chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to a 23 month old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 18-JAN-2017. On 02-MAR-2017, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # M038860 with expiration date of 13-MAR-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 45 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA013888.
Child had fever on 5-24, 5-25 and 5-26 as high as 103F, then on 5/27, the fever broke but child broke out in generalized rash in scalp and all over body was itchy. Child was admitted to the hospital for observation with concerns of seizure. Mother states he just "looked right through you". Had a fixed stare while hospitalized. Released, the next day. Mother states, within 3 days, the rash was gone and he was doing ok.
diffuse rash 72hr p/vax that began @ immunization site & spread (type 4 delayed reaction);
cataracts; detached retina; brain fog; tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (cataracts) and RETINAL DETACHMENT (detached retina) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 042L20A and 023M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CATARACT (cataracts) (seriousness criterion medically significant), RETINAL DETACHMENT (detached retina) (seriousness criterion medically significant), BRAIN FOG (brain fog) and TINNITUS (tinnitus). At the time of the report, CATARACT (cataracts), RETINAL DETACHMENT (detached retina), BRAIN FOG (brain fog) and TINNITUS (tinnitus) outcome was unknown.            No relevant concomitant medications were reported. No treatment medication reported.  Company comment.  This spontaneous case concerns a 59  year  old female patient, with no medical history reported, who experienced the unexpected, serious (medically significant) events of cataract and retinal detachment. Latency cannot be properly assessed since exact onset date and vaccination date were not provided. It was reported that after 2 shots of mRNA  1273 vaccine the patient experienced brain fog, tinnitus, detached retina, and cataracts. No further clinical details were provided for medical reviewing. The benefit-risk relationship of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.
I tested positive on June 9, 2022 I had fevers and rigors. I spoke with an infectious disease doctor who prescribed PAXLOVID. I started feeling better and by June 14, 2022 I started feeling better and testing negative. By June 17 or 18 I started having upper respiratory symptoms and tested positive for COVID 19 again. I am still testing positive as of today June 21, 2022.
The pt experienced a rash, itching, developed several days later, whole body rash, scabbed over developed several days after. Rash continues today with itching.
I took the vaccine on 12/23/20 and the next day I was woken up around 4:30 am by a horrible dizziness, I felt weak, nauseous, and on later days had diarrhea for a day and headaches while the dizziness continued, I decided to go to an urgent care spot facility on 12/29/20 where the doctor prescribed me meclizine 12.5 mg and rest. I still feel dizzy but not as bad as the first day.
Patient was given expired MENVEO. Expired on 12/2012. Called manufacturer and they couldn't give advice on whether to reimmunize or not. Made Drs. office aware as well.
My ear was hurting me so I made a doctor appointment. The day of the appointment I woke up feeling fine and went to work. I went to work and when I was there I started to have a Fever of 102.5 and chills. I was sent home. I called my doctor and they told me I could not come in and gave me a COVID test. The test came back positive. The doctor advised I should take Tylenol and drink a lot of fluids and to rest. While I was recovering I experienced vertigo, lightheadedness and brain fog. I took another test a week later and that came back positive. I started feeling better after about 2.5 weeks. I took another test and it came back negative. I still experience lightheadedness and vertigo. I do still have episodes of brain fog and confusion. I do have an appointment on 05/19/2022 as a follow up to my long COVID symptoms.
