chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stated that he developed confusion; experienced awful dreams; concentration to do normal things/it was too difficult to concentrate on the road and talk to her at the same time.; This is a spontaneous report from a contactable consumer (the patient).  A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3249, expiry 31May2021), intramuscular in the left arm, on 27Jan2021 at 09:30 AM (at the age of 78 years) as a single dose for COVID-19 immunization.  Medical history was none. Concomitant medication included ergocalciferol (VITAMIN D). The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 27Jan2021 he developed confusion, in which it took a lot of concentration to do normal things and he experienced awful dreams last night. The slight degree of confusion causing him to have to concentrate more than usual for ordinary tasks. The clinical outcome of the events he developed confusion, in which it took a lot of concentration to do normal things and he experienced awful dreams last night was recovering.
RED/SWOLLEN RT DELTOID. NO EVIDENCE OF INFECTION NOTED BY DR, BENADRYL AND IBUPROFEN PRESCRIBED AND TO RETURN IF NOT BETTER OR WORSE.
pt recv vax 3JUN98 & 17JUN98 seen in office mom noticed bumps on body x 2 days;MD noted, discrete papular vesicular lesions on extremities;30JUN98 check & noted lesions drying;
pt presents with cough, SOB, and poor appetite x 1 wk; hx of dementia, fluid retention, lymphoma, failure to thrive; diagnosed positive for COVID; COVID pneumonia; given dexamethasone, remdisivir, Barcitimib, O2 therapy; initially made a DNR; refused BiPAP; given high flow O2 on Vapotherm and NRB; had an episode of bradycardia hypoxia and had acute respiratory arrest; wife insisted on CPR; despite CPR pt did not regain a pulse or respirations
Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced burning sensation after injection with PREVENAR. The patient received a dose on an unspecified date. The patient experienced burning sensation after injection with PREVENAR. The outcome was unknown. See related case (s) US-WYE-H13774210 (adverse event, non-expedited). No additional information was available at the time of this report.
Continuous multipitch  ringing (tinnitus) w/some near dizzyspells. since 12.5 hrs post 2nd dose vaccine. NO HISTORY OF TINNITIS PRIOR The night of the administration (1/30/2021 @ 12Noon) 1/31/2021 @ 12:30 AM, I woke up from falling asleep for 30 minutes with this ringing in my ears, which has not stopped since. All of February, All of March, and now, into April.  Will this dissipate? Patient 4/7/2021
Fatigue; Fever; Headache; Passed out; Tachycardia; Shacking; High blood pressure; Breathing issue; A spontaneous report was received from a female patient, unknown age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and passed out, tachycardia, shaking, experienced high blood pressure, breathing issues, fatigue, fever, and headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 04 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.  The patient reported that a fewminutes after receiving the Moderna vaccine shot, she passed out, was shacking, had high blood pressure, and breathing issue. Emergency services (911) was called and the patient was transported to the hospital. The patient recovered after an hour, but since has been feeling fatigue, fever, and headache time to time. No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the event was not reported.  The events passed out, tachycardia, shaking, high blood pressure, and breathing issues were considered recovered/resolved on 04 Feb 2021. The outcome of the events fatigue, fever, and headache were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Vaccines given 11/08/2005 seen in office 11/10/2005 redness and edema, bilateral thigh. TX with Keflex PO.
Plaque psoriasis breakout on inside of legs/backs/arms/couple tiny spots; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Plaque psoriasis breakout on inside of legs/backs/arms/couple tiny spots) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.  No Medical History information was reported.  On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In April 2021, the patient experienced PSORIASIS (Plaque psoriasis breakout on inside of legs/backs/arms/couple tiny spots). At the time of the report, PSORIASIS (Plaque psoriasis breakout on inside of legs/backs/arms/couple tiny spots) had resolved with sequelae.     No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Psoriasis; Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis) and IMMUNISATION REACTION (Vaccination adverse reaction) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Psoriasis) and IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, PSORIASIS (Psoriasis) and IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.            No concomitant medications were provided.  It was unknown if the patient was enrolled in a COVID-19 vaccine trial.  The causality between co-suspect Skyrizi and events Psoriasis and Vaccination adverse reaction was reported as not provided.  No treatment medications were provided.
Pt. states after receiving 2nd Moderna 05/29/2021, started the experience Lump in the arm (size of a dime), soreness traveling up arm, tingling in fingers, bruising.  Still continuing
Parent confirmed DOB 1st dose on 12/12/21 with no allergies and no reaction. Patient was administered second dose of pfizer 0.2ml on right deltoid. At 10:35am patient stared to vomit continuously. Mother confirmed patient had not eaten nor drank before coming for the shot. Bp 121/111, pulse106/min, temp 96.5, resp 19. No signs of respiratory distress noted, patient alert and verbally responsive, pale,clammy and sweating, and feeling dizzy . Mom and patient asked to wait for additonal 30 mins for close observation. Patient's B/P continued to elevate: 10:45am-184/82, 11am and 11:15 am -error no readings. Mother recommended to take patient to ER for further evaluation and COVID-19 testing. Patient and Mother C/O of patient being very fatigued for the last couple of weeks. 11:15 am Patient stablize with no vomiting and released to mother.
