chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ear pain above my ear on my head/ear pain; ear infection in both ears but left is worse; fever of 101.2; body aches; This spontaneous case was reported by a nurse and describes the occurrence of EAR PAIN (ear pain above my ear on my head/ear pain), EAR INFECTION (ear infection in both ears but left is worse), PYREXIA (fever of 101.2) and MYALGIA (body aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant concomitant medications reported No relevant medical history was reported.    On 04-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 05-Feb-2021, the patient experienced PYREXIA (fever of 101.2) and MYALGIA (body aches). On 07-Feb-2021, the patient experienced EAR PAIN (ear pain above my ear on my head/ear pain). 07-Feb-2021, the patient experienced EAR INFECTION (ear infection in both ears but left is worse). On 06-Feb-2021, PYREXIA (fever of 101.2) and MYALGIA (body aches) had resolved. At the time of the report, EAR PAIN (ear pain above my ear on my head/ear pain) and EAR INFECTION (ear infection in both ears but left is worse) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   She states that the infection is in both ears but the left ear is worse. She has had to go through 3 rounds of antibiotics which have not helped heal the infection so far. She is currently on the 3rd round of antibiotics. Her HCP has also referred her to an ENT for further guidance.  Treatment medication she took included Amoxicillin, Omnicef
patient's both legs and ankles started to become swollen; patient's both legs and ankles started to become swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (patient's both legs and ankles started to become swollen) and JOINT SWELLING (patient's both legs and ankles started to become swollen) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Relevant medical history not reported).   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced PERIPHERAL SWELLING (patient's both legs and ankles started to become swollen) and JOINT SWELLING (patient's both legs and ankles started to become swollen). At the time of the report, PERIPHERAL SWELLING (patient's both legs and ankles started to become swollen) and JOINT SWELLING (patient's both legs and ankles started to become swollen) outcome was unknown. Not Provided          Patient reported concomitant medications which include diabetic medication and goat (gout?) medications.   No further detail was provided. No treatment information was provided for the events.; Sender's Comments: 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.
Sudden onset of Bell?s Palsy. Temporary paralysis of left side of face.
Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The reporter stated that the patient received the shingles shot he came down with shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Body aches, chills, fatigue, fever (up to 102F).  Symptoms started approx  6 hours after injection, peak fever measured ~9 hours after injection.  OTC acetaminophen administered.  Symptoms persisted into next day, although less severe (~100F).  Fever cleared the following day, ~40 hours after injection.
RIGHT KNEE SWOLLEN AND ACTING WEIRD; BOTH LEGS SWOLLEN BUT IT MORE ON THE RIGHT ONE; HAS TO WAIT A LITTLE  WHEN TRYING TO GET UP FROM SITTING POSITION BECAUSE LEG LIKE FREEZING; UNCOMFORTABLE GETTING IN OR OUT OF THE CAR/THE LEG BOTHERS WHEN TRYING TO EXTEND IT; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, occasional alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies, and patient was very healthy. The patient was not on heavy medication except regular over the counter medications. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-SEP-2021, the patient experienced right knee swollen and acting weird. On 04-SEP-2021, the patient experienced both legs swollen but it more on the right one. On 04-SEP-2021, the patient experienced has to wait a little when trying to get up from sitting position because leg like freezing. On 04-SEP-2021, the patient experienced uncomfortable getting in or out of the car/the leg bothers when trying to extend it. The action taken with covid-19 vaccine was not applicable. The outcome of the uncomfortable getting in or out of the car/the leg bothers when trying to extend it, right knee swollen and acting weird, both legs swollen but it more on the right one and has to wait a little when trying to get up from sitting position because leg like freezing was not reported. This report was non-serious.
