chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Can't move it independently and states it is immobile; Muscles contractions between her shoulder and her arm, the big part or arm of completely seized/patient is almost still completely unable to lift her arm.; Patient is almost still completely unable to lift her arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of IMMOBILE (Can't move it independently and states it is immobile) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced IMMOBILE (Can't move it independently and states it is immobile) (seriousness criterion medically significant), MUSCLE CONTRACTIONS INVOLUNTARY (Muscles contractions between her shoulder and her arm, the big part or arm of completely seized/patient is almost still completely unable to lift her arm.) and LIMB DISCOMFORT (Patient is almost still completely unable to lift her arm). At the time of the report, IMMOBILE (Can't move it independently and states it is immobile) and LIMB DISCOMFORT (Patient is almost still completely unable to lift her arm) outcome was unknown and MUSCLE CONTRACTIONS INVOLUNTARY (Muscles contractions between her shoulder and her arm, the big part or arm of completely seized/patient is almost still completely unable to lift her arm.) was resolving. Not Provided          Relevant concomitant medications were not reported. Treatment information were included ibuprofen, acetaminophen and diphenhydramine recommended by her doctor but the patient took lower than recommended doses: 800mg ibuprofen, 25mg diphenhydramine and 800 mg acetaminophen.  Action taken with mRNA-1273 in response to the event was not applicable.  Company Comment: This case concerns a 31-year-old female with a serious unexpected event of immobile, and nonserious unexpected muscle contractions involuntary and limb discomfort. Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 31-year-old female with a serious unexpected event of immobile, and nonserious unexpected muscle contractions involuntary and limb discomfort. Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age of unspecified race and ethnicity. Initial information was processed along with the additional information received on 14-JAN-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, (Dose number in series was 1) administered 1 in total to the left arm on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-JAN-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) positive. On 31-DEC-2021, the patient experienced his first symptom. On 04-JAN-2022, the patient had PCR test and on 08-JAN-2022 the results came for PCR test as positive which was a confirmed clinical vaccination failure, and confirmed covid-19 infection, patient denied receiving any booster dose. On 14-JAN-2022 patient only has little cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000211920.regulatory authority; Sender's Comments: V0:20220126030-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination 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 received a dose of Covid Pfizer 10mcg/0.2ml as a second dose instead of 0.3ml Pfizer 59267-1000-01,  30mcg/0.3ml.
I woke up this morning 8/17/21 and could not open or move my left hand. I soaked in warm water and pried it open. Once I got it open the joints in my fingers popped in and out of place repeatedly. My wrists are also swollen. I am also experiencing tightness in my neck and shoulders. I went to my primary care doctor today and she took blood work and then provided me with a Toradol injection to see if that would reduce the swelling. She also ordered an x-ray of my left hand where the joints are visibly the most swollen.
1400: Pt recd. Vaccine and immediately loss conciousness for 20-30 seconds, Pt regained conciousness , was diaphoretic and anxious. Pt VS noted BP 96/60, HR 73, SPO2 100% on RA, RR 22. Pt escorted via wheelchair to ER for further evaluation. Husband notified.
Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 59-year-old male patient who received HAV (Havrix) (batch number 3F349, expiry date 9th August 2022) for prophylaxis.   On 3rd November 2022, the patient received Havrix. On 3rd November 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-Nov-2022 Reporter's comment: The reporter stated that that a patient was administered dose of Havrix that had expired.  The vaccine administration facility was the same as primary reporter. The reporter gave consent to follow up via email. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used. This is 1 of the 6 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022162503:Same reporter US-GSK-US2022162506:Same reporter US-GSK-US2022162505:Same reporter US-GSK-US2022162501:Same reporter US-GSK-US2022162509:Same reporter
2/10/2015 Intussusception. Air contrast enema x3 required for tx.
abdominal pain associated with MORE vaginal bleeding 1day after vaccine (pt already had vaginal bleeding preceding vaccine)
18Aug04-received shots listed below, 9 days later had maculopapular, erythematous rash over entire body all at once. No vesicles, crusts, pustules. Smallpox site progressed well- major take- No other problems suspect Erythema Multiforme- minor, still has rash.
