chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt has a hx of: Bullseye Rash as a child; Mononucleosis at age 5; hemiplegic migraine at age 8, well controlled, medicated ages 8-11. No sx after mediation d/c'd. At age 12, had 3 does of HPV-4 Gardasil (11/2012, 2/2013, 7/2013). Began having increased asthma attacks, dizziness and anxiety in October, 2013. October, 2014 developed weakness of left arm, left leg. Tingling in face. December 2014- ER admission for severe hypokalemia, hypomagnesemia, tachycardia, prolonged QT interval. Sx include: Muscle weakness, Migraines, Seizure-like activity, Hypokalemia, Fatigue, Pruritis, Shortness of breath with simple activity, Alopecia, Neuropathy, Allodynia, Nystagmus, Nausea/vomiting, Periodic Paralysis, Left arm severe pain with episodes of paralysis, Brain fog, Inability to write or perform ADLs, Needed walker or wheelchair for mobility, Difficulty breathing during attacks, On home-bound schooling. Diagnosed with Hypokalemic Periodic Paralysis in 11/2015.
Patient was diagnosed with blood clots confirmed by Ultrasound; This is a spontaneous report received from a contactable physician. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0164), on 21Apr2021 as 2nd dose, single for COVID-19 immunization. The patient's medical history included colon cancer (patient had a history of colon cancer 2 years removed) from unspecified date. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on 30Mar2021 as 1st dose, single for COVID-19 immunization. It was reported that patient was diagnosed with blood clots confirmed by ultrasound during the emergency room visit on 03May2021. Patient was placed on apixaban (ELIQUIS) 5 mg, twice a day.  Patient had history of colon cancer 2 years removed, and recent colonoscopy on 13Apr2021 was clear. The event was reported as non-serious. The outcome of the event was unknown.; Sender's Comments: The event of blood clot is assessed as possibly related to the suspect BNT162B2 based on temporal association, but medical history of colon cancer was confounder. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate.
One day post vaccination the pt was swollen, indurated, and her arm was painful to move. It was indicated that ice and Tylenol seemed to help somewhat. The pt sought unspecified medical attention. Follow up information indicated that the pt had swelling, pain of the arm, cramps and myalgia. It was reported that the myalgia subsided somewhat on the first day. The pt recovered by 08/28/00 and no further information is expected.
Information has been received from a consumer concerning her daughter who in May 2007, July 2007 and December 2007 was vaccinated with her first, second and third doses of GARDASIL respectively. The consumer reported that starting in August 2008, her daughter had been very nauseous and still was very nauseous and in September 2008,her daughter was put on anti-nauseating medication. The consumer reported that her daughter had been working with a GI,, neurologist and primary care physician, but her daughter stated that the anti nauseating medication (name manufacturer is unspecified) only worked in the morning. At the time of this report, 24-OCT-2008, no outcome reported. Additional information has been requested.
Patient is approximately 9 weeks pregnant.  There was no immediate adverse reaction.  Patient did wait her 15 minutes and when she was discharged, provider noted that she had no symptoms of distress.
It was reported that a 15 month old male patient received a Tripedia vaccination on 1/18/02. Reportedly the patient developed a large, local reaction the next day, seen by physician on Monday, the reaction measured 2cm in diameter.
Headache, Rash, NauseaVomiting, hot and cold flashes Narrative:
"Moderna COVID-19 Vaccine EUA"  After the first shot, I had the following side effects:  Difficulty swallowing  and dizzy and unstable on my feet(started approx. 30 minutes after the shot and lasted approximately 30 minutes).  Fuzzy thought process/ difficult to concentrate and tired all day.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 16-MAY-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX Lot numbers: L033311/expiration date: 01-DEC-2016 and L046893/Expiration date: 23-FEB-2017 (administration route was not provided). No concomitant therapies were reported. No adverse events were reported. Excursion data: Temperature no warmer than 46F, Time frame: 63.5 Additional information is not expected, since there was no consent to contact the responsible physician.
7+ weeks post injection left upper arm muscle pain continues, not injection site discomfort, but muscle pain. Never experience anything like it before. Painful to raise arm laterally. Husband has exact symptoms as well. Doesn't hurt otherwise just when lifting out to the side
pt started feeling a little dizzy, stated that she hadn't eaten any thing for breakfast.  Juice given and she ate a banana. Still feeling a little dizzy after, and taken to the first aid room.  Vital signs 185/99 p127, respirations 22.  denies chest tightness ore difficulty breathing.  Md called to assess patient.
