chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning a 76 year old female patient with allergy to penicillin and contrast dye for retinal imaging and no pertinent medical history who on 14-JUL-2011 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (Lot number 669579/0595AA; Expiration date: 30-AUG-2012) in the left deltoid. Concomitant therapy included THYROXIN and loratadine. On 18-JUL-2011 the patient came to see the nurse practitioner for complaints of injection site pain, and "swelling down into the biceps". The medical assistant reported that the nurse practitioner described the patient's arm as "mottled". The medical assistant reported that the patient reported she had also experienced a fever on an unspecified date following the PNEUMOVAX 23. But the medical assistants reported that the patient patient was afebrile on 18-JUL-2011 when the patient was came to the office. The patient sought unspecified medical attention and was not given treatment. No lab diagnostics study was performed. At the time of the report, the patient's present status was unknown. Follow up information has been received from the medical assistant reported that she did remember a female patient in particular who complained a lot, but the one patient was also fine and never heard back from her. Follow up information has been received from a Family Nurse practitioner reporting the patient had penicillin allergy - rash and contrast allergy and no illness at time of vaccination. On 14-JUL-2011 PM, the patient experienced site of injection swelling and then local edema extended to elbow, and yellow / pale discolouration at site & to elbow accompanied with swelling and persistent pain. Subsequently, the patient recovered from these events. Site of injection swelling, local edema extended to elbow, yellow / pale discolouration at site & to elbow accompanied with swelling and persistent pain were considered to be disabling by the Family Nurse practitioner. This is one of several reports received from the same source. No further information is available.
Patient reported no adverse event. Patient's brother brought her for the booster and assisted her in completing her attestation form/consent. The first two doses were verified via database. Later that afternoon it was discovered the patient was in the database twice under different first names. While attempting to merge the duplicate files, it appeared on 11/09/2021 she already received her booster. I called to verify with that facility and faxed the doctor. The booster was given on 11/09/2021 at another facility, but not documented on the patient's vaccination record card.
Huge red swelling on arm site of injection?- hot, burning, itching.  This is subsequent to redness and some heat first three days after injection which had dissipated. This reaction is very bad.
Only HPV second dose administer, flushed, light headed and pale, had juice started to feel better after about 5 minutes. Safely left the office with mother
On 8/15/2021 around 05:00 pm left arm started itching. A red, blotchy, flat rash that was warm to the touch was present around COVID-19 injection site. No pain, and no other rash noted anywhere else on the body. Went to my doctors appointment on 08/16/2021 and informed the provider of reaction. Provider spoke with immunologist at the facility and stated I would be okay to receive second COVID-19 vaccine dose, but to use opposite arm. Rash disappeared 08/17/2021. No treatment necessary.
NUMBNESS/WEAKNESS ON LEFT SIDE OF FACE  WITH SOME DYSARTHRIA NAUSEA, DIZZINESS, HEADACHE
Information has been received from a nurse practitioner concerning a 6 month old female patient with no known allergies who on 01-JUN-2010, was vaccinated with the first one tube dose of ROTATEQ (oral vaccine). There was no concomitant medication. Her relevant past drug history included she was behind on her immunizations and she had very poor immunization records. On 01-JUN-2010, the child received what was thought to be the second dose of ROTATEQ. On 01-JUN-2010, upon later review of the child's immunization records it was discovered that she had never started the ROTATEQ series, so the child actually received a first dose of ROTATEQ series at 6 months old. No relevant laboratory testing was done. As of 01-JUN-2010, it was unknown if the child would receive the remaining doses of ROTATEQ series, and her status was unknown. Additional information has been requested.
Red area softball-size. I instructed patient to apply ice, and take an ibuprofen.
101.7 degree fever,; pain when swallowing; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO183) via an unspecified route of administration in the left arm on 10May2021 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24May2021, the patient reported that after 2 weeks of receiving first dose, the patient noticed white glands in back of throat and experienced 101.7 degree fever, pain when swallowing. On an unknown date, the patient underwent nasal swab test and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit. On 24May2021, the patient underwent test for body temperature and the result was 101.7 degree fever. The clinical outcome for the events fever and swallowing painful were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
First dose no effect. Went into second dose mildly dehydrated, went for a hike and at +6 hrs, myalgias. At +12 hours mild anorexia, nausea, periorbital headache, myalgias. At +14 hours, fevers, throbbing headache, sweats, chills, arthralgia and myalgias, lightheadedness, dizziness, nausea with dry heaves. All symptoms subsided by 25 hours post- injection without residual effects at all.
