chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 9:47 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 9:47 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 45.41. No concomitant medication was reported by reporter. Batch number 025L20A underwent temperature excursion on 07-Jan-2021 with temperature 34 degrees Fahrenheit at 09:00 AM and 10:00 AM. This vial was moved to fridge on 05-Jan-2021 and beyond use date for the vial was reported as 27-Jan-2021. Product moved to clinic on 07-Jan-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021.The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken by using a Fisherbrand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.
Fever. Chills. Headache. Joint and body ache for 1 and 1/2 days
This spontaneous report was received from a registered nurse (other health professional) and refers to a female patient of unknown age. The patient's medical history, concomitant medications, concurrent conditions and drug allergies/reactions were not reported. On 18-AUG-2017, the patient was vaccinated with unspecified dose (1DF) of RECOMBIVAX HB immunization series with (lot # N002202, expiry date:04-NOV-2019) which were improperly stored (Incorrect product storage). No adverse effects were reported. The vaccine was stored at 3.7F at worst for 7 hours. There was previous temperature excursion at 48F for 1 hour. Data logger was involved. The outcome was unknown. No product quality complaint was involved. No further information was provided. This case is cross-referenced with MARRS# 1708USA010454 and MARRS#1708USA010842 (same reporter).; Sender's Comments:  US-009507513-1708USA010454: US-009507513-1708USA010842:
Shortly after receiving flu shot pt. collapsed on the floor. His father and the MA observed him having a seizure. Completely recovered within 3 min. Pt. has a hx. of a febrile seizure 1 mo. ago hours after receiving imms. including flu vaccine. Has been referred to neuro.
I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 1/29/2022 PULMONARY ARTERY HTN I95.9 HYPOTENSION 1/28/2022 PULMONARY ARTERY HTN J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/2/2022 PULMONARY ARTERY HTN R09.02 HYPOXIA 2/15/2022 PULMONARY ARTERY HTN I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 1/29/2022 NONTRAUMATIC ACUTE KIDNEY INJURY I95.9 HYPOTENSION 1/28/2022 NONTRAUMATIC ACUTE KIDNEY INJURY J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/2/2022 NONTRAUMATIC ACUTE KIDNEY INJURY R09.02 HYPOXIA 2/15/2022 NONTRAUMATIC ACUTE KIDNEY INJURY I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 1/29/2022 ASPIRATION PNEUMONIA I95.9 HYPOTENSION 1/28/2022 ASPIRATION PNEUMONIA J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/2/2022 ASPIRATION PNEUMONIA R09.02 HYPOXIA 2/15/2022 ASPIRATION PNEUMONIA I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 1/29/2022 BPH (BENIGN PROSTATIC HYPERPLASIA) I95.9 HYPOTENSION 1/28/2022 BPH (BENIGN PROSTATIC HYPERPLASIA) J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/2/2022 BPH (BENIGN PROSTATIC HYPERPLASIA) R09.02 HYPOXIA 2/15/2022 BPH (BENIGN PROSTATIC HYPERPLASIA) I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 1/29/2022 HX OF ACUTE KIDNEY INJURY I95.9 HYPOTENSION 1/28/2022 HX OF ACUTE KIDNEY INJURY J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/2/2022 HX OF ACUTE KIDNEY INJURY R09.02 HYPOXIA 2/15/2022 HX OF ACUTE KIDNEY INJURY
Patient developed rash, hives, and itching on arms, legs, and buttocks 2 days after receiving MMR and Td vaccines.  Patient treated rash with Gold Bond lotion but did not seek medical attention. Advised to see MD, but patient stated that symptoms had resolved by 9/15/06.
