chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This literature marketed report was received from the authors of a published article. This report refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) for prophylaxis. The patient had immune thrombocytopenic purpura (ITP) post-splenectomy who presented with fever, vomiting, diarrhea, increased white count and drop in platelets to 58. He was admitted to the ICU and required vasopressors for hemodynamic instability. He had streptococcus pneumonia bacteremia even after immunization with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) before his splenectomy (Vaccination failure and Pneumococcal sepsis). His lower extremities developed purpura fulminans-like rash possibly secondary to streptococcus pneumonia bacteremia and gangrenous wounds on lower extremities which warranted amputation due to concern for non-viable necrotic tissue. He was later found to have common variable immune deficiency (CVID) with low levels of IgG, IgA and IgM in his blood on evaluation for recurrent respiratory tract infections. It was reported that, ITP could be the presenting symptom of CVID and hence it may not be unreasonable to test for immunoglobulin levels on diagnosis of ITP. In this patient, inadequate response to the pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) due to co-existing CVID may have resulted in overwhelming pneumococcal sepsis. Adequate gamma-globulin replacements before proceeding with vaccinations could have helped. At the time of this report, the outcome of the events was unknown. Upon internal review, event pneumococcal sepsis was determined to be medically significant. Additional information has been requested.
Patient experienced wheezing and chest tightness 2 hours after receiving the flu vaccine 8/31/09.  She has not felt well since this episode began and today, 9/1/09, she experienced nausea, stomach cramping and feeling like she needed to go to the bathroom. She fainted while in the bathroom.  She woke up sweating, clammy and very weak.  BP 104/60, BS 132 (1 1/2 hours after eating).  She has a history of hypertension, history of hay fever but no other medical problems nor history of an adverse event to vaccine administration.  No one in her family has history of an adverse event after vaccine administration.  She has been taken to a doctor here in town for evaluation.  She received FLU-CSL 0.5 ml IM left deltoid.
RED, HOT, HARD AREA APPROX. 3 INCH DIA. ON LEFT THIGH
achey; sore arm; sore throat; both knees had joint pain; burning sensation in knees; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achey), BURNING SENSATION (burning sensation in knees), LIMB DISCOMFORT (sore arm), OROPHARYNGEAL PAIN (sore throat) and ARTHRALGIA (both knees had joint pain) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. #012A21A and 037A21B)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Tylenol, sulfa, -toprolol).   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced BURNING SENSATION (burning sensation in knees), OROPHARYNGEAL PAIN (sore throat) and ARTHRALGIA (both knees had joint pain). On 06-Apr-2021, the patient experienced CHILLS (chills). On an unknown date, the patient experienced PAIN (achey), LIMB DISCOMFORT (sore arm) and FLUSHING (Flushed). The patient was treated with DILTIAZEM HYDROCHLORIDE (CARDIZEM CD) at an unspecified dose and frequency; MONTELUKAST for Asthma, at an unspecified dose and frequency; ATORVASTATIN at an unspecified dose and frequency and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) at an unspecified dose and frequency. At the time of the report, PAIN (achey), BURNING SENSATION (burning sensation in knees), LIMB DISCOMFORT (sore arm), ARTHRALGIA (both knees had joint pain), CHILLS (chills) and FLUSHING (Flushed) outcome was unknown and OROPHARYNGEAL PAIN (sore throat) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-068293 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068293:2nd Dose.
Hives, itching?.Went to doctor told to take Benadryl?Didn?t work went to Urgent Care and prescribed steroids, also didn?t work. Hives started approx 10 days after booster . Still have hives almost a month after booster
Information has been received from a registered nurse concerning a 20 week female "reported as four month old" with no drug reaction/allergies and no pertinent medical history, who on 08-SEP-2010 was vaccinated with a first dose of ROTATEQ (dose and lot # not reported). The patient had no ill effects when she received that dose of vaccine. There was no concomitant medication. On 23-NOV-2010 the patient was vaccinated with a second dose of ROTATEQ (dose not reported, lot # 668266/0521Z). The patient vomited shortly after receiving her second dose of vaccine (about 2 minutes). The child expelled about a quarter cup of vomit. The patient showed no other adverse signs and was fine when left the office an hour later on 23-NOV-2010. No diagnostic laboratory tests were performed. The patient sought unspecified medical attention. Follow-up information has been received from the nurse who reported that the patient was not their patient. The adverse event might have been from the health center next door to the nurse's office. Follow-up information has been received from the registered nurse concerning the infant patient with no illness at time of vaccination, pre-existing allergies, birth defects or medical conditions and no medical history reported who on 24-NOV-2010 14:47 was vaccinated orally with the second dose of ROTATEQ (lot #668266/0521Z). Concomitant vaccines included the second dose of PENTACEL (lot #C3684AA) given intramuscularly into the right arm, and the second dose of PREVNAR 13 (lot # E70436) given intramuscularly into the left arm. On 24-NOV-2010 14:47, the patient vomited up approximate 1/4 cup of white, watery liquid immediately post vaccination. No further complications noted. On 24-NOV-2010, the patient recovered from the adverse event. The patient did not seek medical attention. No further information is available.
