chrisvoncsefalvay/vaers-outcomes huggingface dataset:
information has been rec'd from a literature article titled Invasive pneumococcal infections in pediatric cardiac transplant pt's (Pediatric Infectious Disease Journal; 20(10): 945-950, Oct 2001) concerning a 21 mth old male pt with history of a cardiac transplant who was vaccinated with one dose of pneumococcal vaccine 23 polyvalent at one year of age. Concomitant therapy included an unspecified immunosuppressive medication at the time of infection. Subsequently, the pt developed an infection (pneumococcal bacteremia). Upon internal review the pt's infection (pneumococcal bacteremia) was considered to be an other important medical event. It was noted that this information was rec'd from medical records of all cardiac transplant pt's receiving their care at a hospital from 3/90 to 11/00 that were reviewed for cases of invasive bacterial infections caused by S pneumoniae that occurred after transplantation. The risk factors for the development of invasive pneumococcal disease included african-american race, transplantation at age <32 yrs and having idiopathic cardiomyopathy as the indication for transplantation. It was noted that the first infection occurred at median age of 20 months post transplantation (range 3 to 48 months). Fever >101F was the presenting sign/symptom in 75% of cases. Other clinical presentations included pneumonia, otitis media and petechiae/purpura. In 25% of episodes patients had received a course of oral anti microbial therapy within 30 days before their invasive disease. All pt's were taking immunosuppressive medications at the time of infection including cyclosporin, azathioprine, systemic corticosteriods and mycophenolate mofetil. It was also noted that four other patients were vaccinated with one dose of pneumococcal vaccine 23 polyvalent and developed similar events (WAES# 01102590,01104800,01104802, and 01104803). A copy of the published article is attached as further documentation of the patient's experience.
Complained of feeling "woozy and flushed".  BP 181/97  Pulse 72 . denied history of hypertension. Rested for 30 min. BP remained at the same level.  No headache, chest pain or other complaints. Discharged home after agreeing to follow up with primary MD and /or going to ER  if symptoms worsened.
Onset of HA, malaise, body aches, sore throat, inflammation around vax site, left arm (11x6 cm erythema).
Diarrhea 1 day after vaccine (7-8 stools per day) this persisted for 14 days.  Mother discussed with pmd by phone and told was a side effect of Pediarix.
Not an issue with box labeled, recall per GSK documentation. GSK was called, pharmaceutical company employee indicates it is not a question of quality. but off abel.
PT STATES THA SHE WENT TO THE EMERGENCY DEPARTMENT AND WAS TOLD THAT SHE WAS EXPERIENCING A "TRANSIENT GLOBAL AMNESIA".
Patient became dizzy, felt faint, sweaty, and clammy. He laid down for about 10 minutes, had some water and applied a cool compress to his head. He felt better after about 10 minutes of lying down.
Per patients wife, 8 days post vaccination the patient presented with stroke like symptoms e.g., lower extremity paralysis. After a spinal tap done in the hospital, a diagnosis of Guillain Barre Syndrome was confirmed. The patient spent 5 days in ICU, and the past month in physical therapy. The patient is now using gabapentin, and is using a walker/wheel chair.
This spontaneous report was received from the patient's mother and referred to a male patient of unknown age. No information regarding the patient's medical history, drug reactions and allergies was provided. On an unknown date, the patient was vaccinated with hepatitis A vaccine, inactivated (manufacturer unknown) (it was unspecified if it was VAQTA or HAVRIX and it could not be clarified) (dose, route of administration, lot number, expiration date were not provided) for prophylaxis. On an unknown date, the patient had a "side effect". On the time of the report, the patient's mother was on her way to the hospital but not further details were provided. The outcome of the event was unknown.  The relatedness between the event and suspected therapy was considered as related.
