chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blurred vision; Abdominal discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 86-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 as dose number unknown, single (Lot number: H64677) at the age of 86 years for covid-19 immunisation. The patient's relevant medical history included: "heart patient" (unspecified if ongoing), notes: He is a heart patient. The patient's concomitant medications were not reported. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset Sep2023, outcome "unknown"; VISION BLURRED (non-serious) with onset Sep2023, outcome "unknown", described as "Blurred vision". Additional information: Reporter stated, 86-year-old husband had a COVID shot yesterday. He is experiencing abdominal discomfort and some blurred vision. Reporter would like to know if abdominal problems and blurred visions can be a side effect of COVID 19. Indication of the vaccine: Reporter stated, Because the news is saying all over that the new vaccine is available and the people over 65 should take it. Reporter was provided with the number of Pfizer Medical Information as (phone number withheld) and was requested to select option 3, Monday to Friday, timings as 8 AM to 7 PM. Further probing could not be done as the reporter was unwilling to complete the report. Hence, limited information was available over the call.
pt inadvertently got varicella vaccine in eye on 24FEB96;pt exp a burning & red eye;
PATIENT RECEIVED VACCINE THAT EXPERIENCED A TEMPERATURE EXCURSION, VACCINE WAS KEPT IN THE REFRIGERATOR FOR MORE THAN 30 DAYS. PATIENT STATED HER ARM WAS RED AT SITE, COULD SEE THE NEEDLE POKE THAT NIGHT AFTER SHE TOOK OFF THE BAND-AID. SHE STATED IT WAS OKAY THE FOLLOWING ARM. NO OTHER SIDE EFFECTS.
Painful injection that felt like it hit bone. Soon after injection I was unable to move my shoulder/arm due to pain and have had trouble sleeping due to discomfort. Three weeks later I am still unable to use my right arm for any amount of weight or upward movement. I have been taking 600mg of Ibuprofen three times a day per my doctor's instructions, with only temporary pain relief and still unable to use arm.
The day after vaccine, I started experiencing cardiac arrhythmia, which continued to get worse. On Thursday night, (2 days after vaccine) it was so bad I couldn't sleep and thought I might be having a heart attack. Friday morning I went to the ER. A chest X-Ray showed my heart was enlarged, but they said it was probably a reaction to the vaccine, I wouldn't die and they sent me home
She received both vaccines in the same arm and days later she stated she could not move her arm. She saw her PCP and states she feels better.
This spontaneous report was received from a licensed practical nurse concerning a 13 year old patient of unknown gender. On 10-DEC-2012, the patient was vaccinated with an adult dose of 1 milliliter (ml) VAQTA (lot number and expiry date unspecified) intramuscularly. No concomitant medications were reported. No adverse effect was reported. This is one of two reports from the same source. Additional information has been requested.
received the Moderna vaccine at 8 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (received the Moderna vaccine at 8 weeks pregnant) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (received the Moderna vaccine at 8 weeks pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (received the Moderna vaccine at 8 weeks pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No medical history reported No treatment was reported No last menstrual period date and due date was reported
C/o edema, erythema, and warmth to (L) upper arm. Also has itching. Advised to place cool compresses to area, oral BENADRYL and apply HC cream to area PRN itching.
Patient requested Hep A. Patient had already had flu shot this year. Patient's primary care provider, stated that patient is recommended to get two doses due to health conditions and he was not concerned. Patient reports no issues.
was given the fluzone high dose quadrivalent with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from a other health professional via Agency (Reference number- 00813036) and transmitted to Sanofi on 14-Oct-2021. This case involves a 74-year-old male patient who received FLUZONE HIGH-DOSE QUADRIVALENT (extra dose administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 14-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ730AB, expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to extra dose administered. (latency: same day).  It was reported "a patient was given the FLUZONE HIGH DOSE QUADRIVALENT on 07-Oct-2021 and then 14-Oct-2021 in error".  At the time of report, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
The evening he received his 1st dose of the vaccine, he developed severe sciatica in his left leg.  He took tylenol and ibuprofen and did gentle stretching. Then 4/2 he sought care because the pain was worse. He was prescribed a steriod-prednisone-unsure of doseage. He was also given a shot of Tordal. He did ok the next 3 days and was alble to walk around. He did have numbness in last 2 toes of left foot, in arch and on the inside of left foot. He called the provider on Monday 4/5 and was given Diclofinac. He  saw Dr. on Thursday 4/9  and had an xray which did show narrowing of L5 through S1. Today, he has a consult with neuroscience APNP, for a consult.
