chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Registered nurse regarding a 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
Information has been received from a patient's mother concerning a 22 year old female patient with no pertinent medical history and no allergies who in approximately May 2008, was vaccinated with the second dose of GARDASIL vaccine (yeast) 0.5ml IM. There was no concomitant medication. In May 2008, the patient tested hepatitis C positive two weeks after receiving her second dose. The patient sought medical attention, Additional information has been requested.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about  06-MAY-2011, the patient was vaccinated at a clinic with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent herpes zoster virus. On or about 30-AUG-2016, the patient was treated by a physician for painful vesicular outbreaks that had been present for a week. The patient was then diagnosed with herpes zoster, or shingles. The patient has been prescribed tramadol and gabapentin for management of his persistent painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Redness around injection site the size of a quarter. About 2" below injection site another circular redness began as a quarter size at Day 7 and grew to 10x the size of a quarter by day 10. Also itching like a bug bite.
Shortly after the shot I became slightly dizzy.  I had what seemed like a mild case of vertigo and nausea.  This hasn?t gone away 6 days after the shot.  Symptoms have existed each day since the vaccine.
I have had Bell?s palsy twice in the past. About ten days after I got the vaccine I started with sores and similar symptoms to Bell?s palsy including twitching and paralysis on my right side. I had some valtrex  on hand and started taking them.
First was sore throat, fever, fatigue, sinus, cough, sore lymph nodes. I couldn't sleep. The symptoms in a lesser degree I still have 12 days later, but they are ebbing quickly. My doctor talked me out of the antiviral medication.
Got the shot at a community clinic on 9/13 and on 9/15 spiked a fever of 101.8 and was very lethargic with limited appetite
hives/urticaria; dermatographia; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives/urticaria) and MECHANICAL URTICARIA (dermatographia) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H21B and 025A21A) for COVID-19 vaccination.     Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL) for Birth control.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced MECHANICAL URTICARIA (dermatographia). On 18-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives/urticaria). At the time of the report, URTICARIA (hives/urticaria) and MECHANICAL URTICARIA (dermatographia) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that patient had no previous history of allergies and did not had covid-19 infection in the past. After booster dose, on 18 Jan 2022, patient woke up in hives. Treatment medication included as Antihistamines.
pt recv vax 8JAN97 & on 4FEB97 lab eval revealed a negative varicella titer of 1:8;
On 1/27/2023 I had a runny nose and slight fever. I tested and the test was positive on 1-27-2023.  I called the clinic on a Sunday morning and they referred me to urgent care to get a blood test  for Creatinine Test  and then they prescribed Paxlovid. My symptoms lasted 5 days.  On 04/01/2023 at 11:20AM my watch gave me a notification that I went into A-Fib that night while I was asleep. The clinic recommended I go to Emergency Room and get checked out and everything was normal on 04/02/2023.  They sent me home and ordered a heart monitor and I have been wearing it for 14 days. I had a 2nd incidence of the A-fib last week when I was awake.
c/o tenderness @ site Monday;husband noticed redness 7" x 2 1/2" red area;c/o tenderness + itching;
I have always had very low blood pressure. As soon as I took my 2nd dose, my blood pressure changed. It spiked and had never had that before. I ended up in the ER. I went through many tests. Blood work, Even my doctor said he had been keeping records of those who took the Pfizer and other patients had also experienced high blood pressure. I have been hesitant to get the booster. I really think it was an adverse reaction. I am still taking blood pressure medication.
Severe myalgias and fatigue for 6 weeks, requiring the use of analgesics and muscle relaxants.
Symptoms developed were primarily congestion, coughing, difficulty breathing (mild), low grade fevered that persisted on first day only.  Please note the onset of these symptoms came after 3 days of exposure from my son living in household who had much worse symptoms including severe coughing and fever.  My son?s symptoms developed about 48 hours after returning from a business trip where we were both exposed to other team members who later tested positive for COVID19.
frequent crying, sleeping little-esp when leg touched;  High fever, not eating well; underdosed APAP; seen by MD on 10MAR94, found that parent was not giving appropriate dose of APAP; have been unable to contact parents since seen on 10MAR;
throbbing h/a especially behind eyes 24hr duration;vomiting 12hr duration;low back pain x 3 days;
patients arm started swelling at the injection site about a minute after administration, redness started spreading to neck and face. had no difficulty talking or breathing.  did not want an epipen, was given 50mg Benadryl  which she had taken before with no problems. was monitored every 10 minutes for 30 minutes.  redness in neck and face almost disappeared but arm was still a bit swollen at the injection site.
