chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient received first dose of vaccine with her mother.  Prior to administration, patient mentioned she was anxious receiving shots having a history of fainting. Immediately after administration, patient stated that she was relieved. About 2 minutes later, patient's mother called for the pharmacist for help claiming patient was having convulsions and was unconscious. Paramedics were called. Patient regained consciousness after 20 secs with nausea & no recollection of loss of consciousness.
On 7/5 I developed 2 bright red rashes about the size of a nickel under my left arm on the anterior breast tissue. This was followed by sharp pains in the area under my left breast where my bra band would ride. There was also a pink rash that extended around on the left side of my back. On 7/6 I was able to see my doctor who was not sure what it might be.  He treated me with shots of Rocephin and Depo-Medrol.  The next day I was in excruciating pain involving the side of my left breast and around to my back.  I called my doctor's office on 7/9 for something for pain and his NP ordered a Medrol 4mg pack. Advil did also provide some relief from the pain.  The pain in my side and back eventually lessened but continued
Employee received the vaccination and the same afternoon arm began hurting, was sore. Around 8-9pm employee had chills, massive headache that triggered a migraine, nausea, unable to sleep, and fever. Patient called into to work, the next day fever broke and 2 days later migraine remains. Employee has appointments with Physician and Neurologist in regards to migraine.
Scratched left arm over vaccination site. Next day, swollen on waking; no fever or pain. In the evening, mid third lower arm, swollen, indurated, warm. Ten superficial abrasions (scratches). No fever. Resolved with Bacitracin, Motrin.
I caught Covid about 2 week after taking the vaccine and then developed internal bleeding in my eye on 9/7/2022 and then had rashes over my face and body on 10/31/2022.
Patient received 2 doses of flu vaccine--one on 10/18/2022 and one on 12/27/2022--no ADRs were reported as a result of this error
Information has been received from a physician concerning a 62 year old female with pulmonary nodules shown in a CT scan in June 2009 and that were improved over previous test, another CT scan on 30-NOV-2009 and a history of lymphoma diagnosed in 2006 that caused bone pain and was treated with radiation and is in remission who on 05-OCT-2009 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included influenza virus vaccine (unspecified). Physician reported that the patient received ZOSTAVAX (Merck) and influenza virus vaccine (unspecified) on 05-OCT-2009 and currently had symptoms of arthritis. She developed chills, myalgias and bone pain about 1 week after vaccines, in approximately 12-OCT-2009. On 19-OCT-2009, she developed increased mucous production in her sputum and in late October 2009, she experienced right knee pain and shortness of breath. An X-ray bone survey was negative on an unspecified date. By November 2009, her right knee was more painful and now she has shoulder arthralgias. Her fingers and thumbs were okay but wrists began to hurt. On 15-DEC-2009, the patient had blood tests: serum antinuclear antibodies test was negative, Rheumatoid arthritis Latex was 15.6 and considered abnormal (normal up to 13.9) and erythrocyte sedimentation rate was 38. On 05-JAN-2010, she had her right knee drained. The white cell count in the knee's synovial fluid was 6125, lymphocytes 71%, macrophage 22%, and polys 3%, crystal analysis was negative. This date, blood work was repeated. A serum antinuclear antibody test was negative, rheumatoid arthritis was 13.7 (barely in normal limit), sedimentation rate 91, and serum C-reactive protein test was 26.3 (normal up to 4.9). Complete blood cell count was normal except whole blood hematocrit was low. A serum Borrelia burgdorferi IgM Western blot antibody test was positive for P41 and P23 but serum Borrelia burgdorferi IgG Western blot antibody test was negative. Physician believes the Lyme test to be a false positive. At the time of reporting the patient had not recovered. The reporter felt that symptoms of arthritis, chills, myalgias, bone pain, right knee pain, shoulder arthralgias/wrist began to hurt, increased mucus production in her sputum and shortness of breath were considered to be disabling. Additional information has been requested.
We got an rx from dr for prednisone and ventolin, on the prednisone rx dr wrote a message that says dear pharmacist, pt developed dyspnea after receiving flu shot. When I spoke to patient she explained that her or the doctor are not sure if the shot really made the patient short of breath, but she started being short of breath the next day after the shot.
Headache, nausea within 15 minutes... was observed for 1 hour....also it is important to note that substantial less amount of caffeine on this day... possible withdrawls  After leaving observation and exiting building... noticed light sensitivity while driving home.  Eye pain that evening and next day... prickly pain like when you are over tired.