Suspected vaccination failure; shingles; 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 was unknown and the outcome of the shingles was not recovered/not resolved.   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: The patient self-reported this case. The age at vaccination was not reported. The patient had both shingles shots. At the time of reporting, he/she was suffering with shingles. The patient stated that it was milder than if he/she had not been vaccinated probably. The patient further stated the vaccine did not prevent getting this virus. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details were available.
Pt called the clinic for a telemedicine appointment at 3 PM 8/12/2021.  Pt reports he had paralysis in his right hand immediately after the shot.  That has resolved.  8/12/2021 he developed a HA and was too weak to get out of bed.  He reports he is now walking around and he is taking IBP "every hour" for his headache which is now 1/10 on the pain scale.  Earlier it was 8/10.  The patient was instructed to have someone drive him to the nearest ED for evaluation of his HA and weakness in light of having received the J & J vaccine.
Information has been received from a physician concerning her daughter who approximately 2 years ago, in approximately 2009 was vaccinated with the first dose of GARDASIL. Within one month after vaccination, the patient was diagnosed with rheumatoid arthritis. The patient never received any additional doses of GARDASIL. The patient continued to see a specialist for her condition and had been undergoing chemotherapy with methotrexate (manufacturer unknown). Upon the time of the report, the patient was not recovered. Rheumatoid arthritis was considered to be disabling and an other important medical event by the physician. Additional information has been requested.
At the first dose he lost his language and communication for 4 years/ Then couple months later, totally lost his language/he was diganosed with pervasive develpmental disorder not otherwise specified (PDDNOS)  which is on the spectrum of autism.; Peanut allergy; Also had a rash on his chest and stomach; This spontaneous report was received from a consumer via Pfizer and refers to an 11-month-old male. On an unspecified date, the patient tested positive for COVID-19. Historical drugs included Paxlovid and influenza vaccine (SWINE FLU VACCINE). He presented peanut allergy, and he was also allergic to: ciprofloxacin, amoxicillin (+) clavulanic acid (AUGMENTIN), ciprofloxacin, codeine, omeprazole (PROTONIX), duloxetine hydrochloride (CYMBALTA), gabapentin (NEURONTIN), tramadol, ketorolac tromethamine (TORADOL), and "Mideton".   On an unknown date in 2010 (reported as either May 2010 or June 2010), the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, anatomical location reported as "maybe in the right arm or thigh" administered as prophylaxis (strength, dose, route of administration, frequency, lot number and expiration date were not provided); and on an unknown date in 2011 (reported as between April 2011 or May 2011), he was also vaccinated with influenza vaccine (SWINE FLU VACCINE), nasally administered (strength, dose, frequency, lot number and expiration date were not provided).  On an unknown date, after the first administration of the vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), the patient lost his language and communication (reported as for 4 years) and he also presented rash in his chest and stomach (rash); therefore, he was put in an autism class. He was still presenting peanut allergy (food allergy), which was reported as still severe. Couple months later, he totally lost his language; therefore, the patient was sent to a child development center, and it was evaluated that it was not autism, since he was diagnosed with Pervasive Developmental Disorder Not Otherwise Specified (PDDNOS), which was on the spectrum of autism (Autism spectrum disorder). The patient was required with 20 hours a week, 5 times a week, every day, for 4 hours of teaching with 4 different teachers. The physician advised the patient to not receive the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). By the reporting time, the patient had not recovered from the event Food allergy. The outcome regarding the event autism spectrum disorder and rash was not provided.   The action taken with the suspect vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was withdrawn.   The causal relationship between autism spectrum disorder, rash and food allergy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.   Upon internal review, the event autism spectrum disorder was determined to be medically significant. The reporter considered the event food allergy to be life threatening.
07/19/2006 received Tdap noticed sore, painful jaw approximately 2-3 weeks later to present time.  Have also had a mild to moderate headache for 3 weeks.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; 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) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 11:42 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 11:49 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 89.81 for dose administered on 28-Feb-2021 and 89.89 for dose administered on 28-Mar-2021. No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 28-Feb-2021 with temperature 35 degrees Fahrenheit from 09:00 AM to 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 28-Feb-2021. Batch number 019B21A underwent temperature excursion on 28-Mar-2021. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 28-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period 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 using a traceable temperature monitor at every hour.  No treatment medications were reported   This case was linked to MOD-2022-566976 (Patient Link).