was more painful than the one that received/arm was sore an extra day or two longer; shot "wasn't that bad"; She experienced some shivering/shivering feeling lasted about a day.; She had some fatigue,; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On 13th July 2020, the patient received the 1st dose of Shingrix and Tdap Vaccine. In July 2020, less than 3 weeks after receiving Shingrix and Tdap Vaccine, the patient experienced pain in arm, feeling abnormal, shivering and fatigue. On an unknown date, the outcome of the pain in arm, feeling abnormal, shivering and fatigue were unknown.   It was unknown if the reporter considered the pain in arm, feeling abnormal, shivering and fatigue to be related to Shingrix and Tdap Vaccine.  Additional case details were reported as follows: The patient received Shingrix shot was not that bad. The arm having received the Tdap vaccine was more painful than the one that received the Shingrix. The Shingrix arm was sore an extra day or two longer, though and experienced some shivering, which improved once she went outside to do her work instead. The shivering feeling lasted about a day. The patient had some fatigue, but it was hot and humid outside and she thought that may be attributed to the fact that The patient had run outside in the heat and humidity.
injection site reaction; Flu-like symptoms; very mild achiness; mild pruritus; oblong in shape with a hard center; reddened area 2.5 to 3 inches; minimal pain; very mild fatigue; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (injection site reaction), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (very mild achiness), VACCINATION SITE PRURITUS (mild pruritus) and VACCINATION SITE INDURATION (oblong in shape with a hard center) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 089M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included RALOXIFENE HYDROCHLORIDE (EVISTA) for an unknown indication.   On 25-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2022, the patient experienced VACCINATION SITE REACTION (injection site reaction), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (very mild achiness), VACCINATION SITE PRURITUS (mild pruritus), VACCINATION SITE INDURATION (oblong in shape with a hard center), VACCINATION SITE ERYTHEMA (reddened area 2.5 to 3 inches), VACCINATION SITE PAIN (minimal pain) and FATIGUE (very mild fatigue). On 27-May-2022, INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (very mild achiness) and FATIGUE (very mild fatigue) had resolved. At the time of the report, VACCINATION SITE REACTION (injection site reaction), VACCINATION SITE PRURITUS (mild pruritus), VACCINATION SITE INDURATION (oblong in shape with a hard center), VACCINATION SITE ERYTHEMA (reddened area 2.5 to 3 inches) and VACCINATION SITE PAIN (minimal pain) outcome was unknown.            Patient had no known health history related to the reaction. The fourth Moderna dose was the last dose as the previous dose. Flu-like symptoms, very mild fatigue and achiness started around noon on 26-May-2022.The patient had no loss of mobility. The patient did not seek medical treatment.
Tdap 8/2/11 - that day developed redness swelling of arm & pain. Seen 8/8/11 - 8x6" area of swelling & redness & tenderness.
Weakness, dizziness, numbness in face, hypertension-evaluated by EMS and refused transportation.
Information has been received from a physician concerning his 7 year old granddaughter who has no known allergies or pertinent medical history who on 20-SEP-2000 was vaccinated with a dose of Varivax. There was no concomitant medication. On 05-SEP-2006 the patient developed a breakthrough case of chickenpox. The rash was described by the patient's mother as 8 pox with progressed from papular to vesicular. It was reported that the patient also had a low grade fever of 99.2, was tired and lost her appetite. It was reported that the patient did not see a physician, though bother her father and grandfather are physician's, and that she did not receive any medication. At the time of the report the patient had not recovered. There was no product quality complaint involved. The patient's sister (WAES # 0609USA00942) had a similar experience following vaccination with Varivax. Additional information from the nurse indicated that there is no further information available
medic did not dilute the vial of pfizer and patient received a full vial of pfizer vaccine undiluted
pt recv vax & mom brought pt back a few min later appeared pale, sweating, fainted;p/rested on exam table for 15-20min was stable & left the clinic BP WNL;
shingles; rash on her front, side and back  has not gone away; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2022, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced shingles and rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR101725   Additional Information: GSK Receipt Date: 01-JULY-2022 Reporter's Comment:  The patient stated, received her first dose of Shingrix a month prior to the reporting. The patient stated that a few days after her dose, patient experienced a rash on her front, side and back which was diagnosed as shingles by her doctor. The patient had been taking Valtrex to treat the shingles. The rash had not gone away.  The reporter did not consent to follow up. Additional supportive information: This case has been linked to the case US2022AMR101725 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR101725:same patient
Redness and swelling at injection site following PNEUMOVAX administration into bicep, left.
