chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt sore all over; Mild temperature of 100.4 F; Delirious; Soreness of arm; Talking out of his head; Shaking; Was very cold; Got real hot; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Delirious) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Reports that the patient had done regeneron infusion on 02 Feb 2021).    On 27-Apr-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced DELIRIUM (Delirious) (seriousness criterion medically significant), PAIN IN EXTREMITY (Soreness of arm), ABNORMAL BEHAVIOUR (Talking out of his head), TREMOR (Shaking), FEELING COLD (Was very cold) and FEELING HOT (Got real hot). On 27-Apr-2021 at 11:00 PM, the patient experienced PYREXIA (Mild temperature of 100.4 F). On 28-Apr-2021, the patient experienced MYALGIA (Felt sore all over). At the time of the report, DELIRIUM (Delirious), PAIN IN EXTREMITY (Soreness of arm), ABNORMAL BEHAVIOUR (Talking out of his head), TREMOR (Shaking), FEELING COLD (Was very cold), FEELING HOT (Got real hot), PYREXIA (Mild temperature of 100.4 F) and MYALGIA (Felt sore all over) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Body temperature: 100.4 Mild temperature of 100.4 F was reported.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included the use of acetaminophen.; 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.
Chills; Tired/fatigue; A mild headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (Tired/fatigue) and HEADACHE (A mild headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced HEADACHE (A mild headache). On an unknown date, the patient experienced CHILLS (Chills) and FATIGUE (Tired/fatigue). At the time of the report, CHILLS (Chills), FATIGUE (Tired/fatigue) and HEADACHE (A mild headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant product use was provided.  No treatment medication was provided.  Patient experienced headache 4 to 5 days after the first dose.   This case was linked to MOD-2021-024870, MOD-2022-455317 (Patient Link).
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 3:39 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 3:39 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 85.59 for dose administered on  14-Feb-202.  Concomitant products were not provided.  On 14-Feb-2021, Excursion time was 03:00 P.M., temperature was 35 degrees Fahrenheit, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Within a week, I experienced muscle control issues in my left eye and my left thumb, and brain fog.  Approximately 3 months later, it resolved and so I got the second dose.  Following the second shot, symptoms returned and have progressively gotten worse over time including blurred vision, difficulty concentrating and balance and coordination issues and previously stated muscle control issues.  I have seen multiple medical professionals this year and I am still being referred to specialists in order to determine diagnosis.  I believe the vaccine may have been a trigger to these issues, as they were  not present prior to the vaccine.
Severe headache and sinus pressure, runny nose. This hasn?t stopped since I received the vaccine. I am taking ibuprofen and Sudafed.  I have sinus pressure daily on the left side. I?m more sensitive to smells now.
I received the vaccine in my left arm and shortly thereafter suffered a medium sized, painful lump in my left armpit. So far its lated 4 days and occurred on the side where axillary Lymph nodes have not been removed.
irritability; This is a spontaneous report received from contactable reporter(s) (Physician).  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as 0.5 ml, single (Batch/Lot number: unknown) intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IRRITABILITY (non-serious), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Significant UE arthralgia, red, tender blotchy local reaction (L) deltoid.
Present to nurse with stomach ache, chills. Progressed to confusion, disoriented to time and place, brief periods of unresponsiveness and loss of consciousness. Pulse rapid and thready. Became short of breath and congested. O2 and albuterol given in ambulance.
