chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchiness; redness, at the injection site; Swelling at injection site; pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th February 2022, the patient received the 1st dose of Shingrix. On 7th February 2022, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site pain. On 8th February 2022, the patient experienced pruritus. In February 2022, the outcome of the injection site swelling and injection site pain were recovered/resolved. On an unknown date, the outcome of the injection site erythema and pruritus were recovering/resolving.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Shingrix in right arm on Monday 7th February 2022 and she experienced swelling, redness and pain at the injection site later that evening in her right arm.   The patient also stated that she experienced itchiness which started the day after her vaccination.   The patient stated that pain and swelling at injection site had since resolved. The patient still had redness and itchiness but both had improved. The patient spoke as per package insert content. The patient gave medical advice disclaimer. Reporter provided limited information and did not wish to provide personal information. The reporter did not consent to follow-up. The case was reported for 1 of 4 report.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022026668:same reporter US-GLAXOSMITHKLINE-US2022026673:same reporter US-GLAXOSMITHKLINE-US2022026674:same reporter US-GLAXOSMITHKLINE-US2022AMR027150:same reporter
Pt presented to office with a flat, impalpable, blanching, hyperpigmented rash on the left thigh on 06/15/2018. Mother states that the rash began the day after the vaccines were given and has not gone away. No other symptoms noted. No treatment provided.
10/23/2005 Child woke up w/ 20-30 varicella lesions. Seen by us today for diagnosis. No fever. Diagnosis Varicella.  10/24/05 child had fever and vesicles started 10/22/05. Came to office for Dx. Had 20-30 varicella lesions on trunk, face, etc - Rx: Benadryl, Tylenol, Calamine Lotion.
I HAD CHILLS, HIGH FEVER, JOINT PAIN, DRY COUGH, SHORTNESS OF BREATH.
day 1 following the vaccine I had pain in the right arm, day 2 worsening pain in the upper traps left and right, day 3 headache and day 4 severe GI issues with diarrhea. day 5 was back to normal
Really bad headaches for a long period of time. When I have bad ear pain. I have neck pain and stiff neck.
He woke up at 2:00 in the morning on 10/13/21 with generalized fatigue, body aches, severe left upper arm pain, muscle weakness, decreased joint mobility. He was seen virtually in clinic at on 10/27/21 due to his symptoms and again on 11/22/21. He has taken OTC medication for pain, heat, ice, rest. He is still having a lot of pain in the shoulder joint with movement and resistance training. He believes he has lost muscle mass in his deltoid region as well. He was instructed to contact his insurance company to see if an MRI would be covered to further evaluate his condition.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In January 2014, a healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In February 2017, the patient was treated by a healthcare provider for shingles.  The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Within 5 minutes of administration, patient experienced soreness, stomach ache, and dizziness. Patient was given water and advised to sit down. Few minutes later, patient seemed pale and complained of experiencing slight chest pain. I offered the patient to call emergency on her behalf, however patient denied. Eventually, patient agreed and paramedics were called and patient was transferred to the hospital.