Patient reports tingling to left arm where she received her vaccination and numbness. No lightheadedness or dizziness. Cleared by EMS
Pt was adopted at about 7 m/o from a foreign country. Her shot records weren't available to us. With consultation, the recommendations was to immune the child assuming none was previous given. Family actually initiated the consultation on their own and was in agreement with the immunizations as recommended by the AAP/CDC. Other than mild motor delay, she was thriving. On 14 day her 1st y/o WCC, she was behind on immunization and she rec'd 6 shots as listed. In early AM of 10/2, she preceded to have seizure. Her sz episode was GTC in nature and estimated to be between 10-15 min. Over the next 24 hrs, she had recurrent sz. Temp of 103 was documented by EMT at the scene (at home). She was initiated stabilized at a local community hospital where a LP was performed, as was head CT. She was then transferred to another hospital, where she was evaluated by Peds Neuro who dx her w/ complex febrile sz. She had had regular outpt f/u's w/ Peds Neuro and no AED was recommended. Pt clinically continues to do very well. Adoptive parents subsequently brought in immunization record which revealed that she had rec'd the following back at home (Please see copy submitted by adoptive mom). Family requested that a report be filed via VAERS.  5/7/09-records submitted with VAERS report. 2/3/09-seen in office for follow-up visit for seizures associated with fever. Complex febrile seizure. URI with elevated temperature. First seizure generalized tonic-clinic in nature with temperature 103, followed by another seizure.
itchiness in right arm; swelling in right arm; redness in right arm; some pain bottom side of arm under injection site; queasy stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (queasy stomach), VACCINATION SITE PRURITUS (itchiness in right arm), VACCINATION SITE SWELLING (swelling in right arm), VACCINATION SITE ERYTHEMA (redness in right arm) and VACCINATION SITE PAIN (some pain bottom side of arm under injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (queasy stomach). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchiness in right arm), VACCINATION SITE SWELLING (swelling in right arm), VACCINATION SITE ERYTHEMA (redness in right arm) and VACCINATION SITE PAIN (some pain bottom side of arm under injection site). At the time of the report, ABDOMINAL DISCOMFORT (queasy stomach), VACCINATION SITE PRURITUS (itchiness in right arm), VACCINATION SITE SWELLING (swelling in right arm), VACCINATION SITE ERYTHEMA (redness in right arm) and VACCINATION SITE PAIN (some pain bottom side of arm under injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant product usage were not reported by the reporter. No treatment details were added.
SM developed erythematous, pruritic lesions at site of primary SPV inoculation approximately 6 weeks post vaccination.  Symptoms: Dermatitis, focal.  Evaluated by dermatology and felt that it was related to vaccine.  Treated with DESONIDE.  2/3/09 Received VHC medical records of 1/22/09. FINAL DX: post vaccine dermatosis of unknown etiology following vaccination w/primary SPV Records reveal patient experienced normal site reaction & scab falling off after approx 30 days.  Then developed erythematous pruritic bump at innoculation site within 2 weeks after scab fall off.  Bump got larger & patient self treated w/topical antibiotic cream after approx 1 week w/improvement.  Stopped treatment & bump enlarged.  Tried using steroid cream until 1/2009 when developed into pimple.  Saw MD for deployment clearance.  Dermatology consult done & tx w/desonide cream.
Brief period of raised heartbeat and accompanying trouble breathing. I believe these side-effects were pretty mild from my perspective and only lasted about 1-2 minutes if memory serves me. Wanted to report due to notifications of more pronounced side effects on second dose, if I proceed with that.   I was only advised to report to see what advice I would receive.
Patient described redness (1 to 1 1/2 inch area) at injection site of right arm, soreness and tender/warm to the touch.  She was worried that the site may be infected as the redness was expanding in area. Patient reported events about 48 hours after injection.  Patient was advised to monitor for 1 more day and if not improved she could go and see her physician.  She was told typical side effects would last 24 to 48 hours.
10/15/07 cellulitis of (R) thigh; erythema-bright red warm to touch treated with Keflex 250 2 tsp po bid x 10 d
Same day as injection: 4:30 PM:  scratchy throat. Stomach Ache Eyes Swollen *One could barely open. High Heart Rate (95) High Blood Pressure (135/90) Chest broken out in welts Sore throat Face Swollen & puffy Diarrhea  Couldn?t sleep Sore Arm Tired Body felt like freezing at 74 degrees in room.  2 hour after the shot you felt fluid in your throat/nose. *Like congestion.  Next day unable to eat up until present day.
