chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On 19-Aug-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In July 2022, the patient experienced COVID-19 (COVID-19). In 2022, COVID-19 (COVID-19) had resolved.            Company comment: This is a spontaneous case concerning a 69-year-old male patient with Hidradenitis suppurativa on treatment with Adalimumab, who experienced the non-serious  unexpected AESI COVID-19, approximately 7 months after the third dose of mRNA-1273.  A SARS-CoV-2 test was performed without reported results. Clinical findings, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.  The patient took adalimumab (solution for injection in pre-filled pen). No concomitant medications were reported. The reporter causality of adalimumab (Humira) for an event of COVID-19 was not provided. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. No treatment medications were reported.   This case was linked to MOD-2022-636464 (Patient Link).; Sender's Comments: Company comment: This is a spontaneous case concerning a 69-year-old male patient with Hidradenitis suppurativa on treatment with Adalimumab, who experienced the non-serious  unexpected AESI COVID-19, approximately 7 months after the third dose of mRNA-1273.  A SARS-CoV-2 test was performed without reported results. Clinical findings, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.
approx 30min p/vax pt c/o nasal congestion, dry cough, watery eyes-hives on face, eye lids swollen-DPh liquid sx persisted but did not worsen;transported to ER;
In March, 2004 had varicella illness despite vaccine. He was seen in ER for fever and rash.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates since 08-JAN-2016, the patients were vaccinated with improperly stored dosed of RECOMBIVAX HB intramuscularly (dose, lot # and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -1 degrees Celsius for 220 hours. Time frame/date of excursion: from 08-JAN-2016 to 24-MAY-2016. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT STATES WAS JITTERY AND HAD SOME SLIGHT SHAKING. PATIENT HAD NOT EATEN ANYTHING. WAS GIVEN DRINK AND CRACKERR AND OBSERVED FOR ADDITONAL 15 MINS. PATIENT SYMPTOMS RESOVED AFTER EATING AND WAITING EXTRA TIME.
Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2016, the patient was vaccinated with ZOSTAVAX, due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). On an unknown date in 2016, the patient experienced shingles (herpes zoster) and other zoster-related injuries despite being inoculated with the ZOSTAVAX vaccine (vaccination failure). On an unknown date in 2016, the patient was treated by a health care provider for shingles. It was also reported that, on unknown dates, the patient suffered serious physical, emotional and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering (Emotional distress and pain), 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; diminished quality of life; increased risk of premature death, aggravation of pre-existing conditions and activations of laten conditions, lost wages, loss of earning capacity and other losses and damages. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased, and the pre-existing unspecified conditions aggravated was unknown. The reporter considered the adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-treathening and medically significant.
After about 18hrs, fever, body ache, fatigue, mild headache; After about 18hrs, fever, body ache, fatigue, mild headache; fatigue; After about 18hrs, fever, body ache, fatigue, mild headache; Pain and stiffness at the shot location; Pain and stiffness at the shot location; Nausea and dizziness within the first few hours of taking the vaccine; Nausea and dizziness within the first few hours of taking the vaccine; After about 24hrs, increasing pain in the armpit of the side where the shot was taken (left). There seems to be inflammation in the armpit area; After about 24hrs, increasing pain in the armpit of the side where the shot was taken (left). There seems to be inflammation in the armpit area; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 23-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EW0182, expiry date : not reported), via an unspecified route of administration in the left arm on 08May2021 16:30 (at the age of 23-years old) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: ER8737, expiry date : not reported), via an unspecified route of administration in the left arm on 17Apr2021 16:45 (at the age of 23-years old) as DOSE 1, SINGLE for covid-19 immunisation. On 08May2021, the patient experienced nausea and dizziness within the first few hours of taking the vaccine. On 09May2021 10:00, pain and stiffness at the shot location. 09May2021 10:30 after about 18hrs, the patient experienced fever, body ache, fatigue, mild headache. In May2021, After about 24hrs, the patient experienced increasing pain in the armpit of the side where the shot was taken, there seems to be inflammation in the armpit area. The patient underwent lab tests and procedures which included Nasal Swab, RT-PCR, covid test, which is negative on 30Apr2021 and 07May2021. No treatment was received for all the reported events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist refers to a male patient of approximately 66 years. The patient's medical history included shingles. On an unspecified date, the patient was previously vaccinated with PNEUMOVAX23 and had experienced edema of the arm. On an unspecified date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date,route and dose were unspecified). Concomitant medications were unspecified. On an unknown date, the patient received ZOSTAVAX then broken out in cold sores. The patient sought medical attention and the reporter believes that the patient had been to an unspecified local private physician. As a treatment the patient was given acyclovir 2 days after receiving ZOSTAVAX. The patient was not experiencing any known symptoms and on an unknown date, the patient recovered from the event cold sores. Additional information has been requested.
