chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received its 30-days Exp date; Patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT CLOSURE ISSUE (Received its 30-days Exp date) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022 at 4:17 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Apr-2022 at 4:17 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT CLOSURE ISSUE (Received its 30-days Exp date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT CLOSURE ISSUE (Received its 30-days Exp date) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported by reporter. Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021. Dose was given at 01-APR-2022 16:17:33. No treatment medication was reported by reporter.
I have a blister on the side of my tongue. It feels like I bit my tongue really severely.  Also, my throat has closed up a tad. It never opened up fully after my spine surgeries, and now I can't get the large vitamin down.   Of course, if it's a choice between this and falling prey to Covid 19 or 20, I'm good.
approx 25 mins after vaccination, pt presented to the nurse with rash on neck.   Benadryl 50 mg given PO at 10:40. symptoms resolved short time later and pt left for home with a ride.
Pt recvd Engerix-B & w/in 16 hrs had t102, stomach feeling funny, diarrhea, chills, no appetite, didn't work for 3 days; 2nd day dizziness, diarrhea, vomiting;
Mom reports (on 8/12/08); Patient experience rash quarter -> palm sized, a little stiffness and itching at injection site for a few days after injection
Nausea; Hard knot in subcutaneous layer; Chills; Body aches; Redness; Believes second dose was administered wrong, didn't feel the needle entered the muscle.; Arm was hot to touch; A spontaneous report (United States) was received from a health care professional who is a 56-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and arm was hot to touch/vaccination site warmth, had hard knot in the subcutaneous layer/vaccination site induration, chills, body aches/myalgia, redness/vaccination site erythema, nausea and believes second dose was administered wrong, didn't feel the needle enter the muscle/incorrect route of product administration.   The patient's medical history was not provided. No concomitant product use was reported.  On 13 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 015M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 13 Feb 2021, post vaccination, the patient reported her arm was hot to touch. The patient believed the injection was administered incorrectly. She reported that she did not feel the needle enter the muscle.   On 14 Feb 2021, the patient reported she had a hard knot in the subcutaneous layer, she had chills, body aches and redness.  On 15 Feb 2021, the patient reported she had nausea.  On 16 Feb 2021, the patient reported she still had redness.   Treatment for the event included acetaminophen.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, arm was hot to touch/vaccination site warmth, had hard knot in the subcutaneous layer/vaccination site induration, chills, body aches/myalgia, nausea and believes second dose was administered wrong, didn't feel the needle enter the muscle/wrong technique in product usage process, were considered recovered/resolved.  The outcome of the event, redness/vaccination site erythema, was considered not recovered/not resolved.; Reporter's Comments: This case concerns a 56-year old female patient who received mRNA-1273 and experienced non-serious events vaccination site warmth, induration, myalgia, erythema, nausea and believes second dose was administered wrong /incorrect route of product administration. 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.
fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine and tested positive for COVID-19; fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine and tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 16 year-old patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: drug ineffective, COVID-19, outcome unknown and all described as fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine and tested positive for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Extreme peripheral neuropathy over entire body Narrative:  Had to see her Neurologist d/t sever peripheral neuropathy over entire body. Lasted approx 3 weeks, received Gabapentin. Hx of guillain-barre syndrome. Her Physician has recommended she not receive the 2nd dose.
Expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.  The vial was punctured on 26-oct-2021 at 3 PM and returned to the refrigerator after administering to a couple of patients on 26 Oct 2021 and then on 27 Oct 2021 at 9:30 AM, the punctured vial was used to administer booster doses to 4 patients. No adverse reactions was reported so far.   This case was linked to MOD-2021-365967, MOD-2021-365848, MOD-2021-366345 (Patient Link).
pt became ill w/sx of meningitis 3wk p/vax;tx on out-pt basis w/meds;8 days later adm to hosp & dx w/meningitis d/t haemophilus influenzae type B;pt recv 10 days of IV med & recovered;immunologic w/u revealed pt has hypogammaglobulinemia;
pt recv vax 2SEP94 & 15mins p/vax pt exp numbness in lt arm;lt arm went numb for 1 day,then dec to numbness below the elbow for 2 days;pt stated heart felt like it would explode;had nausea x 2 days;eyes were blurry;
Redness on left inside of upper arm. Called Dr. Instructed client to ice red area for 30 minutes 3 x per day. Marked border of redness. Client came to PH office 3/30/2015 and redness had resolved and he did not seek any medical treatment for reaction.
