chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (report the side effect/annoying side effect), URTICARIA (I am started getting Hives throughout the body), BURNING SENSATION (It started with the itching and burning sensation), PRURITUS (started with the itching and burning sensation) and ERYTHEMA (later turned to Red skins bumps) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (report the side effect/annoying side effect), URTICARIA (I am started getting Hives throughout the body), BURNING SENSATION (It started with the itching and burning sensation), PRURITUS (started with the itching and burning sensation) and ERYTHEMA (later turned to Red skins bumps). At the time of the report, VACCINATION COMPLICATION (report the side effect/annoying side effect), URTICARIA (I am started getting Hives throughout the body), BURNING SENSATION (It started with the itching and burning sensation), PRURITUS (started with the itching and burning sensation) and ERYTHEMA (later turned to Red skins bumps) had not resolved. No concomitant medication were reported. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2022: Non-significant follow-up. On 24-Jan-2022: Significant follow-up: Added events of Hives, itching, Burning sensation and Red skin.
I had a high fever - for me a high fever is above 98.4 or 98.6. I was running a fever of 99.1-100.2 for three days. I didn't take anything for awhile for it. Thursday morning, on the first, my arm - at the injection site - was swollen to size of nickel. Over the next few days it grew to a size of a paper dollar bill - red, hot and swollen and very itchy. Saturday - 4/3/2021 - I went to a pharmacy where I get my meds and the pharmacist suggested I take anti-inflammatories and Benadryl. I did put ice pack on before taking those. I do still have a lump on my arm at the injection site - it's probably the size of a quarter now.
Swelling, redness, warm around the shot site. Width 7 1/2cm 5 1/2cm of right arm area.
Two days after my first dose (03/05/2021), I was taking a nap on the sofa, and when I got up my husband said he thought I had a stroke because the left side of my face was drooping, my left eye would not close, I could not  manipulate my mouth. We immediately went to a local Hospital. In the ER they immediately called a stroke because of how I looked. One of the Physician Assistants said that it looked like herpes. They proceeded with the stroke call as that was most the severe outcome. A CT scan showed no stroke damage, so Bells palsy was the next logical thought.
Customer fainted after his 1st Moderna covid-19 vaccine. He felt dizzy then fainted on the floor. There was no head injury. We called paramedic and they came checked his BP and asked him to sit on the chair and relax for 30  minutes. He was not admitted to hospital. He finished his 30 minutes observation period then went home. Before leaving pharmacy,  He mentioned that he faint  when having blood drawn at doctor's office. Unfortunately he did not tell us this before the vaccine and he selected NO on the Var question that asks about reaction after receiving a vaccination including fainting or feeling dizzy.
Patient presented to the ER with severe arm swelling and redness. Patient received  a prescription for an eight day course of prednisone and sent home.
Tingling feeling in hands and feet that started 3 months after vaccine was administered.  Tingling has subsided in feet after 2nd week. I now only have slight numbness in both my thumbs.
Systemic: Fainting / Unresponsive-Severe, Additional Details: After vaccine patient was sitting and she passed out.  Her mom was right next to her and caught her. She came to get us and the technician (who is also a nurse) and I went out.  We called 911. She was clammy and pulse was thready. We layed her on the floor and within a few minutes she came to. Patient and Mom went in ambulance together.
slept almost all day; feeling very weak in their arms and legs; not feeling well; arm was heavy; This spontaneous case was reported by a physician and describes the occurrence of HYPERSOMNIA (slept almost all day), MUSCULAR WEAKNESS (feeling very weak in their arms and legs), MALAISE (not feeling well) and LIMB DISCOMFORT (arm was heavy) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease. Concomitant products included MERCAPTOPURINE, VITAMIN C [ASCORBIC ACID] and TURMERIC [CURCUMA LONGA RHIZOME] for an unknown indication.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced LIMB DISCOMFORT (arm was heavy). On 09-Feb-2021, the patient experienced HYPERSOMNIA (slept almost all day), MUSCULAR WEAKNESS (feeling very weak in their arms and legs) and MALAISE (not feeling well). At the time of the report, HYPERSOMNIA (slept almost all day), MUSCULAR WEAKNESS (feeling very weak in their arms and legs), MALAISE (not feeling well) and LIMB DISCOMFORT (arm was heavy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a 18-year-old female. Neither the patient's past medical history nor any concomitant medications were reported. The product expired on 15-Dec-2010. The patient received the expired FLUMIST on 21-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
After vaccination - I was noticing eczema flare up - but not bad; and then 27th,  I got blisters on left cheek likes pins and needles poking my face; next day the blisters popped and created crater on my skin and area was getting bigger and it was oozing and I felt that stinging poking on that affected area. Next day after that,  I went to my dermatologist for a consultation and he said it was Herpes Simplex. Along with that, 2 days after the blisters started appearing on my face, before I went to my dr's office - was having 101. fever, chills, body aches , and severe cough with vomiting and not able and so I got tested the day I went to my Dr. and it was a negative COVID test. Treatment: Antiviral medication for one week; Topical ointment: Bacteralban ointment; I still have the face color with the Herpes was.
