chrisvoncsefalvay/vaers-outcomes huggingface dataset:
26-year-old female patient administer her first dose of Pfizer and upon entering the observation area at 5:45pm she presented Generalized itching throughout the body. It is estimated to be oriented in time, place and person. Presents redness in the area of the thorax and upper extremities. Patient was evaluated with B/P: 110/70, 86 Pulse, 18 RESP and clear lungs on auscultation. In addition, there is no edema in the upper airway, there is no stridor. On the other hand the patient denies feeling fatigues. The case was consulted with Doctor and was ordered intramuscular BENADRYL via telephone. The same was administered in the upper external Gluteus. After 10 minutes body itching decreases and after 30 minutes the patient was evaluated again and the vital signs were B/P: 110/75mmHg, 16 Resp, and 80 of strong and regular pulse, capillary filling 2 seconds, there is no edema and clear lungs to auscultation.
No adverse reaction, patient received H1N1 flu mist and later found out she was pregnant 12/30/09 Prenatal recs received from 11/23/09 to 12/21/09. EDC 6/27/10. Normal IUP. Received H1N1 vax prior to knowledge of pregnancy.
hospitalized with diarrhea due to COVID-19, SARS-CoV-2 positive
Vaccine administered at 7:35am; at 7:55am associate complained that lips felt puffy and hands felt shaky.  Blood pressure and pulse were check several times; was provided crackers and juice; associate said she felt better and left the facility at 8:10am.  Was monitored for 30minutes for due to allergy history;
Patient had DTaP, PCV7, IPV, and HIB #3 on 10/31/03. Patient had no reactions to vaccines while in the clinic. Received telephone call from patient's mother. Mother states patient woke up on 11/1/03 with hard labored breathing and a fever. Patient was taken to ER and was treated with Tylenol and sent home. Patient has no other documented reactions on file.
This spontaneous case, initially received on 17-Oct-2018 (combinedly processed with the follow-up received on 18-Oct-2018) reported by other healthcare professional (nurse), concerns a 15-year-old adolescent, male patient. On 14-Oct-2018 at 11 a.m., the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency unknown), route of administration: intramuscular, anatomical location: deltoid, batch number: 252670 and expiry date: 30-Jun-2019] (at pharmacy). On the same day (reported as Sunday) after vaccination, the patient broke out in hives. It was reported that at 2 o'clock (on the same day), 3 hours after vaccination, the patient's hands felt funny (considered as feeling abnormal) and he developed bumps on his arms (raised rash). it was reported by the patient's mother (nurse), who noticed at 5 o'clock, that the bumps were spreading to the patient's thighs, inner thighs, legs and everywhere, all over his body. The patient experienced no breathing difficulties or respiratory involvement. It was reported that the event kept recurring, due to which the patient was unable to attend school for a full day. The patient had missed a total of 3-5 days of school. On 15-Oct-2018, the patient had an appointment with his paediatrician and was prescribed steroids and antihistamine after which his events improved a little bit. On 16-Oct-2018 (reported as Tuesday morning), the events got worse again. The patient was taking prednisone 15 mg daily, at present. He was also taking diphenhydramine initially but later switched to ALLEGRA in the morning and ZYRTEC at night. It was reported that the events would improve with steroid but as the day went on, events would reoccur. It was reported that the symptoms went on for a week and then subsided. The patient took a total of 5 days of steroids and anti-histamines around the clock until all the symptoms disappeared. The patient was again back to school and had stopped the steroids and antihistamines. The patient had no further problems. On an unspecified date in 2018, the patient had recovered from the events. The reporter assessed this case as non-serious. Follow up received by other healthcare professional (nurse) on 01-Nov-2018: The start date of the product 14-Oct-2018 was confirmed. The outcome of the events was updated from not-recovered to recovered. It was reported that the symptoms went on for about a week and then subsided. The patient took a total of 5 days of steroids and anti-histamines around the clock until all the symptoms disappeared. The patient had missed a total of 3-5 days of school but on an unspecified date, the patient was again back to school and had stopped the steroids and antihistamines. The patient had no further problems. The narrative was amended accordingly.
