chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 22-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (MRK) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004377: Original Case: 1808USA001261; US-009507513-1808USA004378: Original Case: 1808USA001261; US-009507513-1808USA004379: Original Case: 1808USA001261; US-009507513-1808USA004380: Original Case: 1808USA001261; US-009507513-1808USA004381: Original Case: 1808USA001261; US-009507513-1808USA004382: Original Case: 1808USA001261; US-009507513-1808USA004383: Original Case: 1808USA001261; US-009507513-1808USA004384: Original Case: 1808USA001261; US-009507513-1808USA004385: Original Case: 1808USA001261; US-009507513-1808USA004386: Original Case: 1808USA001261; US-009507513-1808USA001261: Original Case: 1808USA001261; US-009507513-1808USA004387: Original Case: 1808USA001261; US-009507513-1808USA004388: Original Case: 1808USA001261; US-009507513-1808USA004363: Original Case: 1808USA001261; US-009507513-1808USA004364: Original Case: 1808USA001261; US-009507513-1808USA004389: Original Case: 1808USA001261; US-009507513-1808USA004390: Original Case: 1808USA001261; US-009507513-1808USA004391: Original Case: 1808USA001261; US-009507513-1808USA004392: Original Case: 1808USA001261; US-009507513-1808USA004365: Original Case: 1808USA001261; US-009507513-1808USA004393: Original Case: 1808USA001261; US-009507513-1808USA004394: Original Case: 1808USA001261; US-009507513-1808USA004395: Original Case: 1808USA001261; US-009507513-1808USA004396: Original Case: 1808USA001261; US-009507513-1808USA004397: Original Case: 1808USA001261; US-009507513-1808USA004366: Original Case: 1808USA001261; US-009507513-1808USA004367: Original Case: 1808USA001261; US-009507513-1808USA004368: Original Case: 1808USA001261; US-009507513-1808USA004398: Original Case: 1808USA001261; US-009507513-1808USA004399: Original Case: 1808USA001261; US-009507513-1808USA004400: Original Case: 1808USA001261; US-009507513-1808USA004369: Original Case: 1808USA001261; US-009507513-1808USA004370: Original Case: 1808USA001261; US-009507513-1808USA004401: Original Case: 1808USA00126.
@ 0925 Patient had subcutaneous inflammation immediately after administration of Moderna vaccine. Vaccine was administered on left deltoid 0.5ml.  She did not complain of pain, denied of any itching, no redness or tenderness noted. RN provided her with an ice pack and was monitored for 15 minutes. @0940 Patient continued to deny any s/s of anaphylaxis, inflammation decreased, was sent home shortly after RN advised patient if to contact her healthcare provider if any sudden changes occur.
about 45 minutes after her injection she started having facial tingling including in the lips. throat felt tight, no trouble breathing or difficulty swallowing. skin felt flushed and rash developed later.
Large, red, swollen area in (Rt) upper thigh approx 8cm x 8cm, very warm to touch.
Pt recv vax on 10/15/98;8 hr later pt exp red flush to skin of face, neck &chest w/ shortness of breath, fever (101.4); tx=Benadryl & Abafed.
I had difficulty breathing, extreme fatigue, body aches, I developed fevers of 103.7F, my wife said I was confused. I went to the emergency room where they ran viral panels that came back negative for everything. I was in the emergency room for four hours and during that time I would spike a fever, it would break and within twenty minutes the cycle would start again. I was told to treat myself as if I was contagious and if my symptoms get worse to return to the hospital.
3 in welt at injection site. Raised, red and warm and itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Oct2023 at 17:00 as dose 1, single (Lot number: HH7595) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "latex allergy" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: OLMESARTAN; OXCARBAZEPINE; VAGIFEN; ASPIRIN [ACETYLSALICYLIC ACID]. Past drug history included: Morphine, reaction(s): "Allergies: morphine"; Tramadol, reaction(s): "Allergies: tramadol". Vaccination history included: Flu shot, for Immunization, reaction(s): "Allergies: flu shot"; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION SITE URTICARIA (non-serious) with onset 20Oct2023 at 15:00, outcome "not recovered", described as "3 in welt at injection site. Raised, red and warm and itchy". Therapeutic measures were not taken as a result of vaccination site urticaria.  No follow-up attempts are possible. No further information is expected.
