chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client received typhoid and yellow fever vaccine. Client reports allergy to egg with "acid reflux" reaction. Client stated that she had received "egg based vaccines in the past without reaction". Client was made aware that she still could have reaction with yellow fever vaccine. Client wished to proceed with vaccination.  Client telephoned clinic to report "severe acid reflux" "worst she has ever had" approximately 30 min after vaccine.  Client was advised to report to nearest ER for evaluation and treatment.  Client verbalizes understanding to this.
Chills, headache,  fever and pericarditis.  Hospitalized on 9/3/21.
welt on her upper arm; Itching; Redness; sensitivity and arm pain; sensitivity in arm; This case was reported by a consumer via call center representative and described the occurrence of welts in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th January 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 13th January 2021, 5 days after receiving Shingrix, the patient experienced welts, pruritus, erythema, pain in arm and sensitive skin. On an unknown date, the outcome of the welts, pruritus, erythema, pain in arm and sensitive skin were not recovered/not resolved.   It was unknown if the reporter considered the welts, pruritus, erythema, pain in arm and sensitive skin to be related to Shingrix.  Additional details were provided as follows: The patient received her first dose of Shingrix and patient began experiencing a welt on her upper arm, itching, redness, sensitivity and arm pain. These symptoms were continuing till the time of reporting and were not resolved.  The reporter gave permission to follow up.
inadvertently administered the Menveo(2-vial) diluent component; inadvertently administered the Menveo(2-vial) diluent component; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMX8733A, expiry date 31-MAR-2024) for prophylaxis.   On 28-JUL-2023, the patient received Menveo (left deltoid). On 28-JUL-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: inadvertently administered the Menveo(2-vial) diluent component) and inappropriate dose of vaccine administered (Verbatim: inadvertently administered the Menveo(2-vial) diluent component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-JUL-2023 The reporter called to inquire that how to proceed. The reporter did not consent to follow-up. The reporter reported that they inadvertently administered the Menveo (2-vial) diluent component only without the lyophilized component to a patient in the left deltoid, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Maternal exposure during pregnancy, second trimester; Rash down the inside of my right leg that started at my groin and ended just about my ankle. I also had some splotches of rash on the exterior of my left leg.; This is a spontaneous report from a contactable consumer, or other non hcp (patient). A 34-year-old pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number was not reported) via an unspecified route of administration in the left arm on 22Mar2021 at 11:30 (age at vaccination was of 34-years-old) as dose 1, single for COVID-19 immunization. Medical history included pregnancy and the gestation period was 22 weeks at the time of vaccination. The expected delivery date was reported as 22Jul2021. The patient had her last menstrual period was on 15Oct2020. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for unknown indication from an unknown date. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 22Mar2021 at 11:30, the patient received the first dose of vaccination when she was pregnant with gestation period of 22 weeks (characterized as maternal exposure during pregnancy, second trimester) and on the same day, the patient experienced a rash down the inside of right leg that started at the groin and ended above the ankle, also had some splotches of rash on the exterior of left leg; the patient noticed the rash about two hours after appointment and it faded before she arrived to her primary care doctor and faintly came back at around 21:00 on the same day. There are now no traces of the rash on 23Mar2021. On 23Mar2021, the patient underwent a nasal swab test, and the result was unknown. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. The outcome of the rash both legs was recovered on 23Mar2021, while that of the maternal exposure during pregnancy, second trimester was unknown.  Information on the lot number has been requested
pt exp urticarial (hives) rash over entire body; on presentation rash had dissipated on extremities but was still present from waist up; no SOB, no wheezing or resp compromise;
numbness at and near injection site noted within 12 hours, numbness extended to elbow and shoulder by 48 hours. Treated at 48 hours with heat and Ibuprofen 600mg PO q6hours x24 hours with reduction in Sx to shoulder and injection site only. Employee work and PCP contacted.
developed much mucous in my throat and chest area; developed much mucous in my throat and chest area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 22Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SPUTUM INCREASED (non-serious), INCREASED UPPER AIRWAY SECRETION (non-serious) all with onset 2023, outcome "recovering" and all described as "developed much mucous in my throat and chest area". Therapeutic measures were taken as a result of sputum increased, increased upper airway secretion.  Additional information: The patient received the RSV shot on 22Sep2023 then developed much mucous in throat and chest area. The patient started taking a Z pack which seems to be getting rid of these but since then, the patient developed a pain in head. It was constant 24/7, sharp pain which radiates from behind left eyeball to left ear. The eye doctor is stumped. The patient was asking where to go to get rid of the pain.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.