Patient started 10 minutes after the dose with tingling in tongue and roof of mouth which progressed to a lump in throat and feeling like she was having trouble swallowing.  She had no respiratory symptoms.  Pulse ox 100%  HR 65 RR 14 BP124/78  She was given Benadryl 25mg IM.  Symptoms resolved within 10 minutes of injection.  Follow up at 30 minutes show complete resolution of symptoms.
Had both shots, got shingles/Suspected vaccination failure; Shingles/got shingles 3 months ago; Very painful; This case was reported by a contact via interactive digital media and described the occurrence of 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 04-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had both shots and got shingles 3 months ago (in 2022), very painful. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the 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.
Inflammation on right side of neck throat and back area. Causing choking feeling of  right side of neck/ throat  for approx. 8-10 hrs. .............Took several days to a gradual subsiding. Pressure felt in back of neck as well.... Same side loud tinnitus in right ear....took a couple days to subside.........during heightened swelling in nick muscles chest/ heartburn. Subsided after a short while.
The soreness in my neck and arm seemed to be the only issues for the first two weeks.  Then I began to have dizzy spells.  These dizzy spells seem to come and go all day long.  The sound going into my ears sounds as if I am under water.
Patient develop a rash after getting chicken pox vacc. After 30 min. of getting vacc. pt's arm was itchie. Pt knew her allergic reaction to vaccine but Mom want her to get it. This date of service.
cervical lymphadenopathy -45mm diameter(i.e. size of a golf ball)
Information has been received from a registered nurse concerning a 25 month old female who on 08-NOV-2006 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). One month later the patient received a second dose of varicella virus vaccine live (Oka/Merck). The doses were not given at the clinic where the reporting nurse was located. On an unspecified date in May 2007, the patient developed a varicella rash. Unspecified medical attention was sought. At the time of this report the patient was recovered. No further information was provided. There was no product quality complaint involved. No further information is expected.
The patient is a 65 y.o. male with history of CHF, chronic respiratory failure, CKD, COPD, coronary artery disease, hypertension, paroxysmal atrial fib and type 2 diabetes who presents to the hospital via EMS from home where he apparently had a syncopal episode while on the toilet at home and was unresponsive for approximately 1 minute.  EMS states the patient's oxygen saturations were in the 70s upon their arrival on 2 L and transported the patient to emergency room for further evaluation.  The patient was found to be positive for Covid pneumonia.  The patient was admitted 9/24/21 for further evaluation treatment.  The patient was also noted to have a large abdominal aortic aneurysm on CT scan. The patient states he has been vaccinated for Covid and has had no exposures he is aware of.  He has had a mild cough.
Patient c/o arm pain the day after receiving injections. Mom looked at the injection sites and there were no reactions noted.  The next day patient complained again and when mom assessed, she noted tactile warmth, redness & swelling.  Mom had not provided any treatment.
Herpes Zoster; This initial spontaneous report has been received from a lawyer regarding a case in litigation referring to an 84-year-old male patient. No information was provided regarding concomitant medications, concurrent conditions or medical history.     On 23-JUL-2013, the patient inoculated with the zoster vaccine live (ZOSTAVAX) vaccine for the long-term prevention of shingles and zoster-related conditions (dose, route, and lot number not provided).  On an unknown date, the patient experienced herpes zoster and was treated by a doctor. The outcome of the events was unknown.  Causality assessment was related.
Erythema of feet and under breasts.  Red and blue toes.  Cool fingers.
