chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 47-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment.   The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
PEA cardiac arrest secondary to hypothermia, hypoxia, or acidosis in the setting of COVID-19 infection.
VOMITING; BODY ACHES WHICH FELT LIKE AFTER A VERY HARD WORKOUT; PAIN IN STOMACH LIKE CRAMPING; HEART POUNDING IT FELT LIKE BLOOD RUSHING THROUGH THE  BODY VERY QUICKLY; UNABLE TO SLEEP; HEADACHE ALL THE TOP OF THE HEAD; NAUSEA; ARM HURTS WHEN IT MOVES; SORE ARM IN INJECTION SITE AREA THAT IS CANNOT BE TOUCHED OR LAY ON IT; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included penicillin allergy, and other pre-existing medical conditions included the patient has not had covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-JUN-2021, the subject experienced arm hurts when it moves. On 08-JUN-2021, the subject experienced sore arm in injection site area that is cannot be touched or lay on it. On 08-JUN-2021, the subject experienced nausea. Laboratory data included: Pain scale (NR: not provided) 6. On 09-JUN-2021, the subject experienced vomiting. On 09-JUN-2021, the subject experienced body aches which felt like after a very hard workout. On 09-JUN-2021, the subject experienced pain in stomach like cramping. On 09-JUN-2021, the subject experienced heart pounding it felt like blood rushing through the body very quickly. On 09-JUN-2021, the subject experienced unable to sleep. On 09-JUN-2021, the subject experienced headache all the top of the head. Laboratory data included: Pain scale (NR: not provided) 6-7. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative.  Treatment medications (dates unspecified) included: ondansetron, acetylsalicylic acid/caffeine/paracetamol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm in injection site area that is cannot be touched or lay on it, nausea, vomiting, body aches which felt like after a very hard workout, pain in stomach like cramping, heart pounding it felt like blood rushing through the body very quickly, unable to sleep, and headache all the top of the head, and the outcome of arm hurts when it moves was not reported. This report was non-serious.
Breakthrough case admission after 3 vaccines Pfizer 4/27/21 Lot# Ew0176;  Pfzer 5/18/21 lot# Ew0183;  Pfizer 12/18/21 lot# FE3594
Received an email from RN infection prevention with limited information stating "here is a hospitalized break through case"  agency form attached with symptoms checked:  Diarrhea, Fatigue, SOB.  No underlying medical conditions or systemic immunosuppressive therapy or medications was selected.  Report checked "yes" that patient was hospitalized for >1 night and that it was related to SARS- COV-2 infection.  Nothing is selected for admitted to ICU or if mechanical ventilation was required.  We also were not given info on how long the patient was hospitalized for.
Patient was unknowingly  given Booster dose with expired vaccine.  Patient was contacted by his provider once the error was realized
In the couple of weeks following my second shot, I became very susceptible to severe bruising. I barely bumped my leg and got a golf ball size contusion on my shin bone. I barely bumped my finger and the fingernail turned black and fell off. I would wake up with bruises from rolling over in bed.
3/24/21 Incoming Triage Nurse call: Hospital called and said patient is there now and had got her 1st Covid Vaccine- Moderna and she did get a small rash on her left forearm that does itch and is red. Nurse said patient got the shot in her left arm and got the rash on her forearm a few minutes later.   3/26/21 ER HPI: dx: urticaria 20 year old female who presents with ITCHING IN LEFT FOREARM.  GOT COVID SHOT ON 3/24/21 AND HAS HAD INTERMITTENT ITCHING ON LEFT FOREARM SINCE.  PT DENIES SHORTNESS OF BREATH AND CHEST PAIN.  PT STATES WHEN TAKES BENADRYL GETS BETTER AND THEN RETURNS.  PT STATES SAW Doctor AND WAS TOLD TO GO TO ER IF IT DID NOT IMPROVE IN 24 HOURS. Triage nurse: Presents to the ER from home with complaints of itching and redness to left lower forearm. States she had the Covid injection (first one) on 03-24. States had taken Benadryl after the injection to help with itching. States "redness comes and goes." Complaining of headache, 8/10 pain, constant throbbing with onset yesterday. States Tylenol did help alleviate pain some, not completely. States she was instructed per PCP to come to ER if redness, itching continues
Extreme soreness at and around vaccination site, upper arm feel hot to the touch and is red and hard. Fever elevated by 2 degrees, headache, and chills 24 hours after injection rec'd. Pain and redness became more pronounced 8 hours following injection. Treated with Ibuprophen and Tylenol for the past day, fever lowered when piggy-backed, but pain has not been reduced.
started with chills and a low grade temp (no higher than 99.8).  Restlessness and mental fog through most of Wednesday, November 17.  Had little appetite during the day.  Also experienced continued brain fog.  Stayed in bed from 10pm on the 16th to around 6pm on the 17th.  Today (11/18), feeling more normal, somewhat fatigued and appetite still not strong, but I'm ready to get back to a mostly normal routine but I don't think I'll be too physical in the things I will be doing.
