chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   On 13-Nov-2021, the patient received dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The other potential cause was reported as Flu vaccine which was administered the same week as that of the Moderna Vaccine.  Patient received the flu vaccine on Nov-13-2021 via injection(unknown manufacturer). Patient reported that on 20-Nov-2021, he woke up with a swollen eye and swollen half face and was later diagnosed with shingles. Patient took medication for it and the condition was slowly improving.
As per patient, arm felt sore immediately after shot and for the next few days. Soreness disappated, but began to feel pain on the injection site (lower deltoid area)  whenever she lifts her arm past her chest. She says that due to the pain, she can no longer take her daily yoga classes. This has been ongoing for the past month since receiving the injection. Did not have any other external trauma or injury to the arm.
nausea & dizzy, hives, dry mouth, scratch throat, BP 172/118, SOB;911 ambulance 6JAN99;
A few days after receiving the first dose of the Moderna COVID19 vaccine, the area surrounding the spot of vaccination became very itchy, red, and swollen. 8 days later my arm is still red and swollen, occasionally itching. The red, swollen part is about 3 inches long and an inch wide.
Patient received Pfizer COVID vaccine on 3/6/21 and 3/28/21. From 1/15/22-1/20/22, patient was admitted to another hospital for COVID pneumonia. On 1/24/22, patient is admitted to our facility (med/surg unit) with acute hypoxemic respiratory failure (suspect secondary to COVID-19 pneumonia however underlying healthcare associated pneumonia cannot be excluded due to recent past hospital admission), and open abdominal wound (suspect ileus/obstruction s/p hemicolectomy). As of today (1/26/22), patient is still admitted in our med/surg unit.
Pfizer administered on 6/7/21, should have received Moderna as 2nd dose (wrong vaccine administered)
I remember laying down and started to feel foggy. I went to bed sweating and got a headache. The next day, everything was blur. I had a bad headache, delusional. My taste and smell has not fully recovered. I had Covid-19 in 2020 prior to the vaccine.
Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced pain during administration of the injection. The patient received a dose on an unspecified date. Relevant medical history was not provided. Concomitant medications were not reported. The patient experienced pain during administration of the injection. As of 25 Oct 2010, it is unknown if patients have recovered from the pain during injection. The reporter was unable to specify the number of patients who experienced this event. Additional reports will be generated when identifying information is provided. No additional information was available at the time of this report.
w/in 45 mins p/receiving vax pt devel generalized urticaria, swollen eyes & face, was extremely fussy; brought back to MD office & DPH administered; sx resolving that day;
syringe got leaked and patient was administered less than half of the dose; syringe got leaked and patient was administered less than half of the dose; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (syringe got leaked and patient was administered less than half of the dose) and UNDERDOSE (syringe got leaked and patient was administered less than half of the dose) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A,) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced DEVICE CONNECTION ISSUE (syringe got leaked and patient was administered less than half of the dose) and UNDERDOSE (syringe got leaked and patient was administered less than half of the dose). At the time of the report, DEVICE CONNECTION ISSUE (syringe got leaked and patient was administered less than half of the dose) and UNDERDOSE (syringe got leaked and patient was administered less than half of the dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were  reported. No Treatment medications  were  reported.
Patient fully vaccinated for COVID admitted inpatient with original COVID positive test on 08/19/21.  Patient with hypoxia (80's) and shortness of breath on 09/07/21 and presented to ED, she admitted to receive remdesivir, O2, dexamethasone.   Respiratory needs maintained in mid to high 90's on 1L O2.  Discharged home on 09/09/2021 with Homecare support and O2 at 1L/NC.
