chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The mother of a 2 month old infant (at the time of receipt of Tetramune) reported that her daughter received IM injection of Tetramune and oral Orimune on 1/12/96. It was noted that she received Engerix-B on 12/15/95. On 1/24/96, the pt was hospitalized and dx'd with an intraventricular stroke. She was on life support for the first 7 to 10 days of the hospitalization, which lasted 85 days. Now, at age 5, the pt does not walk or speak and is visually impaired. She also has a seizure disorder and "global delays". She has a "shunt" placed to control hydrocephalus.
She stated that when she received her immunizations (PNEUMOVAX and flu) that the pneumonia shot caused swelling in her arm, tingling and nerve pain in her arm that spread to her face, and general pain. She states that she went to the ER and they ran tests, but could not find anything wrong. She states that they tested to see if she was having a stroke, but the test came back negative. Patient states that she is still having lingering nerve pain and numbness.
Migraine.  Fever of 103.8.  Body aches.  Chills. Nauseous. Vomiting.  This went on for two days
Chronic intermittent headaches lasting for 1-4 days at once after receiving vaccination.  Symptoms is still persisting.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 53-year-old female patient who received SHINGRIX for prophylaxis. On 14th June 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In June 2018, less than a week after receiving SHINGRIX the patient experienced rash and skin irritation. On an unknown date, the outcome of the rash and skin irritation were unknown. It was unknown if the reporter considered the rash and skin irritation to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in an unknown deltoid. After receiving SHINGRIX, the patient experienced localized spot of irritation on her lower armpit of unknown arm. The reporter did not know the exact timeline for how soon after the second dose in the series was received and the symptom start. The patient called GlaxoSmithKline to inquire if this symptom could be related or not to the SHINGRIX and mentioned time constraints. The general phone number to GlaxoSmithKline's medical information team was provided. The call somehow was disconnected before the transfer to the GlaxoSmithKline medical information team could be completed. Two outbound attempts were made to the pharmacy, but there was a busy signal and no way to leave a message. It was okay to contact the reporter. No further information was provided beyond what was documented above.
1 day after ran out of medication , Migraine crisis; ran out of medication; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 75 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; atogepant (ATOGEPANT), oral (Batch/Lot number: unknown) at 60 mg 1x/day (60mg, daily) for migraine. Relevant medical history included: "Yes" (unspecified if ongoing), notes: relevant Medical History: Yes. The patient's concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "1 day after ran out of medication , Migraine crisis"; PRODUCT DOSE OMISSION ISSUE (non-serious), outcome "not recovered", described as "ran out of medication".  Additional information-It was unknown if patient was breastfeeding mother at the time of vaccination. Patient was not hospitalized for the event. It was reported that patient did not stop atogepant because of event. The patient was still ran out of medication and waiting on a shipment of Qulipta (atogepant) tablets.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
DVT left calf; This is a spontaneous report from a contactable Physician (patient). A 60-year-old male patient started to receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular on 20Dec2020 08:00 at single dose on right arm for COVID-19 immunization. Medical history included Gastric reflux. The patient had no known allergies. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. Concomitant medications included omeprazole (PRILOSEC) and ergocalciferol (VIT D). The patient had not received other vaccine in four weeks. The patient experienced deep vein thrombosis (DVT) left calf on 27Dec2020 09:00 which resulted emergency room visit. Treatment received for the event included Xarelto. The outcome of the event was not resolved.   Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further 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.
