chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe and debilitating shingles, including painful abscesses across her scalp and blisters on the inside of her eyelids; ischemia in the lateral wall of the heart; other acute cardiovascular events; severe and debilitating shingles, including painful abscesses across her scalp and blisters on the inside of her eyelids; The pt was vaccinated with Zostavax on or around 14-MAY-2013 and 30-SEP-2013; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not reported. On or around 14-MAY-2013 and 30-SEP-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered severe and debilitating shingles, including painful abscesses across her scalp and blisters on the inside of her eyelids. She also developed ischemia in lateral wall of the heart, as well as other acute cardiovascular events, as a result of zoster vaccine live (ZOSTAVAX). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, injury and extensive medical treatment. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered all events to be disabling. Upon internal review, the events of severe and debilitating shingles including blisters on the inside of her eyelids and ischemia in lateral wall of the heart were determined to be medically significant.
Information has been received from a pharmacist concerning a 66 year old male patient who on 23-MAY-2011, was vaccinated with a dose of ZOSTAVAX (Merck) subcutaneously (lot number 670381/0171AA, Exp: 07-MAY-2012). On 23-MAY-2011, the patient experienced hive-like reaction to ZOSTAVAX (Merck). The reaction was at the injection site and appeared immediately upon injection and looked like a mosquito bite. It was red but there was no itching. The pharmacist reported that the patient "did not mind it at all". The patient did not sought medical attention. No treatment was given for the event. The patient called the pharmacist and said that his arm was fine, the pharmacist had the patient come in so she could look at the injection site and reported that the mosquito bite-like hive was completely resolved. Additional information has been requested.
This is a spontaneous report from a contactable consumer reporting for her father. A male patient of an unspecified age and ethnicity received on the same unspecified date PREVNAR 13, via an unspecified route of administration at 0.5 ml, single and Flu shot, at 1 DF, single both via an unspecified route of administration. The patient medical history and concomitant medications were not reported. The patient experienced double pneumonia, water around his heart, kidney fail and had been sick for over 30 days all on an unspecified date with outcome of not recovered.
This spontaneous report as received from a Registered Nurse refers to unspecified number of patients. The patients was vaccinated with first dose of GARDASIL on an unknown date. The nurse reported that these unspecified number of patients may have received a second dose of GARDASIL late. No adverse event reported. No treatment information was reported. The outcome was unknown. Additional information has been requested.
Pt's bowel ceased working, 12 hours, post vax. Pt had 2 grey, foaming, bubbly stools, then nothing for 17 days. Per doc 197792, patient still suffers from significant intestinal difficulties, food allergies and has developmental delays.
Received 2nd Hep B vaccine on 10/07/02 . On 10/10/02, very large swollen area deltoid region with redness and warmth.
Feeling unwell, dizziness/weakness, muscle pain, and difficulty breathing. Onset of symptoms under 1 hour from time of vaccination. EMS on site monitored patient and later released. No need for additional care or treatment.
Patient admitted to the hospital on 12/9/2021 for evaluation of body aches, restlessness, vomiting, diarrhea, and decreased oral intake secondary to these symptoms.
On 4-27-19, Patient woke up with a very itchy, swollen upper arm.  Very warm to the touch
10/14/2021 #14th day after 2nd vaccine, I started to heart feeling like falling from high rides every few minutes (PACs and PVSs) which I never had before.
Arms were pretty sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   In December 2022, the patient received the 1st dose of Shingles vaccine and Flu vaccine. In December 2022, 1 day after receiving Shingles vaccine and Flu vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine and Flu vaccine.     Additional Information: GSK Receipt Date: 21-DEC-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter had stated that, the he/she had got his/her first shingles and his/her flu shot on the same day, last week and in the next day his/her arms were pretty sore. The reporter had advised that, never take both on the same day. Additional supportive information: Follow-up would not possible as no contact details were available.
no additional AEs; HCP called to report that VARIVAX was administered to 27 year old female patient less than 4 weeks from  administration of first live vaccine, MMR II.; This spontaneous report was received from a pharmacist referred to a 27-year-old female patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On an unknown date in 2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, as prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided). On 18-MAY-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5ml/once, lot #W031812, expiration date not reported, but upon internal validation established as 05-OCT-2024, as prophylaxis (strength, and route of administration were not provided), which was less than 4 weeks from administration of first live vaccine of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (Inappropriate schedule of product administration). There was no additional adverse event (No adverse event).
Headache, Myalgia, SkinRash, Diarrhea, NauseaVomiting, Fatigue, chills, itching at injection site
? Began approximately 12 hours after booster and lasted for 5 days ? Pain in left arm  ? Body aches all over, particularly back and neck ? Joint pain- fingers, hips, shins ? Swollen, painful lymph nodes, particularly under left arm ? Veiny-like, blotchy rash under left arm and breast formed 24 hours after booster ? Severe night sweats for 4 nights (1/4, 1/5, 1/6 and 1/7) ? Nausea ? Loss of appetite ? Fatigue Had to take 3+ days off work; over the counter medicine prescribed by PCP.
