chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 10:02 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 10:44 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 85.97 for dose administered on 28-Feb-2021 and 86.05 for dose administered on 28-Mar-2021.  The age of patient was provided as 61.04 for 2nd dose LOT 007C21A and 60.97 for 1st dose LOT 030B21A.  Concomitant products were not provided.  On 27-Feb-2021 vials were moved to clinic. On 24-Feb-2021 the vaccines were moved to fridge. On 28-Feb-2021, the vial underwent the excursion. The vaccine beyond use date was reported as 26-Mar-2021.  On 27-Mar-2021 vials were moved to clinic. On 23-Mar-2021 the vaccines were moved to fridge. On 28-Mar-2021, the vial underwent the excursion on the following timings: at 10 AM temperature was 35. The vaccine beyond use date was reported as 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration. It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
On Monday, 3 days after, just felt weak, like a zombie, but didn't have swelling or hurting at injection site or headache. But in the days following, felt whoozy, dizzy, and had low blood pressure, once took a nitro for my heart and then blood pressure went down to 68/36, another time 75/45, another time 90/55,
Swelling in lips and hands. 1/14/16 at 8am BENADRYL given, prednisone 20mg x 3 days.
Below injection site, an area of tissue is painful, dark red, hot to touch,  and itchy, Approximate size  4 "X 4"
"Moderna COVID-19 Vaccine EUA"  Several hours after receiving first dose of vaccine my left arm became very painful to the point of bringing me to tears whenever I tried to move it or use it: lifting something as simple as a glass of water was excruciating pain. Second day is a little better with a little more mobility, but trying to undress and undress is torture, especially lifting my arm over my head or past my chest.
Diffuse 1/2 circle red rash below injection site. Hard and warm to touch. Reaction had cleared up by 10/30/02.
was so sick; thought as going to die because of the flu shot; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 02-Dec-2020.  This case involves a patient of unknown demographics who was so sick (illness) and thought as going to die because of the flu shot (feeling abnormal), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was so sick (illness) and thought as going to die because of the flu shot (feeling abnormal), (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the events.  There will be no information available on the batch number for this case.
Arm pain, breast/chest pain, low back nerve pain migrating to middle back pain.  Back muscular/nerve pain was intermittent and started two days after booster (nov 6 AM), resolved itself after getting up , then came back and was present all day and night Nov 11, 12.  Pain mostly managed by tylenol.  Pain is worse when lying down.  Since then, I have had spinal pain, stiffness is various places in my back, neck approximately every other day or every day since getting the booster.  This includes episodes Nov 14, 15, 16, 18, 20, 21.   Managed with tylenol.  Mon Nov 23, had dizzy vertigo spell for several hours.  As of today, most of the pain is resolved but I still have a stiff neck, fatigue.
Parent states red spots started around injection site on 3/16/2023 and continued until solid red accompanied with swelling and warm to the touch. Mother brought child into doctor's office for evalation. While in office administered 2.5 mL Benadryl and advised parent to draw a circle around site to check for spreading. Advised parent should condition worsen or spread to go to nearest urgent care/ Emergency room. Patient scheduled for Monday 3/20/2023 to follow up.
Information has been received from a 76 year old female with a history of chronic obstructive pulmonary disease and is allergic to codeine, who on 24-OCT-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unknown). Pneumococcal 23v polysaccharide vaccine (MSD), hepatitis B vaccine, recomb (MSD), "Q-Bar 10" (manufacturer unknown), aspirin and analgesic or anesthetic (unspecified). On 25-OCT-2007 the patient felt weak. On 01-NOV-2007 the patient stated that she was completely in and out of it and would fall asleep without knowing it, but she would come to with sharp pains in joints. The patient stated that she may have had a fever. On 02-NOV-2007 and 03-NOV-2007 the patient experienced paralysis in shoulders arms. Her mouth was sore and everything tasted bitter. The patient stated that she became dehydrated because she couldn't lift her arm to drink water. On 04-NOV-2007 the patient went to the emergency room and she received pain pills. The patient stated that the physician said that she may have Guillian Barre. The patient stated that she was still relatively weak but her arms and mouth were doing better. The patient stated that she took 9 aspirin every day and that she was getting relief. No additional informtion was provided. There were no lab diagnostics studies performed. The outcome was reported as recovering. There was no product quality complaint. Upon internal review, Guillian Barre was considered to be an other medical event. Additional information has been requested.  12/12/2007 Vax record received from PCP with note from date of vax.  Info entered in VAERS database. 12/31/2007 MR received for ER visit 11/4/2007 with dx: likely adverse reaction from immunizations.  Pt presented with c/o generalized body aches and chills. Assessment:  Joint and muscle aches or myalgias and arthralgias 2' to complications s/p immunizations. Instructed to return to ER for further problems.  Spoke with pt 12/11/07 who stated she was not dxd with Guillain Barre.