Itchy, red, somewhat circular rash around the  injection site.About 6 inches in length.  I believe this is what people are calling "COVID arm"
This spontaneous report was received from a nurse manager and refers to unspecified school age children of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates in 2015 (reported as "between 16-OCT-2015 and 01-DEC-2015"), the patients were vaccinated with dosed of improperly stored PROQUAD lot # L023113, expiration date 24-DEC-2016 (dose and route of administration not reported). The vaccines with lot # L023113 underwent a temperature excursion up to 21 degrees Fahrenheit for 4 hours. On unknown dates in 2016 (reported as "between 19-JAN-2016 and 08-MAR-2016") school age children were vaccinated with doses of improperly stored PROQUAD lot # L045675, expiration date 19-MAY-2016 (dose and route of administration not reported). The doses of PROQUAD with lot # L045675 underwent the temperature excursion up to 15 degrees Fahrenheit for 7 hours. No adverse effect or side effect were reported. This is on of two reports received from the same source. Additional information has been requested.
pt recv vax 1996 & in the evening of the same day the vax given pt exp fever of 105;fever resolved w/o addtl tx;
Erythema, induration, and itching 14 cm x 12 cm surrounding injection site that started on 3/16/16, one day after vaccines. Treatment with OTC 1% hydrocortisone cream topically, OTC children's BENADRYL and OTC children's CLARITIN.
Patient is a 59 year old male alert and oriented x4 complaining of dizziness immediately following administration of Pfizer COVID vaccine in his left deltoid.  Patient was assisted to a cot and placed in a supine position.  Vital signs stable and within normal limits.  Patient stated that this same type of episode occurs when he gets the flu shot annually.  Patient stated that he felt "much better" and was able to sit up.  The option to call paramedics for further evaluation and transport was offered but the patient refused.  Patient denied any other complaint.  No chest pain, shortness of breath, weakness, signs of stroke and no signs of an allergic reaction.  Patient stated that he now had no symptoms.  Patient was advised risks and consequences and was advised to call 911 or go to emergency if any abnormal symptoms return.  Patient was also advised to contact his primary care physician.  Patient politely refused any further care and left the facility with his spouse.
INCORRECTLY STORED VACCINE WAS ADMINISTERED TO PATIENT; HAD TO RE-VACCINATE
Products used after excursion. Two vials of PEDVAX HIB had already been administered to two different patients.; This spontaneous report was received from a registered nurse and refers to a 2-month-old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history, drug reactions/allergies and historical drugs was not provided.  On 12-SEP-2020, the patient was vaccinated with an improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)(LIQUID PEDVAXHIB) first dose, 1 vial lot #S030967 and expiration date 15-APR-2022 administered as prophylaxis (route of administration was not reported)  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 1.14 degree Celsius (°C) for 2 hours and 20 minutes on, -0.99°C for 10 minutes, -1.23°C for 10 minutes, -0.44°C for 10 minutes on unknown dates; a previous temperature excursion was reported.  The call was made due to a digital data logger.  This is one of two reports from the same reporter
Vaccines given today: Hep A and flu. Pt. had a vasovagal event which occurred a few minutes after receiving 2 vaccines.  Mother reports that she looked dazed and then passed out falling from the exam table in a seated position to the ground hitting the left side of her head on a chair.  When first seen by MA and PA, she was unconscious on the floor.  PA gave called to her and gave sternal rub and she became alert.  She answered questions without confusion but appeared dazed.  When I entered room we layed her down on the floor, she was alert and oriented, pale and seemed dazed and anxious.  We put ice packs on left side of head and neck.  She complained of pain over neck, pain on left side of head and pain on lip (she had a 0.5cn laceration on lip likely from her teeth).  BP 117/72, HR 85, SaO2 95%.  She had tenderness to palpation over c spine.  She Denied numbness or tingling in hands and feet and had full strength in hand grip and feet.  Since I was unable to clear her c spine clinically, we called an ambulance for immobilization and transport to ED for further evaluation.  Plan was discussed with mother
Got my 2nd shot on 10/12 the next day I felt sharp chest pain, the pain got worse and traveled into my left arm. On 10/14 I started to feel tingling and numbing on my hand, pinky finger. Pain continues to grow and on 10/16 i woke up with left side of my face numb and my face was drooping. I went into ER where they treated me with stroke-like symptoms. Till today 10/22 the left side of my face is numb and there is a tingling sensation on my entire face.  WHO is responsible for my pain and suffering? Every day I sleep with fear, If I am going to wake up the next morning or not.
