chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BILATERAL PULMONARY EMBOLISM; EXTENSIVE CLOTTING TO RIGHT LEFT AND ABDOMEN; DEEP VEIN THROMBOSIS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included four spine surgeries, and concurrent conditions included tendinosis, high blood pressure, type 2 diabetes, and platelet rich plasma therapy, and other pre-existing medical conditions included patient had no genetic conditions which would explain the clotting. patient had no prior history of blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, frequency 1 total, administered on 21-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On 25-MAR-2021 and 1-APR-2021 patient underwent a series of Platelet Rich Plasma (PRP) Injections for left elbow for tendinosis. On 02-APR-2021, the patient experienced deep vein thrombosis and extensive clotting to right left and abdomen, and was hospitalized. Laboratory data included: Diagnostic ultrasound (NR: not provided) DVT and clot blood confirmed. Treatment medications included: heparin non-company. The patient was discharged on 03-APR-2021 with instructions to take Eliquis. On 07-APR-2021, the patient experienced bilateral pulmonary embolism and the patient was readmitted to the hospital. Laboratory data included: computed tomography (CT) scan (NR: not provided) Bilateral pulmonary embolism. Discharged on 09-APR-2021. On 23-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) not provided. On 26-APR-2021, the patient was readmitted and thrombectomy was performed. The patient was discharged on 27-APR-2021. On 30-APR-2021, the patient experienced rethrombosis. Laboratory data included: Diagnostic ultrasound (NR: not provided) Rethrombosis confirmed. Treatment medications included: bivalirudin, where doctor placed a catheter and administered an Angiomax IV for 72 hours. On 03-MAY-2021, thrombolysis and thrombectomy surgery was performed. Patient was discharged on an unspcified date with additional treatment medications (dates unspecified) included: clopidogrel bisulfate, acetylsalicylic acid, and levofloxacin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extensive clotting to right left and abdomen, deep vein thrombosis, and bilateral pulmonary embolism was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210525688-COVID-19 VACCINE AD26.COV2.S-extensive clotting to right left and abdomen, deep vein thrombosis, bilateral pulmonary embolism. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Pfizer-BioNTech COVID- 19 Vaccine EUA Approximately 5 minute post vaccination, patient experienced chest pain radiating down left arm, shortness of breath, and nausea. Patient also endorses numbness to left upper arm and left lower leg. Denies any wheezing, throat swelling, facial swelling, diarrhea, urticaria. Vitals: BP 104/65, Pulse 78, SpO2. On chart review, she had similar symptoms in the past with full stroke workup that was ultimately determined to be conversion disorder. Admitted for observation to rule out ACS. EKG and serial troponin unremarkable.
Patient states that she received a Pfizer booster on 12/9 at 5 pm and later that evening, her left arm was warm, painful, swollen, red, and displayed a rash. She says that she's been taking Benadryl 25 mg every 4-6 hours while awake since then, and cold compresses intermittently as well with no resolution. Her symptoms never went away as of 12/12 at 2 pm and I urged her to see a doctor ASAP.
This spontaneous report as received from a healthcare worker refers to one unspecified patient of unknown age and gender. The patient's pertinent medical history, drug allergies, and concomitant medications were not reported. On 14-JUL-2016 the patient received an improperly dose of PROQUAD (lot # L031601, expiry date 18-FEB-2017) (dose and route were unknown ). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced chickenpox. The rash started behind the ears and by the next evening the rash had spread to the back, chest and abdomen. The pt had approximately 12-15 lesions and a temperature of 99.3F.
sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right injection site arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01120A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore right injection site arm). At the time of the report, VACCINATION SITE PAIN (sore right injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-370523 (Patient Link).
