chrisvoncsefalvay/vaers-outcomes huggingface dataset:
zoster related eyes injuries; zoster related eyes injuries; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported). At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Alternatively, in 2014, the patient's healthcare providers included but not limited to a healthcare provider, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects. On an unknown date, reported as subsequent to the vaccination, the patient was treated for zoster related eyes injuries. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of herpes zoster and eye injury was not recovered. The reporter considered herpes zoster and eye injury to be related to zoster vaccine live (ZOSTAVAX).
Booster dose; Got a temperature of a 103; It caused me not to go to the bathroom and I just did not/ I wasn't peeing; My sodium had gone much too low; I was dehydrated/ High temperature was using up all the liquid in my body; I suddenly gained 10 pounds; Constipation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received bnt162b2 (BNT162B2), administration date 11Nov2021 (Lot number: 32030BD) at the age of 83 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Lupus" (unspecified if ongoing), notes: not taking any medication for that; "heart condition" (unspecified if ongoing), notes: have a heart condition and is taking 'Norpace'. Concomitant medication(s) included: NORPACE taken for cardiac disorder. Vaccination history included: Covid-19 vaccine (Dose:01, Unknown manufacturer, unknown lot number), for Covid-19 immunization; Covid-19 vaccine (Dose:02, Unknown manufacturer, unknown lot number), for Covid-19 immunization. No any prior vaccinations. The following information was reported: PYREXIA (hospitalization) with onset 2021, outcome "unknown", described as "Got a temperature of a 103"; URINE OUTPUT DECREASED (hospitalization) with onset 2021, outcome "unknown", described as "It caused me not to go to the bathroom and I just did not/ I wasn't peeing"; BLOOD SODIUM DECREASED with onset 2021, outcome "unknown", described as "My sodium had gone much too low"; DEHYDRATION with onset 2021, outcome "unknown", described as "I was dehydrated/ High temperature was using up all the liquid in my body"; WEIGHT INCREASED with onset 2021, outcome "unknown", described as "I suddenly gained 10 pounds"; CONSTIPATION with onset 2021, outcome "unknown", described as "Constipation". The patient was hospitalized for pyrexia, urine output decreased (start date: 17Nov2021, discharge date: 18Nov2021, hospitalization duration: 1 day(s)). The events "got a temperature of a 103" and "it caused me not to go to the bathroom and I just did not/ I wasn't peeing" were evaluated at the emergency room visit. Additional infomation: Consumer stated that she had an adverse reaction to the Pfizer booster shot and they sent her to the hospital twice and she wants to report it.". Vaccine name: Pfizer Covid-19 Vaccine. Weight: Consumer stated, her weight is 94 or 95 pounds. When further confirmed if discharged date is 18Nov2021, consumer stated that she think so. Treatment: Consumer stated, "The first time, they gave me, I was dehydrated, the high temperature was using up all the liquid in my body and so, they told me to take Tylenol. The patient underwent the following laboratory tests and procedures: blood sodium: (2021) too low, notes: sodium had gone much too low; body temperature: (2021) 103, notes: high; investigation: (2021) unknown results; weight increased: (2021) 10, notes: pounds. Therapeutic measures were taken as a result of pyrexia, treatment included Tylenol.
No appetite; Slept and slept; Achy; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (No appetite), SOMNOLENCE (Slept and slept), MYALGIA (Achy) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Thyroid disorder NOS. Concomitant products included ATENOLOL and LOSARTAN for Blood pressure, LEVOTHYROXINE for Thyroid disorder.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced DECREASED APPETITE (No appetite), SOMNOLENCE (Slept and slept), MYALGIA (Achy) and PYREXIA (Fever). On 22-Apr-2021, DECREASED APPETITE (No appetite), SOMNOLENCE (Slept and slept), MYALGIA (Achy) and PYREXIA (Fever) had resolved.
This spontaneous case reported by a consumer, describes the occurrence of memory impairment in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 6, 2021, patient experienced memory impairment. At the time of the report, memory impairment outcome: unknown.  No concomitant medications or treatment information reported.
Patient felt cold and very weak. His wife called 911 and was taken to the hospital. Blood pressure and blood glucose were elevated.
I woke up at 6AM  the day after the vaccine with a fever (101), aches and pain, and a headache very much like the flu. These symptoms lasted approximately 36 hours and then subsided, around 2 PM the same day of the symptoms I noticed a warm red rash the size of a large avocado at the injection site which lasted almost 60 hours.
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 30-APR-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician at a physician office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
herpes-zoster like rash @ site of administration of varicella vax 7 wks p/vax;
Developed pain in left breast and underarm.  Lasted approximately 5-6 weeks.  Followed up with mammogram which was negative but did show enlarged lymph nodes on left side.
