chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient Started vomiting clear liquids within the 15 min wait time. Vitals were taken immediately (B/P 72/51; Temp 98.4; Hgb 12.5), 30 minutes after the first B/P 78/57. Patient was sent to the ER for low B/P.
Mother brought child in for TB reading concerned about redness on L thigh. Nurse measured red area approx 45x55cm warm to touch. Pt evaluated by Dr no further tx at this time. Child was vaccinated PCV7 on 3/7/01 reaction noted on 3/9/01.
Patient says she had fever near 101 F for 5 days straight after receiving ZOSTAVAX, itching all over, redness/swelling at injection site. Felt terrible. No treatment given.
UPON TAKING THE FLU VACCINE, I BECAME ILL, BECAME HOARSE, DIZZY AND WEAK, EXPERIENCED A FEVER AND CHILLS.  MY THROAT HURT-I COUGHED FOR SEVERAL DAYS, MY HEAD HURT, MY BODY ACHED AND I WAS UNABLE TO GET A GOOD NIGHT'S REST.  ULTIMATELY I CAME TO MEDICAL AND WAS GIVEN SEVERAL PRESCRIPTIONS AND WAS 24 SICK-IN-QUARTERS.
So I went up and got a rapid test for the heck of it and I tested positive; So I went up and got a rapid test for the heck of it and I tested positive; My eyes were itching; This is a spontaneous report from a contactable consumer (herself). A female patient of an unspecified age received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced so I went up and got a rapid test for the heck of it and I tested positive (drug ineffective) (covid-19), my eyes were itching on an unspecified date. Caller stated, her eyes were itching she do have allergies so she put drop in and it goes away. So she went up and got a rapid test for the heck of it and she tested positive. but she felt fine, she had no symptoms other than her itchy eyes that went away with her allergies. She was great but she had to quarantine for 10 days. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unknown date. The treatment measures taken as a result of event my eyes were itching included drop. The clinical outcome of the event my eyes were itching was resolved on an unknown date.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Information has been received from a physician concerning a 64 year old female who on 09/11/2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N).  Shortly after the vaccination, the patient developed an injection site reaction that included soreness, warmth, erythema and swelling.  Unspecified medical attention was sought.  The patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
Nine days after vaccination, she started having periodic dizziness, tightness/soreness around front and sides of neck, chest and shoulders, and feeling of racing/pounding heart.  Symptoms grew worse and came to include difficulty with concentration and focus, muscles spasms in arms, lethargy, and weight loss, peaking around 6-8 weeks after onset of symptoms.  During the peak of symptoms, she found it nearly impossible to read and struggled to comprehend simple written instructions.  She started missing work and had to stop work entirely about two months after symptoms started.  Since the peak of symptoms around 8 weeks, racing/pounding heart has resolved and energy level has partially rebounded, weight loss has ceased.  Periodic dizziness still occurs multiple times per day, generally it is less common and occurs for shorter durations than at the peak of her symptoms.  Three months after symptoms started, she has been able to resume reading and working, though with some difficulty, only working a few hours per week.  Looking at computer screens, and other things that move quickly in her near field of vision is disorienting and seems to bring on symptoms as does being in low-light conditions such as dusk/dawn, or performing rapid movements.   Treatment: About 1 week after symptoms, treated as ear-infection by primary care provider (pcp) based on initial report of dizziness.  Symptoms did not improve with antibiotics and subsequent trip to ENT showed now signs of ear-infection.     ENT has proposed a problem with the Vestibular system, suggesting "mal-disembarkment syndrome" and prescribed Vestibular PT which she is attending weekly while performing daily exercises at-home as directed by the therapist.  She has spoken with mental health professionals who do not believe this to be the result of a mental health issue.    Doctors say they cannot confirm one way or another if this is related to the vaccine, but the consensus is that she should avoid a second dose until a cause is identified or symptoms fully resolve.
