chrisvoncsefalvay/vaers-outcomes huggingface dataset:
right side sore throat on 02Feb2021 for 2 days and still slightly painful; Feeling unwell; I had the flu for 2 days on 28Jan2021; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL1283) via an unspecified route of administration in the let arm on 25Jan2021 13:00 (at the age of 76-year-old) , single for COVID-19 immunisation. The patient relevant medical history included mitral valve prolapse, Allergies to medications, food, or other products: Codeine, Dexamethasone, Keflet, Paxil, Sulfa Class, Tetracycline. Concomitant medications included propranolol hydrochloride (INDERAL); estrogens conjugated (PREMARIN); lisinopril (LISINOPRIL); digoxin (DIGOXIN) all were taken for an unspecified indication, start and stop date were not reported. Feeling unwell like I had the flu for 2 days on 28Jan2021 12:00 AM and right side sore throat on 02Feb2021 for 2 days and still slightly painful. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and Since the vaccination, patient not been tested for COVID-19. Outcome of the event right side sore throat on 02Feb2021 for 2 days and still slightly painful was recovering and Outcome of the other events was recovered on unspecified date in 2021.
Vaccine was stored after the date of expiry; Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored after the date of expiry) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored after the date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored after the date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported  Vaccine was placed in refrigerator on 22-sep-2021  Vaccine had not undergone any temperature excursion No Adverse events were reported
Swelling and redness at injection site and swelling of left arm to wrist along with low grade headache and fatigue for 2-3 days
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication given to paitent.
Delayed chronic urticaria that required short term taper prednisone and multiple daily doses of antihistamines for relief. The hives are intensely itchy and become inflamed/dermatographic in nature when scratched. The onset was ~11 days after the booster and is still occurring about 2.5 weeks later.
A cold 10 days after receiving the booster dose and developed nosebleeds along with cough and runny nose; A cold 10 days after receiving the booster dose and developed nosebleeds along with cough and runny nose; A cold 10 days after receiving the booster dose and developed nosebleeds along with cough and runny nose; A cold 10 days after receiving the booster dose and developed nosebleeds along with cough and runny nose; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (A cold 10 days after receiving the booster dose and developed nosebleeds along with cough and runny nose), EPISTAXIS (A cold 10 days after receiving the booster dose and developed nosebleeds along with cough and runny nose), COUGH (A cold 10 days after receiving the booster dose and developed nosebleeds along with cough and runny nose) and RHINORRHOEA (A cold 10 days after receiving the booster dose and developed nosebleeds along with cough and runny nose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), ATORVASTATIN, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), AMLODIPINE, QUINAPRIL, SERTRALINE and ALPRAZOLAM for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 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 NASOPHARYNGITIS (A cold 10 days after receiving the booster dose and developed nosebleeds along with cough and runny nose), EPISTAXIS (A cold 10 days after receiving the booster dose and developed nosebleeds along with cough and runny nose), COUGH (A cold 10 days after receiving the booster dose and developed nosebleeds along with cough and runny nose) and RHINORRHOEA (A cold 10 days after receiving the booster dose and developed nosebleeds along with cough and runny nose). The patient was treated with GUAIFENESIN (MUCINEX) for Adverse event, at a dose of 1 dosage form. At the time of the report, NASOPHARYNGITIS (A cold 10 days after receiving the booster dose and developed nosebleeds along with cough and runny nose), EPISTAXIS (A cold 10 days after receiving the booster dose and developed nosebleeds along with cough and runny nose), COUGH (A cold 10 days after receiving the booster dose and developed nosebleeds along with cough and runny nose) and RHINORRHOEA (A cold 10 days after receiving the booster dose and developed nosebleeds along with cough and runny nose) had not resolved.            No medical history was provided by the reporter The patient experienced a cold 10 days after receiving the booster dose and developed nosebleeds along with cough and runny nose. Patient stated symptoms are ongoing, the cold has continued on for more than 6 weeks.
