chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot# and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2007, a healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2009, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, 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 include 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. Additional information has been requested.
Post vax, leg became numb. 2 days later, felt numbness around chest down to lower extremeties. Numbness of chest and fingers still 80%. Legs and feet gone.
Swollen armpit, pain in bicep and forearm, pain and tightness in inner bicep down to left thumb
1/29: sore Left arm 1/30: rash on Left arm 2/1: rash on Left arm improved, sore armpit 2/2: rash on left armpit with itchiness
I developed a sore arm and overall was tired late on the day of the vaccination and all during the day after the vaccine.  About 48 hours after vaccination, my arm became red, warm and inflamed at the infection site.  Over the next 3-4 days, the irritation subsided.  However, the irritation at the injection site was more pronounced than expected.  Thankfully, I am fine now.
Arm redness and pain, fever and diaphoresis, body aches and weakness, palpitations.
I am having like severe chest pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unspecified date as single dose for COVID-19 immunization. The patient got the second dose of Covid vaccine and the patient was having like severe chest pain on an unspecified date. The outcome of the event was unknown.    Information on the lot/batch number has been requested.
7/24/11 PM: Patient was uncomfortable sleeping. Had stomach discomfort/cramps. 7/26/11: Patient noticed Rash around Right Breast and on Right side of Back.
covd positive , sob and cough x 2 weeks as of 4/11/22
6 cm x 5 cm diam red, swollen, tender area around vaccine site (L) ant thigh with 1 cm, sl. tender inguinal node.
PATIENT WAS ADMINSITERED 0.25CC BOOSTER DOSE OF MODERNA AT 10:30AM BUT PATIENT WAS DUE FOR HER 2ND DOSE MODERNA. PATIENT RETURNED AT 2:50PM TO GET ANOTHER DOSE OF 0.25CC MODERNA DOSE. EACH DOSE GIVEN TO EACH ARM.
Symptoms of fever (Tmax 102.9), diarrhea, and altered mental status started ~ 24 hours after vaccination.  No evidence of septicemia with negative blood cultures Minimal improvement over 3 days, transferred to tertiary care center for MRI brain after which LP was recommended. However family declined as intubation would have been required and was not consistent with patient's goals of care.
rash all over body; woke up @ 3AM screaming, high pitched crying lasting approx 3 hrs;
Pain in my arm increased over next 3 hours, became hard to move, then by 6pm, I could not move it at all, and in next couple hours, it got excruciating, like it was being sawed off.  I couldn?t get comfortable, didn't sleep. I got a throbbing headache, sweats, nausea, and chills. I was in tears for hours, biting down on a towel to mute my screams. Next day, pain diminished, but upper R arm was still paralyzed from elbow to shoulder area.
big hard red spot on injection site; big hard red spot on injection site; sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (big hard red spot on injection site), AXILLARY PAIN (sore arm), FATIGUE (fatigue) and VACCINATION SITE INDURATION (big hard red spot on injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Leukemia (Patient was treated for Leukemia) in November 2020.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On 23-Jan-2021, the patient experienced AXILLARY PAIN (sore arm) and FATIGUE (fatigue). On 07-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (big hard red spot on injection site) and VACCINATION SITE INDURATION (big hard red spot on injection site). The patient was treated with CORTISONE at an unspecified dose and frequency.   On 09-Feb-2021, VACCINATION SITE ERYTHEMA (big hard red spot on injection site) and VACCINATION SITE INDURATION (big hard red spot on injection site) had resolved. At the time of the report, AXILLARY PAIN (sore arm) and FATIGUE (fatigue) had not resolved.      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.
Went into hospital fell due to black out and hit head. Myocarditis. Also ,extreme dehydration.
Asthma seemed to be worse after getting vaccine 1st dose.  Extreme wheezing and need to use rescue inhaler with increased frequency.  Symptoms improved after about 6 hours and slowly returning to normal asthma condition.  Concerned if this is related to vaccine or just coincidence and risk of getting second vaccine dose.
