chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2/19/10 vaccine administered. 2/26/10 pt called office complaining of "severe" headache, and flu-like symptoms, body aches, fatigue an abdominal cramps beginning last night. H/A better today and pt denies fever. Urine output and appetite ok. Advised symptomatic tx and call prn worsening s and s. 3/2/10 spoke to pt again. Urine output had decreased over the weekend so she had physician friend order labs which were normal. Pt reports feeling improved BUT still has fatigue and H/A. 3/5/10 Pt feeling normal again.
Patient received Gardasil first and then Menactra. Shortly after the Menactra was administered, he fainted and lost consciousness for about one minute. Then, he started to seize for less than fifteen seconds and became conscious again. Shortly after, he became nauseous and threw up and reported that he felt better after he threw up. We monitored him for 15 minutes and gave him water and had him sit down and rest until he was fully recovered and alert again. We did call his prescribing doctor, Dr., to report the incident and the doctor's office stated that if the patient is feeling fine, he is free to go. I called to check on him 4 hours later and spoke to his mother, and his mother stated he is feeling tired and is resting in bed. I told them to give the doctor a call if the patient feels any adverse symptoms and to take Tylenol if he has fever or pain.
This spontaneous report as received from a retired nurse refers to a 67 year old male patient with fatty liver disease, pulmonary embolism, deep vein thrombosis and allergy to penicillin. On 02-OCT-2017, the patient was vaccinated with PNEUMOVAX 23, 0.5 ml for prophylaxis (lot # and expiration date were not reported). Concomitant therapies included argatroban and unspecified statin medication. On 02-OCT-2017, the patient experienced chills, peripheral edema at the injection site, the swelling in his arm which was more pronounced from the injection site to the elbow but the swelling went all the way down to his hand and he had also decreased mobility in his arm. The patient did not seek medical attention. No treatment was given for the adverse events. The outcome of events was reported as not recovered/not resolved. The relatedness between the events and PNEUMOVAX 23.
COVID-19 vaccine immunization received in 2 shots: Pfizer (lot EL8982, 01/26/2021) + Pfizer (EN6201, 02/21/2021) at Hospital. My only side effect immediately after each immunization was minor injection site arm soreness the next day.  I was initially diagnosed with Morton's Neuroma in 2016 and again in 2018 with symptoms that affected only the toe area of my feet (both) and were successfully resolved over a few months by changing to larger shoes and using cushioned shoe insole inserts.  My current symptoms include a feeling of having a "liquid pad" under my feet when walking or behind my toes when bending them downward, an on-and-off burning sensation burning sensation in my legs from my feet up to just above my knees (sometimes initiated when sitting in the legs-bent position), occasional on-and-off quick pin-stick sensations in my feet, increased general skin sensitivity (i.e. itchiness) and some minor edema in my lower leg/feet area.  The burning tends to be significantly relieved temporarily by resting with my legs straight and feet elevated.  These symptoms are DIFFERENT and NEW from my prior Morton's Neuroma episodes and appeared rather suddenly over the course of 3 to 4 days in early to mid-March 2021 (after the 2nd Pfizer COVID-19 vaccination shot on 02/21/2021).  My symptoms do not bother me during the night when I sleep and tend to be better in the morning hours before I have moved around very much.  Although troublesome, my symptoms vary in intensity and do not seem to be getting worse overall at this time.  Walking tends to amplify the symptoms and my ability to walk comfortably further than to the mailbox and back has been significantly degraded in the last 6 months, but since approximately 09/25/2021 I have been able to re-start taking a short walk again without significant pain or great discomfort while in motion. But not yet comfortable as before this problem started in March 2021.  I have no other mobility or muscle weakness problems not explainable by being out of shape due to lack of exercise and symptoms have not spread to my arms/hands.  Other than testing and diagnosis by 2 DPM's, my Primary Care doctor and a Neurologist, I have had not medical treatment for this condition as there is nothing (other than pain relief medication) that is applicable and the pain and discomfort have been manageable without medication so far.  My Neurologist stated on 09/13/2021 that it is not possible at this time to predict whether my Peripheral Neuropathy will get better, get worse or stay the same.  2 Podiatrists (DPM) I consulted in April 2021 and June 2021 (after this problem started) examined me and concluded that my current problem is not Morton's Neuroma.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 16-JUL-2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 20-JUL-2016, the patient was treated by a family physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Very Severe Side Effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Very Severe Side Effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION COMPLICATION (Very Severe Side Effects). At the time of the report, VACCINATION COMPLICATION (Very Severe Side Effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported.
