chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Thrombocytopenia; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced thrombocytopenia on an unspecified date, the seriousness of the event reported as death. The patient died two weeks after receiving a COVID-19 vaccine. Patient's wife said that he died from a condition known as thrombocytopenia, marked by a shortage of the blood platelets that help stop bleeding, after he received BNT162B2. The patient underwent lab tests and procedures which included blood bilirubin: 1.50, blood osmolarity: 297, blood pressure measurement: 159/106, blood urea: 22.3, monocyte count: 12.1 %, platelet count: thrombocytopenia, platelet count: platelet count decreased again to 0 on 21Dec2020. The patient died on an unspecified date.  It was unknown if an autopsy was performed. The outcome of the events was fatal.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Thrombocytopenia
DISTENDED ABDOMEN, BODY ACHE, FEVER, LOCAL INJECTION SITE ERYTHEMA, SORENESS, WARMTH.
This spontaneous report was received from a pharmacist via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unspecified date, the patient experienced swelling and redness around the injection site. The patient reported to an unspecified hospital. The patient was fine and was not admitted to the hospital. The patient returned to the pharmacy on an unspecified date, complaining of not having been told of the potential adverse experience. The outcome of the events was not reported. The relationship between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Chronic leg pain, shortness of breath and fatigue for 48 hours. July 2021, diagnosed with pulmonary artery aneurysm, needed open heart surgery to fix aneurysms.
Patient developed joint pain and complaints of lethargy approximately 2 weeks post receiving vaccine. Patient also complained about numbness in extremities.
Pt received Pfizer booster on 12/30 and was sent to the hospital due to a seizure on 12/31.  Pt was hypoxic and found to be COVID positive.
hives; Initial information received on 08-Oct-2019 regarding an unsolicited valid serious case received from a physician and nurse via sales representative.  This case is linked to cases 2019SA280603 and 2019SA280604 (same reporter).  This case involves a 85 years old female patient who experienced hives (urticaria) and, while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed hives (urticaria) within 24 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized for these events.  Other relevant tests not reported.   Final diagnosis was hives.   It was not reported if the patient received a corrective treatment.  The outcome was unknown for hives.  Information on the batch number was requested.  List of documents held by sender: none.
Pt. c/o shoulder pain more than 1-2 weeks after vaccine was admistered. Per pt. she was diagnosed with frozen shoulder at urgent care and her attending physician stated it was likely caused by the vaccine
PRESENTED TO ED ON 1/25 FOR worsening exertional chest pain and SOB, found to have NSTEMI.
Information was received from an immunization nurse on behalf of a patient on 08JUL2013. On 11JUN2013, a 47 year old female received a 14th dose of BioThrax (lot FAV429) in the left arm. Approximately 30 minutes after immunization she experienced a metallic taste in her mouth. The taste persisted throughout the day to evening despite eating, drinking and rinsing her mouth. The metallic taste was gone upon waking the following day.
Chills, whole body aches Lasted from 2 am until 6-8 am
Patient complain of swelling and redness to left arm, injection site.  Treatment given by urgent care medical doctor for 0.1 percent TAC cream, BENADRYL 25 mg, KEFLEX 500 mg.
c/o stomachache;projectile vomit;dizzy & diarrhea;started to sweat  & shake & could not see out of lt eye;face swollen & eyes swollen shut, hands & feet swollen;tongue swelled & unable to talk;
Adverse event = hives all over body. Treatment = ER visit and prednisone 20mg and allergy medication 25mg was prescribed.
