chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough infection / covid test result=Positive; Breakthrough infection / covid test result=Positive; 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 41 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 15Feb2021 (Lot number: EL3247) at the age of 41 years as dose 2, single and intramuscular, administered in arm right, administration date 26Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Allergies: Tetracycline". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Dec2021, outcome "recovering" and all described as "Breakthrough infection / covid test result=Positive". The event "breakthrough infection / covid test result=positive" and "breakthrough infection / covid test result=positive" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Additional Information: if other vaccine in four weeks: No, other medications in two weeks: N/A, adverse event: Breakthrough infection, if covid prior vaccination: No, if covid tested post vaccination Yes, other medical history N/A. Dose received: 2, Most recent dose details: Product= COVID 19, Brand= Pfizer. Previous dose details: Prev dose product=COVID 19, Prev dose brand=Pfizer.
COVID mRNA vaccine- unspecified which one Reaction: cough, hives, rash, shortness of breath, swelling Severity: High
Bells Palsy. On April 4, I started feeling my mouth move funny while talking. By the next day, the right side of my face is largely unresponsive. When I raise my eyebrows, the right barely moves. When I try to smile wide and show all my teeth, the right side misty closed.
patient reported to have guillain barre aproximately 2 months post vaccine. 11/03/2008 MR received for DOS 7/08-8/05/2008 with D/C DX: Acute Guillain-Barre syndrome.  HTN-new onset.  Persistant sinus tachycardia.  SIADH. Acute CMV infection complicated by CMV hepatitis. Pt presented with worsening weakness of extremities, neck pain and stiffness, numbness, tingling and paresthesias of the hands, feet and legs.  PE (+) for marked weakness, quadriparesis, abnormal unsteady gait, DTRs absent except plantars. Tx with 2 rounds IVIG with little improvement. 1st. BP and HR were persistently increased. Pt developed SIADH tx with fluid restriction. Pt later developed fever to 103.1. Elevated liver enzymes/hepatitis 2' to CMV infection with lekopenia. D/C to rehab with guarded prognosis.
08/15/2012 pt had 10 X 15 duration in left deltoid. Pt taking Motrin and ice tid. Pt happy, playing and eating well.
Persistent increasing body aches, Muscles/joints, headache and severe fatigue. Received late Wed 2/3. No major issues. Thursday very achey and tired, Friday severe fatigue and body aches. Sat same, still able to do stuff just very slow and painful.  Sun. slept all day and body hurt even more. Monday back to work still fatigued and achey not as bad as yesterday.  Advil taken on Sat. with no benefit. Sunday took an old FLexeril that I had and that did knock some of the pain down. Monday aleve with no benefit.
Chills, fever, joint pain, headache, nauseau, diarrahea all started about 7 hours after the shot.  Lasted for about 9 hours.
Migraine equivalent Visual snow syndrome Migraine without aura and without status migrainosus, not intractable Dysautonomia (HCC) Intractable persistent migraine aura without cerebral infarction and without status migrainosus POTS (postural orthostatic tachycardia syndrome) Adverse effect of COVID-19 vaccine
Swelling, redness, entire arm was hot, fever, chills, aches, sense of throat swelling, fatigue.
eye pain; This is a spontaneous report from Pfizer-sponsored program via a contactable consumer. This contactable consumer reported same event for both her son and herself. This is the report for patient herself. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient and her son both got their 1st dose yesterday(20Apr2021) of the Covid vac-cine and now today (21Apr2021) they are experiencing eye pain. She wanted to know if this was a normal side effect. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Lt deltoid injection-10 min. later pain shot to hand and lt thumb numb. Injection site noted in std location, belly of deltoid.
REDNESS  AND RASH  ITCHING IN THE AREA OF INJECTION, FEELS HOT . AREA  2IN   X 3 IN
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 23-SEP-2011, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0345AA expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.