lightheadedness / dizziness; Systemic reaction (hypoglycemia, hypotension, generalized rash); Systemic reaction (hypoglycemia, hypotension, generalized rash); Systemic reaction (hypoglycemia, hypotension, generalized rash); This is a spontaneous report from a non-contactable other healthcare professional (HCP). This other HCP reported for a 71-year-old female consumer (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN6206), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, waiting for 15 minutes after the vaccination, the patient experienced lightheadedness. The patient denied difficulty breathing, difficulty swallowing, itching, facial swelling, lip swelling and tongue swelling. Patient complains of dizziness (lightheaded). The differential diagnosis included systemic reaction (hypoglycemia, hypotension, generalized rash) on an unknown date. The patient was observed in the medical bay for approx. 20 minutes. The patient was able to stand from wheelchair w/o lightheadedness/dizziness. The patient states she feels much better and was ready to go home. The reporter provided handwritten instructions on monitoring her bp (blood pressure) at home and when to follow up with pcp. The patient lab test included blood pressure measurement was unknown results on an unknown date. The patient received water and snacks as treatment for the event lightheadedness / dizziness. Follow up response to treatment was excellent. The outcome of the event lightheadedness / dizziness was resolving. The outcome of the other events was unknown.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. It was reported that on unknown dates, the patients may have been vaccinated with doses of VAQTA (lot number, expiry date, dose and route unspecified) which was stored as low as 31 degrees Fahrenheit (F). No concomitant therapy was reported. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
This spontaneous report as received from a licensed nurse refers to two unspecified patients of unknown demographics. The patients pertinent medical history and drug reactions/allergies were not reported. The nurse reported that the patients were administered VARIVAX (Merck), (Lot number, expiration date, dose and strength were not reported), which had been subject to defrost cycling on unspecified dates. No concomitant medications were reported. No adverse effects were reported. Outcome was unknown. No product quality complaint (PQC) was involved. The case is related to MARRS#1505USA001814 (same reporter). Additional information has been requested.
Moderna Dose 3, 4 & 5; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: EP7534), in right arm and on 11Apr2021 as dose 2, single (Lot number: EL00151) at the age of 60 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14Dec2021 as dose 3 (booster), single (Lot number: 027H21B), in right arm, on 31Aug2022 as dose 4 (booster), single (Lot number: 082B22A), in right arm and on 04Nov2022 at 14:30 as dose 5 (booster), single (Lot number: 010H22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "strep throat prior to Covid" (unspecified if ongoing), notes: other medical history: strep throat prior to Covid. Concomitant medication(s) included: QUETIAPINE FUMARATE; ZOLPIDEM TARTRATE; MONTELUKAST SODIUM; AZELASTINE HCL; CETIRIZINE HCL; DIPHENHYDRAMINE HCL; PHENYLEPHRINE HCL; DAYQUIL SEVERE COLD & FLU; NYQUIL SEVERE COLD & FLU; AMOXICILLIN, start date: 17Nov2022, stop date: 27Nov2022; GLUCOSAMINE & CHONDORITIN; AZO; CENTRUM SILVER [ASCORBIC ACID;BIOTIN;BORON;CALCIUM;CALCIUM PANTOTHENATE;CHLORINE;CHROMIUM;COLECALCIFEROL;COPPER;CYANOCOBALAMIN;FOLIC ACID;IODINE;MAGNESIUM;MANGANESE;MOLYBDENUM;NICKEL;NICOTINAMIDE;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCH; OMEGA 3 FISH OIL [FISH OIL]; TURMERIC [CURCUMA LONGA RHIZOME]; COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE]; CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]; VALERIN [VALPROATE SODIUM]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna Dose 3, 4 & 5". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Dec2022) Negative; (06Dec2022) Negative; (08Dec2022) Positive; (11Dec2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid,treatment start date was 30Nov2022 and stop date was 05Dec2022.  Clinical course: Tested at home as negative on 04Dec and 06Dec. Tested at home as positive on 08Dec with mild cold-like symptoms. Today, 11Dec, I tested at home as positive still. Symptoms are subsiding, but not completely gone. I was diagnosed with strep throat before Covid which was why I was on amoxicillin. I contracted Covid about the same time that I finished the amoxicillin. The patient had No known allergies.
