chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced flu-like symptoms that lasted 24 hours after her 1st dose of SHINGRIX about 6 months ago.
BODY PAIN; DIZZINESS; HEAD FOGNESS; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced body pain. On 22-MAR-2021, the subject experienced dizziness. On 22-MAR-2021, the subject experienced head fogness. On 22-MAR-2021, the subject experienced chills. On 22-MAR-2021, the subject experienced headache. On 22-MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride, and dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, body pain, dizziness, head fogness, and fever. This report was non-serious.
Went to bed on Sunday night; had a knot on hip and back - Hard to walk on hip; hard knot with burning pain. Saw a doctor at Urgent Care  and they sent me to chiropractic- that didn't do anything. I went to Pain Mgmt and they injected my Piriformis muscle with cortisone. I have some residual pain  on my right SI joint and my  hip though. But it's 97% better. I have been sleeping through the night ever since the injection. I am now going back to gym after 3 1/2 months.
Patient received monovalent  Moderna 0.5ml blue cap, purple label. Patient was intended to receive bivalent to Moderna 0.5ml blue cap gray label.
A non-serious spontaneous report of fever, vomiting and "felt pretty crummy" was received from a consumer/ mother concerning her 13-year-old son, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications was reported for this patient. On 17-Oct 2009, the patient received H1N1, Intranasal for an unknown indication. On 18-Oct 2009, the patient experienced fever of 101.8 degrees F, vomiting for one time and felt pretty crummy. On 20-Oct-2009, the patient was afebrile. The outcome of fever was resolved while the outcome of vomiting and "felt pretty crummy" was unknown.
upper anterior chest discomfort, internal poking/pressure sensation almost continuous, also has mild additional tightness across same area which is more intermittant, no SOB, cough, fever or palpitations, symptoms not affected by movement, breathing or exercise, injection given in left deltoid, injection site nontender, not red or swollen, has had mild nausea at bedtime but no vomiting or diarrhea, all symptoms gradually abating
Chronic frequent Cold sores started a month after my first Pfizer Covid 19 vaccine dose, and increasing in both frequency and severity following each of a total of three doses.  It was more than 8 years since my last cold aore outbreak before receiving the 1st Pfizer Covid19 vaccine dose.  Now they occur monthly without medication regardless of diet and other preventive measures.  More recently, I have been having Shingles symptoms that the  Valacyclovir has subdued.  I had a very mild occurrence of Shingles 6+ years ago so I know the symptoms. But never had it again until now.  And the tingling itchy pain continues to return monthly as does the outbreak of oral herpes cold sores on my lips.
Case number PHEH2014US008997 is an initial spontaneous report received from a health care professional on 01 May 2014. This report refers to patient of unknown age and gender. Past medical history and concomitant medications were not reported. On an unknown date the patient was vaccinated intramuscularly with only MenCYW-135, the liquid component of MENVEO (batch number: not reported) and did not receive Men A lyophilized conjugate. No adverse event was reported following this administration error.
Skin broken open; Purple; My lips are extremely swollen; This is a spontaneous report from a contactable consumer or other non HCP. A 56-years-old non-pregnant female patient received bnt162b2 (BNT162B2 formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 24May2021 17:30 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took codeine (MANUFACTURER UNKNOWN) for an unspecified indication and experienced drug hypersensitivity. The patient experienced, my lips are extremely swollen, skin broken open, purple on 24May2021 23:30, about 6 hours after receiving vaccine. Patient received no treatment for the event. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: nasal swab on Jan2021, Feb2021, Mar2021 for which results were negative. The clinical outcomes of extremely swollen lip, purple and skin broken were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
body aches; chills; severe headache/Extreme headache; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; extremely tired; not able to carry out daily activities; This is a spontaneous report from a contactable other health care professional. A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 11Jan2021 07:45 at SINGLE DOSE at left arm for COVID-19 immunization.  Medical history reported as none. The patient has no known allergies. The patient received first dose of COVID19 vaccine BNT162B2 on 24Dec2020 11:45PM at left arm. There were no concomitant medications. The patient stated, On 11Jan2021 16:00, "I'm having body aches, chills, severe headache/extreme headache and chest discomfort/chest pain. I understand that the body is trying to build an immune response and I understand that body aches and chills are part of that but I don't get headaches, ever, and I have never had chest discomfort or heaviness like this so how is that an immune response. I want you to tell me why I feel this way." It was also reported that the patient was extremely tired, and not able to carry out daily activities. The patient did not receive treatment for the events. The outcome of the events was not recovered. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.  Information about batch/lot number has been requested.