Myasthenia Gravis symptoms developed and Dx confirmed; debilitating fatigue; joint pain; headache; chest pain; gastro distress; second vaccination received at 6 months following first shot; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 29Sep2021 as dose 2, single (Lot number: ER8732) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "MCAS" (unspecified if ongoing); "ME/CFS" (unspecified if ongoing); "ME/CFS" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). No Covid prior vaccination. No known allergies. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 1, lot number: 301 358A, vaccine location: Left leg), administration date: 24Mar2021, when the patient was 59-year-old, for COVID-19 Immunization. No other vaccine in four weeks. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 29Sep2021, outcome "unknown", described as "second vaccination received at 6 months following first shot"; MYASTHENIA GRAVIS (disability, medically significant) with onset 13Oct2021, outcome "not recovered", described as "Myasthenia Gravis symptoms developed and Dx confirmed"; CHEST PAIN (disability) with onset 13Oct2021, outcome "not recovered"; FATIGUE (disability) with onset 13Oct2021, outcome "not recovered", described as "debilitating fatigue"; ABDOMINAL DISCOMFORT (disability) with onset 13Oct2021, outcome "not recovered", described as "gastro distress"; HEADACHE (disability) with onset 13Oct2021, outcome "not recovered"; ARTHRALGIA (disability) with onset 13Oct2021, outcome "not recovered", described as "joint pain". Myasthenia Gravis symptoms developed and Dx confirmed following the second vaccination received at 6 months following first shot which caused 6 weeks (as reported) of debilitating fatigue, joint pain, headache, chest pain, gastro distress. The events "myasthenia gravis symptoms developed and dx confirmed", "debilitating fatigue", "joint pain", "headache", "chest pain" and "gastro distress" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test (Covid tested post vaccination): Negative, notes: Nasal swab; Negative, notes: Nasal swab; Negative, notes: Nasal swab. Therapeutic measures were taken as a result of myasthenia gravis.  No follow-up attempts are possible. No further information is expected.
heat and pain at injection site, nausea, cramps, fatigue, mood swings, severe menstrual changes
Shingles outbreak began 12/1/2021; diagnosed 12/7/2021. Prescribed doxycycline hyclate 100mg and valacyclovir HCL 1 gram.
I felt okay until about 9pm last night when I started experiencing an intense headache, then I got chills, then feverish feeling and really hot, then nauseous and couldn?t handle eating. I put an ice pack on my head because it feels swollen and there?s a lot of pressure that it?s painful. This morning I tried to eat crackers so I could take ibuprofen but I threw up immediately. I?m currently still experiencing a lot of head pain/ache and nausea and muscle tightness.
Acted fine at first, I was never told of a fever or anything. I (mother) was about to lay her down for a nap as I thought she was asleep. I look down and she was shaking and looking up into the left corner of her eye, I called her name a few times and she was not making contact. I yelled for my mother to come help, she picked her up as I called 911, she was still seizing until about a minute before paramedics arrived. They immediately said she felt warm. Total seize time was about 2 minutes.
Previous healthy pregnancy with healthy live childbirth Jan 22nd, 2019.  Healthy pregnancy, no complications, due May 23rd, 2021. 38 week check-up with OB on Mon May 10th, 2021 - normal, healthy, heard heartbeat ER visit on Wed May 12th, 2021 due to reduced fetal movement detected and ER OB confirmed no fetal heartbeat Stillborn baby girl delivered via induction on Fri May 14th, 2021 Autopsy and Genetic Testing performed and revealed no known cause for fetal demise
This case was reported by a pharmacist and described the occurrence of injection site pain in a 62-year-old male patient who received SHINGRIX. Previously administered products included SHINGRIX (refer case: US2018GSK085941). In March 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, tiredness, headache and energy decreased. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the tiredness, headache and energy decreased were recovered/resolved. It was unknown if the reporter considered the injection site pain, tiredness, headache and energy decreased to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient experienced worst constitutional symptoms than with first dose. The patient experienced tiredness, headache and low energy lasting about 2 days. The reporter agreed to receive follow up from GlaxoSmithKline. This case has been linked with the case US2018GSK061148 and US2018GSK085969 and US2018GSK085941 reported by the same reporter.