This spontaneous report was received from a nurse practitioner via a sales representative concerning her grandchild (gender and age was not provided), who on an unknown date was vaccinated with a dose of VARIVAX (Merck) (route, dose, lot number and expiration date were not provided). No other co-suspects were reported. No concomitant medications were reported. The nurse stated that her grandchild experienced rash after receiving the vaccine and was given unspecified antiviral treatment for the event. At the time of the report, the patient's outcome was not provided. Additional information has been requested.
About 12 hours after receiving the vaccine, I had chills, body aches, and a fever of about 100 degrees. That lasted about 12 hours. The next day my left arm was sore. 5 days after that I developed hives. I had the covid arm with a rash and sore shoulder and arm. It was also itchy. That lasted for about 3 and a half weeks. I called the doctor and asked if I should do anything for it besides taking Zyrtec and he told to take more Zyrtec. After about a week it went away. Then I ended up with upper gastrointestinal pain. By that time the hives were resolving. I went to an urgent care. They thought I had a gastric ulcer. They changed my diet and put me on famotidine. I still have the gastrointestinal pain, but it's  just a little bit better.
Pt had a vasovagal syncope after getting COVID shot. pt passed out for a few seconds. Had pt lie down for 30 mins. pt states that she felt better after 30 mins.
armpit swollen; big bruise on left breast; armpit painful; painful bruise on breast; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced local swelling, contusion of breast, axillary pain and breast pain. On an unknown date, the outcome of the local swelling, contusion of breast, axillary pain and breast pain were not recovered/not resolved.   The reporter considered the local swelling, contusion of breast, axillary pain and breast pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for herself. The patient's concomitant medications included unspecified other medications. The patient received Shingirx in left deltoid.  She states that her left armpit swelled up really bad and she developed a big bruise on her left breast.  The patient said her both the armpit and the breast were painful though the breast was not as painful as it was.  The patient did not have the lot number/expiration date of the shot but provided her pharmacy contact information who should have that on file.  The reporter consented to follow up.
High fever (103.8), chills, aches within 12 hours of vaccination. Chest pain and shortness of breath developed about 24-36 after vaccination, shortness of breath is worsened with exertion and laying down, better when leaning forward. Chest pain and shortness of breath have continued for over a week, now elevated blood pressure has developed
1st dose- left arm pain, especially when lifting arm, starting 6 hours later and most intense at 12 hours later, pain gone in 24 hours; 2nd dose- pain under left armpit/ lymph node, started 24 hours after 2nd dose, ongoing
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 2, single (Lot number: EN6201), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 11Feb2021 as dose 1, single (Lot number: EM9809), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Morbid obesity" (unspecified if ongoing); "renal insufficiency" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: The patient did not receive any other medication in 2 weeks. The patient received Paxlovid from 31Aug2022 to 04Sep2022 for the treatment of Covid-19. The patient had no known allergies.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events DRUG INEFFECTIVE, COVID-19, INTERCHANGE OF VACCINE PRODUCTS and the suspect drug cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-202201162723 Same patient, different product and event;
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 35 years, in left arm for Covid-19 immunization; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Celiac disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Gluten, reaction(s): "Known allergies: gluten". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of Covid-19. Clinical course: The patient was received vaccine and other medications with in 2 weeks as reported no. The patient tested positive for Covid again 6 weeks after initial infection. After taking 5-day course of Paxlovid as well. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 51-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and chills. On an unknown date, the outcome of the fever was recovering/resolving and the outcome of the chills was resolved with sequelae. It was unknown if the reporter considered the fever and chills to be related to SHINGRIX. Additional details were provided as follows: The reporter was a contractor for GlaxoSmithKline and she works in research. The age at vaccination was not reported. The pharmacist told her that his wife developed the same symptoms after the 1st dose of SHINGRIX about a year before the date of reporting in 2018. The patient received the 2nd dose of SHINGRIX but reported side effects with the 1st dose. The reporter did not have any additional details on this report. The reporter heard about this at time of reporting. This case has been linked to the case US2019027650, reported by the same reporter.
Dose 3 was given 5 weeks early.   No issues, signs or symptoms at this time.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 13-MAR-2014, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU, (dose, route, lot number and expiration date not reported). On 04-OCT-2014 the patient received a second dose of ZOSTAVAX (dose, route, lot number and expiration date not reported). No adverse symptoms reported. Additional information has been requested.
Eye retina  Fluid in eye caused retina pull and now floaters. ALL within two weeks of second vaccine. Sudden retinal pull in both eyes resulting in floaters. Sudden floaters.
