chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slight fever; Upon Follow up the case considered as valid as slight fever (event) reported.  This is a spontaneous report from a contactable Consumer (patient). A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Expiry date: Unknown) dose 1and dose 2 via unspecified route of administration on unspecified date in Feb2021 and Mar2021 respectively, both at single dose for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. The patient experienced Slight fever on unspecified date. The outcome of the events was unknown.    Follow up (03Apr2021): Upon review of the Non-Serious Cases Line Listing report dated [03Apr2021], the following corrections have been made: [recode the event potentially exposed to COVID to no adverse effect and kindly delete the event scheduled to receive the first dose of the vaccine tomorrow'. Please make the case as invalid: this is a medical inquiry only and the patient had not received the vaccine yet].  Follow up (03Apr2021): New information received from Pfizer-sponsored program. A contactable consumer reported that includes: new event and month of vaccination.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient presents for possible reaction to Moderna COVID booster, right arm.  Says pharmacy did not have her wait, was sent home immediately. When got in car about 5 minutes after booster vaccine had a huge heat wave that started in pelvic and went to top of head, turned bright red, difficult breathing. Felt weird for 2 couple hours, then 2 days later developed rash on the right side. Since feeling shaking, nausea, vomiting, has developed painful rash with blisters on rt lateral trunk under arm, on right breast, right side of upper back, unable to sleep due to feeling like "on high dose of caffeine".   Pt used hydrocortisone and Benadryl, for rash, helped sleep first night, but didn't work after.   Treated with prednisone pack, valacyclovir.
8/12/2013 Patient received the Tdap (ADACEL) vaccination in his (L) delt at approx 11:45 am. On 8/15/2013, patient called dr office, spoke to nurse. Patient stated that he felt fine and with no complaints after the vaccination until approx 8pm on the evening of 8/14/2013. Patient stated that felt chills/fever, excess phlegm , c/o had trouble sleeping and the site was painful, red/swollen. Patient stated he took a MUCINEX and went to bed. Patient stated that he felt better this a.m. and stated that he is having no problems today. Patient declined an appt offered.
Nurse states: While setting up the current station with supplies and equipment, I opened the caps of both the normal saline and Pfizer vials, wiped both tops using a different alcohol wipe and obtained a new 1mL syringe with 25g needle. 1mL of air was pulled back into the syringe and injected into the normal saline bottle. The normal saline bottle was then inverted upwards and 1mL of diluent was pulled back into the syringe and injected into the new vial of Pfizer. The same step was repeated a second time with 0.3mL of air injected into the normal saline bottle, 0.3mL of normal saline pulled back into syringe and injected into the vial of Pfizer. The vial was then inverted 10 times to ensure both the vaccine and saline was thoroughly mixed.   But nurse noticed when administering that she was short a number of doses that should had been left over if vial was diluted correctly or the correct dosage was administered.
Patient was administered the Covid-19 Janssen Vaccine at 9:30am and was sent to observation for 30 minutes due to her history of allergic reactions to seafood, grass, morphine, and iodine. At 9:45am patient complained of shortness of breath and itchy throat. Vitals were taken BP 126/76 HR 95 O2 98 RR 20. Walk-In provider was notified, and allergy medications were administered epinephrine 0.5mg and methylprednisolone 125mg and 911 was called. At 9:50am, patient stated she was feeling better and shortness of breath had decreased. Rescue arrived at 9:55am, vitals were rechecked BP 120/70 HR 109 O2 98 and RR 20. Rescue stated patient didn?t have criteria because she had improved and left at 10:00am.  Patient was transferred to the walk-in department to continue observation.   ordered an EKG, which was normal. Patient was observed for an additional 38 minutes and discharged home hemodynamically stable with no further symptoms.   prescribed Prednisone 20mg, Hydroxyzine 25mg, and Cetrizine 10mg.