Breakthrough case. My throat started feeling a scratchy and dry, then felt tired with a lower back ache and felt extremely tired. Started having a dry cough as well. Tested negative with a home COVID-19 test. My lower back pain worsened the next day and felt congested, took another at home test and tested negative again. Still feeling really bad, so went and got the PCR test and tested positive. Stayed home and rested, the next day I got a fever, headache and severe back pain went all the way up my back. I still hadn't had the results back from the PCR test, so I took another home test and it was positive. Just rested and started to slowly feel better a few days later except I got nasal congestion and still have it 3 weeks after testing positive for COVID-19.
my daughter received her first shot of COVID and tested positive for COVID two days later; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, 2 days after receiving the first dose of vaccine, the patient was tested positive for COVID. Reporter wanted to know if her child can receive the Pfizer vaccine or not. The patient underwent lab test and procedures which included SARS-COV-2 test: positive, on an unspecified date. The clinical outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
14 year old female discharged last week on 1/28/22 from ICU after admission for acute respiratory failure requiring HFNC and myopericarditis of unclear etiology; received one pulse dose of IVMP (1000mg) and was started on colchicine 0.6mg daily, as well as coverage for possible pneumonia (received CFX inpatient and went home on Clindamycin).   As per mother and patient, after going home on 1/28/22, the same night, fever developed, with temp of 101. Motrin was given, to which fever responded. Over the weekend, she was noted to have chest pain again, and had fever again on Sunday, temp 101F, associated with dyspnea and chest pain. This morning, chest pain worsened to the point that patient felt she could not breath. She presented to ER  at that time.
Numbness to roof of mouth and difficulty swallowing experienced around 1455 pm, but not reported until 1520 pm; Benadryl 50 mg IM given at 1522;  EMS called at 1524 and client transported to Hospital via ambulance approximately 20-30 minutes after arrival.
Inpt rehab pt w/complex hx including stage IV gleason 10 adenocarcinoma of prostate w/mets to bone admitted for related debility & recent complications (hematuria, bladder spasms, acute on chronic anemia, acute on chronic kidney dx stage 3 w/underlying electrolyte disturbances. Developed fever and cough on 8/1 and has tested positive for COVID (8/1) despite having tested negative twice prior and having had received Pfizer vaccinations on 2/4 & 2/26. Pt has not required any respiratory support at this time. Will continue to monitor for resolution of symptoms as pt is no longer febrile.
Presented with fatigue x3d, body aches; + covid 10/15; CXR:        dx Covid PNA; Labs: D-dimer: 0.67, CRP 10.9; Ferritin 470     Meds: Decadron, Zinc, Vit C, Lovenox, Remdesivir;  Initially on 3 LPM NC; down to 1 LPM at time of dc (baseline is room air); Home on 1 LPM O2, Decadron, zinc and Vit C
This spontaneous report was received from a physician reporting on herself, a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # and dose not provided), via intramuscular route. On an unknown date the patient experienced pain at the injection site. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Patient got the flu shot Saturday, you woke up Monday morning at 4AM with projectile vomiting, body aches, 104.9 degrees temp, shortness of breath, headaches.
Sudden onset of heart arrhythmia 2 1/2 days post-vaccine. I immediately rushed to the ER and was quickly diagnosed with atrial flutter and a heart rate of 160. I was monitored for about 3 1/2 hours and had an X-ray and bloodwork performed. My atrial flutter resolved after about 1 1/2 hours, and I was released from the hospital. I had no prior history of heart disease other than a very mild mitral murmur. So far the arrhythmia has not recurred. I have seen a cardiologist, and have a nuclear stress test scheduled in 3 days.
PAIN; SICK; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced pain, and sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pains and sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20210728450.
Redness/Rash (4 inches by 2 inches) around injection site, headache, slight fever, general tiredness and feeling weak. These still existed at the time this report was filed (3 days). Took over the counter pain reliever (Advil) to address some of the issues being experienced.
Information has been received from a health professional concerning a 15 year old female with no allergies who on an unspecified date was vaccinated with an "injection in the arm" (unspecified) of GARDASIL (lot number not available).  The patient broke out with a rash at the injection site after receiving her first dose of GARDASIL.  The onset was noted as one day after the vaccination.  Unspecified medical attention was sought.  The rash lasted for 2-3 weeks.  Subsequently, the patient recovered from rash at injection site 2-3 weeks after vaccination.  A product quality complaint was not involved.  Additional information has been requested.