pt recvd vax & reported soreness @ site p/vax; parent inspected site, found it to be swollen & very red in a 3" x 3" area @ the inject site; parent contacted MD & applied Epsom-salt compresses, t99.8; To ER, t101;
experiencing a "cigarette smell" sensation; Tenderness; Itch; Doesn't smell as well as she used to, Lack of smell; Lack of smell worsened; Affects apetite; waking up at night; Sensitivity; This case was reported by a nurse via call center representative and described the occurrence of smell alteration in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included tenderness. Concurrent medical conditions included smell alteration (The patient was experiencing a cigarette smell sensation before the first dose of Shingrix) and loss of smell. Concomitant products included COVID-19 VACCINE (COVID-19 BOOSTER).   On 13th June 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced smell alteration, tenderness, pruritus, loss of smell, condition aggravated, appetite disorder, nocturnal awakening and hyperesthesia. On an unknown date, the outcome of the smell alteration, loss of smell, condition aggravated, appetite disorder and nocturnal awakening were not recovered/not resolved and the outcome of the tenderness and pruritus were recovered/resolved and the outcome of the hyperesthesia was unknown.   It was unknown if the reporter considered the smell alteration, tenderness, pruritus, loss of smell, condition aggravated, appetite disorder, nocturnal awakening and hyperesthesia to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-JUN-2022 and 01-JUL-2022 Reporter's Comment: The reporter reported that, she received the Shingrix.  The reporter reported that, she was experiencing a cigarette smell sensation before the first dose.  However, cigarette smell sensation worsened after the first dose.  The reporter stated that, she had tenderness but it wasn't that bad and didn't last that long and an itch but it came and went, both events occurring after her first dose of Shingrix.  She stated that, she didn't smell as well as she used to.  She was experiencing this before Shingrix but her lack of smell worsened after receiving Shingrix.  She also stated that her issue with smelling smoke affects her appetite and she was wakening up at night because she was smelling smoke.  She also shared that, she received her booster shot for Covid two months before receiving Shingrix and that the sensitivity/tenderness with the Covid shot was 10 times worse than it was with Shingrix. The reporter declined to provide additional information. The reporter did not consent to follow-up. Additional Supportive Information: The case had been linked to US2022100573,reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022100573:Same reporter
After patient left clinic, patient was drowsy (he was in his stroller, the while time; the reaction was noted by mom). He was turned to one side as if he was limp. After 2 hours, he was his old self. Patient came back to the clinic. He was fine.
Pain from shoulder into back of neck after 1st dose; 1st dose administered more inward towards chest than other shots; Asleep feeling in hands after 1st dose; Tingling in hands after 1st dose; Hard to open hands after 1st dose; swelling in top of hands and wrists after 1st dose; Can't do normal activity after 1st dose; Ring fingers won't fully extend after 1st dose; Arm pain after 1st dose; Pain into elbows and shoulders after 1st dose; Hand pain after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain from shoulder into back of neck after 1st dose), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (1st dose administered more inward towards chest than other shots), HYPOAESTHESIA (Asleep feeling in hands after 1st dose), PARAESTHESIA (Tingling in hands after 1st dose) and MUSCLE SPASTICITY (Hard to open hands after 1st dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-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 ARTHRALGIA (Pain from shoulder into back of neck after 1st dose), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (1st dose administered more inward towards chest than other shots), HYPOAESTHESIA (Asleep feeling in hands after 1st dose), PARAESTHESIA (Tingling in hands after 1st dose), MUSCLE SPASTICITY (Hard to open hands after 1st dose), PERIPHERAL SWELLING (swelling in top of hands and wrists after 1st dose), IMPAIRED WORK ABILITY (Can't do normal activity after 1st dose), MUSCLE SPASTICITY (Ring fingers won't fully extend after 1st dose), PAIN IN EXTREMITY (Arm pain after 1st dose), ARTHRALGIA (Pain into elbows and shoulders after 1st dose) and PAIN IN EXTREMITY (Hand pain after 1st dose). At the time of the report, ARTHRALGIA (Pain from shoulder into back of neck after 1st dose), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (1st dose administered more inward towards chest than other shots), HYPOAESTHESIA (Asleep feeling in hands after 1st dose), PARAESTHESIA (Tingling in hands after 1st dose), MUSCLE SPASTICITY (Hard to open hands after 1st dose), PERIPHERAL SWELLING (swelling in top of hands and wrists after 1st dose), IMPAIRED WORK ABILITY (Can't do normal activity after 1st dose), MUSCLE SPASTICITY (Ring fingers won't fully extend after 1st dose), PAIN IN EXTREMITY (Arm pain after 1st dose), ARTHRALGIA (Pain into elbows and shoulders after 1st dose) and PAIN IN EXTREMITY (Hand pain after 1st dose) outcome was unknown. Not Provided      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 concomitant medication was reported . No treatment medication was reported .   This case was linked to MOD-2021-083497 (Patient Link).