experienced fatigue; runny nose; sore throat; experienced poor sleep; feeling cold; night terrors; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left (arm), administration date 06Nov2021 11:15 (Lot number: FK5127) at the age of 5 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 08Nov2021 06:00, outcome "recovered" (10Nov2021), described as "experienced fatigue"; RHINORRHOEA (non-serious) with onset 08Nov2021 06:00, outcome "recovered" (10Nov2021), described as "runny nose"; OROPHARYNGEAL PAIN (non-serious) with onset 08Nov2021 06:00, outcome "recovered" (10Nov2021), described as "sore throat"; INSOMNIA (non-serious) with onset 08Nov2021 06:00, outcome "recovered" (10Nov2021), described as "experienced poor sleep"; FEELING COLD (non-serious) with onset 08Nov2021 06:00, outcome "recovered" (10Nov2021), described as "feeling cold"; SLEEP TERROR (non-serious) with onset 08Nov2021, outcome "recovered" (22Nov2021), described as "night terrors". Therapeutic measures were not taken as a result of fatigue, rhinorrhoea, oropharyngeal pain. Therapeutic measures were taken as a result of insomnia, feeling cold, sleep terror.No other vaccine in four weeks,o Other mediation in two weeks, No covid prior vaccination,  Additional information: It was reported that On 08Nov2021 she experienced runny nose and sore throat that resolved by 10Nov2021. On 08Nov2021 she experienced fatigue, feeling cold without chills, and poor sleep due to night terrors. On 09Nov2021 she was began treatment with Melatonin 1mg QHS. The night terrors resolved on 22Nov2021. On 10Nov2021 the fatigue and feeling cold resolved. The causality assessment was related due to the temporality of symptom onset. The severity of all symptoms diagnosed was mild. None of the adverse events were serious. No Covid prior vaccination,no covid tested post vaccination, no Known allergies, no medical history, no other vaccine in four weeks,no Other mediation in two weeks. patient was received Tylenol for adverse event. Pfizer product had a causal effect to the adverse event was reported as yes.Concomitant Drugs, family Medical History ,relevant Tests and Specific relevant test were reported as none   No follow-up attempts are possible. No further information is expected.
exacerbation of lt facial paralysis 3 days p/vax;was in recovery phase of Bell's palsy of unk etiology when recvd vax;hx of rheumatoid arthritis & diabetes;f/u no improvement p/2wks;tx steroids & acyclovir for suspected virus reactivation;
Patient blacked out, fell knees to the floor & then face from a sitting position 2 minutes after vaccine administration. She was tired, had a headache and saw Dr on 9-6 -> ER for imaging -> no problems. Dx: whiplash. Pt good now.
Information has been received from a registered pharmacist concerning a 63 year old patient of unknown gender who on 06-NOV-2012, was vaccinated with a dose of ZOSTAVAX, lot # 671074/1199AA, that expired on 25-OCT-2012 (dose and route not reported). No adverse reactions reported. This is one of two reports from the same source. Additional information has been requested.
My first symptom I had was irritation in my sinuses. Then over the course of several days I started experiencing congestion, sneezing, coughing, body aches, night sweats, muscle pain, a constant headache, fatigue, and brain fog. The fatigue lasted at least a couple of weeks. My doctor recommended to take pain reliever medications if needed and to drink lots of fluids. Sometimes I still have fatigue.
Patient started having symptoms of angioedema and hives in 6/17, has been difficult to control by allergy. Mom feels this is related to GARDASIL.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 01-JUL-2013 at 07:40, ZOSTAVAX lot # J001005 was exposed to an exact T not recorded but noted as equal to or > 12C for an estimated total time out of range of 44.5 hours. On 12-JUL-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX  (dose and route administration were not provided) (Lot number J001005, Exp. Date: 24-APR-2014). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
The patient received the adult formulation of the Hepatitis B vaccine. The patient was monitored for almost an hour following his vaccines and he experienced no adverse effects. The patient's Mother was advised to keep an eye out for any of the adverse effects listed in the vaccine information sheets that she was given. She was advised that the most common adverse effects for Hepatitis B were redness, swelling or soreness of the injection site, fever, headache or fatigue. She was advised to keep the patient hydrated and that if he does experience any fevers that she can give him Tylenol and should he experience any redness or swelling at the injection site that she can apply a cold compress or covered ice pack to the injection site. Mother further advised that should the patient's Mother should contact the patient's Pediatrician for any additional concerns. The patient's Mother verbalized understanding.
Evening after getting vaccination I developed fairly loud tinnitus in both ears.  The ringing was loud enough to keep me awake, even though I felt pretty weak and achy from the vaccine.  It subsided after about a week but is still present to some extent.  I've noticed it off and on before the vaccination, but never so steady or strong.  About one month after the vaccine I'd say it's a little worse than before, but not terrible.