purpuric rash almost confluent on legs & anterior area;Henoch schenoch purpura;
Common side effects of vaccination including low grade fever, chills/hotflashes, and intense body/bone aches began approximately 9/15 at 2300.  I awoke at 0600 noting my heart rate to be at 122 bpm via radial manual pulse, my smart watch, and pulse oximetry; after walking short distance to kitchen, my heart rate was then 140 bpm. I figured maybe I just need to take my metoprolol. I do have a history of tachycardia for unknown reasons at this time but my rates have been controlled between 80-90 or less... even with activity usually my heart rate stays below 120 bpm now. At that time, I took my metoprolol; the day before I had taken it at approximately the same time given that is when I had gotten up for work. I was able to fall back asleep within an hour. I woke up again approximately 120 bpm... I could feel instantly that my heart rate still felt elevated. I checked my watch and pulse oximetry again to find my heart rate was still around 120 bpm just having woke up, still laying in bed. This is quite uncommon for me given my rates have been well-controlled for months now. I ended up discussing with employee health at my workplace who urged me to seek care so I went to the Urgent Care. Heart rate documented at 127 bpm and other vital signs within normal limits. EKG was completed showing sinus tachycardia at 113 bpm. End result was to increase metoprolol dosage until symptoms passed; if they did not improve, pursue ER care. Taking an additional 25 mg on top of my 50 mg ER metoprolol brought my heart rate down for the remainder of the day to 90-100... still elevated from my normal but tolerable. The following day as common symptoms improved so did my heart rate.   I understand this reaction is likely due to my bodies response to creating antibodies; however,  elevated heart rate was not listed as possible side effect which is drastically important for someone like me who has these issues being managed chronically. Expecting tachycardia as a  response would have changed possibly which vaccine I received as well as my medical treatment. Provider at Urgent Care stated that none of their provider's were aware of tachycardia as a common reaction.
Dry cough; Heart palpitations; Worried; This is a spontaneous report from a contactable consumer (patient's child). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the second dose of the COVID-19 vaccine with Pfizer and she can't get a hold of a doctor. On an unspecified date, the patient was experiencing dry cough and a little bit of heart palpitations. The patient's child didn't know if the heart palpitation is because the patient was worried on an unspecified date. The patient's child asked if that was something to be concerned. The patient's child would rather call right now because the patient was really worried; patient's child's time is limited. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
wrong age for this vaccine,  stated was correct age for vaccine on his consent. Vaccinator did not catch the birth date was wrong for this vaccine to be given.  No adverse affects from vaccine, was just give 9 months early.
This is a prospective pregnancy case. This 30-year-old female subject was enrolled in an open label study. The subject received BOOSTRIX (intramuscular) .5 ml on 6th January 2015. The subject's estimated date of delivery was 20th February 2015. The subject received BOOSTRIX at week 33 of the pregnancy and during the third trimester of pregnancy. On 6th January 2015, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided: There was not known if adverse events had occurred.
endometriosis; Information has been received from a nurse via a company representative referring to a 17 years old female patient. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On an unknown date in 2015, at the age of 13 years old, the patient received one dose of hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (batch/lot #, expiration date, strength, dose and route were unknown) for prophylaxis. On an unspecified date in 2019 when she was 17 years old, she developed endometriosis. Unknown medical attention was sought. The outcome of endometriosis was unknown.  The causality between endometriosis and hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Fever 102 at 5am in the morning on Oct 31, 2009.  Temp. raising during the day. Administered Tylenol. Taken child to the clinic. The attending physician performed flu test (negative) diagnosed ear infection, administered Motrin and prescribed amoxicillin.  My son's fever went down after Motrin for the evening.  He went to sleep at his usual time Saturday evening.  He walk up at midnight with very high fever 105.4.  I administered Motrin and have taken him to Hospital.  The doctor checked his ears and said the he does not have an ear infection and advised to take him off the antibiotic.  The also checked his urine for urinary tract infection.  Result was negative.  Because he had no other symptoms he was administered Tylenol and released. His fever lasted through Sat, Oct 31, and slowly decreased on Sun Nov 1.  On Monday a rash appeared all over this body and lasted until Friday Nov 6th.  The rash was the worst on Monday and Tuesday and then slowly started to disappear.
Breastfeeding: I lost all of my milk supply. Went from producing 5+ bottles a day to barely making one overnight.