First Chills, Fever over 101.  The next morning nausea, dry heaves (approximately 6:30).  By approximately 7:00 could not move hands and fingers on both sides. Then my legs were tingling. Had husband call doctor's office and hold phone so that I could talk on it.  The physician on call called me back in about 10 minutes and at that time I had most of my feeling and movement back. Also had a welt on my arm with a diameter of approximately 4 inches across at the longest part that was (and still is the next day) warm to the touch.
He did not receive the second one as scheduled; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (He did not receive the second one as scheduled) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (He did not receive the second one as scheduled). At the time of the report, PRODUCT DOSE OMISSION ISSUE (He did not receive the second one as scheduled) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.   Reporter did not allow further contact
Anxiety; depression; He has been under a lot of stress; This spontaneous report was received from a registered nurse concerning to her son-in-law, a 34-year-old male patient.   The reporter did not provide information on the patient's pertinent medical history, drug reactions, or allergies, nor concomitant therapies included.  Reporter stated that on unspecified date of March 2021(also reported as "one month ago"), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (formulation, concentration, scheme and route of administration, lot numbers, and expiration dates were not reported).   Since that date the patient started experiencing anxiety and depression. Because of this he sought medical attention from a therapist and a psychiatrist. This also cause the patient to attend to an ER twice. He would have a follow up visit with a neurologist. Treatment involves finding the best medications to stabilize. It was also reported that he had been a lot of stress during COVID including being furloughed from his job and starting graduate school. Test included a Computerized tomogram (CAT) scan which result was reported as negative.  The patient's outcome of depression and anxiety was not recovered and the stress was unknown. The reporter did not provide a causal assessment between therapy measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and anxiety, depression and stress.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 11:39 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 11:39 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 30.03 years old. Concomitant products were not provided. On 13-Feb-2021, Excursion time was 09 AM, temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 20 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Breakthrough case admission after 4 vaccines Moderna 2/5/21 lot# 007M20A;  Moderna 3/5/21 lot# 023M20A;  Moderna 10/31/21 lot# 939904;  MOderna 5/23/22 lot# 038A22A
Mother reports 10/28/00 at approximately 4:00AM that her child sat up in bed and then fell back. Mother says body went stiff and jerked all over with urinary incontinence. Reports child gradually awoke from episode over approximately 45 minute time period. She was transported to the hospital by ambulance The physician's report states the chief complaint being seizure. Vitals were taken. Dizziness was noted. Augmentin course was completed on the 27th for OM/URI.
Pt recvd vax 15OCT91 approx 2PM; began screaming inconsolably approx 6-7PM; screamed for 3-4 hrs;
Patient developed arm and leg weakness 1-2 weeks onset after 5 year old vaccinations.  Weakness progressed and was diagnosed with Guillain-Barre Syndrome.
Feeling unwell; a continued and worsening cough; low grade fever 100.2; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Feeling unwell), COUGH (a continued and worsening cough) and PYREXIA (low grade fever 100.2) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient had no known drug allergy.  Concurrent medical conditions included Vitamin D deficiency and Allergy. Concomitant products included COLECALCIFEROL (NATURE MADE VITAMIN D3) from 01-Mar-2022 to 16-May-2022 for an unknown indication.   On 15-Apr-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021 at 6:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2022 at 6:00 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 27-May-2022 at 3:00 PM, the patient experienced MALAISE (Feeling unwell), COUGH (a continued and worsening cough) and PYREXIA (low grade fever 100.2). At the time of the report, MALAISE (Feeling unwell), COUGH (a continued and worsening cough) and PYREXIA (low grade fever 100.2) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2022, Body temperature: 100.2 Low grade fever of 100.2.         The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The patient previously received a COVID-19 Vaccine.  It was reported that the patient four days after finishing the paxlovid course of treatment, started to feel unwell again, low grade fever 100.2 and a continued and worsening cough.  No treatment information was provided.  The device date reported as 27-May-2022.   This case was linked to MOD-2022-580186 (Patient Link).
Baseline heart arrhythmia significantly affecting quality of life at temperatures exceeding 75*F. (Dizzy, weak, brain fog, pounding irregular heart beat). Lost pregnancy 6/5/21 due to heart irregularity. I became pregnant after being vaccinated, but I was only in my first trimester when I lost my baby.
Fevers, sore arm, rash to left arm, headache, shivers, shaking