chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid arm" after the first two vaccine doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm" after the first two vaccine doses) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C27A, 04IJ2IA and 006C21A) for COVID-19 vaccination.     The patient's past medical history included Migraine (childhood( few times per year)) and Acute urticaria on 31-Dec-1983. Concurrent medical conditions included Drug allergy (Only experienced as a baby, probably swelling) since 1984, Allergy to metals (Get a skin rash when I wear cheap metal that's not sterling silver) and Exercise induced asthma (exercise-induced asthma from childhood which never needed to be treated.). Concomitant products included DESOGESTREL, ETHINYLESTRADIOL (AZURETTE) for Birth control.   On 27-Apr-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021 at 12:47 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021 at 5:00 PM, 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 experienced VACCINATION SITE REACTION (Covid arm" after the first two vaccine doses). At the time of the report, VACCINATION SITE REACTION (Covid arm" after the first two vaccine doses) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, Chest X-ray: normal (normal) normal and normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reported patient age was under 38 years old. No treatment medication was reported.   This case was linked to MOD-2022-473367, MOD-2022-439984 (Patient Link).
Nausea; Diarrhea; Low grade fever; Muscle aches; Joint aches; Vomiting; Tired; Extremely exhausted; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 77 year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing She has arthritis. The patient's concomitant medications were not reported. The patient experienced nausea on 27Mar2021 with outcome of unknown, diarrhoea on 27Mar2021 with outcome of recovered, low grade fever on 27Mar2021 with outcome of recovered, muscle aches causing myalgia on 27Mar2021 with outcome of unknown, joint aches causing arthralgia on 27Mar2021 with outcome of not recovered, extremely exhausted causing fatigue on Mar2021 with outcome of unknown, vomiting on 27Mar2021 with outcome of recovered, tired causing fatigue on 27Mar2021 with outcome of unknown.    Follow up (30Mar2021): This is a follow up spontaneous report from a contactable consumer. This consumer (patient) reported that: Additional information regarding adverse events were updated.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fever of 102.6 with second vaccine, shortness of breath, and typical immune response symptoms (sore throat, body aches, headache. chills)--did not think anything of this as they were the symptoms I had when I had COVID in February and I thought it was an exaggerated immune response. (Also, I had similar sx with first vaccine but fever only went to 101.4 and no sore throat and headache/chills weren't as bad). Approximately 2-2.5 weeks after my vaccines and recovery from the above-mentioned symptoms; I experience numbness and tingling of the bilateral feet with intermittent electrical feelings and shooting pains of neuropathy in my feet and lower legs. I am currently being worked up for spinal issues or MS but I had similar symptoms after COVID--symptoms are now constant with severe altered perception of the feet and ankles. I cannot feel tuning fork vibrations on feet up to medial malleolus and cannot distinguish between sharp and dull from the knees down.  My balance is affected due to the lack of sensation.
Pt appeared significantly pale & somewhat limp 5 to 6 hrs p/vax; Later when examined @ office (same day) had recovered color & activity; Swelling noticed @ inject site;
Underarm swelled up; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Underarm swelled up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Underarm swelled up). At the time of the report, PERIPHERAL SWELLING (Underarm swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
2nd Flu shot this season (due to recall vaccine on 10/20/06) same arm right upper arm, red, swollen, warm to touch (whole upper arm).
