chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12yr old female given Moderna vaccine off label.  No chronic med hx or contraindications for Covid vaccine.  CDC was contacted and advised to report as a vaccine administration error.  Family contacted, mother interviewed, does not report any adverse or unusual side effects at this point.
" her arm "got big; dose 1 subcutaneously instead of the indicated intramuscular route; This case was reported by a nurse via call center representative and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced swelling arm and intramuscular formulation administered by other route. On an unknown date, the outcome of the swelling arm and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the swelling arm to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine subcutaneously instead of the indicated intramuscular route, which led to intramuscular formulation administered by other route. The reporter stated that her arm got big and that it took awhile to get better. The reporter did not consent to follow up. Registered nurse declined to provide any demogrpahic information for this AE, remained anonymous. She declined to provide any additional information for this adverse event.
This case was reported by a consumer (subject) and described the occurrence of cold symptoms in a 54-year-old female subject who was vaccinated with influenza vaccine (unspecified), (manufacturer unspecified). A physician or other health care professional has not verified this report. In 2009 the subject received a dose of influenza vaccine (unspecified) (unknown details). In September 2009, less than one year after vaccination with influenza vaccine (unspecified), the subject experienced cold symptoms, pain all over, respiration problem (described as "respiratory issues") and lethargy (also described as "less pep"). The subject reported that the flu vaccination "negatively affected her health from September 2009 until January 2010." At the time of reporting the events were improved; however, the subject reported an end date as January 2010. The subject reported that she had "subsequently taken FLUMIST for the last 3 years and had not experienced any issues." The subject refused to provide details regarding the facility where the vaccine was administered.
I experienced fever, chills, weakness, fatigue, nausea, light-headedness and aches.
Case number PHEH2015US001511 is an initial spontaneous report received from a consumer on 17 JAN 2015 with a follow up report from a consumer received on 29 JUL 2015, and with follow-up information from physician received on 21 SEP 2015. This report refers to a 47-year-old female patient. Her current conditions included severe trigeminal neuralgia which was diagnosed many years ago which was terrible pain. Her concomitant medications included Lyrica, gabapentin, Neurontin and others. She was vaccinated with a post exposure prophylaxis series of RABABERT (batch number: not reported) from FEB 2014 till 16 JAN 2015 after  being bitten by bat. Right away, after receiving the first injection she noticed a reduction in her trigeminal neuralgia. The pain from the neuralgia had been at a 10 for years, and she was on gabapentin or Neurontin to control it. She stopped her medication  when receiving the vaccine because of a fear of any interaction and there was an immediate reduction in pain after receiving RABAVERT. To this day, the pain remains at a 1-2 and she believes the RABAVERT vaccine has changed her life. She was amazed at what a difference this has made in her life. After the bat bit her she had panic attacks and had to undergo phycological counseling, but she said she would do it again. for the  benefit it gave her with her trigeminal neuralgia. The panic attacks were due entirely to the trauma of the attack and the rabies scare. The outcome of the events was reported as unkown. The seriousness of the events was not reported. The causality of unexpected effect was reported as suspected and causality of panic attacks was reported as not suspected. Follow up report from a consumer received on 29 JUL 2015: Updated patient's comment, event (panic attacks) and causality. Follow-up from a physician received on 21 SEP 2015: New event inappropriate schedule of vaccine administered), concurrent conditions and other clinically relevant information updated in the narrative.