Rash started on Tuesday on trunk and by Thursday it covered his entire body and was extremely itchy.  He developed a fever on Friday and continues to have a mild fever today.  The fever at its highest was 102. Rash is getting better but it still quite itchy.  Patient took Benadryl and Tylenol Friday evening and Saturday morning.
Vaccinated on 3/13/03. 4 days after vaccination noted pruritis. Took benadryl. 6 days after vaccination was found to be a "no take", but had red raised area at vac site (no pustule). Also noted to have blotchy mottled rash over backs of arms, hands, knees and legs. Took benadryl at 4:40P. Awoke at 2AM the next morning feeling "jittery", unable to sleep. Rash still present. Seen by MD. Given clonipine. Rash resolved over next 2-3d.
Patient came to the window and there was a communication barrier. They claimed they needed a flu vaccine and presented a paper for the flu. We gave him the form to fill out and he returned. When we did pre-vaccine counseling he said he needed the flu vaccine. We administered the vaccine and he started discussing the pneumonia vaccine. When we checked his profile we searched by name and found he had 2 profiles with 2 different date of births and he had a flu vaccine at the beginning of the month.
Pt. states that about x1 hour after getting vaccine she started having a asthma attack. Pt. states that she took a dose of her inhaler and symptoms subsided and she went to see her allergist, and received a dose of oral steroids. Pt. states that for the past month she has been on several steroids and inhalers without relief. Pt. states that her doctor dx her with long-term exacerbation of asthma. Pt. states that symptoms have not improved.
This spontaneous report received from a registered nurse referred to a 9 weeks old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 19-SEP-2016, the patient was vaccinated with ROTATEQ (lot number: M014544, dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: same reporter.
Received the vaccine and tested positive for Covid today; Received the vaccine and tested positive for Covid today; This is a spontaneous report from a contactable nurse. This nurse is reporting similar events for two patients. This is the first of two reports.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 17Dec2020 at single dose for Covid Vaccine/ COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  It was reported that the patient received the vaccine and tested positive for COVID today (24Dec2020). She was having symptoms on Saturday (unspecified date in Dec2020), she received her vaccine on Thursday 17Dec2020.  The reporter asked several questions, if do they get the second vaccination in 3 weeks and what will be the process, does it do anything to it, or if does it make it worse or better. The outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient might not be completely excluded.,Linked Report(s) : US-PFIZER INC-2020513377 same reporter, same drug, similar event,  different patient.
Immediate significant pain at injections site. Injection felt too high up on arm. Felt like a large volume was being injected.  Injection site was sore for several days and shoulder pain has persisted since.  Can still fell where injection occurred. Pain with lifting shoulder forward up or back.  Have been taking ibuprofen for pain.  At the point that additional medical care may be necessary.
Developed left facial swelling and tingling, with mild left facial droop.  Resolved quickly over 4-6 hours.
4 days after getting the shot,  I began having severe pain in my left hip, thigh and knee   hampering my ability to ambulate x 2/3 weeks. At this time I  am able to walk slowly with a limp, I continue to have almost constant pain in my left knee and frequent pain in my left buttock and thigh. I went to a chiropractor x 4 weeks. I am currently in therapy x 3 days a week. I  saw a surgeon  with the recommendation to continue  with therapy. I was not  having any back or leg pain prior to this. Currently  , unable to work.
Case number PHEH2015US024996 is an initial spontaneous report received from a pharmacist on 25 Nov 2015. This report refers to a 60 year old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 151001) intramuscularly on an unknown date. On 23 Nov 2015, the patient experienced blurred vision after being vaccinated. The outcome of the event was reported as unknown. The seriousness and causality of the event was not reported.
Prolonged inconsolable crying/screaming (3-4 hours stretches) over the course of 3 days (crying would only stop once she fell asleep). After 3 days had passed, she was very quiet and still, almost like she had been drugged. Took upwards of two weeks to get any normal reaction out of her. Decreased appetite (only nursed a few times a day the first 5 days after the vaccine).
