chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was reported that a 68 year old female received Fluzone SV '98-'99 USP on 11/2/98 and 2 days, post vax, she experienced right neck discomfort; and 5 days had facial weakness. Reportedly, was seen in ER and dx'd with Bell's Palsy. From additional information received on 12/4/98, it was reported, "follow-up 11/16/98 facial weakness improved".
Pt denies Adverse Reaction to 0.5 ml Dose instead of 0.3mL dose
muscle soreness around the injection site.; Headache; Low grade fever; muscle pain; Joint soreness/ Pain; Tingling feeling in both legs; This is a spontaneous report from a contactable consumer, the parent. A 19-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on 22Mar2021 (at the age of 19_years-old), as a single dose for COVID-19 immunisation. Medical history included environmental allergy (like pollen and dust). Concomitant medication included unspecified immune-tolerance (MANUFACTURER UNKNOWN) therapy for allergy. Prior to vaccination, it was unknown if patient was diagnosed with COVID-19. Since the vaccination, it was unknown if patient had tested for COVID-19. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021 (within 24 hours), the patient experienced very common side effects or sequelae like muscle soreness around the injection site, headache, low-grade fever, and more generalized muscle; joint soreness or pain and side effect which was most unusual and disturbing was the tingling feeling the patient had (and was still experiencing without any diminution) in both of her legs. It was also reported that, as per doctor the patient was not experiencing any muscle weakness or numbness, then it was not guillainbarre syndrome (GBS), and she should come back if it worsened, but did not prescribe any course of treatment. Therapeutics measure was taken as a result of events vaccination site pain, headache, low grade fever, muscle pain and joint pain which included the treatment with ADVIL (over the counter nonsteroidal anti-inflammatory drug). The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events vaccination site pain, headache, low grade fever, muscle pain, pain, joint pain and tingling were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Product storage error; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter.  Patient received the booster dose. The vial was placed in the refrigerator on 27-NOV-2021.Vial did not undergo any temperature excursion. No adverse event was reported.  No treatment medications were reported.
Thyroid painful to touch.  Began approximately 24-30 hours after vaccine.  Continuing for 7 days now.
This case was reported by a other health professional via call center representative and described the occurrence of erythema in a 4-year-old female patient who received INFANRIX (batch number 2N43Z, expiry date 12th April 2020) for prophylaxis. On an unknown date, the patient received the 3rd dose of INFANRIX. On 14th November 2018, unknown after receiving INFANRIX, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were unknown. It was unknown if the reporter considered the erythema and swelling to be related to INFANRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that the patient had redness and swelling around 5cm in size.
Initial misuse report received from a healthcare professional on 17 October 2013. The cases were received on 21 March 2014. A patient received half of the dose of FLUZONE by error (no other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Large amount of bruising to left deltoid and upper arm. Denies pain at this time. Arm slightly sore on injection day, but not extreme soreness.
Pt developed significant erythema at injection site within 24 hours of injection. Rechecked in office 5/8, 5/9, and 5/10. Began on Keflex to cover for cellulitis though mostly immunization reaction area of erythema is 14cm x 12cm 5/10/07.
Short of breath Fever COVID-19 pneumonia  prednisone 40 mg oral Daily
SORE ARM, RED SPOTS, FEELS LIKE HEAT RADIATING OFF THE ARM.
Pfizer-BioNTech COVID-19 Vaccine EUA - tech hit a blood vessel when administering the first vaccine. This resulted in a large bruise. The bruise eventually went away, but it left a skin discoloration in the size/shape of the bruise. I haven't experienced this before with bruises and thought it may have been caused by a combination of the vaccine + hitting a blood vessel.
1439 Patient states that she was looking at her phone and noticed an increased heart rate. Patient states that she could hear her heartbeat in her ears. Patient assessed. VItals BP 115/70, P 103, O2 97%, R 18. Alert and oriented x 4. Will monitor for 30 minutes. 1509 Vitals BP 115/68, P 97, O2 98%, R 16, alert and oriented x 4. Patient states that symptoms subsided. Patient discharged.