Information has been received from a pharmacist referring to a 92 year old female patient with diabetes, only one kidney, and was allergic to unspecified SULFA products, iodine and penicillin. The patient had previous history of shingles. On 03-SEP-2015 the patient was vaccinated with ZOSTAVAX, lot # K026365, expiry date 15-MAR-2016, 0.65 ml, subcutaneous. Concomitant therapies included insulin, unspecified gout medication, and "other" unspecified medications. The pharmacist reported that the patient developed an "itchy" unspecified rash on her "waist area" after receiving ZOSTAVAX on 14-SEP-2015. No treatment was given for the event. None lab diagnostics studies were performed. The outcome of the event was reported as not recovered. The patient had called the pharmacist on the reporting day to report the event. Additional information has been requested.
Client presented to the vaccination site on 02/25/22 for booster dose of Moderna COVID vaccine. The client reported that he was diagnosed with possible pericarditis in December of 2021. Clients 2nd dose of Moderna COVID vaccine was on 05/13/2021. Lead RN submitted a medical consult via text message to Clinical Project Coordinators requesting to proceed with COVID vaccine Moderna booster dose. Per MD, approval to proceed with booster dose of Moderna COVID vaccine was obtained from medical consult team via text message from Clinical Project Coordinator. Client received booster dose of COVID vaccine Moderna Lot # 025L21B. The client did not report any symptoms during the 15 minute observation period. Nurse Lead educated client on possible adverse  reactions, when to seek medical care. The client left the vaccination site at approximately 1226 with a steady gait.
ARM SiTE injected SWELLS & TAPE IRRATES Skin AS SWELLING CONTiues -pain AT SiTE INCREASES. SweLLing MOVES DOWN The ARM TO ELBOW. LARGE Hive COVERS ARM MuscLE & Begin To TAKE Bendryl 25mg EVERy 2HRS. ARM iTches so I Apply itch CREAM CONTIUE TREATMENT FOR 4 days. Swelling &hive SLowly ResoLVE AFTER A week OF TREATMENT.
Initial report received from health care professional on 01 Dec 2009: This child who was 2 years old was inadvertently vaccinated with FLUVIRIN 0.5 ml, intramuscular, on unknown date. No adverse effects were noted after administration. The outcome of event was not reported.
I couldn't stand, I was weak, I had no strength; heartburn; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (I couldn't stand, I was weak, I had no strength) and DYSPEPSIA (heartburn) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L28A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced ASTHENIA (I couldn't stand, I was weak, I had no strength) and DYSPEPSIA (heartburn). At the time of the report, ASTHENIA (I couldn't stand, I was weak, I had no strength) and DYSPEPSIA (heartburn) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication not reported.   2nd dose on 25Feb2021 Lot 004M20A, 3rd dose on 09Dec2021 Lot 033F21A, 4th dose on 05Apr2022 Lot 002M21A.  18 minutes after 1st Moderna vaccine patient was not able to stand, she was weak, no strength and this was frightening because she was healthy before this. The Medical team checked her, her heart was fine, and they gave her orange juice and after 3 containers of orange juice, she developed heartburn and told them to stop. After a 1 hour, she tried to stand and with the help of her husband and a medical staff, she did. She left and went home. She contacted her doctor, and doctor told her to hydrate a lot before going.  Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-746992 (Patient Link).
achy back and body; slept through the night; swelling and warmth on the left deltoid; Chills; Fever 100.7; chills; swelling and warmth on the left deltoid; right arm was achy and achy all over; A spontaneous report was received from a consumer concerning a 64-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swelling and warmth on the left deltoid, right arm was achy and achy all over, chills, fever 100.7, slept through the night, achy back and body.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the events swelling and warmth on the left deltoid, right arm was achy and achy all over, chills, fever 100.7. On 19 Feb 2021, the patient experienced the events slept through the night. On an unknown date, the patient experienced the events achy back and body.She wanted to know if these side effects we normal.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, swelling and warmth on the left deltoid, right arm was achy and achy all over, chills, fever 100, 7, slept through the night, achy back and body was unknown.
On 4/27/2021 developed nasal congestion and sore throat.   Tested positive for COVID.