8NOV95 pt was seen in clinic & recvd vax;pt left clinic & was driving home when became very nauseated;once home vomited 3-4x that day & exp severe h/a;no h/v, h/a or other sxs on 9NOV95
Narrative:  mental status changes, covid pneumonia, d/c home with monoclonal antibodies, readmit 12/26 with dizziness and low BP ceftriaxone, azithromycin, dexamethasone, oxygen, cough, hx of heart failure, COPD, DM. VTACH-pt expired while in the hospital
Warm to Touch - Near Injection Site; Itchy Sensation - Near Injection Site; Redness - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) and VACCINATION SITE WARMTH (Warm to Touch - Near Injection Site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) and VACCINATION SITE WARMTH (Warm to Touch - Near Injection Site). On 26-Feb-2021, VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) and VACCINATION SITE WARMTH (Warm to Touch - Near Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: NNI
Wife is immunocompromised due to steroids, 6MP, and Stelara for Crohn's disease but received her COVID-19 booster (3rd dose) on 12/26. She complained of arm pain on 12/26. On 12/27 she complained of a general feeling of fatigue and soreness that is commonly associated with receiving the vaccine. On 12/28 she complained that the fatigue, headaches, and muscle pain were getting worse. She developed a fever in the early evening and took tylenol for that and the pain. Overnight she had muscle cramps, pain, and the fever would not break. On the morning of 12/29 she was taken to the Emergency Room where her temperature was measured at 103 degrees and she had to be given pain medication.
Patient was crying and scared during vaccinations. She felt dizziness after last shot of HPV. Had patient lie down and within 5 minutes dizziness went away and stated felt better.
Received varicella at 1500 on 08/16/11. Developed generalized swelling and redness by the afternoon of 8/17/11. Experienced warmness to touch, pain and itching in the generalized area of the immunization. Resolved as of 08/22/11.
This client received Hepatitis B # 3and then went on a hike where she started breaking out in hives at the injection site, and it started spreading all over her body. The client sat in a hot tub that evening and more hives occurred. Breathing was not compromised and she did not seek medical attention. She did start taking over the counter Benadryl.
Became very tired, napped from 4pm-7pm 3/17/11, c/o pain in legs/ difficulty walking upon wakening, feeling weak. Slept from 8pm -1am, awoke with fever 101 degrees Axillary, vomiting & pain in legs. Fever down at 4am. Mom called in at 10:30am 3/18, no longer hurting, temp 98.0 Ax. Gave 2 tsp Children's TYLENOL & Calcium Carbonate at 1am for symptoms. Bruising noted on (L) leg, no swelling on either leg. Mom also applied ice packs to legs & had child sit in warm bath for discomfort.
Within 3-5 minutes developed dizziness, tingling in feet and hands, elevated blood pressure, mild nausea.  Within an hour started having trouble with focusing his vision. Was given IV fluids at hospital in ER 5 hours after the injection, while leaving the hospital developed a slight limp on right leg Felt feverish when he got home, took Tylenol when he got home. Noted extreme fatigue.  The next morning was lethargic, dizzy and right side of face felt heavy, around 11 am.  Called for a telemedicine visit around 12:30p. Became weak and unable to use right side of body, upper and lower extremities and right side of face was drooping, visible to wife. Wife had support of right side of body to move around. Went to urgent care around 2p.  During urgent care evaluation, his vision became more impaired and speech became unclear, had to really focus to speak.  Transferred to ER.  Lost ability to write name, couldn't respond when asked for SSN. Admitted as a "stroke 4". Had CT scan, CT angiogram, MRI, blood labs, cognitive tests, neurologic tests. Neurology consult. Had lost sensation to heat and pressure.  All imaging and labs were normal.  After MRI, had convulsions. Wasn't dx'd as a seizure. Neck felt tight afterwards.   Admitted to hospital x 1 week. Had a burning, red, rash on hands, feet. No bumps, hives, but just a "splotchy" red discoloration on surface of skin that would burn and itch, often flaring at night. Rx'd ativan.  Checked for autoimmune disease, Bell's palsy, followed by neurologists, repeat MRI normal. Started to improve, discharged after one week with no clear diagnosis. Discharged to rehab facility. Patient preferred to transfer care to outpatient rehab service closer to home with more social support.  Repeat hospitalized 3 weeks later, less extreme, went back to ER, stroke eval neg. Developed more aphasia. Called back to ER for further evaluation of C-spine due to mild abnormality on first scan. On further evaluation not thought to be connected to symptoms.  EEG report pending.  +Right hemiplegia, aphasia persists. +Rash, itching, burning persist.
