chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse and a physician referring to a 4 years old patient of unknown gender. Concurrent conditions and medical history were not reported. ON 27-MAR-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot# J005693, expire date 07-MAY-2015, dose, route, anatomical location were not reported) (incorrect product storage). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected since all the follow up has been done.
Fever; Headache; Body aches; Joint pain; Fatigue and tiredness; Chills; Swollen lymph nodes in neck; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 11Apr2021 at 12:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included lipedema (connective tissue/fat disorder) and COVID-19 on an unknown date. The patient was allergic to sulfa drugs. The patient did not receive any medication within two weeks of vaccination. The patient previously took sulfamethoxazole; trimethoprim (BACTRIM) and experienced drug allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 06:30, the patient experienced fever 99.8 which then rose to 100.5, headache, body aches, joint pain, fatigue and tiredness, chills and swollen lymph nodes in neck. Therapeutic measures were taken as a result of the events and included treatment with extra-strength acetaminophen. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event fever was resolved on 14Apr2021; swollen lymph nodes, chills, body ache and joint pain were resolved on 17Apr2021 and headache and fatigue were resolved on 18Apr2021.  No follow-up attempts are needed. No further information is expected.
Sixteen hours after receiving his second Pfizer COVID19 vaccination on 9/17/21 (first was given three weeks prior on 8/25/21 with no issues save brief arm soreness), parents state he began having fevers >100.4F,  Tm 102.5F, treated with acetaminophen/ibuprofen as soon as they approached 102F. Also had headaches with fevers, intermittent myalgias and heart palpitations. Was seen at doctor's office on 9/22/21 where troponin, CRP, CBC, CMP, ESR, C3, C4, urinalysis and total complement were normal/negative.  Seen in ED on 9/25/21 where a COVID-19/Flu/RSV NP PCR was negative. Repeat CBC, CMP, CRP, ESR, urinalysis were normal/negative. EKG was normal. EBV serology showed past infection. Blood culture no growth final. On 9/28/21 the patient had a normal echocardiogram (and has had a second echo and second EKG that were also normal). He was fitted for a Holter monitor and at the time of this writing by report from parent there were no abnormal reports from the cardiac monitoring service. He was seen in Pediatric Infectious Diseases on 9/28/21 (along with Pediatric Rheumatology), and again on 9/29/21 and 10/5/21. Throughout the workup period his physical exam was reassuring and negative for red flags. Labs were repeated: CRP X2, troponin X 2, CMP, CBC, ESR were again all normal. A respiratory pathogen panel was negative (including COVID-19). Antibody for SARS-CoV-2 nucleocapsid was negative. At the second visit, it was discovered that temperatures were being taken via forehead thermometer. Family was counseled to switch to an oral thermometer. Afterwards, except for one temperature to 100.6F on 9/29/21, there were no further temperatures 100.4F or above.  In conclusion, it is unclear if true fevers were present, and for how long, after the second COVID-19 Pfizer vaccination on 9/17/21. At maximum, temperatures were possibly present from 9/18/21 until 9/29/21, 11 days after vaccine (although taken via forehead thermometer).  Labs and imaging did not indicate a myo/pericarditis picture.  So far, at the time of this writing, there were no unusual findings from a Holter monitor. Currently he is not having fevers, and except for the intermittent palpitations and transient nausea/abdominal pain with the palpitations, he is not having any other symptoms.
