chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle soreness; This is a spontaneous report from a contactable Nurse. This Nurse reported for a male patient (husband) with unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced muscle soreness on unspecified date. The outcome of event was unknown.   Information about lot/batch number has been requested.
1. Immediate itching. 2. Local reaction 8" diameter, red hot to touch, hard, pain down to wrist, shoulder blade and neck. 3. Mostly resolved by day 2.
Patient felt groggy, little visual disturbances, shortness of breath--when placed in supine position and elevate feet felt better. Feet became numb but vitals were normal--pulse and 02 stats withing range.
This spontaneous non valid report was received from a nurse and refers to a unspecified number of patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in October 2017 (reported that from 10-OCT-2017 to 12-OCT-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L051124, expiration date: 14-OCT-2018, lot # M046133, expiration date: 26-SEP-2019), PNEUMOVAX 23 (lot # N003997 expiration date: 20-OCT-2018) and GARDASIL 9 (lot # L036301 expiration date: 20-DEC-2017, lot # M028323, expiration date: 26-SEP-2018 and lot # N017686, expiration date: 2-FEB-2020) (for all vaccines doses and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius (C) to 25C (11.4C) for 1 hours. Data logger was involved. Follow-up information has been received from the nurse on 11-JUN-2018. She provided that the temperature excursion took place on 10-OCT-2017. The patient identification information was not readily available. Follow-up information has been received from the nurse on 11-JUN-2018 concerning a patient of unknown age and gender. The patient was vaccinated with PNEUMOVAX 23 (lot # N003997 expiration date: 20-OCT-2018) of temperature excursion which took place on 10-OCT-2017 from 16:32 until 19:02 (maximum temperature 11.4C). No adverse effects were reported. This is one of several reports received from the same reporter. Upon receipt of follow-up information it was determined that this case is now valid because the patient's identifier was received. Sender's Comments: US-009507513-1710USA007686.
CONFIRM IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 72 year old male. The patient's weight was 180 pounds, and height was 175.26 centimeters. The patient's past medical history included prostate cancer and had chickenpox for which the patient's mom gave him lemon tea and he broke out worse. It was reported that the suspected was lemon. The patient had food and drug allergies mainly of penicillin allergy and lemon (lemonade, lemon tea) allergy for which stopped drinking lemonade. The patient had one shot of vaccine, had no past history of similar event, had not taken any vaccine since childhood, no adverse event after any previous vaccinations. He had no history of hospitalization in last 30 days with cause, had no family history of any disease (relevant to vaccination) or allergy. The patient had no other suspected causes including co-administered vaccines or risk factors. The patient did not know of pre-existing acute illness 30 days prior to vaccination and also stated that even not known for prostate thing (had history of prostate cancer) was still a problem and haven't had prostate-specific antigen (PSA). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: unknown) dose was not reported, 1 total administered on 26-JUN-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in early AUG-2021, the patient tested negative for COVID-19 antibody test (confirm immunological vaccine failure).  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirm immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with RA complaint number: 90000191365  Additional information was received from patient on 30-AUG-2021. The following information was updated and incorporated into the case: The patient's height, weight, pre medical history (prostate cancer, chickenpox, penicillin allergy and lemon (lemonade, lemon tea) allergy), number was added.; Sender's Comments: V2-The following information was updated and incorporated into the case: The patient's height, weight, pre medical history (prostate cancer, chickenpox, penicillin allergy and lemon (lemonade, lemon tea) allergy) number was added. 20210857423;COVID-19 VACCINE AD26.COV2.S-Confirm immunological vaccine failure 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: SPECIAL SITUATIONS
pt recv vax OCT97 & the same day pt exp vertigo, h/a, stomach upset, muscles aches;the following day pt recovered;
Pt developed erythema and possible cellulitis on left upper arm. Seen by physician the next day and was placed on Augmentin. Symptoms resolved in 24 hours. Continued course of antibiotics.
2 shots in total taken1 month apart. Bad skin reactions and bad sweating lasting about 2 weeks. Breakout of welts on legs, red rash on arms and breakout of lichusplanis which was dormant prior.  Worst reaction was skin cancer lesions that started a week or two after the second vaccine.   I have had 5 skin cancers removed all from legs and top of foot. Typically I may have one removed every 2 years and they seem to keep popping up every time I have one removed.
