chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: It was unknown that the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment (Paxlovid).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Seizures; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LupusMi-AE2021.12.23.01. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "Seizures". Clinical course: it was mentioned that Pfizer vaccine gave patient and others seizures.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain in left arm from shoulder to wrist during the first 24 hours. Waves of severe fatique for 4 days 2 weeks later herpes on Right lower lip which has not occured for over 2 years and is now painfull despite anti  herpes cream
Feeling Pressure on the Head; Headaches; Fatigue; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 21 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEAD DISCOMFORT (non-serious), outcome "unknown", described as "Feeling Pressure on the Head"; HEADACHE (non-serious), outcome "unknown", described as "Headaches"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; CHILLS (non-serious), outcome "unknown", described as "Chills".  Additional Information: the patient took Pfizer 1st dose 1.5 week ago and had a Feeling pressure on the head, headaches, fatigue, and chills. Asking whether it was normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I have experienced a complete loss of appetite, with no fatigue or nausea. This has been ongoing for three days.
Sick; Initial information was received on 30-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a (unknown demographic) patient who experienced sick (illness) when received INFLUENZA VACCINE.  The patient's past medical treatments, vaccinations, concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On 1976, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 1976, the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I got mine in 1976 and it made me sick."  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
This case was reported by a pharmacist and described the occurrence of expired vaccine used in a 20-year-old female patient who received BOOSTRIX (batch number AC52B094AA, expiry date 8th November 2014). On 3rd December 2041, the patient received BOOSTRIX .5 ml. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.
No additional AE reported; an expired dose of VAQTA was administered to a patient. The dose of VAQTA expired on 04-JUN-2021 and was administered to the patient on 16-JUN-2021; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, allergies, and concomitant therapies were not reported.  It was reported that on 16-JUN-2021, the patient was vaccinated with an expired unspecified dose of hepatitis a vaccine, inactivated (VAQTA) lot # T008698 with expiration date 04-JUN-2021, for prophylaxis (strength, dosage schedule, route, and anatomical location were not reported). No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008698; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Arm soreness right after injection and for 2 or 3 days after.   On Fri01/ 222021  pain under left arm pit, later that day left deltoid hot and swollen hard to touch , very painful to touch or lift arm.. with 2 giant hives . Later in week same symptoms  came back. .Day or 2 came back . now  symptoms gone except when I move arm a certain way.
Sugar spiked increased insulin till comes down to normal, tea and tylenol for the throwing up, fever ,headache body feeling like it weighs 1000pound.  Calling Dr. on monday
Extreme depression with suicidal thoughts, irregular heart beat, tremors in head and hands, nausea, changes in vision, and lack of energy.
husband reported to BOH on 3NOV95: 2hrs p/vax coughing, chills, muscle aches, fever 102, h/a, nausea, diarrhea; bedrest-no medication taken;these sxs lasted approx 24hrs;
Memory loss, memory lapses, all over nerve pain, ovarian vein thrombosis, pulmonary embolism
Upset stomach.  Spitting up (to the point of vomitting on the first shot, severe spit up on second, and extra spit up on third) as well as general stomach upset (pain, gas).  A slight fever as well.  Tylenol was given for the fever as needed, with a reduction in fever.  Gas drops given to help stomach pain, no effect.
