chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sluggishness; bladder issues/did not know what the issue was; kidney issue/did not know what the issue was; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggishness), BLADDER DISORDER (bladder issues/did not know what the issue was), RENAL DISORDER (kidney issue/did not know what the issue was) and COVID-19 (COVID-19) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On 01-Sep-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced SLUGGISHNESS (Sluggishness), BLADDER DISORDER (bladder issues/did not know what the issue was) and RENAL DISORDER (kidney issue/did not know what the issue was). In 2021, COVID-19 (COVID-19) had resolved. At the time of the report, SLUGGISHNESS (Sluggishness), BLADDER DISORDER (bladder issues/did not know what the issue was) and RENAL DISORDER (kidney issue/did not know what the issue was) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2021, SARS-CoV-2 test: (Positive) Positive.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant  medication information provided  No treatment medication information provided  On Oct 2021, patient received first dose COVID-19 vaccine manufactured by Moderna  Humira Causality as per reporter (Drug/Vaccine) : No reasonable possibility
Patient was given 2nd Covid booster too early.  It was given 3 months after the 1st booster rather than 4 months.  No adverse effects were reported per patient's wife/caregiver.
Severe nerve irritation in legs, numbness in feet, loss of feeling in my toes, vaginal flare up, lethargy.   Also exhibited mild Covid symptoms lasting  for two weeks starting 60 hours after vaccination.
Health Department was notified of patient death. Health Department was not informed of cause of death. VAERS report completed.
Head ache; sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 30Jan2021 (at the of 65-year-old) as dose 1, single and second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 20Feb2021 (at the of 65-year-old) as dose 2, single for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease. The patient's concomitant medications were not reported. Allergies to medications, food, or other products were reported as no. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Additional vaccines administered on same date of the Pfizer Suspect was reported as none. On 30Jan2021 the patient experienced head ache, sore arm. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. Patient not received any treatment for the events. Outcome of the events was recovered on unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt developed shingle like welts, per patient to back area and sacrum that itch.
27 y/o patient calls clinic at 1430 on 14MAR13, reporting swelling, redness, warmth, itching of his right upper extremity (RUE) at 48 hrs s/p receipt of Varicella #1 (SC) and Seasonal Influenza (IM) vaccines in his right upper arm. He also received an adult dose of the Tdap and MMR#2 in his LUE on the same date, but denies any swelling, redness or pain of his LUE. He has not experienced any wheezing, lip swelling, facial swelling or difficulty swallowing or developed hives since receipt of the 4 mentioned vaccines. He is left hand dominant (LHD) and denies any paresthesias, numbness, weakness, change in color (blue) or temperature (cold) of his right arm or hand or fingers since receipt of the Varicella #2 or Seasonal Influenza (IM) vaccines on 12MAR13. He is concerned because the swelling, redness, warmth and itching of his RUE extends from his right deltoid to just above his right elbow. He is able to pick objects up and bend his arm. He endorses a slight HA yesterday, but otherwise denies fever, chills, CP, SOB or systemic malaise.
Information has been received from a physician concerning a female (age unreported) who was vaccinated with a dose of GARDASIL vaccine, lot number not reported. Within five minutes the patient passed out for an extended period of time, hit her head on the wall and went to the emergency room. This is one of 2 cases from the same source. Additional information has been requested.
intense blistery rash; rash was also itchy and blotchy /itching; rash was also itchy and blotchy / blotchiness; This case was reported by a consumer via call center representative and described the occurrence of blistery rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 23rd January 2021, 3 days after receiving Shingrix, the patient experienced blistery rash, itchy rash and blotchy rash. On an unknown date, the outcome of the blistery rash, itchy rash and blotchy rash were not recovered/not resolved.   It was unknown if the reporter considered the blistery rash, itchy rash and blotchy rash to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported but could be 62 or 63 years. The patient received the 1st dose of Shingrix in left deltoid. The patient developed an intense blistery rash from her elbow to her wrist on her right arm and the rash was also itchy and blotchy. The patient stated that although it was now less severe, she still had the rash, itching and blotchiness.   The reporter did not consent to follow-up. No other information was reported.