This case was reported by a physician and described the occurrence of injection site joint effusion in an adult subject of unspecified gender who was vaccinated with BOOSTRIX (GlaxoSmithKline), MMR vaccine (non-gsk). On an unspecified date the subject received a dose of BOOSTRIX (unknown route, unknown arm), unspecified dose of MMR vaccine (Non-GSK) (unknown route, unknown arm). The physician reported that both vaccinations were in the same arm. At an unspecified time after vaccination with BOOSTRIX and MMR vaccine (Non-GSK), the subject experienced injection site joint effusion. The physician described "shoulder effusion at injection site but no hematoma." The physician described this event as "severe". The lot number was reported as AC528103AA; however, based on lot number characterization, this lot number is incorrect and the correct lot number will be verified. At the time of reporting the outcome of the event was unspecified. This physician reported three cases of adverse events with BOOSTRIX. See cases A1010984AA and A1010986A for details on the other cases. Follow up received from Vaccine Safety on 8 March 2013. The lot number reported was AC528103AA from the reporter; however, based on the safety lot number review, the lot number was updated to AC52B103AA.
Patient had extreme dizziness in the evening seeing checker board. She stated it lasted approximately 5 minutes
Patient developed "red, hot, swollen" area approximately 3 inches in diameter around the injection site following Zostavax vaccination on 6/23/10.  Reaction reported to the pharmacy on 6/26/10 and had not progressed beyond a local effect.
Patient came in through ED 9/7/2021 with cough for 2 days, fever, body aches, mild shortness of breath, burning in throat Sent home on 9/7/2021 given asprin, amlodipine, lisinopril, nitroglycerine, omeprozole, benzonatate
"COVID arm" - red raised "lump", about 2.5 by 3.5 inches around, like hives but more solid, hot, some pain but and itching but not severe.  Started about 7 days after shot on 3/4/21.
Patient presented with increasing chest pain and elevated troponin two days following third dose of Pfizer vaccine.
maladministration after expiration date; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 5D4H4, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. In October 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received expired dose of Fluarix QV, which led to expired vaccine used.  The reporter consented to follow up by email.  No details from patients involved were available. This is 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021211495:same reporter US-GLAXOSMITHKLINE-US2021211493:same reporter US-GLAXOSMITHKLINE-US2021211492:same reporter
Day 1 Sunday - received shot - instant tingly in my arm and numbness in my hand.  Evening tired & achy Day 2 Monday - Tired, slept, severely achy & sore everywhere, headache and fever Day 3 Tuesday - Tired, slept, severely achy &  sore everywhere, headache and fever Day 4 Wednesday - slightly sore with slight headache Day 5 Thursday - weird sharp, poking tingly feelings all over body (this lasted almost 1 week before noticing....) Day 11 Wednesday - Noticed red marks on my left arm Day 12 Thursday - itching everywhere / went to the doctor and was told it was "SHINGLES" Day 13 Friday - started antiviral shingles pills Day 19 Thursday - No relief - I still have shingles
Severe widespread joint paint (9 or 10 out of 10) for 48 hours, tremors when using muslces (holding items, walking, etc.) for 36 hours, fever (101-103) for 48 hours. Rest, hydration, icing.
Flushing, Sweating Observation, VS, Recumbent, Water, Improved Home/Self Care
Accelerated heart rate: Resting/sleeping rate increased from a normal of 60 to 85-90. Active rate increased to 100.   Increase lasted 36-40 hours. Had mild center chest pain, similar to indigestion that was not relieved by Gaviscon. Also had severe soreness at injection site, as well as a slight fever.
Swelling in right arm near the injection site about 3?X 3?, chills, headache, extremely tired, congested, fatigued ,
Pt presented to ER with abdominal pain,  then was transferred to pediatric floor of another hospital in health system with Dx of Myocarditis 2/2 COVID vaccine: - Patient remains asymptomatic and stable, ECHO yesterday unremarkable. Pt had elevated troponins 300s, 400s, and 500s ng/L from 8/17 through 8/19 when discharged home.
Red bumps on hand, nose, lip, under (R) breast, redness, swelling around injection site. Headache that started on 3/17/11.
This literature marketed report has been received from the authors of the published literature article. This report was a retrospective cohort study and refers to 91 female patients who reached age 11 years while enrolled and who were aged 1522 years at any time during the study period. Additionally, female enrollees had evidence of sexual activity (as determined using the 2012 Healthcare Effectiveness Data and Information Set definition) at any time from age 11 years to the end of the study period. No information on the patients' concurrent conditions, medical history and concomitant medications was reported. However, the patients did not experience genital warts prior to this study and had not had any diagnosis code for immunocompromised state or cancer. On unknown dates, the patients were vaccinated with three doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) (dosage, routes of administration, lot numbers and expiration dates were not provided). On unknown dates, over 6-month after the final vaccine dose, the patients experienced genital warts. The outcome of the events was unknown. The authors of the article considered occurrence of genital warts to be lack of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) effectiveness.
3 days post shot, patient's wife comes to pharmacy for unrelated business.Tell pharmacist the patient's are was red from shoulder to elbow, no other complaints. Has a little sorness at injection site. Patient's doctor told him he is having a mild reaction and might call in rx for steroids for him.
Patient reports throat itching, anxious and was given Benadryl , patient felt better after 10 minutes.