Severe Nausea (5 days) ? OTC Nausea medication, crackers and milk, peppermint tea; muscle/joint pain - left arm, both hands (4 days); extreme fatigue, lethargy (5 days)? bed rest
More than 36 days after the first dose without receiving second dose; tingling in both arms and hands; numbness in both arms and hands; "feels like when your leg falls asleep"; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in both arms and hands), FEELING ABNORMAL ("feels like when your leg falls asleep"), PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving second dose), PARAESTHESIA (tingling in both arms and hands) and VACCINATION SITE PAIN (soreness at the injection site) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 26-Apr-2021, the patient experienced HYPOAESTHESIA (numbness in both arms and hands), FEELING ABNORMAL ("feels like when your leg falls asleep") and PARAESTHESIA (tingling in both arms and hands). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving second dose). At the time of the report, HYPOAESTHESIA (numbness in both arms and hands), FEELING ABNORMAL ("feels like when your leg falls asleep"), PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving second dose), PARAESTHESIA (tingling in both arms and hands) and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient received Anthrax #4 on 29 September 03.  On 6 Oct 03, he developed a diffuse pruritic, erythematous,macular/papular lesions with a few pustulers on the lower trunk anterior/posterior, lower abdomen, right forearm and elbow.  Denies recent illnes, fever. Denies food or medication allergies.  Used Hot Tub 3 days prior to onset of rash. Evaluated by PCM; Referred to Vaccine Healthcare Center; Consulted with Dermatology; DX. with Hot Tub Folliculitis
Initial information received on 14-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 20 years old female patient who was vaccinated with 1 ml first dose of IMOVAX RABIES (Batch number: N1K30 and expiry date: 28-Oct-2019) via intramuscular route in the left deltoid on 14-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications: none. It was a case of actual medication error due to vaccine under dose because the vaccine leaked out and patient did not get full dose. Lot number reported: Vaccine vial- N1K30 expiry date: 28-Oct-2019, Diluent Syringe- Lot: M0304 Expiry date: 28-Oct-2019 and Box N1K303M expiry date: 28-Oct-2019. It was also a case of syringe leak because the liquid leaking from syringe or Luer Lock. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On an unspecified date the patients were vaccinated with doses of improperly stored VAQTA (dose, route and dose number were unspecified), lot# was reported as L017757/exp 08-APR-2018, lot#J010653/exp 02-AUG-2015, lot#J012963/exp 21-SEP-2015, lot#K009506/exp 22-SEP-2016. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sensation of exaggerated cold sensitivity in fingers on 11/22/2016. On 12/5/2016 noted numbness and tingling in fingers spreading to feet, tongue, lips and face. On 12/6/2016 experienced severe back pain. On 12/12/2016 had elevated blood pressure. All movement was limited and legs very weak. Symptoms started to improve 2/17/2017.
A 27 year old female reported that she received an injection of Pnu-Imune 23 in her left arm on 10/26/99. Within 6 hours, post vax, her fever increased to 102F. Two hours later, her fever had increased to 103F. She also developed "extreme" pain in her entire left arm. That evening, she was prescribed Biaxin. The pt recovered.
57 y.o. male admitted with Pneumonia due to COVID-19 virus. Also PE/DVT-on heparin drip currently to transition to Eliquis
The evening after receiving my shot I felt my heartbeat was accelerated abnormally while not exerting myself in any physical activity. I was laying in bed reading. I didn't report it until now because I just got around to reading the information handed out to me at the vaccination site describing the side affects that I could potentially feel. At the time it happened I thought it was a normal side effect but on the information hand out it says that a fast heartbeat is a severe allergic reaction so I figured I would report it. It has since gone away and was only noticeable the evening of the same day I got the vaccine. Otherwise, I feel fine.