Sore throat resolving over 24 hours, but with increasing cold symptoms(nasal stuffiness, cough). Fatigue onset 4/26/2010 with RU flank pain, both worse by 4/27/2010.
Patient stated that she got Technis shot for a job. Arm stayed red. Patient states that arm still aches
Caller got the COVID vaccine on 4-Jan-2021 and at the time had I had COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caller got the COVID vaccine on 4-Jan-2021 and at the time had I had COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 04-Jan-2021, the patient 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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 04-Jan-2021, the patient experienced COVID-19 (Caller got the COVID vaccine on 4-Jan-2021 and at the time had I had COVID-19). At the time of the report, COVID-19 (Caller got the COVID vaccine on 4-Jan-2021 and at the time had I had COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-2 test: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
my arm had a huge knot the size of an egg; it hurt so bad; my arm had a huge knot the size of an egg; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date, refer case US2021AMR024462).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling arm, pain in arm and skin induration. On an unknown date, the outcome of the swelling arm, pain in arm and skin induration were recovered/resolved.   It was unknown if the reporter considered the swelling arm, pain in arm and skin induration to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, after vaccination with Shingrix, had huge knot the size of an egg in the arm and was hurting. The reporter stated that, the side effect lated for 2 weeks and then recovered.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR024462:same patient
2 days post vax, pt developed injection site reaction characterized by pain and 5 cm induration.
legs swelled up like balloon; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 (Lot number: EP7533) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "she has had swollen legs before but usually just when she eats too much salt," (unspecified if ongoing), notes: occasionally she has had swollen legs before but usually just when she eats too much salt,. Concomitant medication(s) included: METHADONE taken for detoxification, start date: 2018 (ongoing). The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 27Mar2021, outcome "recovered" (30Mar2021), described as "legs swelled up like balloon".  Additional Information: Caller states patient was not sure how to handle this, caller stated that patient was not in the hospital, that she got her first Pfizer Covid vaccine about 4 weeks ago, clarifies on 27Mar2021, states the following day, her legs swelled up like balloons, lasted 3-4 days, states she just got the second shot on 24Apr2021, legs are so swollen she cannot get shoes on. Calling because if it gets worse she was going to go to the emergency department. Wants to know if this could be a side effect of the vaccine. States the leg swelling was worse this time after the second dose, states patient noticed the swelling yesterday 28Apr2021. States that was worse than it has been and patient was physically in pain because of it. Noticed from the time she got up this morning to now, it is worse. Caller stated occasionally patient had swollen legs before but usually just when she eats too much salt, states they are really blowing up like balloons, that she cannot get her shoes on and patient Details: States she was between 125-127lb.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a consumer (patient's mother) and refers to her 9 months old daughter. The female child was administered a first dose of COMVAX at the age of 3 months (estimated date: May 2006) and a second dose at the age of 6 months (estimated date: August 2006), (dose and route of administration was not reported). At the age of 3 months, 6 months and 9 months (estimated date: November 2006) she was also vaccinated with PREVNAR, IPV (unspecified) and DTP (reported as "DTP/AaP"). On an unknown date in 2006 (also reported as "twelve day after her daughter was administered these vaccines at 9 months old") the patient began to develop severe eczema, could not digest some unspecified foods and could not digest the protein from milk. On an unspecified date the patient sought a medical attention from an unspecified healthcare professional. The results of lab and diagnostic studies: "allergy testing, G tract analysis, enzymes, vitamin levels" performed on unspecified dates in 2006 revealed that she had no major allergies. Treatment for eczema was hydrocortisone and treatment for inability to digest some foods was a gluten free diet. The patient's outcome was recovered (dates unspecified). The patient continued to eat a gluten free diet. The relatedness between the events and COMVAX was not reported. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 16 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 04-JUN-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 2, lot # K006960, exp. date: 19-FEB-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
feel really bad/feeling really knocked out/not feeling good; feel so bad can hardly walk/so stiff; feel so bad can hardly walk/so stiff; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (feel really bad/feeling really knocked out/not feeling good), GAIT DISTURBANCE (feel so bad can hardly walk/so stiff) and MUSCULOSKELETAL STIFFNESS (feel so bad can hardly walk/so stiff) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 48C21A, 023M20A and 042LA0A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, 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 COMPLICATION (feel really bad/feeling really knocked out/not feeling good), GAIT DISTURBANCE (feel so bad can hardly walk/so stiff) and MUSCULOSKELETAL STIFFNESS (feel so bad can hardly walk/so stiff). At the time of the report, VACCINATION COMPLICATION (feel really bad/feeling really knocked out/not feeling good), GAIT DISTURBANCE (feel so bad can hardly walk/so stiff) and MUSCULOSKELETAL STIFFNESS (feel so bad can hardly walk/so stiff) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: 100 (High) fever of 100.         Concomitant medication details was not reported.   Treatment details was not reported.  In Nov-2021, symptoms started to appear.