Prior to shot child had some congestion, but normal temperature.  Shot received at 9AM.  Fever first noticed at 2PM (approx. 101-102 degrees).  Treated with baby Motrin.  Approximatetly 6:30 to 7:00 PM fever spiked to 103.8 degrees accompanied by labored breathing/shortness of breath.  Treated with a second dose of Motrin.  After calling the on call doctor, we proceeded to the emergency room at Fairfax Inova hospital around 8 PM and were at the hostpital until approximately 10:30 PM.  At that time the fever lowered.  We were released and the fever continued for the following 48 hours with temperatures reaching approximately 102 degrees and continued treatment with Tylenol and Motrin.
Pain and rash starting on lower left jaw eventually moving across face and scalp to right side. Pain was 6-10 and increased with movement. Initially diagnosed with Shingles. Treatment offer no relief. Second appointment two days later was diagnosed with "allergic reaction" Rx was steroids and topical cream. Continues to have pain and numbness in left arm, face and scalp, but at a lower level. Ear pain persists at low level only on left side. Increased herpes outbreaks since vaccination. Prior to shot maybe once a year and after shot increased to weekly for a few months then has subsided to once a month or so.  After 7 months adverse effects are continuing.
Having mild diarrhea, gas and cramping, also occasional lightheadedness. Symptoms began Tuesday 4/6, the day after taking vaccine and have continued.
fever 102-104, inc sleepiness, fussiness since receiving vax; rash on 18JUL94-roseola dx
Left thigh-Adverse skin reaction occured 06/03/2003.  On 06/04/2003, rash to thigh 13 cm x 15 cm with erythematous, slightly raised rash.
Received booster (3rd dose) on November 23rd.  Shortly after (4-5 weeks / around Jan 4th) I began to experience Tinnitus.  Scheduled an appointment with audiologist on February 24, 2022 to discuss and confirm Tinnitus.
her arm was sore; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 01Mar2021 as single dose for covid-19 immunization. Medical history included having cancer twice and concomitant medications were not reported. Patient stated that her first dose was no problem at all, and her arm was sore for a couple of days, and that's it. Patient had an issue when she went to the  for second vaccine. She went to a  for her second dose and states that the nurse who was administering vaccines was very busy and distracted, the patient does not remember being stuck, but that the nurse just put a bandaid on her arm. No other bystanders were able to confirm administration of the vaccine, either. Patient does not believe she received her 2nd dose of Pfizer-Biontech Covid19 vaccine on 01Mar2021. She was asking if there was a clinical trial to evaluate a booster dose. The outcome for the event was unknown.   Information on the lot/ batch number has been requested.
pain in both arm; headache; Information has been received from a healthcare professional via Food and Drug Administration (agency # 847291-1) on 22-OCT-2020 referring to an 18 years old female patient, who was not pregnant. The patient had no prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination. Allergies to medications, food, or other products were unknown. The patient had none other illnesses at the time of vaccination and up to one month prior and no chronic or longstanding health conditions. The patient had no adverse event following any previous vaccine.  On 11-NOV-2019 at 8:00 am, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose 2, lot number 1314898 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast); dose was not reported) via intramuscular in the left arm for prophylaxis. Other suspect therapies included meningococcal b rfhbp rnada rnhba omv vaccine (e.coli) (BEXSERO) (lot# GSKABXA14AB, dose # 1) via intramuscular in the right arm for prophylaxis, influenza virus split virion 4v vaccine inactivated (FLUARIX QUADRIVALENT) (lot# GSK3GG33, dose # 1) via intramuscular in the right arm for prophylaxis and hepatitis a virus vaccine inactivated (HAVRIX) (lot# GSKBESS4, dose # 1) via intramuscular in the left arm for prophylaxis.      On 12-NOV-2019 at 9:00 am, the day after receiving vaccines, the patient came to the school health suite complaining of pain in both arms. School nurse administered 650mg acetaminophen. The patient returned after 2 hours saying that acetaminophen did not help arm pain and was now complaining of headache. The patient dismissed from school early. The patient returned to school the following day (2days after receiving vaccines). Result or outcome of adverse event was reported as none. None medical tests and laboratory results related to the adverse event(s) were performed. Outcome of the events was recovered.  The causal relationship between suspect products and the events was not reported.  Follow up information was received from the Nurse Practitioner, on 17-MAR-2021. The lot # for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, was 1614898 (expiration date not reported, but upon internal validation established as 15-NOV-2021).  Patient's demographics were updated. Additional information has been requested.
