chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Adverse Event; Customer reported an AE for MMRII. The caller said she reported this to Merck previously, however original case was not able to be located. Company awareness date marked 7/12/2023. The caller said the patient received a dose of MMRII on 6/29/2023, af; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 29-JUN-2023, the patient was vaccinated with one dose measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number w039699, expiration date reported and validated as 25-MAY-2024) as prophylaxis, that experienced a temperature excursion (product storage error). No other adverse event.  The vaccine experienced a temperature excursion of 48.8 degrees Fahrenheit (F) for an unknown timeframe. It was unknown if there was a previous temperature excursion.; Sender's Comments:  US-009507513-2307USA006147:
Fever, head ache, low energy, chills, body ache; 24 hours so far.
Person states that she developed chills, diarrhea and cramping, body aches 5 hours after the injection. Symptoms have resolved.
Fever 102F, chills, headache, body aches, nausea, malaise for 2 days; swollen, red, painful, itchy large lump (whole upper arm) at injection site for two weeks, lessening over the two weeks but redness & itch remaining for 2 weeks.
Child received a 2nd dose of FluMist and should have only received 1 dose, due to age. No treatment. Spoke with child's mother, who stated her child did not have any signs or symptoms after adverse event. Adverse event reported.
breast cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 11Oct2021 at 09:30 as dose 3 (booster), single (Lot number: FC3180) at the age of 72 years intramuscular, in arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 11Oct2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1, Time: 10:00, Anatomical location: Arm, Route of administration: Intramuscular, Batch/lot number: EL9267, Expiry date: 03May2021), administration date: 03Mar2021, when the patient was 72-year-old, for COVID-19 immunization; BNT162b2 (Dose: 2, Time: 10:00, Anatomical location: Arm, Route of administration: Intramuscular, Batch/lot number: EN9267, Expiry date: 31Jul2021), administration date: 23Mar2021, when the patient was 72-year-old, for COVID-19 immunization. The following information was reported: BREAST CANCER (medically significant) with onset 25Dec2021, outcome "not recovered". The patient underwent the following laboratory tests and procedures: Biopsy: (25Dec2021) Breast cancer. Therapeutic measures were taken as a result of breast cancer. Clinical course included: Patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FJ4991). She did not receive prior vaccinations. Breast cancer was treated with 3 doses of 1mg Anastrozole on 11Apr2022, 12Apr2021 and 13Apr2022.  No follow-up attempts are possible. No further information is expected.
p/vax pt devel large area on arm 12'' long x 4" wide, raised bumpy, red, hot, itchy; tx: prednisone; lasting 5 to 8 weeks;
alphasia , ..March 4   March 18....MRI,  CT SCAN,  EKG.... brain tumors  March 23....Crainiotomy Brain Cancer
chills, fever, tiredness, headache, sore muscles,swelling at injection site  lasted4 days
itchy throat and bilateral palms beginning a few minute after vaccine administration; improving over several hours; no hives, no dyspnea; exam: clear lungs
I've had intermittent dizziness, nausea, shortness of breath and alternating numbness and tingling in my hands, feet and legs. These symptoms appeared on February 15, 2022, exactly 12 hours after receiving a Pfizer booster shot and were severe enough that I sought treatment at local hospital.
Shot almost unnoticeable at time of injection and no discomfort on first day.  Arm a little sore on second and third day.  On by the fourth day arm was become uncomfortable with red raises area around injection site warm to the touch and lymph node involvement.  Arm and lymph node pain have continued to progress.  Red raised area about 3" diameter.
The patient received dose after the beyond use date; Vial initially stored on 31-JAN-2022 and then administered on 03-MAR-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date) and PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 03-MAR-2022) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2022 at 8:12 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 03-MAR-2022). On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date) and PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 03-MAR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  It was reported that HCP provided doses of the Moderna COVID19 vaccine after the beyond use date as the HCP didn't know that the vials shouldn't be used past 30 days from thawing the vials Vial did not undergo any temperature excursions. Total 20 doses were administered. Total 15 vials were used. Thaw expiration date was reported as 02-Mar-2022.  No treatment medications were reported
Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt) 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 PAIN IN EXTREMITY (Arm hurt). At the time of the report, PAIN IN EXTREMITY (Arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.
This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 68-year-old female patient of unknown race/ethnicity received a single dose of PREVNAR 13 on an unknown date (reported as Friday) for immunization and cortisone (manufacturer unknown) injection in knee on an unknown date (reported as Thursday) for an unspecified indication. Concomitant medications and medical history were not reported. The patient after a glass of wine experienced bright red face for 36 hours. The patient took BENADRYL and symptoms resolved. No nausea and food did not taste the same since. Action taken with cortisone was unknown.
Information has been received from a consumer concerning her 20 year old daughter with no known drug allergies and no past medical history who on approximately 15-JAN-2008 was vaccinated with a dose of GARDASIL (lot# unspecified, site and route not reported). There was no concomitant medication. Subsequently the patient experienced mononucleosis "a couple of weeks ago" after receiving the vaccination. It was also noted that the patient had a cold a week before receiving the vaccine. The patient sought medical attention at her physician's office. A Laboratory diagnostic test was performed. The patient's status was not reported. No further information was provided. Additional information is not expected.