This spontaneous report as received from a physician refers to a 16 years old female patient with no drug reactions/allergies. The patient's pertinent medical history included knee surgery for an unspecified injury on 29-OCT-2012, "2 weeks ago". The patient was intramuscularly vaccinated with 0.5 ml of GARDASIL (Lot # unspecified) on 12-NOV-2012. Concomitant medications included: MOTRIN and an unspecified pain medication on 11-NOV-2012. On 12-NOV-2012 the patient developed headache, vomiting, nausea, lack of concentration, low grade fever and stomach pain after receiving GARDASIL. The patient was absent from school related to her symptoms. The patient had sought medical attention via calling to office. No lab diagnostics studies performed. Treatment of dibromopropamidine isethionate, PHENERGAN and Ranitidine were given for the events. The outcome was unknown. Additional information has been requested.
pt leg swollen up & got a rash, then later, had a febrile sz;pt now has sz & is taking med for them;
I received my vaccine on 12/6/2021 and that evening I had a fever and muscle aches. I had a rash all over my body too not just at the injection. I took Motrin to help with the fever and muscle aches for a couple of days. I have had flare ups since the vaccine in February, April and June with high fever, headache, blurry vision and body/joint/muscle aches. I have been to the doctor and they have prescribed (unknown) medicine but it didn't help. I have alternated Tylenol and Motrin which helps with the fever and headache.
dizzines and fever; fever; headache; body ache; nausea; diarrea; only able to eat crackers with medication; This spontaneous report as received from a other refers to a patient of unknown age. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medication were unknown by reporter.  On 12-OCT-2021, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T028929 with expiration date on 08-MAR-2023, at 0.5 milliliter dosage, intramuscular ly in the right deltoid for prophylaxis.    Subsequently, the patient experienced dizziness, and low grade fever. The fever was consistent with medication, but without Tylenol, the fever reached 103 (units not provided). Other symptoms included: headache, body aches, nausea, and diarrhea and the patient was Only able to eat crackers with medication (dysphagia).   The outcome of dizziness, dysphagia, diarrhoea, nausea, pain, headache and pyrexia was unknown.    The causality assessment between vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the aforementioned events was not reported.
Severe prolonged headache; Nausea; Strong vomiting; Night-time bowel movement though not diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 10:15 (Lot number: ER8732) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CALCIUM. Past drug history included: Tylenol, reaction(s): "Allergies", notes: known allergies: Possibly codeine (vomiting with codeine tylenol); Tylenol, reaction(s): "Vomiting", notes: known allergies: Possibly codeine (vomiting with codeine tylenol); Codeine, reaction(s): "Allergies", notes: known allergies: Possibly codeine (vomiting with codeine tylenol); Codeine, reaction(s): "Vomiting", notes: known allergies: Possibly codeine (vomiting with codeine tylenol). The following information was reported: HEADACHE (non-serious) with onset 30Mar2021 22:00, outcome "not recovered", described as "Severe prolonged headache"; NAUSEA (non-serious) with onset 30Mar2021 22:00, outcome "not recovered", described as "Nausea"; VOMITING (non-serious) with onset 30Mar2021 22:00, outcome "not recovered", described as "Strong vomiting"; BOWEL MOVEMENT IRREGULARITY (non-serious) with onset 30Mar2021 22:00, outcome "not recovered", described as "Night-time bowel movement though not diarrhea". Therapeutic measures were not taken as a result of headache, nausea, vomiting, bowel movement irregularity.  Additional information: Concomitant medications included probiotic and multivitamin for an unknown indication. The patient had known allergy to possibly codeine and experienced vomiting with codeine and paracetamol (TYLENOL). Prior to the vaccination, the patient was not diagnosed with COVID-19. 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. it was reported that event night-time bowel movement though not diarrhea. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events severe prolonged headache, nausea including strong vomiting and night-time bowel movement though not diarrhea.   No follow-up attempts are needed. No further information is expected.