Employee states that she had nausea, severe H/A, fatigue, tingling at injection site and in neck. Fever 100.9, exaustion. Slept 12 hours. Came to our office 0800 01/30/2015 and had pallor, moderately swollen arm on injection site. Site with out redness or heat.
Approximately 1 day after my booster shot Dose 3, I experienced the following symptoms: Severe nerve pain (From elbow to right hand) Low grip strength, It was very painful. I work using the computer and I wasn't able to use the mouse. I took Ibuprofen and generic steroids for a couple of weeks but it did not improve my situation. My wife (a physiatrist) said that my nerve got inflamed because she has been seeing patients with the same situation who recently got the booster.
Patient complained of lightheadedness, shortness of breath and thirst shortly after administration of Fluarix vaccine.  I asked patient to lie down while I call 911 and have our physician assistant from the clinic also evaluate her while waiting for paramedic.  Patient said she felt ok enough to just sit.  Physician Assistant felt was probably anxiety/vasovagal response to flu vaccination.  Paramedics came and evaluated patient and did not feel further treatment was necessary.
Headache; Chills; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 10:00 (Lot number: en6204) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart condition" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot number: en6205, Location of vaccination: Left arm, Administration time: 16:00, Administration site: Left arm), administration date: 26Feb2021, when the patient was 56 years old, for COVID-19 immunisation, reaction(s): "Sore arm". The following information was reported: HEADACHE (non-serious) with onset 19Mar2021, outcome "recovering", described as "Headache"; CHILLS (non-serious) with onset 19Mar2021, outcome "recovering", described as "Chills"; FATIGUE (non-serious) with onset 19Mar2021, outcome "recovering", described as "Fatigue". Therapeutic measures were not taken as a result of headache, chills, fatigue.  Additional information: The patient did not have any allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other medications or vaccines within two weeks prior to the vaccination. The patient did not receive any treatment for events. The clinical outcome of events headache, chills, fatigue was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
When patient woke up this morning, grandmother noticed large erythematous area from injection site up to neck. No swelling or splotching. Not raised. Pruritic and warm to touch. No other symptoms. Advised by PCP to take over-the-counter Benadryl and continue to monitor.
Low-grade temperature for 3 days post-injection; migraine headache requiring treatment for 1 day post-injection; profound lethargy for 1 day post-injection; swelling, redness, heat and pain at the site of injection beginning the morning after vaccination and worsening each day for 4 days. Patient self-reported it as a "bad burn on the surface of the skin". Pain, redness, and swelling extending on day 4 from the top of the shoulder to the elbow.  Patient visited the primary care provider on 3/26/21 who prescribed silver sulfadiazine cream topically, cephalexin, hydrocodone/apap, ibuprofen and acetaminophen.
reporter states nurse has seen an inc number of inj site rxn & inc severity w/a particular TD lot# (368917);rxn consist of erythema & induration;recovered;
Patient is a very pleasant 80 year old female with a history of hypertension and recent pelvic fracture approximately two months ago who presented to the emergency department reporting right sided chest pain.  She states that her symptoms started on Sunday.  She has pain with a deep breath and also with exhaling.  She reports it is a sharp pain.  She states that she has had no lower extremity edema or calf pain, however, she did have a shooting pain down her right leg recently.  She denies any history of personal or family history of deep venous thrombosis or pulmonary embolus.  She reports that she has not had any hemoptysis.  She denies feeling short of breath.  She denies abdominal pain, nausea, vomiting, or diarrhea.  She states that she has not had any COVID exposures or known symptoms.  She has received two COVID vaccine doses.  She reports that she has not been sick and denies fever, chills, or cough.  In the emergency department she was diagnosed with an acute pulmonary emboli in the right main pulmonary artery with extension into the segmental pulmonary arteries.  There is concern for early pulmonary infarct.  This has prompted admission to the hospital.
