chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he hasn't gotten the second one yet.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (he hasn't gotten the second one yet.) 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 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (he hasn't gotten the second one yet.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (he hasn't gotten the second one yet.) had resolved.            No Concomitant medications were reported. No Treatment medications were reported.  He had an underlying condition.
Very lethargic. Boosted in very high fever. Still congested. No appetite. Second booster was given a year later from first shot instead of 6 months later.
I took the first shot of Moderna?s COVID-19 vaccine  the middle of January. Two and a half weeks later, I developed a two inch rash above my right breast even though it didn?t itch or burn, if pressed, it hurt. I treated it with antibiotic ointment and calamine lotion. During that time, I experienced tiredness, exhaustion, sluggishness as well as aches around the right shoulder. I went to get a mammogram where they told me my lymph nodes were swollen on the right side under my arm. They had seen adults who had taken the shot develop swollen lymp nodes  which made it necessary to retake the mammogram. I also went to the dermatologist to see what the inch rash was, he took a biopsy, and it turned out it was shingles even though I had had the shingles shots a year before.
On 3/2000 1400 per telephone call from pt-child with temp up to 102 F, irritable/fussy-sleeping now (giving 0.4 cc Tylenol infant drops-instructed to give 0.8 cc Tylenol per age/wt-review possible s/e of immunizations and to go to PMD/LR if > 103 F, seizures-other concerns.  12/06 050 telephone call from hospital-states infant was seen in ER 3/1/06 at 1954 for reported "shaking" while sleeping, fever and irritability.  Reported by family at 102 degrees. Child afebrile, cold, no seizure activity seen. telephone call to msg number
Severe itching all over bdy during the evening; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Severe itching all over bdy during the evening) and FATIGUE (Fatigue) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced PRURITUS (Severe itching all over bdy during the evening) and FATIGUE (Fatigue). At the time of the report, PRURITUS (Severe itching all over bdy during the evening) and FATIGUE (Fatigue) outcome was unknown.            The patient reported a lot of fatigue that causes her to sleep at 8:00 PM each night.  Treatment information was not provided.   This case was linked to MOD-2021-040815 (Patient Link).
Woke up at 230a wheezing, SOB, OTC cough med.
Patient called 05/29/18, a week after vaccine was administered, to report pain/soreness to her left deltoid, left shoulder and neck. The patient states normal soreness associated with a vaccine, but reports increased pain to shoulder on 05/24/18, 2 days post administration of vaccine. Patient reports increased pain 3-5 days post administration of vaccine to deltoid/shoulder and neck. Patient took ibuprofen for pain and was advised to see her primary care physician if pain increases/persists.
Patient was administered vaccine.  As soon as it was over, she turned sheet white and passed out (onto her husband's shoulder).  Both arms and legs went straight and rigid while she was unconscious.  911 was called immediately.  When she came to, she started vomiting.  Blood pressure was taken, 80/50.  Patient refused to go to the hospital.  Paramedics brought her out of the store.
fatigue beginning at 2:30 pm;  difficulty sleeping beginning at 11 pm chills 2-4 pm fever onset 4 pm; decreasing by 8 AM, gone by 11 AM  headache onset 8 AM
Initial case received from a health care professional on 18 August 2010. An 18-year-old female patient received an injection of MENACTRA (lot number U3509AA) on 30 July 2010. Medical history included anxiety, depression, obesity, hypercholesterolemia, chest pain, vulvodynia, and an allergy to OMNICEF. Concomitant medications included "MYRALAX", LUVOX, CYMBALTA, SEROQUEL, gabapentin, CRESTOR, NEXIUM, ZYRTEC, and naproxen. Approximately 5 days post-vaccination, the patient was hospitalized with complaints of headache, neck pain, chills, nausea, vertigo, visual disturbance, myalgia, and jitteriness. She was released from the hospital on 18 August 2010. The reporter noted that the patient continued to experience symptoms, although it was unknown which symptoms were ongoing.