Pt admitted to hospital on 12/1/06 with chief complaint of ascending weakness bilaterally, upper and lower extremities.  Neuro consult diagnosed Guillain-Barre syndrome.  Pt received the Gardasil vaccine on 11/22/06.  Resident MD asked pharmacist to write up possible ADR of Guillain-Barre from this vaccine. 02/21/2007 records received and reviewed for DOS:12/1/06-02/06/2007 DC DX:Severe form of Guillain-Barre syndrome after HPV vaccine and possible URI. Respiratory failure with prolonged mechanical ventilation and tracheostomy tube placement. Haemophilus influenzae, left lower lobe pneumonia, coag negative staph UTI. Hypertension. Tachycardia associated with dysautonomia now resolved. Presented to PCP with URI around Thanksgiving with associated sinus infection. Began having numbness and tingling in hands days of admission as well as back pain, headache and greater problems walking and began falling over. Able to wiggle her toes but with great difficulty. Pneumococcal vaccine in September/October. HPV vaccine on 11/22/06. Mother has possible MS and possible lupus. Neuro exam:Weakness of deltoid bilaterally, weakness of lower extremities with grade 4/5 weakness at hip flexor, 4/5 hip extension, 4/5 knee flexion, 4+/5 knee extension and 3+/5 plantar flexion. Deep tendon reflexes absent in all extremities even with augmentation. Plantar responses downgoing. Gait abnormal some degree of pelvic girdle weakness and foot drop bilaterally.Began IVIG.  On day 2 began developing post void residuals. Vital capacity deteriorated on day 3 to 2.2 increasing difficulties with secretions as her gag and cough diminished. Able to move only jaw and eyes. Intubated and placed on fentanyl and versed. Developed HTN.  Developed neuropathic pain. At discharge able to stand with assistance.  Off vent on 1/26/07. Tachycardia and hypertension associated with autonomic dysfunction now resolved at discharge. Did not completely recover as of Feb 2007 when she was discharged from a rehabilitation institute.  Still needing physical & speech therapy.  Diagnosis, Guillain-Barre syndrome Per annual follow up information: Unfortunately, since this was a courtesy injection and pt is not our pt we have not seen this pt since and I can not say for sure if she is fully recovered-Sorry. Per 60 day follow up: Unfortunately-pat is seen by another provider & we only did the shot as a courtesy so we have not seen the pt since- Have heard through the grapevine that pt is in Rehab now & off the ventilator & standing to walk again. Per 60 day follow up: Did not completely recover as of Feb 2007 when she was discharged from a rehabilitation institute. Still needing physical & speech therapy. Diagnosis: GUILLAIN-BARRE syndrome
Spreading rashes on feet and face; Rashes look very much like shingles; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced rash and vesicular rash. On an unknown date, the outcome of the rash and vesicular rash were unknown.   It was unknown if the reporter considered the rash and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's husband. The age at vaccination was not reported. Three weeks before the date of reporting, the patient received 1st dose of Shingrix. The patient had rapidly spreading rashes that started on her feet and now on the face. The rashes look very much like shingles. The reporter asked if the vaccine had triggered them and if the patient should receive second dose.
Information has been received on 4/17/02 from a physician who "two or three years ago" was vaccinated with two doses of hep A virus vaccine inactivated. On 4/17/02 it was reported that the physician tested negative for antibodies against hep A. It was noted that the physician did not know what antibody test was used. The physician sought unspecified medical attention. Additional info has been requested.
