chrisvoncsefalvay/vaers-outcomes huggingface dataset:
17 year old patient was seen on March 30th for 1st dose of Moderna Covid-19 vaccine, and was told to provide identification for her 2nd dose and she was 17 years young when 1st dose was administered. Patient stated she had no adverse reaction. Patient did receive her 2nd dose of Moderna Covid-19 vaccine, and released after medical evaluation.
Left arm pain. Painful enough it awoke from sleep when I would roll on it.  It is tender to touch. However no limit to range of motion or use
Received immunizations. Approximately 23 hours later developed congestion/feeling blocked in her right ear. There is a consistent "swishing" noise also in the right ear. Denies any local reaction or other symptoms. Called private provider who is unable to see her. Going to a specialist. As of 10/16/13 (R) ear sensorineural hearing loss. Now resolved. Per physician specialist.
AWARE OF A LOUD CONTINUOS RINGING (TINITIS) IN BOTH EARS 7-8 HRS  (9PM) AFTER INJECTION. I HAVE HAD TINITIS FOR A COUPLE YEARS BUT HAS DRAMATICALLY DECREASED SINCE LEAVING WORKSITE 12/4/20.  IT  CONTINUES AS OF NOW (4/6/21 9:30 AM).  I HAVE A THERMOMETER THAT GOES IN MY EAR FOR A DIGITAL READING. CURRENT LOW GRADE FEVER BUT I COULDN'T USE IT IN MY LEFT EAR THIS MORNING (8:45AM) DUE TO PAINFUL BUMPS AROUND MY EAR CANAL ENTRY AREA. I HAD TO USE OTHER EAR (NON VACINATED SIDE).
Arm pain with movement beginning 2 days after administration, worsening with time. Significant decreased range of motion by late November/increased pain now constant. PCP prescribed physical therapy. went to 4 sessions, but too painful to continue. Saw Ortho PA in Jan/Feb & received steroid injection with no relief. By this time I was in severe pain, interfered with sleep and had little use of my arm. Ordered MRI-referred me an Orthopedist who diagnosed adhesive capsulitis. Recently had procedure :hydrodilation of capsule and manipulation and am now currently in physical therapy 3 times weekly.
Migraine(Rizatriptan, Meloxicam, Propranolol), Joint Pain (Cortisone shot)
No adverse reaction. vaccines were spoiled due to fridge temps were found on log to be below zero.
BLOOD SUGAR SPIKE; TERRIBLE SICKNESS; TOTAL FATIGUE; This spontaneous report received from a patient concerned a 70 year old male. 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 administration not reported, batch number: 1808980, expiry: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced terrible sickness. On 01-APR-2021, the subject experienced total fatigue. On 15-APR-2021, the subject experienced blood sugar spike. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from total fatigue on 15-APR-2021, and had not recovered from terrible sickness, and blood sugar spike. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non serious.
This spontaneous report as received from a nurse refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 14-MAY-2013 the patient was vaccinated with second dose of GARDASIL (dose: 0.5 (units not reported), route: intramuscular) for prophylaxis. Concurrent medications were not reported. The patient received her second dose of GARDASIL one year after receiving her first dose and has not received her third dose yet. No adverse effects were reported. No product quality complaint was filed for GARDASIL. Additional information has been requested.
Client reported a sore arm in the evening following vaccination. The morning after, he had "dry heaves", fatigue, and muscle aches.
Information has been received from a physician concerning a 24 year old female with a history of hay fever and allergy to MACRODANTIN who on 08-MAR-2008 was vaccinated with the first dose of GARDASIL (655604/0052X). On 09-MAR-2008 the patient experienced an "allergic reaction" characterized by "hives and wheezing". Subsequently, the patient recovered from hives and wheezing. The patient sought unspecified medical attention. No other information was provided. Additional information has been requested.