The patient was seen in the ED on 10/9/23 for fever (103.5 F), cough, nasal congestion, and weakness for the past two days. He reported that his wife recently tested positive for COVID-19. A COVID PCR test performed in the ED also resulted positive for the patient.  Ultimately, the patient was admitted 10/9/23 - 10/11/23 with diagnoses including acute hypoxic respiratory failure due to COVID-19. During his admission, the patient required supplemental O2 but was weaned to room air by discharge. Additionally, the patient was on dexamethasone.  Of note, the patient has received three doses of the Pfizer monovalent COVID vaccine (given 2/2/2021; 2/23/2021; 11/2/2021).
Shingles outbreak on left cheek followed by mouth sores and gum bleeding when flossing and a bad taste in mouth.  The outbreak on the cheek resolved within a week and the mouth sores, bleeding and bad taste lasted for about 3-4 weeks.
bacterial infections; cellulitis; a slight temperature raise; headache; a slight fever; chills; developed a rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (bacterial infections; cellulitis) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced INJECTION SITE RASH (developed a rash at the injection site). On 02-Apr-2021, the patient experienced HEADACHE (headache), PYREXIA (a slight fever) and CHILLS (chills). On an unknown date, the patient experienced CELLULITIS (bacterial infections; cellulitis) (seriousness criterion medically significant) and BODY TEMPERATURE INCREASED (a slight temperature raise). At the time of the report, CELLULITIS (bacterial infections; cellulitis), BODY TEMPERATURE INCREASED (a slight temperature raise), HEADACHE (headache), PYREXIA (a slight fever) and CHILLS (chills) outcome was unknown and INJECTION SITE RASH (developed a rash at the injection site) had not resolved. Not Provided          Treatment for the events included antibiotics, Duricef/cefadroxil 500mg per capsules.; Sender's Comments: Based on the current available information and the temporal association between the product sue and the start date of the events a causal relationship cannot be excluded.
Really bad itching in right eye . pain in neck , shoulder, knees and ankles . Tingling in finger tips . Left foot numbness.
Dizziness, increased heart rate. BPs 190/117 (pulse 95), 169/98 (pulse 79). O2 sats 100%, 99%. Juice x 2, crackers.
Fever; Hives; Chills; severe body aches; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 45-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm left on 18Jun2021 at 12:00 (at the age of 45-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included LBS, Gastroperesis diverticulosis disease and chronic fatigue syndrome. The patient was allergic to Alpha-gal. The concomitant medications of the patient included linaclotide (LINZESS) and alprazolam (XANAX). The patient previously received first dose of BNT162B2 (solution for injection, Batch/Lot number: UNKNOWN) as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 18Jun2021 at 22:00, the patient experienced hives, chills, severe body aches and also experienced fever on 19Jun2021 at 04:00. The patient underwent lab tests and procedures which included fever: 101-102 on an unspecified date and fever: 102.5 on 19Jun2021. Therapeutic measures were taken as a result of hives and fever that included rotated Tylenol and ibuprofen to reduce fever and Benadryl for hives. The outcome of all the events was reported as not resolved.  Information about lot/batch number has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information on their medical history, concurrent conditions or concomitant drugs was provided. On 11-AUG-2014 the patient was vaccinated with a dose of expired VARIVAX lot# G007580, expiration date 04-AUG-2014 (dose, route and site of administration were not reported). No adverse effects were reported. Additional information is not expected, as there is no consent to contact the reporting pharmacist.
2 days after receiving the 2 immunizations, pt developed behavior of thrusting tongue to left 2-4 times an hour; disappears during sleep. Symptoms less frequent as of today.
Patient had a simple febrile seizure 9 days after receiving MMR vaccine. Patient without any other symptoms at time of seizure event. Family was away on vacation and child was brought to ER.
headaches; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) and MYALGIA (body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches) and MYALGIA (body aches). At the time of the report, HEADACHE (headaches) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment drugs are not provided by reporter.   Reporter did not allow further contact
PT states she developed numbness in feet and perineum on 3/26/03, subsequently got paresthesias on trunk 3/28/03 and hands. No SXs of muscle weakness or pain, no prob's with walking, talking, eating, no SOB.
Moderna COVID-19 Vaccine EUA: patient presents to oncology clinic with four days of fevers (maximum temperature 103 degrees F), dry cough, left arm erythema and swelling and tachycardic after vaccination. Admitted to unspecified hospital for management of neutropenic fevers.
Patient was given the monovalent vaccine vs the bivalent. no known adverse outcome. We were told by DPH to record this as a med error.