Developed fevers to 102 F two days after vaccination, fever has lasted 6 days so far.  Lab work shows elevated transaminases.  AST is 103 and ALT is 103.
a lot of pain on her left thigh and on her hip on the same side; a lot of pain on her left thigh and on her hip on the same side; she can not walk and can not cross her legs; she can not walk and can not cross her legs; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a lot of pain on her left thigh and on her hip on the same side. She wanted to know of that was a normal reaction after the vaccination, the pain was so strong that she cannot walk and cannot cross her legs. She also wanted to know if the duration of these side effects was known. The seriousness of the events was reported as non-serious. The outcome of the events was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Severe chills, feverish, headache, nausea, fatigue starting 5 hours after vaccination and lasting until the night after. 36 hours after became short of breath with that symptom continuing 72 hours later.
received 2nd dose 21 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 21 days after 1st dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 21 days after 1st dose). On 14-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 21 days after 1st dose) had resolved.            No concomitant medication was reported No treatment medication was reported Patient was not experiencing any symptoms.
Felt like she had a few drinks, given water and felt better. BP 141/57, pulse 80, O2 sat 96%.
Approx. 10 hrs. after injection I developed soreness at the injection site and upper arm. Injection site is tender to touch.  I was unable to lay on this arm as I went to sleep. I also developed a dull ache down my left arm to my fingers. These symptoms remain in the day following the injection
VAXELIS was administered to 6 patients after product experienced an excursion was was not suitable to use.; This non-serious spontaneous safety report, was received on 23-FEB-2023, from a HCP. This case is linked to case MCM-004541 (reference number 2023SA055890 and Inquiry number 01495388).  Due to the nature of the event, the causality between the reported event "VAXELIS was administered to 6 patients after product experienced an excursion was not suitable to use" and Vaxelis was not applicable.  No further information is expected given that there were no adverse events following Vaxelis administration post-excursion.  For reference purposes this case is linked to MCM-004541 (source case), MCM-004562, MCM-004564, MCM-004565, and MCM-004563, due to same reporter.
This spontaneous report was received from a Registered Nurse concerning to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients may had received an improperly stored doses of PNEUMOVAX 23 (dose and route were not reported) lot # M043424, the expiration date: 06-JUN-2018 for prophylaxis. No adverse effects reported. There was no concomitant medication provided. The temperature excursion was reported between 32°F to 35°F during 1 Hour 12 Minutes. The call was made due to "data logger" and there was no previous temperature excursion reported. Additional information has been requested.
Violent uncontrollable shaking (convulsions) for about 30 minutes in the middle of the night.  Started around 2 am I believe.  My wife had the same vaccine the day prior and a similar experience.    Can't overemphasize how serious the shaking was and it was scary.
2/6/2023 passed out, broke a chip off femur and big toe. BP dropped when sitting or standing. Went to ER and admitted to the hospital for 8 days. Doctors double checked pacemaker. Ran an EKG with 12 leads, did a CT scan of brain, neck, chest, both knees, and both feet. Did CBC with differential, full blood work up, Troponin, Full Metabolic panel. X ray of both knees, 2/7 magnesium, Troponin; BNP or ProBNP, Chest x ray, left wrist, right toes. X-ray of femur; 2/8 CVC with differential; Ultrasound Doppler of both legs. 2/9 Echocardiogram 2/10 Ultrasound of right leg and groin; 2/14 right foot x ray, flu/RSV/COVID-19 panel; 2/16 teomery report. Participant developed blood clot and is now on blood thinners.
pt was given the shot and stood up and walked about 5 feet and fell onto the floor hitting his head on the cabinet on the way down. he then began to shake for about 3-5 seconds. we got patient up off the ground onto the bed. he was very pale and nauseated. we administered epi and dexa and pt was monitored over the next 2 hrs in office.
Pt vaccinated with DTP approx 8 hrs after DTP angioedema of face, hands, & feet lasted approx 2 hrs RX Benadryl.
2 days after receiving VARIVAX and IPV on (L) arm, patient developed induration and vesicles, spreading all the way below (L) elbow, required IV antibiotics and hospitalization.  10/6/09 Hospital records received service dates 9/17/09 to 9/19/09. Assessment: Cellulitis arm. Child presents with fever, vomitng, cough. Pain, swelling, erythema, and blisters, upper left arm.  ICD-9 Codes: 682.3 Cellulitis of Arm.
Headache, Sedation, Myalgia, Arthralgia, injection site pain, chills, sweats, ankle and foot pain Narrative:  Other Relevant History:
C/O sudden onset cough and runny nose and wheezing no medicine taken @ 12:00 midnight. Tuesday 12-15-09 during the day symptoms were less. Wednesday 12-16-09 @ midnight, cough, runny nose and wheezing returned over.