Patient reported within 5 minutes of injection arm was tingling and numb and felt it was beginning to swell.  Patient was given dose of oral benadryl and monitored for additional 15 minutes. Patient started to complain of stomach pain and heaviness in chest. Was sent to ER where she complained of difficulty swallowing, increased heaviness in chest, and arm tingling. Patient reported ER gave her a dose of a steroid. She was released to pharmacy with prescriptions for EpiPen and steroids.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with ACETYLSALICYLIC ACID (ALKA-SELTZER) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.            No concomitant medication information was reported. Patient used over-the-counter cold medicine Alka-Seltzer Power Max Gels. The case was not severe and did not need a prescription.
While less severe than the other three shots, I experienced severe whole  body shaking for about 20 minutes and the usual bad headache, however,  this time I also had severe sharp pain in both knees and in my bladder.  Both of these abated overnight after I took a Tylenol.   I also experienced severe ringing in my ears which is still on going.
The day after her first dose of COVID, patient woke up confused and disoriented.  Did not know who her husband was.  Was taken to the ER.  Confusion last about 1 hour.  Patient also had pain at vaccine administration site, temp of 101 and BS of 300+ which is high for her.
Broke out in hives all over body and ran low grade temp 99 degrees - 100 degrees 24 hours after vaccinations.
4: 50 pm - 20 minutes after injection, pt reports feeling flushed, hot and itchy.  pt denies breathing trouble. 5: 03 pm  pt was evaluated by EMS BP 162/105, P91, O2 sat 100%, EKG done 5: 09 pm BP 136/84 P 86, O sat 100 %. Pt reports reports feeling better, declined transport to ED. Pt left AMA.
86 y/o male with past medical history of Vertigo, Open Heart Surgery, HTN, DM and Brain Aneurysm, who presents with mild dizziness post vaccination. Patient states that this is his 1st dose in a two-dose series. Patient denies headache, nausea, sore throat, difficulty breathing of shortness of breath or rash. NP and Paramedics at patients? side. Patient initial vitals 160/90 BP, 99%RA, 78 HR, 12 Resp. Glucose was unable to be obtained due to malfunction. EKG NSR. Patient was closely monitored and placed in Trendelenburg. Patient provided water. Patient states that he took all his meds this am. Patient monitored for 30 mins with resolution of symptoms. Patient vitals upon discharge 156/98 BP, 99% RA, 64 HR and 12 Resp. Patient wheeled to car via wheelchair with staff.
59 year old patient received vaccine which is indicated for 60 year old and older. Patient is NOT experiencing any side effects or adverse event.
body aches in back and shoulders, headache, fatigue, started 18 hours after vaccine, lasted for 24 hours, then went away
eight hours after vaccination felt very sick, indisposed; palpitations; eight hours after vaccination felt very bad; felt something in the chest like a tremendous pressure; Heart Beat was 76 and in a second raised to 151-152; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (eight hours after vaccination felt very sick, indisposed) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MALAISE (eight hours after vaccination felt very sick, indisposed) (seriousness criterion hospitalization), CHEST DISCOMFORT (felt something in the chest like a tremendous pressure), HEART RATE INCREASED (Heart Beat was 76 and in a second raised to 151-152) and FEELING ABNORMAL (eight hours after vaccination felt very bad). On an unknown date, the patient experienced PALPITATIONS (palpitations). The patient was hospitalized for 5 days due to MALAISE. At the time of the report, MALAISE (eight hours after vaccination felt very sick, indisposed), CHEST DISCOMFORT (felt something in the chest like a tremendous pressure), HEART RATE INCREASED (Heart Beat was 76 and in a second raised to 151-152) and FEELING ABNORMAL (eight hours after vaccination felt very bad) outcome was unknown and PALPITATIONS (palpitations) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Heart rate: 76, 151-152 (Inconclusive) 76, 151-152 beats/min.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient went to emergency and was hospitalized for 5 days.  Treatment details included acetylsalicylic acid for the blood flow and heart.  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.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Significant; additional events added with details. Case upgraded to serious.; Reporter's Comments: .; Sender's Comments: 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.
