chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Skin rash as of today I have no relief.; Black bubbles started to develop on my skin; This case was reported by a consumer and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 2nd dose of Shingrix 50 ug. On an unknown date, unknown after receiving Shingrix, the patient experienced rash and blister. On an unknown date, the outcome of the rash and blister were not recovered/not resolved.   It was unknown if the reporter considered the rash and blister to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-MAR-2022 Reporter's Comment: The patient self-reported this case. After the second dose, the patient got skin rash and black bubbles started to develop on his/her skin.  The patient under dermatologist treatment, however till the time of reporting the patient had no relief. The patient asked did anyone else reported this and was there any good cure for this, their response would be helpful in his/her future treatment.
Bell's Palsy; This is spontaneous report from a contactable Other Health Professional. This reporter reported similar events for 6 patients. This is a 6th of 6 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced bell's palsy on an unspecified date with outcome of unknown. Since the use of modified RNA in COVID vaccines, the reporter aware of 6 cases of Bell's Palsy by the companies making these vaccines.   Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event facial paralysis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021007605 Different patient, same drug/event.
9/1/10 - Started to notice left deltoid sl. red and sore. 9/2/10 - Left deltoid - red, warm, firm area 2 inches in diameter. Entire arm "achy". Will contact family physician.
I started to feel extremely weak and tired.  I was completely fine previously.  I'd have to sit when just standing. Lifting my arms would make me feel weak.  In a day I was having severe headaches, body aches, weakness, and slept with the flu for 5 days.  I went back to work and after a day I was again feeling exhausted, my nose started to run, I was feeling achy now in the joints, my chest felt tight and it felt as though harder to breath.  A few times I've wheezed.  My doctor has said the flu shot is the reason for this, before I thought I just had flu like symptoms and now it seems I have the full flu.  I keep feeling run down and worse.  It doesn't improve.  I've had Vitamin A, D, and astralgus along with my normal supplements.  These helped alot along with rest, but I'm not improving, I am feeling much worse.
Information has been received from a LPN concerning a 16 year old white female with asthma and no known drug allergies who on 08/21/03 at 8:40 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (Lot # 643925/0936M).  On 08/21/03, at 8:40 concomitant therapy included an IM dose in the left arm of adult diphtheria toxoid (+) tetanus toxoid (Batch # U0842AA), it was noted that the series was finished on 04/28/92 respectively. On 08/21/03, "in the evening" (also reported as "about 3 days after" vaccination) the pt developed a low grade fever and "a few pox dispersed over her body". The pt's mother reported that there was a "hive-like itchy rash around injection site" and 3-4 days later developed "pox-like lesions" on her face which were red, raised vesicular lesions that scabbed over". There was no prescription drug required. Subsequently, the pt recovered. Medical attention was not sought. There was no product quality complaint involved. No further information is expected.
This child received immunizations of DTaP #5 on 03/13/01 on left upper arm and came in on Friday, 03/15/01 with a complaint of left arm pain, redness, swollen and hard with circumference of 9 3/8'' (+) erythema and edema. Will follow up tomorrow on      03/16/01 to recheck site.
About 2 1/2 days after receiving my first vaccine dose (on 03/27/2021), I started to experience a very painful adverse event on the taste buds on my tongue. Certain taste buds on my tongue were so sensitive that it hurt to touch them to my teeth or the top of my mouth. It was difficult to eat, and I moved to a liquid diet for a few days.  After much research, it was clear that I was experiencing transient lingual papillitis (lie bumps) that persisted for about 7 days then disappeared. At the time, I wasn't sure if it was related to the Pfizer vaccine or not.  When I received my second dose on 04/18/2021, the adverse event happened again after 2 1/2 days. It was then clear to me that this issue was directly related to the Pfizer vaccine.