Initial unsolicited report received from a healthcare professional on 20 October 2015. This case involves 2 patients (age and gender was not reported) who were vaccinated with a dose of FLUZONE QIV (batch number, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unknown date, one day following the vaccination (the day after vaccination), the patients had experienced severe arm pain which continued for more than one week. Laboratory data and corrective treatments were not reported. The patients had not recovered from the event. List of documents held by sender: none.
Muscular soreness at site after receiving flu shot; difficulty raising right arm overhead. Mild discomfort, twinges and aching continuing since injection. Raising arm continues to be painful.
HR 101, anxious, BP cuff not reading, but patient indicates she has always has a low BP. Pt refused snack, symptoms have resolved. SPO2 100% and HR at 80 at discharge.
Pt had hives, syncopal episode, and airway management issues within 30 minutes of receiving vaccine.
Woke up at 5 am sweating, but freezing when not under the blanket. Temperature 99.1 F. Headache. No pain, except for the headache, and the bruise feeling of where the vaccine got injected (which is normal for me each vaccination I had in my life had that feeling the next day). No appetite and weak feeling. Those flu like symptoms lasted the entire day and all I could eat was a soup and drank tee.
Initial information received on 27-Mar-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case involves a three years old patient who was vaccinated with QUADRACEL (lot: C5248AA, expiry date: 21-Aug-2019) via unknown route in the right arm, on 14-Jun-2018. It was reported that patient received QUADRACEL immunization, 4 days prior to fourth birthday. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to inappropriate age at vaccine administration. No adverse events reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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. List of documents held by sender: none.
Patient developed large subcutaneous nodule with overlying scaling on skin at site of injection. Chart review revealed it was site of Hib vaccine. He has an old, smaller subQ nodule at site of 2 month Hib vaccine. Patient is otherwise doing well.
pt recv vax; subsequently, the pt's titer by quantitative test was 0.79;
no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 16-MAY-2019, the patient was vaccinated with improperly stored  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R015745, expiration date 02-DEC-2019; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.  ; Sender's Comments:  US-009507513-1906USA000180:
9/5/2007, 1:32 pm:  After receiving hepatitis B, IPV, MMR, MCV4 and Td, patient complained of not feeling well.  Brought back to exam room for observation.  Became ashen, complained of feeling lightheaded with burning sensation in both ears.  Vomited clear emesis.  Ice pack placed on forehead and brown paper bag given to patient for her to breathe into.  Color returned to pink after breathing into brown paper bag.  Nurse questioned patient about eating lunch and patient stated that she had not eaten anything since early breakfast.  Staff gave patient oatmeal bar and soft drink (COKE).  Stated felt much better.
The pt experienced stiffness, swelling joints of legs, headaches, and weakness in legs.
After receiving the vaccine and waiting the 15min, I left the vaccination site and headed home in my vehicle.  After about 10 to 15 mins I  encountered a metallic taste in my mouth and my mouth almost felt as though it was vibrating almost like a surging feeling.  I then became flushed in the face and my tongue felt odd as if it was swelling.  My throat became dry.  I waiting five more minutes and decided to take the next exit off of I87 and drove directly to a urgent care center.  Upon arrival I sat in my car for 20 more minutes to see if my symptoms would pass and they did.  I did not need to enter into the urgent care facility.  I have not had any other symptoms since this event.
Second shot of Moderna Vccine passed 67days .; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second shot of Moderna Vccine passed 67days .) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Hypothyroidism, Sleep disorder and Asthma. Concomitant products included LEVOTHYROXINE for Hypothyroidism, IMIPRAMINE for Sleep disorder.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second shot of Moderna Vccine passed 67days .). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second shot of Moderna Vccine passed 67days .) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   treatment information was not provided.  concomitant medicine include ProAir inhaler.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: fallow up received on 8-jun-2021 and fax number was updated.  patent race and Ethnic Group was updated and vaccine facility information was updated.
had both vaccinations/ got shingles /suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, vaccinated with both shingles shot in a 6 months period and got a mild case of shingles. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided. This case was linked with the case US2021AMR088532.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088532:comment response
Tinnitus with musical ear syndrome began 6/8/2021 in the evening. Continued through 6/18/2021 and resolved by morning of 6/19/2021.  Urticarial rash at injection site began 6/10/2021 in the morning and spread to cover most of deltoid by 6/12/2021 and resolved by evening of 6/13/2021.