Patient began to experience new, sometimes severe arthralgia about two weeks after vaccination. The location was non-specific but came to dominate on her right side, and particularly in her right knee. While it has varied at times since, it has continued to be a significant cause of pain and inability to function well with the right knee, especially. In an office visit with related tests and discussions, Dr. has excluded the potential of rheumatoid arthritis onset. He has suggested the possibility of fibromyalgia but has not confirmed this with the work-up recommended by specialists such as at the Clinic Fibromyalgia and Chronic Fatigue Clinic. She is being medicated with nortriptyline.
I had not had a menstrual cycle in 11 months and was considered perimenopausal. A few days after my vaccine, my cycle started.
Pt had normal exam on 8/21/00, even though mom reported child had a 1 week history of "screaming fits", "foaming at the mouth", initial choking with feedings and spitting up more than usual. Shots were given that day and mom thinks the screaming worsened for a week and then got better by 8/27/00. The doctor prescribed Zantac to treat a presumptive esophagitis, perhaps associated with gastroesophageal reflux, despite an essentially normal barium esophagram and upper GI. The possible dx of dyspepsia, seizure equivalent, acute paroxysmal vertigo and acute migraine headache were entertained and despite the resolution of symptoms by 8/27/00, an EEG was performed on 8/29/00 and found to be normal. No other therapy was given, although the mom tried the pt on thickened feedings.
Patient noticed a red, spotted, raised rash the evening of the day she received the influenza vaccination. Other causes were ruled out.
chills; fever; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001L21-2A, 009021A and 026B21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot and Flu shot. Past adverse reactions to the above products included Chills with Flu shot; and Fever with Flu shot. Concurrent medical conditions included Sjogren's syndrome (15 years), Drug allergy and Allergy to antibiotic. Concomitant products included LEVOTHYROXINE, ALENDRONATE SODIUM (ALENDRONATE), LORAZEPAM, ESTRADIOL, AMLODIPINE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2022, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) had resolved.            It was reported that the previous Moderna COVID-19 vaccines has made patient really sick. The patient experienced a similar event in the past with flu shot.  Patient had never been diagnosed with/ tested positive for COVID-19.  No treatment details were provided   This case was linked to MOD-2022-646758, MOD-2021-272492 (Patient Link).
2 days after vaccination, developed slight facial swelling and facial rash.  By day 3 facial swelling included around eyes.  Denies difficulty swallowing or breathing.   Seen in ED. Patient treated with Benadryl and Pepcid PO.  Discharged from ED to take Benadryl every 6 hours as needed.  Spoke to this patient about incident 1 week later and she has reported that symptoms are almost completely resolved.
Approx 8 hours after receiving the vaccine I was awakened in my sleep by EXCRUCIATING pain in my shoulder/upper arm (elbow to shoulder)/ which then radiated into the clavicle area. It felt as though I'd been hit with a baseball bat multiple times. Although my arm appeared normal, it felt broken. I had zero range of motion and my whole arm tingled from shoulder to fingers. I became very nauseous from the pain but did not vomit. It was impossible to find a comfortable position.  This went on for approx 2 hours. I took two 350 mg acetaminophen. It was AWFUL and terrifying.  I'm uncertain I would EVER receive this vaccine again (ie 5 yrs) and will caution all friends/family who are contemplating receiving it.
Pt got 4 prescribed immunizations IPV + DTaP in right arm. Area became quite swollen and red, hot and painful. Entire upper arm involved.
accidently giving the adult Pfizer vaccine to 10 years old patient. Patient is feeling fine.
I was administered 5 times the recommended dose. At this time I am not experiencing any adverse effects to the vaccine.
Random menstrual cycle. Patient is on birth control and is getting full periods and spotting in the middle of pill packs. Patient also had a reaction at the injection site after both doses of vaccine. Patient continues to have a rash on injection site every time she starts random menstrual cycle.