similar things after the vaccine/still having her adverse reaction; double vision/doesn't follow any typical patterns from any of the textbooks, it's a unique pattern; Steroids made her vision much much worse, significantly worse; There is a slow rebound effect. When she gets off steroids, it very slowly improves but never to normal.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (similar things after the vaccine/still having her adverse reaction), DIPLOPIA (double vision/doesn't follow any typical patterns from any of the textbooks, it's a unique pattern), VISUAL IMPAIRMENT (Steroids made her vision much much worse, significantly worse) and REBOUND EFFECT (There is a slow rebound effect. When she gets off steroids, it very slowly improves but never to normal.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (similar things after the vaccine/still having her adverse reaction), DIPLOPIA (double vision/doesn't follow any typical patterns from any of the textbooks, it's a unique pattern), VISUAL IMPAIRMENT (Steroids made her vision much much worse, significantly worse) and REBOUND EFFECT (There is a slow rebound effect. When she gets off steroids, it very slowly improves but never to normal.). At the time of the report, VACCINATION COMPLICATION (similar things after the vaccine/still having her adverse reaction), DIPLOPIA (double vision/doesn't follow any typical patterns from any of the textbooks, it's a unique pattern), VISUAL IMPAIRMENT (Steroids made her vision much much worse, significantly worse) and REBOUND EFFECT (There is a slow rebound effect. When she gets off steroids, it very slowly improves but never to normal.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Serum ferritin: low (Low) Low. On an unknown date, Vitamin D: low (Low) Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had an MRI and was reported she would have lumbar puncture to verify the MRI results. She was been taking supplements for low vitamin D and ferratin, but after several months, they were still really low. Steroids made her vision much much worse, significantly worse. There was a slow rebound effect. When she gets off steroids, it very slowly improves but never to normal. Her doctor stated this events were from the vaccine. Patient was being seen primarily by her neuroophthalmologist for many months. Doctor did not recommend her taking another shot of Moderna.  Treatment medication was not reported.
Patient had a vagal response. She became sweaty, dizzy, her vision  was impaired then she passed out or seemed to.
Within a few minutes after injection I noticed slight swelling of the injection site and asked to change the Band-Aid. When the Band-Aid was removed, there was blood (considerable amount but not too much). By the time I came home the skin around the site became pink-purple and the change became more striking and dark rather rapidly. I still have it (getting slightly better). It has striped/mottled appearance and does not look like a bruise. I am a retired physician and I can tell a bruise. The overall area measures roughly  4.5 x 2.5 cm. It is not painful. I took a picture of it. I can submit it if necessary.
minor arm ache, followed by a headache. Tylenol was taken and headache went away after 25 minutes
Following my 1st injection (2/4/21, I had mild flu symptoms. After my second injection (2/26/21) , I began to feel are and achy in my shoulders, neck and hips. By March and April I was not able to do my normal activities.  My clinic for my arthritis, told my I had a rotator cuff tear on the left side and arthritis on the right.
Low-grade fever, chills, fatigue, body-aches, specifically aching neck,
A report has been received from a Health Professional concerning a Female patient. No information was provided regarding medical history and concurrent disease of the patient. Concomitant medications included pregabalin, irbesartan, fenofibrate, atorvastatin calcium, fludrocortisone, metformin hydrochloride, duloxetine hydrochloride, levothyroxine and insulin lispro. The patient had been receiving unknown Influenza Vaccine (influenza vaccine) and oral CRESTOR which started on an unknown date. The patient experienced allergy. The outcome of the event of allergy was unknown. The report was considered to be non-serious.
Mother reports child's right arm became red and swollen approx 3" diameter area on the day after injection - 2/8/14. Today (R) arm is nontender and no redness or swelling noted.