Had shingles 11 times. Also got both shots/ Suspected vaccination failure; Had shingles 11 times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles 11 times and also got both Shingles shots. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Lower lip became red and swollen as well as itchy; Red area appeared around nipple of left breast; round 50 cent piece size red area also appeared on left chest -patient went to urgent care the next day to be seen- MD was ruling out cellulitis vs. breast issue- prescribed antibiotics (doxycycline BID for 10 days) and sent for diagnostic ultrasound and mammogram of left breast
Information has been received from a physician concerning a 12 month old female patient who suffered from allergies ("very sensitive"), who on 09-JUL-2010 was vaccinated subcutaneously with "one shot" of VARIVAX (Merck) (lot # 666821/0223Z) (getting her one year well child shots). Concomitant therapy included MMR II (MSD), PREVNAR 13 and ACTHIB (MSD). The physician reported that the patient was using VARIVAX (Merck) and experienced large red knots at injection site. On an unspecified date, the patient recovered. The patient sought unspecified medical attention. This is one of several reports received from the same source with the same vaccine lot number. The physician expressed concern for this lot. A lot check has been requested. A preliminary lot check investigation was performed. To date our investigation has found that lot # 666821/0223Z conformed to quality release parameters and the manufacturing was typical of a lot of VARIVAX (Merck). Additional information will be provided upon finalization of this manufacturing investigation. A standard lot check investigation has been finalized. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information has been received from the physician concerning the 12 month old female patient with soy, milk and peanut allergies, who on 09-JUL-2010, at 9:15, was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (lot # 666821/0223Z) into her right thigh, the first dose of MMR II (MSD) (lot#666249/1660Y) SC into the left thigh and the first dose of PREVNAR 13 (lot#E61989) IM into the left thigh. At 9:45, the patient was vaccinated with the fifth dose of ACTHIB (lot# UF817AB) IM into the right thigh. On 10-JUL-2010 the patient developed local reaction: red, hot and swollen at shot site on thigh. At the time of this report, the patient had recovered. Additional information is not expected.
Pfizer gray cap vaccine was punctured on 6/26/22 at 10:45 am and two doses were drawn and administered. The vaccine was not disposed of at the end of business day on 6/26/22. On 6/27/22 we gave an additional dose that came from the same vial. The vial had been expired (per storage conditions) since 10:45 pm on 6/26/22. The dose was drawn up and then administered at about 6:20 pm on 6/27/22. Upon calling Pfizer, they stated that they only have data to show stability for up to 24 hours after first puncture when the vial is held between 28 and 86 degrees Fahrenheit. Therefore, according to the CDC, the dose should be repeated immediately with no minimum interval. We have left a message on the patient's voicemail to have them call us back regarding their vaccination. Upon a call back, we will explain the discrepancy and recommend re-vaccination immediately. No adverse events have been reported yet.
Pain in arm and all over, extreme pain in left knee. Extremely tired, fever, chills, nausea. I still have extreme pain in my knee and can hardly walk. I use a cane, but it is painful to get around. I have never experienced it as bad as it is now after this shot.