Nurse reported that a patient received VAXELIS and VAXNEUVANCE by mouth on 6/15/2023.; This spontaneous safety report, with reference number 02410179 (Interaction #02410170), was received by the partner on 19-JUN-2023 and forwarded to agency on 20-JUN-2023, from a health professional.  Due to the nature of the event, the causality between the events "Nurse reported that a patient received VAXELIS and VAXNEUVANCE by mouth on 6/15/2023." and Vaxelis was not applicable.  Further information is expected.
91 YEAR OLD FEMALE COMPLAINED OF BEING TIRED AFTER RECIEVEING VACCINE. ON SITE EMS RESPONDED.  VITALS BELOW. SHE REFUSED FURTHER EVALUATION AND CARE AND WENT HOM
No adverse effects; unspecified patients received improperly stored doses of PNEUMOVAX 23; This spontaneous report was received from a medical assistant, referring to a 65-year-old patient of unknown gender. No information regarding the patient's pertinent medical histories, concurrent conditions, concomitant therapies, drug reactions or allergies.  It was reported that on 09-OCT-2019, the vaccine pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was exposed to a temperature excursion with a lowest temperature below 36 Fahrenheit (F) degrees (30.5 F degrees) for 10 hours. There was no previous temperature excursions.  On 01-NOV-2019, the patient was vaccinated with the improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S029265, expiration date 31-MAR-2021 (dose, dose number, route of administration and anatomical injection site were not reported) for prophylaxis. The call was placed because of the Digital Data logger report. No adverse effects reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S029265; expirationdate: 31-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1911USA001801: US-009507513-2005USA002426: US-009507513-2005USA002452: US-009507513-2005USA002454: US-009507513-2005USA002455: US-009507513-2005USA002456: US-009507513-2005USA002457:
Reaction to vaccines (flu, Menactra) left arm Note - pt has had Menactra before without issues. Localized skin reaction LA.
Pt came in about 4 days after the vaccination and presented with a rash/bruising on the same arm as the vaccination. She later reported that it only lasted for 2 days and disappeared.
Right sided jaw to chest pain. Right sided chest pain was intermittent and became severe enough to go into ER.
Beginning the evening that I received my pneumonia vaccine, I began to have severe pain in my left arm up through my shoulder.  The area seems to only have some slight swelling and has no bruises or bumps.  The pain is still quite severe, getting worse during the night hours.
pt recv vax 22AUG96 & 26AUG96 pt exp rash of tiny red itchy bumps on the arm pits, arms, & forehead;
The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.; vial undergo temperature excursions; No adverse event; erroneously vaccinated with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 56-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Nov-2022, 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. On 11-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.) and PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions).    No concomitant medications were reported.  It was reported that the patient was administered dose after 30 day use by date.   The size of the vial was 2.5 ml.   Beyond use date was reported as 02-Nov-2022.   The vial underwent temperature excursion.   9 days past expiry date the patient received the vaccine.  The last date the vaccine with lot number 057F22A was administered on 11-Nov-2022.  No treatment information was reported.   This case was linked to MOD-2022-514073 (Patient Link).
This case was reported by a consumer (subject's mother) and described the occurrence of increased fetal movement in a foetus subject of unspecified gender who was exposed to KINRIX (GlaxoSmithKline), FLUARIX. A physician or other health care professional has not verified this report. On 22 November 2013 the 29-year-old mother of the patient received a dose of KINRIX (transplacentary), a dose of influenza (transplacentary). The mother's last menstrual period was not reported. The estimated date of delivery was reported as 26 January 2014. The neonate was exposed to KINRIX and influenza approximately 30 weeks (calculated) during the 3rd trimester. Prenatal diagnostic tests included amniocentesis with normal results. Prenatal diagnostic tests also included ultrasound examinations on 28 June 2013, 16 August 2013, and 4 September 2013 with no evidence of defect from prenatal testing. On 22 November 2013, less than one day after vaccination with influenza and KINRIX, the neonate experienced increased fetal movement, drug exposure in utero. At the time of reporting, the outcome of the event was resolved per the mother.
Patient is asymptomatic but the ECF sent patient in as they are not allowed to keep COVID positive patients per ER note.
THIS PERSON WAS SCHEDULED TO RECEIVE HIS 1ST MODERNA VACCINE ON OR AFTER 08/11/21 (18TH BIRTHDAY). VACCINATION CLINIC HAD TO BE MOVED UP TO 08/06/21, AND HE WAS MOVED UP WITH OTHER SCHEDULED CLIENTS AND GIVEN HIS VACCINATION 5 DAYS BEFORE HIS 18TH BIRTHDAY IN ERROR.  NO ADVERSE EFFECTS WITH 1ST OR 2ND VACCINATIONS.
