.  Two declined revaccination and plan to get Dose 2 as previously scheduled.  A Concise Incident Analysis (mini- Root Cause Analysis) is being conducted to determine root causes and ensure effective process improvements are implemented.
Really dizzy; Nauseous; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Really dizzy) and NAUSEA (Nauseous) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Really dizzy) and NAUSEA (Nauseous). At the time of the report, DIZZINESS (Really dizzy) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter No treatment medications provided by the reporter.
Information has been received from a nurse concerning a 17 year old female who on 25-MAR-2008 was vaccinated intramuscularly with a third dose of GARDASIL (Lot # unknown).  Dates of the previous doses are not reported.  On 25-MAR-2008, the patient developed a fever of 101 and aching in both her arms and legs, vomiting and shaking.  No lab diagnostics studies were performed.  Unspecified medical attention was sought.  No product quality complaint was involved.  Outcome unknown.  Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. Initial and follow up information has been received from a nurse concerning a 17 year old female and no illnesses at the time of vaccination, who on 25-MAR-2008 was vaccinated intramuscularly with a third dose of GARDASIL (Lot # 659964/1978U). Dates of the previous doses are not reported. On 25-MAR-2008, the patient vomited 1x and on 26-MAR-2008 the patient developed a fever of 101 and aching in both her arms and legs, and shaking. No lab diagnostics studies were performed. Unspecified medical attention was sought. The patient was advised to take MOTRIN and see PCP if symptoms persisted. No product quality complaint was involved. Outcome unknown. Additional information is not expected.
pt recv vax 1JUN96 & 3JUN96 pt exp generalized patchy hives mostly on torso going down into the groin area;no further details were provided;
Started with swelling, redness and heat of entire deltoid on day of followed by lymphadenopathy on the left neck and supraclavicular and headache, temp of 100°, diarrhea 9-10 days following injection.