chrisvoncsefalvay/vaers-outcomes huggingface dataset:
off label use; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to an 8-year-old female patient. No information regarding the patient's concurrent conditions or concomitant medications was provided. On an unknown date, the patient presented to the emergency department (ED) with intermittent vaginal bleeding for approximately 1 month. Initially, the patient reported dysuria, which resolved with a course of antibiotics (unspecified) for a presumed urinary tract infection. On presentation to the ED, her vaginal lesion was visualized at the introitus, extending up the right vaginal wall and towards the urethra as a 1-2 cm red/purplish polypoid and friable mass. The patient was taken for an exam under anesthesia with vaginoscopy (no result was provided). On an unknown date, biopsy of the vaginal mass revealed a squamous papilloma with koilocytic atypia. There was no evidence of malignancy. The atypia present, although significant, was similar to that seen in human papilloma virus (HPV) infections. Tissue was sent for HPV in situ hybridization testing which indicated positivity for HPV types 6 and/or 11. On an unknown date, approximately 1 month after the procedure, the bleeding had decreased to intermittent spotting, but there was minimal change observed in the appearance of the vaginal lesion. It was recommended for the patient to have early administration of the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine.  On an unknown date, the patient was vaccinated with a dose of the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, frequency, route of administration, lot# and expiration date were not reported) for squamous papilloma and start applying Imiquimod cream.  Literature Report:.
it was feeling like a sensation in my leg, that wasn't there prior to the shot; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself). A 45-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0178), via an unspecified route of administration on 24May2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced it was feeling like a sensation in my leg, that wasn't there prior to the shot on an unspecified date in 2021. Patient stated, I got vaccinated on 24May2021, Okay, now the latest, the information that regards to the information so, right after I got my first vaccination, I held off. I held off because I wanted to find out what exactly was going on, give it a little time to see what was going on and that's what I did. So, now it's today and I want to get the second vaccine. It's almost a month and almost 6-7 weeks since I got my first vaccine. Will I be still be able to go and get vaccinated? Will I need a third dose? Well. I went to the pharmacy and they said to contact my doctor because they wasn't sure, If I had missed the window in regards to getting my first shot and my second shot and the time lapse, that has occurred. Okay. So, it's been 53, yeah it's been 2 months now, it's been a little under 7 weeks since I. Scheduled date for second shot: Patient stated, It was 3 weeks after the first shot. It was not an actual date. It was just 3 weeks from the day after first shot. Anatomical site for first vaccine: Patient stated, I really can't remember, to be honest with you. I want to say, may be it was my left, but I am not sure. May be it was my left but again I am not sure. I ended feeling, I wind up feeling something in my leg as well. I can't remember, what was it was on. I do remember, it was feeling like a sensation in my leg, that wasn't there prior to the shot. Outcome of the event was unknown.
Return of covid symptoms; Return of covid symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old male patient received BNT162b2 (BNT162B2), on 28Oct2021 at 12:30 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN, start date: 01Jan2022. Past drug history included: Ibuprofen, reaction(s): "Drug allergy".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Return of covid symptoms". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other medication in 2 weeks. Anti-viral details: Product: COVID 19 Treatment; Paxlovid, start date: 29Jun2022, Stop date: 04Jul2022, for treatment of COVID-19). Return of covid symptoms began 2 days ago (6 days after finishing Paxlovid) with pain in the lower left abdomen (did not occur prior to first infection); yesterday followed by fatigue, congestion, and sneezing; today followed by sore throat, coughing, loss of taste (did not lose taste during original infection), malaise, body aches, chills, clamminess, and 100.8 fever (his first infection prior to Paxlovid treatment saw his fever spike at 103).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Dizziness, brain fog, fever, chills, headache, and all over sore muscle aches.
2nd dose - after approx hour of administration - face tingling and numbness, light-headed/ floaty feeling, difficulty swallowing and breathing; 2nd dose - after approx hour of administration - face tingling and numbness, light-headed/ floaty feeling, difficulty swallowing and breathing; 2nd dose - after approx hour of administration - face tingling and numbness, light-headed/ floaty feeling, difficulty swallowing and breathing; 2nd dose - after approx hour of administration - face tingling and numbness, light-headed/ floaty feeling, difficulty swallowing and breathing; 2nd dose - after approx hour of administration - face tingling and numbness, light-headed/ floaty feeling, difficulty swallowing and breathing; 2nd dose - after approx hour of administration - face tingling and numbness, light-headed/ floaty feeling, difficulty swallowing and breathing; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient (not pregnant at the time of vaccination) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and batch no: not reported/lot number: EW0181) via an unspecified route of administration, in left arm on 25Aug2021 11:00 AM (at the age of 53-years-old) as single dose of for COVID-19 immunization at Pharmacy or Drug store. Medical history included as allergy. Concomitant medications included the patient received medications within 2 weeks of vaccination included amlodipine at 2.5 mg for an unspecified indication. Historical vaccine included as patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and batch no: not reported/lot number: EW0181) via an unspecified route of administration, in left arm on 04Aug2021 11:00 AM (at the age of 53-years-old) as single dose for COVID-19 immunization and experienced tingling cold in left arm and leg within 15min of administration. The patient had not received any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and since the vaccination, the patient has not been tested for covid-19. On 25Aug2021 at 12:15PM after approx. hour of administration, patient experienced face tingling and numbness, light-headed/ floaty feeling, difficulty swallowing and breathing. The outcome of the events was not recovered. Follow-Up (02Sep2021): Follow-up attempts are completed. No further information is expected.