At 10:30 p.m. the day of the vaccine, I started to have pain in both feet and they were really cold.  Started with some chills and then at 2:00 a.m. (4/2/21) I had a fever of 103.9, chills, shakes and heavy breathing.   I felt froze to the bone.  Took 2 Tylenol for the fever and it went down to 102.4 for approximately 12 hours.  My feet were very sore for the first 48 hours and hurt to walk on them.    For the next two days, had a fever of 101-102 along with periods of heavy sweating that got worse during the nights.  This lasted for three days/nights.   Since I had the shot one week ago, I have been experiencing the same sore feet and have different aches and pains that appear in my body.   They kind of feel like a muscle ache after a Charlie horse and it happens in my calves, back of the legs and back area throughout the day.   I am experiencing fatigue during the day .  I did not have any nausea  with the vaccine.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On 05-FEB-2016, the patient was vaccinated with an improperly stored dose (temperature: 6 degrees F, time frame 8 hours) of ZOSTAVAX (lot# L029483, expiration date 06-NOV-2016) (dose, route of administration and frequency were unspecified). No adverse effects were reported. Concomitant medications were not reported. No product quality complaint was involved. Additional information has been requested.
Red swollen warm right upper lateral arm. Slightly warm to touch. To give Compresses when necessary. Ibuprofen 8 mL every 6 hours if needed for pain or fever. Monitor closely and call for worsening.
Left sore arm and headache day 1 and difficulty clearing  throat to breathe; Day 2 breathing issues continue coughing and clearing of a very dry throat, dizziness and ringing in ears, hard time sleeping because of shallow breathing and wheezing. Every joint hurts especially back neck chest; Day 3 arm not as sore but breathing and dry coughing and clearing of nose and throat continues with heavy chest.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with a history of unspecified tetracycline allergy and possible allergy to doxycycline. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and site of administration, lot# and expiry date were not reported). The patient used many unspecified medications. On an unknown date, the patient experienced pain in her arm all day long and a red line. The outcome of the events was unknown. The relatedness between the events and the PNEUMOVAX 23 was not reported. Additional information has been requested.
Tinnitus: two weeks after receiving shot, my existing low-level tinnitus in both ears suddenly became much louder. 10+ weeks later, the tinnitus remains just as loud. Had right ear pain and pressure from
Pt had pain in her left shoulder after administration of the vaccine and was unable to lift her arm to be perpendicular with her body. She came in and reported the event almost 3 weeks after the vaccine was given. No swelling or redness was ever seen after the vaccine was given. However, the patient was taking the proper measure to try to help with the pain and irritation such as Aleve, ice/heat to the shoulder.
FEVER OF 104, VOMITTING, DIARRHEA, PASSED OUT-- WENT TO ER AND RECEIVED FLUIDS, PAIN MEDICATION AND NAUSEA MEDICATION
pt recv vax 21JUN94 & 2JUL94 pt devel a rash, head to toe including soles of feet & palms of hands, & fever of 101; pt also exp itching, h/a & nausea;
Symptom onset on 1/24/22 with productive cough, weakness, and decreased energy and strength.  Treatment includes Oxygen.
Nausea, cold sweats, blacking out, vomiting for 7 hours
This is a spontaneous report from a contactable pharmacist. This pharmacist reported same events for 2 patients. This is the second of two reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that two patients who have been testing positive for Covid-19 after they got their first dose of the vaccine. The outcome of the events was unknown.   Information about the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021455895 same reporter/drug/event, different patient
Rash that resembles chicken pox on chest, torso, legs. Not very itchy. Started about 10 days after shot.  Has continued to spread for 8-10 days.
On 11/12/21 @ approximately 1:11 pm resident 02 saturation decreased to 84%. rebounded after breathing treatment to 91% but residents overall condition continued to decline. 02 increased to 3 liters with orders to titrate up to 6 liters. This resident was a hospice patient and had been having recent episodes of aspiration. Condition continued to decline and resident expired on 11/15/21 @ approximately 9:44 am
pt fever of 102 10JUN97 p/vax;13JUN97 neck pain, pt having trouble moving head especially hurts when turning to the rt since 11JUN97 evening;pt had also become less active & more irritable over time w/some nausea;MD felt sx musculoskeletal
BNT162B2 DOSE 3 (BOOSTER); Passed out; drenched in sweat; half vision; This is a spontaneous report received from a non-contactable consumer.  A 17 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "BNT162B2 DOSE 3 (BOOSTER)"; LOSS OF CONSCIOUSNESS (medically significant), outcome "recovering", described as "Passed out"; HYPERHIDROSIS (non-serious), outcome "recovering", described as "drenched in sweat"; VISUAL IMPAIRMENT (non-serious), outcome "recovering", described as "half vision". Additional information: The patient got her booster Wednesday at 2 and got up Thursday am around 10:30 and passed out. The patient was drenched in sweat with half vision. She's seeming better now, had some gingerale and crackers and is laying with me in bed. No other issues, seeing normally now, no chest/breathing issues.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.