Very normal healthy child at 14mths.  Received MMR vaccine 02/22/02.  He developed low grade fever, Dr. said to give Tylenol.  On 3/21/02 he received HIB-4 and PnC7-4 vaccines. His immune system crashed.  He developed fever which was very high in the evening but normal when I took him to doctors office next day.  Over course of next week, he became very irritable and seem to develop fever in the eveining.  He became a little sluggish, as well as being constantly irritable, crying & whining.   We thought was teething issues.   He often seemed to have a very grayish sleepy look when I picked him up in the mornings.  At 18mth check up got referral from Ped to see Neurologist.  In Aug 02 dx PDD.  Over next several mth. he continued to regress. He had constant diahrrea, developed multiple allergies,  had constant viral illnesses.  Aug 03 Dx severe Autism.  Regression stabilized due to serveral medical interventions.  However 4 years later he is profoundly mentally retarded.  He is non-verbal, but also receiptive language is assessed at 3-6mths level. He is not and cannot be potty trained.    We have a home video, which very clearly depicts how normal & healthy he was at 14mths.  6 weeks later the same child has a swollen head, he is wobbly on his feet and is staring into space.  Doctors who have seen the tape have expressed the opinion that his immune system crashed after the 3/21/02 HIB & Pcn7 vaccine, most likely because it was given too close to the MMR (30 days apart), at this point the viruses from the MMR took over and he developed encephalitis causing permanent brain damage.  01/29/2008 MR received for multiple OVs with pediatric neurologist.  Initially seen 8/20/2002 with provisional DX: of speech delay. Seen again 10/23/2002.  Neuro exam revealed poor eye contact, lack of response to name or bell. Behavior inappropriate for age.  DX:  shows features of Pervasive Developmental Disorder.  OV 11/26/2002 with Impression:  Autistic disorder and language delay. DX confirmed by educator and psychologist. 02/01/2008 MR received from vax provider.  WCC 3/21/02 with normal exam.  Seen again 4/4/02 for coughing and acting up. Assessment:  URI/Bronchospasm. 1/15/2010 Patient will be 8 on Dec 21st. He is all non-verbal non recapture language, not potty trained. He needs direct 1 on 1 supervision at all times. He is permatently brain damaged.
Panic attack following, both cheeks red. symptoms left. 6 hours after L side of face started swelling, pain at cheek bone followed by numbness of entire left side of face. numbness lasted for  5 hours. Today face is still swollen. I went to the ER and was kept for two hours for observation, no intervention
Tested positive for COVID during hospital admission for large hematoma, acute blood anemia, ESRD. No respiratory symptoms, supportive care only.  Admitted 1/7/2022, tested positive 1/7/2022.
Pt was given double dose of flu vaccine. Next morning complained of arm pain radiating into breast area. Sent to Occupational Health facility for follow up.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 12:00 as dose 5 (booster), single (Lot number: GJ3277) at the age of 79 years, in left arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 28Dec2020 at 17:00 as dose 1, single (Lot number: EL1284), in left arm, on 18Jan2021 at 12:00 as dose 2, single (Lot number: EL8982), in left arm, on 11Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 03Jun2022 at 12:00 as dose 4 (booster), single (Lot number: FM7553), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "AFib" (unspecified if ongoing); "Post cardiac ablation" (unspecified if ongoing); "Kidney issues" (unspecified if ongoing); "Allergy: sulfa medications" (unspecified if ongoing); "Allergy: egg based vaccines" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jan2023) Positive; (08Feb2023) Negative; (12Feb2023) Positive. Therapeutic measures were taken as a result of vaccination failure, COVID-19 which included Paxlovid from 31Jan2023 to 05Feb2023.
Severe swollen underarm with under arm pain lasted a week. Swelling on the side of the neck started a few days later and is still there. Swelling in arm pit is down but can still feel lumps in my arm pit and new lumps on my bicep all on the injection side of the body.
Patient was sitting in chair extremely pale, slow to respond Place on floor legs elevated p 80 BP 80/40   at 4:02pm   a little more responsive color improving by 4:13 pm BP 100/60 P 72 still c/o dizziness, tired and weak
About 12 hrs after administration, patient developed pain in left shoulder (injection site) left elbow, left knee and in neck. Also developed stiffness and numbness in fingers. Was seen in emergency room. Evaluation in ED positive only for neck pain. Patient given MOTRIN with relief of pain.
Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients; Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 3/23/2023 ADENOCARCINOMA LUNG, UNSPECIFIED SITE I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 3/24/2023 ADENOCARCINOMA LUNG, UNSPECIFIED SITE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/24/2023 ADENOCARCINOMA LUNG, UNSPECIFIED SITE I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 3/23/2023 ADENOCARCINOMA LUNG, UNSPECIFIED SITE I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 3/24/2023 ADENOCARCINOMA LUNG, UNSPECIFIED SITE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/24/2023 ADENOCARCINOMA LUNG, UNSPECIFIED SITE
24 hours after injection pt developed large red area up his arm. Area is red, raised and hard underneath. Counseled pt to apply ice and call us tomorrow with condition of red area.