Information has been received from a Registered Nurse (R.N.) concerning a 16 year old female with a history of smoking and use of oral contraception who was vaccinated IM with a second dose of Gardasil. Concomitant therapy included hormonal oral contraceptives (unspecified). The nurse reported that after 2 months getting her second vaccination the patient had a stroke and she was hospitalized. The patient continued to have weakness on one side of her body. The patient was recovering. The reporter considered the event stroke as disabling and life threatening. Additional information has been requested. 7/4/08-records received for DOS 3/12-3/21/07-DC DX: Left-sided middle cerebral artery stroke with subfalcine herniation status post left-sided craniectomy for decompression. Presented with left-sided MCA stroke. Witnessed collapse to the ground had been exerting herself physically lately. PE: reflexes increased on right side, awakens to voice but does not follow commands, semipurposeful movement in left upper extremity. Consensus cause of stroke was postulated to be a combination of smoking and birth control pill use. Discharged to rehab. 7/9/08-ER report for DOS 3/11/07-non-responsive- 7/9/08-records received for DOS 4/6-4/9/08-DC DX: Encephalomalacia. During rehab hospitalization developed worsening headache and swelling in area of craniectomy flap, new baseline right-sided weakness secondary to stroke. Questionable LSD use.  Readmitted to rehab.
Widespread macular rash starting from injection site and spreading to involve chest, torso and thighs
LMP 24Jul15, Urine Pregnancy Test done prior to vaccine administration on 22Aug15, result positive series discontinued at that time.
Fever began on August 2, 2012 at around 8:00 PM and then continued until August 4, 2012. It reached a high of 102.3 and was treated with Infant Advil. Then the fever seemed to just disappear and a rash appeared. First noticed rash on August 5, 2012 around 6:00 PM after a bath. It was just a couple red bumps on the lower stomach area. The next day on August 6, 2012 the rash covered the entire chest, stomach and back area. However, no fever or other symptoms are present. Child was given 2ml of liquid Benadryl.
Soar arm that had the  vaccine, horrible aches through the whole body, heavy chest and a swollen lymphoid in the arm pit of the injection.  Also fatigued.
Fatigue, Short of Breath. Chest Pains, the whole summer of 2021. Was referred to a Cardiologist in April for turbulent heart sounds. Stress tests, Echo's., Heart Cath, X-rays, Calcium Score Etc. all show Aortic Valve Stenosis but not bad enough to do anything about it. I told cardiologist (3 of them) about the chest pains. I was turned away and actually told it was my imagination because he would not accept it could be from the vaccine. He said I was too old to have an adverse reaction. Chest pains became few and fewer about mid-September 2021.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 16-DEC-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L035127, expiration date:14-SEP-2017, as prophylaxis (Strength and dose were not reported), which experienced a temperature excursion between 14 and 46 Fahrenheit degrees for 3 hours. There were no previous temperature excursions reported. Digital data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000452: US-009507513-1702USA003692: US-009507513-1702USA003693: US-009507513-1702USA003694: US-009507513-1702USA003695: US-009507513-1702USA003697.
stuffy nose due to allergies; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: she is having a stuffy, nose due to allergies. The patient's concomitant medications were not reported. The following information was reported: RHINITIS ALLERGIC (non-serious), outcome "unknown", described as "stuffy nose due to allergies".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse concerning a 14 month old patient who on 21-AUG-2007 was vaccinated with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) instead of a dose of MMR II (Enders-Edmonston, Jeryl Lynn, MSD).  On that same day, the patient was also given a dose of Varivax (Oka/Merck) (MSD).  No adverse events were reported.  It was unknown whether medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a 67 year old female patient with SPIRIVA hypersensitivity. On 19-JUN-2018, the patient received the first dose of PNEUMOVAX 23 lot # R002084, expiration date 26-OCT-2019 for prophylaxis. On 21-JUN-2018, the patient received the second dose of PNEUMOVAX 23 lot # R002084, expiration date 26-OCT-2019 in the right arm for prophylaxis. In approximately June 2018, the patient experienced swelling in the right arm, bilateral arm pain from shoulder to elbow making it hard to move her arms, chills, nausea, and vomiting. She called the office on 22-JUN-2018 and was seen by a nurse practitioner. The nurse practitioner prescribed an unspecified treatment for the patient to control her symptoms. The outcome of swelling in the right arm, bilateral arm pain from shoulder to elbow making it hard to move her arms, chills, nausea, and vomiting was unknown. Causality assessment was not provided.