Client reports her right arm began to swell and was painful to the touch on the evening of 10/24/14. She states she had fever but never checked with a thermometer. States it hurt so bad it woke her up that night. also reports headache. Began taking Motrin which does relieve the discomfort.
This literature report (initial receipt 26-Dec-2011) concerns a 52-year old male patient, who had a history of thyroid cancer. One year after radiation therapy for metastases to the cervical spine, the patient had mild baseline bilateral upper extremities (UE) weakness consistent with radiation fibrosis (RF) and expansile C7 metastases seen on magnetic resonance imaging (MRI). After influenza vaccination, the patient noted increased pain and rapid acceleration in his arm weakness in a pattern not accounted for by prior C7 cervical radiculopathy (CR) and RF middle trunk brachial plexopathy. The patient presented with severe pain and progressive weakness in the bilateral upper extremities that progressed toward flaccidity. Electrodiagnostics (EDX) showed diffuse, patchy right brachial plexopathy. Nerve conduction studies showed reduced right median and ulnar motor amplitudes, an absent right median F-wave response, unobtainable right UE sensory responses, and a normal bilateral radial sensory response. Needle electromyography showed fibrillation potentials and reduced recruitment diffusely. Large motor unit potentials were noted in C7-C8 innervated muscles. No myokymic discharges were seen. MRI showed minimally improved expansile C7 metastases and evolving post radiation changes. The event outcome was not reported. Reporter's comment: Parsonage-Turner syndrome (PTS) is marked by acute shoulder and/or arm pain and progressive weakness of affected UE. With preexisting CR and RF brachial plexopathy, PTS may be difficult to differentiate. This patient's presentation and EDX findings of new diffuse, patchy brachial plexopathy without myokymic discharges were consistent with PTS overlying chronic C7-C8 radiculopathy and argued against solely RF induced symptoms. Improvement of C7 metastases on MRI favored a diagnosis of PTS over worsening cervical spine compression. A diagnosis of PTS may be complicated by the likeness in the clinical course with CR secondary to expansile metastases and RF brachial plexopathy. EDX was vital in distinguishing PTS from other potential underlying causes of acute weakness in this cancer patient.
Mouth started to swell with fine bumps. Used Pimecrolimus cream and it subsided after a couple of days. Right as the swelling was receding, I started feeling a tingling in my throat. I went and got a PCR COVID-19 test and I tested Positive.
Information has been received on 20-APR-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 21-OCT-2013, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-SEP-2014, the patient was treated for an ongoing painful rash which was diagnosed by a physician as the shingles. On or about 16-SEP-2014, the patient was swabbed for a culture that came back positive as a zoster culture, confirming that the patient has a strain of shingles that was classified as "abnormal" based on the culture results. Although shingles is an incurable viral condition, the patient was prescribed oxycodone for management of her painful symptoms. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
10-15 felt fullness in left ear-went to PMD-thought to have been wax in ear. 10-16 &17 flulike symptoms with vertigo. 10-17 felt better but had ringing in left ear-referred to ENT. 10-30 ENT= profound sensorineural hearing loss treated with steroids and ordered MRI r/o acoustic neuroma. 11-7 Second opinion sensorineural hearing loss after flu shot.
Pt vaccinated with TD became faint, nauseated & sweaty. BP dropped from 116/84 before injection to 90/60. No Syncope. After resting 2-3 min BP rose to 102/72. After 30 min she felt well enough to leave for home. 3 hrs later all right now.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: appeared to convulse on way down from floor to chair and on floor -Medium, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: convulsions
developed headache, myalgia, arthralgia, fatigue, collarbone & back motrin helped 1/13 begain again  1/14 redness tangerine size at injection site- motrin 1/15/21 recovered no redness at injection site- aches gone
Discomfort was worse; injection site swelling; injection site pain; Her arm was painful; Limited range of Motion; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MOVEMENT IMPAIRMENT (Limited range of Motion), DISCOMFORT (Discomfort was worse), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PAIN (injection site pain) and AXILLARY PAIN (Her arm was painful) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.  On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 03-Feb-2021, the patient experienced INJECTION SITE MOVEMENT IMPAIRMENT (Limited range of Motion), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PAIN (injection site pain) and AXILLARY PAIN (Her arm was painful).   On 04-Feb-2021, the patient experienced DISCOMFORT (Discomfort was worse).   At the time of the report, INJECTION SITE MOVEMENT IMPAIRMENT (Limited range of Motion), DISCOMFORT (Discomfort was worse), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PAIN (injection site pain) and AXILLARY PAIN (Her arm was painful) was resolving.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
IT WAS DISCOVERED THAT THE DOSE WAS GIVEN OUTSIDE OF THE 12 HOUR ROOM TEMPERATURE RANGE.  MODERNA WAS CALLED AND IT WAS DETERMINED THAT THE VACCINE IS STABLE UNDER CERTAIN CONDITIONS FOR UP TO BUT NO LONGER THAN 24 HOURS.  THE DOSE WAS GIVEN AT ABOUT THE 21ST HOUR.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-395985 (Patient Link).