Receive vaccination on 4/7/21, on 4/17/21 evening minor chest pain simulating heartburn started, on 4/19/21  progressed to severe pain, went to Emergency Room, where she was admitted the FIRST TIME, several test were done and they could not locate source of pain, Just treated with Morphine for pain; my mother was discharged on 4/21/21 with NO answer to the cause for SEVERE pain, just chest ray  showed a SMALL amount of fluid. Upon release my mother continued with mild pain, Until it was unbearable on 4-30-21 Admitted for the SECOND TIME until this present, This time alot of fluid was found outside her lungs, then moved to around her heart causing cardiac unrest AND STILL IN HOSPITAL....A biopsy of the fluid was done before her cardiac unrest and hospital is still waiting for results of Fluid Biopsy.
people had worse AEs after the second dose than from the first one; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (people had worse AEs after the second dose than from the first one) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (people had worse AEs after the second dose than from the first one). At the time of the report, VACCINATION COMPLICATION (people had worse AEs after the second dose than from the first one) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications reported.   This case was linked to MODERNATX, INC.-MOD-2021-098231, MODERNATX, INC.-MOD-2021-098231 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098231:Cross linked to MOD-2021-098231 US-MODERNATX, INC.-MOD-2021-098231:cross linked to
After receiving HPV (#1) to L delt., pt walked to reception area & "felt dizzy" & fell to floor.  Skin pale, clammy & cool.  BP 70/40, P 48, faint.  Assisted to supine position x20 mins until fully recovered.
Patient administered vaccine. With in 2 minutes patient slumped forward and was caught by mother and laid back on table. Child grabbed ears and started screaming.
Patient says she was sore for one day after getting the vaccine, became ok but started becoming painful. She says she is unable to hold anything with that hand.
Patient is a 60 y.o. male who presents today with RLE swelling and pain. Pt. has a PMH of factor V Leiden mutation with recurrent DVTs, chronic back pain, essential HTN. Pt. was recently admitted from 7/10/22 to 7/16/22 with recurrent RLE DVT despite compliance with pradaxa. He was started on a heparin qtt and hematology and IR were consulted. He underwent a thrombectomy with right common iliac stneting. Hematology recommended changing oral anticoagulant to coumadin with 30 days of plavix. Since discharge patient was doing well until about one to two weeks ago he started to have RLE swelling and now worsening pain. Found to be COVID positive. CT abdomen and pelvis with thrombotic occlusion of the right iliofemoral stent. He underwent Right lower extremity venography with catheter directed mechanical thrombectomy8/25.Hematology following since patient has multiple anticoagulation regimen failure, recommend warfarin with INR goal 2.5 to 3.5 and Plavix.  In the meantime, patient was anticoagulated on IV heparin drip. Pharmacy dosed patient's Coumadin while in the hospital.  Eventually over an extended period, patient's INR began to climb and on the day of discharge was at 2.1.  Patient was comfortable with Lovenox bridging at home and following up with his PCP at discharge.  An appointment was made for him prior to discharge.  Patient already had prescriptions for Lovenox at home and was trained on its use.  Patient was medically stable for discharge.
She called me on Friday, May 13, 2022  stating that she had a reaction to the Hepatitis B vaccine within a couple of hours after receiving the vaccine.  She complained of feeling dizzy, weak, confused with a headache like a migraine and brain fog.   She does have an underlying condition of having migraines ever since she had a car accident in 2014.  I advised her to speak with her PCP about these symptoms to see if maybe she was having an allergic reaction to the vaccine.  I spoke with her again on Monday, May 23, 2022 and she stated she was feeling much better now.
Development of an Adenoma in the salivary gland, first being noticed as a notable growth in June of 2022. As the tumor is not causing any discomfort, unless it grows further, it has been decided to not extract it.