This female subject was enrolled in a study. On October 2008 and November 13 2008, she received the 1st and 2nd dose of THIMEROSAL free, FLUARIX or FLUZONE. This subject received FLUARIX 0.5ml. On 30 November 2008, 17 days after the 2nd dose of blinded vaccine, this eight-month-old subject developed cyanosis and apnea. The subject was hospitalised. The events resolved on 30 November 2008. The investigator considered that there was a reasonable possibility that the apnea and cyanosis may have been caused by investigational vaccine and that the events were possibly due to suspected gastroesophageal reflux (not proven). Investigator comments: Subject is an 8 month old female who entered the study on 8 October 2008. On 30 November 2008, 17 days after receiving the 2nd dose of study vaccine, the subject was admitted into the hospital due to an episode of apnea with cyanosis. As per mother, the subject has not had any previous occurrence of apnea. However, she reported that the subject has had a cough, congestion and Rhinorrhea on the day of the event. On admission, the subject was not in acute distress. Oxygen saturation was 99 %. Heart sounds had regular rate and rhythm. On lung examination, coarse breath sounds were heard. CBC, electrolytes and urinalysis results were within normal limits. CXR was done and showed no acute disease. Pneumogram study was done and was normal. No other episodes of apnea were observed while admitted. Subject was discharged after 3 days. Investigator believes there is a possibility that event is related to study vaccine. Other possible causes of event include gastroesophageal reflux (not proven).
BLOOD CLOT LIKE SYMPTOMS; This spontaneous report received from a health care professional via other manufacturer (Moderna) concerned an adult patient of unspecified sex, age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802072 expiry: unknown) dose was not reported, 1 total administered on 25-MAR-2021 for covid-19 prophylaxis. No concomitant medications were reported.  On an unspecified date in 2021, the patient experienced blood clot like symptoms (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot like symptoms was not reported. The patient additionally received booster dose of non-company vaccine included: Moderna covid-19 Vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on 01-NOV-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with Moderna covid-19 Vaccine (elasomeran) (dose number in series 2). This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230314384-blood clot like symptoms. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Patient had syncopal event; transient low blood pressure; sweaty and spontaneous urination.
Approximately 15 minutes post injection, experienced hot flash and elevated BP 184/97. Was monitored before release for over an hour, and was given water and juice.  2 days post vaccination experienced tightness in chest, abdominal pain, headache, difficulty breathing, pain/swelling in underarm of left /arm, body aches. - Was seen by doctor on 12/07/2022, told to continue Tylenol, and drink plenty of water and continue to rest. That side effects can take some time to resolve.  Continued issues with swelling and pain under left arm and on the left side groin and down the left leg. Increased bloating and pain across abdomen, and new pain/pressure in the left eye. Was seen at urgent care on 12/19/2022. Eye pressure in right eye 11 left eye 17. Was told to follow up with Opthalmologist. Appt. set for 12/21/2022. and that swelling/pain reaction post vaccine can last weeks.
After I received the vaccine I was okay for a few days but then I started to have shortness of breath and went to the doctor and had an EKG done. But there was nothing shown on the results. I then ended up going to the doctor about a week later and they did a chest xray and an ultrasound. Nothing came from both tests. I still have chest pain and it has gotten worse since I tested positive with Covid.
Information has been received from a registered nurse concerning a female adult coworker with sulfamethoxazole (+) trimethoprim (Bactrim) and enverionmental allergies and a history of varicella who may have had varicella virus vaccine live splashed into her eye. Unspecified medical attention was sough. A product quality complaint was not involved. Follow-up information from the consumer who is a registered nurse indicated that on 12-Aug-2003 between 3:45 and 4:00 pm she was vaccinated a 10 year girl with the varicella virus vaccine live SC in the right deltoid. When the safety syringe was activated "spray" hit the nurse in the forehead. She then washed her forehead with soap and water. Approximately 30 minutes later, her eyes became irritated, the left greater that the right. She then flushed her eye with water for about 1 minute. Her eyes were somewhat itchy. Approximately 2 hours later she flushed her eyes again and the itchiness improved. On 13-Aug-2003, the patient was seen by a physician and an eye exam was done. The diagnosis was irritation to both eyes due to exposure to chemical. It was noted that her condition was stable. Her treatment included artificial tears supplement qid and polyehtylene glycol (+) propylene glycol (SUSTANE) 1 drop to both eyes qid for 2-3 days. Subsequently the patient recovered. No further information is expected.
Hives 3-4 hours after flu shot initially noted surrounding flu shot but spread diffusely. Pt presented to ER due to symptoms. No difficulty breathing or facial swelling.