Initial and follow up information has been received for the Pregnancy Registry for GARDASIL from a Registered Nurse (R.N.) concerning a 22 year old female patient who on 02-JUL-2007 was vaccinated with a first dose of GARDASIL lot #656050/0245U.  The nurse reported that patient received the injection during pregnancy.  No adverse reactions were reported.  Unspecified medical attention was sought by the patient.  In follow up information the doctor's office reported that patient had shingles approximately at 26 weeks of her pregnancy.  She had ultrasound x3 was done and they were reported as normal.  On 28-FEB-2008 she delivered a female normal baby 39 weeks from her last menstrual period.  The baby weighed 6 lb 8 oz and was 21 inches in length.  Her Apgar score was 8/9.  There was no congenital abnormalities reported.  Additional information is not expected. Pediatric medical records were received and reviewed concerning a female normal infant which reported the following: On 07-MAR-2008 the one week old infant weighted  9 7 pounds and 4 ounces. The physical exam and development were normal. On 17-MAR-2008 the infant weighted 7 pounds 12 ounces with clothes. Patient had stuffy nose, no fever and also white cuating of tongue which was diagnosed as thrush and URI. Heart and lung examinations were negative. Abdomen, nott. The infant was treated with saline nose drops and nystatin suspension 60 ml, 1 ml QD. On 08-APR-2008 the approximately 2 month old infant weighted 9 pounds 2 ounces with clothes. Her height was 22.5 inches. Infant is doing well except for thrush. Ear, nose, throat (ENT) examination showed tongue coated white. Heart and lung examinations were negative. Abdomen soft. Infant continued with nystatin suspension treatment. On 22-APR- 2008 lab and diagnostic test from the newborn screening lab report were within normal limits. The patient still had thrush. On 09-MAY-2008 the approximately 2 month old female infant was vaccinated with PEDIARIX, PREVNAR. The infant with age appropriate growth and development weighted: 12 pounds. Height: 24 inches, and (FOC): 41.4. Physical exam revealed positional plagiocephaly (infant was encourged to look towards left) and constipation. Reinforced safe sleep practices, supervised (tummy time) were recommended. Also 1 ounce of prune juice added to 1 or 2 bottles of formula per day was recommened. In June 2008, the approximately 3 month old infant with age appropriate growth and development weighted 15 pounds and 1 ounce. Height : 25.5 inches and FOC: 43.0. Physical exams were normal. Ocassional constipation was noted. Reinforced safe sleep practices supervised were recommended (tummy time). On 19-JUN-2008, mild eczema-like rash was noted on left cheek treated with EUCERIN. On 15-JUL-2008 the approximately 4 month and a half old infant was vaccinated with PEDIARIX, PREVNAR. Weight: 16 pounds. Height: 26.25 inches and FOC: 44.4. Physical and development exams were normal. As stated above, the infant experienced constipation, mild eczema-like rash on left cheek while on therapy with Hib conj vaccine (OXPC) (MSD) (WAES 089USA01524). No further information is available.
three patients tested positive for COVID-19 virus after first dose of Moderna COVID-19 Vaccine; three patients received second Moderna COVID-19 dose over 37 days after first dose; three patients received second Moderna COVID-19 Vaccine less than 90 days after receiving; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (three patients tested positive for COVID-19 virus after first dose of Moderna COVID-19 Vaccine), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (three patients received second Moderna COVID-19 dose over 37 days after first dose) and SARS-COV-2 ANTIBODY TEST (three patients received second Moderna COVID-19 Vaccine less than 90 days after receiving) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced COVID-19 (three patients tested positive for COVID-19 virus after first dose of Moderna COVID-19 Vaccine), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (three patients received second Moderna COVID-19 dose over 37 days after first dose) and SARS-COV-2 ANTIBODY TEST (three patients received second Moderna COVID-19 Vaccine less than 90 days after receiving). At the time of the report, COVID-19 (three patients tested positive for COVID-19 virus after first dose of Moderna COVID-19 Vaccine) and SARS-COV-2 ANTIBODY TEST (three patients received second Moderna COVID-19 Vaccine less than 90 days after receiving) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (three patients received second Moderna COVID-19 dose over 37 days after first dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. Treatment medications were Monoclonal Antibody Shot on 15Feb2021.