severe headache by night time; got a light nosebleed; This is a spontaneous report from a contactable consumer (patient himself). A 45-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8737; Expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 07May2021 as single dose for COVID-19 immunization. Patient medical history included food allergy, allergic to aspirin and shellfish, everybody got COVID-19 in the house from, local anaesthesia from 07May2021 to 07May2021, Caller stated he had a dental cleaning that same morning as the vaccine with anesthesia that was local, from 07May2021 to 07May2021. Patient's Medical History (including any illness at time of vaccination) was none. Family Medical History Relevant to AE(s) was not provided. The patient had not any other products. The patient had not received any other vaccines within 4 weeks of COVID vaccine. The patient's concomitant medications were not reported. The caller reported that he was about to get his second dose of the vaccine and the nurse asked about his first dose. On 07May2021 after first dose he had a severe headache by nighttime about an hour later which lasted for 4 days. Caller stated the nosebleed started on the same day 07May2021 as receiving the vaccine around 10:00-10:30 which lasted until Sunday. The pharmacist asked him to call us to see if he could get the second dose. They did not know what could happen to him with his second dose because of this. He stated he was really allergic to aspirin and shellfish too and didn't know if that was the problem. The caller wanted to know if shellfish was a part of the vaccine. It was enquired that, Pfizer-BioNTech COVID-19 Vaccine contain aspirin or not. Patient was not visited to Emergency Room/ Physician Office. Reporter seriousness for headache and nosebleed was Unspecified. AE(s) following prior vaccinations was not provided. Caller stated he just took Tylenol for side effects and went to bed. Patient had not any relevant tests. The outcome of event headache was recovered on 09May2021 and nosebleed on 10May2021.  Information about lot/batch number available, no further information is expected.
Patient's wife stated he has been suffering from blood clots and is currently being treated with anticoagulants.
On day 4 post vaccine, 12/27/2020, patient began with head and neck soreness, a migraine, and nausea/vomiting. Patient saw MD on 12/30/2020, MD stated patient had inflammatory response to the vaccine. Patient received a steroid injection. Patient states she feels better after steroid injection.
pt devel fever to 105 15 hrs p/vax fever resolved w/APAP; pt back to nl 16 hrs p/event;
experiencing severe OCD / OCD symptoms; nervous; can't even go to the grocery store any more; asks weird questions a thousand times\ needs explaining like a 5-year-old; severe weight loss - 35 pounds\ "Feels like she is disappearing before our eyes; not eating; Lexapro it's been making her sick; This spontaneous case was reported by a consumer and describes the occurrence of OBSESSIVE-COMPULSIVE SYMPTOM (experiencing severe OCD / OCD symptoms), NERVOUSNESS (nervous), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't even go to the grocery store any more), ABNORMAL BEHAVIOUR (asks weird questions a thousand times\ needs explaining like a 5-year-old) and WEIGHT DECREASED (severe weight loss - 35 pounds\ "Feels like she is disappearing before our eyes) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OBSESSIVE-COMPULSIVE SYMPTOM (experiencing severe OCD / OCD symptoms), NERVOUSNESS (nervous), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't even go to the grocery store any more), ABNORMAL BEHAVIOUR (asks weird questions a thousand times\ needs explaining like a 5-year-old), WEIGHT DECREASED (severe weight loss - 35 pounds\ "Feels like she is disappearing before our eyes), DECREASED APPETITE (not eating) and ILLNESS (Lexapro it's been making her sick). The patient was treated with ESCITALOPRAM OXALATE (LEXAPRO) for Obsessive-compulsive disorder, at an unspecified dose and frequency. At the time of the report, OBSESSIVE-COMPULSIVE SYMPTOM (experiencing severe OCD / OCD symptoms), NERVOUSNESS (nervous), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't even go to the grocery store any more), ABNORMAL BEHAVIOUR (asks weird questions a thousand times\ needs explaining like a 5-year-old), WEIGHT DECREASED (severe weight loss - 35 pounds\ "Feels like she is disappearing before our eyes), DECREASED APPETITE (not eating) and ILLNESS (Lexapro it's been making her sick) outcome was unknown.            No concomitant medications were provided.  Patient got tested for dementia and other scan , everything came back 100% fine.
Dizziness, Headache, Myalgia, Arthralgia, ErythemaMultiform, NauseaVomiting, chills Narrative:
This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. In February 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient stated that, he was vaccinated with the 1st dose of SHINGRIX in February, 2018 and got shingles at the end of June, 2018. The patient inquired, why was he not protected and should he get the second shot. The patient also inquired that, his wife when she was young had Guillain-Barre was it safe for her to get SHINGRIX.
Before I got my vaccine, they asked if I had an adverse events prior to any other vaccines. I did tell them about my experiences with my first and second dose. They tried to talk me out of getting the vaccine and tried to get me to switch vaccine manufacturer. I denied changing the vaccine. Within 5-10 mins my face and mouth started to tingle. After about an hour I started to have the severe chest pain on left side which is the same side as the vaccination. The chest pain started to increase so I made an appointment to see my doctor. They did an EKG but I wasn't having the chest pain at that moment so they could not confirm anything was wrong. They told me I was having an anxiety attack and sent me home. I tried to explain that the chest pains would come on at random times. For example I went to the grocery store to buy chicken then the severe chest pain would come on. The chest pain lasted about 1.5 weeks. I am still experiencing the numbness and it comes at sporadic times and lasts for about 5-45 mins.