chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient had a bad reaction to it; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (patient had a bad reaction to it) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced IMMUNISATION REACTION (patient had a bad reaction to it). At the time of the report, IMMUNISATION REACTION (patient had a bad reaction to it) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Injection site soreness (+3 hrs), High fever (+12 hrs), Headache (+12 hrs), AFIB (+22 hrs), Tachycardia (+22 hrs)
The lower left side  of my face went completely numb.  Severe Face pain on the same side. I am still like this to date. Went to dentist, dental surgeon, primary care and neurologist. As of now, no one knows what is wrong. I also got an MRI.
SORE THROAT, MILD COUGH, LOW GRADE FEVER.  CONCLUDED PAXLOVID PROTOCOL. SYMPTOMS SUBSIDED WITHIN 5 DAYS.
Patient admitted to GHS 10/23/2021 on Observation Status with epigastric abdominal pain and was cound to have acute pancreatitis.  She has a medical history that includes cholecystectomy, hypertriglyceridemia, pancreatitis, H pylori, alcohol withdrawal, hypertension, depression/anxiety, and GERD.  Patient was tested for COVID 19 as per protocol on admission 10/23/21 and did test Positive.
Large red circle on arm,  firmness, hot and sore.   Showed up shortly after shot and still there 2.5 days later.  Feels like a hard mass under the skin at injection site
¨little bruising on right arm after the 2nd shot ¨; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (¨little bruising on right arm after the 2nd shot ¨) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 047A21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (¨little bruising on right arm after the 2nd shot ¨). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of one hour before the 1st and the 2nd Moderna shot. At the time of the report, VACCINATION SITE BRUISING (¨little bruising on right arm after the 2nd shot ¨) outcome was unknown. Not Provided          Other concomitant medications were reported included Lupus Medication,Blood pressure medication,medicine for depression and cholesterol medicine.   This case was linked to US-MODERNATX, INC.-MOD-2021-080362 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Non Significant:Contact information updated. On 19-Jul-2021: Follow up information received and contains non significant information- Husbands Information provided; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080362:Husband case
Information has been received from a nurse practitioner concerning a 25 year old female with no allergies who on 22-MAY-2007 was vaccinated IM with the first dose of GARDASIL (lot# 657621/0387U).  In April 2008, eleven months later, the patient experienced seizure.  A magnetic resonance imaging (MRI) was performed (result unknown).  Subsequently, the patient recovered from seizure.  On 22-OCT-2008 the patient received the second dose of GARDASIL (lot# 661530/0575X) IM 0.5mL.  The patient sought medical attention at the practice.  Upon internal review, seizure was considered to be an other important medical event.  Additional information has been requested.  7/27/09 Medical records received DOS 10/22/08 to 12/17/08. Includes EEG report from 5/13/08 and MR Brain from 5/15/08. Assessment: HPV. Patient presents with fatigue, sores in mouth, vaginitis. Cervical dysplasia. Acid Reflux. Alcohol use. Seizure in Fall 08  - patient considers event related to shellfish. Desires STD testing. Would like to restart Gardasil series (had initial dose in 5/07 but did not return for 2nd or 3rd doses). Dose of Gardasil given on 10/22/08 visit.
Patient fainted after receiving vaccine. Patient did not hit his head. Girlfriend assisted him to the ground. Patient had stated he had not had anything to eat in the past 6 hours. Patient was seated in a chair, drank some water, and ate a snack. Patient stated he felt better after eating.
her teenage daughter has been given Shingrix / by accident at the pharmacy; This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 13-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 23rd June 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional case details were reported as follows: This case was reported by patient's mother. The teenage daughter was given Shingrix vaccine by accident at the pharmacy, which led to inappropriate age at vaccine administration.   No side effects were reported. The reporter did not have the last name of health care professional, mailing address, fax number, or an email address.  The reporter did not know the phone number to the pharmacy where the vaccine was given.  The reporter gave her personal email address. The reporter did not know the lot number/expiration date or the dose of the vaccine. The reporter consented to follow up with patient's health care professional.
BY ERROR THE PATIENT RECEIVE COVID 19 PFIZER - BIOTECH PEDIATRIC VACCINE INSTEAD OF MODERNA TODDLER.
