chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A bump and a 3 inch rash at the site of administration of the vaccine; A bump and a 3 inch rash at the site of administration of the vaccine; This spontaneous case from was received on 24-Sep-2020 from other non-health professional via The Agency (reference number: SEQW20-02263) and concerned a patient of an unknown age and gender.  The patient's medical history and concomitant medications were not reported.   On 17-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 283849 and expiry date was 30-Jun-2021.   On the same day, after receiving Flucelvax QIV, the patient developed a bump and a 3-inch rash at the site of administration of the vaccine. The patient did not receive any treatment measures associated with the events.  On an unspecified date in Sep-2020, the patient recovered from the events.  The reporter did not provide a causality assessment to Flucelvax QIV.   The case was assessed as non-serious.  This case is linked to cases 202004678, 202004696, 202004697, 202004698, 202004699, 202004700, 202004701, 202004702, 202004703, 202004704 and 202004706 due to the same reporter.  Additional non-significant information received on 06-Jan-2021 from other non-health professional via The Agency (reference number: SEQW21-00065) with additional document received on 12-Jan-2020 from other health professional (reference number: SEQW21-00149) (being processed together): Two additional reporters added. Narrative was not amended.  Company comment: A patient of an unknown age and gender was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient developed vaccination site rash and vaccination site mass. The patient's medical history and concomitant medications were not reported. Chronology is plausible. Causality is assessed as possibly related for both events.; Sender's Comments: A patient of an unknown age and gender was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient developed vaccination site rash and vaccination site mass. The patient's medical history and concomitant medications were not reported. Chronology is plausible. Causality is assessed as possibly related for both events.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient's mother was with her at time of vaccine administration. A few minutes later she stated her daughter was not feeling well.  Patient was confused, stated she was unable to see at that time &dizzy. Then the patient lost conciousness and was unresponsive. 911 was called and epinephrine was administered due to concern for anaphylaxis. Patient regained consciousness and was responsive to questions.  EMTs &police arrived, evaluated her & recommened she go to ER. Mom was going to take her to ER
Narrative:  32 yo female received a Tdap vaccine in March 2021. A few days later, she secure-messaged her primary care team stating that for the past 5 days, she had red spots/bruising throughout her body she believed to be hives. She stated that she takes daily Zyrtec and started taking OTC Benadryl to help with the symptoms. She also stated that she gets hives from the influenza vaccine. She had a video Appointment with her PCP who suggested she sees an allergist prior to any other vaccinations such as the Covid vaccine.
1/29/21 Patient received COVID - 19 vaccine (#1 series) that night she developed redness, itching & swelling to left upper arm. Patient took Claritin over the weekend. Redness & swelling better on 2/1/21 But, still very itchy. Will order Prednisone 60mg QDx14d take Benadryl PRN & use Sarna sensitive for itching f/u PRN
expired dose administered to a patient; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED 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 EXPIRED PRODUCT ADMINISTERED. At the time of the report, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.
pt recv vax 11MAR99 & on 24MAR99 pt devel swollen lymph nodes on the lt side of neck, bilat clogged ears w/o fluid, h/a, dizziness & equilibrium was way off;dx viral infect;
shaking of her legs / And it is very irritating; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (shaking of her legs / And it is very irritating) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A or 027620A and 013M20A) for COVID-19 vaccination.     no medical history reported.    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TREMOR (shaking of her legs / And it is very irritating). At the time of the report, TREMOR (shaking of her legs / And it is very irritating) outcome was unknown.            patient also received her Shingles vaccine on 12Mar2021. She visited her doctor (Neurologist) and was prescribed a Parkinson's medication. She stated, she will not take this Parkinson's' medicine.
Left thigh, mid-anterior with reaction, extending primarily medially, swelling and redness.