Narrative: Patient reports history of airway constriction and syncope with COVID-19 vaccine; no other details available
This spontaneous report as received from a nurse refers to an unspecified patient of unknown age. On 01-NOV-2016 the patient was vaccinated with VARIVAX lot # M024680, (conflicting information, also reported as M023680) expiration date 18-MAY-2018 subcutaneous. The nurse reported that an improperly stored dose of VARIVAX lot # M024680, expiration date 18-MAY-2018, was administered to an unspecified patient on 01-NOV-2016. No adverse effects reported. The outcome of incorrect product storage and no adverse event is unknown. No further information available. VARIVAX lot # M024680, expiration date 18-MAY-2018: Temperature: 7.3C. Time frame: 1 hour. Call due to a data logger: Yes. No previous excursions. Additional information has been requested.
Client reported that she chest pain, pain on her "breast bone."  Also reports her right arm is swollen, experiencing   lymph node tenderness or pressure in right armpit.  Called and made a doctor's appointment for today.
20MAR - "tight cough"; 22MAR temp 99(ax); 25MAR- cough loosened, unconsolable, dx w/lt otitis media by MD;
No adverse effects; Was administered inadvertently an expired dose; Information has been received from a medical assistant concerning to a patient (age and gender not reported). No medical history, concurrent conditions nor concomitant medications were reported. On 15-OCT-2019, the patient was inadvertently vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) (Lot. No R022983, exp. date 09-AUG-2019) (strength, dose and route not reported) for prophylaxis. No adverse events were reported. There was no temperature excursion.
Information has been received from a physician's office staff concerning a 4 year old female with no past medical history who on 30MAY2003 was vaccinated IM with a second dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation) and SC with a first dose of varicella virus vaccine live. There were no further concomitant medications. The following day, on 31MaY2003, the pt had a "systemic hypersensitivity reaction that resulted in hives all over her body." Unspecified medical attention was sought and the physician determined that this was not a varicella breakthrough but an allergic reaction. No diagnostic studies were performed. The pt was treated with Benadryl and Hydroxyzine for the symptoms. At the time of this report, the patients condition had improved, but she still was showing hives on her skin. Additional information has been requested.
A lump in the arm/noticed several days after the 1st dose, several inches (3 inches) below the injection site/: smooth, oblong, 2 inches/ it has not gone away and is at the injection site on the left arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (A lump in the arm/noticed several days after the 1st dose, several inches (3 inches) below the injection site/: smooth, oblong, 2 inches/ it has not gone away and is at the injection site on the left arm.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (A lump in the arm/noticed several days after the 1st dose, several inches (3 inches) below the injection site/: smooth, oblong, 2 inches/ it has not gone away and is at the injection site on the left arm.). At the time of the report, VACCINATION SITE MASS (A lump in the arm/noticed several days after the 1st dose, several inches (3 inches) below the injection site/: smooth, oblong, 2 inches/ it has not gone away and is at the injection site on the left arm.) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No Concomitant medication were reported. No treatment medication were reported.  Patient stated that It doesn't hurt or itch, no rash. It was not an allergic reaction. It has been more than a week and has not gone away or diminished in size. It smooth and oblong in shape, about 2" by 3". She know for a fact that it was not there before.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Patient demographics were updated. On 28-Oct-2021: Follow up contains non significant information.
Period began abnormally on night of first shot. Period was come every 2 weeks since shot. Heavy, cramping, painful. I have never experienced anything like this kn my life. I regret the decision to get the vaccine
C/o redness, swelling & hardness-on (L) deltoid 1 hour after receiving vaccine. C/o some fatigue w/in 24 hours. Pt notified 6/29/15 & was seen. C/o tenderness, slight redness, & tingling
"I received my covid vaccine (Moderna) first dose on 1/7. I developed a fever up to 102F over the following few days and severe pain at the injection site. On about 1/18 my ankles started swelling and turning bright red. I took tylenol / motrin not knowing this could even be associated and thinking maybe I overworked my muscles running around at work that weekend. Over the following few days the reaction has become much more severe. I have nodules that are red, painful and flat all over the front of my legs and thighs and continued swelling and pain to my ankles and knees. This makes it difficult to walk. I followed up with a Dr. on online as I am unable to drive myself to an appointment at an office at this time who diagnosed me with Erythema Nodusum and started me on prednisone. I missed 2 days of work with the initial reaction to the vaccine and will miss 3 shifts this weekend as I cannot walk and need to start prednisone"
Patient ended up with a 16 day hospital stay within 6 weeks of receiving the covid vaccine.