Pt recvd 3 doses of Engerix-B found to be a nonresponder;
Pt had previously normal not heavy regular menses before vaccine. The cycle following vaccine menses 5-7  days with large clots kept her from leaving house. Menses have not gone back to normal but started to get better in June or July.  Below from visit notes. She has been getting more clotting with menses recently as well. Clotting was very bad after covid vaccine lasting 2 days for several months, she couldn't leave her bath tub, couldn't go to work.
PT FAINTED FOR ABOUT 2-3MINSAND WAS AROUSED BY VERBAL STIMULI, BP141/85 HR 58 R18 O2SAT 98%. PTSTATED THAT HE IS SCARED OF NEEDLE,HE WAS TALKING. HE STATED THAT HE IS NOW FINE AND CAN DRIVE HOME. PT LEFT THE SITE AT5:35PMDRIVING HIMSELF. INSTRUCTED TO KEEP TALKING  TO HIMUNTIL HE GETS HOME.
Patient received the first dose of Moderna on 3/31/2021. 1 week later, patient experienced an extremely sore arm and enlarged breast without pain on the side patient received vaccine. According the patient, she received an ultrasound that showed enlarged lymph nodes without clogs. Patient is currently still experiencing an enlarged breast and has a follow up appointment for an ultrasound in 2 months.
Flu like: muscle pain throughout body, pain at injection site, and low grade fever for about 36 hours.
4/9/11 First symptoms - swollen finger, nodule on wrist next week pain in jaw and times when she called not straighten her finger. Increasing pain and swelling in knees, hands, feet, fingers and toes. Back and shoulder pain. Fatigue. Saw rheumatologist 6/8/11. Fever and rash all over body 6/19/11. Dx w/Lupus (SLE) 6/29/11, Tx prednisone and PLAQUENIL.
Breakthrough case admission after 2 vaccines Moderna 2/21/21 NO LOT #;  Moderna 3/21/21 NO LOT# THERE WERE NO LOT NUMBERS DOCUMENTED IN THE DATABASE
(L) shoulder swelling adverse vaccine reaction. Ice pack, TYLENOL/MOTRIN x pain 98 degrees.
Injection site was painful; Nauseous; overall body aches; Severe chills; overall fatigue; A spontaneous report was received from a consumer who is a 61-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe chills, body aches, overall fatigue, nauseous and  injection site pian  The patient's medical history included rheumatoid arthritis, COVID-19. No concomitant product use was reported.  On 04 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 039K20-2A) in the right arm intramuscularly for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the same day as the vaccination, the patient reported she had severe chills, body aches, and was overall fatigued.   On 05 Jan 2021 and 06 Jan 2021, the patient reported she was not able to work due to her symptoms.  On 07 Jan 2021, the patient reported she was nauseated and fatigued. She stated her injection site was so painful she was unable to lay down on it at night. She also reported she had arthritis in her shoulders but was not sure if that was related to her rheumatoid arthritis.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, severe chills, body aches, overall fatigue, nauseous, injection site pain  were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Feeling weird; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling weird) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and HYDROXYZINE for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling weird). At the time of the report, FEELING ABNORMAL (Feeling weird) had resolved. Not Provided          No concomitant medication was given by reporter. No treatment medication was given by reporter Patient felt weird after the second dose for 10 hours.   This case was linked to MOD-2021-375333, MOD-2021-375339, MOD-2021-375342 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow-up received on 09-Nov-2021 contains information about concomitant medication.
High fever 102-103 for two days, arm swollen and very sore, swelling underarm for 3 days
There was no adverse events reported by patient. Due to the refrigerator temperature excursion on 8/12/16, manufacture determine the vaccine is not viable and CDC recommend revaccinate.