24 hours later - body aches, fever (3 degrees)  continued to 36 hours later
Beginning of September, eyes starting bothering. Dr diagnosed herpes of the eye. Was prescribed Zorgan oph in sup  oral acyclovir in Oct. (burning, watering, light sensitivie, itchy eyes).
day of vax pt exp red itchy welts on trunk only. welts faded after 2days
generalized itching; Sore Left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Left arm) and PRURITUS (generalized itching) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (cholesterol pills).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Left arm). On an unknown date, the patient experienced PRURITUS (generalized itching). At the time of the report, PAIN IN EXTREMITY (Sore Left arm) and PRURITUS (generalized itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were reported and it contains water pill, blood pressure pill and pills for acid reflect .  Treatment medication was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Itchy and swollen Lips (12hrs), muscle and joint pain, headache, Chills
Chronic hives urticaria. On the 4th- 5th day after my 3rd Moderna booster vaccine, I began feeling a numbness in my upper lip and developed a rash, that slowly went away within the next week. Then I started developing extreme itching in my feet and my hands. The itch was so extreme that nothing would make it go away. I developed patches of rash hives on my bottom legs and feet as well as my arms, neck, and back. For the last 5 weeks, I have been having hive patches. Most days it is in the morning and afternoons, but really there are no set times. They appear for a few minutes and then disappear only to come back later. The only thing that makes them go away for a whole day is Allegra allergy medication, but after a day they return. These past weeks the hives have been focused on my arm, neck area, and arm area close to my hands. A few weeks ago I was having the hives also all over my face cheeks. I have never had hives in my life, I am not one to be allergic to anything especially as manifested in my face, it is very clear most of the time.
Headache fatigue chill fever nausea diarrhea lymph node swelling.  Pain itchiness
Approximately 20 hours after vaccine she got up to go to work and felt extremem pain from shoulders to mid-thighs (bone pain). Also had numbness and tingling in hands, feet and forehead. On 10/24/02 appointment was made with MD. Medrol dose pack prescribed, off work 4 days. Flexoril for final relief of pain on 10/28/02.
received second dose more than 35 days apart from the first; LT BREAST MASS/CYST; Diarrhea; Upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), DIARRHOEA (Diarrhea), BREAST CYST (LT BREAST MASS/CYST) and MEDICATION ERROR (received second dose more than 35 days apart from the first) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) from 03-Feb-2013 to an unknown date and AMLODIPINE BESILATE, OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL) for Hypertension.   On 07-Jan-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach). On 11-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). On 21-May-2021, the patient experienced BREAST CYST (LT BREAST MASS/CYST). On an unknown date, the patient experienced MEDICATION ERROR (received second dose more than 35 days apart from the first). On 07-Jan-2021, ABDOMINAL DISCOMFORT (Upset stomach) had resolved. On 11-Jan-2021, DIARRHOEA (Diarrhea) had resolved. On 06-Jun-2021, BREAST CYST (LT BREAST MASS/CYST) had resolved. At the time of the report, MEDICATION ERROR (received second dose more than 35 days apart from the first) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Mammogram: inconclusive (Inconclusive) Exam : 3D Mammogram screening Digital w/CAD [116]-Breast -B   Result : No other significant masses,calcification, or other findings are seen in either breast.. On 10-May-2021, Mammogram: inconclusive (Inconclusive) Exam : 3D Mammogram Diagnostic Unilateral Digital [115]-Breast -L Result : No other significant masses, calcification, or other findings are seen in either breast.. On 10-May-2021, Ultrasound scan: hypoechoic (abnormal) Exam : Breast Ultrasound -Limited Unilatera  [137] -Breast -L The 1.4 cm ova mass in the left breast is suspicious of malignancy..         The patient did not take any treatment medication. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-219845 (E2B Linked Report). This case was linked to MOD-2021-219845 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Significant follow up appended.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product. US-MODERNATX, INC.-MOD-2021-219845:Dose 1
Initial report received from a consumer on 14 Jan 2010: This patient, with an unknown medical history, was vaccinated with FLUVIRIN 0.5 ml, intramuscularly on 21 Dec 2009. On 23 Dec 2009, she developed a rash on her left arm. The rash had progressively worsened, appearing on her right arm, trunk and legs. The outcome of the event was that the rash on her arms slowly disappearing, but was still present on other areas of her body.
Vaccine was beyond the use date. Administered 12/27/21- beyond use date 12/24/21, manufacturer expiration date 12/31/21.
This spontaneous report as received from a nurse refers to a 6 months 7 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
pt recv vax 13OCT98 & that noc devel rash around lt arm, urticaria around lips & on abd;on exam a sl larger fifty cent piece urticarial on arms & some small ones on abd;tx DPH & cool compresses;
No symptoms of adverse reaction noted following administration of vaccine. Autopsy performed and cause of death was listed as "Cardiorespiratory failure as a consequence of seizure".