Several hrs (2-3) p/receiving inject, pt broke out in generalized rash (face & upper body), periorbital edema; no SOB; pt got epinephrine inject @ peds office & was sent home rash & edema resolved;
got sick; fever; chills; swollen lymph nodes under left arm pits; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Jan2023 at 10:30 as dose 4 (booster), single (Lot number: GH9697) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; TRADJENTA; LISINOPRIL; VIT D [COLECALCIFEROL]. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL1284, Location of injection: Arm Left; Vaccine Administration Time: 08:30 AM), administration date: 28Dec2020, when the patient was 54-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EL8982, Location of injection: Arm Left; Vaccine Administration Time: 08:00 AM), administration date: 15Jan2021, when the patient was 54-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: EW0196, Location of injection: Arm Left; Vaccine Administration Time: 08:00 AM), administration date: 15Oct2021, when the patient was 55-year-old, for Covid-19 immunization, reaction(s): "chills", "got sick", "swollen lymph nodes under left arm pits", "fever". The following information was reported: CHILLS (non-serious) with onset 04Jan2023 at 21:00, outcome "recovering"; PYREXIA (non-serious) with onset 04Jan2023 at 21:00, outcome "recovering", described as "fever"; MALAISE (non-serious) with onset 04Jan2023 at 21:00, outcome "recovering", described as "got sick"; LYMPHADENOPATHY (non-serious) with onset 04Jan2023 at 21:00, outcome "recovering", described as "swollen lymph nodes under left arm pits". The events "got sick", "fever", "chills" and "swollen lymph nodes under left arm pits" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300025237 same reporter/patient/AE, different dose.;
I am having pain under my right armpit. It started on 4/30/2021 and as of today it still hurts.  I apply a cold pack underneath my armpit to try to help it.  I experienced the same thing from the first vaccine but I didn?t think it was from the shot itself until now.
Hip is so inflamed; She could hardly walk; Felt terrible; Right hip is so inflamed; Pain in hip; Little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Hip is so inflamed), GAIT DISTURBANCE (She could hardly walk), FEELING ABNORMAL (Felt terrible), INFLAMMATION (Right hip is so inflamed) and PAIN IN EXTREMITY (Little sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Little sore arm). On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced JOINT SWELLING (Hip is so inflamed), GAIT DISTURBANCE (She could hardly walk), FEELING ABNORMAL (Felt terrible), INFLAMMATION (Right hip is so inflamed) and ARTHRALGIA (Pain in hip). At the time of the report, JOINT SWELLING (Hip is so inflamed), GAIT DISTURBANCE (She could hardly walk), FEELING ABNORMAL (Felt terrible), INFLAMMATION (Right hip is so inflamed) and ARTHRALGIA (Pain in hip) was resolving and PAIN IN EXTREMITY (Little sore arm) outcome was unknown.            Patient mentioned this is her 6th week of having a little pain in hip but is better now. Concomitant medication list was not provided. Treatment information was not provided.    This case was linked to MOD-2021-074727 (Patient Link).
ULCERATIVE COLITIS FLARE UP; CONTRACTED COVID; VACCINE CAUSED SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE UP) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Colitis ulcerative.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE UP) (seriousness criterion medically significant), COVID-19 (CONTRACTED COVID) and VACCINATION SITE PAIN (VACCINE CAUSED SORE ARM). At the time of the report, COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE UP), COVID-19 (CONTRACTED COVID) and VACCINATION SITE PAIN (VACCINE CAUSED SORE ARM) had resolved.            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  Concomitant medications were not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial. Treatment medications were not reported.   The reporter's causality for the event(s) of vaccine caused sore arm, contracted covid and ulcerative colitis flare up was not provided.  Company comment: This is a spontaneous case concerning an adult male patient with Ulcerative colitis on treatment with Adalimumab, who experienced the non-serious unexpected event COVID-19 (AESI) and colitis ulcerative flare up. The events occurred on an unknown date after the third dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning an adult male patient with Ulcerative colitis on treatment with Adalimumab, who experienced the non-serious unexpected event COVID-19 (AESI) and colitis ulcerative flare up. The events occurred on an unknown date after the third dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Fever, trouble sleeping, lethargy, irritability loss of appetite, pain/redness at injection site vomiting, diarrhea. AU above for 1 week. Dr visit required. Dr said it was not flu or stomach virus.