Pain at injection site only; received 0.5mL dose versus 0.25mL dose.
muscle stiffness that affected his mobility; muscle stiffness that affected his mobility; hamstrings were tight; This case was reported by a consumer via call center representative and described the occurrence of muscle stiffness in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2021, the patient received the 1st dose of Shingrix. In November 2021, less than a week after receiving Shingrix, the patient experienced muscle stiffness, mobility decreased and tendinous contracture. On an unknown date, the outcome of the muscle stiffness and tendinous contracture were unknown and the outcome of the mobility decreased was not recovered/not resolved.   It was unknown if the reporter considered the muscle stiffness, mobility decreased and tendinous contracture to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR084332   Additional Information: GSK Receipt Date: 25-MAY-2022 Reporter's Comment: The patient self-reported this case. the patient received dose of Shingrix and within a week or so after, he started experiencing muscle stiffness that affected his mobility. The patient went to his primary doctor who referred him to an orthopedic doctor.  Around January 2022, the patient saw the orthopedic doctor and was told that his hamstrings were tight which was why bending and moving was difficult for him. The orthopedic doctor recommended either physical therapy (PT) or yoga. The patient stared doing yoga and his muscles were starting to loosen up. Beginning of April 2022, he went on a trip and he wasn't able to do yoga during that time. The patient received  his second Shingrix shot on 18-April-2022 and around that time the muscle stiffness was getting worse and even with doing the yoga it was not improving, refer case US2022AMR084332. The patient also reported that he had abnormal blood work. He did not remember what specific lab value was abnormal or if that value was high or low. The reporter did not have the lot number for the Shingrix vaccines but he did provide his doctor's contact information as he received the shots at his doctor's office and they should have the lot numbers on file.  The reporter consented to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR084332:same reporter
pt recv vax approx 2 days ago approx 2 to 3PM; pt exp a mad spell for about 45mins; turned white w/bluish around the mouth; pt was limp all over; pt was trying to sleep or pass out; hyporesponsive episode
Severely sore around eyes, swollen lower lid and hurts to smile since adds pressure to the under eye area; slightly dizzy and head feels hot.
Extreme chills andfever. Dry mouth,edema, of etrmities,weakness,loss of appitite,sleepiness
The patient reported that she has a red, itchy spot below her injection site that appeared days after her vaccination.  She has been using an over the counter topical on the site to control the itch.  It has been visible and itchy for a couple days, so far.
Received immunizations this AM. Very fussy since immunizations. MOC denies fever, no redness or warmth at injection sites. Advised TYLENOL; massage to sites, warm compress to sites.
Breakthrough COVID infection in fully vaccinated patient. Positive date 08/31/2021.
Information has been received from a nurse, for the Pregnancy Registry for GARDASIL concerning a 23 year old female patient who on 06-APR-2007 was vaccination with the first dose of GARDASIL 0.5 ml intramuscularly.  On 06-JUN-2007 the patient received the second dose of GARDASIL 0.5 ml intramuscularly and the third dose of GARDASIL 0.5 ml intramuscularly was administered on 06-OCT-2007.  The patient had an abnormal Pap smear result on 01-OCT-2008.  Also the patient was currently pregnant.  Second Pap smear results are pending.  The patient sought medical attention. Follow up information was received concerning the patient's due date: 01-MAY-2009, last menstrual period: 25-JUL-2008. Additional information has been requested.
Within the first 24 hours after dose 1 I became intensely nauseous with low grade fever chills, and sweats. My entire body ached. It seemed to resolve within 36 hours. This happened with both doses, 1 and 2. Beginning in May of 2021 many symptoms began to become noticeable that were not applicable to obvious injury: low testosterone extremely high cholesterol light sensitivity; heat intolerance brain fog memory loss with poor recollection hearing loss vision loss pain bumps on right jaw and right wrist that felt like it was on a bone that was exposed increased anxiety inability to tolerate to any kind of stress lack of patience exaggerated irritability, Within the last 12 months I have spent time with the following doctors to help diagnose my conditions and have now been referred to the General Practitioner ; Orthopedic ; Endocrinologist; Rheumatologist ; Physiatrist ; Cardiologist.