HCW Came to HCF on 08/27/2021 around 0800am and received Pfizer Covid-19 vaccine, which was her first dose. on 08/28/2021 around 1900, Hcw noticed red spots on  bilateral lower extremity ( the thighs and the legs).Redness to the lower extremity is improving at this time. On 08/30/2021 around 0600am Hcw experienced itchiness  on the bilateral arms and hand which lasted for 24 hours.  Treatment:  On 08/30/2021, Hcw took Benadryl  50 mg   by mouth   one time 0utcome: On 08/31/2021 itchiness was gone , redness is improving
I recieved the moderna covid vaccine.  I ate a few things that just tasted a little off.  I thought the product may have just been bad.  For instance, a few candies in a pack had a bitter aftertaste.  Tortilla chips and corn chips had an off aftertaste.  It is generally subtle for most items but certain things are more noticable.  I asked others if the things that tasted different to me tasted different to them and they said it tasted normal.  This has continued for about 3 weeks at this point.  Last year I had a presumed case of covid where I completely lost taste and smell for 10 days.  This is very different in that I can still taste, it just seems that my taste buds have changed and it is persistent thus far.
Stiffness in my neck; Was achy; Had pain on both sides of neck, maybe that was lymph nodes; Felt heat in my chest; Felt achiness in my chest; Achiness in my back; Achiness in my rib cage.; Mildly sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Mildly sore arm), NECK PAIN (Had pain on both sides of neck, maybe that was lymph nodes), CHEST DISCOMFORT (Felt heat in my chest), CHEST PAIN (Felt achiness in my chest) and BACK PAIN (Achiness in my back) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 024M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Mildly sore arm). On 23-Nov-2021, the patient experienced NECK PAIN (Had pain on both sides of neck, maybe that was lymph nodes), CHEST DISCOMFORT (Felt heat in my chest), CHEST PAIN (Felt achiness in my chest), BACK PAIN (Achiness in my back) and MUSCULOSKELETAL CHEST PAIN (Achiness in my rib cage.). On 06-Dec-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness in my neck) and PAIN (Was achy). At the time of the report, PAIN IN EXTREMITY (Mildly sore arm), NECK PAIN (Had pain on both sides of neck, maybe that was lymph nodes), CHEST DISCOMFORT (Felt heat in my chest), CHEST PAIN (Felt achiness in my chest), BACK PAIN (Achiness in my back), MUSCULOSKELETAL CHEST PAIN (Achiness in my rib cage.), MUSCULOSKELETAL STIFFNESS (Stiffness in my neck) and PAIN (Was achy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-405428, MOD-2021-405481 (Patient Link).
Patient vaccinated x4 (3/4/21, 3/25/21, 10/7/21, 5/3/22) Patient admitted to hospital and tested COVID+ on 10/30/2022
This spontaneous report was received from a physician refers to a 77 year old male patient with penicillin allergy (caused hives). The patient's medical history included a heart disease. On 18-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry not reported). Other suspect therapies included influenza virus vaccine (Manufacturer unknown). Concomitant therapies included atenolol 25mg/once daily and LIPITOR, 20 mg/once daily. On 19-SEP-2013, the patient experienced vertigo after receiving ZOSTAVAX and influenza virus vaccine (Manufacturer unknown). Patient sought medical attention. Patient received ANTIVERT 25 mg/once daily as treatment. An unspecified test was performed that determined he had vertigo. The outcome of vertigo was reported as not recovered. This is one of 2 reports received from same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with 0.5 ml dose of VARIVAX (Merck), subcutaneous (lot # and expiration date were not provided) that underwent temperature excursion. No adverse experience reported. This is one of the several reports from the same reporter. Additional information has been requested.
Pt had a seizure 6 days after MMR was given. No previous neuro history.
Headache, Chills w/skin feeling like it was stinging, felt tired and achy all over
first headache then nausea then 3 days after had chest pain and elevated troponins.  Is being admitted for ECHO and serial troponins
Patient started complaining of cold sweats, chills, and sweating. She states she suffers from anxiety and thinks she is having an attack. Patient then escorted to the post vaccination area and asked to remove jacket, and given water. After 10 mins of observation she states she is feeling better. Patient then escorted to her car without any incident
Patient received flu vaccine around 5pm and called the pharmacy at 8pm to report a severe headache localized to the top of the head. Patient took 400mg of ibuprofen and then called the pharmacy.