chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient with history of CHF, diabetes, dementia, and Factor V Leiden.  He was brought to the ED by EMS on 2/2/23 for evaluation of weakness, fever, congestion, and low O2 saturations. Patient was currently recovering. Over the last few days, staff noted patient was more confused and disoriented. He was placed on 2L O2 by staff. In the ED, patient was febrile, tachypneic, and hypoxic with O2 saturation at 85% on room air. COVID PCR test was done and resulted positive. He was admitted to the hospital on 2/2/23. On 2/4/23, the patient passed away unexpectedly. Discharge diagnoses include sepsis suspected due to pneumonia, acute hypoxic respiratory failure, bilateral pleural effusion, and COVID pneumonia.
Pain at injection site lasting more than 24 hours; fatigue; This is a spontaneous report from a contactable consumer (patient).   This  73-years-old not pregnant female patient received,at hosptial,  bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) administered in Arm Left on 08Mar2021 as SINGLE DOSE  at age of 73 years for covid-19 immunisation  .  Medical history included pneumonia from an unknown date and unknown if ongoing (but have since been vaccinated for it 2x in last 4 yrs ), iodine allergy from an unknown date and unknown if ongoing.  No other vaccine received in the last four weeks .Concomitant medicatoins includes: OTC vitamins & health aids.The patient experienced pain at injection site lasting more than 24 hours on 08Mar2021 21:00 with outcome of unknown  and fatigue on 08Mar2021 21:00 with outcome of unknown.  No treatment recevied for the events.No covid prior vaccination: No covid tested post vaccination.  Information about lot/batch number has been requested.
pt had fever @ 4days of life which required a complete septic work-up which was neg;
1 year and 5 months after getting the Pfizer vaccination i was diagnosed with blood blots and am embolism. Currently I am still being treated.
Within one hour of receiving the shot, I felt a hot burning sensation going through my body and the burning continued on in the back of my head for the next hour. Ever since the shot I have had numbness on and off in my extremities and in my face.
warmth; local stiffness; nausea; temperature at that time was 98.6F; Headache; fatigue; they treated it as cellulitis in her arm; extreme soreness, swelling, redness and warmth from shoulder to elbow; swelling; rednes from shoulder to elbow; This spontaneous report was received from a Registered Nurse and refers to a 77 year old female patient of unknown age. Information about the patient's medical history, concurrent conditions or concomitant medications was not provided. The patient had received pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 23 in 2006.  On 24-AUG-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) at 0.5 mL dose, intramusculary, which had a lot # T009744 with expiration date on 28-JAN-2022 (anatomical location of administatrion was not reported) for the prevention of pneumococcal disease.   On 25-AUG-2020, the patient complained of "extreme soreness, swelling, redness and warmth from shoulder to elbow". Then, on 26-AUG-2020, the "swelling and warmth had extended to her hand", reported "local stiffiless, but no tingling", "nausea, no vomitting", "felt like I was running a temperature" (caller reported temperature at that time was 98.6F). Nurse reported that the patient had called the pharmacy and the health care profressifonal stated that "they treated it as cellulitis in her arm"; The patient was prescribed "linezolid 600 mg BID for 10 days".  At the time of this report the "area remained red, mildly swollen, forearm to wrist" and that she was experiencing "headache and severe fatigue". However, the patient was recovering from pain, fatigue, headache, cellulitis, pyrexia, nausea, musculoskeletal stiffness and joint warmth.  The reporter did not provide teh causality between the events and vaccination with  Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).  Upon internal review, cellulitis was considered to be medically significant.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: T009744; expirationdate: 28-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2009USA002460:
tested positive (COVID-19)between first and second doses; 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 COVID-19 (tested positive (COVID-19)between first and second doses) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive (COVID-19)between first and second doses). At the time of the report, COVID-19 (tested positive (COVID-19)between first and second doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive)   No concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
About 3 hours after getting the vaccine I started to feel short of breath. About 5 hours after that I got chills that made me shake all over because I got a fever of 103. Then 2 hours later my heart started to beat very rapidly and got up to 126 beats per minute, my heart was also not only beating vast but very very hard. Then throughout the night and all of the next day, I had pain in my chest on the left side and also pain in my rib area on the left side. The pain lasted for over 24 hours and because of that I went to the emergency room. It turned out they didn't find anything life threatening at the emergency room but all the pain I had was very scary and very uncomfortable. It was a terrible experience and because of it, I am telling people not to get the Johnson and Johnson vaccine.
