chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. During 2015, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 23-MAY-2016, she was treated at a treatment center (medical clinic) (by an unspecified health care professional) for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.   Additional information has been requested.
LITTLE SORE ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 2021, the subject experienced little sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little sore arm was not reported. This report was non-serious.
Woke up the following morning at 4:30 am w/ headache, hot flashes, and burning stomach. Woke up again at 7:00 and still had a headache and burning stomach, and a low-grade fever had developed (99.2 degrees). Stomach got better throughout the day as I ate, but headache and fever are still present that night. I have also started developing cold flashes.
MMR given 4/14/17. Onset 4/16/17 PM of rash on back, eye lids (white center with red around it). Itching. Low grade fever (100 degrees), nausea and fatigue. Employee Health notified of symptoms 4/19/17. Referred to PCP who felt this was a vaccine reaction.
Patient was administered the smallpox vaccine on 24Jan2020. On his 7 day smallpox check, patient had a whitish blister at the site. Patient went to the ER on 03Feb2020 for a possible allergic reaction (generalized rash). He was given steroids and an antihistamine and seen at the clinic today, 04Feb2020.
Covid Arm: hypersensitivity red rash with swelling 2" by 2", headaches and severe fatigue.
In May I started noticing thinning of my hair at the front. It has progressed and in July I received a diagnosis of FFA, frontal fibrosing alopecia. I received steroid injections in my scalp, and take prescription doxycycline daily as well as use clobetasol Drops on the scalp twice a day. I have follow-up appointments with the dermatologist and am still losing hair.
Arm hurting around injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and VACCINATION SITE PAIN (Arm hurting around injection site) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C2ZX and 037C21A) for COVID-19 vaccination.     Concurrent medical conditions included Depression. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Depression.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache). On 18-Jun-2021, the patient experienced VACCINATION SITE PAIN (Arm hurting around injection site). At the time of the report, HEADACHE (Headache) and VACCINATION SITE PAIN (Arm hurting around injection site) outcome was unknown.            No treatment drugs were reported.   This case was linked to MOD-2021-229301 (Patient Link).
t101-102, chills, photophobia persistant, severe h/a & vomiting; admit 7OCT95-Tigan supp, MS IV, Compazine, IV fluids, Toradol, Xanax, Flexeril, APAP, Phenergan, Pred
Tiredness; muscle aches; chills; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Dec2021 13:45 (Lot number: FH8027) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CLARITIN; VITAMIN C; VITAMIN B12. Vaccination history included: Bnt162b2 (Dose 2, Lot No: EL3247, Route of Administration: Intramuscular), administration date: 11Feb2021, when the patient was 49 years old, for COVID-19 Immunization; Bnt162b2 (Dose 1, Lot No: EL3247, Route of Administration: Intramuscular), administration date: 21Jan2021, when the patient was 49 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 13:45, outcome "unknown", described as "Booster"; FATIGUE (non-serious) with onset 02Dec2021, outcome "recovered" (Dec2021), described as "Tiredness"; MYALGIA (non-serious) with onset 02Dec2021, outcome "recovered" (Dec2021), described as "muscle aches"; CHILLS (non-serious) with onset 02Dec2021, outcome "recovered" (Dec2021), described as "chills". Therapeutic measures were not taken as a result of fatigue, myalgia, chills.  Additional information: The patient did not receive other vaccine in four weeks. The patient did not have covid prior vaccination. The patient did not get covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Blotchy rash appeared on arm within an hour of injection, BENADRYL/antihistamine and TYLENOL given immediately. It took about 2 days for it to away completely.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing). Concomitant medication(s) included: FLUTICASONE PROPIONATE, start date: Jun2022, stop date: 21Jun2022; SALMETEROL, start date: Jun2022, stop date: 21Jun2022. Past drug history included: Codeine, reaction(s): "Known allergies: codeine"; Oxycontin, reaction(s): "Known allergies: oxycontin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Negative, notes: a rebound case of Covid 2 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: The patient received Paxlovid from 21Jun2022 to 26Jun2022 for the treatment of COVID-19. Patient had first severe metallic taste in back of mouth when as soon as she took dose of Paxlovid. A rebound case of Covid 2 days after testing negative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a nurse refers to a 70 years old female patient. On 17-AUG-2012, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (lot: not reported). The nurse stated from physician's office that the patient was using ZOSTAVAX and on an unspecified date experienced cellulitis (also reported as cellulites) to the right arm. The patent was put on treatment KEFLEX. The patient sought medical attention office visit. At the time of the report, the outcome of cellulitis to the right arm was unknown. Additional information has been requested.
She developed a rash on both of her legs/thighs about the third week. Her eczema also flared significantly. She had eczema flaring in her right arm, all over her neck, lower part of her face cheeks.