Patient presented with a 3 inch bruise/rash that she said was not painful and rarely if any itches. She bruises easily while taking blood thinners. She felt a knot in the area on Saturday morning (4/22/2017) and bruising/rash. She talked with a nurse at a local clinic her daughter uses and was directed to return to us to look at the site of the ZOSTAVAX administration.
patient received the second dose of GARDASIL subcutaneously. It is unclear if the patient received quadrivalent GARDASIL or GARDASIL 9; This spontaneous report has been received from a consumer, concerning his wife a female patient of unknown age.     The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On an unknown date, the patient was vaccinated with the first dose of unidentified Merck hpc vaccine administered intramuscularly into her left arm, and later on unknown date (reported as "two months later"), the second dose of unidentified Merck hpc vaccine was administered subcutaneously (incorrect route of product administration) (lot number and expiration date were not reported) as prophylaxis.
Pt noticed itching evening of 1/19. The next morning swelling and red and itching. Swelled to a 3" x 3" area inflamed and hot, red. Pt started taking antihistamine and it is not subsiding.
One week of extreme fatigue (in bed all day), felt feverish but temp. just slightly elevated, hoarse voice, clear nasal discharge
May 2021 - symptoms include chills, body aches, fever (102 at highest), nausea, vomiting, diarrhea for one-two days followed by a mucusy cough and shortness of breath for an extended period of time (4-6 weeks). Body aches and fever continued every couple of days for almost a month. Tested negative for COVID. Was diagnosed with "pneumonia" and prescribed LevoFLAXacin which seemed to help the symptoms go away. I felt better and almost back to normal for a month until the symptoms showed up again, end of July 2021. Symptoms were the same as mentioned above for one-two days followed by a mucusy cough and shortness of breath, this time with elevated heart rate (resting rate 120-140) with low sat (85-90) particularly
On 06/03/2022 a older female patient approached the pharmacy after receiving the second Moderna booster with a large red splotchy rash around the site of injection and down the arm complaining of pain and itching. The patient was advised to take Benadryl and if the rash does not resolve on its own or worsens to seek medical attention.
on 11/10/2021 about an hour after dose 3 my heart rate went up to 225 BPM for 9 seconds. I am already on a heart monitor for. 11/14/2021 I had another even that my heart rate went up to almost 150 BMP.  I turned the heart monitor on  11/16/2021 but I do feel I had another rapid heart rate increase on 11/25/2021.  On 12/2102021 I will be going in for a stress test and we will know results then.
Approximately four hours after administration I noticed pronounced dark red spotting on the interior portion of my right big toe (hallux).  Concerned that this may have been a thrombotic event associated with the "covid toe" symptom seen with the disease.
Bleeding; Spotting; This is a spontaneous report from a contactable consumer(patient). A 66-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on 08-FEB-2021 12:00 at the 66 years old at single dose for COVID-19 immunisation.  The medical history and concomitant medications were not reported. The patient was not pregnant.There was no other vaccine in four weeks. On 22Feb2021 the patient experienced Bleeding, Spotting with outcome recovered in 2021. All of events resulted in Physician Office Visit. There was treatment for events. The patient underwent lab tests and procedures, which included Biopsy : Unknown results; Ultra sounds: Unknown results. There was no COVID prior vaccination. There was no COVID tested post vaccination.   Information about Lot/Batch number has been requested.
Swelling described as size of half a golf ball with warmth. Reported no respiratory issues or chest pain.
SORE ARM; FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia, and reaction to medicine, and other pre-existing medical conditions included the patient had other health issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and sore arm was not reported. This report was non-serious.
AE: Dizziness, extreme fatigue, inability to stand or walk immediately after administration of vaccine. Treatment: Vitals taken; stable. Blood glucose taken; not hypoglycemic. Gave Pt water to sip on. Pt assessed by PCP and cleared to go home.