SENSATION OF TICKLING PINS AND NEEDLES ON BOTH ARM TO HANDS; This spontaneous report received from a patient via a company representative concerned a 40 decade old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced sensation of tickling pins and needles on both arm to hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sensation of tickling pins and needles on both arm to hands on APR-2021. This report was non-serious.
slight fever, muscle pain akin to those suffered with statin medication, pressure in the head, light headed, some chest pain
At time of vaccine, felt twitch in arm as vaccine was administered. On day 4 there was sudden intense pain in arm from shoulder to each finger tip - pain seemed to be from within arm and lasted 9-10 hours. Improved some with ice. When ice was off severe pain    returned. Next day pain improved somewhat and gradually improved over next few days.
13Feb - No fever, had chills & aches after Anthrax vac on 4Feb11. Neck tenderness under ears. 25Feb - No fever, neck pain under ears. 6Mar - No fever, neck pain under ears, submandibular gland irritation.
This spontaneous case, was received on 09-Oct-2017, from a consumer, concerning a 49-year-old adult female patient. The patient's current condition included allergy to skin of fruits (apples, plums). On 06-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195125 (as reported), expiry date: not reported). On the same day (06-Oct-2017), within 5 minutes of vaccine administration, the patient had itchy lips, throat and mild wheezing. The patient was taken to the urgent care and was prescribed with VENTRANQUIL inhaler. The patient did not use the inhaler and the reaction lasted for 12 hours. The patient recovered from the events. The reporter assessed the events as non-serious.
Information has been received from a Nurse Practitioner (N.P.) concerning a 40 year old female patient who was vaccinated with a dose of Gardasil. Subsequently the pateint developed welt on both arms. She was taken to the emergency room (ER). The patient recovered. Additional information has been requested.
My arm has never recovered from this shot given 10/12/2018. The pain in the shoulder has burned, ached, radiated down to the mid arm and there is severe loss of strength and mobility with pain. I have been forced to take over the counter pain medication daily to tolerate the pain. I have used a lidocaine patch during the day and a heating pad at night. I had a steroid injection trying to relieve the pain in January,4 2019 from Dr. Back to Dr March 15,2019 to get another injection. He did not treat but recommended I get ultra sound. I then went to a Sports Med Dr. on March 18, 2019 who did an ultrasound to see if there was a tear. No tear. Then went to a PT March 20, 2019 to get exercises to help. The exercises hurt so bad that I could only do them on my days off because of the pain it caused after. It has caused issue with the work and daily routine as well. I was doing yoga 3-4 days a week. I have gone to one day a week with much modification.
Symptoms: red blotches on; face, feet, ears, back, legs, and arms, swelling of; face, lips, hands, ears, and feet, lack of appetite. Treated with 1 tsp. Children's Benadryl.  Following Dr. visit was prescribed Hydroxyzine 10mg.
Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    Concomitant drugs were not reported.  It was reported that there was a dark blue cap vial with a dose of 25 mcg for age group 6 months to 5 years instead patient was administered with 10 mcg dosage from the dark pink cap and a label with a yellow box.  Treatment medications were not provided.  This case was reported for patient 8 out of 18 (12 Patients-Initial Dose).   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)
THE INJECTION SITE WAS RED, SWOLLEN, AND LUMPY. PATIENT FELT MODERATE PAIN WHEN TOUCHED IT.
He was administered the shot and by the next day started having fevers & spitting up his food. His fever got worse and his appetite also. He was sleeping & crying for the most part and his fever was being stabilized by MOTRIN and TYLENOL.
pt devel Bell's palsy on 6JUL95;was seen by MD on 10JUL95 who confirmed dx;initial sxs were lack of facial muscles & strength on lt side, sensitivity to loud noises & inability to completely close lt eyelid;
This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date (reported as "at least 2 years ago"), the patient's mother was vaccinated with a dose of ZOSTAVAX (lot #, dose and route were not provided). The pharmacist reported that the patient's mother who received ZOSTAVAX never developed a rash or any other symptoms. No adverse effect was reported for the patient's mother. On an unknown date, the patient's mother transmitted the virus to the patient and he developed shingles. The patient was hospitalized on an unknown date for awhile after coming down with the shingles and he had severe pain. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/21/2022 PNEUMONIA R09.02 HYPOXIA 1/28/2022 PNEUMONIA J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/21/2022 UNSPECIFIED ANXIETY R09.02 HYPOXIA 1/28/2022 UNSPECIFIED ANXIETY J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/21/2022 ACUTE RENAL FAILURE, UNSPECIFIED R09.02 HYPOXIA 1/28/2022 ACUTE RENAL FAILURE, UNSPECIFIED
THIS CASE MEETS CRITERIA FOR VACCINE BREAKTHROUGH REVIEW.  SXS INCLUDE WORSENING SOB.  WAS PREVIOUSLY ADMITTED FOR COVID PNA.