The reason I am filling this out is that the pharmacist gave me the wrong shot. This is a medical error a huge one. I felt this should be brought to your attention? She was 100% wrong and need to be careful in the future. Due to her error I winded up have 2 flu shots instead of pneumonia 13 shot I went in for and this is a huge medical error!
There was no seriousness criteria reported. Based upon appropriate medical judgement, this case is considered serious: important medical event (OMIC). From initial information received on 8/23/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that an 18 year old female patient received her first dose of MENOMUNE A/C/Y/W-135 vaccine, lot number UE132AA, administered in the left deltoid and a TUBERSOL 5 TU skin test, lot number C1677AA, administered in the left forearm at 1:00 PM on 8/23/04. Within a few minutes the patient felt dizzy and weak, she felt her throat tighten and became bradycardic and had trouble breathing. The patient was given epinephrine, oxygen and Albuterol. She was taken to the hospital emergency room by ambulance. The patient's recovery status is currently unknown. From additional information received on 17Sep04 from the initial reporter, it was reported that the MENOMUNE vaccine was administered SC. The pt was given Benadryl in the ambulance and was dischared home from the ER on 25Aug04. It was reported that the ER physicians thought the event was either vasovagal, an allergy to latex, or an allergy to MENOMUNE. The pt recovered from these events and was referred to an allergist.
Approx 10 hours post vaccination pt experienced: Chills numbness of fingertips and lips shaking.
p/vax pt exp fever, sore throat & aches & pains 13 days p/vax;pt is still achy today;pt suffered from fever, sore throat & gen aches 13 days p/vax;
flu; Initial information received on 24-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional (patient).   This case involves patient [age and gender unspecified] who got the flu (influenza), while patient received vaccine INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (influenza) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
flu; Initial information received on 17-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who had flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE (form, strength, dose, frequency, site, route: unknown, with an unknown batch number and expiry date: unknown) for Prophylactic vaccination (Immunisation)  On an unknown date the patient had flu (influenza) (unknown latency) .  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event  At time of reporting, the outcome was Unknown for the event flu.
Maybe 1 minute after receiving the vaccine I began to have a syncopal episode, the nurse practitioner thought that since I was heavy I began to have a vasovagal reaction.  From there they asked me to sit with the others waiting 15 minutes to make sure they were ok to leave. As I sat the symptoms would come and go, as if in a pattern, and then return.  The longer I sat there the more the symptoms began to grow, after sitting for an hour they decided to send me to the ER. At this time I was experiencing nausea, vomiting, sweating, I was itchy, I could not stop coughing, it was difficult to breath, and I had the worse headache.  When I got to the ER they gave me drugs to reverse the allergic reaction and told me they would watch me for a while. In the next 4 hours all of the symptoms started again and I had to get another round of the reaction drugs, I ended up going through this process 4 times before I was safe enough to go home the next day.  The provider that saw me and admitted me did not do any blood work or labs, they simply provided me with the reaction drugs when needed and my home medications.
5/12/99 mom thought pt had diaper rash;following AM woke up w/T102 that evening, T104 & rash noted on stomach;T102 persisted until 5/15/99 & rash cont to spread;mom suspected chickenpox & was verified over phone w/MD;
Red swelling of left upper arm, sore, tender. Its been 5 days. Tingling/sharp pain of the arm right arm. Tiredness and light dizzy spells.
Symptomatic, started on 7/9 with cough, runny nose, sore throat, & nasal congestion.
1 hour after vaccination felt rapid heartbeat, faint, muscle weakness. Called doctor but did not get a call back. Feels better after 2 days but still has muscular weakness and nervousness.
PATIENT WOKE UP WITH RIGHT EYE REALLY RED SWOLLEN. ALSO FACE WAS SWOLLEN.  TOOK BENADRYL WHICH HELPED TO ALLEVIATE AND BRING DOWN SWOLLEN FACE.
This is a 64y.o. female with past medical history of asthma, COVID-19, DVT, hypertension, OSA, PE, HFpEF presents to the emergency department with chief complaint of chest pain. Patient states that she was diagnosed with the coronavirus on the 27th been experiencing chest pain, diarrhea, myalgias, cough, and shortness of breath ever since the 24th. She states that her chest pain is described as a pressure and is located diffusely throughout the chest.  She rates it an 8 out of 10 at its worst and gets down to a 6 out of 10 currently.  She denies any alleviating or exacerbating factors.  She also complains of 2 days of respiratory phlegm.  She states that it is clear and not malodorous.  Troponins are negative.  Patient denies any abdominal pain, numbness and tingling, or any abnormal bleeding.  Of note, the patient had a recent DVT and PE in July 2021 and was placed on Eliquis.  She recently stopped taking her Eliquis last month due to hematuria.
