chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very large swollen lymph node; developed a very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (developed a very sore arm) and LYMPHADENOPATHY (very large swollen lymph node) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No medication history provided by the reporter.  Concomitant products included ATENOLOL for Blood pressure.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 INJECTION SITE PAIN (developed a very sore arm) and LYMPHADENOPATHY (very large swollen lymph node). At the time of the report, INJECTION SITE PAIN (developed a very sore arm) outcome was unknown and LYMPHADENOPATHY (very large swollen lymph node) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Blood pressure measurement: 150/84 (High) normally 122/70. On 08-Apr-2021, Heart rate: high High.         Patient took 25 mg of Atenolol for S.V.T. control and high blood pressure 90 minutes before the 2nd shot.  Action taken with mRNA-1273 in response to the events was not applicable.
died suddenly and unexpectedly; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non- healthcare professional (hcp).  This case involves a 17-year-old Adolescent patient who died suddenly and unexpectedly while receiving vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency, route: unknown) (lot number not reported) in unknown administration site for Prophylactic vaccination. Information on the batch number was requested.  On an unknown date the patient developed a serious event, died suddenly and unexpectedly (sudden death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  Reportedly, 17-year-old died suddenly and unexpectedly, cause given by media, unclear It is unknown if the patient experienced any additional symptoms/events.   Final diagnosis was (fatal) died suddenly and unexpectedly.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (died suddenly and unexpectedly).  At time of reporting, the outcome was Fatal for the event died suddenly and unexpectedly. It is unknown if an autopsy was done. The cause of death was reported as Sudden death NOS.; Sender's Comments: Sanofi company comment dated 04-Feb-2022: This case concerns a 17 year old adolescent patient who died suddenly and unexpectedly, after vaccination with Influenza Vaccine. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, therapy details, latency, medical history, concomitant medications, autopsy findings would be needed to rule out any alternative etiologies. Based on the reported information, role of the individual vaccine cannot be assessed.; Reported Cause(s) of Death: died suddenly and unexpectedly
Extreme joint and muscle pain throughout my whole body. Pain and a fever in my shoulder where I got the shot. I was laid up in bed for 3 days after the shot before starting to feel any relief from the pain. I was ok until that evening the day I got the shot. Then the pain started and it started in my neck and then a terrible headache. It then turned into joint, then muscle pain everywhere.  I am slowly beginning to have my pain go away. Muscle pain first, then my joint pain seems to be improving. I still have a headache and neck pain, but it seems o be subsiding slowly. I still have pain and a fever in my shoulder where I got the shot. The pain is slowly improving. I feel like with time I will get back to normal.
no events occurred.   A Covid booster shot was administered of 0.5ml instead of the CDC recommended 0.25ml
48 hrs after vaccination developed severe abd/low back pain. Worked up for diverticulitis but all tests were WNL. 8 days after vaccination she develop blisters on left lower back and abd area and was then dx with shingles and started on acyclovir.
Ringing in my ears. Slight hearing loss in right ear compared to baseline in January 21.
she noted the MMR II expired 08/30/2020.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 31-AUG-2020, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) with expiration date of 30-AUG-2020, for prophylaxis (route of administration, frequency and lot/batch # were not reported).
This spontaneous report as received from a consumer via Clinic refers to a currently 5 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (Lot # M020073, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
A large rash developed on my left shoulder on 4/8, eight days after the vaccination.  The rash is swollen and itches sometimes.
Two days after shot started to have chest discomfort went to er to see what cause it they could not find anything wrong been having bad gas problems that I never had been throwing up and chills and fevers and nauseous going on day 5 with chest discomfort
Hives. Methylprednisolone 40 mg once, diphenhydramine 50 mg once.
Shortly after receiving the second dose of the Pfizer vaccine I immediately began to feel fatigued. That evening I went home after work and slept for a few hours. The next morning (Friday 10/15) I had a low grade fever and severe right arm pain near the injection site. Body aches as well. Over the course of the next couple of days (weekend) I began to feel extremely lethargic and unable to stay awake. Severe upper back pain set in on Sunday 10/17 as well as a horrible headache that was not relieved by OTC pain relievers. As of today 10/18 symptoms still persist.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 09-OCT-2012 04:13, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not provided. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0395AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Pfizer on 3/13 and 4/10. Positive on 8/30. admitted on 8/30 to current
Two days after receiving the first shot I broke out in a rash on my abdomen. It began to spread throughout my body consisting of large geographic areas that were red and raised on the edges. The rashes were solid red and covered my inner arms, under my armpits, back of my neck, my back, down the back of my legs. The rash continued to increase in redness and throughout my body on the third day after receiving the vaccine. On the fourth day it begin to subside. By the fifth day I had a ghost of a rash.