Case number PHEH2015US020988 is an initial spontaneous report from a pharmacist received on 15 Oct 2015. This report refers to a 16-months-old female patient who was inadvertently vaccinated with FLUCELVAX (batch number:173991) at a dose of 0.5 ml intramuscularly on 09 Oct 2015. No adverse event reported following this medication error.
Knocked out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Knocked out) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Knocked out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Knocked out) outcome was unknown.            No relevant concomitant medications were reported.   No treatment information was provided.    Very limited information regarding this event has been provided at this time. Further information has been requested.  Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
HAD HEADACHE AND GENERALIZED MUSCLE ACHES AFTER VACCINATION. ARM OF VACCINATION SORE.
Redness, swelling and itching on injection site, warm to the touch.  Keflex 375mg BID x 10 days.
10cmx10cm circular, indurated, erythematous area over right lateral thigh.
Arm sore at injection site; Felt pain when moving injected arm forward or backward; Low grade cough; Feels like a tickle in the throat; A spontaneous report was received from a consumer concerning a 77-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm sore at injection site, felt pain when moving injected arm forward or backward, low grade cough, feels like a tickle in the throat.  The patient's medical history was not provided. Concomitant medications reported were Vitamin D, Vitamin B Complex, Calcium, Levothyroxine, Melatonin, Biotin for drug use for unknown indication.  On 11 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown)unknown route for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced the events arm sore at injection site, felt pain when moving injected arm forward or backward, low grade cough, feels like a tickle in the throat.  Treatment details included Zinc, Steam.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, arm sore at injection site, felt pain when moving injected arm forward or backward, low grade cough, feels like a tickle in the throat was unknown.
PEDIATRIC BIVALENT VACCINE INCORRECTLY ADMINISTERED AS A PRIMARY SERIES MONOVALENT DOSE
Rash on left arm where shot was given on day10.  Left arm for a day after shot.
As of disease investigation of 8/22/21 case reported symptom onset of 8/9/21 which included fever, chills, sore throat, headache, fatigue and cough. Still symptomatic.
Blurred vision; This spontaneous case was reported by a patient and describes the occurrence of VISION BLURRED (Blurred vision) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma. Concomitant products included DORZOLAMIDE HCL for Eye drop instillation, LATANOPROST for an unknown indication.    On 10-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VISION BLURRED (Blurred vision). At the time of the report, VISION BLURRED (Blurred vision) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
(L) deltoid swollen Benadryl 1 1/2 tsp: Q 6 hr Ice pack to deltoid.
At approximately 9 -9:15 felt a little fuzzy headed & went to sleep.  woke up at 11:30 pm and could not go back to sleep. When I woke up at 10:30 am Saturday my face was extremely swollen.  My left side seemed to be more swollen then my right side.  Called Dr. on Monday & decided to wait a few days.  Also started to have diarrhea as well on Monday.  The swelling was better by Friday.  Also found that I was having trouble sleeping even though I was feeling extremely tired.  That Thursday I had an extreme burning in my stomach. Only way I can describe it is that it felt like there were flames in my stomach. The burning was so bad that it was making me extremely nauseous.  Friday the burning was better but the burning is still coming &going but no where near as bad as the first time.  Please note that I stopped all vitamins & supplements after I received the shot on Friday.  Im only still taking my adder all.
a little red; it itches a lot; a little swollen; a soreness; a soreness; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of MYALGIA (a soreness), VACCINATION SITE ERYTHEMA (a little red), VACCINATION SITE PRURITUS (it itches a lot), VACCINATION SITE SWELLING (a little swollen) and the second episode of MYALGIA (a soreness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included ZOLPIDEM TARTRATE (AMBIEN), ALPRAZOLAM (XANAX), ZOLPIDEM and ALPRAZOLAM for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced the first episode of MYALGIA (a soreness) and the second episode of MYALGIA (a soreness). On 01-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (a little red), VACCINATION SITE PRURITUS (it itches a lot) and VACCINATION SITE SWELLING (a little swollen). At the time of the report, VACCINATION SITE ERYTHEMA (a little red), VACCINATION SITE PRURITUS (it itches a lot), VACCINATION SITE SWELLING (a little swollen) and the last episode of MYALGIA (a soreness) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications provided by the reporter.