Information has been received from a physician's assistant concerning a 50 year old female with rheumatoid arthritis, "shogun's syndrome", scoliosis, hypertension, diabetes, seafood allergy, allergy to nuts (almonds) and multiple medications drug hypersensitivity (unspecified) who on 01-OCT-2007 was vaccinated with a first dose of Gardasil. Concomitant medication was unspecified. On 01-OCT-2007, within one or two hours after being vaccinated, the patient experienced respiratory distress. The patient went to the emergency room and was treated for an allergic reaction. She was given epinephrine injection, albuterol inhaler, and (Benadryl). At the time of reporting, 02-OCT-2007, the patient was still experiencing mild to moderate respiratory distress. The reporter considered the respiratory distress and allergic reaction as serious to disability, immediately life-threatening, and as Other Important Medical Events because epinephrine injection was required. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. In approximately 2016 (reported as on or after 23-APR-2016), the patients were vaccinated with improperly stored doses of ROTATEQ lot # L029618, expiration date reported as 20-MAY-2017, lot # L033545, expiration date reported as 30-MAY-2017 (dose was not reported) oral. There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 34.8 degrees Fahrenheit for 6 hours 43 minutes and 53.2 degrees Fahrenheit for 8 minutes. Data logger was involved. There was no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
approx 15 mos p/vax pt devel 2 itchy varicella-like lesions a inject site
Vaccine expired on 10/2/21 but was administered on 10/8/21
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns an 83-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD TIV vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 15-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. The reported batch number (250795), does not mathc FLUCELVAX batch number, however, the batch number was mapped to FLUAD (TIV). Hence, the suspect vaccine was coded as FLUAD (TIV). At the time of this report, no adverse event was reported. This case 201805480 was crossed linked to original case 201804863 due to same reporter.
chronic pain lt shoulder muscle;weakness in lt shoulder when using arm in palm down position;constant aching in lt shoulder;soreness in area of inj site;pt felt had overwork or sprain type injury to lower shoulder;
Pt presented to office with swelling, unable to bend L elbow and redness and pain.
No adverse event; incorrect product storage; This spontaneous report as received from a physician, concerning a 13 month old patient. The patient's medical history, concurrent conditions and concomitant medications were not provided.   On 20-MAY-2021, temperature excursion occurred and on 24-MAY-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # T037957 with expiration date 09-MAY-2021, first time dose (strength, frequency and route were not provided) for prophylaxis.  No signs or symptoms reported. No other adverse events reported.  The vaccine was stored at a temperature of 43.7 Fahrenheit with a time frame of 84 hours. It was not reported if digital data logger was involved.
sever throbbing arthritis with fluid affecting left knee  chronic diarrhea requiring prescription for IBS which continues to this day after starting in June 2021
Nausea, vomiting, chills, fever, aches, head ache , dizziness. Took Advil. Relief after 24 hours.
This infant had a pruritic rash onset 1 week after vaccine administration. Had rash on 04/27/01 and bilateral otitis media. Started on Amoxicillin.
HIT INJECTION LOT HARDER THAN EXPECTED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced hit injection lot harder than expected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hit injection lot harder than expected was not reported. This report was non-serious.
Vaccine administered was stored greater than thirty days in refrigerated temperatures. A case opened with the vaccine manufacturer demonstrated the vaccines were still safe and effective but requested we make an official report.
Ringing in the ears; Cough; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in the ears) and COUGH (Cough) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced TINNITUS (Ringing in the ears) and COUGH (Cough). At the time of the report, TINNITUS (Ringing in the ears) and COUGH (Cough) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.
the patient came in to the pharmacy and indicated that she is having swelling at the injection site and that it is hot to the touch. The patient also noticed inflammation of local lymph nodes.
fever 101(only took temp. once during whole episode tho i had ongoing fever)---aches and pains esp. joints--sweats--decreased appetite(felt i would vomit if i ate)--tired and weak--slept most of the time for over 54 hrs.
Hello, I received my first dose of Pfizer Sunday morning and felt sick in the evening. Monday morning I woke up and felt like I had the full on flu (light headedness, headache, ringing in ear, body aches) I took Tylenol to get through the work day.  Yesterday morning I woke up with my left leg tingling, cooling sensation, numbing just like sciatica and later in the day I had really bad stomach pain radiating all around. I emailed my doctor my symptoms and she just informed me to keep monitoring my symptoms. Not sure if its all a coincidence but could this be related to my vaccine? It almost seems like the vaccine made my stomach and nerves inflamed?  Today my left leg is fine with mild stomach pain.