Information has been received from a physician concerning a 17 year old female who was vaccinated with a 0.5 ml second dose of Gardasil.  Two and a half weeks after receiving the second dose of Gardasil the patient experienced tremors in hands.  The patient's tremors in hands persisted.  No product quality complaint was involved.  Additional information has been requested.
pt recvd vax & had swelling from shoulder joint to elbow; also pain in arm; mom advised to tx w/ ibuprofen & hot & cold packs; swelling was in Lt arm;
itchy rash on upper arms, thighs, & bra line; new areas appearing right elbow 7 days after injection; calamine lotion was applied by pt.
fainted approximately 5 minutes after receiving vaccine. pt was given water and cool compress on back of neck. blood pressure 1:06 89/61, 1:12 98/67
Six inch deep red circle at shot sight. 2 inch allergy like wheal in the center that lasted from shot day (Thurs) through Monday. It still felt hot to the touch on Monday. Now there is a 7 inch bruise (Tues).
See attached notes - Pt got a tetanus shot & developed a peculiar pain reaction with no evidence of any other medical problem to explain her symptoms. Likely conclusion - adverse reaction to vaccine.
Paresthesia in left arm/hand lasting 7 months after first dose.  Weakness in left hand causing difficulty with normal tasks (grasping, writing) lasting 7 months after first dose.  Lymphadenopathy on left side has not yet resolved (8 months after 1st dose.) Uticaria lasting 4 months after 2nd dose.
17 year old received Moderna booster. This was per the parent/patient's request. Patient should have received Pfizer booster based on her age. Patient's parent has been informed of the mistake and there was no adverse reaction to the vaccine.
Started experiencing persistent dizziness and fatigue. Evaluated in Urgent Care the next day and diagnosed with benign paroxysmal positional vertigo due to bilateral vestibular disorder and palpitations.
Pt. complained of hurting if he slept on that arm and woke up from his sleep 3 days later. Went to hospital a week later and claims that Dr. diagnosed it as an infection from shot.
received vaccine on 1/11 and on 1/18 developed pain, redness, and swelling at injection site. also developed rash on left arm, under left breast and torso.
Complaint of achy normal feeling but later 10/19/2005 strong pain especially with arm hanging or moving.  Any movement increases pain.  Swelling identified by doctor at visit to clinic.  Diagnosed as inflammation of deltoid muscle.  Prescribed Darvocet, muscle relaxers, compresses.  10/28/2005 symptoms gone.
My left arm injection site was achy and sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My left arm injection site was achy and sore) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced VACCINATION SITE PAIN (My left arm injection site was achy and sore). At the time of the report, VACCINATION SITE PAIN (My left arm injection site was achy and sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.    This case was linked to MOD-2021-336762 (Patient Link).
The pt experienced a warm painful, swollen, red spot at the injection site about an inch in diameter, no where else on the body and left a bruise after a week of symptoms.
This spontaneous report was received from a pharmacist concerning an approximately 74 year old male patient. The patient's medical history, concomitant therapy and concurrent conditions were not provided. The patient had no known drug allergies. On an unknown date in APRIL 2015 (when the patient was 73-year-old), the patient was vaccinated intramuscularly with a dose of ZOSTAVAX (lot #, expiration date and dose were not reported). The reporting pharmacist stated, that the patient came to the pharmacy with a prescription for antivirals because the patient had shingles (onset date was unknown). The reporter discussed vaccination failure. The patient received unspecified treatment. The outcome of the event was unknown by the reporter (also reported as the event did not improve). The causality assessment between the event and ZOSTAVAX was not reported.  Additional information has been requested.
Patient was observed 30 minutes post vaccination, then returned to work. Came back after feeling unwell. Heart rate was taken and >100. Patient sent to holding area for further observation.
sore arm; itching at site; pinkish in color (size of a nickel); soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE PRURITUS (itching at site), VACCINATION SITE DISCOLOURATION (pinkish in color (size of a nickel)) and VACCINATION SITE PAIN (soreness at injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M120A) for COVID-19 vaccination.     No medical history for the patient was reported.  Concomitant products included LEVOTHYROXINE.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site). On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION SITE PRURITUS (itching at site) and VACCINATION SITE DISCOLOURATION (pinkish in color (size of a nickel)). On 22-Feb-2021, PAIN IN EXTREMITY (sore arm), VACCINATION SITE PRURITUS (itching at site) and VACCINATION SITE DISCOLOURATION (pinkish in color (size of a nickel)) outcome was unknown. At the time of the report, VACCINATION SITE PAIN (soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.