Pt received Comvax and Hib at the same time. Comvax is Hib and Hep B together. This was pt 2nd Hep B and 1st Hib- Therfore pt received 2 Hib vaccines- NO reaction as of 24 hours after vaccination.
joint pain; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received first dose of bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EN6202), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 as dose 1, single for covid-19 immunisation (at the age of 44 years). Medical history included covid-19 and illness from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks of vaccination. On an unspecified date patient experienced joint pain. Consumer reports the vaccine card says Covid 19 vaccine given on 01Mar2021, she reports that is wrong, she had the vaccine on a Tuesday, on 02Mar2021. She does have a history of joint pain, but this is worse. Her right arm is bothering her more. Her joints are hurting her more. She has taken Tylenol for it. When probing indication for receiving the Covid 19 vaccine, she reports she was infected with the Covid 19 virus, everyone at her work was infected. She didn't want to get sick again because she was sick. She got the Covid 19 vaccine for safety. The outcome of the event joint pain was unknown.  No follow-up attempts are possible. No further information is expected.
Extreme sore arm?unable to use, Chills Achy all over Extreme fatigue Lower back pain causing difficult to bend, move, walk Headache
Retracted nipple; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Sep-2021 and was forwarded to the company on 08-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RETRACTED NIPPLE (Retracted nipple) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (patient is allergic to Dilaudid), Parkinson's disease since 2019, Essential tremor and Bone disorder (NOS). Concomitant products included VITAMIN D NOS for Bone disorder (NOS), PROPRANOLOL for Essential tremor, ETHINYLESTRADIOL, NORETHISTERONE (BALZIVA) for Hormone therapy, MULTIVITAMINS [VITAMINS NOS] and ASCORBIC ACID (VITAMIN C ACID) for Prophylaxis.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced RETRACTED NIPPLE (Retracted nipple). At the time of the report, RETRACTED NIPPLE (Retracted nipple) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided.  Laboratory investigations include ultrasound and mammogram. on an unknown date of Mar-2021 patient nasal swab covid-19 test with unspecified result.   This case was linked to MOD-2021-281250 (Patient Link).
On second day got a very upset stomach, no throwing up, and in minutes blacked out in shower. Woke up about 20 min. later. Got bruised eye and mouth and muscle pain in back after the fall. Was checked out by my doctor and have RX for a CT-scan of the bruise of eye.
Extreme fatigue  Caused period to begin weeks early. Extreme clots. Cramps similar to labor cramps. Extremely painful, nausea
Vaccine was administered on 5/11/2021 but it expired on 5/6/2021 per the 30 day guidelines. Vaccine was received from vendor on 4/6/2021.
This spontaneous report as received from a pharmacist via company representative refers to 2 patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On an unknown date the patients were vaccinated with unknown doses of ZOSTAVAX (strength, route unspecified). The pharmacist reported that on unspecified dates after receipt of ZOSTAVAX, two patients were diagnosed with shingles and this happened years ago (dates unspecified). The outcome of event reported was unknown. Varicella zoster virus (VZV) packet was sent. No product quality complaint was involved. Intervention to prevent seriousness criteria was not done. Additional information has been requested.