REceived moderna vaccine on 4/7/21 and 5/5/21. Presented to ER on 2/9/22. Found to be COVID positive on 1/31/22. Patient reports his symptoms for COVID started approximately 3 weeks ago, he was tested positive on 31st January, he received monoclonal antibody treatment and reports he received 2 doses of vaccine.  Over the course of time he was slowly getting short of breath mainly with exertion and also has been coughing along with sharp pleuritic chest pain.  He reports he does not use oxygen at home.  Went to PCP was found to be hypoxic sent to the ED.In the ED patient was tachycardic, oxygen saturation 84% on room air, was put on supplemental oxygen. acute hypoxia requiring 3 L of nasal cannula oxygen. He had received 2 doses of the Moderna vaccine. He was started on antibiotics, decadron and oxygen supplementation. He was also diagnosed with acute bilateral pulmonary embolism without right heart strain, was initially treated with full-dose Lovenox. Clinically did well. We were able to wean down his oxygen. He was discharged home in stable condition on February 13 th 22. 6 minute walk test was completed and was determined that he requires no oxygen at rest but needs 3 L with exertion. Discharged on 2/13/22
Sick all night; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got shingles shot and was sick all night.  They said the second shingles vax was worse.  Not looking forward to that, but a couple sick days was better than an outbreak of shingles. Additional Supportive Information: The follow up would not possible, as no contact details were available.
two episodes of vertigo; Lightheadedness and dizziness; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (two episodes of vertigo) and DIZZINESS (Lightheadedness and dizziness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 030L20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included QUINAPRIL, CELECOXIB (CELEBREX) and AMLODIPINE BESILATE (NORVASC) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-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 experienced VERTIGO (two episodes of vertigo) and DIZZINESS (Lightheadedness and dizziness). At the time of the report, VERTIGO (two episodes of vertigo) outcome was unknown and DIZZINESS (Lightheadedness and dizziness) had not resolved.            .  No concomitant medication was provided by the reporter.   No treatment information was provided by the reporter.   This case was linked to MOD-2021-018255 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up received on 03-jun-2021 contains information about 2nd dose
Pt had what appeared to be a vasovagal / syncope response after receiving vaccines today. Pt was sitting up in chair smiling and talking after receiving all three vaccines. Pt did not complain of feeling dizzy or unwell. Within minutes, pt suddenly tensed up and fell out of the chair and onto the floor hitting her forehead. Pt was alert and assisted to the exam table where vitals were assessed, an ice pack was applied, and a coke was given to drink. Vitals assessed: BP 110/73 and HR 92 @ 11:24 AM and BP 117/81 HR 93 @ 11:38 AM. Pt stated after the event that she felt a little dizzy "after the third shot" (HPV vaccine) but did not say anything at the time. Pt sister stated she had not had much to eat and was a little anxious about getting shots but has never reacted like this before. Pt was monitored for about 30 minutes sitting up on exam table until father arrived to pick her up. Pt stated she felt fine with the exception of her head hurting where she hit it on the floor. Pt had about 3x3 cm knot on forehead. Pt father stated he was going to take her the ER to be checked out.  Contacted patient's father to check on patient around 5:00 PM. Pt father stated he took her to the ER where they did a cat scan and everything checked out fine. Pt father stated pt is okay and appreciated the phone call.
Headache; injection site is at hurts a little bit.; he is feeling warm, is not sure if it's due to the vaccine and he thought he might want us to know; arm hurts; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 27-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on 22Jun2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. The patient experienced headache, injection site is at hurts a little bit, he is feeling warm, is not sure if it's due to the vaccine and he thought he might want us to know and arm hurts on an unspecified date in 2021. Patient asked if it's alright to take Aspirin or place an ice pack on the injection site. Outcome of all the events was unknown.  Information about Lot/batch number is requested.
Wife had the shot and has the Shingles/Suspected vaccination failure; Shingles right now, really bad / going thru living HELL; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female 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 reported as follows: The case was reported by the patient's spouse. The age at vaccination was not reported. The patient got the shingles shot and right now she was going through living hell. The shingles was not preventable and it was really bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Couple of hrs. after shot, screamed, cried, "unconsolable" "like she was hurting" for 4 1/2 days. Would stop crying/screaming for some time, but would start again. Had to walk & bounce her, but was still "crabby".