This spontaneous report was received from a other health professional refers to a 6 year old male patient with unspecified preservative allergy, jello allergy and neomycin allergy. The patient's medical history included Kawasaki's disease. Patient was previously vaccinated with M-M-R II on 08-MAR-2006 and developed flushing, sneezing and water eyes(see related case 1307USA002246). Patient was also previously vaccinated with DTaP(manufactured by GlaxoSmithKline) and inactivated IPV (manufactured by PMC per the caller) on 08-MAR-2006. On 20-MAR-2008, the patient was vaccinated with a dose of VARIVAX (Merck) (lot#, expiry not reported). On 20-MAR-2008, the patient developed wheezing and hives. The patient was given a nebulizer treatment and an unspecified steroid medication, then was evaluated in the emergency room at the Hospital and released. No other vaccines were given on 20-MAR-2008. The patient's symptoms resolved that same day on 20-MAR-2008. The outcome of wheezing and hives was reported as recovered. This is 1 of 2 reports regarding the same patient. Additional information is not expected.
Child developed diarrhea after 1st dose of flu - increased frequency and decreased consistency. Partially resolved. Then received second dose and again had diarrhea.
I have generally been sick with breathing problems and congestion since a week or so after the second shot. I was having trouble breathing on 10/22/21 and went to ER. They believed it to be Covid symptoms. Ultimately diagnosed with atypical pneumonia and prescribed albuterol sulfate and zithromax. Symptoms improved but never completely cleared. This has been ongoing since vaccination.
States few days after shot on 12th or 13th itchy at site and joint pains in both hands and redness on L forearm. Came and went few times a day 6/17 or 6/18.
This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 57-year-old female patient who received FLUARIX QUADRIVALENT (batch number BD742, expiry date 14th May 2018). On 27th September 2017, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced extensive swelling of vaccinated limb (serious criteria disability), skin warm (serious criteria disability), injected limb mobility decreased (serious criteria disability), injection site mass (serious criteria disability) and arm discomfort (serious criteria disability). On an unknown date, the outcome of the extensive swelling of vaccinated limb, skin warm, injected limb mobility decreased, injection site mass and arm discomfort were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, skin warm, injected limb mobility decreased, injection site mass and arm discomfort to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT in left deltoid. On 10th October 2017, an healthcare professional reported that the patient had experienced swelling of the left arm from the shoulder to the wrist, unable to lift her arm, warmth, arm feels full and had a knot at the injection site. The healthcare professional believed the reported symptoms were debilitating, since the patient was left handed.
Due to mis-communication with pharmacist 1.0 mL dose was administered instead of 0.5 mL dose - no reaction noted
Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021; Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 11:21 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 11:21 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 83.03. No concomitant medication was reported by reporter.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. Vial was moved to fridge on 08-Jan-2021 and moved to clinic on 11-Jan-2021. Vial was punctured right before administration. Vial best before use date was 07-Feb-2021.After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.   No treatment medication was reported by reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Nurse reported a 2nd 2-yearr-old patient developed appendicitis 1 week after receiving the vaccine; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 2-year-old patient received BNT162b2 (BNT162B2), as dose 1 (maroon cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was unknown if the patient had other vaccine in four weeks after vaccination. It was unknown if the patient had Covid prior to vaccination. The following information was reported: APPENDICITIS (hospitalization, medically significant), outcome "unknown", described as "Nurse reported a 2nd 2-yearr-old patient developed appendicitis 1 week after receiving the vaccine". It was unknown if therapeutic measures were taken as a result of appendicitis. It was unknown if the patient was tested for Covid-19 post vaccination.  The lot number for [BNT162b2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event appendicitis with the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201110817 same reporter/product/AE, different patient;
Information has been received from a registered nurse (R.N.), for GARDASIL, a Pregnancy Registry product, concerning a 15 year old female patient, who on 23-APR-2008 was vaccinated with the first dose of GARDASIL. On the same day, the patient also visited the OB/GYN, and had a positive pregnancy test. Details of the pregnancy and gestation were not reported. Follow-up information was received on 05-FEB-2009 indicating that on 22-APR-2008 (previously reported as 23-APR-2008), the patient with behavioral problem and school problem and a history of varicella disease was vaccinated intramuscularly in the right deltoid with a first dose of GARDASIL (Lot #659439/1267U). It was reported that the patient had 0 previous pregnancies. An ultrasound performed on 25-JUN-2008 revealed possible brachycephaly. Amniocentesis performed on 27-AUG-2008 showed no brachycephaly. Maternal serum alpha-fetoprotein (MSAFP) on 07-JUL-2008 was negative. It was reported that the patient developed anemia during pregnancy. There were no infections or illnesses during pregnancy. On 16-NOV-2008, 38 weeks from LMP, the patient had a cesarean section for occiput posterior descent, and delivered a normal male baby, weighing 6 pounds 10 ounces. The baby's length was 20 inches, head circumference was 13 inches and apgar score was 8/9. There were no congenital anomalies, other complications or abnormalities. Upon internal review, "cesarean section for failure to progress" was determined to be an other important medical event. Additional information is not expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2008, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2014, the patient was treated by a healthcare provider 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 vaccine, 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 including 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 was considered to be not recovered. Additional information has been requested.