patch of red; rash; one red raised hive; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (patch of red), RASH (rash) and URTICARIA (one red raised hive) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (patch of red), RASH (rash) and URTICARIA (one red raised hive). At the time of the report, RASH ERYTHEMATOUS (patch of red), RASH (rash) and URTICARIA (one red raised hive) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reports "not taking or putting anything on the affected area "to relieve symptoms "and will contact doctor if it gets worse". No concomitant medication reported. Upon internal review on 04-Aug-2021, age units was updated to years.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: NNI
Four hours after receiving the flu vaccine I started experiencing overall body weakness, severe dizziness/vertigo, nausea, vomiting, headache, motion sickness, and light sensitivity. Following the instructions on the vaccine paperwork, we went straight to the ER.
Initial - typical sore arm, redness at injection site.  DELAYED reaction 8 days after injection - itchiness, red circle (2.5"-3" diameter)  around injection site, some swelling, warm to touch, upper arm feels "heavy".
AFib; Fast heart beating; Rash; Dizziness; Weakness; Shortness of breath; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Apr2021, for COVID-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 2021, outcome "unknown", described as "AFib"; HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "Fast heart beating"; RASH (non-serious) with onset 2021, outcome "unknown", described as "Rash"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Dizziness"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Weakness"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "Shortness of breath". The reporter stated that he just wanted to know his wife had the first and second Pfizer vaccines and she had the very bad problems with some risks. The patient experienced afib, fast heart beating, rash, dizziness and weakness and shortness of breath. She had the first vaccine in Apr2021 and then she had the second shot in Apr2021 and then she started having the effects after that. Now, it's the time to get the booster and he was wondering if they would recommend her getting the booster or just skipping it because she had the bad effects with the second shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
acute, mild pancreatitis, associated with symptoms associated with Nausea and vomiting and abdominal pain.  Patient's symptoms started 1 day after her vaccination.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Low thyroid" (unspecified if ongoing), notes: Other medical history: Low thyroid. Concomitant medication(s) included: BUPROPION, start date: 01Dec2020, stop date: 14Jul2022; LEVOTHYROXINE, start date: 01May2006, stop date: 14Jul2022; ESTRADIOL, start date: 01Mar2014, stop date: 14Jul2022; PROGESTERONE, start date: 01Mar2014, stop date: 14Jul2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course included: The patient had no known drug allergies. Other medication in 2 weeks included Bupropion, Levothyroxine, Estradiol & Progesterone. The patient received COVID 19 Treatment drug (lot number-1916517A) from 12Jul2022 to 14Jul2022 for treatment of COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a physician concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with 0.5 milliliter (ml) of PNEUMOVAX 23 (lot number and expiry date unspecified), intramuscularly. No concomitant medications were reported. On an unknown date, the patient experienced hives. The patient did not specify if it was life threatening or if any emergency measures were used. The patient sought an unspecified medical attention. An unspecified treatment was given to the patient. It was unspecified if any lab tests were performed. The outcome of hives was unknown. The relatedness for hives was unknown for PNEUMOVAX 23. This is one of the two reports from the same source. Additional information is not expected.