@ 3-5 min... arm started feeling a little sore, like a dead arm. That was the extent of things for a few hours.   @ 4 hours... randomly while doing absolutely nothing started getting short of breath + breathing through a tube feeling + drastically increased brain fog.   @ 11 hours... splitting headache + arm at the injection site painful to the touch + combination of pain/discomfort kept me awake all night despite my sleep Rx for insomnia.   @ 17-18 hours later... leg muscles were sore and achy and cramping if I stayed in any position for too long. Began to feel feverish yet had no temperature (yet). My saturation which frequently drops but always rebounds fairly quickly stayed at about 90% for over an hour.   @ about 20 hours... I began to get swollen lymph nodes and my temperature started climbing into the high 90?s (my ?normal? is around 97° so this made me feel like I was on fire). My SpO2 dropped to 84%... the lowest I?d measured it, even when hospitalized for a week back in December. Everything also felt heavy?every part of my body, anything I?d try to pick up... as of gravity had suddenly increased.   @ 22 hours... low grade fever of 100.2° while on Tylenol... so w/o it likely would have been higher.   @ 24 hours later... (330pm next day) it all really hit me... my saturation dropped to 79%. With otc cans of oxygen it only went up to 84% and kept dropping back to 80%. I was unbearably hot and uncomfortable and sore everywhere, but especially my neck and shoulders. I had zero appetite.   @ 26 hours... chills so bad I couldn?t get warm when wearing a fleece, under 3 blankets, and head covered.   @ 29 hours... so nauseous I couldn?t eat + my temperature (still with Tylenol in my system) peaked at 101°.   @ around hour 30... so unbearably hot had to shed all the layers I?d put on + over me. My temperature was just barley back under 100° at this point (Tylenol still in system).   @ 34 hours... Overnight arm pain + chills retuned to the point woke up from sleep Rx. I had to take more Tylenol due the pain. Got fully dressed with hoodie + fleece on all under my comforter in bed. Despite deep chills my forehead felt like it was literally on fire, but I couldn?t find the thermometer so who knows what my temperature was.   @ 42 hours... dizzy + disoriented + saturation 86% + injection site pain.   @ 48 hours... appetite still suppressed + injection site pain (though less than at worst)
COVID-19 INFECTION (FLU LIKE SYMPTOMS/COUGH); This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-MAY-2021 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 06-MAY-2021, the subject experienced covid-19 infection (flu like symptoms/cough).  Laboratory data included: COVID-19 virus test (NR: not provided) Positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine  was not applicable. The outcome of covid-19 infection (flu like symptoms/cough) was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Started having tightness in chest, shortness of breathing, fast heartbeat, body was shaking. Went to Emergency room. Took chest X-ray, blood work. All the heart and lungs related tests were normal. Doctor gave Prednisone 20mg, Benadryl shot, and Albuterol inhaler. Same symptoms repeated after couple of weeks. I could able to manage with Alegra, Nasacort, and Albuterol. Visited Cardiologist for heart evaluation in May. Cardiologist confirmed that heart is healthy.
Patient received her 1st GARDASIL shot on 1-16-09. She received no other shots and was on no medication. On 1-20-09, patient woke up with flu-like symptoms fever, upper respiratory congestion, body aches, and weakness. On 1-22-09, patient was treated at urgent care for her flu-like symptoms and bronchitis. She was given a 1st dose of Azithromycin, PREDNISONE and MUCINEX mid-morning. After sleeping for 2 1/2-3hours, patient got up, sat down to eat felt ill, got up, and passed out, hitting her two front teeth and severing them. She went by ambulance to hospital ER, although she regained consciousness right away, her skin was a strange white color and her pupils were dilated. She has had no other problems since her ER treatment, but her two front teeth had to be replaced with crowns.  3/16/09-ED records received for DOS 1/22/08-presented with C/O lightheadness, syncope, nausea, felt faint, brief loss of consciousness. Abrasions on inner lips, oral laceration, suturing required. Dental injury. Impression: syncope.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received bnt162b2 (BNT162B2 NOS), on 11Sep2022 at 16:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). No known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Sep2023) Positive, notes: positive test 2 days after completing final dose. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Left deltoid noted warm to touch, redness with 1.0cm X 1.5cm nodule.  Dr. assessed area; ordered cool cloth then warm compress.
mild soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (mild soreness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Allergy to antibiotic (Tetracycline). Concomitant products included INSULIN for Diabetes mellitus.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-1021, the patient experienced PAIN (mild soreness). At the time of the report, PAIN (mild soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.   This case was linked to MOD-2021-059515, MOD-2021-059515 (Patient Link).
Janssen COVID-19 Vaccine EUA  HPI The patient presents urgently with a friend after right lower extremity venous dopplers revealed an acute DVT. The patient apparently presented to podiatry, for foot pain and the doppler was ordered. When the result was positive yesterday, office reportedly told radiology to call my office after I had already left the office.  The patient reports the pain in her RLE is improved.  The patient denies any trauma to the leg or recent prolonged immobilization including car/plane trip. Of note she does say she received the J&J covid vaccine a month ago.  Discussed risks of DVT and treatment options. Discussed association with breast cancer and Arimidex as well as covid vaccines.  Will try to treat with Eliquis 10mg bid for a week then 5mg bid. Will discuss with oncology whether she may stop Arimidex. If she can, will likely treat with Eliquis for 3 months; otherwise will treat with Eliquis until she completes her course of Arimidex.  Will report possible adverse event to VAERS.    5/7/21 ADDENDUM Discussed case with oncology, who corrected me that Arimidex does not increase risk of VTE. Will continue Arimidex with long term anticoagulation. Patient will be notified.
