chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very sick; Every time she stands, bends, or changes position she has breathing problems; Cardiac disorder / Every time she stands, bends, or changes position she has heart problems; lost all of her energy / hard to get up everyday; very bad joint pain; chronic fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick), DYSPNOEA (Every time she stands, bends, or changes position she has breathing problems), CARDIAC DISORDER (Cardiac disorder / Every time she stands, bends, or changes position she has heart problems), ASTHENIA (lost all of her energy / hard to get up everyday) and ARTHRALGIA (very bad joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (very sick), DYSPNOEA (Every time she stands, bends, or changes position she has breathing problems), CARDIAC DISORDER (Cardiac disorder / Every time she stands, bends, or changes position she has heart problems), ASTHENIA (lost all of her energy / hard to get up everyday), ARTHRALGIA (very bad joint pain) and FATIGUE (chronic fatigue). At the time of the report, ILLNESS (very sick), DYSPNOEA (Every time she stands, bends, or changes position she has breathing problems), CARDIAC DISORDER (Cardiac disorder / Every time she stands, bends, or changes position she has heart problems), ASTHENIA (lost all of her energy / hard to get up everyday), ARTHRALGIA (very bad joint pain) and FATIGUE (chronic fatigue) outcome was unknown.            No treatment medications provided.  No Concomitant medications provided.  Spike protient antibody test was done with a score over 4000, of which passing score was 1.00 or 0.8.
coughing after vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jul-2021 and was forwarded to Moderna on 23-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing after vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (coughing after vaccine). At the time of the report, COUGH (coughing after vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatments were provided.
Patient was vaccinated 10/02/10 Sat. She said she noticed redness and swelling on Sunday afternoon. She also said the area is warm & tender to the touch. Patient visited MD had gave Rx for ZOSTAVAX. MD said pt. may have a localized infection and prescribed an antibiotic for patient. Patient is following up with MD.
Swollen arm, fever, redness at site. Encapsulated in arm for 3 month followed by itching, arm pain, swollen arm, sneezing, watery eyes;  sore left shoulder continues with difficulty lifting left arm at shoulder.
One month after vaccine, body started to itch. And allergies to polyester, shock when touching metals objects.. Now headache.
an unspecified number of patients were administered improperly stored Pedvaxhib and Rotateq; No additional adverse events; This non-valid spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On an unknown date the patients were vaccinated with improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # R036177, expiration date 08-OCT-2021; lot number S016870, expiration date 26-FEB-2022; lot number S006470, expiration date 15-JAN-2022 and lot number S009234, expiration date 24-JAN-2022 (dose and route of administration were not provided) for prophylaxis. On an unknown date, the patients were also vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot number S004400, expiration date 14-NOV-2020 (dose and route of administration were not provided) for prophylaxis. All the reported lot numbers were verified to be valid.   On an unknown date, the administered doses of vaccines experienced a temperature excursion of above 47 Fahrenheit (F) degrees (also reported as 64F and 47F) for 7 hours 30 minutes and for 3 hours respectively. The patients did not experience any additional adverse events. Digital Data Logger was not involved.  This is a non-valid report due to lack of patients' identifiers.
local reaction: local tender (w/o rubor/tumor/calor); hot/cold; Several days later reported awoke w/ noise in ear.  Patient seen socially other day and tells me developed acute hear loss: c/o ENT ; 55% hear loss AD.  In retrospect (but not documented in chart) he says hearing loss was abrupt and immediate.  5/18/07 Received medical records from ENT which reveal patient experienced patient seen 7/31/06 w/abnormal hearing exam but stable.  Next visit on 1/29/07 for acute decreased hearing left ear approx 12 hours s/p pnemo vax.  Handwritten notes are difficult to read but patient was started on IM prednisone, prednisone ear gtts & valtrex.  Audiogram done 2/8/07 revealed unchanged hearing loss left ear, normal hearing right ear.  Consulted another MD for possible intralynganis steroids.  Was to have repeat MRI.  DX: possible AIED.  Referred to opth & neuro & was advised to undergo intra typanic steroid trial which was done 4/2/07.  Repeat audiogram done 4/23/07 revealed left hearing decreased from prior studies.  Seen again on 4/24/07 but unable to read most of note.  Noted severe sensorineural hearing loss of left ear, mild sensorineural hearing loss of right ear.  LABS: MRI done 3/2/07 revealed left parietal hyperintensity c/w vasculitis or microvascular disease; normal cochlear vestibular complexes bilteral w/o evidence of acoustic neuroma; & retention cyst in right max sinus.  FINAL DX: severe sensorineural hearing loss left ear; mild sensorineural hearing loss right ear.