patient was on a delayed immunization schedule with no reported adverse event; Initial information received on 04-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 years old female patient was on a delayed immunization schedule with no reported adverse event involving vaccines DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (strength, formulation, lot number and expiry date were unknown) via unknown route in unknown administration site for Immunization. In August 2021, the patient received a 1st unknown dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (strength, formulation, lot number and expiry date were unknown) via unknown route in unknown administration site for Immunization. In October 2021 she also received a second dose of the same vaccine (strength, formulation, lot number and expiry date were unknown) via unknown route in unknown administration site for Immunization. In March 2022  she also received a 3rd dose  (strength, formulation, lot number and expiry date were unknown) via unknown route in unknown administration site for Immunization. On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (strength, formulation, lot number and expiry date were unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious patient was on a delayed immunization schedule with no reported adverse event (inappropriate schedule of product administration, Latency: unknown). Patient was in the office for a fourth dose today on 04-Oct-2022, but wasn't sure what to give between QUADRACEL, DAPTACEL and ADACEL due to the patient's age not being indicated for either of those vaccines.  Action taken: not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt received Moderna Vaccine at 04:56pm, was placed on observation for 30 mins due to hx of allergies. Upon observation of patient, patient stated she was experiencing possible allergic reaction tingling sensation to lips and irritation to throat. No angioedema, no wheezing, no hives, generalized rash or respiratory distress, O2 sats were noted to be 100% on RA. Pt stated she felt as her throat was closing up, pt was noted to be anxious due to symptoms, and continued to state her throat was closing up.  Epi pen 0.3mg IM administered at (05:09) was administered, pt was also medicated with benadryl 50mg IM (05:10)  and solumedrol 125mg IM (05:16pm). Pt was alert, oriented, no angioedema noted, no wheezing, no respiratory distress, no ALOC, no hives, no chest pain. Overall, pt stated she felt better and symptoms had resolved after administration of medication. Pt was transported to hospital for further evaluation.
stating that they have administered an expired PENTACEL to a patient with no reported adverse event; Initial information received on 26-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient to whom they have administered an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an expired dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot UJ736AAA; Expiration Date :18-SEP-2023) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency: on same day).  Action taken : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
redness; 4 inch circumference of swelling; severe itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (severe itching), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (4 inch circumference of swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PRURITUS (severe itching). On 20-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (4 inch circumference of swelling). At the time of the report, PRURITUS (severe itching), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (4 inch circumference of swelling) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Patient started feeling skin tingling in the chest and both arms about 5 minutes after the vaccine. He then started feeling weak, sweating and lightheadedness. At that point he started having sweating and mental confusion. This was about 30 min after the vaccine. After he started having  symptoms, he was evaluated with vital signs which were normal. He was made to lay down and this resolved the skin tingling. He also had improvement in his muscle weakness and fatigue when he was laying down. He also had some improvement in his groggy feeling. Every time he was sitting up, he became lightheaded. He was observed for 3 hours. At that point, he was sent home to rest and advised on signs of worsening reaction that would require ER evaluation.  Vitals were normal throughout his observation period.
This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in April 2018). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided are as follows: The age at vaccination was not applicable for this report. No lot number neither expiry date of 1st dose were provided. The Clinic's Vaccine coordinator reported that till the time of reporting, the patient did not receive a dose of Shingrix, which led to incomplete course of vaccination. The patient now wanted to get 2nd dose of Shingrix but did not know how to proceed with schedule. The health care professional provided limited information. The reporter did not consented to follow-up.
11:55 c/o itching @ inj site-area sl red;12:00 c/o hand swelling-epi;pt states is fine-911 called given above site;12:05 DPH given c/o numbness, tingling face;9DEC c/o dizziness
Pt was vaccinated and one day post vaccination, the pt developed redness, warmth, edema, and mild itching from left shoulder to elbow. Within 3 days of onset the pt recovered.
Typical arm soreness and limited range of movement. However, it has not gone away and has gotten worse over the past two weeks to now include some numbness and tingling in fingers of left hand.
Patient was in first trimester of pregnancy at time of vaccination. Patient received booster dose on Thursday 12/8 around 5pm. Later in the evening she began to bleed and went to be seen. States she continued to bleed through the weekend and had miscarried the pregnancy.
Vaccine administered in (L) deltoid. Lymph nodes swollen and tender to touch in (L) axilla noted day after administration of vaccine and became very pronounced and exquisitely tender over the course of the next 2-3 days.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 29-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The reporter stated that their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.
pt recv vax & approx 3min p/vax pt c/o dizziness, h/a & nausea;pt became very pale, c/o SOB & chest pain;pt was then given epi & DPH;and had been called transported to hosp
Muscle pain, tachycardia, headache, insomnia, nasal congestion
Left groin lymph node swollen to 1/2", slight fever 99.5 on 10/20, then on 10/22, spots on stomach & upper legs for 2 days. Lymph node still swollen as of 11/11/99. Tx'd with antibiotic x 10 days. Fever & spots gone but gland still swollen.