Achy feeling; Started to feel like it affected her arms "really bad"; Hands hurt; Throbbing in arms and hands; Numb feeling in finger tips with prickly and tingly feeling; Numb feeling in finger tips with prickly and tingly feeling; Aches/pains; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Throbbing in arms and hands), PARAESTHESIA (Numb feeling in finger tips with prickly and tingly feeling), HYPOAESTHESIA (Numb feeling in finger tips with prickly and tingly feeling), PAIN (Aches/pains) and LIMB DISCOMFORT (Started to feel like it affected her arms "really bad") in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Aches/pains). On 17-Apr-2021, the patient experienced PAIN (Throbbing in arms and hands), PARAESTHESIA (Numb feeling in finger tips with prickly and tingly feeling), HYPOAESTHESIA (Numb feeling in finger tips with prickly and tingly feeling), LIMB DISCOMFORT (Started to feel like it affected her arms "really bad") and PAIN IN EXTREMITY (Hands hurt). On an unknown date, the patient experienced MYALGIA (Achy feeling). At the time of the report, PAIN (Throbbing in arms and hands), PARAESTHESIA (Numb feeling in finger tips with prickly and tingly feeling), HYPOAESTHESIA (Numb feeling in finger tips with prickly and tingly feeling), PAIN (Aches/pains), LIMB DISCOMFORT (Started to feel like it affected her arms "really bad"), PAIN IN EXTREMITY (Hands hurt) and MYALGIA (Achy feeling) outcome was unknown.            Patient was taking high blood pressure medication. Treatment medications  was not provided. The middle, pointer and thumb fingers are affected in both hands.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Significant Follow-up received on 26-JUN-2021: Events and concomitant medication were updated
Patient states she got a sore throat the day after the flu shot, then it progressed into the flu.  Yesterday, 11/10/19, her top lip swelled up and she believes it was a result of an allergic reaction to the flu shot.
At 11pm on the day of receiving my 2nd does I became cold and started shivering very bad, had to get into a hot bath to make it stop then I got extremely hot and a headache that lasted until 10am the following day
16 yo female observed child was very anxious prior to receiving vaccine. Child had not eaten breakfast. After giving ADACEL and Hepatitis A vaccine. I stopped to see if child was ok. Said she felt a little dizzy. Waiting a few minutes had child drink orange juice. Pt said she felt better. I proceeded to give last vaccine-MENACTRA and color of pt face went pale and pt fainted. After pt awoke, laid pt down, applied cool towels and drank additional orange juice. Pt evaluated by doctor, pt released to go home with Mother, who stated "I'm a Nurse". Advised to F/U with PMD for further eval.
Patient states that she woke up on 5/24/19 and was experiencing all over body aches and nausea.
Pfizer BioNTech COVID-19 Vaccine EUA:  Individual reported receiving COVID-19 vaccine from a retail pharmacy on 8/16/2021. Later that day at 2300 individual reports loss of feeling in legs. Fire department was contacted and individual was transported to Hospital. Patient reports treatment with IVIG infusion, and received a lumbar puncture. Patient reports having feeling in legs, but that they are still weak.
Headaches and body aches; Redness on the arm; "A ball" on the arm; Headaches and body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Headaches and body aches), ERYTHEMA (Redness on the arm), SWELLING ("A ball" on the arm), HEADACHE (Headaches and body aches) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Headaches and body aches), ERYTHEMA (Redness on the arm), SWELLING ("A ball" on the arm), HEADACHE (Headaches and body aches) and CHILLS (Chills). At the time of the report, PAIN (Headaches and body aches), ERYTHEMA (Redness on the arm), SWELLING ("A ball" on the arm), HEADACHE (Headaches and body aches) and CHILLS (Chills) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Flu vaccine administered 9-3-10 at 915AM, left deltoid. 9-4-10 at 9AM pt complains of pain in the "butt" of her left hand when pressure applied. 9-4-10 at 5PM pt states pain subsiding. 9-5-10 at 10AM pt states pain practically nonexistent.
Severe headache for 5 days prior to admit to hospital for 48 hours. Muscle aches, tonsillar hypertrophy, pharyngitis. Given PCN, Tylenol, Phenergan, Motrin.
Excruciating and sudden onset of pain and spasm and cramps in left shoulder shooting down arm and into elbow and upper neck area.
Chills, shakes, headache, nauseous and full body aches for 6 hrs. Temperature for 3 days started at 102 for 4 hrs.  Then down to 101 - 100 next 24-36 hrs.  Next 24 hrs temp. was 99.  - 100.  Chills, shakes and nauseous came back again 72 hrs later and lasted about 4 hrs.   Headache and nauseous lasted a large part of 3 days.  Took Tylenol when symptoms first started and stopped after 3 days when symptoms completely stopped.
Pt was seen on 3/31/03 for problems received a day after 2nd anthrax. Pt's arm is swollen all throughout from upper arm to fingertips. Also covered with erythema then pts was seen here at 4/3/03 and his arm has gotten worse from first visit at another hospital. Still edema and erythema all throughout pt's arm.