Narrative: Patient received a J&J covid vaccine first dose on 3/17/2022 at hospital facility. On 4/2/22 pt died at private hospital. This information found in pt's chart regarding pt's death. Death does not seem to be related to the covid vaccine given pt's advanced age and multiple comorbidities. "Brief Hospital Course: 90M found down by neighbor who normally lives alone with only the neighbor periodically checking on him for assistance. Patient brought in after being found down, confused, and found to have hyperkalemia, hypernatremia, troponemia and aki on ckd4. Patient had worsening encephalopathy and suspected underlying dementia, developed new afib, and unfortunately despite adjusted diet per speech had an episode of aspiration. No family was available and the listed emergency contacts had passed away. Nephrology and pulmcrit assisted with evaluation. Unfortunately patient had continued declined despite interventions and given the wishes listed in his advanced directives was transitioned to comfort measures only. Final Diagnosis: AKI vs progression of CKD4 to CKD5 Uremia Hypernatremia Hyperkalemia Metabolic Acidosis Acute metabolic encephalopathy/hospital delirium Aspiration Pneumonia New pAfib NSTEMI type 2 suspect demand ischemia in setting of aki/ckd rhadbo AOCD Rhabdomyolysis RLE Superficial thrombophlebitis in small saphenous vein Suspect underlying vascular dementia Time of Death: 2255 on 4/2/22  Electronically signed by MD at 04/03/22 1439"
fever (temperature) 99° F; His memory was affected, he could not remember things; Arm pain; Muscle sore/muscle pain; Tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (His memory was affected, he could not remember things), PAIN IN EXTREMITY (Arm pain), MYALGIA (Muscle sore/muscle pain), FATIGUE (Tired) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.   On 31-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MEMORY IMPAIRMENT (His memory was affected, he could not remember things), PAIN IN EXTREMITY (Arm pain), MYALGIA (Muscle sore/muscle pain), FATIGUE (Tired), HEADACHE (Headache) and PYREXIA (fever (temperature) 99° F). At the time of the report, MEMORY IMPAIRMENT (His memory was affected, he could not remember things), PAIN IN EXTREMITY (Arm pain), MYALGIA (Muscle sore/muscle pain), FATIGUE (Tired), HEADACHE (Headache) and PYREXIA (fever (temperature) 99° F) had resolved.            Patient is immunocompromised and received the third dose of vaccine. No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-323101 (Patient Link).   Reporter did not allow further contact
RASH ON BACK OF THIGHS AND BUTTOCKS; PAIN IN BOTH SHOULDERS  RASH STARTED IN SEPTEMBER; PT SAY DERMATOLOGIST IN OCTOBER; TOPICAL MEDICINE FOR PSORIASIS PRESCRIBED BY MD MADE IT WORSE; 2ND DIAGNOSIS:FUNGAL; MEDICATION DID NOT WORK; 3RD VISIT:UNDIAGNOSED AND PERFORMED BIOPSY; RESULT:NON-CONCLUSIVE YET EXCLUDES PSORIASIS AND FUNGAL INFECTION;
PREVNAR 13 injection caused redness swelling, itching, very hard knots underneath the skin at the injection site, then extending to the side areas of the arm as well as underarm area. The arm feels very feverish, and the first night, I had chills and pain in the joints of the arm that was injected. I have pain in the hand and arms are aching as well. On the third day the arm swelling and reactions have not decreased. The pain in the arm has been consistent and has not improved.
Rash started on back of hands, fingers and feet on 7/26-7/27. No fever, achy joints. Saw PCP and Allergist. Take Zyrtec BID Allergist appt on Monday 8/2/21.
Arm pain since shot administered and never had arm pain until after the shot. Went to MD and had MRI. Two small tears were found in rotator cuff right accross from each other...the tears are not big enough to have surgery. Going to PT. Taking pain medication at bedtime to help sleep...this is when pain is the worst.
Sharp pain to back between shoulder blade and waist on right side, pain initially took breath away and made it difficult to breathe. Pain most intense between 0000-0800. Took Tylenol at 0800 and then an anti-inflammatory at 1130. Client reports pain is improving now and is not currently experiencing shortness of breath. Recommended client follow-up and be seen by physician, recommended to be seen urgently for any shortness of breath/difficulty breathing.
Severe rash on right arm, muscle soreness, skin soreness. Rash area was hot and sensitive to the touch. Full body aches especially lower back. Fever that reached 102.2. Irritability.
Fever, pain in every muscle and bone in the body, weakness, feeling faint, jaws hurt when eating, burning throat, feeling like a stone is on my chest, lost 2 lb & 6 oz in 4 days, on day 3 pain travelled to underarm and on day 4 pain is in neck with pain still in the arm and headaches.
Heavy breathing; Binge eating sugary foods; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on an unknown date at 13:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient had no known allergies. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN) and birth control (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Mar2021 at 16:00 the patient experienced heavy breathing, binge eating sugary foods within 6 hours after both the first vaccination and second vaccination. Patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 30Mar2021, the patient underwent color (covid test type post vaccination was nasal swab) and the result was negative. The clinical outcome of the events heavy breathing and binge eating sugary foods was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.