chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around JANUARY 2017, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for its intended purpose:  the prevention of shingles. Shortly after receiving ZOSTAVAX, the patient suffered Herpes simplex keratitis and vision loss. As a direct and proximate result of ZOSTVAX, the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his (Conflicting information, as patient is reported as a female (female name)) condition. As a result of 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 and injury. As a direct and proximate result of ZOSTAVAX, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The reporter considered the events to be related to ZOSTAVAX. Upon internal review, Herpes simplex keratitis and vision loss were determined to be medically significant events. The events of Herpes simplex keratitis and vision loss were considered to be disabling. Additional information has been requested.
shingles; rash genr; blster on his left cheek bone and by the corner of his left eye and in his left ear canal; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included feeling bad, headache, fever, pain and hives.   On 23rd November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, couple of days after receiving Shingrix, the patient experienced shingles, rash and blister. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles, rash and blister were unknown.   The reporter considered the shingles, rash and blister to be unrelated to Shingrix.  Additional details were received as follows: The patient reported that he started to feel bad a couple of days before getting his first dose of shingrix.  The patient had headache and felt feverish and also had some pain in the top of his head at the crown and some markings that looked like hives on his left cheek. The patient after vaccination experienced  rash progressed and he developed blisters on his left cheek bone and by the corner of his left eye and in his left ear canal. The rash was also at the top, bottom and behind his left ear.  The patient was confident that the vaccine did not cause the shingles.   The patient stated that he waited too long to get treatment and it just progressed after receiving the shot. The patient did not consent to follow up.
Pt did not seroprotect after 3rd hepta B vax on 02May90.  Recv 4th dose 25Sep90 & titer indicated pt seroprotected.
Red streaks over the shoulder and under the arm. Very painful and sensitive. Injection site itself was okay.
WOKE UP DRENCHED IN SWEAT; DIARRHEA; my heart felt like it was coming out of my chest and my heart rate was 162bpm for few hours; Tachycardia; FELT VERY FATIGUED / WOKE UP VERY TIRED; pounding headache; Nausea; chills; Vomiting; fever of 102.8°F; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (WOKE UP DRENCHED IN SWEAT), DIARRHOEA (DIARRHEA), HEART RATE INCREASED (my heart felt like it was coming out of my chest and my heart rate was 162bpm for few hours), TACHYCARDIA (Tachycardia) and FATIGUE (FELT VERY FATIGUED / WOKE UP VERY TIRED) in a 67-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 Surgery (cardiac stents), Asthma on 26-Jan-1999 and COVID-19 on 30-Mar-2021. Concomitant products included ALBUTEROL [SALBUTAMOL] from 26-Jan-1999 to an unknown date and FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) from 08-Apr-2000 to an unknown date for Asthma, CHLORTHALIDONE from 03-Mar-2021 to an unknown date for Hypertension, LEVOTHYROXINE from 14-Dec-2020 to an unknown date for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced HYPERHIDROSIS (WOKE UP DRENCHED IN SWEAT), DIARRHOEA (DIARRHEA), HEART RATE INCREASED (my heart felt like it was coming out of my chest and my heart rate was 162bpm for few hours), TACHYCARDIA (Tachycardia), FATIGUE (FELT VERY FATIGUED / WOKE UP VERY TIRED), HEADACHE (pounding headache), NAUSEA (Nausea), CHILLS (chills), VOMITING (Vomiting) and PYREXIA (fever of 102.8°F). The patient was treated with RIVAROXABAN (XARELTO) (oral) ongoing from 09-Mar-2021 at a dose of 20 mg. On 11-Apr-2021, NAUSEA (Nausea) outcome was unknown. At the time of the report, HYPERHIDROSIS (WOKE UP DRENCHED IN SWEAT), DIARRHOEA (DIARRHEA), HEART RATE INCREASED (my heart felt like it was coming out of my chest and my heart rate was 162bpm for few hours), TACHYCARDIA (Tachycardia), FATIGUE (FELT VERY FATIGUED / WOKE UP VERY TIRED), HEADACHE (pounding headache), CHILLS (chills), VOMITING (Vomiting) and PYREXIA (fever of 102.8°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Body temperature: 102.8 f (Inconclusive) 102.8 F. On 10-Apr-2021, Heart rate: 162 bpm (Inconclusive) 162 BPM. On 11-Apr-2021, Body temperature: 102. f (Inconclusive) 102. F and 99 f (Inconclusive) 99 F. On 11-Apr-2021, Heart rate: 100-110 bpm (Inconclusive) 162 BPM.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment includes Zeralto.   This case was linked to MOD-2021-079161 (E2B Linked Report). This case was linked to MOD-2021-079161 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: follow up received on 26 May 2021. Events are added, concomitant medication information added; Sender's Comments:  MOD-2021-079161:Husband's case
Temp up to 101 x 3 days following immunizations. Lethargy, headache, body aches, generalized malaise, sore throat.