Enlarged lymph nodes in left axillary area still present 3 months post vaccine injection.
bad reaction after both doses; Heart was raced; arm was pain; head was pain; felt like all her inside organs were painful; Could not use the arm; Pain and sore in the muscle; two legs had pain and sore; had like period cramps; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction after both doses), HEART RATE INCREASED (Heart was raced), PAIN IN EXTREMITY (arm was pain), HEADACHE (head was pain) and PAIN (felt like all her inside organs were painful) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. 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 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (bad reaction after both doses), HEART RATE INCREASED (Heart was raced), PAIN IN EXTREMITY (arm was pain), HEADACHE (head was pain), PAIN (felt like all her inside organs were painful), MOBILITY DECREASED (Could not use the arm), MYALGIA (Pain and sore in the muscle), PAIN IN EXTREMITY (two legs had pain and sore) and MUSCLE SPASMS (had like period cramps). At the time of the report, VACCINATION COMPLICATION (bad reaction after both doses), HEART RATE INCREASED (Heart was raced), PAIN IN EXTREMITY (arm was pain), HEADACHE (head was pain), PAIN (felt like all her inside organs were painful), MOBILITY DECREASED (Could not use the arm), MYALGIA (Pain and sore in the muscle), PAIN IN EXTREMITY (two legs had pain and sore) and MUSCLE SPASMS (had like period cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment medications were provided   This case was linked to MOD-2021-326867 (Patient Link).
My right arm is weak; it's spreading through my entire upper arm, my neck and my other arm; My right arm is painful with limited mobility; My right arm is painful with limited mobility; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number and expiry date not reported), via an unspecified route of administration, in Mar2021 as dose 1, single; then second dose of BNT162B2 (Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration, in Apr2021 dose 2, single, both for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient had COVID shots in Mar2021 and Apr2021. The patient experienced right arm weak and right arm was painful with limited mobility on an unspecified date in 2021. It was reported that the patient need help. The patient was in so much pain, and it was spreading through entire upper arm, neck and other arm. The patient was seeking help and reported that the doctors couldn't help the patient. The outcome for the events was not recovered.  Information on lot/batch number has been requested.
Patient received Fluad and Prevnar 20 at the pharmacy on 8/1/2022. Patient called pharmacy on 10/5/22 stating that some time after administration (about 2-3 weeks after) she experienced the following: numbness, tingling in feet, dropping things, tipping over own feet, losing ability to walk, no control of bladder/bowel. She ended up getting hospitalized and diagnosed with Guillain-Barre Syndrome and the hospital ran tests and concluded that the GBS was from the flu and prevnar vaccines. Patient is currently still in the hospital; also mentioned getting physical therapy to help with walking.
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and gender. It was reported that on an unknown date an unknown number of patients were vaccinated with GARDASIL (information captured in MARRS # 1305USA010598) or VAQTA (dose, route, lot number and expiration date not reported) for prophylaxis. Medical assistant reported that the vaccine was stored lower than -1C (Celsius degrees) from July 2012 until the present. No adverse effect was reported. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 09-FEB-2015, the patient was inoculated (by an unspecified person) with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) at a pharmacy for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, she was treated (by an unspecified healthcare professional) at a clinic for a blistering vesicular outbreak which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Pt's husband reported pt was well until apparent stroke 8NOV91 @ 12noon; pt then died 9NOV91 @ 235AM; no autopsy was done; Cause of death listed as possible aneurysm;
Within 24 hours had fever 102.9 for 48 hours, headach, chills, swollen and painful lymph node left arm pit side of injection site pain rain down arm and extreme fatigue. Symptoms cleared about 72 hours.  Then - adverse event- roof of mouth has blisters and gums are swollen and feel raw and sore.  I have not had this happen with any other shot.
On 1/22/2009 my daughter received the Gardasil shot. She felt dizzy and had clouded vision that went away after a while. On 3/24/2009 she received her second shot and she almost passed out and had tunnel vision the rest of the day. The nurse praticioner said this was normal. I called the health department the next day and they said NO THIS IS NOT NORMAL. Since then my daughter has had only 3 periods in the past 4 years and has been sickly with respiratory infections, pneumonia, bronchitis, sinus infections, headaches and stomach problems. She has missed a lot of school due to this. she is on allergy medicine weekly allergy shots, headache and stomach medicine.
I experienced shivering, became very cold and dizzy. I took a Tylenol and Benadryl but it didn't work. I woke up in a pool of sweat and went to work; then, I noticed that my neck started to turn red that was a welt that was raised and swollen. At dinner time, I went to Urgent Care at 7:00PM and I was told to get some Zyrtec but it didn't work (noticed while taking a bath that it traveled to my groin area/down my legs)  and I called them again...was told to keep taking the Zyrtec and it finally went away after a week. I have noticed that my core body temperature has changed (keeps me cold and it takes a lot to get me warmed up).
1st COVID vaccine received on 1/8/21; 2nd COVID vaccine received on 2/12/21. About a week later she developed neck pain and tenderness, which resolved by the time she saw her PCP on 2/22/21; neck ultrasound was ordered and done on 3/3/21, showing left internal jugular and left innominate vein thrombosis. She was started on apixaban.