Child's leg at injection site became red, warm and swollen the next day. Second day after injection redness spread. Mother had applied cool compress. Took to ER when worsened
Pain, swelling & redness at site of vaccination. Diagnosed as cellulitus per urgent care visit documentation (The patient presented to the urgent care 5/1) onset of symptoms 1 day ago (4/30/2015) no other information known re: specific time course.
Same day of vaccination later on at night I got a fever of 105F,  felt very nauseas, every time I stood up I felt like I was going to pass out & my blood sugar was high. This event lasted about 48hrs but I'm also experiencing swelling & problems with unration. I'm still waiting to get in contact with my doctor. Have not fully recovered from advers event waiting to get lab work done.
After his 4 month shots, he got a fever and screamed all night and then after a couple of days went to the doctor for a double ear infection.
At approximately 10 pm on 1/28/2021, I got shivers and continued with fatigue, headache, (almost like a migraine that I used to get), overall achy, nausea, dry heaves, and fever of 100.5. During the night when I got up for the bathroom, I was very dizzy.  In the morning, the dizziness, shivers, and the dry heaves were gone.   However, the fatigue, headache,achiness  and nausea  and fever continued until approximately 6 PM on Friday.  Everything started to get better and  continued to improve.  It is Saturday 1/30/2021 at 5 pm and all symptoms have disappeared.
Patient reported to health center on 1/7/2021 with complaints of redness and  rash to LUE. Received Moderna Covid vaccine on 12/30, reports symptoms started on Wednesday January 6 in the evening. Rash is red and raised, measures 7 cm x 15 cm, warm to the touch and tender. No other systemic reactions were noted or reported by the patient. Patient was prescribed Cephalexin 500 mg TID for 7 days. Encouraged to treat symptoms with Tylenol or Advil as needed and to follow-up via phone with provider on 1/8/2021.
she had a really bad migraine; This is a spontaneous report received from a contactable consumer (the patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0170) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8734) on an unspecified date for COVID-19 immunisation. Caller stated after the second dose of Pfizer's COVID vaccine, she had a really bad migraine and wanted to know if that is associated with the vaccine. Caller asked if there was any reason to avoid taking Aspirin. The outcome of the event was unknown. The report was non-serious.   No follow-up attempts are needed. No further information is expected.
sore and red arm / bigger patch of redness on arm; sore and red arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (sore and red arm / bigger patch of redness on arm) and VACCINATION SITE PAIN (sore and red arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (sore and red arm / bigger patch of redness on arm) and VACCINATION SITE PAIN (sore and red arm). At the time of the report, VACCINATION SITE ERYTHEMA (sore and red arm / bigger patch of redness on arm) and VACCINATION SITE PAIN (sore and red arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported after 12 days there was a bigger patch of redness on arm. Concomitant medications were not provided. Treatment information was not reported.
Pulmonary embolism, Dystonia Recovered from PE Struggling with Dystonia, Starting Treatment
Later evening notice my daughter's skin was getting warm, and she was complaining about headache, pain in her knees and her neck. Fever 102+. Gave 1 /12 tsp ibuprofen at approximately 8pm. Woke up at 4am, fever 102+. Gave 1 1/2 tsp Ibuprofen. Woke up at 7am this morning. Fever at 101.8. Still complaining legs and neck hurting, headache. General discomfort. Will call health care nurse for my health insurance.