Ringing in ears starting 2 days after vaccine.  Continues to this day (11/18/2023). Fairly loud and constant.
started losing eye contact;glazing over eyes;not paying attention w/in 2-4wk p/vax;
This spontaneous report as received from a healthcare worker refers to a 6 month old patient of unknown gender. Concurrent conditions and medical history were not reported. On 09-JUL-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # K015816 and expiration date 29-MAR-2016 (dose was not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Right ear unable to hear; Right ear loud ringing; Right side of face swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOACUSIS (Right ear unable to hear), TINNITUS (Right ear loud ringing) and SWELLING FACE (Right side of face swollen) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Urinary tract infection. Concomitant products included CIPROFLOXACIN (CIPRO CARE) from 23-Feb-2021 to an unknown date for Urinary tract infection.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced HYPOACUSIS (Right ear unable to hear), TINNITUS (Right ear loud ringing) and SWELLING FACE (Right side of face swollen). In February 2021, HYPOACUSIS (Right ear unable to hear), TINNITUS (Right ear loud ringing) and SWELLING FACE (Right side of face swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Rash on arm where shot was given  Muscle aches  Fever (100.2°) not fixed with ibuprofen  Fatigue
passed out on way to bathroom; Maybe it was a seizure; Feeling weak; Fever of 103,Lowest the fever could get is 101; Diverticulitis attack; A spontaneous report was received from a consumer concerning a female patient of 68 years old, who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced Diverticulitis attack, felt weak, passed out, seizure and Fever of 103.  The patients medical history included sensitivity to medicines. No relevant Concomitant medications were reported.  On 08 Mar 2021,prior to the onset of events, the patient received the first of two planned doses of mRNA-1273(Lot number: 011A21A) vaccine through unknown route for prophylaxis of COVID-19 infection.  On 10 Mar 2021, at 1am, she woke up with a fever of 103. The highest was 103 and the lowest she could get it down to was 101. The patient passing out on way to bathroom at one point also and does not know how long she was out for. She believes she could have had a seizure. She also had a diverticulitis attack in this time period which she states being the worse attack and she felt pretty weak .  Treatment for the event included Tylenol and used icepacks and was on a liquid diet.  Action taken with the mRNA-1273 in response to the event was not provided.  The fever resolved on 12 Mar 2021 while the diverticulitis attack and weakness resolved on 16 Mar 2021. The outcome were unknown for other events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Headache, Myalgia, Fever, CoughWheeze, pain, redness and swelling at injection site Narrative:  Other Relevant History:
Pain; Muscle ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 30Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (frst dose), for COVID-19 immunization. The following information was reported: MYALGIA (non-serious) with onset 01May2021, outcome "unknown", described as "Muscle ache"; PAIN (non-serious), outcome "unknown", described as "Pain". Therapeutic measures were taken as a result of myalgia.  Additional information: The reporter stated that started an hour twenty minutes ago muscle ache, already took the pills but was calling to ask, the reporter had Pfizer shot and wanted to know if Acetaminophen and Aspirin could be taken for the pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dose on 24Aug2021 was 1ml and she was informed it was 0.25ml./immunocompromised and received two-dose as primary series and booster. This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Dose on 24Aug2021 was 1ml and she was informed it was 0.25ml./immunocompromised and received two-dose as primary series and booster.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A., 010A21A. and 039KZCA) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 milliliter. On 24-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE (Dose on 24Aug2021 was 1ml and she was informed it was 0.25ml./immunocompromised and received two-dose as primary series and booster.). At the time of the report, ACCIDENTAL OVERDOSE (Dose on 24Aug2021 was 1ml and she was informed it was 0.25ml./immunocompromised and received two-dose as primary series and booster.) outcome was unknown.        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. Patient has  reported not had COVID-19.
Arm sore; Injection site bruising; A spontaneous report was received from a nurse concerning a 71 year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Injection site bruising and sore arm. The patient's medical history included covid-19 and liver transplantation. Products known to have been used by the patient were not reported. The patient received their first of two planned doses of mRNA-1273 (Batch number: Batch number not provided) on 25 Jan 2021, intramuscularly for prophylaxis of COVID-19 infection. On an unknown date the patient experienced injection site bruising and sore arm. While receiving the vaccine the patient told the nurse "you came all the way down to the bone". The sore become black and blue later on. No treatment information was provided.   No relevant laboratory details were included. Action taken with the drug in response to the events were not reported. The outcome of the events were unknown.