Last Tuesday (10/12), I had my 4th COVID vaccine AND a flu vaccine at the same time.  My body was reacting to it slowly with aches and fever just like what happened in the past 3 COVID vaccine injections.  However, Wednesday night I noticed a strange feeling on the full surface of my tongue.  I told my partner about this strange feeling.  I thought I might have burnt my tongue from hot food even though I did not eat anything super hot. Everything appeared to be ok except my tongue for a couple days. Saturday night is when I started feeling swollen on my face.  Sunday morning, when I woke up. My left face had dropped.  Our first reactions were Stroke.  My partner rushed me to the ER at the Medical Center.  I walked into the ER door to the administration.  She got a nurse for me right away to take me to the triage.  At the triage, I lost my speech function and clasped on the right side of my body.  They rushed me to ICU with the assumption of stroke and gave me a CT scan quickly.  The result came back negative for any infraction of major brain arteries.  They did many tests on me. My speech came back slowly, but I lost more control of my left face.  After the MRI, they didn't see any small vessel damages.  The ER doctors concluded that I developed Bell's Palsy.
Want to note I do not know what type of flu shot I had, I got it from the pharmacy.  For a few days after I received my COVID booster and flu shot, as expected, I was sore and tired for a few days/. However, over a week later while all of my other symptoms are gone, I have notice I still have a lot of breast tenderness that can be mildly painful when moving around.  I wanted to report this in case this is something other women are experiencing, and to better understand hoiw long I should expect this to last.
Within 2-3 weeks of receiving the booster patient developed significant dyspnea with low level activities such a going up a flight of stairs.  On approximately 5/20 he was noted to have yellowing of his eyes and continually worsening shortness of breath and fatigue.  His dyspnea and jaundice progressed over the next few days On May 24th  we went to the ER and was found to have Autoimmune Hemolytic  Anemia with a Hemoglobin of 4.4, enlarged inguinal lymph node on L, as well as splenic and liver enlargement.  He was transferred to hospital and was admitted to the ICU where he received a blood transfusion which required a full medical team to be present in the case of an allergic reaction.  He stayed at hospital for approximately 1- 1 1/2 weeks where he received multiple blood transfusions, steroid infusions, and eventually was started on chemotherapy with Rituximab.  He was discharged home with oral steroids and returned to hospital weekly for 4 weeks for Rituximab infusions.  He then started a drug called Mycophenolate Mofetil. As of this week he continues with monthly IVIG infusions and had been transitioned to Abatacept to manage his newly acquired condition.   He was found to have an underlying genetic condition called CTLA 4 protein deficiency. He has had no symptoms related to this in the past 20 years.
The next day she developed lumps around injection site and it was painful for about 10 days and she still has slight pain and the lump is still there after 4 weeks
ED provider notes as follows:  Initial Vital Signs [01/20/21 0010] Blood Pressure 136/74 Heart Rate 82 Respiratory Rate 20 Temp 36.7 °C (98.1 °F) Temp src Oral SpO2 98 %  44 y.o. female who arrived  to the emergency department for Episode of right mid anterior chest pain intermittently ongoing starting around 10 PM this evening.  She has had similar episodes in the past thought to be related to her gallbladder.  Tonight she took some Pepcid and Tylenol.  She denies any shortness of breath, or persistent chest pain, states pain has resolved since arriving in the emergency room.  She denies any recent fever however she was recently given the second vaccine dose for COVID, and is having myalgias and symptoms she believes are related to the vaccination.  She is requesting a COVID test.  Patient denies sore throat, cough or abdominal pain.  At this time only symptoms or myalgias.  She continues to have no symptoms, her workup is reassuring, low suspicion for severe significant pathology, however would have a low threshold to return to the ER if chest pain would return or any other symptoms were to arise.  COVID test came back negative.
urticaria all over arms and trunk (severe raised red rash) some mild/ mod rash on lower extremity worse at the knee joint
Pt reports fear of needles, also reports history of "passing out" around needles.  Client reported feeling lightheaded while in observation unit post vaccine administration. Client fainted while sitting, did not fall to floor as family was sitting beside client. Client came to immediately, assessed by EMT and MD on site. vitals obtained.  1st set of vitals 100/44 HR: 47 02 sat 98%, second set of vitals 105/57 HR 58 02 sat 98%. Client left site after observation time completed without incident family at her side.
decided not to get the second dose.; severe head pain/headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (decided not to get the second dose.), HEADACHE (severe head pain/headache) and FATIGUE (fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 08-Jan-2021.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced HEADACHE (severe head pain/headache) and FATIGUE (fatigue). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (decided not to get the second dose.). On 01-Feb-2021, FATIGUE (fatigue) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (decided not to get the second dose.) and HEADACHE (severe head pain/headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided.