Immediately after shot given, lips started to tingle, face got red, and headache started. Chills followed by fever, nausea, and vomiting  started about 4 hours after shot. Also had shallow breathing which worsened, and had trouble breathing and chest pain. Called 911, and brought to Hospital ER.  Zofran, rocephin, aspirin, and acetaminophen given. Also given IV fluids (normal saline). Other tests performed: Chest X-ray, CT scan to r/o brain bleed, blood and urine test performed.
D65 - Disseminated intravascular coagulation (defibrination syndrome)
shingles; burning rash on right side; Blister on right side; Burning rash; residual fatigue; Woke up at night with tremors; chills; intense body aches; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 3rd October 2022, the patient received Shingles vaccine and Flu vaccine. On 5th October 2022, 2 days after receiving Shingles vaccine and Flu vaccine, the patient experienced fatigue. On 8th October 2022, the patient experienced shingles, burning sensation, blister and rash. In October 2022, the patient experienced tremor, chills and general body pain. On an unknown date, the outcome of the shingles, burning sensation, blister and rash were not recovered/not resolved and the outcome of the tremor, chills and general body pain were recovered/resolved and the outcome of the fatigue was unknown.   It was unknown if the reporter considered the shingles, tremor, chills, general body pain, fatigue, burning sensation, blister and rash to be related to Shingles vaccine and Flu vaccine.  Additional Information: GSK Receipt Date: 08-OCT-2022 Reporter's Comment: The case was reported by the patient. The patient received a flu vaccine and a shingles vaccine on Monday.  After going to bed, the patient woke up in the middle of the night with tremors and chills along with intense body aches.  This lasted through the day with a return to normal with residual fatigue on Wednesday.  At the time of reporting, the patient developed a blister, burning rash on right side which had been diagnosed as shingles.
pt recv vax; swelling, warmth, pain over inject site; fever; tx w/ apap & ice 2-3 x 1 day; moderate activity
Result of BOOSTER:   Chills;  Dizzy:   Tired;  Trouble standing up;  Trouble sitting down;  lower back pain; painful to bend  down; painful to move in bed due to pain in lower torso and lower  back; and difficult to sleep due to pain in lower back.   For previous Vaccine Doses #1  (Feb. 2, 2021) and #2 (Feb. 23, 2021), I was just tired and had soreness around the injection site.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022; No adverse event; Patient administered the vaccine after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022).    No concomitant medication was reported by reporter.  Total 35 vials were affected. Vial was initially stored in refrigerator on 04-Jun-2022 and did not undergo temperature excursion. Manufacture code for the lot. Patient was administered with half dose.  No treatment medication was reported by reporter.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (2-4 drinks a week) on 15-Dec-2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from December 2020 to an unknown date for Pregnancy.    On 25-Feb-2021 at 1:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 20-Nov-2020 and the estimated date of delivery was 27-Aug-2021. On 25-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 25-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Dec-2020, Pregnancy test: positive (Positive) positive. On 22-Jan-2021, Ultrasound abdomen: normal (normal) NO ABNORMAL FINDINGS. On 12-Feb-2021, Ultrasound abdomen: normal (normal) NO ABNORMAL FINDINGS.     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.   No treatment information was provided.
Extreme nausea and dizziness resulting in vomiting.   Lasted about 5 hours.
Patient did not take seizure medication this am but failed to tell me that until after shots were administered.  Patient experienced  a seizure activity 5 minutes after shots were administered.  Fully recovery after seizure.
fatigue; sore arm; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 74-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6206), dose 1 intramuscular, administered in Arm Right on 11Mar2021 12:45 at dose 1, single for COVID-19 immunisation. Medical history included ongoing migraine (onset date: Decades ago) and patient- 3 weeks of guillian barre symptoms with flu shot 1960's. Family history included Nephew's child- Respiratory arrest with 1st childhood vaccine. The patient concomitant medications were not reported. The patient experienced sore arm on 11Mar2021 18:00 and fatigue on 12Mar2021 07:00. The clinical outcome of the event sore arm was recovered on an unspecified date in 2021 (lasted 3 weeks) and fatigue was recovered on an unspecified date in May2021 (lasted 7 days).  Follow-up attempts are completed. No further information is expected.
