chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Jan-2022; Vaccine administered to patient past its 30 day expiry date, Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 25-Jan-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past its 30 day expiry date, Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 25-Jan-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Jan-2022) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2022 at 8:15 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 25-Jan-2022 at 8:15 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past its 30 day expiry date, Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 25-Jan-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past its 30 day expiry date, Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 25-Jan-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Ethnicity of the patient was reported. Concomitant medication of the patient was not reported. Patient received booster vaccine past its 30 day expiry date .This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. Reporter no longer possess this lot number. On 25-Jan-2022, the patient took the booster dose of the vaccine. No treatment information was provided by the reporter.
Case number PHEH2013US012479, is an initial spontaneous report received from a nurse on 04 Jun 2013: This case refers to an 18-year-old female patient. She received only Men A lyophilized conjugate of MENVEO vaccine (batch number: A11042) reconstituted with sterile diluent intramuscularly on 23 May 2013. She did not receive Men C, Y, W-135 liquid conjugate component of MENVEO vaccine. No adverse reaction was reported following this administration error.
Painful red, warm to touch, swollen area on left deltoid, measuring 12cm x 13cm.
12 hours of sleeping unable to wake for feeding. When awoke inconsolable hysterical screaming. Fever of 101.7 degrees and 3 days of swollen injection site.
7-7-15 5:PM flu symptoms-fatigue all night. 7-8-15 10:45 AM almost fainted-legs trembling-fast heartbeat-dizziness, swelling of throat. Went to the urgent care-TSH test-Chem 8-Troponin single Biosite, CBC w/ auto differential-Strep-A screen- Chest X-ray. 7-9-15 4:PM the arm where I got the injection is swollen-lots of pain, getting hives and rash-running nose-little bit of cough.
Fever, severe nausea, incapacitated in bed for 36 hours, unable to eat/drink, headache, body aches, severe pain in muscles, especially one hip (right), mild form of symptoms lasted another 24 hours after the first really bad day.
dizzy, lightheaded, numbness and tingling in left/right hand and legs. Evaluated by EMS-Refusal to transport.
Client had the following symptoms: Shortness of Breath Dizziness Nausea & vomited X1 Headache Severe cramping in right Hand & Leg Racing Heart  Profuse sweating 911 EMT Services were called with EMT assessment. B/P=90/76 cardiac monitor & pulse oximetry were utilized. Lung/breath sounds were good. No Hives/rashes or swelling (anywhere on body) were noted. Client was transported to Hospital via ambulance on O2 & monitors for further assessment & evaluation.
Stomach ache; Urinary incompetence; Diarrhea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach ache), URINARY INCONTINENCE (Urinary incompetence), DIARRHOEA (Diarrhea) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache), URINARY INCONTINENCE (Urinary incompetence), DIARRHOEA (Diarrhea) and CHILLS (Chills). At the time of the report, ABDOMINAL PAIN UPPER (Stomach ache), URINARY INCONTINENCE (Urinary incompetence), DIARRHOEA (Diarrhea) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment medication was not provided.
Cannot walk without feeling fatigued.; Extreme Fatigue; This spontaneous case was reported by a patient family member or friend and describes the occurrence of GAIT DISTURBANCE (Cannot walk without feeling fatigued.) and FATIGUE (Extreme Fatigue) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Epstein-Barr virus infection (when patient was 16).    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced GAIT DISTURBANCE (Cannot walk without feeling fatigued.) and FATIGUE (Extreme Fatigue). At the time of the report, GAIT DISTURBANCE (Cannot walk without feeling fatigued.) and FATIGUE (Extreme Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Patient was not taking any concomitant medications. It was reported that patient had visited many doctors and taken all kinds of treatments, but nothing seemed to help and did not specify which treatment patient had taken.
Next day after shot leg was swollen, tender, red, splotchy and felt hard. Swelled area was whole thigh.
Right Elbow pains within 7 hrs after shot. Next day elbow and right hand swollen and throbbing pain. still swollen and can not bend all the way 3 days later.
Approximately 14 hours after first covid vaccine I was nauseous, muscle cramps in whole right arm (the side I was given the shot), migraine, dizzy, trouble lifting arm, redness swelling and pain at injection site.  Felt ok the next day.  6 days after receiving vaccine it felt like I had swallowed razor blades and was hard to breathe.  I went to local emergency room where they tested me for strep and was negative and they said they had never seen a swab come back so bloody.  They also did a covid test and I got the results back today showing invalid.  Yesterday I had a low grade fever and today at the injection site my arm is red, swollen, has a knot and sore to the touch.
Moderate chills, headache, body aches Chills resolved after six hours.  Headache and body aches continued for an additional day. We used acetaminophen over 36 hours.
About 3 hours after my injection, I started experiencing severe headaches, body aches and fatigue that lasted 72 hours. Every day my symptoms were less, the fatigue lasted the longest.