Delayed reporting of arm complaint in arm rec'd Hep b vaccination. R delt 2/7/02 Recombivax dose rec'd. Did not report this post vaccination. Stated arm was sore and had some hand and digit aching for three days. Stated complaints onset 2 days after he had the injection. States it completely resolved. Pt stated to nurse it was the left arm that was sore. He did not call back to verify as requested.
This spontaneous report received from a registered nurse referred to a 1 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-MAR-2017, the patient was vaccinated with VARIVAX (dose, frequency not reported, lot:M028546, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided (incorrect product storage). The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
patient came in to office on 04/15/2021 for severe left lower extremity pain  and ecchymosis affecting gait. STAT venous ultrasound ordered.
20 Y female with h/o of cardiac transplant in 4/29/20 for HCM with history of early ACR 5/2020 treated with rATG and steroids and early CAV 1 (20% mRCA lesion) on prograf and zortress. Admitted on 7/13 with symptoms of chest pain, lower extremity swelling, chest pressure and orthopnea for rule out rejection. Found to be COVID positive on transfer. On 7/13 underwent a EmBx that revealed 1R/1A. Today, on 7/14, patient denies symptoms of chest pain. Due to COVID hospitalization, patient will be given EUA of Casirivimab and Imdevimab intravenous administration prior to discharge. Deemed stable for discharge.    HX OF orthotopic heart transplant on 4/29/2020 at  with hypertrophic cardiomyopathy  - tacrolimus/everolimus/pred immunosuppression             -- tac goal 8-10               -- everolimus goal 3-8 -- current prednisone dose 5 mg daily  -- RTC in 1 month for OV -- lab work on Friday    - OIP: -- CMV: D+/R+- valganciclovir   -- Toxo/PCP: TMP/SMZ  -- fungal: posaconazole (for 3 months after last rATG ~ 8/22/2020) -CV: on pravastatin -  delayed d/t elevated transaminases  - osteoporosis: zoledronic acid 5mg 5/11/2020   COVID positive --appreciate ID; Casirivimab and Imdevimab today   -isolation precautions
pt recv vax & 3hr later diff breathing then sat & sun hives on chest, upper arms, back & neck;called clinic took DPH-no more hives sl fever also;
Patient did not have any reactions noted in the clinic. I administered a Tdap and a Quadracel (DTAP&IPV), because his sibling was getting 4 yr old vaccines today as well and I just grabbed the wrong immunization to give him. resulting in an extra dose of Dtap
swelling , redness, warmth  tenderness below injection site ,  lasted 3 days & resolved
Immediately after the 3rd vaccine, patient lost consciousness, eyes rolled back in head, became pale, had full body twitching with hands, clinched in a claw, regained conscousness, then 5 minutes later experienced the same symptoms again. Medics arroved, assessed patient, ran an EKG. After 20 mins, medics released patient. Fiance drive pt home.
Woke up in the morning (day after vaccination) with a fever, aches and pains, fatigue, and general grogginess. Took 2 naps during the day for a few hours each with fluctuating levels of discomfort throughout the day. By the end of the night (9pm or so) I started to feel better but was sweating profusely. Woke up in the middle of the night damp from sweat. Went back to bed and slept the rest of the night. Woke up feeling 100%
Pain in hip and nerves in hip and lower back.  Have taken aspirin, Ibuprofen, Tylenol, medical marijuana and lots of coffee.  Only the coffee seems to consistently relieve pain.  Have taken 10 physical Therapy treatments, 4 chiropractic treatments
patient developed COVID; patient developed COVID; This is a spontaneous report from a Pfizer-sponsored program. A contactable Physician reported for a patient that: The patient of unspecified age and gender received first dose of BNT162B2 ( Solution for injection, Batch/Lot Number: Unknown; Expiration Date: Unknown) via an unspecified route of administration, on 13Feb2021 as 1st dose, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient developed COVID  on an unspecified date after the administration of the vaccine. It was reported that physician had a patient who already got the first dose of the Pfizer vaccine on 13Feb2021. Subsequently her patient developed COVID and was wondering when the patient can get the 2nd dose or if there is any timeframe. Outcome of events was unknown. On Follow-up (18Mar2021): This is a follow-up spontaneous report received in response to mail trail sent regarding the confirmation of below mentioned query. This report included that: Query received as an Attachment which included as an escalated comment from 15Mar2021. Reference as a source document with a medical inquiry. Response received as This email is to confirm receipt of inquiry. Please see case for details.  Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the Lack of efficacy, COVID-19 Positive and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)
Untoward effects from COVID; This spontaneous case was reported by a pharmacist and describes the occurrence of ADVERSE EVENT (Untoward effects from COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Untoward effects from COVID). At the time of the report, ADVERSE EVENT (Untoward effects from COVID) 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 reported. No treatment medications were reported. No relevant Lab Data was provided.   This case was linked to MOD-2021-250591 (Patient Link).