Large, crusted "psoriatic" appearing  lesions to arms. The first one started around June 3rd as a small 1 cm x 1 cm lesion that opened and spread, It is now 5 cm x 5.5 cm in size.  It is not plaque appearing, but crusted,  he has had several smaller areas develop over his bilateral arms.
Severe axillary lymphadenopathy with onset approximately five days after injection, and persisting for at least three days after that. Very tender, interferes with daily functioning.
Pt presents with red, warm to touch site on LA approx. 25 mm in diameter.
approx 11 hrs after vaccine administration pt began to experience some sweating and fatigue; the next day, noted to have shortness of breath with exercise during softball game; pt is a runner and prior to vaccine had no difficulty with running long distances and endurance training; the day prior to her vaccine pt had a 2 hr softball game which included sprinting/running and had no difficulty;  the day after vaccine she was unable to tolerate even 30 min of light/moderate exercise; pt noted considered to be significantly iron deficient and started on iron supplements however, her inability to endure moderate exercise persisted despite correction of iron deficiency; has required a pulmonology consult and use of SABA for exercise induced bronchospasm; pt was also evaluated by cardiology and found to have no cardiac etiology of her shortness of breath
Common symptoms began on 11.26.2021 around 10pm Injection site soreness Under arm soreness  During the night other common symptoms began Body aches and pains Chills and sweats Headache Intermittent nausea Tiredness  During the day 11.27.2021 Common symptoms continued Also developed very sore throat and persistent cough  Common Symptoms slightly reduced but continued into 11.28.2021 Cough and sore through no change.  11.29.2021 Did not attend work. Cough and sore throat continue. Also symptoms include chest pressure and congestion. Went to pick up medication to help with symptoms (cough drops, cough medicine and guafenessin). While out I felt my breathing was heaving than normal and heart rate was increased more than usualy while walking.  Spoken with telehealth Dr about my symptoms and was directed to urgent care for examination.  Attended urgent care where I was tested for flu, covid and strep. All results negative.  Dr listened to breathing and heart and reported that heart rate was elevated but not concerning and lungs sound normal..  11.30.2021 Did not attend work. Sore throat has gone but persistent cough, chest pressure and congestion and throat clearing continue.   At this point I am continuing treating with cough drops and guafenessin.
Itching, redness, swelling of left anterior shoulder, left upper back, left upper eyelid, right supraclavicluar lymph node enlargement.
Patient developed hemichorea (L hemibody and face) approximately 3 weeks after vaccination, confirmed at initial neurological consultation of 4/29/21 (referred by PCP). Chorea steadily improved without medical intervention and was minimal at follow-up on 6/10/21, then essentially absent at final visit of 7/22/21.
Patient was initially referred to the ED following routine labs as his creatinine had tripled since 12/1 accompanied with elevated BUN and decreased potassium.  Patient visited the ED earlier today but left without being seen after triage and having labs done.  Patient did have CBC and CMP done with creatinine of 3.09, BUN of 63, and eGFR of 21.  Patient was called and instructed to return to the ED for admission.   Currently, patient reports he feels lightheaded.  He denies abdominal or back pain.  He states he has been urinating normally.  He denies fever, chills, chest pain, or cold/flu symptoms.  He does report some shortness of breath, but indicates this is normal for him.  Patient reports that he has had normal LVAD numbers and currently they are: RPM 5300, 4.0 flow, 4.5 PI, and 3.9 PWR.  He denies any source of bleeding.  He denies any new leg swelling within the past week.
Information has been received from a registered pharmacist concerning a 67 yr old male who was hospitalized for cholecystitis and was post op cholecystectomy who on 25Jun05 was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649978/0709P). On approx 25Jun05, the pt developed a localized skin reaction, fever, and cellulitis. The pt was treated with IV antibiotics for the cellulitis. It was noted that the pt has a previous unspecified reaction to a tetanus toxoid vaccination. Subsequently, the pt recovered. The pharmacist did not believe that the adverse events prolonged the pt's hospitalization and she did not feel this was an other important medical event (OMIC). A product quality complaint was not involved. No additional information was available.