severe headache with phono- and photo-phobia beginning 12 hours after vaccination and unabating for 11 days Not responsive to ibuprofen, acetaminophen, sumatripan, caffeine No neck stiffness, normal CN and neurological exam, no confusion or cognitive symptoms.  No nausea/vomiting Had brief 1-2 day headache after 2nd dose that resolved spontaneously
Soreness at injection site; Soreness radiated down to elbow and thumb/Joint pain; Soreness radiated down to elbow and thumb; Intense body aches; chills; This is a spontaneous report from a contactable other nurse (patient). A 32-year-old female patient received the first dose of BNT162b2 (Lot number: EK9231), via an unspecified route of administration at right arm on 04Jan2021 13:30 at single dose for covid-19 immunization. Medical history included birth control. Concomitant medication included probiotics, ethinylestradiol, norethisterone acetate (JUNEL) for birth control. The patient experienced soreness at injection site on 04Jan2021 18:00; soreness radiated down to elbow and thumb, Intense body aches, joint pain, chills on 04Jan2021. The patient received the treatment Acetaminophen 1000mg every 6 hours and Ibuprofen 400mg for events. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.
Received Moderna COVID booster Jan 02, 2022. Had Numbness and tingling in body within 5 days. It went away. Then had TD vaccine on June 30, 2022, July 25, 2022 had numbness and tingling in entire body again. This time with deep aches, malaise, and has not gone away.
Red, indurated area at injection site, fatigue, somnolence. Began within hours of injection, persisted over 24 hrs. Patient advised to treat with ice and acetaminophen and return if not improved in 24 hrs.
Anaphylactic reaction; Had severe itching in the whole body; chills; A spontaneous report was received from a physician concerning a 80-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced anaphylactic reaction, severe itching in the whole body and chills.  The patient's medical history was not provided. Concomitant medications reported included tamsulosin, omperazole, simvastatin, amlodipine and finasteride all for unknown indications.  On an unknown date, approximately 2 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number 01120A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced severe itching and chills for about a day following vaccination. 2 days following vaccination, the subject experienced an anaphylactic reaction. He sought medical attention from his dermatologist who gave him the diagnosis. Treatment for the event included sertac at night, claritin in the morning, and betamethasone 0.05% cream.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events anaphylactic reaction, severe itching in the whole body and chills were unknown.; Reporter's Comments: This case concerns a 80-year old, male patient, who experienced a serious unexpected event of anaphylactic reaction and pruritus (had severe itching in the whole body), and a non-serious expected event of chills. The event of anaphylactic reaction occurred 2 days after first dose of mRNA-1273, lot # 011L20A. The event of, pruritus and chills occurred on an unspecified date after first dose of mRNA-1273, lot # 011L20A. Treatment included Sertac-one pill at night, Claritin- one pill in the morning and Betamethasone dipropionate 0.05% cream.  Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Day 1 within four hours I developed random vomiting, I was fine one moment then all of a sudden vomiting. Day 2 was muscle fatigue which continued to Day 3 and subsided on the 11/6/21 I developed severe stomach upset and symptoms of a gastric ulcer. I can't afford the cost of the tests to prove I have an ulcer, but I can't drink a glass of water or eat without belching. I have abdominal bloating and haven't felt hungry since four days after the covid shot. Discomfort has become my norm, haven't lost any weight, but don't eat much either.
Swelling of injection site, medium size nodules around vaccine site, left arm shooting pain 7 days post vaccine
Medical Decision Making     52-year-old male with past medical history of HIV, fibromyalgia, status post VP shunt, presenting to the emergency room with chief complaint of fever, headache, nausea, generalized malaise and body pain after receiving the 2nd Kaiser COVID vaccine yesterday morning.  Patient is hemodynamically stable on arrival and afebrile.  He is well appearing on examination without any acute neurovascular deficits on examination.  He is placed on cardiac monitor and IV access was established.  He was given symptomatic treatment with IV fluids Toradol and Zofran as well as a 25 mg IV dose of Benadryl.  No evidence of anaphylaxis or concerning vaccine reaction, likely side effect.  EKG was reviewed and grossly unremarkable.  Patient was signed out to oncoming ED physician Dr. pending reassessment for symptom control.  No further interventions while under my care in the emergency room.  Patient was in agreement with plan of care and all questions and concerns were answered best my ability.
had a slight rash on her arm around the site of injection; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site rash in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy (unknown arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site rash (Verbatim: had a slight rash on her arm around the site of injection).  The outcome of the injection site rash was not reported.   It was unknown if the reporter considered the injection site rash to be related to Arexvy.     It was unknown if the company considered the injection site rash to be related to Arexvy.   Additional Information: GSK Receipt Date: 07-SEP-2023 The healthcare professional mentioned that her Mother got Arexvy the other day and had a slight rash on her arm around the site of injection. The reporter did not consent to follow up.