Shortly p/child left clinic, started vomiting & had laboured breathing; Seen by ER MD said child had URI unrelated to vax;
Patient received PNEUMOVAX 23 on 12-JUL-2023 and reported left upper extremity paresthesia on 14-JUL-2023.; This spontaneous report was received from a physician and refers to a 67-year-old female patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 12-JUL-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 1 dose, administered for pneumonia vaccination (prophylaxis) (strength, dose, lot #, expiry date, and route of administration were not provided).  On 14-JUL-2023, the patient experienced left upper extremity paresthesia (paresthesia). At the time of reporting, the patient had not recovered from the event.   The reporter considered the event paresthesia to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
A non-serious spontaneous report of inadvertently administered second dose of H1N1, Intranasal was received from a physician concerning a 35-year-old male. The patient received first dose of H1N1 vaccine on 28-Oct-2009. On 11-Nov-2009, the physician inadvertently administered second dose of same vaccine thinking that it was FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
DM; HF; HTN; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US093754_OS (Company).  A 54-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 01, Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "DM"; CARDIAC FAILURE (medically significant), outcome "unknown", described as "HF"; HYPERTENSION (non-serious), outcome "unknown", described as "HTN". Clinical course was reported as, Patient believes he had HF/HTN/DM from 2nd COVID-19 Vaccine. . No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sore Arm; This is a spontaneous report from a contactable consumer (patient himself). A 42-year-old male patient received bnt162b2 (BNT162B2) via an unspecified routes of administration, administered in left arm (at the age of 42 years old); on 10Mar2021 at 13:30 (Batch/Lot Number: EL3247) as 1st dose, single dose, then on 31Mar2021 at 13:45 (Batch/Lot Number: EP6955) as 2nd dose, single dose; both for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and he was not tested for COVID post-vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 10Mar2021 at 14:00, it was reported that the patient experienced sore arm. The patient also experienced sore arm on 31Mar2021 at 13:45. The patient did not receive a treatment for the adverse event. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Patient having side effects from second Covid Shot; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Patient having side effects from second Covid Shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient having side effects from second Covid Shot). At the time of the report, VACCINATION COMPLICATION (Patient having side effects from second Covid Shot) outcome was unknown. Vaccination adverse reaction      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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up Information contains No NewInformation.
Narrative: One week later had redness and itchiness at injection site redness & itchiness at injection site on week later
BODY PAIN; HEART PALPITATIONS; VAGINAL BLEEDING; FEVER; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies and was not taking any medications. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 27A21A, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced body pain. On 15-MAY-2021, the subject experienced heart palpitations. On 15-MAY-2021, the subject experienced vaginal bleeding. On 15-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, body pain, heart palpitations, and vaginal bleeding. This report was non-serious.
"Uncomfortable feeling" in right armpit area. Hurts with coughing, laying on side, and reaching.
Bruises to bilateral thighs and buttocks with no history of trauma.  Ongoing leg pain although bruising is resolving
Rash/hives over entire body, including mouth. Unbearable itching and swelling for about two weeks.
Throbbing, non-stop, migraine headaches with no relief, I pray this is temporary.
Patient presented at ER with c/o SOB and hives. She stated she started having hives/vasculitis afternoon 11/27-Now processed large areas of vasculitis, legs back, arms. Large local reaction (L) upper arm.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer (patient's spouse) via company representative concerned a male of an unspecified age, race, and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered on an unspecified date in MAR-2021 (reported as approximately 14-MAR-2021) for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 26-SEP-2021, the patient had PCR test (polymerase chain reaction test) which revealed a confirmed breakthrough infection (confirmed clinical vaccination failure and confirmed covid-19 infection). It was reported that currently, the patient had mild case with reoccurring fever and minimal congestion. The patient was quarantine at home and had contacted his physician for any additional or needed monitoring. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).  This report was associated with RA: 90000194837; Sender's Comments: V0 20210953404-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS.
Information has been received from a 53 year old female licensed practical nurse with allergies to CECLOR, morphine, DEMEROL, codeine, and TEQUIN who on 19 Oct 2006 vaccinated a patient with a dose of VARIVAX (Merck). The next day, the nurse developed a large blister like rash in her mouth which was subsequently diagnosed by an oral surgeon as herpes zoster in the roof of her mouth. This was the very first dose of vaccine the nurse ever administered to a patient. The nurse's rash has improved but her present status was unknown. A product quality complaint was not involved. Additional information has been received from the nurse who reported that on 19 Oct 2006 she administered a dose of varicella zoster virus vaccine live to a patient. The next day, on 20 Oct 2006, her front teeth began to hurt. The day after that, on 21 Oct 2006, shingles lesions erupted on the right side of the roof of her mouth. She was also exposed to an active shingles patient on 18 Oct 2006. She was placed on FAMVIR 150 mg for eight days and pain medications. The patient recovered after nine days, on 29 Oct 2006. Follow up information: It was also reported that the patient experienced an adverse experience following vaccination of VARIVAX (Oka/Merck) (WAES# 0709USA00291). Additional information is expected.