Prolonged fever, headache, fatigue, gen weakness, vomiting/diarrhea
6 hrs after H1N1 injection, severe arthralgia in all joints, low grade fever - all movement of joints very painful; 12 hours later only joint pain in wrists and ankles, by 24 hours all joint pain gone. (Have gotten flu vacc for many yrs with without similar probs).
19OCT fever 102; 18OCT t101.4; 20OCT t101; soreness, localized react
Very painful right knee joint.  Started Friday afternoon after getting the vaccine and continued through the weekend and still have some pain in my knee today (Monday).
patient called about 15 minutes after her shot and said she had trouble breathing and her whole body was burning. her husband was already driving her to the ER...haven't heard from them since....called twice
12 hour post vaccine severe muscle joint pain, headache , nausea with vomiting, extreme Fatigue and muscle weakness.
Rapid heart beat; Sensation of fluid moving around her body; Brain spin; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heart beat), FEELING ABNORMAL (Sensation of fluid moving around her body) and DIZZINESS (Brain spin) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced HEART RATE INCREASED (Rapid heart beat), FEELING ABNORMAL (Sensation of fluid moving around her body) and DIZZINESS (Brain spin). At the time of the report, HEART RATE INCREASED (Rapid heart beat), FEELING ABNORMAL (Sensation of fluid moving around her body) and DIZZINESS (Brain spin) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was reported.   Concomitant product use was not provided by the reporter.
Patient at clinic 2/8/18 with raised, red, hot itching area approximately 3/4 down right arm from deltoid down X2 days. Patient reports it was circling around the back of arm on 2/7/18. Had fever of 102 on 2/7/18. Redness is resolving but itching and heat continues. Instructed to try BENADRYL if can tolerate, cool compress. If symptoms do not resolve contact PCP.
Pt c/o soreness at injection site, axilla swollen and red rash.  Red streak 1" wide down arm that spread around to front of arm
Pain and swelling at injection site, hard outgrowth, difficulty sleeping, possibly febrile.
INJECT 0.3 ML PFIZER VACCINE INSTEAD OF MODERNA FOR 2ND DOSE.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 12-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). Other suspect therapy included FLUZONE. In approximately 2014 the patient experienced erythema and swelling of upper arm after receiving PNEUMOVAX 23. It was not known if the patient received FLUZONE in the same arm (on 12-SEP-2041). The outcome of erythema and swelling of upper arm after receiving PNEUMOVAX 23 was not reported. The relatedness between PNEUMOVAX 23 and the events of erythema and swelling of upper arm after receiving PNEUMOVAX 23 was not reported. This one of several report received from the same reporter. Additional information has been requested.
One week after his Moderna  booster  shot, he told us that he felt like he was "out of himself after the vaccine".  people  around him thought he was not being reasonable.  He had injection site pain, redness, and swollen.  The injection site reaction has been  improved, but still not completely go away.
lightheaded, nausea, vomiting, sweating, trouble breathing All for about 1 hour
Infected with Covid-19; Infected with Covid-19; This is a spontaneous report from a contactable consumer or other non hcp.   A 47-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 25Apr2021 09:15 (Batch/Lot Number: EW0176) as single dose, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 04Apr2021 09:30 (Batch/Lot Number: ER8737) as single dose for COVID-19 immunisation.  Medical history included Testicular Cancer from 1999 to an unknown date. The patient's concomitant medications were not reported. The patient has no known allergies. The patient infected with Covid-19 on 07Jun2021 09:30. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Jun2021 Nasal Swab, sars-cov-2 test: positive on 12Jun2021 Nasal Swab. Event occurred in a country different from that of the reporter. No treatment was received for the adverse events. The patient was not diagnosed with Covid prior vaccination and has been tested via Nasal Swab for Covid post vaccination. The outcome of the events was not resolved.  Batch and lot number was obtained. Further information has been requested.
2-3 minutes after administering vaccination, patient became dizzy, lightheaded, and nausea.  Patient then proceeded to vomit into a trashcan.   Water was given to the patient and the patient was laid back into a reclining chair.  Patient reported that he experiences these symptoms with previous injections.  Additionally, patient reported that he did not eat anything during the day.  After 10 minutes of sipping water and laying back in the chair.  The patient's symptoms had subsided and felt alright to leave the store.  Patient was instructed to return to the pharmacy or hospital if his symptoms returned.