Case number PHEH2106US022942, is an initial spontaneous report received form a pharmacist on 07 Sep 2016. This report refers to a 64 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1618701) at a dose of 0.5 ml, intramuscularly on 06 Sep 2016. The pharmacist stated that a patient received a dose from the FLUVIRIN multi dose vial (MDV) that had been part of the temperature excursion (60F for up to 37.5 hours) (reported as yesterday). No adverse event was reported following this medication error (incorrect storage of drug).
This spontaneous report as received from a nurse via field employee refers to a 11 year old female patient. The reporter stated that a patient received her first dose of GARDASIL (0.5 ml, route unspecified) on 06-APR-2014 (also reported as date therapy started: 09-APR-2014) and had been experiencing vomiting since. The reporter also stated that the patient had lost 14 pounds due to the vomiting. The reporter also reported that the patient received her second dose of GARDASIL on 11-JUN-2014 and continues to experience vomiting after that dose, as well. The patient sought medical attention and visited office (details unspecified). The outcome of the events was reported as not recovered/not resolved. The causality was unknown. No further AE information provided. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 26-SEP-2013 the patient was vaccinated with M-M-R II (reported lot # H018950 corresponding with lot# 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures of 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
refrigerator containing Fluzone went down to 29.1F. the vaccine was given to the patient inspite of being compromised / no AE; Based on information received on 07-Feb-2020, the report previously considered as non-case became valid case because of patient information given in follow up: [reason for non-validity and validity].  Follow up information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2020SA038302, 2020SA038343, 2020SA038344, 2020SA038345, 2020SA038346, 2020SA038347, 2020SA038348, 2020SA038349, 2020SA038350, 2020SA038351, 2020SA038466, 2020SA038467, 2020SA038468, 2020SA038469, 2020SA038470, 2020SA038471, 2020SA038472, 2020SA038473 and 2020SA038474.  This case involves a 2 years old patient who received a dose of 0.5 ml of (once) INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot UJ254AC (Expiry date 30-Jun-2020) via unknown route in the left thigh for Prophylactic vaccination on 13-JAN-2020 which was exposed to the temperature of 29.1 F (Product storage error).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was given.  It was an actual medication error case due to Product storage error temperature too low.  It was reported that refrigerator containing Fluzone went down to 29.1F and the vaccine was given to the patient inspite of being compromised.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder 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.
After receiving 3 vaccines pt. fainted - this occurred 10 minutes after receiving vaccines. Pt was standing with his mother about 5 minutes after receiving vaccines. Nurse was making next appointment & Pt fell while nurse was talking to Mom. VS & Neuro checked - normal. Pupils equal & reactive. Mom stayed after 1/2 hr & then took pt to MD to be checked.
Patient presented to clinic, completed vaccine questionnaire indicating he had not received another manufacturer's messenger RNA vaccine and upon closer examination it was discovered that he had received Moderna for #1.
pt was given a PPD & hep B #1 mom states 2hr p/vax broke out in hives;pt exp vomiting, flu sx;taken to MD;
The patient had a fixed drug eruption on volar surface left wrist.  She also had a bit of dermatographism on volar surface left wrist.  Patient has a history of dermatographism, though.
Circumference of a softball hurt and ached for 3-4 months after; Whole arm at the injection site hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Circumference of a softball hurt and ached for 3-4 months after) and VACCINATION SITE PAIN (Whole arm at the injection site hurt) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN (Circumference of a softball hurt and ached for 3-4 months after) and VACCINATION SITE PAIN (Whole arm at the injection site hurt). At the time of the report, PAIN (Circumference of a softball hurt and ached for 3-4 months after) and VACCINATION SITE PAIN (Whole arm at the injection site hurt) outcome was unknown.            No concomitant product use was provided.  No treatment medication was provided.    This case was linked to MOD-2022-437114, MOD-2022-437218 (Patient Link).