TINNITUS.  CANNOT TELL WHICH SIDE IF THERE IS ONE.  NO TREATMENT FOR IT.  SO LOUD AT TIMES IT AFFECTS MENTAL STATUS, IRRITABLE, HAVE TO MAKE OUTSIDE NOISE SO LOUD TO DISGUISE IT.  DR. REFERRED TO ANOTHER DOCTOR.  NO LUCK. SITE LED TO NATIONAL HEARING SITE.  HELPED WITH IDENTAFICATION OF SOUND.  7500 HZ....ALL THE TIME VARIYING IN VOLUME.
congestion in her chest; intense headache; tired; sinus infection; arm was also sore; felt sick; This case was reported by a consumer via call center representative and described the occurrence of lung congestion in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2020 16:00, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2020, less than a week after receiving Shingrix, the patient experienced lung congestion (serious criteria GSK medically significant), headache, tiredness, sinus infection, pain in extremity and malaise. On an unknown date, the outcome of the lung congestion, tiredness and sinus infection were unknown and the outcome of the headache and malaise were not recovered/not resolved and the outcome of the pain in extremity was recovered/resolved.   It was unknown if the reporter considered the lung congestion, headache, tiredness, sinus infection, pain in extremity and malaise to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left deltoid. After receiving Shingrix, when the patient woke up on 8th August 2020, Saturday morning, she had an intense headache which lasted all day. It had improved since but was still there at the time of reporting.  The patient was tired and felt like she had a sinus infection.  There was some congestion in her chest.  The patient's arm was also sore but was resolved at the time of reporting. The patient had felt sick every day. This case was linked with case US2020159617, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159617:same reporter
Localized reaction to injection - Has not resolved - Edema and erythema present.  Bilateral arm numbness and upper extremity weakness starting on 3/25/ 2022 at 3am. Symptoms ongoing - bilateral arm pain and weakness at night intermittently.
Cellulitis-like patch couple an inch or so below injection site. Warm, taut, and red puffy skin
Patient reports tinnitus in the L ear, loud and high pitched, 2 days after the vaccine. He just reported this so work up is just beginning now in February 2022.
About 5minutes after vaccination had syncope episode, in and out for about 5-10, malaise, feeling like ? under anesthesia since then.
I started feeling light headed about two hours after I received my shot. Then I started getting diarrhea a could hours later, then by 7:00 pm that night I ended up with a fever, headache, diarrhea, vomiting, body aches, chills, fatigue, extreme tiredness . I took DayQuil/NightQuil Cold and Flu. I was sick for 48 hours.
pt recvd measles vax on 5SEP91 & on 10SEP91 pt exp arthralgia in fingers; presented to MD office; 1 wk later recovered; no further details were provided;
Progressed - getting worse day by day:  Started with dizziness next day followed by tightness in chest, then arm swelling especially at injection site - streaking radiating outward.  Getting bigger and bigger, redder and redder, felt raw to the touch.  Doctor notified - got on Benadryl right away, which settled down right away.  Otherwise, patient did not need Prednisone course.
pt recv vax 27JUN97 & 30JUN97 pt devel  a rash @ inj site & trunk;pt also devel a few little dots on back & chest;24 hr later pt recovered from sx;
Soreness 4 days after receiving vaccination-pain has radiated to shoulder, clavicle-no more pain at injection site-client has never had from-but notes it is worse since injection.
Patient was due for their second dose of the Moderna Vaccine. Our facility only had the monovalent vaccine and administered to the patient due to their need for the second dose of the covid vaccine.
Unknown lot number or facility where vaccine was received. 2nd dose of Pfizer given in left arm. Patient with swelling of external right lip and rash on shoulder around 5 hours after vaccination which improved with benadryl
Sleep unwell, irritable. A non-serious spontaneous report of irritable and not sleeping well has been received from a consumer concerning a 35 month old male, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history included "constant cold every other week before and after receiving FLUMIST" and teething. Concomitant medications have not been reported for this patient. The patient received FLUMIST on 20 -Sep-2009 and 20-Oct-2009. The patient received one dose prior to the onset of the events. The patient has been irritable and not sleeping well at night since receiving FLUMIST on 20-Sep-2009. The outcome of the events was not reported. Required follow-up attempts have been performed, requested information unable to be obtained.  01-Mar-2010.