flu like symptoms; extreme lethargic; delayed reaction; headache; severe muscle ache; fatigue; sever chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), LETHARGY (extreme lethargic), TYPE IV HYPERSENSITIVITY REACTION (delayed reaction), HEADACHE (headache) and MYALGIA (severe muscle ache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.     On 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), LETHARGY (extreme lethargic), TYPE IV HYPERSENSITIVITY REACTION (delayed reaction), HEADACHE (headache), MYALGIA (severe muscle ache), FATIGUE (fatigue) and CHILLS (sever chills). The patient was treated with IBUPROFEN ongoing since an unknown date for Fatigue and Chills, at a dose of 200 milligram. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), LETHARGY (extreme lethargic), TYPE IV HYPERSENSITIVITY REACTION (delayed reaction), HEADACHE (headache), MYALGIA (severe muscle ache), FATIGUE (fatigue) and CHILLS (sever chills) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included Over the counter Prilosec: 20 milligram once a day.
Father and Mother filled out paperwork at site as his age of 18. He was given the vaccine of Moderna (not currently approved for  less than 18) when putting information in state immunization program, clerk noted his age was populating 17.  Individual still on site waiting his 15 minutes and family was still on site. Asked again and they verified is birthdate but that he was 18 not 17.
This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a patient who received FLUARIX QUADRIVALENT. Previously administered products included Flu vaccine with an associated reaction of adverse reaction (for tolerance refer case US2016GSK169626). On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced injection site swelling, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site warmth and injection site erythema were unknown. The reporter considered the injection site swelling, injection site warmth and injection site erythema to be related to FLUARIX QUADRIVALENT. Additional details were provided follows: The patient's age at vaccination was not provided. The reporter had limited vaccination details. This was 5th case of 6 cases reported by the same reporter. This case linked with US2016GSK169626, for the same patient.
Blurred vision, abnormal headache, fever (103.1), severe muscle pain in both legs, bone/joint pain in left arm, swollen left arm around injection site with rash, early start of menstrual cycle (1 week), diarrhea
Shot itself was painless. Within a few hours of injection, left shoulder started to hurt. Couldn't lift arm above 50 degree angle. 14 days later because of pain, still can't lift arm beyond 50 degrees. Hand and arm shakes when lifted above 50 degrees, awakens at night because of pain.
This spontaneous report as received from a Registered Nurse via field representative refers to two patients of unknown age and gender. No medical history, concurrent conditions and concomitant medication were reported. On an unknown date, the patients were vaccinated with VARIVAX (Merck) subcutaneously (dose, lot #, expiry date were not provided). Ten days after administration of VARIVAX (Merck), the patients presented with cellulitis and hematoma at the injection site. The outcome of the events and the relatedness between the events and VARIVAX (Merck) were not provided. Additional information has been requested.
Severe pain in shoulders and neck, couldn't breathe, felt  like she was going to pass out. ( 2 episode) 7/30/2021 at 2:30/3am.
Bell Palsy; sever leg pain; This is a spontaneous report from a contactable nurse (patient). A 51-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in the right arm on 12Jan2021 (Batch/Lot Number: EL3246) as a single dose for COVID-19 immunization. Medical history was reported as none. The patient had no known allergies and no other medical history. The patient had no Covid prior vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 5730) in the right arm on 22Dec2020 at 11:00AM for COVID-19 immunization. The patient had no other medications in two weeks and no other vaccines in four weeks. The patient experienced Bell Palsy and sever leg pain on 28Mar2021. The patient was hospitalized for the events for 1 day. The patient was tested post vaccination. The patient underwent lab tests and procedures on 31Mar2021 which included Nasal Swab: negative. Treatment for the events included steroids and antiviral as well as antibiotics. The events had not resolved.
This case was reported by a nurse via sales rep and described the occurrence of vomiting in a female patient who received SHINGRIX for prophylaxis. On 16th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced fever and injection site inflammation. On 16th July 2018, the patient experienced vomiting, pain in arm, blood sugar increased, pulse decreased and oxygen saturation decreased. On 17th July 2018, the patient experienced influenza-like symptoms, pain, fatigue and nausea. On an unknown date, the outcome of the vomiting, influenza-like symptoms and fever were recovering/resolving and the outcome of the pain in arm, pain, fatigue, nausea and injection site inflammation were not recovered/not resolved and the outcome of the blood sugar increased, pulse decreased and oxygen saturation decreased were unknown. It was unknown if the reporter considered the vomiting, pain in arm, influenza-like symptoms, pain, fatigue, nausea, fever, injection site inflammation, blood sugar increased, pulse decreased and oxygen saturation decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that about 2 hours after receiving SHINGRIX the patient began vomiting. The patient also reported that the patient had a blood sugar spike, her oxygen saturation decreased and her pulse decreased, her arm pain was pretty severe and extremely tender to touch. On the second day after receiving the vaccine patient stated that she had some pretty severe flu like symptoms, she was extremely achy, very fatigued, nauseas. A fever was reported as well. On the day of reporting on 18th July 2018 she stated that she felt a little better than she had been feeling the last two days except for the continued fatigue, achy feeling and a very tender arm or inflamed injection site, the patient reported that her symptoms were so bad that she did not want to get the second dose.