Large red rash that was hard to the touch, hot and itchy. They I got a very bad headache for 2 days, a fever for 2 days and a cough for about a week.
PATIENT WAS DISPENSED EXPIRED PFIZER GREY CAP VACCINE. THIS VIAL WAS FIRST PUNCTURED 2:20PM 5/26/22 AND EXPIRED 12 HOURS LATER ON 5/27/22. THIS VIAL WAS ACCIDENTALLY NOT THROWN AWAY AT CLOSE OF BUSINESS AT 7PM 5/26/22. THE NEW IN DATE VIAL WAS REMOVED FROM THE FRIDGE AT 11AM 5/27/22. THE EXPIRED VACCINE VIAL WAS DRAWN FROM BY MISTAKE AND ADMINISTERED TO THE PATIENT AT 11:20AM 5/27/22. BOTH PFIZER AND CDC WERE CONTACTED TO DETERMINE REVACCINATION PROTOCOL AND PATIENT RETURNED TO PHARMACY AT 12:30PM TO RECEIVE IN DATE VACCINE.
Arm soreness, bruising, large rash at injection site thsg got bigger overnight, headache, fever (102 F), chills, fatigue, swollen lymph node in left collarbone,
Information has been received from a consumer, concerning her little sister, a female patient of unknown age. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On approximately 24-MAY-2017 (reported as: 2 weeks ago), the patient was vaccinated with an unspecified dose of M-M-R II (strength, dose number, dose, anatomical location, route of administration, lot number and expiration date were not provided) for routine vaccination. On an unspecified date in 2017, the patient experienced rash, faint, tenderness and migraines; therefore the patient was hospitalized. At the time of the report, the outcome of the patient regarding the hospitalization and the adverse events were not reported. The consumer considered the adverse events to be related to M-M-R II since the reporter consider this as a really badly reaction to the M-M-R II. This is one of three reports received from the same reporter. Additional information is not expected since there reporter did not consent for further follow up. Sender's Comments: US-009507513-1706USA004399: US-009507513-1706USA004400.
Headache; Fatigue; Chills; Nausea; Vomiting; Brain fog; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) in a 72-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.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and FEELING ABNORMAL (Brain fog). At the time of the report, HEADACHE (Headache), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and FEELING ABNORMAL (Brain fog) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided Treatment information was not provided
Flu-like symptoms, low-grade depression, joint pain, nausea, swollen lymph nodes.  Condition persisted for several weeks.  Lymph nodes still swollen after several months.
Patient has had flu vaccines before but this time she had more of a localized skin reaction. Day 1 was soreness. Day 2-4 involved redness, swelling, and heat. Day 5 when the patient came to us at Pharmacy she had redness and heat. She says it was getting better but was still concerned and wanted to report and make us aware.
Severe constipation and impaction; Severe constipation and impaction; Continual runny nose; Inflamed sinus passages which caused nose bleeds; Inflamed sinus passages which caused nose bleeds; Shingles outbreak in right nostril; Headache; Nausea; This is a spontaneous report from a contactable consumer (patient).   A 58-years-old female (not pregnant) patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 08Sep2021, at the age of 58 years old, as 2nd single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome with diarrhea, reflux disease (GERD), hypothyroidism, chronic shingles, and known allergies to sulfa, meperidine (DEMEROL), and amoxycillin. Past vaccination history included the 1st dose of BNt162b2 received on 18Aug2021 in the left arm, at the age of 58 years old. There were no other vaccinations within the 4 weeks prior to the 2nd dose of BNt162b2. The patient received unspecified concomitant drugs. The patient had not had COVID prior to vaccination and was not COVID tested post vaccination. On 09Sep2021, the patient experienced continuous runny nose, inflamed sinus passages which caused nose bleeds, shingles outbreak in right nostril, headache, nausea, and severe constipation and impaction. Treatment due to the events included valacyclovir (VALTREX), suppositories, Fleet Enema. The patient was recovering from the above-mentioned events.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
On March 8 we went and got the 2nd vaccine and he came home with a fever and confusion and I guess dementia just seeming crazy. He was eating dinner on March 9 sitting at the bar with my Mom and for whatever reason when she got back to him (with 5minutes) he was on the floor balled up in a ball, all his muscles were tight- it was hard for us to get him to stretch or even move, unable to move or control his bowels. I went and got him and put him in bed, in the middle of the night he woke up and was going crazy. My Mom called the ambulance and they took him to the hospital and he stayed for 3 days. They got him some Occupation therapy and they were able to snap him out  a little bit. They helped him walk a little it was hard because he has only one arm. We ended up taking him to a nursing home for physical rehab for him to snap out of it but after 2 weeks in the home his brain and cognition and physical abilities deteriorated everyday. To the point we had to send him to a behavioral health hospital who tried to get him on medication to keep him from getting violent- he was there for 31 days and sent back to nursing home and lasted 3 weeks and then he passed away. It was just rapid exponential deteriorated from day to day and was unbelievable to watch.  Every Dr. that saw him said that the vaccine was a contributor to his rapid decline.