"Post client vaccination client monitored for symptoms. She reported 'being jittery' and light-headed. EMT evaluation and recommendation to transfer to hospital. Client noted increased history of allergy and notes that's most allergic reactions start with 'jittery and light headedness" Site Supervisor Resport
Swollen, sore, red lump injection sight larger than silver dollar; Swollen, sore, red lump injection sight larger than silver dollar; Swollen, sore, red lump injection sight larger than silver dollar; Swollen, sore, red lump injection sight larger than silver dollar; Fatigue; achy joints; This is a spontaneous report from a non-contactable consumer (patient). A 69-years-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: FF2589, patient was not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 30Sep2021 at 01:15 PM (at the age of 69-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccine received in four weeks, no Covid prior vaccination, no Covid tested post vaccination. On 30Sep2021, the patient experienced swollen, sore, red lump injection sight larger than silver dollar, fatigue, achy joints. No treatment received for reported events. The outcomes of all reported events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Papular vesicular rash left T5 T6 area - c/w zoster
I?m having extreme pain in my right breast. So much so it wakes me up at night. It is extremely sore throughout the day and painful. I went to my general practitioner who gave me a referral to get a mammogram. In the mammogram multiple spots were located. I was sent to go get an ultrasound. I had two  ultrasounds technicians look at me. And then they brought in the radiologist. Multiple  Spots were notice. The report from the radiologist said ?probably benign ? and to follow up with an ultrasound in a couple months. Because of the extreme pain I am in, I made an appointment with my gynecologist. She stared they?re are multiple spots, and suggested I get a second opinion from a radiologist  and suggested i see a surgeon about them removed since it is so painful. I?m currently waiting on an appointment for to speak to a surgeon.
The patient was administered an improperly stored dose of ROTATEQ; This spontaneous report was received from a registered nurse and refers to a patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported.   On 26-MAY-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (therapy type: digital data logger) lot # 1660704 and expiration date reported as 20-MAR-2021 for prophylaxis (product storage error). The administered dose of the vaccine was stored at a temperature of 12.1 degree Celsius for 16 hours and 11 minutes as recorded by a data logger. The vaccine had no previous temperature excursion. Product quality complaint (PQC) was not involved.
disease recurrence; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL3249), in left arm, on 10Feb2021 as dose 2, single (Lot number: EL9264), in left arm and on 14Oct2021 as dose 3 (booster), single (Lot number: EW0172) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "recovered" (Aug2022) and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 18Aug2022 at 18:00, outcome "recovered with sequelae" (24Aug2022). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive, notes: treatment of COVID-19; (20Aug2022) Negative; (21Aug2022) Positive; (22Aug2022) Negative; (23Aug2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: The patient received Paxlovid as treatment from 10Aug2022 to 14Aug2022. After finishing Paxlovid series and finishing 5 day isolation period, the patient returned to work. On 18Aug22, started seeing symptoms return; Sore throat Congestion Slight fever Very fatigued 20Aug22 negative at home test 21Aug22 positive at home test 22Aug22 negative at home test 23Aug22 negative at home test On 24Aug22 symptoms started to resolve, still have cough. The seriousness was reported as non-serious.  No follow-up attempts are possible. No further information is expected.
Patient presented for COVID vaccine (Janssen) and went through normal screening process (County Screening form).  Post-vaccination the patients information was being submitted in immunization registry and it was discovered that the patient had previously received the 1st dose of Moderna in January.  The patient had denied receiving a COVID vaccine previously during the screening process.  This constitutes an administration error/deviation per CDC and requires VAERs submission.  Patient had no adverse reaction during observation period.  Attempt to contact patient so far unsuccessful
BLOOD CLOTS; ADVERSE REACTIONS; This spontaneous report received from a patient via a company representative via media concerned a patient of unspecified age, sex, 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, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient had adverse reactions including blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the adverse reactions and blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220350556-COVID-19 VACCINE AD26.COV2.S- blood clots. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
On approximately 11/01/2000, the patient developed chickenpox. It was reported that the patient was "peppered with lesions". The child also had cold symptoms before the varicella occurred. The patient's sister had a similar experience following exposure to varicella virus vaccine live. Follow up information from a NP reported that the patient had greater than 100 lesions and that in November 2000 the patient recovered. No further information is available.
upper lip numbness similar to shellfish in past, superficial throat pain, given 25mg Benadryl, symptoms resolved
10 minutes later my daughter had trouble walking and as the day progressed she had a headache, fever, shaking, joint pain, throat pain, difficulty swallowing.