Lightheaded , diaphoretic  states this always happen when I get shots. Patient did not want treatment or transport
face swelling; bright red with little red dots; skin was red and systemic rash; full body urticarial rash all over the body; arm swelling, on 20th march 2021 bilateral swelling on palms of arm and forearm; inj site became paper like rough; Moderna Arm; redness; pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE DRYNESS (inj site became paper like rough), VACCINATION SITE REACTION (Moderna Arm), RASH ERYTHEMATOUS (skin was red and systemic rash), URTICARIA (full body urticarial rash all over the body) and PERIPHERAL SWELLING (arm swelling, on 20th march 2021 bilateral swelling on palms of arm and forearm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE DRYNESS (inj site became paper like rough), VACCINATION SITE REACTION (Moderna Arm), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PAIN (pain). On 17-Mar-2021, the patient experienced RASH ERYTHEMATOUS (skin was red and systemic rash), URTICARIA (full body urticarial rash all over the body) and PERIPHERAL SWELLING (arm swelling, on 20th march 2021 bilateral swelling on palms of arm and forearm). On 20-Mar-2021, the patient experienced SWELLING FACE (face swelling) and ERYTHEMA (bright red with little red dots). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form and PREDNISONE at a dose of UNK dosage form. On 19-Mar-2021, RASH ERYTHEMATOUS (skin was red and systemic rash) and URTICARIA (full body urticarial rash all over the body) had resolved. At the time of the report, VACCINATION SITE DRYNESS (inj site became paper like rough), VACCINATION SITE REACTION (Moderna Arm), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PAIN (pain) outcome was unknown and PERIPHERAL SWELLING (arm swelling, on 20th march 2021 bilateral swelling on palms of arm and forearm), SWELLING FACE (face swelling) and ERYTHEMA (bright red with little red dots) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information was not provided. The patient was treated with steroid in the emergency room on 21-Apr-2021.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Additional information received captured no new information.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 30-JAN-2014, the patient was treated at a medical center for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested
No adverse event.  The adult Pfizer 12yr+ vaccine was given to a patient who is 11 years and 9 months.
This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a patient who received MENVEO (batch number M16124, expiry date unknown). On an unknown date, the patient received MENVEO .5 ml. On an unknown date, less than a year after receiving MENVEO, the patient experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to MENVEO. Additional details were provided as follows: It was reported that, the clinic recently changed their meningococcal vaccine from MENACTRA to MENVEO. All the injection site reactions were resolved without further sequelae. The nurse raised concern that there was an increased rate of reactions when compared to what they were used to seeing when they used MENACTRA. In obtaining the lot number for the report, the nurse noted that all doses from that box have been administered. No additional reports from remainder of the doses administered from that box were noted. The case was linked to US2017GSK117470 and US2017GSK119108, reported by same reporter.
Sore arm that lasted for 3 days that went away on its own.  Small, movable lump below collarbone on the same side the vaccine was given noticed on 8/27/21 which was not there before vaccination.
After 2nd vaccine syptoms began 12 hours laterheadache, chills, body aches, sore arm. 2 days after 2nd vaccine a burning itching rash covering chest, neck and back. The rash was recurring and grew.
pt became diaphoretic presyncopal w/BP drop from 130/80 to 100/60; a non productive cough occurred;
5 mins post vaccination while being observed, suddenly reported blurry vision, turned pale, clammy, near syncope. Event lasted for 4 seconds with complete resolution of symptoms. Placed in a lying position, modified tredelenberg. Vital signs remained stable, HR 93-102, BP 106/67, SPO2 97-99%, RR 18. Continuous monitoring and observation, Alert and oriented, activity level at baseline. Observed for 30 minutes total. Offered fluids, tolerated. Placed in sitting position. No further events. Discharged home stable with instruction to report to nearest ED for recurrence or worsening of symptoms. Mother verbalized understanding.
both experienced pain but just in the vaccine area; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "both experienced pain but just in the vaccine area".  Additional information: The reporter stated that the coworker had experienced pain but just in the vaccine area not in the opposite side like the caller has experienced.  Relevant Family History related to AE(S): No, her son and her daughter they as well got the COVID vaccine and they suffered from pain in the vaccine area. Her issue and her preoccupation is her arm but it is not where she got her COVID vaccine. Yesterday when she was taking a shower and grabbed her soap she realized that she couldn't move it and it hurt all night and all morning. This morning she called her daughter who works at a pharmacy and she asked her about the pain and the daughter and her coworker have both experienced pain but just in the vaccine area not in the opposite side like the caller has experienced. Obtained clarity from caller and she says that her son and his wife live in the same house as the caller and they all got the Pfizer COVID vaccine and they all got pain in the arm, just a little in the area. Her daughter and the coworker had the COVID vaccine and they had pain in the same area. Caller declined to complete a report on her son, her son's wife, her daughter and her daughter's coworker at this time. Unable to obtain further details  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient complained of Left lateral chest extending to Left underbreast pain, 3/10, dull,  that occurs only with deep inspiration and relieved by "not taking deep breaths."  Patient denied pain on the area with normal breathing.  Patient further described it as " a pulled muscle."