Nausea and vomiting beginning am on 6/27/2013, client reported vomiting multiple times. Low grade fever (reported around 99 F), reported general achiness, especially in left deltoid where shot was given; also feeling localized tenderness in neck/collarbone area, denied sore throat. Client reported symptoms were improving when seen on 6/28/13 at 2:15 pm.
elevation in my blood pressure; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) and HYPERTENSION (elevation in my blood pressure) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DIZZINESS (dizzy). On 18-Feb-2021, the patient experienced HYPERTENSION (elevation in my blood pressure). On 21-Feb-2021, DIZZINESS (dizzy) had resolved. At the time of the report, HYPERTENSION (elevation in my blood pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant included blood pressure medication Treatment included Allergy medication and Ibuprofen and Tylenol hoping that would help. I tried to rest as much as I could.
4 hours after injection, sharp pains in head and neck. 10 hours after injection chills and all over body pain. 18 hours after injection pain is less.
Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient had the Shingles shot and got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Pt recvd DTP/OPV in 1990; 10 days p/vax, recvd MMR; @ the time of report, pt was asymptomatic;
p/vax pt devel 8x9 cm lt arm; no swelling; tx: benadryl & ice ordered by MD
About 30 minutes after 2nd vaccine, I felt abrupt pain, shocks and tightening in 3 fingers on my right hand, starting at the knuckles down to finger tips. Pain occurred with or without movement.  Knuckles are swollen on that  On day 4, pain moved from knuckle to the joint between knuckle and finger tip.  Pain occurs mostly with movement but not always, and is from mild to moderate pain. It is day 16 post vaccine, and I still have intermittent pain in the 3 fingers  where I hadn?t previously had any prior to vaccine. 30 hrs after 2nd vaccine, I also had a severe headache lasting about 1 1/2 hrs.
Bilateral rash on upper arms. The rash was most pronounced on the left arm (site of my 2 vaccinations). The rash appeared just short of a week after my first injection.; Bilateral rash on upper arms. The rash was most pronounced on the left arm (site of my 2 vaccinations). The rash appeared just short of a week after my first injection.; This is a spontaneous report from a contactable consumer.  A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left in Mar2021 (Batch/Lot Number: ER8730) as 1st dose, single for covid-19 immunization. The patient's medical history included hay fever; severe case of chicken pox at age 14 from an unknown date and unknown if ongoing. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) and fluticasone propionate (FLONASE ALLERGY RELIEF) taken for an unspecified indication, start and stop date were not reported. The patient previously took nickel, cherry fruit. The patient experienced bilateral rash on upper arms. the rash was most pronounced on the left arm (site of my 2 vaccinations). the rash appeared just short of a week after my first injection on 31Mar2021 07:00. It was further reported as bilateral rash on upper arms. The rash was most pronounced on the left arm (site of my 2 vaccinations). The rash appeared just short of a week after my first injection.  It faded somewhat over the 3 weeks leading up to my final vaccination on April 14. The rash became more apparent a week following the 2nd dose and continues at the present moment. The area was approximately 10 inches along the inside of the left arm and is half that length on the right arm. The rash was slightly raised. Patient applied  lotion as needed to help with the itching but the rash remains. Telehealth appointment on May 1 (yesterday) resulted in prescriptions for hydrocortisone cream for the rash and a 7-day supply of Cephalexin. The outcome of the event was not recovered. Patient has was not diagnosed with COVID-19 prior to vaccination and the patient has not tested for COVID-19 since the vaccination.   No follow-up attempts are needed. No further information is expected.
Left arm sore; headache; generalized muscle aches; Temp at home in evening was 101.2; This is a spontaneous report from a contactable Nurse (patient). A 58-year-old female patient receive first dose of BNT162B2 (lot number: EL1284) on left arm via an unspecified route of administration on 30Dec2020 15:45 at single dose for covid-19 immunisation. Medical history Environmental allergies, diverticulosis, uterine fibroids, and Known allergies: Broccoli and Bell peppers. The patient was previously diagnosed with COVID-19 prior to vaccination. Concomitant medication included omeprazole (PROTONIX), levocetirizine dihydrochloride (XYZAL), famotidine (PEPCID), fluticasone furoate (FLONASE SENSIMIST ALLERGY RELIEF). The patient experienced left arm sore around 4 am 31Dec2020. Gradual onset of generalized muscle aches and headache. Worse as day progressed. Xhills late afternoon. Temp at home in evening was 101.2. The patient received tylenol (self administered) for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered.
Injection site has turned into red hive-like bump, approximately 1.5-2 in. in diameter, and is incredibly itchy. There has been minor itchiness since time of injection (1/14/21, 2:30 pm), nothing major. Starting 1/21/21 approximatelt 5:30-6:00 pm, noticed the injection site is now large red bump and has remained there and itchy.