Case number PHEH2017US004421, is an initial spontaneous report received from a consumer on 09 Feb 2017. This report refers to a 49 year old non pregnant female patient. Prior vaccination history included vaccination with influenza vaccine (unknown whether seasonal or pandemic, other manufacturer) on an unknown date (reported as last year) with no side effects. Medical history and concomitant medication were not reported. She was vaccinated with single dose of FLUVIRIN (batch number: 1619521) at a dose of 0.5 ml, intramuscularly on 05 Feb 2017. On the same day after vaccination, she developed a golf ball size swelling at injection site immediately after receiving vaccine, then immediately felt warm, sweating profusely, lost ability to speak and muscle control and dropped onto floor, could not walk. It was reported that she never lost consciousness and was on floor for 30 minutes and sat in chair until paramedics came and took vitals. She was then was able to stand and speak. She felt queasy on 06 Feb 2017 and was continued the next few days and the queasiness had subsided on 9 Feb 2017. It was reported that the swelling resolved on 06 Feb 2017 and the arm at injection site continued to hurt. She fully recovered from hyperhidrosis, aphasia and syncope on 05 Feb 2017, vaccination site swelling on 06 Feb 2017 and nausea on 09 Feb 2017. The outcome of the events skin warm, coordination abnormal and abasia was not reported and for the event vaccination site pain was reported as condition unchanged. The events were considered as non serious by the reporter and causality of the events was not reported. Seriousness assessment of the event abasia (medically significant) was upgraded based on the Novartis Important Medical Event List.
Erythematous, edematous at vaccines site on right arm. BENADRYL, apply ice.
No additional AE; Caller reported the administration of Improperly Stored PROQUAD; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 30-NOV-2020, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) lot # T021639, expiration date 21-DEC-2021 (dose, route of administration and anatomical location were not reported). There was no additional adverse event reported. Administered dose of vaccine experienced the temperature excursion in range from -10 degrees Celsius to 8 degrees Celsius for 1 hours and 32 minutes. Data logger was involved. There were no previous excursions reported.
Feeling very bad; Very weak; Very tired; Difficulty eating due to nausea; Difficulty eating due to nausea; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  An 89-year-old female patient received BNT162B2 (BNT162B2), administered in arm left, administration date 17Apr2021 (Lot number: EP7533) at the age of 89 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Single, Lot Number: EN6199; Left Arm.), administration date: 20Mar2021, when the patient was 89 years old, for Covid-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 18Apr2021, outcome "not recovered", described as "Feeling very bad"; ASTHENIA (non-serious) with onset 18Apr2021, outcome "not recovered", described as "Very weak"; FATIGUE (non-serious) with onset 18Apr2021, outcome "not recovered", described as "Very tired"; NAUSEA (non-serious), EATING DISORDER (non-serious) all with onset 18Apr2021, outcome "not recovered" and all described as "Difficulty eating due to nausea". Additional Information: The patient was not taking any other products. She received the second dose of the Covid Vaccine last Saturday, 17Apr2021 between 1100 and 1200. On Sunday, 18Apr2021, she started feeling very bad, very weak, very tired, and had difficulty eating due to nausea. The patient asked if this should last long or something she could do. The patient stated her symptoms were continuing, they have not gotten any better or worse. She was concerned about the difficulty eating most of all because at her age she does not want to lose any weight. The patient had not additional vaccines administered on same date of the COVID-19 Vaccine. The adverse events did not require emergency room nor physician office visit. The patient has no prior vaccination within 4 weeks and has not adverse events following prior vaccinations. The patient has no medical history including any illness at time of vaccination and has no family medical history relevant to the adverse events. There were no relevant tests done.  No follow-up attempts are possible. No further information is expected.
She was thought to of had a seizure 3-4 minutes after vaccines. Laid back on bed with eyes open and limbs shaking making gurgling sound .35 seconds in duration. Stopped shaking with eyes open and stopped all movement wasn't breathing about 7 seconds. Doctor treated her with oxygen and checked blood glucose level. I then took my child to E.R.
About 15 minutes of receiving the second dose I started to get dizzy and about 30 minutes after getting the vaccine I started throwing up. I continued to feel that way for 7 days. I had extreme body aches and headaches. I was pretty miserable. After 2 days of feeling like that I started having heart palpitations so I went to the ER on 03/01/2021. Because my heart was racing to 180. When I went to the ER 2-3 days after the vaccine, they said everything came back normal. They said I just had dehydration and anxiety. Later when I got home I got my EKG results and they were actually abnormal, it said anterior infarct age undetermined abnormal. I decided to contact a cardiologist and he did another EKG and I wore a Halter monitor. He explained he felt it was the position of my heart but he was not sure why the abnormalities were there. A week later I felt great. But since, I have spells where my heart continues to go to the 180s. I have been following up to get that checked on. My cardiologist said I might have had covid before and that might be the reason of my symptoms. Also, my period has been crazy, I have been bleeding  heavily. I have been off birth control for over a year and my periods have been pretty regular.  But since the vaccine I bled 12 out of 18 days.