This spontaneous report was received from a physician via company representatives, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 07-OCT-2014, the patient was vaccinated with an unspecified stored dose of PNEUMOVAX 23 "10 Single dose 0.5mLVIs 10SDV" with lot number J009689 and expiration date of 29-JAN-2015 (route of administration and anatomical location were not reported), which was stored at 59.9 Fahrenheit (F) Degrees (15.5 Celsius) (highest recorded temperature) for a total of 5520 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported and nor product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Vaccine reactions First dose = first day = slightly sore at injection site.  Second day =arm soreness worsened fatigue-set in in the afternoon.  Third day =slightly fatigued and injection site only slightly sore but hot to the touch , swelling under the eyes. Second dose =First day= injection site slightly sore. Second day= injection site swollen and much more sore , tiredness and  fatigue , shortness of breath and dizziness was experienced later in the day  Third day =  injection site still sore and hot to the touch tiredness a fatigue , shortness of breath was experienced all day , loss of appetite and nauseous . Had a slight Headache and it hurt to brush my hair. Forth day= slept 10 hours which I never do, had to force myself to get out of bed, experienced extreme fatigue , shortness of breath and dizziness all day . Took blood pressure and found it to be very low 109/68 . I am on meds for hypertension. Injection site sore and warm to the touch. Under eyes very swollen. Fifth day=  pretty much back to normal other than slight shortness of breath.
VACCINE ADMINISTERED FROM THE OVERNIGHT REFRIGERATED PUNCTURED VIAL; This spontaneous report received from a health care professional concerned a 71 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-JUN-2021, the subject experienced vaccine administered from the overnight refrigerated punctured vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered from the overnight refrigerated punctured vial was not reported. This report was non-serious. This case, from the same reporter is linked to 20210613154.
Brain fog; Extreme fatigue; can barely stay awake; Not wanting to do anything; Trouble with balance control; Headaches in rear of head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: EW0Z0Z), in right arm for covid-19 immunisation. The patient's relevant medical history included: "PE" (unspecified if ongoing); "DVT" (unspecified if ongoing); "Afib" (unspecified if ongoing). Concomitant medication(s) included: CELECOXIB; FOLIC ACID; GABAPENTIN; HYDROXYCHLOROQUINE. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: CW0198, Anatomical location: Arm Right,, Vaccine Administration Time: 09:00 AM), for Covid-19 Immunization; Bnt162b2 (DOSE 1, SINGLE, Lot number: FL3209, Anatomical location: Arm Right, Vaccine Administration Time: 09:30 AM), for Covid-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "not recovered", described as "Brain fog"; FATIGUE (non-serious), outcome "not recovered", described as "Extreme fatigue"; HYPERSOMNIA (non-serious), outcome "not recovered", described as "can barely stay awake"; DECREASED INTEREST (non-serious), outcome "not recovered", described as "Not wanting to do anything"; BALANCE DISORDER (non-serious), outcome "not recovered", described as "Trouble with balance control"; HEADACHE (non-serious), outcome "not recovered", described as "Headaches in rear of head". The events "brain fog", "extreme fatigue", "can barely stay awake", "not wanting to do anything", "trouble with balance control" and "headaches in rear of head" required physician office visit. Therapeutic measures were not taken as a result of feeling abnormal, fatigue, hypersomnia, decreased interest, balance disorder, headache.  Additional information: The patient had no known allergies. Prior to vaccination, patient was not diagnosed with Covid. Post vaccination, the patient was not tested with Covid. The patient did not receive other vaccine in four weeks
Pt received Pfizer vaccine on the evening of 11/7/2021.  The morning of 11/8/2021 she woke up with 104° temperature. Her fever  persisted for 4 days, despite pharmacological and non-pharmacological interventions, On 11/12/2021, fever subsided, but right eye visual impairment was noted in her peripheral field. She was seen by an Ophthalmologist that day and diagnosed with Posterior pole vitreous detachment. She was released without treatment. Vision in her right eye continued to deteriorate over the following days. Her right eye vision was affected globally, and she started seeing rapid flashes of light. She was seen a 2nd time by Ophthalmology, and retinal images showed worsening. Symptoms remain unchanged as of today. Laser surgery was recommended if there's no improvement by February.