This vaccine was stored at room temperature outside of 2 hours. The vial was opened around 11AM and the vaccine was administered around 2PM. I did not realize this was incorrect until 11/5/21. I have contacted my managers and the manufacturer who did not have stability data past 2 hours and advised to use clinical judgement.  The patient's first 2 doses were Pfizer.
after 2nd dose, pt. developed fever 102+, nausea, vomiting, fatigue, swollen lymph glands under arsm and in throat, lost tase sensation in "parts of mouth reports must be genetic b because mother and grandmother had some similar reactions after first vacc pt. developed TMJ pain and 3 day "hive rash" on torso
LITTLE FEVER; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: heart condition, chronic obstructive pulmonary disease (copd), congestive heart failure (chf), and human immunodeficiency virus (hiv). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the patient experienced little fever. Laboratory data (dates unspecified) included: HIV test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little fever on 25-MAR-2021. This report was non-serious.
Positive  for Genital Herpes Virus .  First time in my life I have ever had an outbreak.  The only change in my medical history was having received COVID vaccine.
Woke up in the middle of the night with severe shivering, achiness, fatigue, headache. Chest pain started later in the day. Most symptoms subsided after about 3 days, but the chest pain slowly improved over 6-7 weeks. As it was stopping, afib set in that ended up with me in an ER and then the hospital from the severity leaving me unable to function. No prior history of heart issues. Afib did/is responding well to first calcium channel and now beta blockers.
Received 2nd dose of Pfizer COVID vaccine 1/7/2021.  On 3/20/21 developed cough, headache, rhinorrhea, sore throat.  Tested positive for COVID.
chicken pox; red itchy bumps by the injection site; red itchy bumps/ they are raised/; This case was reported by a consumer via call center representative and described the occurrence of chickenpox in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included Patient did not know if had chicken pox as a child..   On 4th October 2021, the patient received Shingrix. On 6th October 2021, 2 days after receiving Shingrix, the patient experienced chickenpox, itchy rash and erythropapular rash. On an unknown date, the outcome of the chickenpox, itchy rash and erythropapular rash were not recovered/not resolved.   The reporter considered the chickenpox, itchy rash and erythropapular rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient did not know if she had chicken pox as a child. The patient received the Shingrix vaccination on Monday and on Wednesday developed red itchy bumps by the injection side and over the days this spread to the chest, around the waist and on the back. They were very itchy and looked like chicken pox. The patient thought that she had chicken pox. The patient thought that the red itchy bumps she was experiencing was due to Shingrix.  She said they were raised, and they were itching terribly. She said she woke up on reporting day morning and they were all over her back.  The patient did not have the lot number because she threw away the paperwork.  She had got the shot at her doctor's office and provided consent to follow up with her doctor. This case was linked with US2021AMR212333, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR212333:same reporter
sore arm; couldn't sleep at night; severe chills; fever; muscle soreness,bodyaches; headache; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INSOMNIA (couldn't sleep at night), CHILLS (severe chills), PYREXIA (fever) and MYALGIA (muscle soreness,bodyaches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM for Thyroid disorder.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), INSOMNIA (couldn't sleep at night), CHILLS (severe chills), PYREXIA (fever), MYALGIA (muscle soreness,bodyaches), HEADACHE (headache) and NAUSEA (nauseous). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), INSOMNIA (couldn't sleep at night), CHILLS (severe chills), PYREXIA (fever), MYALGIA (muscle soreness,bodyaches), HEADACHE (headache) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 100 (High) 100 degree.
t103 evening & thru noc p/vax;used motrin 6-8hr;morning t100, cranky, crying, won't eat instructed to cont w/Motrin, tepid bath PM t101;DPH advised;If motrin not effective try APAP;use cold compress to lt leg x 24 then switch to warm compre
pt recvd vax 330PM; 10-15 mins later felt dizzy, pressure behind eyes, nauseate, no vomit; tightness in throat, difficulty breathing, did not feel well allover;
1) Arm sore where injected  2) lethargic 3) flu-like aching in shoulders 4) joints in had s (knuckles) are sore and painful
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of covid-19.; Sender's Comments: Based on the information available, a possible causal relationship between reported events Drug Ineffective and COVID 19 and suspect drug BNT162B2 cannot be excluded.