ED/Hospitalization within 6 weeks of receiving COVID vaccination; Only 1 dose received.
FELT FINE THE DAY OF INJECTION, WITHIN THE NEXT 24 HOURS PATIENT EXPERIENCED FEVER, NAUSEA, MALAISE, WARM/RED INJECTION SITE. OVERALL FELT SICK AND HEAD FELT CLOUDY.
Soreness in the arm; Conjunctivitis; Episcleritis; This is a spontaneous report from a contactable physician (dentist, dental surgeon/patient's husband).  A 57-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284), via an unspecified route of administration on 30Dec2020 at 57-years-old at a single dose for COVID-19 immunization.  Medical history included blood pressure increased, and blood cholesterol increased; both from an unknown date and unknown if ongoing. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) taken for blood pressure from an unspecified date to an unspecified date, "normal hormones" from an unspecified date to an unspecified date, "statin for cholesterol" from an unspecified date to an unspecified date. On 10Jan2021, the patient experienced conjunctivitis (non-serious). In Jan2021, the patient experienced episcleritis (non-serious). On an unspecified date, the patient experienced soreness in the arm (non-serious). The clinical course was reported as follows: The physician (patient's husband) stated that he and his wife received the Pfizer COVID-19 vaccine on 30Dec2020; and both had "a little bit of soreness in the arm, nothing spectacular." The patient developed a pink eye and was diagnosed with conjunctivitis 12 days (also reported as "approximately 10Jan or so") later after getting the vaccine (as reported). The doctor prescribed some topical cortical steroid eye drop. The eye was still swollen, and not totally resolved; "continually got worse." The patient consulted an ophthalmologist who gave the patient some prednisone ophthalmic (also reported as cortisone) and over the counter lubricant for the eyes. The patient was still symptomatic. The patient was diagnosed with episcleritis. The ophthalmologist classified the episcleritis as an autoimmune disease. Regarding the causality between the vaccine and the events, the patient's husband stated that his wife did not think it was related, and that the events could be totally idiopathic and there could be no correlation. The patient underwent lab tests and procedures which included COVID test: negative   on an unspecified date.  Therapeutic measures were taken as a result of conjunctivitis and episcleritis. The clinical outcome of the events was unknown.
This report describes headache in a 50 year old male who received Lyme disease vaccine recombinant OspA (Lymerix). It  was received from the vaccinee and has not been confirmed by a physician or other heathcare professional. Medical history and concurrent were not specified. reportedly. The vaccinee received no concomitant medications or vaccines. On 02/19/02, the vaccinee reportedly received his first injections of Lymerix. He  stated that on 02/20/02, he experienced headache and sinus "issues". The subject was reportedly seen by a physician. The reporter stated that the headaches resolved on 02/20/02, and the sinus "issues" improved. The Lymerix series was reportedly discontinued. The adverse event "headache" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the 06/20/00 letter.
Information has been received from an office manager concerning a 62 year old female who on 08-JAN-2009 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot# 662996/1618X). On approximately 08-JAN-2009, the patient experienced a large, red and inflamed/raised area at the injection site. The patient was seen on 09-JAN-2009 for the reactions. No treatment were given. The patient was told to monitor the reaction and call the office if symptoms got worse or did not improve. In January 2009 the patient recovered. This is one of several reports from the same source. Additional information has been requested.