TDAP AND MMR ADM. BY PHARMAJET NEEDLE-FREE INJECTION SYSTEM ON 8/18/2010 AND RETURENED ON 8/20/2010 C/O PAIN ON UPPER R ARM (LOCATION TDAP ADM.) RADIATING TO RIGHT SIDE OF NECK AND UPPER BACK. LOCAL ERYTHEMA AND SWELLING ON R UPPER ARM. SKIN WARM TO TOUCH. PT TAKEN ADVIL FOR PAIN CONTROL AS NOTED BY EXAMINATING NURSE PRACTIONER.
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) in a 7-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 216K22A and 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 17-Jun-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 10 microgram. On 17-Jun-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.).    The route of administration of dose 1 and dose 2 was reported as BI Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
pt recv vax 10OCT96 & 25NOV97 pt devel a rash;
7/23/19 (1 day post injection): redness and swelling at injection site appeared.  patient applied ice and took Benadryl.  As the day progressed, she developed a fever of 99.4 degrees F.  She felt lethargic so she stayed in bed all day.  She said it took her 3 to 4 days to regain her energy.   On approximately 7/29/19, she noticed a sore on her right cheek.  By Friday that sore had spread to other areas of the same cheek and to behind the right ear, but remained only on the right side.  Her daughter, a wound-care nurse, diagnosed it as shingles.  She started taking Lysine tablets over-the-counter with success.  The sores started to seem to dry up and minimize in appearance once the Lysine was started.  They did not seek medical attention (outside of consulting with her daughter) as she had experienced the condition for over a week.  They felt it was too late to start a prescription antiviral and the Lysine seemed to be working.   She still has a small sore at the injection site on the left arm.  The sores are not painful, but mostly cause itching.
Itchiness; Redness, rash and swollen arm of injection; Rash; Hot rash; Swollen on the arm of injection; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Redness, rash and swollen arm of injection), RASH (Rash), VACCINATION SITE WARMTH (Hot rash) and VACCINATION SITE SWELLING (Swollen on the arm of injection) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction. Concomitant products included CAPTOPRIL, VITAMIN D3 and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Redness, rash and swollen arm of injection), RASH (Rash), VACCINATION SITE WARMTH (Hot rash) and VACCINATION SITE SWELLING (Swollen on the arm of injection). At the time of the report, PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Redness, rash and swollen arm of injection), RASH (Rash), VACCINATION SITE WARMTH (Hot rash) and VACCINATION SITE SWELLING (Swollen on the arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Other Concomitant Medication: Centrum silver.  Treatment provided was Aller-Tec started when itchiness started.
Vaccine, Fluzone HD, received 10-10-19 at Pharmacy. Customer came back to store on 10-13-19 ask Pharmacist to look at arm. Left arm very bruise (red/purple-about 3x3 inch surface) abt 6 inches down from shoulder. States it was hot & swollen on 10/11/19 until iced.