temperature of 102; elevated blood pressure; stomach burning; muscle aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (elevated blood pressure), DYSPEPSIA (stomach burning), MYALGIA (muscle aches), FATIGUE (fatigue) and PYREXIA (temperature of 102) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product LENVATINIB MESILATE (LENVIMA) for Endometrial cancer.    Concurrent medical conditions included Hypertension and Endometrial cancer. Concomitant products included LISINOPRIL from 07-Apr-2021 to an unknown date for Hypertension.   On 03-Mar-2021, the patient started LENVATINIB MESILATE (LENVIMA) (Oral) 20 milligram once a day. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (elevated blood pressure), DYSPEPSIA (stomach burning), MYALGIA (muscle aches) and FATIGUE (fatigue). On 12-Apr-2021, the patient experienced PYREXIA (temperature of 102). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 13-Apr-2021, PYREXIA (temperature of 102) had resolved. At the time of the report, BLOOD PRESSURE INCREASED (elevated blood pressure) had resolved and DYSPEPSIA (stomach burning), MYALGIA (muscle aches) and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Blood pressure measurement: 120/89 (abnormal) 120/89. On 12-Apr-2021, Body temperature: 102 (High) 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
No adverse effects reported; improperly stored dose of MMR II was administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concomitant medications or drug reactions/allergies.     On 08-MAY-2019, the patient was vaccinated with one dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose and route were not reported, lot # was R027999, expiration date was 01-OCT-2020) for prophylaxis (product storage error). There was no previous temperature excursion. The highest temperature was above 9 Celsius for 3 hours and 45 minutes. No adverse effects were reported.
Patient is not a patient of our clinic. When called to confirm appointment for second dose, we were notified patient was deceased.
In September of 2022, I broke out in hives. I had a rash and was itchy all over with a discomfort in my chest between my breasts that felt like pressure. That lasted for around an hour. I thought it was an allergic reaction to something I ate. This happened again around a month later but was worse, my whole thigh was covered. I went to the hospital, but by the time they saw me, everything was gone. The third time it happened, the same thing occurred but the itchiness was worse. I couldn't bare it, so I went to an urgent care clinic where they gave me a shot, and everything started to go away in around an hour. They also prescribed Diphenhydramine and Prednisone. Everything came back though, so I called an ambulance, and they treated me. The fourth time it occurred, I just waited for around an hour and a half. I also took Diphenhydramine, and I began to feel better. I haven't had another episode since that time.
Patients legal guardian reported the patient experiencing a warm, raised, red area surrounding each injection site. The sites were red, raised, and tender to the touch. The patient was vaccinated on 6/27 and the guardian called to report on 6/29.
Felt tachy, had a "funny feeling", injection site in left arm sore, itching and large welt forming.  "Panic" feeling increasing.  Coughing, wheezing increased. Then audible wheezing, tried to take 50mg of Benadryl orally and hard to swallow. Was double swallowing. Increasing feeling of "something bad was going to happen".  Chest pain, couldn't breathe, hard to swallow and arm now had softball size welt. Was overwhelmed with "fear" and barely could dial 911..then ambulance came. Had just ended shift at work and was in car when it hit. Ambulance took me and went to ER. Was a bit delayed reaction and then blew up.
No other AE reported; a temperature excursion involving GARDASIL 9 administered to a patient; This spontaneous report as received from a other and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies, historical drugs and concomitant medications was provided.  On 12-JAN-2021, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, 0.5 milliliter (ml), lot # 1602284, expiration date 26-SEP-2021 (dose number, route of administration, anatomical location were not reported) for prophylaxis.  It was reported that the dose of the product administered to the patient was stored improperly for the time frame of 30 minutes in the temperature of 31.2 Fahrenheit (F). There was no previous temperature excursion. Digital Data Logger was involved.  No other adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
ITCHING AND REDNESS AT INJECTION SITE. GAVE PATIENT BENADRYL AND PUT HYDROCORTISONE CREAM AT SITE AND MONITORED PATIENT FOR 30 MINUTES BEFORE SHE LEFT.
Vaccine was stored and administered beyond 30 days use by date; Vaccine was stored and administered beyond 30 days use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date) and PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date) and PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Deltoid was reported as anatomical location of vaccine administered.  It was reported that the vial was initially stored in the refrigerator on 27-May-2022. The vials did not undergo any temperature excursions. Patient did not have allergies to medications, food and other products. Patient had never been diagnosed with or tested positive for COVID-19. Patient did not have acute illnesses at the time of vaccination and up to one month before vaccine.  No treatment details was provided.