Chills, fever 100.0 F, achy, nausea, headache.
This was the 2nd of the Moderna shots, taken exactly 12 weeks after the first shot.  push out the protection. Received it around the 5pm hour Sunday 11/21/2023, then woke up the next day Monday morning, felt like I got hit by a mac truck or train. Several hours of waves of pains. I had to take the rest of the day off at work at about 11am that morning. I got into the bathtub, Epsom salt trying to relieve pain. Could not go get my childrenfrom school, laid in bed for most of the day, waves of pains. eventually felt like my ovaries and stomach intestines were being ripped out of me. I felt like I was in labor, pulsating waves of pains would come every few minutes. felt like I was going to have a baby, and i have had two child prior to this shots. Because of this reaction, I will never be getting any other Flu/Covid-19 boosters ever again. I am a healthy woman still currently and I keep good care of myself, and am not at high risk for death from Covid-19 which I've had most likely more than once since those shots. I was still messed up, and not 100% for several days, and even several weeks. Not everyone needed to take these shots, I had no co-morbidities.
Pt awoke in AM with severe neck and upper back pain.  Developed numbness and tingling from shoulders down and then quickly turned into weakness then paralysis from shoulders down.  Went to emergency room and diagnosed clinically with T4 transverse myelitis. 12/02/09 DC Summary  and hospital records received for  DOS 10/02/07-10/08/07.  Pt. awoke on morning of 10/02/07 with stiff neck, shooting pain down both arms and progressive weakness of bilateral upper extremities. Admitted to hospital and treated with steroids with initial improvement of left upper extremity weakness. Developed gait ataxia during hospital stay which also improved by discharge. Diagnosed with mycoplasma pneumoniae and infectious disease consult obtained; tx. with antibiotic. Right upper extremity significant weakness remained.  Discharged home to continue physical therapy as outpatient.  DC DX: Transverse myelitis; positive mycoplasma in serum with CSF 12/02/09 Neurology records received for DOS: 10/12/07, 11/20/07, 06/10/08, 01/01/08, 02/15/2008 Pt. presents with continued numbness of left leg with loss of pain and temperature sensation; persistent weakness of right arm  DX: Transverse myelitis; mild lateral gaze nystagmus 12/7/09:  Neurology consult received for date of service 12/2/09:  Dx:  Transverse Myelitis. Full movement of affected arm with continued weakness.  No pain.  Numbness of left leg to pain. Trouble balancing on right leg at times.  mild lateral gaze nystagmus.  Assessment:  Improved, continue Physical Therapy.
A few minutes after patient received the Moderna vaccine in his left shoulder, he reported that his left arm was numb down through his 'pinky' finger (although he was able to move it).  He subsequently reported that he felt tired, he developed a headache, he had some stomach cramps and began to get nauseous.  He did not ever vomit during this period. His blood pressure was monitored and found to be elevated initially at 173/121 (with a pulse of 69). His blood pressure was monitored over the course of just over an hour.  It varied over this period but was elevated.  The pharmacist in charge determined that patient was not able to go back to work. Patent stated that his girlfriend with whom he lives was off work today and could stay with him.  He was advised to call 911 if he started feeling worse. Patient was driven to his home by a co-worker.  Through the course of the day, contact was made with Patient and his girlfriend (per his authorization).  He ate and then slept for some time.  Upon awakening, he vomited for awhile - but  "not alot".  The numbness in his arm started subsiding.  The headache maintained. They had no way to check his blood pressure.  At 3:36pm he indicated he was "doing somewhat better" but the nausea was not any better.