Within seconds of receiving the shot around the injection site turned very red and my whole arm was itching pretty badly and had a burning sensation. It lasted for a good 30 minutes at least.
Pt. states that after receiving the 2nd dose of Shingrix 12/27/2021, started experiencing symptoms that evening with fever, chills, flu-like symptoms, body aches, and headache. No noted Primary visit/communications. Still continuing to experience symptoms.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Medium
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: pt experienced hives on the right hand and elbow about 16 hours post dose
HYPOXIA 1/31/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Information has been received from a physician and a consumer concerning her 31 month old son with milk intolerance and autism who on 02/14/2001 was vaccinated with the first dose of varicella vaccine. Concomitant therapy included vitamins. Within 12 hrs post vaccination, the pt was very lethargic and would not move for the next two days, his ears were bright red and he ha a fever. It was noted that the pt never had a fever until the varicella vaccine and the mother thought something was wrong. The physician reported that he did not know that the child had developed a fever, lethargy, bright red ears and a lack of movement for two days. He reported that the mother of the tp did not call the office to report this event, nor did the pt come into the office for a visit. The pt was not seen again in the office until June 2001. It was noted that the pt was vaccinated with a dose of MMR vaccine on 07/21/1999 and was diagnosed with autism. About three months after that, in approximately January 2000, the pt was vaccinated with a dose of hib conjugate vaccine and a dose of diphtheria toxoid pertussis vaccine teta. The physician who noted that the pt's mother had an uncomplicated pregnancy and delivery. Additional info has been requested.
She said she's generally ill; sore throat; tiredness as well as joint pain after getting the vaccine; tiredness as well as joint pain after getting the vaccine; This is a spontaneous report from contactable consumer (patient) via a Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route of administration on 28Mar2021 as dose 1, single for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient would like to know how long a vaccine recipient could be experiencing side effects. She said she was generally ill. She received the first dose on 28Mar2021, and she had been experiencing sore throat, tiredness as well as joint pain after getting the vaccine. The outcome of events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
One week after vaccination left arm itching, warm, headache, 14 hours after symptoms started rash appeared. Home treatment with Tylenol and ice pack.
Went from feeling great to terrible in less than 15 minutes. Symptoms were: -Vomiting -Oversensitivty to sound and light -High fever (101.5) -Chills -Aches -Fatigue
This spontaneous report as received from a healthcare worker refers to a 4 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 09-OCT-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally (incorrect product storage). The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of th several reports received from the same reporter. Additional information has been requested.
Ache with infrequent sharp pain, sometimes cannot hardly move arm at all Ache is all day, gets to point to hurt to take a couple times a week Tylenol helps relieve pain normally 4/5 but can get up to a 10
Moderna Covid-19 vaccine was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022; vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No known allergy was reported to medications, food, and other products.  Concurrent medical conditions included Osteoarthritis. Concomitant products included OMEPRAZOLE, AMLODIPINE, ESCITALOPRAM, ERGOCALCIFEROL, IBUPROFEN, ACETAMINOPHEN and TRIAMCINOLONE for an unknown indication.    On 13-Apr-2022 at 4:03 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022 at 4:03 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not experienced covid infection within last month.  The vial was initially stored in refrigerator on 25-Feb-2022. The vial did not undergo temperature excursion. it was reported that the patient was vaccinated post 30 day use period (expiration date 25-Mar-2022). The patient did not experience any side effects.  No treatment medications were reported.