Admitted from facility 77-year-old history of pulmonary embolism on  chronic anticoagulation with Eliquis. Had a fall today unclear whether mechanical  versus syncope patient does not remember event in the ER work-up negative with  a CAT scan of the head complained of hip pain found to have a left hip fracture.  Hospital service called for inpatient admission for further management of syncope  and left hip fracture. Pain is relatively well controlled this point no fevers no  chills no diarrhea she is resting in bed comfortably at this point no nausea  vomiting. Ortho disagrees with original xray read, feel it's more consistent with a  greater trochanter fracture which is nonoperative and recommend NWB to that LE  for probably 2 weeks and reassess with repeat x-rays for possible progression of  weight bearing. Brain MRI shows No acute intracranial findings. Mild to  moderate chronic microvascular changes. Diffuse cerebral volume loss most  pronounced in the medial superior frontal lobes. Paranasal sinus mucosal  thickening, as above. Echo shows EF 55-600 0, RV pressure overload, mod TR,  severe Pulm HTN, DD 1. Patients oxygen requirement went up to 8 L,COVID  tested and is positive. Patient started on remdesivir and dexamethasone. Of note  the patient tested positive for COVID-19 3 weeks ago and reports being  quarantined for 14 days in the nursing home, was asymptomatic and no change in  her normal 3 L oxygen she wears normally at home. Given her change in oxygen  requirement will continue treatment. Chest x-ray shows Diffuse, bilateral,  peripheral interstitial lung disease, most likely idiopathic pulmonary fibrosis. No  interval change dating back to 8/10/2021. No pleural effusions. Normal heart size.  Osteoporosis again noted. Patient normally wears 3 L oxygen for it history of  interstitial lung disease now requiring 8 L discharge to SNF
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: NEUROMYELITIS OPTICA SPECTRUM DISORDER (medically significant), outcome "unknown", described as "neuromyelitis optica". Additional information: a woman suspects she has developed neuromyelitis optica as an adverse effect of the Pfizer booster. She developed the symptoms less than a month after vaccination, and has no underlying health conditions, NMO (neuromyelitis optica) usually needs to be preceded by infection, the vaccination was the only major event preceding her symptoms. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On 8/19/21 awakened with a very sore upper arm, skin was warm to touch. As the day progressed upper arm became red and swollen. At 6pm on 8/19 went to Express Care and was examined by a APRN,CNP.  She recommended I apply warm compresses, take, Ibuprofen and report this as an adverse effect.
This spontaneous report was received from a certified medical assistant and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies were reported. On an unknown dates, the patients might have been vaccinated with improperly stored doses of ROTATEQ oral liquid (dose, lot # and expiry date were not specified). The administered doses of ROTATEQ underwent a temperature excursion at 30 Fahrenheit degrees for 14 days. There were no previous temperature excursions reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several cases received from the same reporter. Additional information has been requested.
Strong Metallic Taste in Mouth lasting about 2 days with a painful sore throat
Information has been received from a nurse practitioner concerning an unspecified number of patients who were vaccinated with a dose of GARDASIL (route, site of administration and batch number not reported). The patient have had pain from GARDASIL. The outcome is unknown. This is one of several reports from the same source.
I was given the High dose Flu shot in my left arm. Five-six days later I started feeling a little sluggish. About 5 days after that I had the flu for 2 1/2 weeks! Finally! My left arm quite hurting on 11-7-16.
Initial information received on 13-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse by phone. This case is linked to cases 2019SA071898, 2019SA073917 and 2019SA073919 (same reporter). This case involves a 76 years old male patient who experienced itching at the injection site, while he was accidentally vaccinated with 0.1 ml dose of FLUZONE (batch number: UI998AD and expiry date: 30-Jun-2019) via intradermal route in left forearm, instead of TUBERSOL on 13-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unspecified date, the patient developed a non-serious itching at the injection site, following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. It was also a case of actual medication error due to wrong vaccine administered. No lab data was reported. Final diagnosis was itching at the injection site. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Throwing up, headaches, the runs, real weak, stuffy head, sneezing, runny nose, achy body.