The primary reporter is nurse practitioner. This nurse practitioner noted that patient, was inadvertently administered VARIVAX and PROQUAD during the same office visit today (10/25/2012). For both VARIVAX and PROQUAD, it is not known which dose these doses were in their respectively vaccination schedules. No adverse effect reported. All AE fields apply to both vaccines. No further information is available.
Low grade fever, chills, muscle aches, headache, fatigue, and cold sore on bottom lip
Patient presented to clinic requesting booster/3rd dose of vaccine - administered.  On review of chart, this is 4th dose (prior booster in 1/2022).  No known adverse event.
Pt was diagnosed with Covid on 12/23/22 at the long term care facility (LTCF) where he resided and subsequently died on 1/5/23 due to complications from his illness.
about 2-2 1/2 hrs post vax pt started crying; mom noticed redness near lt knee then pt devel several pinhead sized clear water blister like bumps; pt would cry on/off; vomited today,t99ax, went to ER;did not sleep well;sl pink @ inject site
2inch by 2 inch red circle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (2inch by 2 inch red circle) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029LZ0A and 030A21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, VITAMIN D2, BUPROPION and LEVOTHYROXINE for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (2inch by 2 inch red circle). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, VACCINATION SITE ERYTHEMA (2inch by 2 inch red circle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Rash on her arm that is 5 to 6 inch lenghty by 3 inch wide; Nodular Scleritis in left eye; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SCLERITIS ALLERGIC (Nodular Scleritis in left eye) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (Patient is allergic to shell fish, food color food dye and many artificial products).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced SCLERITIS ALLERGIC (Nodular Scleritis in left eye) (seriousness criterion medically significant). On an unknown date, the patient experienced RASH (Rash on her arm that is 5 to 6 inch lenghty by 3 inch wide). At the time of the report, SCLERITIS ALLERGIC (Nodular Scleritis in left eye) and RASH (Rash on her arm that is 5 to 6 inch lenghty by 3 inch wide) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was interrupted on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information is not provided.  Treatment medication prescribed was an anti-inflammatory and the patient developed a reaction to the anti-inflammatory and then was prescribed a steroid prednisone and that was effective in helping the nodular scleritis.   The patient was recommended not to take the second dose of the Moderna  covid-19 vaccination.; Sender's Comments: 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. No follow up is possible.
Vaccine expired 10/13/2021, but given 10/22/2021.
COVID-19; Lack of drug effect; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 028L20A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included High cholesterol (hig cholesterol, controlled with statin) and Drug allergy.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-Apr-2022 to 28-Apr-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.            Concomitant medication information was not provided by the reporter.  On 04-May-2022, it was reported as resurgence of symptoms 6 days after last Paxlovid. Uncontrollable sneezing, runny nose and body aches. Now in 2nd full day of those, no improvement.   Device date was reported as 06-May-2022. Company comment: This spontaneous case concerns a 69-year-old male patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19. The date of onset of the event was not specified in respect to the administration of mRNA-1273, hence latency could not be assessed. Additionally, Drug ineffective was also reported. The initial two doses of mRNA were administered 8 months prior to the administration of third dose Pfizer, the interval between the two doses is 29 days. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69-year-old male patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19. The date of onset of the event was not specified in respect to the administration of mRNA-1273, hence latency could not be assessed. Additionally, Drug ineffective was also reported. The initial two doses of mRNA were administered 8 months prior to the administration of third dose Pfizer, the interval between the two doses is 29 days. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
6 weeks later got DVT R leg.  pt iwth ulcerative colitis on meds for this.