rash on injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (rash on injection site). On 03-Mar-2021, VACCINATION SITE RASH (rash on injection site) had resolved.            This case was linked to MOD-2021-027529 (Patient Link).
I had a fever 99.9 I also had body aches; felt very tired; At 4pm I start feeling really cold and I could not warm up; came the shivers and aches; came the shivers and aches; This is a spontaneous report from a contactable consumer (Patient). A 66-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL969? Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 08Feb2021 21:00 (age at vaccination 66 years) as dose 1, single for covid-19 immunisation. Medical history included covid-19 from Jul2020 to an unknown date (if covid prior vaccination: Yes). Concomitant medication(s) included colecalciferol (VITAMIN D); simvastatin (SIMVASTATIN); bifidobacterium infantis (ALIGN). Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. The patient previously took bactrim and experienced allergy, celebrex and experienced allergy. On 09Feb2021 16:00 the patient experienced at 4pm she start feeling really cold and she could not warm up, came the shivers and aches, she had a fever 99.9 she also had body aches, felt very tired. The patient underwent lab tests and procedures which included body temperature was 99.9 on 09Feb2021 evening around 9pm I had a fever. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Rash, abdominal pain. Back pain Nov 3,4,5,6. No actual treatment taken to ER given pain medicine then admitted. Ran MRIs and CTs. No diagnosis. Home keeps falling, lost all muscle tone in legs. Finally went to neurologist admit to hospital November 20 from doctor's office. November 20 given IVIG IVs for 2 hours a day for four days. Then Friday November 24 released from St Vs to RHI (rehab) for 1 week. had physical therapy intense 3 hours a day times 7 days. Was using walker when he first came home, Goes to physical therapy twice a week. No longer using a walker. Able to walk by himself. Still has tingling in fingers and toes. After coming home from St Vs November11, doctor taking care of him ordered St Vs home care, they contacted us on November 17, they were here that day.  1/18/07 Received medical records from hospital which reveal patient seen multiple times: 11/4/06 -- Seen in ER for right abdominal pain radiating to back.  Also noted to have diffuse rash on back thought to be secondary to Cipro patient was on.   Final Dx: constipation. 11/5/06 -- Seen in ER for weakness & dizziness x approx 1 week. Final Dx: vertigo. 11/6/06 -- Seen in ER for back pain s/p fall on 11/5/06. Final Dx: back contusion, arthritis LS spine. 11/6/06 -- Returned to ER later same day with dizziness, back pain & abdominal distention.  Advised to be admitted but declined. Final Dx: Compression fractures, constipation, back pain, dizziness & abdominal pain. 11/7-11/11/06 -- Return to ER & was admitted for GI work up for back pain & possible chronic appendicitis.  Patient had lost 10# over past 6 weeks due to poor appetite.  Having constipation, back pain & abdominal pain although currently resolved.  Surgery, ID, heme/onc & neuro consults done.  Possible dx: post myeloencephalopathy syndrome.  DX: possible ADEM, possibly induced by virus. 11/20-11/24/06 -- Readmitted to hospital due to progressive weakness, numbness & tingling of hands & feet. Unable to stand without max assist.  Exam revealed mild upper ext weakness & severe weakness of lower exts & was areflexic in both upper & lower exts.  Received IVIG x 4 days as well as PT/OT. FINAL DX: Guillian Barre Syndrome.