Nerve pain, burning sensation on total body.   From top of head to feet, includes stomach, arms, back, legs, head
11-30-06, 3:45PM CHILD WAS C/O PAIN AT INJECTION SITE. MOM CHECKED AND FOUND AREA 5 CM X 3.5 CM. RIGHT UPPER ARM RED, HOT, TENDER, RAISED AT INJECTION SITE OF DTAP.
Sore arm with moderate pain Headaches - began at 5:00 PM the day of vaccination - Symptoms were bad for first 72 hours Tired - Symptoms were bad for first 72 hours Muscle pain - Symptoms were bad for first 72 hours Stomach pain - Symptoms were bad for first 72 hours Nausea - Symptoms were bad for first 72 hours Redness at injection area - appeared 3 days after vaccination and lasted 36 hours Swelling at injection area - appeared 3 days after vaccination and lasted 36 hours
Developed shingles at site of vaccination (laboratory verified). No prior history of varicella.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On an unknown date, the patient was inadvertently vaccinated with improperly stored doses of PEDVAXHIB (lot# N007751, expiration date 30-NOV-2019); VAQTA (lot# N017094, expiration date 31-AUG-2018); and VARIVAX (lot# M033906, expiration date 20-JUL-2018) reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (unknown lot # and expiration date) (for all vaccines exact doses, dose # and routes of administration were not reported). Administered doses of PEDVAXHIB and VAQTA experienced the temperature excursion of 47 Fahrenheit degrees to 77 Fahrenheit degrees for 30 minutes. Administered dose of VARIVAX experienced the temperature excursion of 15 Fahrenheit degrees to 46 Fahrenheit degrees for 30 minutes. Regarding all vaccines, there were no previous excursions reported and the digital data logger was involved to capture the temperature excursion. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1806USA008595:
Received the varicella vaccine on 04/09/2002 and began with chicken pox symptoms and rash 12/18/2002.
broke out all over in a terrible rash; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the parent.  A 19 year-old female patient received bnt162b2 (BNT162B2) (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: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization.  The following information was reported: RASH (non-serious), outcome "unknown", described as "broke out all over in a terrible rash".  Additional information: After her second Covid vaccination She broke out in a terrible rash all over her body. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was extremely anxious prior to receiving COVID vaccine. After 30 minutes of administration, vomiting occurred. Dry heaving followed. Did not have an allergic reaction. Did not need to call 9-1-1. Just worked himself up so much about it. Sent him home as I didn't want him to complete his shift while vomiting. Was having chills and wasn't sure how long they were going to last. Left him to go home with girlfriend. Went out front to wait for his ride and get some fresh air. Exchanged numbers so I could keep in contact with him. Knows to contact EMS if symptoms worsen.
COVID-19; Lack of Efficacy; she felt sick; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), DRUG INEFFECTIVE (Lack of Efficacy) and MALAISE (she felt sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included Oral surgery (to have a tooth pulled) in August 2021.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19), DRUG INEFFECTIVE (Lack of Efficacy) and MALAISE (she felt sick). At the time of the report, COVID-19 (COVID-19), DRUG INEFFECTIVE (Lack of Efficacy) and MALAISE (she felt sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative, negative (Negative) Negative and positive (Positive) Positive.         No concomitant medications were provided by reporter. No treatment medications were provided by reporter.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 and mRNA-1273 is assessed as not applicable. For the rest of the events, 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.
Patient felt like passing out 9.30.14 dizzy - 9.30.14. Headache 10-1-14 in am. Not feeling well, foggy 10-1-14 am.
Anaphylaxis- Tongue swelling, tightening of throat, dryness of throat, difficulty swallowing, swelling above eyes, skin dryness, rapid pulse, increase blood pressure
Stiff, sore right upper arm. In the night, terrible stomach ache, nausea, headache. Next day: nausea, fatigue, headache. I took a 3 hour nap in afternoon and I never take a nap unless I don't feel well.
Shortly after getting the second dose, my legs started cramping the 3rd day after and then I came down with shingles. It started at my lower back and traveled down my left leg to the bottom of my left foot.
Started with a high temp, exploding headache, upset stomach, and extreme back ache and shivers/ tremors. After 18 hours, all side effects had went away except for a slight headache and the tremors  Tremors are over the body and happen about 4/5 times a minute,
Case number PHEH2014US003678, is an initial spontaneous report from a pharmacist received on 20 FEB 2014. This report refers to a 16-year-old patient of unknown gender. The patient's medical history and concomitant medications were not reported. This patient under the age of 18 might have vaccinated with 0.5 ml of FLUCELVAX (batch number: unknown) intramuscularly on an unknown date in NOV 2013. No adverse event was reported following the medication error. No further information was provided.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 20 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".