Information has been received from a pharmacy student concerning a 64 year old male with allergy to Tdap vaccine which caused widespread body swelling, who on 04-AUG-2010 was vaccinated with a single dose of ZOSTAVAX (Merck) (lot # 665522/1765Y, SC) in the left upper arm. On 06-AUG-2010 the patient developed a red, raised, itchy rash on his right foot. The rash spread to the left foot and the back of the left thigh. The patient was evaluated in the office on 10-AUG-2010. No treatment was initiated. The patient not recovered. Follow-up information received from nurse practitioner (also registered nurse) concerning a 64 year old male with history of rash swelling to Tdap in past, right foot fracture, and no illness at time of vaccination, who at AM on 06-OCT-2007 (previously reported on 04-AUG-2010) was vaccinated with the first dose of ZOSTAVAX (Merck) (lot # 665522/1765y, SC) in the left arm. On 06-AUG-2010 the patient developed itchy rash on the lateral aspects of the right foot which went to medial aspect. The patient had been wearing boot on the right foot. Rash then was centralized to left leg/foot and back of both thighs. Rash was raised erythema rash on both legs and back of the thighs. There were no labs or diagnostic tests performed. No pustules. The outcome was unknown. Additional information has been requested.
1721: patient w/c/o "itchy throat, difficulty swallowing and talking and felt like she had a lump in her throat."; 911 activated 1725: BP:118/84; P:82; RR:20; O2 sat: 99%; patient had no LOC but nurse concerned about patency of airway, patient speaking but complaining of throat feeling tight; placed patient on cot in a supine position. Patient speaking, still w/c/o throat feeling tight. Remained with patient and asked questions about her health hx. 1730: BP:120/78; P:88; RR:18; O2 sat: 99%; patient not experiencing increased difficulty breathing; able to maintain a conversation with this nurse. 1735:BP:124/80; P:78; RR:18; O2 sat: 100%; EMS arrival; report given to EMS and care transferred to EMS; Blood sugar: 91 p/EMS 1745:EMS departed, patient left w/friend; stated she was feeling much better. 2030: This nurse called patient and left message for patient to call back in order to see how she was doing. 2036: Patient returned call and stated she was much better; "lump feeling in throat went away ~30 minutes after she left our facility, still has a tickle in throat but over all is feeling fine." Informed patient to please contact 911 if she experiences any difficulty breathing, patient verbalized understanding.
MUSCLE ACHES, HEAD PAIN RADIATING TO BOTH SIDES OF HEAD, PAIN DOWN TO TAIL BONE, RINGING IN EARS, SHIVERING, DIFFICULTY MOVING ARM.  PATIENT STATES FINALLY FEELING BETTER TODAY (4 DAYS LATER)
Skin sensitivity, 9:30 pm chills, 1:40 am hot flashes, 3am Treatment only for soreness with H-E-B brand pain killers
I developed a rash the next morning after receiving the vaccine. I had a rash on my right breast into my arm pit, and my breasts became enlarged...I had a high fever and was feeling lethargic. I felt terrible over the next few days and started developing even more rashes. My face was swelling . I went to the Emergency Room and they diagnosed me with Shingles, I was on medication for the shingles and i still kept breaking out with rashes. the left side of my face began to droop and I was not thinking straight. I went to the ER about 4 more times along with visits to my OBGYN and dermatologist. My dermatologist did biopsies of the rashes and it was found to be that I had an allergic reaction to the Moderna Shot.
urticaria around injection spot spreading down the rest of the arm. It was warm to the touch.
On 1/27/2021 Had adverse reaction, was Headache, Body Ache , Sore Throat, Nausea, Stayed off work for two days. Self medicated with Tylenol, Aleve, Reactions started four days after vaccination. Nurse advised Covid 19 Test on 1/29/2021 which was Negative.