Upon presentation for 2nd dose, patient related that he had a stiff, sore arm with limited range of motion requiring evaluation by a healthcare professional. He showed photos of his arm with a circle around what appeared to be an injection in the front part of the deltoid muscle area. Patient related that he visited FNP (noted in this report) for evaluation within a few days of the shot. Per patient history, he declined imaging or other scans and elected to treat symptomatically using Naproxen. Per patient, symptoms subsided after a couple of weeks to the point range of motion generally returned but soreness remains. Patient desired to receive his second dose to complete series which was administered.
On 10/17/01, the pt received Fluvirin and Pneumovax II and 12 hours later, he experienced a convulsion. During this episode, the pt fell down and fractured his ankle. He was subsequently hospitalized. The pt was treated with Phenytoin for the convulsions. There was insufficient information to determine the reporter's causality assessment.
Initial information received on 07-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old male patient who received 0.5 mL dose DAPTACEL (lot number: C5216AA, expiry date: 17-May-2019) intramuscularly in right deltoid instead of ADACEL (lot number and expiry date not reported) on 07-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. Documents held by sender: none.
Non responsive; Slept the rest of the day; Chills; Extremely fatigued; Fever; She vomitted and totally incapacinated.; This spontaneous case was reported by a consumer and describes the occurrence of UNRESPONSIVE TO STIMULI (Non responsive) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037CZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included LISINOPRIL, INSULIN and ATORVASTATIN for an unknown indication.    On 26-May-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNRESPONSIVE TO STIMULI (Non responsive) (seriousness criterion medically significant), SOMNOLENCE (Slept the rest of the day), CHILLS (Chills), FATIGUE (Extremely fatigued), PYREXIA (Fever) and VOMITING (She vomitted and totally incapacinated.). On 27-May-2021, VOMITING (She vomitted and totally incapacinated.) had resolved. At the time of the report, UNRESPONSIVE TO STIMULI (Non responsive), SOMNOLENCE (Slept the rest of the day), CHILLS (Chills), FATIGUE (Extremely fatigued) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided.  This case concerns a 38-year-old female with a serious unexpected event of unresponsive to stimuli, and nonserious somnolence, chills, fatigue, pyrexia and vomiting. Event latency within 24 hours after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Added patient demographics height 4'6'' inches, weight 100 pounds, race, ethnic group. Added new medical history diabetic, high blood pressure. Added drug information's start date, dose number, batch number, body site. Added concomitant medications Lisinopril ,Insulin in siding scale, Atorvastatin. Added events were non responsive,extremely fatigued, she slept the rest of the day, vomited. Added event out come recovered.; Sender's Comments: This case concerns a 38-year-old female with a serious unexpected event of unresponsive to stimuli, and nonserious somnolence, chills, fatigue, pyrexia and vomiting. Event latency within 24 hours after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
A little more than 5 minutes after receiving vaccine she felt flushed, dizzy and her blood pressure elevated to 155/80.  She was given Benadryl and monitored. Her symptoms did not worsen or improve. She went home. Symptoms included a low grade headache and feeling "foggy headed" Blood pressure remained elevated. Symptoms took hours to resolve. She only had expected side effects in AM of arm soreness.
Fatigue, enlarge lymph node under left arm, chills, body aches all lasting 48 hours after injection.
Patient came in today on 04/24/2017 around noon. Patient had an administration site reaction: right arm with mild swelling and redness, and mild flu-like symptoms that per the patient did not occur until the evening of the shot, and worsened the next day. Called patient's physician's office, spoke to RN, who asked the patient to come in for an immediate visit and asked that the patient take a BENADRYL prior to visit. Patient left the pharmacy to go to the doctor's office.
On 12/16/13 mom brought patient in to report anxiety/crying bout episodes lasting several weeks after each of three HPV doses on 1/29/13, 4/2/13 and 7/31/13. Seen on our office only once for this problem on 2/19/13 reporting onset of crying and school refusal beginning 2/14/13. Referred to behavioral specialist and note from 4/30/13 reports diagnoses depressive disorder and anxiety.