Within minutes of receiving the Janssen vaccine, patient c/o dizziness, difficulty breathing, and feeling like her throat was closing.  Her breathing was labored, shallow and fast RR high 30s, 93% RA, HR 120s.  Lungs sounds with poor air entry, no wheezing. No rash, injection site unremarkable. Pt disclosed extensive history of allergies and h/o anaphylaxis needing Epi. States that current symptoms feel like previous anaphylaxis events.  Called Code. Administered Epinephrine IM L thigh and within 2 minutes patient felt better, vital signs improved to HR 121, 99% RA, 170/86 speaking in full sentences. Allergy fellow and ED team arrived and patient was transported to ED alert and responsive in NAD.
pt recv vax & devel an inj site rxn characterized by swelling, redness, & tenderness;also exp upper resp sx;thick throat, cough, & fever;
Information has been received from a certified medical assistant regarding 26-year-old patient of unknown gender. There was no information about the patient's concurrent conditions or medical history. The patient's concomitant medication included sterile diluent. On an unknown date, the patient was administered inadvertently a dose of ZOSTAVAX subcutaneous, lot # N013274 and expiration date 04-JUL-2018 (strength, dose and anatomical location were not reported) instead of varicella virus vaccine live (manufacturer unknown) for prophylaxis. No adverse effects were reported.
Patient received vaccine in the morning and started having severe pain in the injection site that afternoon. It never went away, and patient had to go to the doctor to get scans done, and receive pain medication. (over a week later).
A five year old had the 2nd MMR on 03/21/2002. On 03/24/2002 had glands swelling, discomfort, erythemetous. Went to local ER and treated with Tylenol.
Intense Headache from shot #1 on August.  Sight impairment and ringing in ears, headache/migraine for 3 days. Fever of 103 post shot.
Initially some flu-like symptoms a few hours after getting the vaccination, but felt fine Friday morning.  Late Sunday evening, developed a intense headache followed by chills overnight and restless sleep (1-hr periods thru the night). Continued Headache thru 3/18 with general body aches and weakness. No pain at injection site after first night. Lightheadedness when standing with loss of focus (brain fog). Occasional and temporary feeling of nausea.
Right arm -> deltoid muscle at shot site of varicella became red, swollen painful with movement began 12/21 - on 12/22 notice clear discharge -> scabby, redness, sore no pain, no itch.
Patient developed a painful rash to the left buttock a week after vaccine administration. Was diagnosed with herpes zoster
On 6-3-08 I administered 4 yr vaccines Dtap 5 and IPV 4 to L thigh 1 on middle of front thigh and 1 on side of thigh MMR L arm sub Q VAR R arm Sub Q with no problems. On 6-5-08 pt came in with redness, swelling, itching of L thigh - treated for cellulitis - given Bactrim.
Hospitalization (8/9/2021-8/18/2021) and death (8/18/2021) due to COVID-19
Itchy left arm; Red right arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itchy left arm) and ERYTHEMA (Red right arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 023M26A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PRURITUS (Itchy left arm) and ERYTHEMA (Red right arm). On 10-Apr-2021, PRURITUS (Itchy left arm) and ERYTHEMA (Red right arm) had resolved. Not Provided          Concomitant medication was not provided by the reporter.  Treatment medication included Triamcinolone Acetonide Cream prescribed by doctor.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up information received on 17-May-2021 and Updated AE contact information and event outcome was updated..
1:30 a.m. on 2/4/04 woke up with chills, vomiting, dizzy & seeing spots; stepmom says feels warm to touch
fever & vomiting for 1-2 days w/in 12-24hr;w/in 1-2hr, both arms were swollen & tender;pt is not sure, but thinks the rt arm was much worse than lt;