Severe muscle tension; About 12 hours after receiving my second Pfizer vaccine dose, I had EXTREME, VIOLENT CHILLS for SEVERAL HOURS with severe muscle tension to try and control the chills. I used 4 or 5 blankets but that; My heart rate was between 120-130 bpm whenever I checked it.; Fever; POUNDING HEART for SEVERAL HOURS; Symptoms were miserable and frightening; Symptoms were miserable and frightening; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 09:45 (Lot number: ER2613) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: L-THYROXINE [LEVOTHYROXINE]; SIMVASTATIN. Past drug history included: No., reaction(s): "Allergy". Vaccination history included: Bnt162b2 (1st Dose, 1 Batch/Lot No: Pfizer EN6208 Location of injection: Arm Left), administration date: 24Mar2021, when the patient was 63 years old, for COVID-19 Immunization. The following information was reported: MUSCLE TIGHTNESS (non-serious) with onset 16Apr2021 22:00, outcome "recovered" (17Apr2021 02:00), described as "Severe muscle tension"; CHILLS (non-serious) with onset 16Apr2021 22:00, outcome "recovered" (17Apr2021 02:00), described as "About 12 hours after receiving my second Pfizer vaccine dose, I had EXTREME, VIOLENT CHILLS for SEVERAL HOURS with severe muscle tension to try and control the chills. I used 4 or 5 blankets but that"; HEART RATE ABNORMAL (non-serious) with onset 16Apr2021 22:00, outcome "recovered" (17Apr2021 02:00), described as "My heart rate was between 120-130 bpm whenever I checked it."; PYREXIA (non-serious) with onset 16Apr2021 22:00, outcome "recovered" (17Apr2021 02:00), described as "Fever"; PALPITATIONS (non-serious) with onset 16Apr2021 22:00, outcome "recovered" (17Apr2021 02:00), described as "POUNDING HEART for SEVERAL HOURS"; FEELING ABNORMAL (non-serious), FEAR (non-serious) all with onset 16Apr2021 22:00, outcome "recovered" (17Apr2021 02:00) and all described as "Symptoms were miserable and frightening". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscle tightness, chills, heart rate abnormal, pyrexia, palpitations, feeling abnormal, fear.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. I had a Fever of 100-101.I had a pounding heart for several hours (along with the chills). My heart rate was between 120-130 bpm whenever I checked it.  Follow-up attempts are completed. No further information is expected.
pt recv vax 13OCT97 & 27OCT97 pt exp an exacerbation of herpes zoster described as an orange peel texture on the rt arm;pt was seen by MD on 5NOV97 w/no definite dx reported;
Experienced chest discomfort at home. In emergency department, BP 240/104.  Subsequently found to have renal infarction.    Admitted for hypertensive emergency.  Anticoagulation with full dose heparin.   As of 5/15/23 - stillinpatient
Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Patient came to pharmacy for Covid vaccine. He said he once fainted after giving blood and has a fear of needles. He was given his vaccine and after 10 minutes he felt nauseated and fainted. The patient awoke within 30 seconds but then vomited. EMS was called to make sure the pt was okay. After another 30 minutes of rest the patient was able to leave the pharmacy.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, an unspecified number of patients were vaccinated with RECOMBIVAX HB (route, dose, lot # and expiration date were not reported). It was reported that RECOMBIVAX HB was improperly stored and the temperature excursion was found to be supported with in-house stability data. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Client had vaso vagal response 10 minutes after vaccinations when standing to leave clinic room. Client was seated on the floor when he briefly lost consciousness. Pulse/blood pressure monitored. Given orange juice upon regaining consciousness. Remained stable, regained color and strength.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: ER8737), in left arm, on 24Apr2021 as dose 2, single (Lot number: ER8731), in left arm, on 01Nov2021 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Knwon allergies: sulfa drugs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: I tested negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 04May2022  to 08May2022.  Clinical course: When she had COVID and was taking Paxlovid, she had sudden sharp jaw pain and blacked out. Also, after she finished Paxlovid, her symptoms were gone and she tested negative. Then, a few days later, her symptoms came back. For 10 days, she had an elevated temperature, cough, and fatigue.
Shingles- TX: BENADRYL TYLENOL Topical treatment of lesions
pt woke up 5AM very lethargic, fever 106; no redness @ either vax site; wen to ER; MD told mom rxn to immun;
first day :Severe exhaustion, Sleep did not remove any muscle pain gained during the day,  Tired all the time,  urge to vomit,  second day: Muscle pain did not go away get tired just sitting in bed  third day: more of the same fourth day: muscle pain in legs tired all the time slight cough developed
pt recvd vax; several hrs later, devel swollen glands in neck, fever 102-103 & "started staring & fell out"; had MD's appnt but cancelled;
Involuntary movements in the cheekbones and left eye very pronounced. Then both legs, arms, mouth and right eye severe headache on the right side. These symptoms still exist.