On March 22nd I had a high fever, and I was really achy. On the 23rd I had the same thing, but my lower back started hurting a lot. On the 24th my back was so painful that I went to the Hospital. They said my appendix had became enlarged so they performed an appendectomy.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB injection, lot # M034188 with expiry date 20-MAY-2019, lot # M034189 with expiry date 23-MAY-2019 and lot # M036612 with expiry date 19-MAY-2019 (dose, route of administration and anatomical location were not specified) for prophylaxis. Administered doses of LIQUID PEDVAXHIB underwent a temperature excursion at 31 Fahrenheit degrees or colder (25 Fahrenheit degrees) for 29 hours. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
MOTHER CALLED AND STATED THAT CHILD'S LEFT UPPER THIGH WAS RED AND SWOLLEN. STARTED ON 06/20/2006 APPROX AT 8:15PM.  MOTHER DENIED OTHER SYMPTOMS. STATES,"CHILD ACTING NORMAL."  MOTHER DID GIVE CHILD 1/2TSP. CHILDREN'S BENEDRYL AND APPLIED ICE TO SITE.
1st dose on Jun2021, 2nd on 05Oct2022; This case was reported by a pharmacist via sales rep and described the occurrence of drug dose administration interval too long in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose was received on June 2021).   On 5th October 2022, the patient received the 2nd dose of Shingrix. On 5th October 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 06-OCT-2022 Reporter's comment: The pharmacist asked if there was any information over 12 months. The pharmacist reported that the patient had received a late dose of Shingrix. The first dose was received on June 2021 and the second dose administered on 05th May 2022. The reporter had consented to follow-up. Additional supportive information: The patient received the second dose later than the recommended interval, which led to lengthening of vaccination schedule.
Pain in finger joints when waking up in the morning. My wife got the vaccine the same day and we both developed the same finger joint pain
SkinRash Narrative: Employee reported generalized facial rash noted on 12/24/20, 2 days post vaccine denies itching, swelling or pain and totally resolved by 12/26/20.
This spontaneous case was reported by a consumer and describes the occurrence of MYASTHENIA GRAVIS (Generalized myasthenia gravis exacerbated after the 2nd and 3rd shot of the vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036821A and 014M20A) for COVID-19 vaccination. The patient's past medical history included Ocular myasthenia (Prior getting Moderna COVID-19 vaccine, just about finishing treatment for Ocular Myasthenia). On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MYASTHENIA GRAVIS (Generalized myasthenia gravis exacerbated after the 2nd and 3rd shot of the vaccine) (seriousness criteria hospitalization and medically significant). At the time of the report, MYASTHENIA GRAVIS (Generalized myasthenia gravis exacerbated after the 2nd and 3rd shot of the vaccine) had not resolved. Concomitant medications were not reported. The patient had got monthly infusion treatment of IVIG. It was reported that generalized myasthenia gravis was then exacerbated after the 2nd and 3rd shot of the vaccine. The patient's doctor said they didn't had an idea if her symptoms were related to the vaccine. Patient's online reading suggested it might be due to the mRNA. The patient symptoms had worsened. Patient had not ever tested COVID positive test or had COVID-19 diagnosis. No other vaccination were given within 1 month prior to Moderna COVID-19 vaccine. Company Comment: This is a Spontaneous case concerning a 74-year-old female patient, with medical history of ocular myasthenia, who experienced the unexpected, serious (hospitalization and medically significant), and AESI of Myasthenia gravis. The event started approximately 3 weeks after the first dose of mRNA-1273 vaccine, and was exacerbated after second and third dose. She gets monthly infusion of immunoglobulin IV. Medical history of ocular myasthenia remains confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-529107, MOD-2022-529243 (Patient Link). Sender's Comments: This is a Spontaneous case concerning a 74-year-old female patient, with medical history of ocular myasthenia, who experienced the unexpected, serious (hospitalization and medically significant), and AESI of Myasthenia gravis. The event started approximately 3 weeks after the first dose of mRNA-1273 vaccine, and was exacerbated after second and third dose. She gets monthly infusion of immunoglobulin IV. Medical history of ocular myasthenia remains confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Moderate pain in upper left arm at injection site Feeling of fatigue in the left arm Moderate pain in upper right arm Numbness in left forearm and hand