Felt like a truck hit me for about 24 hours; temp went up to 101.1F; soreness in left arm; low grade fever; nauseous; vomiting; aches in legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (aches in legs), FEELING ABNORMAL (Felt like a truck hit me for about 24 hours), PYREXIA (temp went up to 101.1F), MYALGIA (soreness in left arm) and PYREXIA (low grade fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Acute myeloid leukemia (5 years remission.) since 15-Sep-2015. Concurrent medical conditions included Allergy (Scents and hayweed.). Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), VALSARTAN for Blood pressure high, LEVOTHYROXINE SODIUM (SYNTHROID), ZOLPIDEM TARTRATE (AMBIEN), ALPRAZOLAM (XANAX) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 10-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (aches in legs), PYREXIA (temp went up to 101.1F), MYALGIA (soreness in left arm), PYREXIA (low grade fever), NAUSEA (nauseous) and VOMITING (vomiting). On an unknown date, the patient experienced FEELING ABNORMAL (Felt like a truck hit me for about 24 hours). At the time of the report, PAIN IN EXTREMITY (aches in legs), FEELING ABNORMAL (Felt like a truck hit me for about 24 hours), PYREXIA (temp went up to 101.1F), MYALGIA (soreness in left arm), PYREXIA (low grade fever), NAUSEA (nauseous) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included ibuprofen.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up was received on 22 April 2021. Patient demographics , historical condition , concomitant medication, second dose information and new event ( feeling abnormal ) was added.
This case was reported by a consumer and described the occurrence of fever in a 4-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date, the subject received erroneously an unspecified dose of BOOSTRIX (unknown route, injection site and batch number) that led to inappropriate age at vaccine administration and wrong vaccine administered. At an unspecified time after vaccination with BOOSTRIX, the subject experienced fever. The outcome of the event was unspecified.
Received Td on 8/05/2002- Developed severe l arm pain 4 days after vaccine which spread to r arm, up neck, down back, and down leg- seen on 8/14/2002 with NL exam, persist symptoms, and NL CBC, CPK, ESR--no Tx
Patient was given injection approx 10 minutes later she came up to the nurse and asked if it was normal to taste the vaccine. When questioned she stated that she felt funny. Her tongue felt weird and it was tingly. 911 was called. Vitals were obtained. P - 86 R - 18 B/P 160/80. She stated that her throat was starting to feel tingly as well. Epinephrine 0.5 mg was given Sub Q in left arm. While waiting for EMS to arrive patient stated that she was feeling better. No shortness of breath was noted. Fire Department arrived and placed the patient on a stretcher and removed her from the area. On 9-28-11 I spoke to the patient. She advised me that she was fine, but felt tired and had a headache today. She advised that she had not gone to the hospital. She had refused to be transported by EMS. She also asked if she should contact her doctor. I advised her to contact them as soon as she could today and let them know about the event and see if they wanted to see her for a follow up.
38 hours after recieving vaccination he developed a fever of 102.3 that lasted for three days.  The day after the fever broke he developed a rash that covered the trunk of his body.  the rash took four to five days to clear up.  Then a few days later (12 days after the vaccination) he broke into another rash.  He was seen by physicians for both rashes.  Both times it was stated that it could be a reaction to the vaccines.
Pt developed new onset seizure 5 days after the vaccine given. Pt was admitted through ER (via ambulance) and following tests were ordered. Pt started on DILANTIN, lorazepam and discharged on DILANTIN.
p/vax pt exp varicella;the reporting nurse noted pt was treated w/DPH & colloidal oatmeal (aveeno bath) symptomatically;
painful breathing; fatigue / tired; whole body hurts; can't lift anything; can hardly walk; right arm hurts at injection site; feeling sluggish; light headaches; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (painful breathing), FATIGUE (fatigue / tired), PAIN (whole body hurts), MOBILITY DECREASED (can't lift anything) and GAIT DISTURBANCE (can hardly walk) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Thyroid disorder.   On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced DYSPNOEA (painful breathing), FATIGUE (fatigue / tired), PAIN (whole body hurts), MOBILITY DECREASED (can't lift anything), GAIT DISTURBANCE (can hardly walk), VACCINATION SITE PAIN (right arm hurts at injection site), SLUGGISHNESS (feeling sluggish) and HEADACHE (light headaches). At the time of the report, DYSPNOEA (painful breathing), FATIGUE (fatigue / tired), PAIN (whole body hurts), MOBILITY DECREASED (can't lift anything), GAIT DISTURBANCE (can hardly walk), VACCINATION SITE PAIN (right arm hurts at injection site), SLUGGISHNESS (feeling sluggish) and HEADACHE (light headaches) outcome was unknown.            No concomitant medication was mentioned. No treatment medication was mentioned.