My wife for 23 days was never the same after the shot on 1/9/2023; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION (My wife for 23 days was never the same after the shot on 1/9/2023) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In January 2023, the patient experienced VACCINATION COMPLICATION (My wife for 23 days was never the same after the shot on 1/9/2023). At the time of the report, VACCINATION COMPLICATION (My wife for 23 days was never the same after the shot on 1/9/2023) had resolved.            No concomitant medication information provided.  It was reported that reporter's wife for 23 days was never the same after the shot, went to urgent care and her doctor. Stated due to this she would never take another covid shot.  No treatment information provided.
Itchy on her scalp; Red ears; Hot ears; Swollen Nose; Felt tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy on her scalp), ERYTHEMA (Red ears), EAR DISCOMFORT (Hot ears), SWELLING (Swollen Nose) and FATIGUE (Felt tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 023M20A) for COVID-19 vaccination.     No lab data was provided by the reporter.  Concurrent medical conditions included Immunocompromised, Rheumatoid arthritis and Cancer ((Not on Chemo now)). Concomitant products included INFLIXIMAB (REMICADE), METHOTREXATE and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PRURITUS (Itchy on her scalp), ERYTHEMA (Red ears), EAR DISCOMFORT (Hot ears), SWELLING (Swollen Nose) and FATIGUE (Felt tired). On 19-Mar-2021, PRURITUS (Itchy on her scalp), ERYTHEMA (Red ears), EAR DISCOMFORT (Hot ears), SWELLING (Swollen Nose) and FATIGUE (Felt tired) had resolved.            No treatment medications were provided.  Reporter stated that patient  followed the doctor's instructions and took Benadryl.
Left arm still in severe pain nearly a month later. All through left arm, and into shoulder. With a low grade fever between, 99.2- 100.2.
Patient was given vaccination and asked to sit in  observation area for a minimum of 15 minutes. Within the first 5 minutes, the pharmacist was alerted to the patient dropping his phone and glasses to the floor and staring off into space. The pharmacist proceeded to make contact with patient by calling their name and giving them gentle taps on the shoulder and knee. The patient "came to" within a few minutes stating that they could hear and see but felt as though they were "off in space" . Once the patient "came to" they were coherent but perspiring a bit.  The patient was offered water and a cool damp cloth. The patient was offered EMT services which they declined. The patient was made to wait another 15 minutes in the observation area. The patient did have a spouse with them who would be driving them home. The patient was called later in the day to by the pharmacist to see how the were feeling. The patient stated they were fine and appreciated the follow-up call.
Information has been received from a certified medical assistant concerning unspecified patients who on an unspecified date were vaccinated with VAQTA that stored at colder that recommended temperatures. No adverse symptoms noted. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
Non-Hospitalized Breakthrough, patient here for inpatient rehab (admitted 8/13/21) prior to infection. The patient says her sore throat and voice hoarseness remain unimproved.  She is still on isolation due to positive rapid COVID test result.  She says her husband also tested positive for COVID and has similar symptom.  She denies having fever, chill, shortness of breath, cough, sputum production, or chest pain.
Tingling and slight swelling in lips, face, hands and palms of hands; red rash on neck; given 50 mg benadryl, symptoms controlled by that, red rash is fading by 11am; still feel tingling feeling in face and lips at 11am
Patient received the Meningicoccal B vaccine in the left arm, then received the Meningicoccal ACWY (Menactra) in the right arm. Almost immediately after receiving the second vaccine, the patient appeared to faint. The patient became very sweaty and pale. Patient was difficult to arouse and for approximately 5 minutes, the patient drifted in and out of alertness. When patient became more alert, he reported that his legs were cold, he could not see (reported everything was gray), and he was nauseous. Ice pack was applied to neck, cold cloth to forehead, patient was provided a few sips of orange juice and some water, per his request. The nausea subsided and vision returned to normal, and once able, patient was moved to a cot to lay down. Patient was monitored for 10 more minutes and his last immunization (Gardasil 9) was given while he was lying on the cot. Patient was monitored for 10 more minutes after the final immunization and when he felt like he recovered, he was allowed to sit up slowly, stand, and then leave with parent.