Woke up at 3am and it felt like a truck had ran me over.  I was hot, had cold chills muscle and joint aches my hair follicles hurt and i had a temperature of 102.  It felt like the worst case of the flu in my entire life.  It is now 5pm on 2/12/2021 and I'm feeling better still a little dizzy, and still tired.
The following day (after 2nd shot): tiredness, chills, site swelling, site soreness. Rested the entire day. Returned to regular activity the second day after the shot.
Information has been received from a physician concerning a 16 year old female who on 25-MAR-1996 was vaccinated with a first dose of MMR II (route, site, dose and lot number not reported respectively). On 18-JAN-1998, the patient was vaccinated with a second dose of MMR II (route, site, dose and lot number not reported). On 19-NOV-2009 the patient experienced mumps. Lab results for 19-NOV-2009: IgM was<1:10, IgG was 9.13 and Serum Amylase was 30. The patient was afebrile. The outcome for mumps was not reported. Follow up information has been received from the physician concerning a 16 year old (also reported as 14 year old) female patient who on 25-MAR-1996 was vaccinated with a first dose of MMR II (route, site, dose and lot number not reported respectively). On 18-JAN-1998, the patient was vaccinated with a second dose of MMR II (route, site, dose and lot number not reported). On 10-NOV-2009 the patient experienced mumps (also reported as 19-NOV-2009). The patient was diagnosed with mumps on 11-JAN-2010. Labs results for 11-JAN-2009: IgM was<1:10, IgG was 5.87 and Serum Amylase was 550. The patient had left parotitis and experienced cough. The final outcome for mumps was not reported. This is one of several reports from the same source. No further information is available.
Weakness; Dizzy; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), DIZZINESS (Dizzy), NAUSEA (Nausea) and HEADACHE (Headache) in a 98-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 044A2) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced ASTHENIA (Weakness), DIZZINESS (Dizzy), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, ASTHENIA (Weakness), DIZZINESS (Dizzy), NAUSEA (Nausea) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient stated doing very good right now and had no problems.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-053413 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received , adverse events outcome and case narrative were updated.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 59 years, in right arm and as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: Tested positive again after course of med. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Systemic: Allergic: Rash Generalized-Medium, Additional Details: DEVELOPED HIVES THE NEXT DAY, THROUGHOUT THE ENTIRE BODY TO THE BOTTOMS OF THE FEET
pt recvd vax; redness at site p/ dose 1 & 2; nausea x 7 days p/ dose 1; sl fever p/ dose 2;
SEVERE MUSCULAR ARM PAIN, UNABLE TO LIFT ARM.  NO REDNESS OR SWELLING. ALSO SOME BODYACHES, FATIGUE.
horrible headaches;pain on the top left side of the head and Pressure in the head; pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (horrible headaches;pain on the top left side of the head and Pressure in the head) and LIMB DISCOMFORT (pain in the arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CRATAEGUS LAEVIGATA, MAGNESIUM CITRATE, PLECTRANTHUS HADIENSIS, THEANINE, THEOBROMA CACAO (HIGH BLOOD PRESSURURE) for Hypertension.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced HEADACHE (horrible headaches;pain on the top left side of the head and Pressure in the head) and LIMB DISCOMFORT (pain in the arm). On 14-Feb-2021, LIMB DISCOMFORT (pain in the arm) had resolved. At the time of the report, HEADACHE (horrible headaches;pain on the top left side of the head and Pressure in the head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also included Reflux medication. Treatment details included Excedrin.
Back of neck started swelling as well as my shoulders; My chicks became swollen; There was something wrong with my face; It feels like my neck is asleep.; Back of neck started swelling as well as my shoulders; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Back of neck started swelling as well as my shoulders), SWELLING FACE (My chicks became swollen), FACIAL DISCOMFORT (There was something wrong with my face), HYPOAESTHESIA (It feels like my neck is asleep.) and JOINT SWELLING (Back of neck started swelling as well as my shoulders) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced SWELLING (Back of neck started swelling as well as my shoulders), SWELLING FACE (My chicks became swollen), FACIAL DISCOMFORT (There was something wrong with my face), HYPOAESTHESIA (It feels like my neck is asleep.) and JOINT SWELLING (Back of neck started swelling as well as my shoulders). At the time of the report, SWELLING (Back of neck started swelling as well as my shoulders), SWELLING FACE (My chicks became swollen), FACIAL DISCOMFORT (There was something wrong with my face), HYPOAESTHESIA (It feels like my neck is asleep.) and JOINT SWELLING (Back of neck started swelling as well as my shoulders) had not resolved. Not Provided          No relevant concomitant medications were reported. Treatment information included two Benadryl late afternoon and night time only, as advised by the nurse from the vaccination facility to try alleviate the symptoms (Benadryl Tablets for allergies, 200 mg).  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-095552 (Patient Link).