Felt dizzy, nauseous. vomited multiple times, claimed of stomach cramps and stomach pains due to anxiety
Drewup a dose from an expired punctured vial; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Drewup a dose from an expired punctured vial) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Drewup a dose from an expired punctured vial). On 13-May-2021, EXPIRED PRODUCT ADMINISTERED (Drewup a dose from an expired punctured vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter.  The pharmacist reported that accidentally the immunization technician drew up a dose from an expired punctured vial which was kept for more than 12 hours and was given to patient. As per the pharmacist the patient was doing fine.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Death  5/31/2021 Causes of death listed on death certificate: 1. Autoimmune cold-agglutinin hemolytic anemia  2. COVID 19  3. rheumatoid arthritis, chronic immunosuppression
UrticariaPruritus  Puritic, erythematous, painful induration 9x6 cm  Narrative: immed induration , resolved then  recurred to 9x6cm red and painful.
Tingling in feet, weakness in legs worsening over course of about 2 weeks. Treated with IVIG.
Ocular migraine activity (flashers) lasting for at least 48 hours (still ongoing); fatigue
Morning of 1/5/2021 - I woke up with an extreme headache and nausea and extreme coughing. That went on all day. On the 6th, went to the Dr office for cough medicine as I thought my normal chronic cough was that much worse. Urgent Care Had COVID test - positive. From that point on - very severe coughing, headaches; extreme fatigue. My oxygen saturation level went down to 91 from normal 98% and I was at that for about four days. Z-Pack for seven days and then they gave me a second rounds for another 7 days plus antibiotic - Doxycycline (for second round of antibiotics - Azithromycin  first round of antibiotic) Promethazine ; and nasal drop - Azelastine ; Benzonatate cough drops.  Initially I had seven day of  Prednisone steroids plus 5 more days after steriods I had extreme coughing and fatigue.
ITCHING, THROBBING, TINGLING, REDNESS AND SWELLING AT INJECTION SITE.
tongue coated by fungus; Oral thrush; tongue swollen up; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE COATED (tongue coated by fungus), ORAL CANDIDIASIS (Oral thrush) and SWOLLEN TONGUE (tongue swollen up) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient tested positive for COVID-19, but symptoms were very mild.) in November 2020. Concurrent medical conditions included Blood pressure. Concomitant products included TAMSULOSIN, FINASTERIDE, ATORVASTATIN and VITAMINS NOS for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced TONGUE COATED (tongue coated by fungus), ORAL CANDIDIASIS (Oral thrush) and SWOLLEN TONGUE (tongue swollen up). The patient was treated with NYSTATIN (oral) at a dose of 1 milliliter once a day and FLUCONAZOLE at a dose of 2 pills on the 1st day, followed by 1 pill for next 6 days. At the time of the report, TONGUE COATED (tongue coated by fungus) outcome was unknown and ORAL CANDIDIASIS (Oral thrush) and SWOLLEN TONGUE (tongue swollen up) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was taking concomitant medications for Prostate. Patient was back on nystatin oral antifungal suspension just a few days ago.
Information had been received from a physician via market research program regarding a patient who had been vaccinated with ZOSTAVAX. Physician reported, "I had a patient that got shingles from the shingles vaccine". Adverse event onset date was "about 6-7 years ago" (specific date not provided). Outcome of shingles was reported as recovered/resolved with sequelae. Physician reported patient recovered six weeks after becoming symptomatic. It was reported that shingles did not reappear after restarting suspect therapy. Additional information has been requested.
Patient was vaccinated in left deltoid with Moderna vaccine as her first dose, however patient was only 16 years old, not 18
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. This is former enlisted military member who is permanently grounded due to a severe autoimmune condition involving severe bone and joint pain, memory loss and unexplained gray-outs. His pre-vaccination blood work showed no evidence of auto-immunity while his post vaccination blood work showed positive evidence of auto-immunity. (OMIC)
Information has been received from a physician concerning his 6 year old daughter who approximately February 2004, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). the physician reported that in February 2004, his daughter developed mild breakthrough chickenpox. Unspecified medical attention was sought. subsequently, the patient recovered from the mild breakthrough chickenpox. No further information is available.
Myocarditis, two weeks.  I had extreme chess pain that spans mostly the right side of my chest. I had breathing problems or feeling of not catching my breath.  Weakness and lack of energy.  I usually run but due to condition I was not able to do any physical activity. I also had fever.   It has been a year and I still have trouble performing physical activity but am about 90% of previous performance.