81 y.o. 7/14/1941   Admit Date:  8/11/2022   Discharge Date:   8/14/2022   Discharge Diagnosis:  Principal Problem:   COVID-19 virus infection Active Problems:   Hyperkalemia   Stage 3b chronic kidney disease     Hospital Course:  81 year old vaccinated male was admitted forCovid-19 infection and hyperkalemia. He has been on Remdesivir. Hyperkalemia resolved with treatment. He will be discharged home today in stable condition after receiving the 3rd dose of Remdesivir. Patient educated on appropriate level of care post-discharge. Follow up with Primary Care Doctor in 5-7 days.   Physical Exam on the day of discharge: Last Recorded Vital Signs: Temp: 98.3 °F (36.8 °C) Heart Rate (Monitor): 68 Pulse: 56 BP: 132/56 Respirations: 18 SpO2: 98 % O2 Flow Rate (l/min): 2 l/min General Appearance: no distress  Eyes: PERRLA ENT: moist mucus membranes, no adenopathy Lungs: clear to auscultation bilaterally  Heart: regular rate and rhythm Abdomen: soft, non-tender  Skin: No rashes or lesions  Extremities: full ROM Neuro: alert, normal strength and tone    Consults:  IP CONSULT TO SOCIAL WORK   Significant Diagnostic Studies:   CXR   Operations: none   Disposition:  Home    Discharge Condition:  Fair
APPROXIMATELY 13 MINUTES after receiving my first dose, my stomach started to gurgle and create gas. Had an incident of uncontrollable diahrrea.  Morning breakfast passed with most vegetables( shredded cabbage, carrots and frozen peas intact. NO pain, just humiliation in not being able to get to a porta potty. Fortunately, I was in my car for the entire vaccine procedure and could drive home to clean up.
Had tingling from my elbow down to my hand all day long after receiving vaccine. Wrist felt like I had carpal tunnel syndrome. The next morning i had fever and chills. The next day i woke up with nasal congestion and post nasal drip, sore throat, currently still have nasal congestion 10 days later.
Dizziness, Headache, Myalgia & UrticariaPruritus Narrative: NOT SEVERE, MODERATE INTENSE PRURITIS TO CHES TAND BACK
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction and activities of daily living impaired. On an unknown date, the outcome of the adverse reaction was unknown and the outcome of the activities of daily living impaired was recovered/resolved. It was unknown if the reporter considered the adverse reaction and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported an adverse event (AE). The patient said that she experienced nearly every single adverse reaction (except for the very rare ones) to the SHINGRIX vaccine. It was literally kept away the patient from her normal activities for 7 days. The patient's nurse practitioner (PCP) only said that they might not want the patient to have the 2nd dose. The patient was scared to death to take it and need to know where to go to find out more about this new vaccine and people's reactions to it to date. She already had found obvious reports from the FDA (Food and Drug Administration) and asked to print out more. The patient quickly left the chat with no detailed information.
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 05-JAN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius) for 32 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
PAIN AT SITE OF INJECTION 21 DAYS POST VACCINATION DATE 4/2/22
Eyes water a lot; Rash; This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (Eyes water a lot) and RASH (Rash) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included MONTELUKAST SODIUM (SINGULAIR), VITAMIN C [ASCORBIC ACID], VITAMIN D NOS, VITAMIN B NOS, CALCIUM and ZINC for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced LACRIMATION INCREASED (Eyes water a lot) and RASH (Rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 25 mg. At the time of the report, LACRIMATION INCREASED (Eyes water a lot) and RASH (Rash) outcome was unknown.        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.   Concomitant medications are there Concomitant medications provided in initial source document which is submitted, but they are not captured, but captured in follow-up 1.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Added concomitant medication, treatment medication and anatomical location.
pt c/o extremities fatigue, sore muscles & aching all over & chest pain 2-3 days;pt referred to pvt MD;
Patient received one(1) booster dose with a date that exceeded the Beyond Use Date. Patient has been contacted. Patient physician has been contacted. Patient will also follow up with physician to determine if revaccination is necessary at this time.
Had MMR and Hep B on 5/11/2000, on same evening felt very hot and itching, states entire body broke out in rash and lots of itching, currently still with rash and itching a lot. Referred to PMC for evaluation.