Symptom of hyperthyroid/high thyroid levels in blood; nerve damage in left eye;   This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (not available). The reporter is the patient. Other Case identifier(s): 21K-163-4164592-00 (Company).  A 71 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 1, single and intramuscular (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at 40 mg (citrate free (40 mg,1 in 14 d)) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERTHYROIDISM (medically significant), outcome "unknown", described as "Symptom of hyperthyroid/high thyroid levels in blood"; OPTIC NERVE INJURY (medically significant), outcome "unknown", described as "nerve damage in left eye". The patient underwent the following laboratory tests and procedures: blood work: thyroid issues; thyroid level: high. The action taken for adalimumab was unknown.  The reporter's causality for the event(s) of symptom of hyperthyroid/high thyroid levels in blood with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility and causality for the event(s) of nerve damage IN LEFT EYE with HUMIRA 40MG/0.4ML(ADALIMUMAB) was a reasonable possibility. The reporter's assessment of the causal relationship of the events with bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of events hyperthyroidism and nerve damage in left eye cannot be totally excluded. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Migraine-like headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine-like headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MIGRAINE (Migraine-like headache). On 09-Apr-2021, MIGRAINE (Migraine-like headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history provided. High Blood pressure concomitant medication mentioned but not provided.
The same day of the injection only had the front of the leg tight; just little arm pain but 1 or 2 days only; Can't hold anything, her arm is so week to her elbow; a lot of chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (The same day of the injection only had the front of the leg tight), PAIN IN EXTREMITY (just little arm pain but 1 or 2 days only), MUSCULAR WEAKNESS (Can't hold anything, her arm is so week to her elbow) and CHILLS (a lot of chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder since 1989. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced MUSCLE TIGHTNESS (The same day of the injection only had the front of the leg tight), PAIN IN EXTREMITY (just little arm pain but 1 or 2 days only), MUSCULAR WEAKNESS (Can't hold anything, her arm is so week to her elbow) and CHILLS (a lot of chills). On 27-Feb-2021, MUSCLE TIGHTNESS (The same day of the injection only had the front of the leg tight) and CHILLS (a lot of chills) had resolved. At the time of the report, PAIN IN EXTREMITY (just little arm pain but 1 or 2 days only) and MUSCULAR WEAKNESS (Can't hold anything, her arm is so week to her elbow) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment was taken by the patient for the adverse events.   This case was linked to MOD-2021-237500 (Patient Link).
delayed hypersensitivity reaction at site of injection about 1 week following the first injection in the two dose series.
temperature excursion involving a punctured IPOL with no reported adverse event; five patients received the punctured IPOL post excursion with no reported adverse event; Initial information received on 13-Apr-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case is linked to cases 2023SA119119 and 2023SA119126.  This case involves a 13 years old male patient who  received the punctured ipol post excursion and temperature excursion involving a punctured ipol with no reported adverse event after receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.   On 22-Mar-2023, the patient received a suspect IPV (VERO) dose number 2  at dose of 0.5 ml  (lot V1B901M, Expiry date: 02-Jun-2024) via intramuscular route in the left arm for prophylactic vaccination  On 22-MAR-2023 the patient diagnosed with a non-serious temperature excursion involving a punctured ipol (product storage error), five patients received the punctured ipol post excursion with no reported adverse event (poor quality product administered)  following the administration of IPV (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both events.    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.; Sender's Comments:  US-SA-2023SA115479: US-SA-2023SA120330: US-SA-2023SA119119: US-SA-2023SA119961: US-SA-2023SA119119:
PT DESCRIBED PAIN AT INJECTION SITE AND TINGLING IN FINGER TIPS. STATED TIME THAT ELAPSED BETWEEN INJECTION AND SENSATION FELT WAS THE TIME IT TOOK TO LEAVE VACCINATION ROOM.
Pt received 1st dose Moderna and 2nd dose Pfizer in Covid-19 vaccine series. No known adverse reaction reported.
flu symptoms. Pt received Covid J&J vaccine at 0920. At 2100ish stared to have ha/blurry vision/body aches, cough, chills, nausea. History:  pt received J&J COVID-19 vaccine this morning and after 2100 or so tonight, pt developed body ache, nausea, non-thunderclap headache, and cough, here for eval.  Denies any symptoms prior to vaccination and went to the area once over the weekend in the past 2 weeks and no recent travel/COVID-19 hotspot visit, no sick contact, and denies also ear pain, sore throat, runny nose, SOB, focal abdominal pain, vomit/diarrhea, rash, prior co-morbidities, use of any meds.
Patient had received 3 injections, influenza, Hep A, and Hep B.  He was standing while receiving the injections.  Immediately following the Hep B injection, he passed out and fell to the floor, hit his head on a chair leg, and convulsed for about 5 seconds.  Patient awoke with confusion and was directed to sit in a chair.  He reported no memory of the event, feeling very unwell and hot, and was sweaty and pale.  His BP at 11:30 was 92/58 and HR 58bpm.  Patient did not have any difficulty breathing or hives.  No epinephrine was administered.  EMS responded at appx 11:40 AM.  His BP was within normal range.  He was given an EKG, results within normal range.  His HR remained appx 58 bpm, patient is in good cardiovascular condition.  EMS suspected the reaction was a vasovagal response.  Patient's father was present immediately following the episode and transported him to the clinic.