Patient had a Seizures Without Status Epilepticus after the vaccine. Onsite EMS was called vitals were taken BP 164/100  BG 154 HR 93. Patient Treated and Transported by the EMS to the hospital.
Moderna Vaccines 1/14/21 and 2/4/21.  Unclear what LOT or site of admin Hospitalized 12/16/21
swollen lymph node under the shot arm; feel pain and weakness in her hands/pain has now spread to her feet; feel pain and weakness in her hands; inability to drive her car as she was unable to grasp the steering wheel; pain has now spread to her knees and feet; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 38 year-old female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), administration date: May2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered" (2021), described as "swollen lymph node under the shot arm"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "feel pain and weakness in her hands/pain has now spread to her feet"; MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "unknown", described as "feel pain and weakness in her hands"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "inability to drive her car as she was unable to grasp the steering wheel"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "pain has now spread to her knees and feet". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, pain in extremity, muscular weakness, loss of personal independence in daily activities, arthralgia.  Additional information: The reporter mentioned that the patient (her daughter) age 38 and in previously good health before receiving vaccine. Twenty-four hours after receiving the second dose she reported a swollen lymph node under the shot arm. Five days later she began to feel pain and weakness in her hands. The swollen lymph node returned to normal shortly thereafter. Her daughter's pain and weakness in her hands has slowly increased over the days and months. Today she reported an inability to drive her car as she was unable to grasp the steering wheel. The pain had now spread to her knees and feet. She was currently under the care at a rheumatologist. Her blood work had all been negative or insignificant for Rheumatoid Factor, Lyme Disease, Parvo, Celieac Panel, Serum protein electrophoresis, CRP, ESR, ANA, etc. He had her on a regimen of steroids and hydroxychloroquine. The patient's pain level, especially in the morning, was nearing a nine out of ten. She had never had COVID. Reporter queried if there was any treatment for resulted events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt c/ left arm swelling and redness, hot to touch that developed around 24 hrs after receiving vaccine.  Pt given  Benadryl in office then started on Cephalexin. Pt in office for f/u on 8/9 greatly improved.
I was 30 weeks 4 days pregnant, due February 11, 2022. The morning after getting the vaccine I developed clogged sinuses and a really bad cough that does not want to go away. I have been self treating with cough drops and I have not called the doctors office yet to inform them due to not feeling good.
Reported Fever 103F, fatigue, chills, sweats, and muscle aches.
Normal side effects of chils, achiness, nausea and arm pain.  Nine days later a hard red lump appeared on arm where vaccine was given.
Painful localized small rash not at injection site. Over the course of 2 weeks the rash grew slightly larger and scabbed over. At 2 weeks pain level greatly reduced and scabbing almost gone
This bivalent covid 19 vaccine was given after the FDA ended the EUA on 9/11/2023. Our clinic was not notified of the FDA ending the EUA until 9/13/2023. The vaccine was discarded upon receiving the email notification of the EUA ending.
Immediately after receiving the vaccine and around 48 hours after, I experienced dizziness/nausea, headache and severe injection site pain; Immediately after receiving the vaccine and around 48 hours after, I experienced dizziness/nausea, headache and severe injection site pain; Immediately after receiving the vaccine and around 48 hours after, I experienced dizziness/nausea, headache and severe injection site pain; Immediately after receiving the vaccine and around 48 hours after, I experienced dizziness/nausea, headache and severe injection site pain; This is a spontaneous report from a contactable nurse (patient herself).  This 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK5730), via intramuscular, on 23Dec2020 at single dose for COVID-19 immunisation.  Vaccine location was left arm. The patient was not pregnant. Relevant medical history included diabetes and hypertension. No known allergies. Relevant concomitant medications included metformin and losartan. The patient was vaccinated at hospital, age at vaccination was 62-year-old. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. Immediately after receiving the vaccine and around 48 hours after, she experienced dizziness/nausea, headache and severe injection site pain. No therapeutic measures were taken as result of the events. The patient had recovered from the events in Dec2020.
Shortly after receiving the flu shot while patient was in observation area, patient fell to floor. He was having tonic clonic movement while falling prone and hit head during the fall. EMT's were called. He was placed on his side. Approx 3 seconds he returned to consciousness. BP 100/60, P 60, T 98.9. Redness noted to forehead and c/o discomfort, ice was applied. Patient was aware of place, name and receiving the vaccine. Approx 6:15pm EMT arrived to assess, BP 112/64, P 88, PO2 99%. EMT's stayed with patient until 6:45 and parents took him to Hospital. Hospital stated patient was negative for concussion, they did orthostatic VS, EKG and neuro checks, all normal. He was sent home with parents.
4 days after shot, site inflamed and very itchy. Recommended BENADRYL and have the Dr look at it. Dr felt it was due to her having shingles several times before.