Pain at site of injection has not gone away. Pain in deltoid area when lifts arm over head.
This spontaneous report was received from a company representative and refers to a 25 year old male patient. The patient's relevant medical history, concomitant medications and concurrent conditions were unknown. On 02-MAR-2018, the patient was vaccinated with the first dose of GARDASIL 9; on 02-MAY-2018, the patient was vaccinated with the second dose of GARDASIL 9. Both doses were administered for prophylaxis (strength, route of administration, frequency, lot# and expiration date were unknown). On April 2018, the patient experienced gradual onset of generalized extremity and facial weakness (muscular weakness)(facial paresis) with muscle fasciculations (muscle contractions involuntary), hypnic jerks (myoclonus), hypersalivation (salivary hypersecretion), startle reflex (exaggerated startle response), spasticity (muscle spasticity), gas (flatulence), trouble swallowing (dysphagia), and difficulty breathing (dyspnoea) ongoing over last few months. On an unknown date, the patient had lab test results of ANA 1:640 and an MRI of brain and spine that were reported as normal. The patient has been evaluated by a primary health physician, a neurologist and a rheumatologist with inconclusive results. Causality between GARDASIL 9 and the mentioned events was unknown.
Nurse reported VAQTA was administered after improper storage; unknown of VAQTA was prefilled syringe or vial, however it is known that it was a pediatric dose administered. The operator of the device was a healthcare professional. Requested follow up; This spontaneous report was received from a registered nurse (RN) referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On 28-JUL-2023, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA), 1st dose (pediatric) for prophylaxis (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number X003791 with an expiration date of 01-JUN-2024). The administered dose of the vaccine experienced a temperature excursion of 51 degrees Fahrenheit for 1 hour. There were no previous temperature excursions. It was not reported if this information was recorded by a data logger or not.
Redness and itching at site of injection from Afluria Influenza Vaccine (R Deltoid). Pt. C/O itching on both arms after injection. Symptoms & redness diminished after being treated with Benadryl 25 mg P.O. times 1, S&S resolved within 20 minutes.  Pt. was monitored in clinic total of 2 hours as she remained stable. Pt was discharged to home in stable condition, itching resolved. Vital Signs Stable, with OTC RX:  Benadryl 25 mg 1 q- 6 PRN. Telephone call F/U 2 days later pt. stated she was feeling great had no additional concerns or questions.
The patient is a 64 year old white male known with diabetes mellitus type II, hypertension, osteoarthritis of his knees, and abnormal liver enzymes. Patient is being seen today for a routine follow up appointment. Patient is experiencing no pain and expresses no new concerns. Patient denies SOB, NVD, cough, cold, etc.  Recent labs reviewed A1c 6.9%, LDL 100, total chol 180, Trig 301, HDL 29, VLDL 51. TSH normal at 1.290, AST 39, ALT elevated at 52. alk phos 81 , bun 11, Cr 1.01, GFR 78 , WBC 5.4, Hgb 15.1, Plt 180 reviewed during visit. GM 5/19/21   Patient reports after second Covid-19 vaccine he had 3 weeks of diarrhea, got dehydrated and then had to pass 5 kidney stones. States several coworkers who also had Moderna had diarrhea but it did not last that long.  He also had joint pain and headache. He states the headache was mild it was "not bad".  He unfortunately did not seek care during this time. Headaches lasted 1.5-2 weeks. Did not hold him up. Had no other sick contacts.   Diarrhea and headaches started the next day.  He had diarrhea any time he ate anything "a straight shot". At times full watery diarrhea. No fatty or floating stools. He did feel a little warmer at times but when checked Temp was normal. We do have cases of Norovirus in community but symptoms lasted too long for that and no other sick contacts in household with similar symptoms.  Did not have a COVID-19 test during that time. Did not notify our clinic. Had fecal urgency. Denies blood in stool.