My arm was sore and felt pain when I would touch it or have any type of movement of my arm. The next morning the injection site on my arm was swollen and still is and still tender.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unspecified demographics. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was not provided. On unknown dates, the unspecified number of improperly stored doses of LIQUID PEDVAXHIB, lot # M014927 with expiration date on 18-FEB-2019 (dose, route of administration and anatomical location were not reported) were administered to the unspecified number of patients. The temperature excursion was recorded via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 29.7 degrees Fahrenheit for 60 days before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA009653: US-009507513-1705USA012911:
1130 RN called. When this RN arrived patient was sitting up in a chair and was found to be pale, clammy, and non responsive verbally. Ammonia salts placed under nose and patient immediately aroused. Blood pressure at 1132 was 95/54 pulse-58, and 02 sat was 99% sitting.  1136 Blood pressure at 1136 was 76/44, pulse 66, 02 sat 99%, and  Patient was still responding but somewhat dazed. Still alert and oriented. Ice pack applied. Sweatshirt removed.  Patient was given water and a granola bar. Patient transferred to guerny and repeat blood pressure taken. 911 called by RN.  Patient talking and awake.1138 blood pressure lying down was 113/62, pulse 67, and 02 sat was 98%. Transferred to nurse treatment room by RN RN. Patient's Mother present. 1147 Paramedics here and report given. 1158 Patient is awake and stable and transported to ER via ambulance.
1 day following vaccination, patient presented to hospital with significant edema of the left thigh and difficulty bearing weight on left leg. Minimal erythema. 72 hours later, edema hardly detectable and pain has subsided.
Pt recv vax on 9/19/98; 4 hr later pt exp facial flushing, fever (102F) & increased blood sugar; pt imp 9/20/98.
Injected 31OCT; 1NOV flu sx w/temp to 105-tx w/Advil; 2NOV -severe aches & pains, fever to 103; 5NOV fever gone, aches in arches of feet.
This nurse removed opened vial of Moderna from storage, 2-8 C. Placed in cooler with ice packs along with two other unopened vials of Moderna. This nurse then transported and gave the three vials to the agency nurse. Agency nurse administered open vial of Moderna to persons who had signed up for the Booster vaccination of the Moderna Vaccination 0.25ml. Once completed updated Manager that the bottle given to her was open and was going to open another vial. This nurse confirmed with the manager that the bottle had been opened previously, 1/19/2022. This nurse had mis read the storage information regarding Moderna to be stored unopened and unused for 30 days. This nurse made telephone call to each person affected by this opened vial. Per Medical Director, offered everyone a dose of 0.25ml out of the new unopened vial. RN
Patient began w/ a pruritic rash 03/01/21 all over her body that spread and developed "welts." Patient was instructed to begin Allegra and Benadryl on 03/04/21. Hives worsened on 03/05/21 and Hydroxyzine was prescribed. Spoke w/ patient 03/08/21 and reaction has compeltely resolved.
Swollen throat; Swollen lips; Swollen tongue; Swollen ears; Everything was itchy; Facial numbness; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Swollen throat), LIP SWELLING (Swollen lips), SWOLLEN TONGUE (Swollen tongue), EAR SWELLING (Swollen ears) and PRURITUS (Everything was itchy) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VALPROIC ACID, LEVOTHYROXINE SODIUM (SYNTHROID), OMEPRAZOLE and LORAZEPAM for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PHARYNGEAL SWELLING (Swollen throat), LIP SWELLING (Swollen lips), SWOLLEN TONGUE (Swollen tongue), EAR SWELLING (Swollen ears), PRURITUS (Everything was itchy) and HYPOAESTHESIA (Facial numbness). The patient was treated with EPINEPHRINE (intravenous) ongoing since an unknown date at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (Swollen throat), LIP SWELLING (Swollen lips), SWOLLEN TONGUE (Swollen tongue), EAR SWELLING (Swollen ears), PRURITUS (Everything was itchy) and HYPOAESTHESIA (Facial numbness) had not resolved.            She had facial fillers on 8April 2021 at 10:30am. Four hours after the facial filler procedure, her throat, lips,tongue, and ears were all swollen. Everything was itchy and she had facial numbness. She went to the Emergency room two times in a day.   Treatment medications included steroid given at the emergency room, along with above mentioned medications.  She was feeling better right now but the problem was still ongoing
Covid arm , very swollen red bulge on arm under injection site , it is not red or swollen at injection site but is above and below the injection site , itchy , It feels like how  a infection from a boil ,
This spontaneous report as received from a Medical Assistant (C.M.A.)(also reported as nurse) refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a doses of PEDVAXHIB dose number, lot# and expiration date was not reported, which underwent a supported temperature excursion. No adverse effects reported. Follow-up information has been received. On 04-FEB-2015 several telephone attempts were placed to the certified medical assistant however she was unavailable at the time of calls. This is one of several reports from the same reporter. Additional information has been requested.