Information has been received from a physician concerning a 12 year old female, with no medical history and no allergies, who, "10 years ago", in approximately 1996, was vaccinated with a dose of Varivax. On 17-AUG-2006 the patient developed shingles on her right arm. The rash presented as hundreds of vesicular lesions following a dermatomal distribution. The patient also reported pain. The patient was treated with VALTREX, 1000mg, TID, for 7 days. At the time of the report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
first dose of Twinrix in March 2020 and then a second dose in 5-22-2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 49-year-old female patient who received HAB (Twinrix) (batch number 2PG39, expiry date 19-SEP-2025) for prophylaxis.   Previously administered products included Twinrix (received 1st dose in March 2020).   On 22-MAY-2023, the patient received the 2nd dose of Twinrix. On 22-MAY-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: first dose of Twinrix in March 2020 and then a second dose in 5-22-2023). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:15-AUG-2023 The reporter consented to follow up via email agreed. The Vaccine Administration Facility was the same as Primary Reporter. The patient received 2nd dose of Twrinrix later than the recommended schedule , which led to lengthening of vaccination schedule.
Fever; temperature of 100.4/temperature was 104; Headache; Cold; Chills; acting very weird; Nightmares; This is a spontaneous report from a contactable consumer. This consumer reported for a 12-year-old male patient (reporter's son). A 12-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EW0173) via an unspecified route of administration on 07Aug2021 13:00 as dose 2, single (age at Vaccination: 12 years) for COVID-19 immunisation. Medical history included asthma, hypertension, ADHD, all from an unknown date and unknown if ongoing. Concomitant medications included guanfacine hydrochloride (INTUNIV) taken for hypertension, start and stop date were not reported; lisdexamfetamine mesilate (VYVANSE) taken for attention deficit hyperactivity disorder, start and stop date were not reported; albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for asthma, start and stop date were not reported. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The reporter stated, I am calling on behalf of my son (consumer), he received his second shot at 1 o'clock in the afternoon. On 07Aug2021, the patient experienced acting very weird he had a temperature of 100.4 and he was complaining of headache, cold, chills and like nightmares. When queried for consumers height and weight reporter stated, he is about 3 something, dont know. He had got high fever, I just want to know what is going on with him. All I want to know that if he was sick, I mean the temperature was 100, I want to speak to a Doctor what is going on and what do I need to do, do I need to bring him in. Treatment received was Tylenol as his temperature was 104. The patient underwent lab tests and procedures which included body temperature resulted as 100.4/100/104 on 07Aug2021. The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
On day 3, rash on feet/ankles. On day 4 spread to legs. On day 8, rash spread to upper legs/buttocks. Biopsy of legs of 1/20/12 revealed vasculitis. Pt also experiencing arthritic joints, swollen hands, swollen feet, and abdominal pain. Spoke w/pt today (1/24/12) rash resolving slowly.
The patient presented to the ER that evening after receiving the 4-month-old vaccines, "spasming," per ER notes. ER physician reported that parents stated patient's "right arm was stiff/extended with fist clenched and her neck was turned to the left, eyes open." "The episode lasted for an unknown period of time, but somewhere between 2-5 minutes." "The patient was back to baseline by the time she arrived in the ER." Patient developed a seizure in the ER that was witnessed by the ER providers, and patient was given 2 doses of IM VERSED, which eventually stopped the seizure. The infant had a fever in the ER. T-max of 101.2F. Work up was done, which included blood culture, UA, urine culture, CBC, CMP, KUB, and head CT. No abnormalities were found. Patient was admitted to the PICU. No more seizures overnight. Temperature went down and fever did not return. Patient was back to neurological baseline. Neurology was consulted, and it was suspected vaccine-related and has a referral to neurology. Patient was discharged next day.
Diffuse rash on chest treated with diphenhydramine 50mg po and hydrocortisone cream 1% topically. Resolved by 05/22/2017 AM.