No adverse event; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of NO ADVERSE EVENT (No adverse event) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 37-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Sep-2022, 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, NO ADVERSE EVENT (No adverse event) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.            No concomitant and treatment medications were reported. Patient's husband also received the Moderna bivalent booster vaccine on 12-Sep-2022. Age and Date of  birth was reported as 36 and 14-Feb-1986 respectively.  Company comment: This regulatory authority case concerns a 37-year-old pregnant female patient with gestational age of 36 weeks, with no other relevant medical history, was administered booster dose of mRNA-1273 BIVALENT.222  vaccine. There is no information if patient suffered any adverse event after the vaccination. Available data on Moderna COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This regulatory authority case concerns a 37-year-old pregnant female patient with gestational age of 36 weeks, with no other relevant medical history, was administered booster dose of mRNA-1273 BIVALENT.222  vaccine. There is no information if patient suffered any adverse event after the vaccination. Available data on Moderna COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. The benefit-risk relationship of mRNA-1273 is not affected by this report.
No additional adverse effects reported; an improperly stored dose of PROQUAD was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, drug reactions/allergies and concomitant therapies was not provided.   On 29-MAY-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA (recombinant Human albumin)) (lot # S031702, expiration date 06-APR-2021; vaccine dosage detail and route of administration not reported) for prophylaxis (product storage error). Current temperature excursion was 32.7 Fahrenheit degrees for 4 hours. There was no previous temperature excursion. No additional adverse effects reported (no adverse event). No product quality complaint (PQC) was involved in this case. Data logger was involved.
Itching with hives with  never had before; Itching with hives never had before,itch; Hole stomach with hives too red; Feel okay until night, went to bed and I wasn't feeling to well; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Itching with hives with  never had before), PRURITUS (Itching with hives never had before,itch), ERYTHEMA (Hole stomach with hives too red) and VACCINATION COMPLICATION (Feel okay until night, went to bed and I wasn't feeling to well) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 10C014-825, 007M20A and 025A21A) for COVID-19 vaccination.     The patient's past medical history included Hip fracture in 2020. Concurrent medical conditions included Weight loss (a lot of weight because of fracture and is very skinny, 90 pounds.). Concomitant products included HYDROCORTISONE for Itch, HYDROCHLOROTHIAZIDE, PARACETAMOL (TYLENOL [PARACETAMOL]), SIMVASTATIN, LISINOPRIL, CALCIUM and LATANOPROST for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced ERYTHEMA (Hole stomach with hives too red) and VACCINATION COMPLICATION (Feel okay until night, went to bed and I wasn't feeling to well). On 04-Nov-2021, the patient experienced PRURITUS (Itching with hives never had before,itch). On 04-Nov-2021 at 11:00 PM, the patient experienced URTICARIA (Itching with hives with  never had before). On 03-Nov-2021, VACCINATION COMPLICATION (Feel okay until night, went to bed and I wasn't feeling to well) had resolved. At the time of the report, URTICARIA (Itching with hives with  never had before), PRURITUS (Itching with hives never had before,itch) and ERYTHEMA (Hole stomach with hives too red) outcome was unknown.            No treatment was received by the patient.  Patient reported 2days after the vaccine, that night she experienced itching with hives never had before. Patient got up, sat on a chair to read or do something else to not think of the itching. After, the patient talked to a friend that usually got hives and told her to sleep with gloves so does not scratch during the night. The patient said: "Last night went to bed with gloves so not to scratch and sleep better.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 22-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # H010656, expiration date 01-SEP-2013) (0.65 ml, subcutaneous route). Concomitant therapy was not reported. It was reported that the patient received an improperly stored ZOSTAVAX, the ZOSTAVAX was exposed to a temperature of 40F for 2160 hours. No adverse effect reported. Additional information has been requested.