Left arm double in size, swollen from shoulder to elbow,  extremely hot to touch and hard,  cellulite appearance.  Appeared 40 hours post injections.
On 6th day after vaccine, child was "not himself" and had fever.  On 4th day, 4/15/08, T 101.9 with vesicles in various stages - some super infected and a left otitis media.
Developed nickel size hive on forearms 5 days after YF shot. Denies any other symptoms. Taking Thuja Occidentalis from accupuncturist.
fever, headache, full-body muscle aches, generalized joint pain, injection-site pain, chills, purple, speckled rash bilateral arms, eczema flare on  left arm around injection site
Patient was admitted to hospital for symptoms of weakness and areflexia consistent for Guillain-Barre Syndrome.
Headache a day after until 36 hours after. Fatigue. Pain in hands. Swollen lymph nodes under arms.   Concern: blood in urine, not UTI
15 days following 2nd vaccination (which had typical yet very strong side effects on me) I suffered an Ischemic Stroke. I had severe nausea, complete loss of balance and numbness in my face and left fingers. It affected the limbic portion of my brain, and as a result, I had no cognitive impairment, nor significant loss of strength in my limbs. As a result, it was not immediately diagnosed as a stroke by EMT medics, however the next morning after admitting myself to the ER, an MRI shoed an acute stroke to my right Pons. It was described as a result of high blood pressure and cholesterol, however I am a relatively active, healthy and fit 55 year old (54 at time of stroke.)
HE DID NOT MOUNT AN ADEQUATE RESPONSE AND MANUFACTURE ANTIBODIES; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included abatacept and methotrexate.  On an unspecified date, the patient did not mount an adequate response and manufacture antibodies because had reason to believe. Consumer was very concerned that patient needs additional protection against covid and would like him to receive additional doses. The action taken with covid-19 vaccine was not applicable. The outcome of he did not mount an adequate response and manufacture antibodies was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000192651; Sender's Comments: V0: 20210915814 -COVID-19 VACCINE- "He did not mount an adequate response and manufacture antibodies". This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
06Jun21 came down with an unusual rash on stomach, face, and to both arms and hands; This is a spontaneous report from a contactable Healthcare professional (patient) reported for herself. A 49-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0179, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 12May2021 at 09:30 am (age at vaccination was 49 years) as 2nd dose, single for COVID-19 immunization. The patient did not have any medical history. The patient had known allergy to adhesive. Concomitant medications were not reported. The patient previously took Tetracycline and experienced allergy. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0170, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 21Apr2021 at 10:00 am (age at vaccination was 49 years) as 1st dose, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 06Jun21, the patient came down with an unusual rash on stomach, face, and arm. Rash spread within a week on stomach, face, and to both arms and hands and was still present. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment with internal steroid, benedryl, and medicated lotion. The event was reported as non-serious. The device date was reported as 16Jun2021. The outcome of the event was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on known drug safety profile and temporal association, there is reasonable possibility of causal association between the event rash and the suspect vaccine BNT162B2.
Ofc. rec'd call from mom stating pt had an adverse reaction to shots given on 8/22/06. MD advised pt to return to the office to assess for treatment, mom refused, stating pt will return to previous MD for care.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient Received the expired vaccine) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.  No Medical History information was reported.On 19-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient Received the expired vaccine). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient Received the expired vaccine) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No Concomitant informations were reported. No Treatment informations were reported.total nine doses were administered from one vial. The vial was initially stored in the refrigerator on 11-NOV-2021. The vial was fist puncture on 18-NOV-2021 at 10 hours. The vial was store in the fridge post puncture and no vial undergone any temperature excursions.
Tongue swollen, but I?m able to breathe, since an hour after getting vaccinated.  Previous to being vaccinated I had minor allergy to pollen where nasal passage swollen, sneezing and throat itches. I was not taking allergy medicine since allergy was previously manageable. Since vaccine dose 1, the allergy symptoms increased.   Since tongue swelling, I have only taken ibuprofen two (2) times.   Tongue is swollen, but has not increased swelling. I am monitoring tongue, nasal passages and throat closely.
Day after vaccines, patient had rash on legs and stomach lasting 1-2 days.  No fever, no other complaints.  Resolved without intervention.
4-5 weeks after the Shingrix (1st shot) vaccine, I started getting double vision. The double vision got worse until I could not drive or work. I went to an Eye doctor who told me I need to go to the Emergency Room. I received a Cat scan at the ER and was then admitted to the hospital to get an MRI and many other tests. The diagnosis is Sixth Nerve Palsy in my right eye. At this time, it has still not corrected itself and I cannot work or drive.  The double vision persists and makes it hard to do anything without covering one eye.
1child recv vax & sibling devel forty lesions starting on 27JAN99;
Patient woke up with debilitating migraine that made her feel as if she could not lift her head. The pain ran from the back of her skull, down into her right shoulder and arm. The migraine lasted from Friday morning until Saturday afternoon.