GAVE PT OVERDOSE: 0.5 ML INSTEAD OF 0.3 ML.  NO ADVERSE REACTION COULD REPORTED NOW, JUST MINOR PAIN AT THE INJECTION SITE
Back Pain/Ache, Chest Pain/Ache, Joint Pain and Aches, Possible inflammation. Started aprox 10 days+ after Moderna 2nd dose.  Still present
pt recv vax NOV94 & 2 days p/vax devel inj site rxn characterized by erythema & soreness, 8x12cm in diameter;rxn lasted several days & resolved;
Notable swelling of the entire upper arm, with heat near injection site. Severe pain in full arm, armpit, and right breast.  Pain is bad enough to interrupt sleep, and restrict mobility
With first two covid-19 vaccines my arm got soar; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (With first two covid-19 vaccines my arm got soar) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Fruit allergy (Avacados make him nauseous), Diabetic since 2010, Vitamin D deficiency (Low vit D) since 01-Jan-2015, Iron deficiency (Low iron) since 01-Jan-2015, Renal impairment (Protect kidney) since 01-Jan-2012 and Abdominal discomfort (Protect stomach) since 01-Jan-2012. Concomitant products included OMEPRAZOLE from 01-Jan-2012 to an unknown date for Abdominal discomfort, CETIRIZINE HYDROCHLORIDE (CETRIZINE) from 01-Jan-2012 to an unknown date for Allergy, METFORMINE [METFORMIN] from 01-Jan-2012 to an unknown date for Diabetic, COLECALCIFEROL (VIT D3) from 01-Jan-2015 to an unknown date for Hereditary hypophosphataemic rickets, IRON from 01-Jan-2015 to an unknown date for Iron deficiency, LISINOPRIL from 01-Jan-2012 to an unknown date for Renal impairment, MULTIVITAMIN [VITAMINS NOS] from 01-Jan-2011 to an unknown date, ASCORBIC ACID (VIT C) from 01-Jan-2015 to an unknown date and FISH OIL from 01-Jan-2015 to an unknown date for Supplementation therapy.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (With first two covid-19 vaccines my arm got soar). At the time of the report, VACCINATION SITE PAIN (With first two covid-19 vaccines my arm got soar) outcome was unknown.        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.   No Treatment use were reported Patient height was 5.11 inch   This case was linked to MOD-2021-400010, MOD-2021-403189 (Patient Link).
PATIENT PRESENTED TWO DAYS AFTER VACCINATION WITH RASH ON ABDOMEN WITHIN A DAY OF IMMUNIZATION; NO RASH AT INJECTION SITE (A LITTLE REDNESS). DID NOT REPORT ANY ITCHING. STATED THAT THIS HAPPENED BEFORE AFTER THE LAST VACCINE. RECOMMENDED BENADRYL AND, IF IT BECAME ITCHY, HYDROCORTISONE. PATIENT WAS TO REPORT TO THE DOCTOR OR EMERGENCY ROOM IF SHE PRESENTED WITH DIFFICULTY BREATHING/SWELLING.
I started the night after the vaccine with chills, fever of 102, headache and weakness and aches those lasted about 2-3 days. My arm started to swell after those symptoms went away. The swelling started to swell all the way down where you bent the arm. I contacted the doctor and she advised to go to the emergency room. I went the emergency room at hospital. The doctor came and the looked at it they were unsure of what was causing the swelling. The looked like it could have been a reaction or infection. It was beat red and warm to the touch. They gave me an antibiotic and Benadryl. They also told me to take Pepcid AC. He drew a line where the swelling was, and it should not go past that line. The next morning it was swollen all the way to my wrist. I did go back to the emergency room and took pictures and they told me to keep doing what I was doing. I got an appointment with my PCP a few days later and she took me off the antibiotic and put me on a sulfur drug. I took a good month for the swelling to go down. I kept comparing it to my other arm. I also was experiencing nausea, extreme fatigue, and headaches during that time as well. I also got shingles about two months ago and I have had the original vaccine and the recent vaccine as well.