Vaccine administered BUD (on day 32)/Vial was put in the fridge on 14Jun2021 and doses were administered on 16Jul2021 (on Day 32). No temperature excursion episodes occurred. Vial was kept between 36 and 45.9 degrees Fahrenheit.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)/Vial was put in the fridge on 14Jun2021 and doses were administered on 16Jul2021 (on Day 32). No temperature excursion episodes occurred. Vial was kept between 36 and 45.9 degrees Fahrenheit.) in a 19-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)/Vial was put in the fridge on 14Jun2021 and doses were administered on 16Jul2021 (on Day 32). No temperature excursion episodes occurred. Vial was kept between 36 and 45.9 degrees Fahrenheit.). On 16-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)/Vial was put in the fridge on 14Jun2021 and doses were administered on 16Jul2021 (on Day 32). No temperature excursion episodes occurred. Vial was kept between 36 and 45.9 degrees Fahrenheit.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2021: Follow-up information includes no new information.
Large raised area around injection site approx. 3inches across, reddened, warm & painful. Applied compress.
Pt not happy. About 2-3 hours after getting vaccination started to shake all over but did not have temp. lasted 3/4 night then felt hot until morning, stomach was also upset.
After getting home (within 30 minutes of receiving vaccine ) patient said she felt off. She had chills (non-febrile), she said her symptoms progressed to a rash on her arms and abdomen, chest discomfort and shortness of breath. She said she  took her sublingual nitroglycerin when she experienced chest discomfort and took some tylenol at some point. Patient said she didn't seek any medical treatment she "toughed it out" as her symptoms leveled off the day of vaccination. Patient said the next day she just felt really weak, but was feeling back to normal within a couple of days.
Painful lump in arm pit; Pain in her whole upper arm/ Pain at injection site; very painful to touch; This case was reported by a physician via call center representative and described the occurrence of axillary lump in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th September 2019, the patient received Shingrix (intramuscular). In September 2019, 3 days after receiving Shingrix, the patient experienced axillary lump, injection site pain and tenderness. The patient was treated with levomenthol (Icy Hot Patch). On an unknown date, the outcome of the axillary lump, injection site pain and tenderness were not recovered/not resolved.   It was unknown if the reporter considered the axillary lump, injection site pain and tenderness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had the Shingrix in right deltoid three days later physician noted the lump in the right arm pit, in the anterior aspect of her upper right arm. The lump was about one and a half to two inches in diameter. Physician states she also has injection site pain and pain in her whole upper arm. She notes the arm was still very painful to touch now.  The patient put Icy Hot pain patches on it for the last week and it helped. The whole upper arm was still sore to touch. The lump, the pain at the injection site, and upper arm pain are ongoing as of the time of this call.  The reporter consented to follow up. No further details were provided.  The physician consents to follow up.
Fever 101.5, nausea, chills, arm red, swollen and hot.
Received Vaccine while pregnant; Fever; Body aches; Chills; Headache; Tongue Hurt; Arm hurt; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received Vaccine while pregnant), PYREXIA (Fever), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache) in a 41-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.     The patient's past medical history included Heart disease, unspecified, COVID-19 (Suffered from Covid-19) in November 2020, Gestational diabetes, Pregnancy (Live,full-term birth) on 20-Aug-2008 and Pregnancy (Live,full-term birth) on 17-Feb-2010.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in May 2020 and the estimated date of delivery was 07-Feb-2021. On 31-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received Vaccine while pregnant), PYREXIA (Fever), MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headache), GLOSSODYNIA (Tongue Hurt) and PAIN IN EXTREMITY (Arm hurt). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 31-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Received Vaccine while pregnant) outcome was unknown. On 01-Jan-2021, PYREXIA (Fever), MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headache), GLOSSODYNIA (Tongue Hurt) and PAIN IN EXTREMITY (Arm hurt) had resolved. Not Provided      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.   No concomitant medication details were reported. No treatment medication details was reported. She was 9 months pregnant and was about to deliver on 26 Jan 2021. She had three previous pregnancies of which two were live and full term birth on 20 Aug 2008 and 17 Feb 2010.; Reporter's Comments: This is a case of product exposure during pregnancy with associated non-serious AEs (fever, chills, body ache, headache, arm and tongue pain) for this 41-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
chills; fever; arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever) and PAIN IN EXTREMITY (arm hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event (No medical history reported).   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced CHILLS (chills), PYREXIA (fever) and PAIN IN EXTREMITY (arm hurts). At the time of the report, CHILLS (chills), PYREXIA (fever) and PAIN IN EXTREMITY (arm hurts) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided Treatment not provided