Initial unsolicited report received from a nurse on 13-Jul-2018. This case involves a four-month-old patient (gender not reported) who was vaccinated with a first and second dose of PENTACEL (Batch number, expiration date, dose, route and site of administration was not reported) on 11-May-2018 and 16-May-2018 respectively (unknown batch number via unknown route in unknown administration site). The patient's medical history and concomitant medications were not reported. It was an actual medication error due drug dose administration interval too short. It was reported that the patient had no side effect. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
she is diabetic; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 7Mar2021 as a single dose for covid-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported. On an unspecified date, after receiving the vaccine, the patient reported that she has an appointment with her physician next week and needs to get an A1 blood test done, as she is diabetic. She wants to know if the vaccination could interfere with the lab results. The outcome of the event diabetic was unknown.   Information about lot/batch has been requested.
PRESENTED THEMSELVES FOR A SECOND SHOT OF MODERNA ON 07/08/2021 AFTER RECEIVING A ONE AND DONE SHOT OF J&J ON 06-30-2021 CONCELING THAT FACT JUST TO RECEIVE A GIFT CARD
Mild Tachycardia, small SOB, diaphoretic for 5 min, digits tingly , very dizzy
I experienced an acute sensory neural hearing loss in my left ear/my ear felt full like there was a sudden air pressure change; Initially, all I could hear was buzzing; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS NEUROSENSORY (I experienced an acute sensory neural hearing loss in my left ear/my ear felt full like there was a sudden air pressure change) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In October 2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS NEUROSENSORY (I experienced an acute sensory neural hearing loss in my left ear/my ear felt full like there was a sudden air pressure change) (seriousness criterion medically significant) and TINNITUS (Initially, all I could hear was buzzing). At the time of the report, DEAFNESS NEUROSENSORY (I experienced an acute sensory neural hearing loss in my left ear/my ear felt full like there was a sudden air pressure change) and TINNITUS (Initially, all I could hear was buzzing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: brain tumor and visible nerve damage was not observed..         Concomitant medications were not reported.   It was reported that approximately 11 days later of booster shot, patient experienced an acute sensory neural hearing loss in her left ear. Initially, all she could ear was buzzing and her ear and felt full like there was a sudden air  pressure change. She sought medical attention immediately. She was referred to an ENT. After multiple audiological exams, physical examination and a cat scan a brain tumor and visible nerve damage was not observed. The ENT recommended hearing aids to boost her residual hearing. She could not help thinking her loss was due to a negative reaction to the booster.   No treatment medication was provided by the reporter.  Company comment: This spontaneous case concerns a 66-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of deafness neurosensory 11 days after the third dose of mRNA-1273.222. Patient experienced an acute sensory neural hearing loss in her left ear, which initially presented with tinnitus and air pressure change sensation. Patient was referred to an ENT who performed multiple audiological exams, physical examination and a CT scan which discarded a brain tumor and nerve damage. The ENT recommended hearing aids to boost her residual hearing. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.
Patient received FLURIVIN 9/25/10 but she is still experiencing extreme pain in left arm (3 wks). She has bubbles and scabs at injection site still.
On 8-26-10, patient received a Tdap, Hep A, Varicella, Menactra, and a HPV vaccines.  On 9-22-10, I received a call from the patient's mother, stating that patient was 8 weeks pregnant.  Client had filled out a contracindication sheet the day of getting the vaccines.  She stated that she was sexually active and on no birth control.  Her last period had been one month previous.  She stated that she was not pregnant.
It was reported that a pt rec'd Menomune A/C/Y/W-135 on 8/27/02 in the L arm. A few minutes after injection, the pt experienced "redness to injection site" and was treated with 50mg po of benadryl. The pt's pulse 18 minutes after the reaction was 84 and respiration's were 24. No further information was provided.
pt recv vax 16ARP97 & 12hr later exp a rash on the neck & nape of the neck;
11/8/05: Was given Flu vaccine at 9:30am and broke out in hives at approximately 1:30pm which subsided without medical treatment by 2:30pm. No other signs or symptoms.