Myalgia, Arthralgia & Fever Narrative:  dose 1-day 2-pain in inj site/bodyache dose 2-day 1-2 pain in inj site fever/ bodyache/fatigue
rash is red; itchy; rash is red, itchy that comes and goes and is on the side of his stomach and looks like it wants to go up under my breast; This is a spontaneous report from a contactable consumer (patient himself). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Left on 11Mar2021 11:30 as dose 1, single for COVID-19 immunisation (Age at Vaccination was 73 years). The patient medical history included Blood pressure high (controlled by medication) and Blood thinner. Concomitant medications included ongoing Clopidogrel, 75mg daily taken for blood thinner from 2005 and ongoing Atenolol, 25mg twice daily taken for Blood pressure high from 2005. On 13Mar2021, the patient experienced rash is red, itchy that comes and goes, and is on the side of his stomach and looks like it wants to go up under my breast. Therapeutic measures were taken as a result of events include topical Triamcinolone Acetate 1% cream. The seriousness of the events was non-serious. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
The Meningococcal Conjugate vaccine that I administered was 11 days expired (5/31/2020) when I gave it. I did not catch this error until I had begun charting, at which point, I took the following steps:  1. Assessed client for any adverse effects and monitored closely for 10 minutes. 2. Made client aware of situation and informed them of steps I would take to rectify the situation. 3. Promptly alerted supervisory staff.   Client stated that he felt fine and did not appear to be experiencing any adverse effects, so I allowed him to leave the clinic with the understanding that if anything changed, he should contact me immediately.
Information has been received through the manufacturer mentioned pregnancy registry from a physician concerning a 38 year old female with no known medical history or allergies who on 02-Jun-2006 was vaccinated with a 0.5 ml SC dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (lot#652325/0953R).  There was no concomitant medication.  After the vaccination the patient called the office complaining of nausea and was given a pregnancy test on 19-Jun-2006.  The pregnancy test was positive.  At the time of the report the patient was "three weeks pregnant", with her LMP of approximately 01-Jun-2006.  There was no product quality complaint involved. Additional information has been requested. Follow-up information was received from a nurse who reported that the "office" was unable to contact the patient, and therefore she had no information regarding the pregnancy outcome of the patient.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. During 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about April 2016, the patient was treated at a medical center and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Patient said she had fever, rash on arm that was warm, headache, and sore arm for two days post vaccination.
This spontaneous report as received from a nurse refers to unspecified patient of unknown age and gender. No medical history and current conditions were reported. The nurse reported that on an unknown date unknown number of patients were inadvertently vaccinted with GARDASIL (not GARDASIL 9) (unspecified dose and route) lot # K008931 expiry date 04-MAR-2017. On an unspecified date the vaccine had been improperly stored. The outcome of event was unknown. No adverse effects reported. Product quality complaint (PQC) was not reported. No furhter infromation provided. This is one of several reports received from the same reporter. Additional information has been requested.
She got her vaccine, and then in the evening her teeth locked up and she was just trembling and it lasted about an hour.  She hasn't had any problems since.  She did report this to her doctor and he told her to give us a call.