Tinnitus began fifteen minutes after the 1st dose and has been constant ever since. Over the next week there was an increase in pain and itching in the ear canal. Over the next three months there was an increase in pressure in the middle ear and difficulty in ear equalization. Also, I had headaches in the back of the head and head rushes whenever I bent over or was bearing down. These side effects peaked around the fourth month and have been decreasing ever since. I did not take the 2nd dose.
Information has been received through the Merck pregnancy registry from a health professional concerning her 16 year old daughter who on 16-FEB-2007 was vaccinated with a dose of Gardasil (lot #655618/0186U). There was no concomitant medication. Subsequently, the patient became pregnant (date of conception was reported as 14-FEB-2007). The patient had a pregnancy test with positive results on 20-MAR-2007. it was reported that the patient experienced headache, nausea and may also have had a slight fever. Additional information has been requested. 07/08/2008 Initial and follow-up information has been received through the Merck pregnancy registry for GARDASIL from a health professional concerning her 16 year old daughter who on 16-FEB-2007 was vaccinated with a dose of GARDASIL (lot 655618/0186U). There was no concomitant medication. Subsequently, the patient became pregnant (date of conception was reported as 14-FEB-2007). The patient had a pregnancy test with positive results on 20-MAR-2007. It was reported that the patient experienced headache, nausea and may also have had a slight fever. Additional information is not expected. The patient was lost to follow-up.
Miscarriage on March 30 following the vaccine. Was only approximately 5.5 weeks pregnant
It wasn't related to the vaccination. I had a UTI (cause unknown). I felt strange in my lower left abdomen & had to urinate frequently in short bursts. I only answered that I saw a doctor and required medical attention because you asked. I am on antibiotics & the issue has resolved since then.
Swelling 1-3 days, fatigued all week with interspersed bouts of lots of energy (that could just be me); sore all over ( L arm / L neck / back - but again that could just be me and caused by carrying around a toddler); the injection site was sore last night, a little itchy this morning (3/5) and now I have a red bumpy rash (possibly in part from scratching).   Also, bouts of diarrhea  all week (not too unusually, hence possible dairy allergy referenced above).
SMALL RED BUMPS/ HIVES ON BOTH ARMS; ITCHY RASH ON BOTH ARMS AND ITCHY RASH ON ANKLE; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies and has not been exposed to new chemicals or foods prior to the occurrence. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 20-MAR-2021, the subject experienced itchy rash on both arms and itchy rash on ankle. On 21-MAR-2021, the subject experienced small red bumps/ hives on both arms. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itchy rash on both arms and itchy rash on ankle and small red bumps/ hives on both arms was not reported. This report was non-serious.
After hep b vaccine I had many low incidence side effects. I did not have an allergic reaction. Ever since the shot I have had physical fatigue, low exercise tolerance. I recently have been diagnosed with low cortisol levels. These recent symptoms are the same as I have had all along, but got more severe. I am wondering if there have been others at with cortisol issues after a hep b vaccine. I am not looking for blame, just trying to find ways to feel better.
Breakthrough case admission after 3 vaccines  Moderna 2/18/21 Lot# 031L20A;  Moderna 3/18/21 Lot# 040A21A;  Moderna 1/5/22 Lot# 028K21A
Arms soreness, hurts to raise arm up; Hurts to raise right arm up; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In NOV-2022, the patient received the 1st dose of Shingles vaccine (right arm). On an unknown date, immediately after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arms soreness, hurts to raise arm up) and mobility decreased (Verbatim: Hurts to raise right arm up). The patient was treated with ibuprofen and non-drug therapy (Ice Pack (No Medication)). The outcome of the pain in arm was resolving and the outcome of the mobility decreased was not reported.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and mobility decreased to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR067434   Additional Information: GSK Receipt Date: 04-APR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and still experience soreness arm. The patient stated that it was hurts to raise his or her right arm up to brush his or her hair or drive a car. The patient reported that the arm was sore as soon as the vaccine was administered. The patient received ibuprofen and held ice pack on arm as a treatment and it relieved some of soreness but not completely. Follow-up would not possible as no contact details were available. This case had been linked with US2023AMR067434 by same reporter for same patient.; Sender's Comments:  US-GSK-US2023AMR067434:Same reporter
Rapid heartbeat and arrythmia  lasted about 18 hours.  Lightheaded also
Immediate pain at injection site. Patient reports injection was given high in the shoulder. It is tender and sore. Loss of motion.