Syringe malfunctioned so some of the dose did not get injected; Syringe malfunctioned so some of the dose did not get injected; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Syringe malfunctioned so some of the dose did not get injected) and DEVICE CONNECTION ISSUE (Syringe malfunctioned so some of the dose did not get injected) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced UNDERDOSE (Syringe malfunctioned so some of the dose did not get injected) and DEVICE CONNECTION ISSUE (Syringe malfunctioned so some of the dose did not get injected). At the time of the report, UNDERDOSE (Syringe malfunctioned so some of the dose did not get injected) and DEVICE CONNECTION ISSUE (Syringe malfunctioned so some of the dose did not get injected) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  Treatment information was not provided.  After receiving 2nd dose patient didn't  have adverse reactions.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Follow up received on 08-APR-2021 included updated reporter information, patient information, vaccine information and AE information.
patient came to flu clinic requesting flu vaccine which was administered.  Later when entering information into the Immunization Registry staff found that patient previously recieved flu vaccine this season, Oct 2021.
severe inflammatory pain in my hands, wrists, forearms; debilitating nausea; muscle spasms in my right arm; extreme fatigue; IGG level is critically low; I am desperate i cannot work; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Avascular necrosis" (unspecified if ongoing). Concomitant medication(s) included: OXYCODONE. Vaccination history included: BNT162b2 (Dose 1, single, Lot number: EJ1686 , Administration time: 09:30 AM, Vaccine location: Left arm), administration date: 04Jan2021, for Covid-19 immunization, reaction(s): "Severe nausea", "headache", "sweating with chills", "sweating with chills", "chest pain", "injection site soreness", "shaking hands"; BNT162b2 (Dose 1, single, Lot number: EJ1686 , Administration time: 09:30 AM, Vaccine location: Left arm), administration date: 04Jan2021, when the patient was 50-year-old, for Covid-19 immunization, reaction(s): "sore throat". The following information was reported: IMPAIRED WORK ABILITY (non-serious) with onset 28Feb2021, outcome "not recovered", described as "I am desperate i cannot work"; BLOOD IMMUNOGLOBULIN G DECREASED (non-serious) with onset 28Feb2021, outcome "not recovered", described as "IGG level is critically low"; NAUSEA (non-serious) with onset 28Feb2021, outcome "not recovered", described as "debilitating nausea"; FATIGUE (non-serious) with onset 28Feb2021, outcome "not recovered", described as "extreme fatigue"; MUSCLE SPASMS (non-serious) with onset 28Feb2021, outcome "not recovered", described as "muscle spasms in my right arm"; INFLAMMATORY PAIN (non-serious) with onset 28Feb2021, outcome "not recovered", described as "severe inflammatory pain in my hands, wrists, forearms". The events "severe inflammatory pain in my hands, wrists, forearms", "debilitating nausea", "muscle spasms in my right arm", "extreme fatigue", "igg level is critically low" and "i am desperate i cannot work" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of inflammatory pain, nausea, muscle spasms, fatigue, blood immunoglobulin g decreased, impaired work ability.  Additional information: Patient had no COVID prior vaccination. Patient had no other vaccine in four weeks. Patient had no known allergies. Orthopaedist, Rheumatologist, Neurologist, Immunologist no one can account for patient's debilitating symptoms that started right after my 2nd vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient via interactive digital media. The patient stated that, he/she had shingles now (at the time of reporting). The reporter stated that, 14 months after 7 injections still no results, do not miss being vaccinated. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Pt noted to have 5x5cm area of induration, erythema, warmth and tenderness at site of DTaP #5/IPV #4 immunizations-24 hrs prior to rxn.
Fatigue; Sore arm; Body ache; Chills; Fever; No taste; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN (Body ache), CHILLS (Chills), PYREXIA (Fever) and AGEUSIA (No taste) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included METOPROLOL, ROSUVASTATIN CALCIUM (CRESTOR), SPIRONOLACTONE and GABAPENTIN for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN (Body ache), CHILLS (Chills), PYREXIA (Fever) and AGEUSIA (No taste). On an unknown date, the patient experienced FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), PAIN (Body ache), CHILLS (Chills), PYREXIA (Fever), AGEUSIA (No taste) and FATIGUE (Fatigue) outcome was unknown. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test positive: other.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medication include some non prescribed pain killers.
Started feeling "bad" with "knots and swelling" at injection sites in right shoulder. Had "chills and sweats" no "energy" or "appetite". Ran a fever from 101 to 103 over the next 48 hours.
24 hours after injection I felt fine except for sore arm. 6 hours later I undressed to take a shower and noticed a rash developing around my waist. About an hour later I was in bed and began to itch all over. I got up and had broken out in hives covering both arms and torso. My entire back from the waist to upper back was bright red. Never any problem breathing but took a Benadryl to see if it would help. When I got up at 6am this morning the rash and welts had largely disappeared. All redness gone but still some bumps. I am going to seek out information about what to do about the second dose I am supposed to take on March 6. What precautions should I take?
1st dose-sore arm/no treatment required 2nd dose-sore arm & approx. 16 hours later I awoke to shivering, profuse sweating & temp of 101.8/Advil reduced temp. Next 18 hours temp would respond to Advil & go down to 100.  This morning 02/25/2021, temp was 96.7 and now at bedtime is 99.8.  I've also experienced. Slight body and headaches.
right when the injection was given, patient c/o dizziness. RN attention was called. patient look pale, clammy. briefly loss consciousness, called 911. Vital signs taken, BP 93/59, HR 59, Sat 100% in room air.  repositioned patient, BP 94/64, hr is 57, 97% in room air.   paramedics came. patient transferred to gurney. A/Ox4. patient awake. feeling better. BP stable. EKG done by paramedics.  patient refused to go to ED for further eval. will monitor patient onsite
He was diagnosed with mycosis fungoides in 12/2021 and died in mid-2022 after unhelpful chemotherapy treatments.