Case previously recorded as MA2009-4069. Initial case report received from a physician via MedCom on 09 NOV 2009. A patient 8-month-old female was vaccinated with S-OIV FLUVIRIN (batch no. 1008143P) 0.5mL i.m on 06 NOV 2009. No adverse event was reported. MedCom reference no: NA09-007849.
redness @ inj site, tachypnea, t103 ax;Motrin or APAP PRN;ice to inj site;
Localized reaction to injection site.  Measured 40 X 45 mm raised, reddened, and warm to the touch.  No other symptoms.
severe pain in upper left arm and limited range of motion. treatment include use of Motrin 800mg twice a day for 6-8weeks, followed by a single Dexamethasone 1mg injection, followed by meloxicam 15 mg once a day for 2 months, then a course of methocarbamol 750mg ( muscle relaxant ) for 3 weeks. pain ranges from moderate to severe and persistent limited range of motion.
Patient developed skin lesions that are suspicious for varicella the previous day.  Over 1 day, there has been a change in appearance, consistent with the natural history of varicella
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with VAQTA lot # N005605 (formulation, strength, dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the patient was administered an expired dose of VAQTA. The outcome of the event was unknown. Causal relationship between and VAQTA was not provided.
burning sensation down right side of neck. Blistery rash on right side of upper torso. Self diagnosis: Shingles. FYI, I also had Shingles when I was 22 years old. This is my second occurrence of the disease
1/2-1hr p/vax pt told mom lt arm was numb;RN reference them to own MD;ER could not find any problem-referred to psychiatric eval;
allergic rxn: red, watery eyes, congestion, tightness in chest, constricted feeling in throat, wheezing, coughing, diff swallowing onset was rapid, going from no sx to full blown in about 15min;bodyaches & low grade fever;tx w/pred;
Pt was administered Hepatitis B vaccine and left clinic within 15 minutes feeling fine. Within 25 minutes, her lips swelled, she felt shortness of breath and mild chest pain. Within 10 minutes, pt obtained Benadryl tablet (25mg?) from the nurse at her job. All symptoms disappeared. About 45 minutes later, the lip swelling occurred again and the pt took 1/2 tablet of Benadryl. The symptom resolved, and the pt did not have any further problems. The only other intake during this time was iced tea, which pt says she drinks all of the time.
the patient was inadvertently administered an expired Ipol, No AE; Initial information was received on 02-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional.   This case involves a 8 years and 9 months old male patient who was inadvertently administered an expired POLIOMYELITIS VACCINE (INACTIVATED) IPV (VERO) [IPOL] (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included RUBELLA VACCINE, HEPATITIS A VACCINE, VARICELLA ZOSTER VACCINE (VARICELLA) and INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) for prophylactic vaccination.  On 02-Sep-2020, the patient received a 0.5 mL dose of suspect IPV (VERO) (lot P1A171M, expiry date: 24-Apr-2020) once via intramuscular route in unknown administration site for prophylactic vaccination. On the same day, the patient visited the physician.  It was a case of an actual medication error due to expired vaccine used (latency same day).  At the time of report, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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..
Patient developed left arm pain in deltoid after injection that has been intermittent since. She has trouble laying on that arm at times and lifting weights.