More than 8 weeks muscle and site soreness and pruritus at injection site with foreign body sensation in deltoid region (L).
CLAMMY, SWEATY, SEIZURE LIKE ACTIVITY, NAUSEA, AND VOMITING
Administered GARDASIL vaccine in left arm. Patient stayed in room while vaccine record was updated and after visit summary was being printed out. Patient stood up from sitting for about 10 mins. Patient was standing for less than 2 minutes when she began to complain of not feeling well-mom noticed her face was pale/ashy in color and eyes widened and began to arch back and make a "animalistic noise" per mom. Mom reached to grab her because she thought she was fainting. Mom called for help and Dr rushed to the room, then patient began posturing and was limp with a fixed gaze. Dr laid her down on the ground and elevated patient's legs. Dr used stethoscope and heard minimal air movement and shallow respirations. Dr began to stimulate her chest and patient began to respond. Heart rate was normal and respirations increased. Blood pressure and pulse were taken-BP: 130/84 Pulse: 80 Saturated oxygen: 100%-Both were monitored for 30 mins. Patient was given oxygen for 10 minutes. Patient was also given Gatorade to help with nausea. Blood pressure was taken again 105/52 Pulse: 72 and Saturated O2: 100%. Patient stayed laying down with pillow and blankets. Dr has ordered EKG today and gave information to mom about Merck's website. Mom then told us that patient had not eaten today, we gave her peanut butter crackers that patient ate two crackers and continues to drink Gatorade but continues to feel nauseated.
Awoke in the middle of the night with spiking fever 101.5, headache, muscle aches, diarhea, In bed from Monday night to Wednesday morning started feeling better.
Developed itchy pustular rash (varicella) on trunk, neck, face.  Over the counter symptomatic treatment only
Localized swelling 1 cm, firm, tender, mobile. Walks with slight limp.
Several hours after the first vaccine I became dizzy. It was not severe but it continues to this day; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 10Mar2021 at 11:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included A fib (Atrial fibrillation). The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Mar2021, several hours after the first vaccine, the patient became dizzy. It was not severe but it continued to the day of the report. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The patient did not receive any treatment for the event. The clinical outcome of the event dizzy was not recovered, at this time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient developed shingles to her left upper torso under breast around to the axilla a few days post vaccination
10/7/19- chills, shivering, nausea, painful to touch injection site, swelling and redness, fever 10/8/19- better, arm still very red and sensitive to touch 10/9/19- vomiting, nausea, chills, shivering, 104F temperature
Received first pfizer covid vaccine 2/24/21. that same night, he started having vertigo.  It lasted 2 days; then resolved for 3 days; then returned more severe.  Was to the point where he had to hold on to the wall to keep from falling and ended up in ER Pfizer-BioNTech COVID-19 Vaccine EUA
Patient fainted less than 5 minutes after vaccination. She recovered less than 5 minutes later
stopped lactating; Breast size decreased; This is a spontaneous report from a contactable pharmacist. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0153) via an intramuscular route of administration in the left arm on 20Apr2021 at 15:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. It was unknown whether the patient had any allergies to medications, food, or other products. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications within two weeks of vaccination. On 20Apr2021 at 15:00, after the first dose of vaccination, the patient stopped lactating and breast size decreased to a full cup size in less than 24 hours and the patient was no longer able to breastfeed her infant. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events stopped lactating and breast size decreased were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Shortness of breathe, severe neck and shoulder pain while breathing, body pains, throat pain