This is a non-serious case from a nurse in the USA reporting a patient experienced Lightheadedness:  (Unlabelled, USA) after receiving FLUMIST.  The reporter causality is not provided.  This case is submitted according to the VAERS Safety Surveillance accelerated reporting agreement for FlLUMIST. An adult patient experienced lightheadedness 20 minutes after receiving FLUMIST. The patient's clinical outcome is unknown. The reporter causality was not provided. Additional information is being requested.
Patient only received maybe a quarter dose of vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient only received maybe a quarter dose of 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 ACCIDENTAL UNDERDOSE (Patient only received maybe a quarter dose of vaccine). At the time of the report, ACCIDENTAL UNDERDOSE (Patient only received maybe a quarter dose of vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter No treatment information was provided by the reporter
COVID-19 PCR positive test, fatigue, sore throat, cough, SOB, Leg swelling
Urticarial lesion on the left thigh extending inferomedially; blanchable, non-tender; no fever, given oral antihistamine daily.
05/22/2021 stated feeling unwell with pain in chest due to activity of walking and when stopped walking the pain stopped. 05/23/2021 repeated of activity of walking and pain stopped. On Sunday 05/31/2021 1AM chest pain would not stop and no activity sleeping. Then chest pain increase and spouse took her to the hospital. Hospitalized for a week. Could tell there was a blockage based on blood test. Heart Damage. COVID May 2020 survivor.
Information has been received from a clinical medical assistant referring to patient of unknown age and gender. On 26-JAN-2015 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX lot K005180, expiration date 10-APR-2016, (dose, frequency, therapy route unspecified). No adverse effects were reported. The outcomes of events reported were unknown. No product complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Pt got PENTACEL, Hep B, and PREVNAR at health dept. on 06/07/10. Within 12 hours, pt had temp 104-105 and cried for more than 4 hours, was irritable. Mom that PM 6-7-10 took child to medical center ER. Told there pt. had no cold, no ear infection and fever was due to "shot".
injection site blotches; injection site rash; injection site itch; injection site redness; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (injection site blotches), RASH (injection site rash), PRURITUS (injection site itch), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE PAIN (injection site pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced RASH MACULAR (injection site blotches), RASH (injection site rash), PRURITUS (injection site itch), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE PAIN (injection site pain). On 29-Mar-2021, RASH MACULAR (injection site blotches) outcome was unknown and RASH (injection site rash), PRURITUS (injection site itch), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE PAIN (injection site pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Pt recvd vax 29SEP93 & on 12APR94 pt was hospitalized w/fever of 104.8; BC revealed haemophilus influenza type A;
25MAR92 recvd DTP/OPV/HIB by Pm pt feverish 103 ax, lt arm swollen, red & warm; APAP & cold compresses; Fridya AM 27MAR92 taken to ER w/same sx; sx w/bilateral ear infect; mom states pt also had hive-like rash below inject site on lt arm;
Information has been received from a consumer concerning her 18 month old son with gastric issues, reflux and no known drugs allergies, who in approximately August 2005, was vaccinated with a dose of MMR II. A couple of months after received the MMR II the patient started to had repetitive behavior of spinning and not responding to his name. The consumer reported that she did bring her son to the pediatrician's office and he was first diagnosed with autism in May 2006, then he went to the physician's again and was diagnosed with autism for the second time in August 2006. The consumer reported that from the autism the patient had severe constipation, reflux and gastritis. Laboratories studies performed include a blood work done in August 2006. The patient had been hospitalized in November 2006 for two nights because of his gastritis. The patient was doing a little better due to many therapy sessions but he still had a mind set of a two year old. The patient sought medical attention through a pediatrician and a physician visits. Upon internal review autism was determined to be an other important medical event. Additional information has been requested.
Injection site became red, hot to touch, swollen, and very itchy. Patient was given Benadryl 25mg tab 1 PO.