My arm started to hurt in the evening, nothing major. The big problem was that I PASSED OUT a few minutes after I got up the next day, so 03/19/21. I was in the bathroom washing my hands at the sink, and then I woke up on the bathroom floor. I don't know how long I was out, but I felt like it was not very long.  PLEASE NOTE, this happened to me again after the Booster shot I had on 10/01/21. I don't know if I can make a second report about that date, so I add it here. My side effects were much worse after the Booster. More pain, fever, chills, shaking, teeth chattering so hard that one tooth was loosened. I could not get to sleep for hours, so I got up later the next day, but again, I PASSED OUT a couple of minutes after I got up the next day. I had been on the landline phone when I passed out, so it was the noise that the phone makes when it isn't hung up that woke me from my faint.
Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Facial nerve affected and continued to Bell's palsy. Evicting the right side of my face. Including but not limited to the inability to close my right eye properly suck on his straw. Swallow speech and overall balance.
Hematoma at injection site per patient she put topical Benadryl on it. Blister rash developed on forehead pt also applied topical Benadryl. Pt reported incident to me on 10/31/07. Both are resolving.
Information has been received from a health professional concerning a 16 month old white male, with a history of eczema and no known drug allergies, who on 01-SEP-2006 was vaccinated with a first dose of Varicella (Lot# 653434/0563F). Concomitant vaccination, administered on the same day, included a first dose of Hib conj vaccine (Lot# 652867/0084F). There was no illness at the time of vaccination. "A few days after the vaccination", on approximately 03-SEP-2006, the patient developed 8 clear to yellow blisters on his face and trunk. It was reported that the patient also experienced a low-grade fever for a few days. At the time of the report the patient was recovering. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information from a health professional indicated that on 12-SEP-2006 the patient developed 20-30 vesicles on his face legs and trunk. It was noted that TYLENOL and calamine was to be given. Subsequently the patient recovered. Additional information is not expected.
I had 3 ocular migraine instances with 20 hours starting the day after the injection. I had 3 migraine headaches within the first week following the injection. I had flu-type symptoms for one week starting the day after the injection and malaise for a week following that.
103 temp for the first 30 hours. Dry heaving for 1 hour (12 hours after shot). 0 energy; stayed in bed first 48 hours. Don't remember much about past 2 days. Injection site sore.
About 5 minutes after vaccine patient complains of weakness in arms and legs that progressed to tingling in arms, chest and a little around the mouth.  Took Patients vitals, Pulse ox, breathing and heart rate were normal, blood pressure elevated. Put patient in treatment area to see Nurse Practitioner. Given 1 dose of diphenhydramine 25mg capsule. Tingling and weakness started to leave and was gone after about 20 minutes.  Blood pressure also returned to normal range. Patient was observed  about 20 more minutes and was fine. Was given diphenhydramine to take with her and sent home.
Local pain at injection site then extending up L arm across back, into R arm, pain up and down spine, headache. Subjective fever. Onset of pain 3 degrees after injection lasting 36 hours then resolved. Ibuprofen for diffuse muscle ache/pain. No erythema, swelling. Not seen during ncn.
SHARP ELECTRICAL TYPE PAIN IN HEART / AREA. SPLIT SECOND PAIN THAT CAME ON  INTERMITENT LASTING UP TO 20 MINUTES. HEART DID STOP BEATING ONCE WHILE SHARP PAIN CAME ON SPLIT SECOND THEN STARTED. BLOOD PRESSURE WAS ELEVATED TO 180 OVER 60 FOR EVENING ON 9/12/21. SYMPTOMS STOPPED 926/21
Pt received ZOSTAVAX on 9/14/12. Pt presented to pharmacy on 9/16/12 with soreness in left arm. Upon exam, arm was red and tender in a lateral line across bicep muscle.
pt had vax 15FEB & on 17FEB called arm sore, red swollen started 16FEb;
1st dose, a little pain in left arm (injection arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (1st dose, a little pain in left arm (injection arm)) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure high (High blood pressure) and Candida infection. Concomitant products included LISINOPRIL for Blood pressure high, METFORMIN for Diabetes.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (1st dose, a little pain in left arm (injection arm)). On 10-Mar-2021, VACCINATION SITE PAIN (1st dose, a little pain in left arm (injection arm)) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment was not given to the patient. Patient started taking a naturopathic pills for candida around the same time as the booster, but she stop medication.   This case was linked to MOD-2022-456404, MOD-2022-456407 (Patient Link).