8/18/2021 client received an expired dose of Moderna.  10/4/2021 called patient, states she received her second dose on 9/15/2021. Will  return to the clinic on 10/18/2021 at 12:30 pm to receive a full dose of Moderna in her right arm.  12/23/2021 2:41pm Viewed portal. Client did not return for her second full dose of Moderna. Called patient. States she spoke with someone in healthcare and they told her she was probably protected just not at a higher level. Advised client to return to the clinic to receive a full dose of Moderna. She will go to the clinic on Monday, 12/27/21. Note left in vaccine portal for client to receive a full dose.
This spontaneous report was received from a physician and refers to a 15 year old female patient. The patient did not have any pertinent medical history, drug reactions or allergies. She did not take any concomitant medications. On 25-APR-2017 the patient was vaccinated with a dose of GARDASIL 9 injection, intramuscularly in the left upper arm (dose, lot number and expiration date were not reported) for Human Papillomavirus (HPV) prevention. On 25-APR-2017 (reported as "within minutes"), the patient began to feel light-headed, hot, developed difficulty breathing and had pain at the injection site. She was given ibuprofen as treatment for the events and was monitored at the office for 40 minutes. The symptoms resolved "in that time she was in the office" (on 25-APR-2017) and the patient left the office. On 05-JUN-2017, she was seen in the office again. The patient was complaining of chronic pain in her left arm, which was worse at night and she was unable to sleep at times (since an unknown date in 2017). It was reported that "while the patient stated that symptoms resolved in the office on 25-APR-2017, the physician reported that the pain in her arm came back and persisted." No lab diagnostic studies were performed. The events were treated with ibuprofen, which as "effective at times". The reporter stated that strength and sensation was normal in the left arm and referred the patient to a pain management center for further treatment. At the time of reporting, the event of chronic pain in the left arm was not resolved. The outcome of being unable to sleep was not reported. Action taken with GARDASIL 9 was considered to be not applicable. The relatedness between the events and the vaccination with GARDASIL 9 was not reported. Product quality complaint was not involved. No further information was available. The reporting physician considered the event of chronic pain in the left arm to be disabling.  Additional information has been requested.
On June 8th I started having a headache and watery eyes. I started coughing on June 11th, 2022. On my drive home on June 12th I felt like I had a head cold.  I tested positive on the 13th. I stayed home for 5 days taking extra Vitamin C, Zicam, and Vitamin D along with one aspirin per day. I used Mucinex DM and Tylenol to treat my symptoms. My cough was better by the 16th. By Friday the 17th all my symptoms had all dissolved. I still tested positive on the 5th day so I quarantined for another 5 days. I was negative 10 days after my first positive test.
5 minutes following injection patient complaint of dizziness, hands and feet tingling, blurry vision. Patient was flush, diaphoretic. VS 144/74 HR 61 (10:00am) 10:07 BP 144/77 HR 60- Pt reports palpitations, legs shaking (trembling). 10:09 Diphenhydramine 25mg administered to LD IM. No adverse reactions noted. 10:15 VS BP 144/77, HR 61- patient states he is "feeling better". 10:30 BP 127/72 HR 61 Patient remained in clinic until 11:00 am. He was escorted to his home by family. Instructed to seek emergency medical attention for any adverse reactions at home.
Spouse called RN at home approximately 4 hrs. after shot, states left upper arm grossly swollen, redden and warm to touch. Size of a "baseball" painful to move arm and client is crying. treated with cold compress, Advil X4 tabs, and Benadryl X2 at home. 11/8 at 8 am, area still red and enlarged. Not as painful and planning to go to work today. No doctor seen yet.
In March 2021 was "putting in vinyl flooring and had issues with lower legs". Early April 2021 noticed pain/swelling in bilateral feet. June 7, 2021 saw PCP to rule out gout. Negative for gout. Was being treated for possible nerve pain. Decreased PO sodium intake. June 21 prescribed gabapentin for 3 weeks; did not complete course due to increased swelling in feet. Asked PCP if this was a Moderna side effect, reports PCP was unsure. Patient now as an EMG ordered to rule out neuromuscular etiology.
no adverse event; Patient was administered expired GARDASIL 9; This spontaneous report was received from a medical assistant, concerning a female patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 14-JUL-2022, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe (lot number 1637651, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 09-JUN-2022) (dose, frequency, route of administration, anatomical location and vaccination scheme were not reported), as prophylaxis (expired product administered). No additional adverse event reported.