Worst sickness/flu like symptoms I have ever experienced. Bad dehydration, diarrhea, throwing up, fatigue, light headed, chills, fainting/passing out. Had to diarrhea over 30 times in one day, throw up several times. Went to emergency room for treatment. IV treatment plus anti naseau and anti cramping   Medication. Cramping was severe in upper intestine. Symptoms have decreased, but still linger after 2 weeks of 2nd shot.  Concern if side effects are permeant. I still very tired/fatigued,  have cramping, dirahaha, throwing up, aches muscles and joints- not feeling like myself and regret taking the vaccine if it results in lifelong side effects.
arm swelling; Asthma; Slight difficulty breathing; wheezing; feeling weak; Injection site pain; Site swelling; injection site redness; extreme tiredness; headache; muscle pain; joint pain; nausea; feeling unwell; itching; arm pain; This is a spontaneous report from a contactable nurse or other health care professional (patient) reported for himself. A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: FA7484; Expiration date: not provided) via an unspecified route of administration on 02Aug2021 left arm at 16:00 in left arm as dose 1, single for Covid-19 immunization at pharmacy/drug store facility. Medical history included known allergies: penicillin and no asthma incidents for several months prior to injection from an unknown date and unknown if ongoing. Other medical history was reported as none. Patient received other medications within two weeks of vaccination as concomitant medications included tamsulosin hydrochloride (FLOMAX (TAMSULOSIN HYDROCHLORIDE)); atorvastatin (ATORVASTATIN); fish oil (FISH OIL); VIT D (VITAMIN D NOS) and multivitamin all were taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Aug2021 17:00, patient experienced injection site pain, extreme tiredness, headache, muscle pain, joint pain, injection site redness, site swelling, arm swelling, nausea, arm pain, feeling weak and unwell, itching, asthma, slight difficulty breathing and wheezing. Therapeutic measures were reported as yes for event asthma, because he was now using his asthma albuterol inhaler and there were no asthma incidents for several months prior to injection, while for all other events reported as no. The outcome of the events was reported as not recovered.  Follow-up attempts are completed. No further information expected.
I started to see blurred vision. Then developed into double vision. I contacted my eye doctor. I had 3 blood tests and checked my eyes. The blood work indicated Myasthenia gravis. After the results, I called my doctor and went to a eye neurologist and was told I was definitely diagnosed with MG. I have researched and seen a spike in MG after vaccination. It has affected my life.
received expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number unknown, expiry date 30th September 2022) for prophylaxis.   In October 2022, the patient received Boostrix. In October 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's Comment: The pharmacist reported that a dose of Boostrix given by error on the past few days to the patient and it was already expired.  No other information was available at the moment. The reporter did not consent to follow up.  Additional Supportive Information: The use of Boostrix dose, which was already expired on 30th September 2022, which led to expired vaccine used. This case was one of four cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR147249:same reporter US-GSK-US2022AMR147250:same reporter US-GSK-US2022AMR147251:same reporter
PT RECEIVED FIRST DOSE OF PFIZER COVID-19 VACCINE (LOT NO. EN6207, EXP 07/2021). FIVE MINUTES AFTER RECEIVING DOSE, PT COMPPLAINED OF FEELING HOT, DIFFICULTY SWALLOWING, AND DIFFICULTY BREATHING. HX OF ANAPHYLAXIS AND CARRIES AN EPIPEN AROUND. PT RECEIVED ONE DOSE OF EPIPEN (LOT NO. 0FM407, EXP 02/2022). NO OTHER VACCINES RECEIVED WITHIN THE LAST 14 DAYS ON PATIENT?S RECORD. TRANSPORTED TO EMERGENCY DEPARTMENT FOR FURTHER EVALUATION. EMERGENCY DEPARTMENT VISIT TIME SEEN BY PROVIDER: 0958, 17 MAR 2021. CHIEF COMPLAINT: ALLERGIC REACTION. NO SKIN RASH, DIZZINESS, OR FAINTING EPISODE. HAD DIFFICULTY BREATHING BUT NOT HAD ITCHING OR SWELLING. SYMPTOMS STARTED PRIOR TO ARRIVAL AND IS STILL PRESENT BUT IMPROVING. VAERS REPORT: . PATIENT DISCHARGED FROM THE EMERGENCY DEPARTMENT AT 1143, 17 MAR 2021.  CONDITION: STABLE.  CLINICAL IMPRESSION:  ANAPHYLAXIS DUE TO A DRUG.