Patient said feels achy. She said has been since the vaccine. She is able to do her regular routine. Says it comes and goes, not all the time and not sure if really related to the vaccine.
Red, itchy bumps mostly on ankles.; Red, itchy bumps mostly on ankles.; being tired after vaccine; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration date not reported) via an unspecified route of administration on an unspecified date as 2nd dose single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration date not reported) via an unspecified route of administration on an unspecified date as 1st dose single for COVID-19 immunization. After vaccination on 16May2021, the patient was tired. The physicians did not have her Xeljanz to stop for vaccines. The patient reported that, she was been bitten by 9 or 10 mosquitos recently. The patient also experienced Red, itchy bumps mostly on ankles. The patient reported that, the physician was aware that she was taking Neosporin. The outcome of events was unknown.   Information on the lot/ batch number has been requested.
This patient received his first shot of covid-19 vaccine and was asked to wait in the pharmacy observation area for 15 minutes. others in the observation area witnessed the patient appear to have some form of seizure while seated in his chair. the patient slipped from his seat and apparently hit his head on the floor. medics were called and patient was transported to an unknown local hospital.
Red, itchy rash at vaccine site.  In office measured 8x9 cm.  Not tender.  Not cellulitis.
patient tested positive today, 04May2022, for COVID-19; patient tested positive today, 04May2022, for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9264), on 20Feb2021 as dose 2, single (Lot number: EL9266) and on 10Oct2021 as dose 3 (booster), single (Lot number: FH8020) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04May2022, outcome "unknown" and all described as "patient tested positive today, 04May2022, for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04May2022) Positive, notes: patient tested positive today, 04May2022, for COVID-19. Clinical course: Patient tested positive today, 04May2022, for COVID-19. Patient had previously been vaccinated and boosted with the Pfizer BNT vaccine. Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
Information has been received from an office manager concerning a 66 year old male patient who on 12-NOV-2008 was vaccinated with PNEUMOVAX (lot#661529/0868X) intramuscularly.  Subsequently the patient experienced cellulitis at the site of administration.   Patient called the practice.  Subsequently, the patient was placed on antibiotics and recovered.  The practice would like to know if there have been any other reports of cellulitis concerned with this lot of PNEUMOVAX. A standard lot check investigation was performed.  All in-process quality checks for the lot number 0661529/0868X were satisfactory.  The lot met the requirements of the agency and was released.  This is one of several reports received from the same source.  Additional information has been requested.
Fever, chills, headache, weakness that lasted a week.   Took OTC tylenol
Patient called in reporting diarrhea, abdominal pain, and nausea that she believes to be caused by the flu vaccine she received.
Pt recvd vax & 5 hrs p/vax devel tingling in hands; No further details were provided;
Information has been received from a health professional concerning a patient who was vaccinated with a first dose of Gardasil. Subsequently the patient became "lossy" and had a heavy feeling on the arm after the receiving the vaccine. Therapy with Gardasil was discontinued. Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On 24-JUL-2014, the patients were vaccinated with doses of VARIVAX (Merck) (lot # J012377 exp date 03-OCT-2015 also reported as 08-NOV-2014) (dose not reported) subcutaneously that were improperly exposed to 7 degrees C from 13-MAY-2014 to 24-JUL-2014. No known adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected. All follow ups requested to complete the case were received.