Left arm began to become swollen red, and hard from the wrist up to the neck; Left arm began to become swollen red, and hard from the wrist up to the neck; Left arm began to become swollen red, and hard from the wrist up to the neck; This spontaneous case was received on 25-Oct-2021 from other non-health professional (consumer's mother) via agency (reference number: SEQW21-04503) and concerned a male patient of an unreported age.  The patient's current conditions included allergy to eggs, bananas and outdoor allergy. The patient's concomitant medications were not reported. The patient's historical vaccines included flu vaccines followed by a reaction in the past three years. As reported, the other two reactions were from different manufactures.  On an unspecified date in the fall of 2019, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; anatomical location: left arm, dose, and route of administration: not reported) to prevent influenza. The batch number reported was 261210.  On an unspecified date in 2019, an unknown amount of time after Flucelvax Quadrivalent, the patient's left arm became swollen, red and hard from the wrist up to the neck. The patient visited the doctor and was treated with steroids.   On an unspecified date in 2019, the patient recovered from the events.   The reporter assessed all events as related to Flucelvax Quadrivalent. As reported, her son received the vaccine in fall of 2019 and had a reaction.  The reporter assessed the case as non-serious.  Company comment: A male patient of unreported age developed swelling, induration and erythema of the arm after vaccination with Flucelvax Quadrivalent. Due to lack of information regarding chronology, causality for the reported events is unassessable.; Reporter's Comments: Her son received the vaccine in fall of 2019 and had a reaction.; Sender's Comments: A male patient of unreported age developed swelling, induration and erythema of the arm after vaccination with Flucelvax Quadrivalent. Due to lack of information regarding chronology, causality for the reported events is unassessable.
First vaccine - within the first 24 hours , swollen breasts and extremely heavy menstrual bleeding lasting 5 days. Headache and arm pain lasting several days.   Second dose - within 3 hours  resting heart rate above 110 bpm for 24 hours. Stabbing pain in head behind right ear, constant ringing  in right ear that still  continues to this day.  Menstrual bleeding within the first 24 hours lasting 4 days.  Nausea and weight loss.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Hives around the injection site on my arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Aspirin), Drug allergy (Ibuprofen), Anxiety, Vitamin D deficiency (Low on Vit D), Migraine and Sleep disorder (Sleep). Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) and LORAZEPAM (ATIVAN) for Anxiety, SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Migraine, MIRTAZAPINE (REMERON) for Sleep disorder, VITAMIN D NOS for Vitamin D deficiency. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (Hives around the injection site on my arm). On 16-Mar-2021, VACCINATION SITE URTICARIA (Hives around the injection site on my arm) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information includes patient took Benadryl and hives around vaccination site recovered within few hours. This case was linked to MOD-2022-452688, MOD-2022-520470 (Patient Link).
Diarrhea; Abdominal Pain; Chest Pain; Green Mucus Coming Out of Nose; Bumps - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal Pain), CHEST PAIN (Chest Pain), SECRETION DISCHARGE (Green Mucus Coming Out of Nose) and RASH PAPULAR (Bumps - Near Injection Site) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal Pain), CHEST PAIN (Chest Pain), SECRETION DISCHARGE (Green Mucus Coming Out of Nose) and RASH PAPULAR (Bumps - Near Injection Site). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal Pain), CHEST PAIN (Chest Pain), SECRETION DISCHARGE (Green Mucus Coming Out of Nose) and RASH PAPULAR (Bumps - Near Injection Site) outcome was unknown. Not Provided      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.   No relevant concomitant medications were reported.
Persistent left upper arm pain at site of injection for almost 2 months. Decreased ROM of left shoulder. Patient without fever, chills, erythema or edema at site of injection.