Since I received my second dose of the vaccine. I have been getting allergies non stop; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "not recovered", described as "Since I received my second dose of the vaccine. I have been getting allergies non stop". The event "since i received my second dose of the vaccine. i have been getting allergies non stop" required physician office visit. Therapeutic measures were taken as a result of hypersensitivity.  Additional information: Patient have been to different type of hospitals and doctors and they keep prescribing medicine but nothing helped patient.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Presented to ER with a local anaphylactic reaction. Swelling in left upper arm, heart rate 120, SOB, and itching left upper arm; temp 102.0. She was transferred to a room and observed for 1 day.
Patient refilled her epi pen prior to second dose of COVID vaccination. It is unclear if patient had developed a rash after her first or second vaccination, or none at all. She did develop a rash near her groin and was seen at her doctor's office 3/22/2021.
Patient quickly developed hives all over her body. This was the second dose and no reaction after first dose. Patient was brought to clinic to see Dr. who prescribed a dexamethasone injection, sliding scale to manage diabetes in response to steroid injection and hydroxyzine orally.
Pt woke-up 11/6/99 disoriented, dizzy, nauseated, vomiting, blurred vision, difficulty breathing. Went to ER and tx w/iv fluids, antivert. She felt better and was discharged. No overnight stay.
On day 2 I broke out in a ton of mouth ulcers.  I saw the doctor  and was given Lidocaine for pain. I got the second dose and the sores got worse on day 2.  I still have these sores and can?t seem to fight them.  I am on my second round of steroids, antiviral and antibiotics. After I finish the antiviral I am being put on it for another round for 3 weeks. These sores were huge and covered my throat cheeks and tongue.
Fatigue, nausea, HA, fever,  chills, light headed, SOB w exertion, body aches.  Treated with rest ibuprofen
Redness and induration (L) lateral and anterior thigh at site of PROQUAD and Influenza administration. No pain/tenderness/nor itching noted. Advised oral ibuprofen as needed. Area was warm to touch.
Excessive prolonged crying, redness/swelling of left thigh, patient was brought back to doctors office later in the afternoon, given Tylenol, and symptoms resolved, then developed high fevers and staring spells for next two days, followed by decreased vocalization for two weeks.
Patient had a CVA on 3/13/2022. Left sided numbness throughout. Dizziness
This spontaneous prospective pregnancy report was received from an office manager refers to a currently 19 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. On 13-APR-2016, she was vaccinated with GARDASIL 9 (lot # L027282, expiration date 21-SEP-2017) dose 3. It was unknown when the patient received first and second doses. Concomitant therapies included prenatal vitamins. At the time of the report, she was about 5 week's pregnant. Her last menstrual period was approximately on 28-JUN-2016 and estimated due date is 04-APR-2017. The outcome of pregnancy was pending. On an unknown date, she had an unspecified prenatal work done. She was doing fine. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown ages and genders. There was no information about the patients' pertinent medical history, drug reactions or allergies and concomitant therapies provided. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX (exact dose, dose number, route of administration, lot # and expiration date were not reported), for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse effects were reported. The administered doses of vaccines experienced a temperature excursion between 15 and 46 Fahrenheit degrees for 1 hour. Digital data logger was used to capture the temperature excursion. Previous temperature excursions occurred, but no details were provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008478: US-009507513-1709USA008479: US-009507513-1709USA008477.
Fatigue; Mild Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The reporter is the parent.  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 07Nov2021 12:30 (Lot number: FK5127) at the age of 10 years as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications.  The following information was reported: FATIGUE (non-serious) with onset 08Nov2021 08:00, outcome "recovered" (Nov2021), described as "Fatigue"; HEADACHE (non-serious) with onset 08Nov2021 08:00, outcome "recovered" (Nov2021), described as "Mild Headache". Therapeutic measures were not taken as a result of fatigue, headache.  Additional information: On 08Nov2021, the patient had mild headache and fatigue without fever. No other vaccine was received in four weeks and other medications in two weeks was Children's Vitamins (unspecified). No Covid prior vaccination and was not tested for covid post vaccination. The patient had no known allergies and none other medical history.  Follow-up attempts are completed. No further information is expected.