Pt vaccinated w/FLUZONE developed cold next day - upper respir then cough. Seen by MD; normal WBC & HGB, but had cough w/ yellow mucous. Chest x-ray negative. Treated for bacterial bronchitis; improved for 2 days.  Found dead 2 days later.
While attempting to inject the vaccine, an unknown amount leaked out of the connection between the needle hub and the luer lock on the syringe.  Following CDC recommendations stated in the document "COVID-19 Vaccine Administration Errors and Deviations" (document # CS321629-Y, published 03/17/2021), the injector immediately administered another (full) dose in the opposing deltoid (left arm).
PT felt dizzy and weak, like they were going to pass out. Symptoms resolved before patient left
About 330PM noticed ankles were swelling; quickly progressed to calfs, knees; itching, burning of legs, stomach & arms; throat became tight, face red, SOB; p/noticed ankles swelling called MD was referred to MD or ER;
"fever up to 102.F, body aches, fatigue, lasted 48 hours"
Case number PHEH2014US008251 is an initial spontaneous report received from a nurse on 23 Apr 2014. This report refers to an 11-year-old female patient. Her medical history and concomitant medications were not reported. Inadvertently, she received only Men A lyophilized conjugate component of MENVEO (batch number: not reported), reconstituted with a sterile water instead of MenCYW-135 liquid component intramuscularly on an unknown date. No adverse reaction reported following this administration error.
h/a & dizziness; may have had h/a prior to vaccine; hx unclear; no tx needed;
severe body aches; 100.2 fever; chills; sweating; fatigue; generalized weakness; This is a spontaneous report from a contactable other hcp (patient). A 23-years-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in arm left on 04Mar2021 at 08:45 AM (age at vaccination was 23 years) as DOSE 2, SINGLE for covid-19 immunisation at public health clinic/veterans administration facility. The patient was not pregnant at the time of the vaccination. Medical history was reported as none. No known allergies was reported. No other vaccines were received within four weeks of vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken within two weeks for an unspecified indication, start and stop date were not reported. Historical vaccine included bnt162b2 (Batch/Lot Number: EN6201), via an unspecified route of administration, administered in arm left on 11Feb2021 at 10:00 AM (age at vaccination was 23 years) as DOSE 1, SINGLE for covid-19 immunisation. On 04Mar2021 at 05:00 PM, the patient experienced severe body aches, 100.2 fever, chills & sweating, fatigue, generalized weakness. The patient underwent lab tests and procedures which included body temperature: 100.2 on 04Mar2021. Therapeutic measures were taken as a result of events. Treatment included 400 mg ibuprofen. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Pt received a SHINGRIX vaccine, reports there arm swelled up significantly, became bright red and was giving off heat. Pt reported 4 days after and most of the swelling had retreated. Asked to have event reported.
I developed a sore for a few days that I could not shake with over the counter medications so I went to urgent care and had a COVID-19 PCR test performed which was positive. I was prescribed an antibiotic for 3 or 4 days. The sore throat was eliminated after 3 days.
Extreme tingling and numbness in arm down to the fingers. I rode my bike to the appt. I asked if it would be ok to ride home. They it would be ok. When I got home there was extreme tingling and numbness that went down to my fingers. I waited and it went away.  Today, Sunday 3/21/2021, I rode my bike again and experienced the same tingling and numbness in the same left arm. It went away after a while. I plan to call my doctor Monday.
"Required transportation to ER same day as the 1st dose. Still feeling symptoms of headache, stomach pains, and extreme fatigue"
MUSCLE ACHES IN UPPER LEGS; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced fever. On 29-MAR-2021, the subject experienced muscle aches in upper legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and muscle aches in upper legs. This report was non-serious.
High grade fever (103), headache, muscle aches, nausea, general Flu Symptoms.
EXCESSIVE COUGHING TO WHERE SHE SAW BLOOD (NOT A LOT, MAYBE DUE TO THE EXCESSIVE COUGHING, IT HAD STOPPED SOMEWHAT) SHORTNESS OF BREATH, TONGUE HAD TURNED RED AND SHE FELT VERY ILL. SHE SAW HER DOCTOR ON MONDAY AND WAS GIVEN A ZPAK.
Redness, Inflammation, Fever, Welt at injection site (approximately half-dollar size).
patient began to experience chest pain (6 on 10 scale) 10 minutes after administration.  no other associated symptoms.   Vital signs normal.  Evaluated in Emergency Dept.  Discharged.  Note that patient was very anxious prior to and after vaccination.
Lymph nodes sore in vaccine arm. Began 4 days post vaccine. Very sore  days 5 and 6  but not palpable nodes. Slightly sore now on day 10 post vaccine. Also at day 9 injection site became red and sore with palpable lump. This resolved at day 10 post injection.