Headache, Myalgia, Fever,  severe headache, muscle aches, fever, skin tenderness Took medications for above sx but did not specify what
severe rash all over entire body, pronounced on both arms, reddened, itchy, bumpy, painful (some soft the touch- some rough to touch)
This is a spontaneous report by a contactable nurse. A 12-month-old male patient received third dose of PREVNAR 13 on an unknown date at 13:30, on left arm. Relevant medical history and concomitant medication were none. Vaccines given on the same day were none. Vaccines taken within the last four weeks were none. On 27Jun2013 while on PREVNAR 13 after he was administered the third dose he experienced fever up to 104. Relevant lab data was none. At the time of the report he had not recovered from fever up to 104. Follow-up (07-AUG-2013) Follow-up attempts completed. No further information expected.
red maculopapular rash on face & trunk 9 days p/vax;
Shortness of breath, dizzy, fever all about an hour after - lasted about 4 hours.
I was vaccinated and still got COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I was vaccinated and still got COVID-19) 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 COVID-19 (I was vaccinated and still got COVID-19). At the time of the report, COVID-19 (I was vaccinated and still got COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
red, raised area, lt leg very hot; pt very "fussy" mod amt fevered-(not measured);
A small subdeltoid fluid collection is present.  There is also minimal edema within the anterior aspect of the deltoid muscle itself.  The adjacent subscapularis portion of the cuff has mild tendinosis.  A rotator cuff tear is not seen.  The labrum has a normal appearance.  There is no tendon dislocation.  There is no bone marrow edema.  A type I acromion is present with a small subacromial spur is present.  Mild AC joint hypertrophy is present.  A small amount of fluid is present within the subdeltoid bursa.  The adjacent deltoid muscle has minimal edema ant the adjacent subscapularis portion of the cuff has mild tendinosis.  While the findings could represent an infection, it is less likely.  An infection usually has a more exuberant inflammatory response.  There is no other significant abnormality.
A consumer reported the development of redness on the neck and face of her 49 year old sister hours after receiving her first FluMist inhalation. The pt has a history of early childhood brain damage associated with whooping cough and a detailed history involving drug reactions to other medications. Detailed drug allergy history was not provided. The pt received FluMist on the afternoon of 23Oct04. The reporter stated that by dinner a red streak formed done one side of the pt's face and it had gradually spread to her neck by evening. Pain nor itching were not reported. As of 28Oct04 the redness had resolved.
First Day my head was in a fog, struggled to concentrate.  Day two and three I feel like I have a hangover with headache.   still struggling to concentrate.
No abnormal side effects - sore arm (given tylenol by mother) *given adult dose
lower abdominal cramping, especially right lower quadrant and right lower back pain.  Felt like menstrual cramps but was not accompanied by a period (I have had an endometrial ablation), nor was it the time for me to have a period. I have never had this pain so persistent and severe. Completely relieved by Tylenol 1000mg every 6 hours, which was needed around the clock to keep the pain away so I could function. On day 5 I was seen by the NP who ordered a transvaginal ultrasound.  She did not feel my pain was GYN-related. the pain stopped on Saturday Jan 2, 2021. GYN NP referred me to GI Dr., who I saw on  1-13-2021, he did not feel the pain was GI related, no testing done at that time (I was no longer having the pain).  I am scheduled for colonoscopy on 2-3-2021, only because I need a routine screening because of my age, it was not ordered because of the pain I felt in December.