About 3 months after receiving my second dose of the Pfizer Covid vaccine, I began to lose a significant amount of hair; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster),single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid 19 immunization. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "About 3 months after receiving my second dose of the Pfizer Covid vaccine, I began to lose a significant amount of hair".  Additional Information: About 3 months after receiving my second dose of the Pfizer Covid vaccine, patient began to lose a significant amount of hair. The loss finally subsided 6 months after patient got the second dose. Patient received my booster at the end of November and the hair loss has returned. Patient did not had covid and assumed there was some correlation between the vaccine and my hair- loss.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No  further information is expected.
Stiff neck muscles, sweating at night, headache - symptoms rendered 3-6 days after inoculation
12/12/22 presents to ED for "shortness of breath, cough". PMHx of "DM and HTN"
Soreness in vaccine arm. Arthralgias started 9h after shot, bad enough to prohibit sleep, lasting approximately 5h. Myalgias began approximately 15h after vaccination, lasting 18h or so. Fatigue lasted several days. Sore throat 48h.
Bone pain in knees, elbows, painful to touch. Knees swollen. Severe hip and back pain. Was able to touch toes prior, now unable. Bones in toes hurt, painful to go up and down stairs. Pain in extending arms and legs. Unable to pick up heavy objects. Bleeding from vagina not time for my cycle lasting over a week.
Patent reported Swelling on the arm and hot to touch  and did not feel well for few days . Patient did not seek medical attention and it felt better after a few days .
Mother reports child received shot (DTaP) on 4/21/2004.  One day later (AM) face, arms, hands, and feet were swollen.  Fever of 102 degrees and was irritable.  Blotches over body.  No difficulty breathing.  Went to ER and released. Went to doctor - given Benadryl - was to continue to give as directed.  Advised to report event to Health Dept at child's next visit.
redness, induration, itch, heat, pain @ inject site w/persistent 3x6 cm redness next AM; redness, itch lasted 3 1/2 days total; also mild malaise 6 hrs p/vax;
Shortly after the booster shot, I was unable to move my left arm backwards. I could move my arm straight forward and up but not backwards. I lost this motion in my arm and continued to have this issue until recently. (2/18/22)  I was also hospitalized for a suspected stroke/blood clot in February. I had a small TIA and after seeking treatment for the TIA, which was blood thinners, the movement in my arm became better. The doctor thinks that the booster could of had a negative effect on my body and could be the reason the TIA happened.
Interchange of Vaccines; Wrong vaccine administered; Incomplete course of vaccination; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 45-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received in November 2018) and Havrix (received on 30th April 2019).   On an unknown date, the patient received Twinrix at an unknown dose. On an unknown date, unknown after receiving Twinrix, the patient experienced drug dose administration interval too long, wrong vaccine administered and incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long, wrong vaccine administered and incomplete course of vaccination were unknown.  Additional information was reported as follows: The age at vaccination was not reported. The patient received a dose Havrix after 1st dose of Twinrix, which led to wrong vaccine administered and lengthening of the vaccination schedule for the Hepatitis A. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination. The reporter consented to follow up.
pt recvd 3 doses of Recombivax & a booster dose of Engerix-B never seroconverted;
Approximately 21 hours after receiving vaccines, pt developed inconsolable crying at home. The patient was brought into the clinic approximately 28 hours after receiving vaccines, was afebrile, with normal exam except for appeared to be in significant distress and inconsolably crying. She had only taken approximately 4 ounces of formula in the previous 12 hours and had decreased urine output. There was no rash, no fever, no bulging fontanelle, no seizure activity, and no signs of trauma. She was sent to the Emergency Room at Hospital. She was admitted to the hospital overnight, where she received IV hydration, Acetaminophen and Benadryl, and was discharged after less than 24 hours admission. After discharge, the patient has been well and has not suffered any neurologic sequelae. She has not yet received her 6-month shots (not due until next month), but we plan to give all scheduled vaccines except DTaP will be deferred.
PATIENT RECEIVED 1ST DOSE, THEN SAT IN OBSERVATION AREA WITH HIS MOM. PATIENT SLUMPED IN CHAIR AND HAD FAINTED - MOM YELLED FOR HELP. I CAME OVER TO HELP THE PATIENT DOWN TO THE GROUND AND ASSESS. A BYSTANDER CALLED 911.  PATIENT WAS PALE, HAD A PULSE. PATIENT HAD A PULSE AND WAS BREATHING, COLOR STARTED TO COME BACK TO HIS FACE. HE WOKE UP AND PULSE WAS ABOUT 60-64BPM. PATIENT KNEW WHERE HE WAS. THE AMBULANCE CAME AND TOOK HIM TO THE HOSPITAL.
Received HPV 1-21-14 PM. Woke up this with face and abdomen itching. Face also red all over. Dad took child to convenient care and was told to bring her to Health Dept. They advised her to take BENADRYL for itching.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On 13-FEB-2018, the patient was vaccinated inadvertently received with an expired dose of Oka/Merck VARIVAX lot # M006726; expiry date 08-FEB-2018, subcutaneously (strength and dose were not reported). No adverse effects were reported.