Patient turned 17 at the beginning of the month. She received the first dose of Moderna vaccine approved for patients 18 and older. Staff did not realize it until after vaccine administration
Information has been received from a health professional concerning a 16 month old patient who on 12-SEP-2005 was vaccinated with a dose of Varivax (Oka/Merck). On 29-JAN-2006 the patient developed chickenpox. Unspecified medical attention was sought. The patient was treated with acyclovir. There was no product quality complaint involved. The patient's chickenpox was considered to be an other important medical event by the reporter. Additional information has been requested.
No other AE.; Caller is a nurse who reports a dose of VARIVAX which expired on 12Aug2022 was given to a patient on 17Sep2022.; This spontaneous report has been received from a nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 17-SEP-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), subcutaneous injection, at a dose of 0.5 milliliters (ml) as prophylaxis(lot number T027300, which has been verified to be valid, expiration date reported and established as 12-AUG-2022)(strength, route of administration, and anatomical site of injection were not reported) plus a sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion (expired product administered).  No additional adverse events were reported.
diaphoresis Narrative:  Patient was clammy and pale and vomited after receiving Moderna Covid-19 vaccine. Patient BP dropped to 70/40 and HR 120. Patient felt dizzy. 2L of oxygen by nasal cannula given. 911 was called and patient taken to hospital and  seen in ER. Patient was discharged from hospital. Patient previously tested positive for COVID-19
Moderna COVID-19 Vaccine EUA  subclavicular lymphadenopathy, left side
Patient reported pain in arm on 10/1/16.  She then returned to pharmacy 10/2/16, and said pain was still present. Pharmacist looked at arm and the arm was red from just under the armpit region to 1 to 2 inches about elbow.  The arm was felt to be warm to the touch. Patient also reported her arm was not moving well.
Blood clots; a pain in leg near right knee; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Baker's cyst (Right knee), Clot blood (in lower leg), and Factor V Leiden mutation.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-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 THROMBOSIS (seriousness criterion medically significant) and PAIN IN EXTREMITY (in leg near right knee). The patient was treated with XARELTO at an unspecified dose and frequency and WARFARIN at an unspecified dose and frequency. At the time of the report, THROMBOSIS and PAIN IN EXTREMITY (in leg near right knee) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  Patient had received a cortisone shot in her knee a month or 2 earlier for Baker's cyst in her right knee.  This case concerns a 80-year-old, female patient with relevant medical history of Baker's cyst, Clot blood, and Factor V Leiden mutation, who experienced the unexpected events of Thrombosis and Pain in extremity. The events occurred on an unknown date after a dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the events of the first dose was disclosed. The patient's medical history of Baker's cyst, Clot blood, and Factor V Leiden mutation remain as confounders for the occurrence of the events. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Case is assessed as Serious since Thrombosis is on the list and the outcome of the events is still unknown.
Right Bundle Branch Heart Block. ECG 11/20 was normal. ECG 5/21 showed RBBB.
Instant twitch in left eye and then numbness in left upper arm/shoulder Started to burn and tingle throughout left side of body including face  10 min later noticed it moving to right side and feeling throat constrict  Fuzzy headed feeling -  Went to ER where Benadryl was administered and a CT ordered  Blood draw and UA  After 2.5 hrs - feeling much better
Day 1, arm was extremely sore in 6" radius around shot spot.  Day 3, arm still sore and red splotches appeared up to 10" from shot spot.  Day 4, soreness and red splotches begin to disappear.
I was 4/5 days pregnant the day the first dose was administered. I was 21 days pregnant the day the second does was administered.  I was supposed to be due December 31st, 2021.   On my 8 week appointment check up; the OB discovered there was no longer a heartbeat they could find for baby. I subsequently went in for a recheck 1 week later ( today) to discover there was still no heartbeat for baby. I was diagnosed as having a misses miscarriage. I was given the same medication that patients receive when they want to have a medical abortion by choice. I will go back to the OB in 10 days to make sure that all of the pregnancy has vacated and the uterus is clear for a new pregnancy.
After 14 days I had a delayed reaction. I developed a triangular shape area in my right arm that was red, warm and very itchy. I saw my PCP and dermatologist who recommended I apply a cortisone cream for the itching. My symptom was resolved within 48 hours.
Starting 11/1/2022, child developed an increasing area of redness around the vaccination site, to 10 x 12 cm circular area with intense redness, warmth, no induration.  This progressed despite starting Amoxicillin for her right otitis media on the same day the redness started. The area was itchy, only painful if prodded. It was treated with a combination of Benadryl orally and topical antibiotic.
This is a spontaneous report from a contactable other healthcare professional. A 71-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on Feb 26, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient previously took the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. Reportedly, she and her husband both had a sore arm for 2 days after the vaccine was administered. She stated she also had a sore arm after her flu shot. She took B12 injections every 30 days. She wondered if it would be safe for her to take the B12 injections before the vaccine or if should she wait. She wanted to know if it was ok to take pain/fever reducing medication after receiving the Pfizer vaccine. The outcome of the event: unknown. Follow-up attempts completed. No further information expected.