pain exp @ time of inject & all day swelling occurred that evening from site to finger tip; rings had to be cut off; swelling had subsided in 24 hrs; no tx sought; no other sx ie wheezing etc;
felt like a tiny prick and felt like it did not go all the way in; felt irritated on the injection spot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE IRRITATION (non-serious) with onset 25Oct2023, outcome "unknown", described as "felt irritated on the injection spot"; VACCINATION SITE PAIN (non-serious) with onset 25Oct2023, outcome "unknown", described as "felt like a tiny prick and felt like it did not go all the way in".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse event; Pharmacy manager stated the vaccine was administered to one patient on 18May2023 and two patients on 19May2023. Patients are 1 female and 2 males.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy manager stated the vaccine was administered to one patient on 18May2023 and two patients on 19May2023. Patients are 1 female and 2 males.) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.     It was reported that patient did not receive any other vaccines in 4 week prior to COVID-19 vaccine.  Concurrent medical conditions included Diabetes, Obesity, Heart disease, unspecified and Renal disease.    In May 2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. In May 2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy manager stated the vaccine was administered to one patient on 18May2023 and two patients on 19May2023. Patients are 1 female and 2 males.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy manager stated the vaccine was administered to one patient on 18May2023 and two patients on 19May2023. Patients are 1 female and 2 males.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacy manager stated the vaccine was administered to one patient on 18May2023 and two patients on 19May2023. Patients are 1 female and 2 males.).    Concomitant drugs were not reported.  It was reported that the vaccine which was expired on 17-May-2023 was administered to three patients one on 18-May-2023 and two on 19-May-2023.  Treatment medications were not provided.  This case was reported for 1 female patient.   This case was linked to US-MODERNATX, INC.-MOD-2023-725921, US-MODERNATX, INC.-MOD-2023-725912 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-725921:(Male Patient no-2) US-MODERNATX, INC.-MOD-2023-725912:(Male patient no-1)
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, Fatigue Narrative:
Information has been received from a 66 year-old female consumer with hypothyroidism and no known drug reactions or allergies reporting on herself. On 09-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (dose and lot # not provided). Concomitant medications included EFFEXOR and AMOUR THYROID tablets. It was reported that, on 09-OCT-2013, the patient experienced nausea and headache after receiving ZOSTAVAX. No treatment was given. The patient did not seek medical attention. No lab tests were done. At the time of the report, the patient was recovering from nausea and headache. Relatedness between nausea and headache and ZOSTAVAX was not reported. Additional information is not expected.
Fatigue, thirst. Went to bed. Woke up couple hours later and had throat pain, trouble swallowing. Next day, weakness, fatigue, dehydration, diarrhea, chills, sllght fever, upset stomach, cold feet, heart laboring, slight labor in breathing with slight cough.
Janssen COVID-19 Vacccine EUA - fever which reached almost 102 approximately 12-14 hours after vaccination; also within the same time frame accelerated heart rate (99 after laying in bed for an hour), shallow frequent breaths, severe headache, nausea and vomiting, aches, chills, sore muscles, fatigue. Headache dissipated after approximately 12 hours after onset. Nausea/vomiting occurred approximately 12 - 20 hours after vaccination. Fever completely gone 26 hours after vaccine. 48 hours later back to normal. If the booster is reported to have similar side effects I will skip it.
Oth complications following immunization, NEC, sub on 2017-12-13.
Red round circle 1.5 by 3.5 inches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red round circle 1.5 by 3.5 inches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red round circle 1.5 by 3.5 inches). At the time of the report, VACCINATION SITE ERYTHEMA (Red round circle 1.5 by 3.5 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.
felt herself losing consciousness; Low blood pressure following event (50/20); My vision went blurry first; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 25Jan2021 at 09:30 at a single dose in the workplace clinic for COVID-19 immunization. Medical history included asthma and history of vasovagal syncope following vaccinations; this adverse reaction to the vaccination directly aligns with other episodes that have occurred to her following vaccinations/interactions with needles (ie. blood draws). The patient had no COVID prior to vaccination. The patient is not pregnant. Concomitant medication included levonorgestrel (MIRENA). On 25Jan2021 at 09:30 (after getting the vaccine), the patient felt herself losing consciousness, her vision went blurry first and she was able to brace herself by lying down against a wall, and low blood pressure following event (50/20). Blood pressure and pulse rose over the next 25 minutes. 15 minutes more of observation was completed. The patient did not receive treatments for the events. The patient was not tested for COVID post vaccination. The patient recovered from the events.  Information on the Batch/Lot number has been requested.