Swelling at arm site for 10 days with radiating pain into left chest wall, heart palpitations, loss of taste and smell, and hair started falling out in clumps
An unidentifiable amount of vaccine went down my arm, and I believe it was over 1/2 the dose. I was instructed to make a report to see whether or not I should get another dose immediately. This is what I was advised to do. I am a high risk individual with doctors note of approval.
Respiratory infection; Got sick there; Tested again 5/17 this time Positive; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RESPIRATORY TRACT INFECTION (Respiratory infection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested again 5/17 this time Positive). On an unknown date, the patient experienced RESPIRATORY TRACT INFECTION (Respiratory infection) (seriousness criterion medically significant) and ILLNESS (Got sick there). At the time of the report, RESPIRATORY TRACT INFECTION (Respiratory infection), ILLNESS (Got sick there) and SARS-COV-2 TEST POSITIVE (Tested again 5/17 this time Positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2021, SARS-CoV-2 test: negative (Negative) Negative. On 17-May-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications was not provided/ unknown. Text:  AE submitted via social media: "I received 2 Moderna vaccines, 2/14 and 3/14. I traveled to another country 5/5 and got sick there (respiratory infection). Got Covid tested there 5/15, which was negative. (Antigen test). Tested again 5/17, this time Positive! Received Re" "Seems that my body did not produce enough antibodies to prevent infection. C I get re-vaccinated or would that even help?"   Treatment information was provided/ unknown.  Company Comment: Limited information regarding the reported sick / respiratory infection has been provided at this time and a causal relationship cannot be excluded.  The positive test for Covid-19 is unlikely related to the previous administration Moderna vaccine.; Sender's Comments: Limited information regarding the reported sick / respiratory infection has been provided at this time and a causal relationship cannot be excluded.  The positive test for Covid-19 is unlikely related to the previous administration Moderna vaccine
Pt recvd 3 doses of Engerix-B vax & did not convert;
arm was hurting a lot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was hurting a lot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History was provided.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METOPROLOL, RALOXIFENE and SPIRONOLACTONE for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was hurting a lot). At the time of the report, PAIN IN EXTREMITY (arm was hurting a lot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Treatment Medications were provided.   This case was linked to MOD-2021-291651 (Patient Link).
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Medium
Fever to 99.9  total body ache of muscles from 3 hours following shots of both flu and pneumonia  on 10/11/07 to 5:00 am 10/13/07. Wife who had just flu shot felt none of these sysmptoms.
Patient passed out briefly in RPH arms, came to but was weary. Patient stopped responding for a moment.  EPI was administered. EMS took patient away.
Initial misuse report received from a health care professional on 05 February 2014. Inadvertently administered intradermal 0.3 ml fifth dose of DAPTACEL to a patient. (No information was provided regarding the patient) thinking it was the TB skin test syringe on an unspecified date.  No adverse event was reported. List of documents held by sender: none
Pt reported a reaction that developed days after receiving the vaccine.  She said she had a reaction on her arm, leg, and back.  She did not report any swelling.  She took a picture of it and I didn't see any redness, but it looked like there were some bumps that developed on her arm.  It may have been more than a week after getting the vaccine and she is not sure the vaccine actually caused that reaction.  I made the decision to counsel her on signs and symptoms of anaphylaxis reactions and to seek medical attention if needed and gave the second dose.  I saw her mother 5 days after she got the second dose.  Her mother said she hasn't had any reaction to the second dose.
Patient at primary care provider's office on 2/13/21 for workup before planned intervention for PVD.  Lab results from 2/12 blood draw showed platelets=15k.  Unexpected thrombocytopenia.  Patient had NOT had URTI/cold/flu symptoms.  No bleeding.  No blood in stool. No tarry-black stools.  No fever or chills.  No headache.  Provider sent patient immediately to the emergency room for a repeat CBC.  Platelets=3k (1 day after the result of 15k).  Patient admitted to hospital.   Hematologist consulted.  Dexamethasone 40 mg po q day prescribed (to take 2/13-2/17).     Discharged from hospital 2/15 as platelets had risen to 21k.  Expected follow up with hematologist (Dr.) within a few days.
The pt developed ankle pain and swelling, erythema nodosum, hives on legs and inside elbows and a mild sore throat which occurred at the end of November.
Information has been received from a store manager concerning a female patient who on 12-NOV-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot #663198/1419X). In November 2008, the patient sought medical attention. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
Severe back pain and shooting pain down both legs beginning on 4/2/21 Severe shoulder pain beginning on 4/2/21 Migraine headache beginning on 4/5/21 uncontrolled by medication Loss of facial muscle use on 4/7/21. Went to emergency room on 4/7/21 Conditions treated: facial nerve palsy likely in the setting of Johnson and Johnson COVID vaccine, elevated CSF protein, headache, unspecified, parenthesis of hand