Unknown adverse event; 48 days after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Unknown adverse event) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (48 days after first vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 27-Jan-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 COMPLICATION (Unknown adverse event) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (48 days after first vaccine). At the time of the report, VACCINATION COMPLICATION (Unknown adverse event) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (48 days after first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.
THREE DAYS AFTER VACCINATION, MY DAUGHTER STARTED BLEEDING INTENSIVELY THRU HER NOSE.  PRESSURE WAS APPLIED BUT HEMORRAGE LASTED FOR 15 MINUTES.  AT THE END, A BLOOD CLOT WAS EXPELLED NASALLY.
did not receive the full recommended VARlVAX dose as patient moved his leg during administration; This spontaneous report as received from a nurse and refers to a 17-month-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 13-OCT-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (exact dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. The patient did not receive the full recommended dose as patient moved his leg during administration. The reporter did not know the exact quantity patient may have received. This was patient's first dose in the series.
flushed feeling & pressure in head; BP elevated to 184/92 (nl is 100-120/70-80; BP dec p/45 mins to 126/76; fine remainder of day; pt reported no anxiety about vax
C/O throat swelling and feeling like her tongue was thick and swollen. Symptoms lasted several hours and subsided after she vomited. Admitted because of "tightness in her throat".
Swelling of throat, tongue, and lips. Dizziness. Symptoms resolved 6 hours after they began.  Symptoms began approximately 2 hours after the vaccination. Allergist has advised me I may not take dose 2 of the SHINGRIX vaccine.
Patient developed arthralgias, headache, stiff neck, sore throat, "spacy" inability to focus x 1 week, and left sided burning in ear followed  by soreness in face  associated with worsening tinnitus in left ear after first 3/19/2021. She was seen in the Emergency department for severe rib pain.   Her symptoms were gradually improving over the following three weeks until her second shot on 4/9/2021. She immediately developed similar but less severe symptoms to the first shot except for her tinnitus which was markedly worse and in both ears. She also had lymphadenopathy and eye "soreness and burning" with the second shot. Her tinnitus continues to be moderate to severe and impacting her ability to sleep and function. She has been evaluated by several ENT specialists.
he may have gotten COVID from a gas station. Symptoms seemed to start on the 31st with SOB, fatigue and fevers. He has had worsening SOB through the morning which brought him to the ED today. He notes CP in the ED. It does seem to be worse with palpation of his chest.
Dizziness, nausea, not hungry next morning at school. (>12 hr later) fever 24 hr later for less than 24 hr
large rash at the injection site; Slight fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Slight fatigue) and VACCINATION SITE RASH (large rash at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and CALCIUM for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced FATIGUE (Slight fatigue). On 31-Jan-2021, the patient experienced VACCINATION SITE RASH (large rash at the injection site). On 24-Jan-2021, FATIGUE (Slight fatigue) had resolved. At the time of the report, VACCINATION SITE RASH (large rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fatigue started first and is still present. Nausea started around 4:00 PM and continues on and off. Vomiting started around 6:30 PM and ended around 9:30 PM. Headache started around 4:00 PM also and continued till I went to bed the evening of 02/07. Fever started around 3:30 PM and is still on and off. Highest temperature was 3.8 degrees above what my temperature usually is. Body aches on and off continue.
Redness & swelling to LT DT hot to touch. Ice to LDT 4x a day.
dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) outcome was unknown. Not Provided          No Concomitant medications were reported. No treatment medications were reported. Action taken with mRNA-1273 in response to the events was Not applicable.   This case was linked to MOD21-057158 (E2B Linked Report).; Sender's Comments:  MOD21-057158:Cosslinked wife case
1033 patient received vaccine. 1035 patient reported not feeling well, he was noted to be pale, disoriented, diaphorietic, and loss of bladder control.  Vital signs of B/P 107/53, HR 45, RR 16, SpO2 100%. He was transferred to a cot. He was alert and orientated but very anxious, 911 was called. EMT arrived at 1100. Patient reported he was feeling better, vital signs of B/P 128/86, HR 67, SpO2 100% on room air, Blood sugar was 174. The patient stated he was feeling better and declined to go to Emergency department. He called his father who arrived and picked him up at 1130, patient stated he was feeing fine and walked out of clinic with his father to drive him home.