toe pain/A week later her toes are improving but is still tender to touch; redness on both feet; Her great toe on her right foot and the second toe on the left foot were red and inflamed; minor arm discomfort; This is a spontaneous report from a non-contactable consumer (patient herself) received via a sales representative. A 52-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date: Not reported), dose 2 via an unspecified route of administration on 06Jan2021 as 2nd dose, single for COVID-19 immunisation. The patient previously received first dose of BNT162B2 for COVID-19 immunization. Medical history included diagnosed with COVID-19 on Oct2020 with mild symptoms and recovered with no sequelae. Patient reported she has no underlying conditions and occasionally takes vitamins, she is quite active and walks several miles a day, she had not injured her feet nor purchased new shoes. This is the first time this has ever occurred. She has no history of autoimmune diseases or Raynaud's. On 06Jan2021, after vaccination patient had some minor arm discomfort but no other issues. On 28Jan2021, Patient started to experience toe pain and redness on both feet, her great toe on her right foot and the second toe on the left foot were red and inflamed (she has pictures). A week later her toes are improving but is still tender to touch. The outcome of minor arm pain was unknown and for other events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Vaccine 4/12/21. Afterwards severe headaches and feeling of getting sick for one week . On 4/19/21 had headache and feeling very tired. Suffered from seizure after being five years seizure free. Suffered three seizures in 30 minutes. Had never had more than one seizure in 3 prior events five years ago. Had a clean EEG done on 2/2/21 with no spikes seen   Was hospitalized for two days.
Headache still present since first dose swollen lymph nodes on neck lasted  a week after second dose, tiredness , legs feel very heavy since second dose.
pt recvd vax 8JUL93-woke up from nap 630PM took bottle well then started screaming uncontrollably-held breath & turned blue & limp; was fine on exam; mom recalled similar episode p/ 2nd vax; site of inject was red & swollen;
My symptoms began with a sore throat and hoarseness around 8:00 PM. By 10:00 PM my left eye became very reddened, sore and itchy. I continued to be restless and itchy throughout the night. By morning of the 27th my left eye was a little less red, but still sore throughout the day. I called my physician and she recommended that I take 10mg of Claritin (over the counter) because I was having an allergic reaction. She strongly recommended that I avoid getting a flu shot in the future.
Pain in right shoulder, difficulty in movement, patient stated significant amount of pain notified pharmacy 11/18/2016 was going to try heat therapy to improve, patient talked his doctor 11/19/2016 had ultrasound and CT scan showed a hematoma diagnosis was told to pharmacy 11/22/2016 patient stated that issue was improving and range of movement improving continue using heat and massage therapy patient confident will get back to normal.
Day of vaccine (1/8): experienced some soreness at injection site, sore arm, headache  1/9-1/11 - sore arm and shoulder, muscle/joint fatigue, headache resolved   1/12 - few (maybe 4) small bumps/welts near injection site that were red and itchy, resolved within 24 hours . radiating arm pain still occurring   1/13-1/14 - small bumps/welts gone, radiating arm (extending down to forearm/wrist) and shoulder pain throughout   1/15 - radiating arm/shoulder pain gone. In the evening, a quarter-size raised bump/welt/hive at spot of injection. itchy & slightly warm to the touch. Drank water, took benedryl   1/16 - quarter-sized bump/welt/hive at injection site reduced and was mostly flat, area where the bump was is now red. Still slightly warm, not as itchy. Continued with benedryl, water, and cortisol creams. Radiating Arm/shoulder pain came back, had some overall fatigue and overall did not feel well, slight headache   1/17 - feeling better/less fatigued, injection site bump mostly resolved, redness is fading. Slight arm/shoulder pain present
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent disease were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, route, lot number and expiration date were not reported). Co-suspect and concomitant therapies were not reported. On an unknown date the patient complained that their arm hurts at injection site after administration. At the time of the report the outcome and the action taken was unknown. Additional information has been requested.