Between the joints are swollen/ 1 ankle is swollen; 2-3 hours her digits were swollen/ both hands, 2 middle fingers; It hurts to bend/ take Aleve or something due to pain; 1 ankle is swollen, but later mentioned painful; This spontaneous case was reported by a physician and describes the occurrence of JOINT SWELLING (Between the joints are swollen/ 1 ankle is swollen), PERIPHERAL SWELLING (2-3 hours her digits were swollen/ both hands, 2 middle fingers), PAIN (It hurts to bend/  take Aleve or something due to pain) and ARTHRALGIA (1 ankle is swollen, but later mentioned painful) in a 40-year-old female patient who received mRNA-1273  (MODERNA COVID-19 VACCINE for COVID-19 vaccination.     Concurrent medical conditions included Allergic to dogs (has taken allergy shots) and Allergic to cats (has taken allergy shots).    On 10-Sep-2022, the patient received fourth dose of mRNA-1273 MODERNA COVID-19 VACCINE, (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 10-Sep-2022, the patient experienced JOINT SWELLING (Between the joints are swollen/ 1 ankle is swollen), PERIPHERAL SWELLING (2-3 hours her digits were swollen/ both hands, 2 middle fingers), PAIN (It hurts to bend/ She can take Aleve or something due to pain) and ARTHRALGIA (1 ankle is swollen, but later mentioned painful). At the time of the report, JOINT SWELLING (Between the joints are swollen/ 1 ankle is swollen), PERIPHERAL SWELLING (2-3 hours her digits were swollen/ both hands, 2 middle fingers), PAIN (It hurts to bend/ She can take Aleve or something due to pain) and ARTHRALGIA (1 ankle is swollen, but later mentioned painful) outcome was unknown.        For mRNA-1273 MODERNA COVID-19 VACCINE(Intramuscular), the reporter did not provide any causality assessments.   Patient never had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. No concomitant medications were provided. On an unknown date, patient received primary series as well as 1 booster dose of Moderna vaccine. No treatment medications were reported.
Fibromyalgia/Pain all over/Stiffness; This spontaneous case was reported by a patient and describes the occurrence of FIBROMYALGIA (Fibromyalgia/Pain all over/Stiffness) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A, 011J20A and 030L20A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: FLU I. Past adverse reactions to the above products included No adverse event with FLU I.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FIBROMYALGIA (Fibromyalgia/Pain all over/Stiffness). The patient was treated with DULOXETINE HYDROCHLORIDE (CYMBALTA) at an unspecified dose and frequency. At the time of the report, FIBROMYALGIA (Fibromyalgia/Pain all over/Stiffness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient did not have any relevant medical history/conditions, allergy, concomitant diseases and risk factor. No concomitant medication was reported. Company comment This spontaneous case concerns a 54-year-old male patient with no relevant medical history reported, who experienced the unexpected, non-serious AESI of Fibromyalgia and received the 4 doses of mRNA-1273. It was reported that after the 1st monovalent booster he started developing mild symptoms of fibromyalgia, and after the last bivalent booster they were worse. A specific date when symptoms started was not provided, it happened gradually, but about 2 months after the third dose of mRNA-1273, he was in so much pain all over even when doing normal things. Pain and stiffness were what he first noticed first. He was treated with Cymbalta (Duloxetine). The event had not yet recovered at the time of the last observation. No further clinical information was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2023-738995 (Patient Link).
was weak and very tired two hours after vaccination slept for 14 hours and recovered.  I was concerned because no one I know has had these effects. I will be 90years old and will get a second shot on the 16th.  I would like to know the cause of these effects on me.
SUSPECTED COVID 19 INFECTION; This spontaneous report received from other health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid 19 infection. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid 19 infection was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
I felt slightly dizzy within 15 minutes of receiving the vaccine, but shrugged it off as unimportant.  I developed a slight headache within an hour of the vaccine.  I continued to feel a bit dizzy and confused the rest of the day but didn't take anything for the slight headache.  When I awoke this morning, I had a bad headache, chills, body aches all over, dizziness, light-headedness and confusion.  I was so confused that I didn't remember making coffee for my son.  I've also had difficulty concentrating or keeping on task.  I took less than half of a Benadryl tablet about 45 to 60 minutes ago in case my body was experiencing an allergic reaction.  Hopefully the dizziness and confusion will subside soon.
I had fever, chills, muscle ache headache. After 2 days, I developed tinnitus, ringing on my both ears, head - which is still going as of this writing. I have constant ringing on my head 24 hrs a day with no relief.  I had Moderna covid 19 EUA vaccine
went  unconscious  Three rounds of epi drugs.  Overnight observation.  Allergic reaction.
blood clot to the brain; This is a spontaneous report from a contactable consumer (patient's relative). A female patient (mother-in-law) of an unspecified age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient died from a blood clot to the brain on an unspecified date. The reporter personally think that it was from the Pfizer shot. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Information about lot/batch number not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Reported Cause(s) of Death: blood clot to the brain