A report has been received from a pharmacist concerning a 66 year old, male subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 24-Sep-2013. They inadvertently gave FLUMIST to a 66 yo on 24-sep-2013. The outcome of the event of administered FLUMIST to a 66 yo is unknown. The report was considered to be non-serious.
prolonged irritability (mom states up to 2wk from DTP given 17OCT96;
left side of throat was not working properly; would cause lot of pain; could feel heaviness on left side of the face; no strength in the left arm; had pain in the left shoulder and left elbow; headaches in left eye; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (left side of throat was not working properly), PAIN ( would cause lot of pain), DISCOMFORT (could feel heaviness on left side of the face), MUSCULAR WEAKNESS (no strength in the left arm) and ARTHRALGIA (had pain in the left shoulder and left elbow) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced DYSPHAGIA (left side of throat was not working properly). In July 2021, the patient experienced PAIN ( would cause lot of pain), DISCOMFORT (could feel heaviness on left side of the face), MUSCULAR WEAKNESS (no strength in the left arm), ARTHRALGIA (had pain in the left shoulder and left elbow) and HEADACHE (headaches in left eye). At the time of the report, DYSPHAGIA (left side of throat was not working properly), PAIN ( would cause lot of pain), DISCOMFORT (could feel heaviness on left side of the face), MUSCULAR WEAKNESS (no strength in the left arm), ARTHRALGIA (had pain in the left shoulder and left elbow) and HEADACHE (headaches in left eye) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that he got the shot in the left arm and lasted for a month and was living on scrambled eggs and apple sauce as nothing else would go down and pain was radiated down from spine all the way down to shoulder and into the hand. Patient had no power to hold up bottle of water or cell phone  No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.
Vaccine administered after temperature excursion; No other AEs reported; This spontaneous report has been received from a registered nurse referring to a 5-month-old patient of unreported gender. The patient's pertinent medical history, concomitant medication, drug reactions, and allergies were not reported.       On an unspecified date, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number T030458, expiration date 11-APR-2021, which has been verified to be valid) was involved in a temperature excursion of 35 degrees Fahrenheit (F) for 30 minutes (product storage error). There was no previous temperature excursion. On 18-OCT-2021 (also reported as "after temperature excursion"), the patient was vaccinated with the involved rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliters, for prophylaxis (dose number, vaccination scheme, and route of administration were not reported).       No other adverse events (AE) were reported (no adverse event).
pt recv vax 8OCT96 & 22OCT96 pt devel a rash on trunk, back, face & extremities;it was reported that pt was pretty well covered & the rash was not blistery;
During 15 minute observation period post vaccine: Patient develop tightness in the throat and had trouble breathing.  Reported head pounding, throat swelling and sweaty feet.  BP of the patient was taken by Nurse faculty at the facility and recorded at 201/110.  Heart Rate was recorded at 180. Benadryl was given to the patient.(50mg total)  Patient was taken to hospital by staff at facility at 11:02am.  Confirmed check-in at 11:25am.
I bit my cheek on Thursday. It healed on the surface but the pain did not go away. A week later, it became more painful and swollen. There was no way to drain it. Through testing, they determined a less than 3mm blockage of the duct in my face. I was given various pain meds. One was an injection that helped. One was a pill that did not affect it. I was told to suck on lemonheads to keep saliva flowing. I was eventually given morphine which took care of the pain and it got better. I was also given a great deal of antibiotics IV I was in much less pain by Monday. I slept a lot and also ran a fever. They noticed in my sleep; my heart rate dropped to 30.  They found some irregularities in my blood pressure and blood sugar levels as well. Currently, there is still a bit of tenderness and a noticeable swollen spot.
The following day after vaccine, I had a severe headache. I could not move my neck, it was stiff, I told my wife to call 911. The ambulance came and took me to the medical hospital. They took me to neurosurgery to relieve pressure in my brain. I was put on medication for intracranial pressure.  I was in the hospital and rehab in the hospital for almost 2 months. I was put on a small dose of lisinopril.
Patient was given a second dose of flu vaccine in error. Mom called to report development of nausea.