A 41 year old male pt was treated with OncoTICE for bladder cancer. On 02August04 he presented with fine red rash all over his body and a pea sized lump in his lip.
Headache in back/right of head began on 3/5/2021, on 3/7/21 began experiencing facial paralysis in lips which progressed to the rest of right side of face. Went to Emergency Department that evening. CT scan was "unremarkable" and blood work was normal. Was diagnosed with Bells Palsy. Prescribed Valtrex and Prednisone. 3/10/2021 still experiencing partial facial paralysis and headache in same location.
Flu like symptoms; Body aches; Feels like garbage; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body aches), MALAISE (Feels like garbage), CHILLS (Chills) and PYREXIA (Fever) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.     On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body aches), MALAISE (Feels like garbage), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body aches), MALAISE (Feels like garbage), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included High Blood Pressure Medications and Diabetic Medications.
This spontaneous report as received from an emergency medical technician and refers to his daughter, a female patient of unknown age. Concurrent conditions, medical history, historical or concomitant drugs were not reported. The reporter informed that on an unspecified date in June 2016, the patient was vaccinated with the first dose of GARDASIL 9 Injection, for prophylaxis (strength, dose, route, anatomical location, lot # and expiration date were not reported). Later, on an unspecified date in July 2017, she was vaccinated with the second dose of GARDASIL 9 Injection, for prophylaxis (strength, dose, route, anatomical location, lot # and expiration date were not reported). The reporter also informed that the patient attended to the doctor's office on 23-MAY-2018 in order to receive the third dose of GARDASIL 9, however it was not confirmed whether she received the third dose or not. No adverse effects reported.
Swelling, warmth, pain at injection site R upper arm above elbow where Pneumovax given. Trouble moving arm for a few days. Took Tylenol. During recheck 1 month later, c/o weakness fully lifting arm above head compared to other side of body but swelling/warmth/pain had resolved.
Right eye drooping and right hand joint pain developed @ 2-3 days after receiving Tdap vaccination.
HEADACHES, JOINT PAIN, MUSCLE PAIN, TINGLING AND NUMBNESS IS HANDS AND FINGERS, STOMACH PAIN. 5/14/2010 follow up: On 3/20/10 patient started a 90 day cleanse by taking several vitamins and minerals. She is starting to feel better. Still having bad headaches and some joint pain. But numbness and tingling in her hands/fingers has stopped.
warm to touch; arm itchy; arm red, redness got bigger and extended down to elbow; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm itchy), ERYTHEMA (arm red, redness got bigger and extended down to elbow) and FEELING HOT (warm to touch) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0C1A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PRURITUS (arm itchy) and ERYTHEMA (arm red, redness got bigger and extended down to elbow). On 15-Mar-2021, the patient experienced FEELING HOT (warm to touch). At the time of the report, PRURITUS (arm itchy), ERYTHEMA (arm red, redness got bigger and extended down to elbow) and FEELING HOT (warm to touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.   Patient was prescribed an unspecified steroid and antihistamine for the treatment of the events.
Exacerbated her eczema- weird bumps on her hands and her skin began to peel/the peeling has brought her hands down to the 3rd or 4th layer of skin./she has had a purple band around her arm at the height of the vaccination site; covid hands; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Exacerbated her eczema- weird bumps on her hands and her skin began to peel/the peeling has brought her hands down to the 3rd or 4th layer of skin./she has had a purple band around her arm at the height of the vaccination site) and VACCINATION SITE REACTION (covid hands) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     The patient's past medical history included Eczema.    On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced ECZEMA (Exacerbated her eczema- weird bumps on her hands and her skin began to peel/the peeling has brought her hands down to the 3rd or 4th layer of skin./she has had a purple band around her arm at the height of the vaccination site) and VACCINATION SITE REACTION (covid hands). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, ECZEMA (Exacerbated her eczema- weird bumps on her hands and her skin began to peel/the peeling has brought her hands down to the 3rd or 4th layer of skin./she has had a purple band around her arm at the height of the vaccination site) and VACCINATION SITE REACTION (covid hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient tried multiple different lotions and creams for her hands, eczema medication and psoriasis medication.   No concomitant medications were reported.