Adverse event: none; Nurse calling to report that she administered PROQUAD and VARIVAX at the same time. No PQC. No additional information.; MMR Proquad route of administration: IM; This spontaneous report was received from a nurse and refers to a 12-month-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not reported.  On 09-JAN-2023, the patient was vaccinated with pneumococcal vaccine conj 13v (crm197) (PREVENAR 13), intramuscularly, lot # FN5556, expiration date: 30-AUG-2024 (strength, dose and anatomical location were not provided), hib vaccine (HIB), intramuscularly, lot # YH44IU, expiration date 13-DEC-2023 (strength, dose and anatomical location were not provided), varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (mL), subcutaneously, # W017552, expiration date: 01-JUN-2024 (strength and anatomical location were not provided) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) 0.5 mL, intramuscularly (incorrect route of product administration), lot # W019629, expiration date: 19-DEC-2023 (strength and anatomical location were not provided). All suspect vaccine were given for prophylaxis.   On 09-JAN-2023, the nurse "grabbed vaccines for the patient. She thought she grabbed a single MMR and did not realize it had varicella in it. She gave additional single varicella vaccine". The nurse called the mother of the patient and made her aware that "the patient received 2 doses of the varicella vaccine" (accidental overdose). The patient's response was provided as "no issue". Suspect vaccines were used according to the instruction leaflet. No temperature excursion occurred as a result of a reading from a data logger. No adverse events following a prior vaccination (no adverse event), no illness at the time of vaccination and no pre-existing physician-diagnosed allergies, birth defects and medical conditions was reported. The outcome of the event of accidental overdose was provided as recovered. The outcome of remained events was unknown.
Site: Redness at Injection Site-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Severe, Additional Details: Patient stated it felt just like having COVID allover again for 48 hours (patient tested positive on December 7th).
I had a breakthrough case of Covid, delivered by C-section at 39 weeks, caught Covid, had to start an albuterol until the baby was delivered.
After receiving High Dose flu shot:  7:30 PM - severe chills and felt there was a blockage in throat; 8:30 PM extreme nausea and headache lasting for 6 hours.
Approx 5 hrs after receiving his most recent AVA vaccine, SM developed a HA, unlike any other HA he's ever had.  On the date of his phone interview on 07/15/09, he was still having the HA.  It was responding to the use of EXCEDRIN, but SM states never had a headache that kept returning like this one.  No FMH of migraines or other types of HA.
left arm Swelling; Pain Under the Left Arm/left arm Tenderness; booster; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 19Nov2021 12:30 (Batch/Lot number: unknown) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Lot: EM9810, Right Arm), administration date: 20Mar2021, when the patient was 55 years old, for COVID-19 immunization, reaction(s): "Site Soreness Arm"; Bnt162b2 (Second Dose, Lot: EW0169, Left Arm), administration date: 18Apr2021, when the patient was 55 years old, for COVID-19 immunization, reaction(s): "Site Soreness"; Flu shot (within 4 weeks the week before in her Right Arm), for immunisation. The following information was reported: HEADACHE (medically significant) with onset 19Nov2021, outcome "recovered" (20Nov2021), described as "Headache"; PERIPHERAL SWELLING (medically significant) with onset 20Nov2021, outcome "not recovered", described as "left arm Swelling"; PAIN IN EXTREMITY (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Pain Under the Left Arm/left arm Tenderness"; IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "booster". Therapeutic measures were taken as a result of headache, peripheral swelling, pain in extremity. Clinical courses: No additional vaccines administered on same date of the Pfizer suspect. The time of onset of AE(s) was evening. No family medical history relevant to AE(s).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060A22A, 067F21A, 016M20A and 030L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the temperature excursion was not known of at the time of administration of the vaccine. The temperature excursion was found out about after a review of the temperature datalogger on the refrigerator that the Moderna Covid-19 vaccine was stored in. The Nurse has used the online temperature excursion tool and is comfortable that her patients doses are valid and that the affected vaccine is viable for future doses.  The Nurse had discovered temperature excursions of the Moderna Covid-19 vaccine in the refrigerator reached to 13.1 degrees Celsius on 28 JUN 2022.None of the vaccine in the refrigerator underwent two different temperature excursions.  The side effects after vaccination with any dose was unknown.   No treatment medications were reported.
Patient received flu shot and pnuemovax vaccine on 9/5 at 9:30am. She has received the flu shot in previous seasons but this was her first time receiving her pneumonia vaccine. At 12noon, she reports feeling tired and having aches and pains at home. at 7:30pm her pain intensified and she began running a fever of 102 degrees. Her aches were so bad that she could not sleep. On Friday 9/6, her headache was pounding and her muscles began spasming. She did call the pharmacy on 9/6 to discuss her reaction. She was taking advil and using a cool compress on injection arm. She could not lift her injection arm and she had redness on her injection arm, further down from the injection site itself. On 9/7, she had to stay in bed all day and her discomfort intensified at night. On 9/8, she has presented to the pharmacy to document her adverse event. She still reports that her back is hurting, her arm is still very red and swollen. She also now has some phlegm with a cough developing. Patient has missed two days of work and anticipates missing a third day due to adverse events.
FLUZONE QIV NP PFS, reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no reported adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2023SA057733 and 2023SA057309.  This case involves Child patient of an unknown age and gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.  It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  It is unknown if the patient experienced any additional symptoms/events  It is unknown if there were lab data/results available.  Action taken: not applicable.  Outcome:  Unknown for both the reported 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.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.