This case was reported by a healthcare professional and described the occurrence of decreased blood pressure in a 35-year-old female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified) for prophylaxis. The subject's medical history included celiac sprue and gluten intolerance. The reporter was not aware of any reactions experienced by previous influenza vaccinations other than this reported event. On an unspecified date in 2005 the subject received unspecified dose of Influenza virus vaccine (unknown). In 2005, less than one year after vaccination with Influenza virus vaccine, the subject experienced decreased blood pressure, vomiting, cough, passed out and blood count "changes." The healthcare professional reported on 30 October 2007, that the events occurred 2 years ago. The subject reported to the healthcare professional that the reaction was similar to those reactions she developed following exposure to Gluten. The subject was seen in an emergency room. At the time of reporting the events were resolved. Comment: Passed out was assessed as medically serious by GSK.
pins and needles/tingling all over her body that have not stopped; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (pins and needles/tingling all over her body that have not stopped) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PARAESTHESIA (pins and needles/tingling all over her body that have not stopped). At the time of the report, PARAESTHESIA (pins and needles/tingling all over her body that have not stopped) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: other Other.     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.   Concomitant medication was not provided. Treatment information was not provided.
Arm is mildly sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is mildly sore) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm is mildly sore). At the time of the report, PAIN IN EXTREMITY (Arm is mildly sore) 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.  No treatment information was provided.
mom called stated pt has cried from 830AM to now & is stilll crying;mom to notify PMD now or take child to PMD or ER for eval of poss pertussis rxn;
I20.9 ANGINA, UNSPECIFIED 1/19/2023 ABDOMINAL PAIN J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/18/2023 ABDOMINAL PAIN I20.9 ANGINA, UNSPECIFIED 1/19/2023 ACUTE ON CHRONIC RESPIRATORY FAILURE J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/18/2023 ACUTE ON CHRONIC RESPIRATORY FAILURE
12/30/2021 Started having covid symptoms; headache, body pain, no taste, shortness of breath, fever cough.
Muscle stiffness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Muscle stiffness) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Muscle stiffness). At the time of the report, MUSCULOSKELETAL STIFFNESS (Muscle stiffness) outcome was unknown. 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.   No concomitant medications were reported. No treatment medications were reported.
This spontaneous report as received from a registered nurse refers to a patient of unkonwn age. On 25-APR-2014 the patient was vaccinated with ZOSTAVAX (vial, lot# unspecified), which expired on 22-APR-2014. ZOSTAVAX was supported as per spreadsheet. No adverse effects reported. The outcome was unknown. Additional information has been requested.
Case received from a healthcare professional through the MIS on 11 October 2010 under the local reference number 10-0698. A 32-year-old female patient, with no illness at the time of vaccination, no pre-existing physician-diagnosed allergies or medical conditions, no other medications and no adverse event following prior vaccination, had received her intramuscular dose of ADACEL, batch number U3298CA (C3447) in the left deltoid, her intramuscular dose of TYPHIM VI, batch number D1087-1, in the left deltoid, her dose of IPOL (batch number, route and anatomical site of administration not reported) and her dose of hepatitis A vaccine (manufacturer unknown, batch number, route and anatomical site of administration not reported) on 01 October 2010. On 03 October 2010, i.e. 2 days post-vaccination, the patient developed a red raised scaly patch on her left deltoid. Dry patches also erupted on her stomach, back, few patches. They were also itchy. The patient was seen by a physician. She received BENADRYL. The patient reported any areas being less itchy, but no improvement otherwise. Documents held by sender: none.
Information has been received from a health professional concerning an 8 yr old white female, with no known medical history and no known allergies who on 23Apr98 was vaccinated with a dose of varicella virus vaccine live. On 03Dec05 the pt experienced 30-40 lesion mostly from the waist up with a few on her legs. It was noted that half of the lesions did blister and scab over. At the time of the report the pt was still breaking out in new lesions. It was reported that it was unk if the pt had recovered at this time. The pt was treated with home care. There were no lab or diagnostic tests performed. Medical attention was not sought. Follow up information from a health professional indicated that the pt had no new lesions since 06Dec05 and the pt wanted to go back to school. The pt was reported as recovered on 07Dec05. Additional information is not expected.