Rapid heartbeat; Great Fatigue; Whole body intensely hot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 3 (booster), single (Lot number: GH9694) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroiditis", start date: 2008 (ongoing); "Graves' disease", start date: 2005 (ongoing); "chemically sensitive" (ongoing), notes: Caller states that she is chemically sensitive to many things, she cannot even name them all. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1, Lot Number: FJ6369), administration date: 08Mar2022, when the patient was 73-year-old, for COVID-19 immunization; BNT162b2 (Dose: 2, Lot Number: FJ6369), administration date: 29Mar2022, when the patient was 73-year-old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 13Sep2022, outcome "recovering", described as "Great Fatigue"; HEART RATE INCREASED (non-serious) with onset 13Sep2022, outcome "recovering", described as "Rapid heartbeat"; FEELING HOT (non-serious) with onset 13Sep2022, outcome "recovering", described as "Whole body intensely hot". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, fatigue, feeling hot.  Additional information: The patient took no prior vaccinations (within 4 weeks) to the first administration date of the suspect vaccine. NDC number of Covid Booster, Comirnaty, Omicron Booster: Unknown. Caller (patient) stated that she had an adverse event with this booster dose that she did not expect. She had her first Covid Vaccines in Mar2022, prior to that she had none. States that with this booster dose she had a rapid heartbeat, great fatigue, and her whole body was intensely hot. States that she is feeling better now but wanted to report it. Says that she does not blame Pfizer, she blames her own body; she is a chemically sensitive person. The patient stated that Rapid heartbeat has improved, Great fatigue (started several hours after she received the vaccine) has gotten slightly better, Whole body intensely hot; she feels a bit heated now, but not as much as before and all these events began the same day that she got the booster vaccine. Caller stated that she did not want to go to a hospital and figured the symptoms would alleviate in time, which they seem to have done. She requested the Pfizer vaccines because she trusts Pfizer more than the other companies since she uses other unspecified Pfizer Products. Follow-up attempts are completed. No further information is expected.; Reporter's Comments:
Information has been received from a physician concerning an "over 4 months" old female who was vaccinated PO with the second 2.0 mL dose of Rotateq (human bovine) (1st dose given at 2 months old). The physician reported that, a day or two after receiving the second dose, the patient experienced some intestinal pain. The patient was also noted to be very irritable, but no mention of diarrhea was made. Unspecified medical attention was sought. The patient subsequently recovered. Additional information has been requested.
Fever Severe  Cold/Chills Fatigue Headache Nausea Body Aches Chest pressure Knot (perhaps a clot in left leg behind the knee)-(still as of 4/13) Severe on-going Dizziness (still as of 4/13)
Localized rash developed around injection site. Small red bumps- approx 2in x 2in.
I had the shot on 3-10 and on 3-18 early morning I woke up and felt lots of tingling in my arms and legs.  I woke up a couple days before this feeling the same way but laid back down for a while until I felt better.  The day of 3-18 I could not walk or dress myself to go to urgent care or hospital.  I did the best I could to call my mother to pick me up immediately.    She had to dress me and walk me to the car.  I was throwing up and could barely sit up on my own.  I had lots of spinning.  I was tested for covid (negative) and stroke symptoms.  This was a very bad experience that was discounted as migraine and dehydration.  I was sent to a Neurologist who also had no answers.   I do have migraines every now and then but nothing nowhere near this feeling I had that day and without extreme tingling in arms and legs.