This spontaneous report as received from a nurse refers to a 56-year-old female patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On an unknown date, the patient was inadvertently vaccinated with GARDASIL 9 (concentration, dose, route of administration, lot number, expiration date and indication were not reported). No adverse effects were reported.
My dad had his first Moderna shot on 3/2/21; second shot was on 3/30/21.  On 3/3/21, he woke up and got Bell's Palsy. After doing some serious research, I discovered that Bell's Palsy is a side affect and per VAERS,, there's over 400 cases.  My dad's right side of his face was getting worse to wear he couldn't close his right eye and as of today, 4/23/21, he still can't close it and my mom has to continue to put eye drops in his eye so his eye doesn't dry and damage his cornea.  My dad goes see's his eye dr every two (2) weeks. One time the eye dr told my mom that my dad's face was getting better when it was obvious that it was getting worse.  My dad has Dimentia and from this reaction to his first shot, the dimentia has gotten worse; going downhill really fast and this is coming from my mom who is with him 24/7.  Prior to getting the second shot on 3/30/21, all the doctors were telling my mom that it's fine for my dad to get the second shot.  I told my mom that I didn't have a good feeling about my dad getting the second shot since most of the common side effects come with the second and if my dad is like this from the first shot, I can't imagine what would happen from getting the second shot. My dad said that he didn't want the second shot and all that he wants is eye to get better and to this day, that's all he wants and we keep on telling my dad that it'll eventually go away but we don't know when.  Studies need to be done on who the vaccine reacts to those with dimentia.  Not enough studies on why people get Bell's Palsy and other major side effects from the vaccine.
Redness, swelling, warmth, defined margins expanding 3-4 inches from injection site, and itching. Patient instructed to apply Benadryl cream, take H2RA and oral Benadryl until symptoms improve. Within 2-4 hours patient began noticing an improvement of symptoms.
Emergency visit with extreme pain from top of head to base of rib cage. Blood tests, xrays taken.  Pain killer administered then sent home.  Subsequent visits on 11/06/2010 and finally hospitalized on 11/09/2010 with paralysis in face and extreme pain in extremeties.
Patient had suffered a prior adverse reaction to Dtap/Rotavirus (see VAERS report 188063) but we gave MMR because of a possible outbreak.  The encephalitis side effects were not as pronounced as the prior adverse reaction but we noted that he became rather irritability, his personality changed to more withdrawn and his eye contact diminished.  These symptoms have persisted for years.
Patient reported receiving a first dose of vaccine in January 2022. He did not have his immunization card to verify. On the pre-vaccination form, completed by the patient, he indicated that the first dose he received was Pfizer. Staff checked system to obtain the date of previous dose, but did not note manufacturer. Administered 1 dose of Pfizer.  Requested that patient remain for observation for 15 minutes following administration. While writing out an additional vaccination card, staff who administered the vaccine noted that the first dose in the series had been Moderna. Per CDC guidance, it is not neccessary to repeat the dose. Patient did not remain on site during observation period, despite education provided. Attempted to phone the patient at the shelter where he is residing, as he does not have a phone of his own. Patient was not available. Will continue to attempt to contact him to alert him of error.
weakness Narrative:  77 y/o male patient with h/o Parkinson's disease, CAD (s/p stents), supraventricular tachycardia, received first dose of COVID19 (Moderna) vaccine on 02/11/21. On 02/12/21, legs were weak and shaky, had a fall. On 02/13/21, continued to feel weak. On 02/14/21, fell and felt chest pressure. Ambulance called and was taken to outside facility and found to be in afib RVR, treated with diltiazem. Had cardiac cath on 02/15/21 which showed NSTEMI due to extensive CAD, not a surgical candidate therefore medical management optimized. Started on amiodarone for afib. Discharged on 02/17/21. Has no prior ADRs to vaccines or anaphylactic reactions to medications. No prior COVID19 infection.