Hypertrophic cardiomyopathy; Left Ventricular Hypertrophy with Dyspnea; Left Ventricular Hypertrophy with Dyspnea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 10Dec2021 (Lot number: 33130BA) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot Number: EP7534), administration date: 22Mar2021, for COVID-19 Immunization; Bnt162b2 (Dose: 2, Lot Number: ER8737), administration date: 12Apr2021, for COVID-19 Immunization. The following information was reported: HYPERTROPHIC CARDIOMYOPATHY (medically significant), outcome "unknown", described as "Hypertrophic cardiomyopathy"; LEFT VENTRICULAR HYPERTROPHY (non-serious), DYSPNOEA (non-serious), outcome "unknown" and all described as "Left Ventricular Hypertrophy with Dyspnea". The events "hypertrophic cardiomyopathy", "left ventricular hypertrophy with dyspnea" and "left ventricular hypertrophy with dyspnea" were evaluated at the physician office visit. The patient reported that he has been diagnosed with Left Ventricular Hypertrophy with Dyspnea and Hypertrophic cardiomyopathy. His cardiologist cannot find the origin of heart condition.  Follow-up attempts are completed. No further information is expected.
Went to the hospital on Sunday August 22nd with shortness of breath and abdominal pain. The test they ran are basic metabolic panel, CBC with audio differential, hepatic functional panel, lipase, POCT Troponin I, ECG (electrocardiogram ) 12 Lead, they gave me an IV and some oxygen, dicycomine. They sent me home with dicycomine and ondansetron still was feeling bad so went to see my doctor and they prescribed a few other prescriptions and now I'm starting to feel better
SUSPECTED COVID-19 INFECTION; This solicited report received from a patient  from Janssen  for STELARA Crohns concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient was treated with ustekinumab (solution for injection, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication.  The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s, and ustekinumab was not applicable. The outcome of suspected covid-19 infection was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and suspected covid-19 infection as possible; and between ustekinumab, and suspected covid-19 infection as possible.  This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious
Information has been received from a physician concerning an 8 yr old male pt who was vaccinated with varicella virus vaccine live. On 09Jan06 the pt experienced varicella. No further information regarding the event or the pt's outcome was available. Additional information has been requested.
Information has been received from a Licensed Visiting Nurse (L.V.N.) concerning an 8 year old male patient with shellfish allergy, fish allergy, hypersensitivity, attention deficit/hyperactivity disorder and history of asthma who on 21-JUL-2002, at age one year and one month, was vaccinated with a dose of VARIVAX (Merck). It was reported that on 27-JUN-2009 the patient was diagnosed with shingles on his right leg. He was prescribed ZOVIRAX and acyclovir. The patient was seen in the office. It was reported that the patient recovered on an unknown date. Additional information has been requested.
1ST FLU SHOT IN 19 YEARS. LEFT ARM SITE REACTION: 70 MM CIRCULAR, HOT AREA, WITH CENTRAL HARDNESS FELT, ERYTHEMATOUS. Pt. denied HA, SOB, wheezing, urticaria, chest/sinus congestion.
Scheduling error occurred and patient was given vaccine outside of recommended age group. No adverse reactions observed on 3/30/21 at clinic, patient's parents notified and will continue to monitor.
Patient experienced low fever, muscle aches/pains, weakness over night. She treated with acetaminophen. 2 days after the vaccine the injection site was red/swollen/warm to the touch. Patient contacted the pharmacy as well as her primary care physician to let them know about the swelling.
PAINFUL LYMPH NODES IN GROIN, ESPECIALLY ON THE RIGHT SIDE.  INJECTION GIVEN ON RIGHT SIDE, FATIGUE.
01/11/2021: 0901 assoc felt light headed b/p 139/96. felt well enough to leave site, no intervention. 01/13/2021: 0923 pt went to ED for reaction to vaccine. left supraclavicular node swelling extending up neck with erythema, tenderness. was seen in ED
Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced vomiting. Unspecified medical attention was sought. Additional information has been requested.