Information has been received concerning a 4 month old male who on 5/3/00 was vaccinated. On 5/3/00, 3 minutes, post vax, the pt developed small hives on his legs and lower trunk. The pt was treated with Benadryl and the hives resolved. It was noted that when the pt received the vaccines at 2 months of age, he did not have any reaction. No further information is available.
fever; chills; muscle pains; dizziness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 5th August 2019, 1 days after receiving Shingrix, the patient experienced fever, chills, muscle pain and dizziness. On an unknown date, the outcome of the fever, chills, muscle pain and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, muscle pain and dizziness to be related to Shingrix.  Additional information received were as follows: The caller reported that he received the 1st dose of Shingrix the day before the reporting date. The patient woke up this morning with mild side effects of fever, chills, muscle pains, and dizziness. The reporter consented to follow up.  The case was related to patient.
I had pain at the injection site with fatigue for a day after receiving the injection. I have had back pain for a number of years, but it was getting worse. I went on vacation with my family and when we returned, I saw my doctor. I was referred to the orthopedist's specialist. I have a lot of inflammation in my back and was given an injection. The first worked for a while and the second did not help. I take medication to help with my symptoms.
Patient complained of blurred vision, momentary disturbance in hearing, dizziness, body sweats - all within 5 minutes of injection. Red splotches appeared but disappeared within 20 mins of injection. Denied any trouble breathing. Patient recovered back to normal after sitting for 20 mins!
Information has been received from a 65 year old white female pt who on 10/12/99 was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent, IM in the left deltoid. It was noted that the 1st dose was administered in 1986. She also had influenza virus vaccine, IM in the left deltoid and "trivalent A and B." Approximately 3 to 4 hours, post vax, the pt reported that her arm became "swollen, red, hot and raised." She also reports that "it's now migrating down to the area near my elbow." unspecified medical attention was sought. Follow-up information from a physician indicated that 1 day, post vax, the pt was seen by a NP. The pt presented with "pain, erythema, hot and mild swelling just below the injection site in the left deltoid. She also had pain in her left elbow and left forearm. The pt was treated with Benadryl, Celebrex and amoxicillin. The pt was seen on 10/14/99. The pt's swelling and reaction symptoms had greatly improved." Follow-up information from a LPN, indicated that on approximately 10/14/99, the pt recovered.
After receiving vaccine, patient walked down hallway stopping at check-out desk, while standing at desk area patient fainted hitting nose on door handle.
Pt claimed she has severe pain in (L) arm/shoulder where she had received a flu vax.
Systemic: Chills, Systemic: Fever, Systemic: Diarrhea; symptoms lasted 2 days
nausea; chills; soreness of arm; This is a spontaneous report received from a contactable consumer reported for herself. A female patient of unspecified age received first dose bnt162b2 (batch/lot number: unknown, brand: Pfizer) via unspecified route of administration at unspecified location on an unknown date at single for covid-19 immunisation.The patient relevant medical history and concomitant medications were not reported. The patient got the first dose of her Covid vaccination about a week ago and she needs to get a TB test and wants to know if she needs to wait until she is finished with all the Covid vaccines, if it is okay to go ahead and get it, or how long will she have to wait after the second Covid vaccine dose to get the TB test. One week after vaccine administration, the patient experienced chills, soreness of arm, and nausea. Outcome of the events chills, soreness of arm, and nausea was unknown.  Follow-up attempts have been completed and no further information is expected.
sore throat; it hurts when he swallows; he had a lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), PHARYNGEAL SWELLING (it hurts when he swallows) and OROPHARYNGEAL PAIN (he had a lot of pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), PHARYNGEAL SWELLING (it hurts when he swallows) and OROPHARYNGEAL PAIN (he had a lot of pain). The patient was treated with AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOXICILLIN & CLAV. POTASSIUM) ongoing from 19-Feb-2021 at a dose of UNK dosage form. At the time of the report, OROPHARYNGEAL PAIN (sore throat), PHARYNGEAL SWELLING (it hurts when he swallows) and OROPHARYNGEAL PAIN (he had a lot of pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.