Pfizer / BioNTech - Dose number: 4 / Moderna - Dose number: 2; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jun2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Jan2021 as dose 1, single (Lot number: 028L20A), in left arm, on 26Feb2021 as dose 2, single (Lot number: 002A21A), in left arm and on 29Oct2021 as dose 3 (booster), single (Lot number: 011F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Just dry eyes for which I take Xiidra" (unspecified if ongoing), notes: Just dry eyes for which I take Xiidra. Concomitant medication(s) included: XIIDRA taken for dry eye; TURMERIC [CURCUMA LONGA RHIZOME]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 16Jun2022, outcome "unknown", described as "Pfizer / BioNTech - Dose number: 4 / Moderna - Dose number: 2". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 26Sep2022 to 01Oct2022.  Clinical course: Patient had no known allergies. patient received Other medication in 2weeks.
1 to 2 hrs post vax first dose vacinee had onset of nervousness, flu-like sx, achiness, nausea (no vomiting), slight headache.
Pt received Shingrix Dose #2 vaccine on Monday, 7/11, at Facility Pt called to report fever, chills, body aches, weakness around midnight on 7/12. Pt reported feeling better on 7/13.
This spontaneous report was received from an office manager and refers to an unspecified amount of patients of unknown demographics. The patients' pertinent medical histories and drug reactions or allergies were not reported. From 01-JAN-2017 to 25-SEP-2017, the patients received an improperly stored doses of VARIVAX (lot # N012618 with expiration date at 21-APR-2018, for prophylaxis; dose, route of administration and anatomical location were not reported), reconstituted with properly stored sterile diluent (dose, lot # and expiration date were not reported). There were previous temperature excursions (unknown by reporter). The reporter did not know the ranges of temperature excursions and their time frames. Data logger was not used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012635: US-009507513-1709USA012745: US-009507513-1709USA012747: US-009507513-1709USA012744.
p/vax T101.9 went up to 103.7 ax;cried a lot;some unusual movements made;sometimes had staring appearance;mom thinks may have had jerking @ times;
Due to the irresponsible employee at this pharmacy, Pharmacy Manager, an injection of Pneumovax 23 was placed too high in the left arm which caused severe tearing of the rotator cuff resulting in surgery.
Soreness in the right shoulder began a few hours after injection at injection site. The pain worsened over several days from the muscle to deeper in the shoulder joint and rotator cuff. Mobility was severely limited and painful. The pain with and without movement and limited mobility in the right arm at the shoulder have persisted now for 30 days. Arm cannot be lifted laterally more than a few inches; arm cannot be extended backwards at all without severe pain; I cannot sleep on my right side without pain, and shoulder hurts throughout the day and night.
Received the vaccine during break at work at approx 11:00 am. Sudden onset blinding headache with visual disturbance at 15:30 pm while working. Fifteen minutes after that the headache started to subside and I suddenly became very dizzy and was rolled to a stretcher and assisted to lie down ,associated diaphoresis and pale clammy skin. The following day, experienced significant joint pain and lethargy. I continue to have joint pain but otherwise feel relatively normal.
Patient's daughter called to state we poisoned her mom/she had to be seen at urgent care. Patient received Rx for BACTRIM.
Patient received vaccine in the morning on Friday 9/8. On Saturday 9/9 patient woke up with a bad headache and fatigue. By Monday 9/11, patient had numbing in the lower lips and beginning on Tuesday 9/12 patient started to experience left facial drooping. Patient went to the emergency room on Tuesday 9/12 following recommendation from family physician and spent the night until Wednesday 9/13 in the afternoon. Stroke was ruled out. Patient followed up with a neurologist this morning on 9/18 and was instructed to come to the pharmacy and report the adverse event. We are unsure if the flu shot is the direct cause at this point. Patient was diagnosed with Bell's Palsy and gave patient a loading dose of 60mg of prednisone in the hospital followed by prednisone 20mg daily for 1 week and valacyclovir 500mg twice daily for 10 days.
devel red rash on face-itching, fever of 101, swollen inj site;started p/recv vax in school based project;when mom picked up p/school had rash all over body;mom did not take to MD;T102;fever & rash gone by AM 4NOV;
I had my vaccination on 04/25/2022. Within 6 hours of vaccination I started to experience grogginess headache fatigue fever cough sore throat. I had body aches and tried to sleep it off. I took a COVID-19 test 06/28/2022 which was positive. I contacted the pharmacy for a telehealth visit. I was prescribed something for the cough. The cough is still present on 10/25/2022.