Information has been received from a healthcare worker referring to a currently 22 years old female patient. There was no pertinent medical history, drug reaction or concomitant medication reported. On an unspecified date in 2003 when the patient was 9 years old, the patient was vaccinated with the first dose of GARDASIL (strength, lot number expiration date, dose, route of administration unspecified). On 17-FEB-2016, when the subject was 22 years old, she was vaccinated with her second dose in the HPV vaccine series with GARDASIL 9 (strength, lot number, expiration date, dose, route of administration unspecified) (Interchange of vaccine products and Inappropriate schedule of vaccine administered). No adverse effect was reported. Additional information has been requested.
REASON FOR ADMISSION: Splenic laceration, alcohol intoxication, aggravated assault.  covid 19 positive upon admission
pt felt nauseous so got up to go near a trash can to vomit and he fell on the floor.
Approximately 10:00pm, I started having mild body aches, general malaise, and mild fever/chills.  Around 1:00am (4/11/21), my fever and chills escalated, my body was shaking until I wrapped up in several blankets.   At 2:30am, I woke up with nausea. At 3:00am, I vomited. I continued to have fever and chills and body aches.   At 9:30am, I had body aches and felt only slightly feverish. I took acetaminophen for the rest of the day and had no problems.
Narrative: THIS WAS WITH SECOND COVID SHOT: TEMP TO 103, GENERALIZED MYALGIA AND ARTHRALGIA.
Headache, Myalgia, NauseaVomiting, achey, chills, lightheadness, back pain Narrative:
Case number PHEH2014US014769, is an initial spontaneous report received from a nurse on 21 Jul 2014. This report refers to a 12 year old female patient. Nurse reported that the patient inadvertently received only the Men CYW-135 liquid component of MENVEO (batch number: M13014) intramuscular on 17 Jul 2014, without being reconstituted with Men A component. No adverse event was reported. No further information was provided.
Pt received Tetanus diphtheria booster on morning of 4/24/03; within 12 hours she experienced increasing hoarseness in her voice. Seen by our FNP that PM and again 4/30/03 for feeling of shortness of breath as well. Pt referred to ENT who did laryngoscopy finding paralysis of right vocal cord - he scheduled CT - negative findings. Pt also referred to GI to consider GERD.
Quarter-sized area at injection site that is swollen; Quarter-sized area at the injection site that is swollen, hard; Quarter-sized area at the injection site that is swollen, hard and tender; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 10-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 5X5J2, expiry date 30th June 2021) for prophylaxis.   On 4th October 2020, the patient received FluLaval Tetra 2020-2021 season. On 5th October 2020, 1 days after receiving FluLaval Tetra 2020-2021 season, the patient experienced injection site swelling, injection site induration and injection site tenderness. On an unknown date, the outcome of the injection site swelling, injection site induration and injection site tenderness were not recovered/not resolved.   The reporter considered the injection site swelling, injection site induration and injection site tenderness to be related to FluLaval Tetra 2020-2021 season.  Additional details were provided as follows: The patient was vaccinated wth FluLaval shot. Next day after vaccination patient had Quarter-sized area at the injection site that was swollen, hard and tender. Till the time of reporting symptoms were not recovered. The reporter did not consent to follow up.
Sitting or laying down had a fast heart beat and was issued by my doctor a heart monitor for test. SDT was discovered and I understood what needed to be done for this issue.
patient taken second dose 50 days after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient taken second dose 50 days after first dose) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient taken second dose 50 days after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient taken second dose 50 days after first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were used. No Treatment medication were used
PATIENT EXPERIENCED THROAT CLOSING 1 HOUR AFTER RECEIVING VACCINATION AND CHEEKS WERE FLUSHED. PATIENT WENT TO ED TO BE SEEN. THE DAY AFTER PATIENT REPORTS HAVING A RASPY VOICE.
I received my 2nd COVID-19 vaccine on  3/21/2021. I had the normal 24 hour pain in the location of my vaccine. (Left arm same as the first vaccine (2/28/21). But this time it continued to hurt.  I started working out with a personal trainer July hoping to get some relieve from the pain.  She advise me to  ice the area because I could not do the exercises  it hurt to bad.  I applied an ice pack to the area, it swelled up the size of an egg  it still hurts.
had rather shingle shot but they still got it/suspected vaccination failure; still got it; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 1-Mar-2023 Reporter's comment: The case was received form the consumer via interactive digital media. The reporter know some had rather shingles shot but they still got them. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As per narrative information case was created as master case.