For weeks I had severe arm pain and limited range of mobility - couldn't lift my arm to put on a shirt or coat. The pain woke me up several times during the night. It has slowly gotten better over time and after receiving a cortisone shot in my shoulder, but after 3 months, I still have pain when I lift my arm in a certain way. I had never had any shoulder/arm pain prior to receiving the flu shot.
Raised reddened area 5 in diameter to left upper quadrant thigh. MOTRIN, TYLENOL, and ice applied by mother upon noticing swelling yesterday. Office visit today, mother reports slightly better.
Positive for the virus; Positive for the virus; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient).  A 70-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 at single dose for COVID-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient received his 1st dose of Covid 19 Vaccine 11Jan2021 and after a couple of days showed positive for the virus, but in other results, it shows negative, but he doesn't want to take the risk that's why he's concerned now for his safety. He's aware that his 2nd dose of Covid 19 Vaccine will be on 01Feb2021. He's feeling good now but just wants to let us know. On 21Jan2021, he tested positive. The outcome was unknown.  Information about Batch/Lot number has been requested.
bleeding from right ankle / lost a lot of blood; saw a pencil eraser/red looking spot; A spontaneous report was received from a non-healthcare professional (caregiver) concerning a 76 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and hemorrhage and erythema.  Medical history included being mentally challenged. Concomitant medication included unspecified cholesterol medication, two unspecified blood pressure medications, baby aspirin, vitamin D, and lorazepam.  On 04 Feb 2020, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 05 Feb 2021, the patient experienced bleeding from a pencil eraser red looking spot on the right ankle, had lost a lot of blood.  The bleeding had stopped and no treatment was reported.  Action taken with the mRNA-1273 in response to the event was not reported.  The outcome of the event of hemorrhage was considered resolved. The outcome of the event erythema was unknown.; Reporter's Comments: 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. Further information has been requested.
EMPLOYEE INTITIALLY FELT LIGHT HEADED AFTER VACCINE ADMINISTRATION. LIGHT HEADEDNESS RESOLVED AND EMPLOYEE STATED SHE FELT FINE. EMPLOYEE WENT TO BATHROOM WHERE EMPLOYEE VOMITTED X2. EMPLOYEE THEN SAT DOWN IN BREAK ROOM AND STATED SHE FELT LIGHT HEADED AND DIZZY. EMPLOYEE TREATMENT CONSISTED OF APPLYING COLD WATER TO NECK AND TAKING VITALS AT 06:20PM. EMPLOYEE PULSE WAS 85 AND BLOOD PRESSURE 137/102 RESPIRATIONS 16 PER MINUTE UNLABORED. EMPLOYEE RESTED FOR APPROXIMATELY 20 MINUTES AND HAD NO FURTHER COMPLAINTS EMPLOYEE STATES SHE DID TAKE HER BLOOD PRESSURE MEDICINE TODAY.
Large area erythema, warmth, tenderness at injection site, noted w/in 24 hrs.
headache; feel fatigued/super worn out; pretty lethargic/Lethargic as all get out; kind of almost flu-like feeling; arm pain/soreness like "someone punching me in the arm."/arm hurt; Not feeling too good; This is a spontaneous report from a contactable consumer (patient). A contactable 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 32-year-old, on 15Apr2021 at single dose for COVID-19 immunization. Medical history included COVID (Patient had COVID probably within the first few months of COVID being a thing, so that was a while ago). Concomitant medication was not reported. patient received his first Pfizer Covid vaccine dose on 15Apr2021. The following day (16Apr2021) he experienced arm pain/soreness like "someone punching me in the arm." On 18Apr2021 he states he started to feel fatigued, "super worn out", and a headache (19Apr2021). Patient asked if it was normal to experience. He is not feeling too good and doesn't know if that is from the Pfizer Covid-19 Vaccine. Caller's wife got the Moderna shot and caller got the Pfizer Covid-19 Vaccine shot on 15Apr2021. It seemed like his arm hurt on Friday. Saturday it seemed like he was alright. Sunday (18Apr2021) he felt pretty lethargic and kind of almost flu-like feeling, today (19Apr2021) just severe headache and just lethargic as all get out, walking to refrigerator is kind of a task. He was wondering, he heard of like the day after, but if it is a normal thing to have these events a few days after the Pfizer Covid-19 Vaccine. He does not feel like he needs to be rushed to the hospital. Outcome of arm pain was recovered on 17Apr2021 and outcome of other events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.