My left ankle became swollen and hot to touch this was ongoing for several weeks. I'm still experiencing joint pains and the swelling has reduced. I have received Perineural injection therapy.
Vaccine received 10:30 am Monday 3/22.  Headache, muscle and joint soreness, very tired starting 4:30 pm Wednesday 3/24. Slight elevated temperature 3/24. Continue through Friday 3/26.  Starting afternoon of Thursday 3/25, skin sensitivity on upper body, front and back. Feels like a sunburn to touch. Ongoing.
Information has been received from a nurse practitioner concerning a 23 year old female patient who on 25-OCT-2010 was vaccinated with a first dose of GARDASIL (Lot # not provided). It was reported that the patient developed hives which spread over her whole body. The rash began at the injection site on the same day she received the dose and spread all over her body, accompanied by itching. The nurse practitioner advised her to take BENADRYL, and also prescribed AMBIEN for her because the itching was keeping her awake. Her rash and itching were improving but had not completely resolved. The nurse stated that the patient did not want to receive the second and third dose of GARDASIL. Additional information has been requested.
Faulty syringe/needle that bent while attempting injecting patient.  new syringe was delivered.  the dose of initial bent syringe was not injected in patient but was discarded.  Pt unharmed. no further issues
This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with the second dose of GARDASIL (dose, lot # and route not reported). The physician reported that during an office visit where the patient was scheduled to receive VARIVAX (Merck) the patient was inadvertently administered the second shot of the GARDASIL vaccine, two and a half weeks after she receiving the first dose of GARDASIL vaccine. Additional information has been requested.
My ears and throat got itchy. Ears felt stuffy. Tingly all over body. Symptoms lasted about 45mins and the subsided.
SENSATION OF INTERMITTENT PINS AND NEEDLES IN FINGERTIPS; EXTREME LIGHT HEADEDNESS INTERMITTENTLY; BRAIN FOG/NOT FEELING LIKE MYSELF; UNABLE TO CONCENTRATE; IT FEELS  ALMOST LIKE GOING TO FAINT, BUT DON'T, IT'S NOT DIZZINESS, IT'S WORSE WHEN STAND UP FROM SITTING; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 155 pounds, and height was 64 inches. The patient's concurrent conditions included: non alcohol user, and non-smoker, and other pre-existing medical conditions included: Patient has no significant medical history, no known allergies and patient was not pregnant at the time of reporting. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 21-SEP-2021) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-AUG-2021, the patient experienced extreme light headedness intermittently. On 24-AUG-2021, the patient experienced brain fog/not feeling like myself. On 24-AUG-2021, the patient experienced unable to concentrate. On 24-AUG-2021, the patient experienced it feels almost like going to faint, but don't, it's not dizziness, it's worse when stand up from sitting. On 01-SEP-2021, the patient experienced sensation of intermittent pins and needles in fingertips. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from extreme light headedness intermittently, brain fog/not feeling like myself, sensation of intermittent pins and needles in fingertips, and unable to concentrate, and the outcome of it feels almost like going to faint, but don't, it's not dizziness, it's worse when stand up from sitting was not reported. This report was non-serious.
presented to ED with SOB, c/o fever, SOB, nausea, decreased appetite x 1 wk; hx of DMT2; tested positive for COVID-19; acute respiratory failure and pneumonia due to COVID; refuses to be intubated; will use BIPAP; pt's condition worsened where he passed away in the hospital
This spontaneous report as received from a nurse, refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with a improperly stored PEDVAXHIB (which had a lot # of M006710 and an expiration date of 06-DEC-2018; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccines experienced the following temperature excursions on an unknown date: 9°C to 25°C (21.9°C) for 6 hours. Reportedly, there had been no previous temperature excursions and the aforementioned one were identified due to a data logger. Furthermore, no product quality complaint was involved.
Reporter indicates a total of ten nurses rec'd Engerix-B & all but one employee experienced events described in labeling e.g., low grade fever, joint pain, generalized aching.