Subsequently post vax, the pt experienced thrombocytopenia and was hospitalized. The reporter stated that the pt's experience was related to her disease state and not to therapy with vax.
approximately 4 weeks after the second vaccine, I began with mild left axillary adenopathy--no swelling at this point, just some mild pain.  As the weeks progressed, the left axillary became pronounced and swollen, and by mid March, required ED visit---ultrasound was done and diagnosed with lymphadenitis, still no abscess seen. Another week goes by and now range of motion has definitely decreased---return to ED last night, 3/21 where I had to have 4cm x 2 cm abscess in the axillary incised and drained.  Most prominent region was to the most lateral region of my axillary area with pain that has been sharp and radiating. Cultures are pending. I am convinced, as a healthcare provider, that this is correlated to the vaccine series, both received in the left arm---it is known that women should not have a mammogram for months after the vaccine due to a lymphatic response---i had a response with an associated infection; this has never happened to me before, it is no coincidence---it is related to the vaccine in some regard. Thank you.
Terrible pains and/or aches in shins, calves, thighs, hamstrings, lower and upper arms, back , sides and headache.  I curled up in my bed in my flannel pajamas with my electric blanket on high.  I never felt sick to my stomach but  did feel hot and cold and shivery.  made it through the night and felt somewhat better in the AM but slept  all morning and most of the afternoon.  I have a bad knee and hip and was in much pain walking or doing much of anything..  Finally went to PA and Hospital a couple of weeks later as I could hardly walk because of pain in right leg and hip.  He ordered x rays and  apparently it didn't show anything different than what we already knew that I have arthritis in my knee and hip.  I am feeling better but plan to see and orthopedist soon to gather more information on the xrays.
Information has been received from a medical assistant concerning a 22 year old female who was vaccinated with a dose of RECOMBIVAX HB, on an unspecified date. Subsequently the patient experienced an unspecified severe reaction to RECOMBIVAX HB (manufacturer unknown). The patient sought unspecified medical attention. She was subsequently determined to be allergic to yeast and she fully recovered after unspecified treatment. No further information is available.
About 2 AM I woke up with a headache, some chills, felt a little feverish, and had some nausea.  I have some pain in arm and shoulder by injection site. These are still present now at about 4:30AM
At the site of the immunization there was significant redness, swelling, and warm to the touch. The swelling spread beyond the elbow.
Within approximately 5 minutes of observation post vaccination, patient suddenly became unresponsive to questions asked by her granddaughter, no respiratory distress.  After 3-4 minutes, she was responsive and alert , oriented to person, place and time. Then after a few more minutes, was unresponsive again with her BP 70s/ 40s  HR 48 complaining of abdominal pain and "feeling warm ". She was then transferred to the Emergency Department.
Slight imbalance of body about 5 days after the first dose. After the second dose, about 5 days later started feeling very off balance with the constant sensation of being on on a boat/vertigo. Episodes of racing heart with  unexplained anxiety. Headache, head pressure, heavy head. Lightheaded and feeling like I will pass out. Also unexplained itchy red spots on skin after the first dose that still itch.
High fever, sweating, skin rash over entire body, joint pain.  Prescribed Benadryl, Tylenol
COVID, Paxlovid, COVID rebound, exacerbated asthma and reactive airway infection (bronchitis) followed by more asthma
SHORTNESS OF BREATH; BRAIN FOG; CAN BARELY WALK; SEVERE FATIGUE; This spontaneous report received from a consumer concerned a male of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. 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 APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up request batch/lot numbers. No concomitant medications were reported.  On JUL-2021, the patient experienced shortness of breath. On JUL-2021, the patient experienced brain fog. On JUL-2021, the patient experienced can barely walk. On JUL-2021, the patient experienced severe fatigue. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe fatigue, shortness of breath, brain fog and can barely walk was not reported. This report was non-serious. This case, from the same reporter is linked to 20210815104.
Bladder infection; This is a spontaneous report received from a non-contactable consumer (reported for mother) via Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced bladder infection. The reporter called on behalf of her Mom, her mom had the Covid 19 Vaccine on 14Jan. and then 01Feb. Mom had a Bladder infection, reporter was not sure if the Doctor already asked her to take antibiotics yet. But just wanted us to know about this situation, if possible, they would cancel and reschedule the 2nd dose for today. The outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE TRANSIENT CEREBRAL ISCHEMIA RIGHT BELLS PALSY
Vaccine stored outside of manufacturer guidelines, product stability is unknown. Potential expired product used for immunization.  pt stated he did not experience any adverse reactions from vaccine after administration