Information has been received from a Registered Nurse referring to a 2 year old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 25-JUN-2015 the patient was vaccinated with a dose of improperly stored LIQUID PEDVAXHIB (route not reported, lot # reported as K026532, dose 0.5 (unit not provided). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
9/27/02: 7am-two spots with pruritis. 7pm-head to toe hives/pruritis. Benadryl 25mg with relief from pruritis only. 9/28/02: hives head to toe remain. 10am Benadryl 25mg-relieved pruritis only. 9pm increase in hives and pruritis-Benadryl 50mg and hives faded and prutitis relieved. 9/29/02 8am, Benadryl 25mg-hives and pruritis relieved. 8pm hives head to toe-Benadryl 25mg relieved itching only. 9/30/02 8:30 am hives worse head to toe and more of facial hives/pruritis. Mother called family practice and spoke with PA, instructed to give Benadryl 25-50mg q 4h relieved 50mg at 8:30am 25mg at 12:30pm 25mg at 4:30pm 50mg at 8:30 pm 10/1/02 awoke and symptom-free.
My daughter got high fever for 8 days. The highest temperature was 105.5. She was kind of unconscious in one of the morning. No crying, no movement.  We took her to both emergency room and urgent  care.
Achy muscles; Injection site rash; Fatigue; Injection site which was hot; Injection site which was itching; Knot at the injection site; A blue spot that resembles a bruise between her neck and her hairline/ large bruise; Stiff neck on the right side; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck on the right side), CONTUSION (A blue spot that resembles a bruise between her neck and her hairline/ large bruise), VACCINATION SITE WARMTH (Injection site which was hot), VACCINATION SITE PRURITUS (Injection site which was itching) and VACCINATION SITE INDURATION (Knot at the injection site) in a 63-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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced HEADACHE (Slight headache). On 04-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck on the right side). On 15-Mar-2021, the patient experienced CONTUSION (A blue spot that resembles a bruise between her neck and her hairline/ large bruise). On 17-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site which was hot), VACCINATION SITE PRURITUS (Injection site which was itching) and VACCINATION SITE INDURATION (Knot at the injection site). On an unknown date, the patient experienced MYALGIA (Achy muscles), VACCINATION SITE RASH (Injection site rash) and FATIGUE (Fatigue). On 06-Mar-2021, HEADACHE (Slight headache) had resolved. On 18-Mar-2021, VACCINATION SITE WARMTH (Injection site which was hot) and VACCINATION SITE PRURITUS (Injection site which was itching) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck on the right side), CONTUSION (A blue spot that resembles a bruise between her neck and her hairline/ large bruise), VACCINATION SITE INDURATION (Knot at the injection site), MYALGIA (Achy muscles), VACCINATION SITE RASH (Injection site rash) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information included biofreeze, some stuff in a tube for achy muscles and heatable neck pillow with a scent for neck.
After the first vaccine on 08/21/2014 I began having unusual pain in the area of my lower hips.  I felt like I could hardly walk some days.  This persisted through the next date of the vaccine and through today.  I was becoming unusually tired as well.  I had to ask my husband to help me comb my hair after I showered some evenings...totally out of character for my normally healthy, very strong body.  A horrible headache began on 09/26/2014 followed by an itchy, red rash between my thighs lasting two days.  On 10/03/2014 I woke up at 2:30am due to a horrible, sharp shooting pain in the left side of my neck and shoulder area.  Also a frigid cold was over my entire body.  I felt like I had died I was so cold.   I couldn't lift my left arm or move my neck without severe pain for three days.  I took a vicodin for the pain at 3pm 10/03/2014 and again at 12pm on 10/04/2014.  I was extremely fatigued and unusually upset.  On 10/06/2014 vision changes began.  First I noticed trouble focusing then double vision began on 10/06/2014.  Very scared I went to the emergency room on Wednesday, 10/08/2014.  Double vision lasted until 10/22/2014.  Deep muscle twitches, ringing in my ears,  eye pain, burning on my left palm, severe pressure in my head and neck pain are still symptoms.  On 11/16/2014 I had a sharp, shooting nerve type pain in my right knee which lasted for just 1 day, but required me to stay in bed because I could not walk without the severe pain.  It left as fast as it appeared with no reason or cause whatsoever.  The pressure in my head and trouble concentrating on everyday things are what scare me most.  I have sensitivity to both light and sound.  I feel like a definite central nervous system disruption is present and I cannot make it go away.  Tests have not revealed a definite problem, but I know I have a definite problem!  I cannot sleep at night and I am feeling extremely frustrated with how my body feels.  I am not the same as I was prior to the vaccine.  I've seen my internal medicine Dr., a Neurologist, an optha-neurologist, a rheumatologist.  Not one of them know what to do for my symptoms which I know are caused from the Twinrix vaccine I received.