Dizziness / Vertigo.  Began after sharp movements, has not subsided as of this date.  Mild to moderate. Symptoms. Still able to function.
Positive COVID-19; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Positive COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) 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) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced COVID-19 (Positive COVID-19). At the time of the report, COVID-19 (Positive COVID-19) 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.   No concomitant medications were reported. No treatment related information has been reported.
was accidentally given Fluzone High Dose Quadrivalent in the left deltoid instead of an age-appropriate influenza vaccine, with no reported adverse event; an 8 year old patient was accidentally given Fluzone High Dose Quadrivalent in the left deltoid instead of an age-appropriate influenza vaccine with no reported averse event; Initial information was received on 09-Nov-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 8 years old male patient who was accidentally given fluzone high dose quadrivalent in the left deltoid instead of an age-appropriate influenza vaccine, with no reported adverse event and an 8 year old patient was accidentally given fluzone high dose quadrivalent in the left deltoid instead of an age-appropriate influenza vaccine with no reported averse event after receiving influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 06-Nov-2022, the patient received a dose of 0.7 ml suspect influenza quadrival a-b high dose hv vaccine (formulation, strength, expiry date, lot number not reported) via unknown route in the left deltoid for immunization.  On 06-Nov-2022 the patient developed a non-serious events of was accidentally given fluzone high dose quadrivalent in the left deltoid instead of an age-appropriate influenza vaccine, with no reported adverse event (wrong product administered) and an 8 year old patient was accidentally given fluzone high dose quadrivalent in the left deltoid instead of an age-appropriate influenza vaccine with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) following the administration of influenza quadrival a-b high dose hv vaccine.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt had vaccine on April 6, 2021 and was in the ER on April 15, 2021 with a right popliteal blood clot
This spontaneous report as received from a physician refers to an 14 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 12-JUL-2017, the patient was vaccinated with an improperly stored GARDASIL 9 lot # M043731, expiry date 22-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766.
Below, copied from Providers clinical note on 2/10/2023. "Warm, elevated, mildly tender, erythematous local region, with well defined borders of induration"
Product was administered to three different patients post TE.; No additional AE/no PQC; This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unspecified date, the patient was vaccinated with an inappropriate stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, lot number 1968382 with expiration date 21-MAY-2024, administered as prophylaxis (dosage regimen was not provided) (Product storage error). No additional adverse events were reported (No adverse event).   This is one of three cases from the same reporter.
7:00 PM onset of chills and fairly severe body aches - concentrated in lower back and hips. Went to bed early - slept to 8:00 PM. Woke up so got up to take evening meds and brush teeth. Had vertigo and moderate nausea. While brushing teeth, I fainted. Came around quickly - was on bathroom floor. Took only one of my medications - the one to prevent migraines and went back to bed. Continued with body aches and chills on and off through the night. In the morning I had worsened vertigo and nausea, but this is typical of my vestibular migraines and I think that was what was going on. I called in sick to work, took one of my  pills for treating migraines and basically slept all day. I do not get migraines often - usually
I received my flu shot yesterday im not sure which exact shot it was.  I felt fine until today I have a slight fever which i know is normal. The area that was injection has a lump it feels really hard and is spread pretty wide. I cant touch it too much as it hurts so i've left it alone. I get the flu shot yearly and i've never experienced this.
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 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12May2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Allergies: sulfa" (unspecified if ongoing); "Allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Mar2020, stop date: 18Jul2022. 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: (18Jul2022) Positive, notes: Reoccurance of symptoms and positive test on 18Jul. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received paxlovid as Treatment of COVID-19 from 02Jul2022 to 06Jul2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
10/18/2021 1:52 pm called patient, the service has been restricted or is unavailable. Text message and an email sent via vaccine portal. 10/18/2021 2:19 pm Wife called. States he will be home in a little while. 12/23/21 called patient, the service has been restricted or is unavailable. Text message sent. Message posted client needs a full dose of Moderna. 12/23/21 11:35 am Wife called. States her husband is aware he received an expired vaccine. He said he is sure it is fine and will not get another shot.
This case was reported by a physician via call center representative and described the occurrence of generalized rash in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown. It was unknown if the reporter considered the generalized rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. For generalized rash emergency room visit was required.