small ball at the injection site; ¨it is very itchy and I can't stand it ¨; Could not move it; It was painful; Received the 2nd dose on day number 44 after the 1st dose; Swollen arm ( left arm); painfull at injection site; was red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received the 2nd dose on day number 44 after the 1st dose), VACCINATION SITE SWELLING (Swollen arm ( left arm)), VACCINATION SITE PAIN (painfull at injection site), VACCINATION SITE ERYTHEMA (was red at injection site) and VACCINATION SITE INDURATION (small ball at the injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 30-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Received the 2nd dose on day number 44 after the 1st dose), VACCINATION SITE SWELLING (Swollen arm ( left arm)), VACCINATION SITE PAIN (painfull at injection site), VACCINATION SITE ERYTHEMA (was red at injection site), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not move it) and VACCINATION SITE PAIN (It was painful). On 01-May-2021, the patient experienced VACCINATION SITE INDURATION (small ball at the injection site) and VACCINATION SITE PRURITUS (¨it is very itchy and I can't stand it ¨). On 02-May-2021, VACCINATION SITE PAIN (painfull at injection site) had resolved. At the time of the report, INCORRECT DOSE ADMINISTERED (Received the 2nd dose on day number 44 after the 1st dose), VACCINATION SITE SWELLING (Swollen arm ( left arm)), VACCINATION SITE ERYTHEMA (was red at injection site), VACCINATION SITE INDURATION (small ball at the injection site), VACCINATION SITE PRURITUS (¨it is very itchy and I can't stand it ¨), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not move it) and VACCINATION SITE PAIN (It was painful) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medications were not provided. the Treatment information was not provided.
Itching at the shot site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose-1 (Manufactruer Unknown)), for Covid-19 immunization; Covid-19 vaccine (Dose-2 (Manufactruer Unknown)), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE (Manufactruer Unknown)), for Covid-19 immunization. The following information was reported: VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "Itching at the shot site".  Additional information: Consumer stated, ''Yes, just had my second booster (Suspect clarified as Pfizer Covid 19 shot) today which was fourth shot and experienced itching at the shot site. Patient questioned, I don't need to go hospital for that, do I.'' Consumer further stated, "Yes it was just a shot site you know with a shot, that's the only place I itch.'' Further probing could not be done as the consumer hung up the call abruptly. Hence, product details (LOT#, NDC, UPC and expiration) were unknown and limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling and tenderness in left deltoid, with possible cellulitis entire upper left arm.
Patient received first dose of Moderna vaccine. He felt dizzy and fell over his chair, but quickly sat up. He felt fine afterwards. He disclosed he didn't have much to eat or drink all day. He sat up and was monitored for another 15-20 minutes. He kept reassuring me that he felt fine and decided to leave after 15-20 minutes.
pt's mom recv 2 doses of vax 09JUL93 & realized that  the infant's mom was pregnant (LMP 15JUN93); infant was born on 08MAR94 40 wk gestation via vaginal delivery; pt born w/Tetralogy of fallot
First night hours after vaccination  I had really bad headaches. The next two days all my joints and muscles ached really bad to the point I could no longer stand at work. Those symptoms subsided but now I have chronic fatigue and insomnia.
about 5-7 days after 1st dose i developed swelling and tenderness on the side and behind my right knee
Parent signed up patient as a walk-in at pediatric clinic. The covid-19 mass vaccination form was filled out with patients name, date, DOB, chart number, indicating they wanted 2nd vaccine. This nurse was one of two nurses giving immunizations. I did verify the E.H.R. to see if any other immunizations were due. I did not verify that it had been three weeks since the last covid shot. The age appropriate covid vaccine was administered. When I was entering the covid vaccine, I then realized that it had only been two weeks since the last shot.  First dose was received 7/29/2022. Parent was then informed that patient received too soon.
SORENESS AT INJECTION SITE SWOLLEN LYMPH NODE UNDER ARM Narrative:
Left ear filled with mucus and all over body chills and vertigo. Then was hit with a bout of Shingles in the evening.
Next day my little son woke me  up at 10 am because I was making noises like whimpering. I was covered up to my neck in a blanket because I was freezing but felt hot to the touch. I have a headache still and pain on my injected arm and neck. I notice a swollen bump of the side of my collarbone/neck where I was injected. I feel tired and I?m pain. I also had a fever of 101 the day after the injection.