chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Nausea; Clementine size lymph node under left armpit; Sore forearm muscle; Left elbow joint pain; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Mar2021(at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) from unknown date and for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021 at 21:00, the patient experienced fever, nausea with throwing up, clementine size lymph node under left armpit, sore forearm muscle ongoing for more than a month. Left elbow joint pain, recently pulsated throughout the night for 12 hours. Lymph node swelling went away within 48 hours, but left arm muscle weakness/soreness and left elbow joint pain continues into a month after shot. The patient had underwent Nasal Swab test on an unknown date and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of these adverse events. The clinical outcome of the events fever, nausea were recovered with sequelae on an unknown date in Mar2021 while that of the events clementine size lymph node under left armpit was recovered with sequelae on 18Mar2021, after the duration of 2 days, and the events muscle weakness/soreness and left elbow joint pain was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
sz w/in 24 hrs lasting few minutes, parents brought pt to ER; did not require any tx x/noted to have OM send home on Ceclor;
Flu symptoms occurred - aching body, low fever, light congestion, headache, sore throat
26AUg 2AM felt feverish-no temp taken given motrin evening of 26AUG @ inj site of rt arm, red lump w/little bumps approx 2" across;27AUG 340PM now has felt like appearance from inj site up shoulder & covering shoulder blade area;
I had an episode March and 3 weeks ago. I would be sitting down and my heart beat would race very fast. My heart would race to about 100 BPM. I have to wear heart monitor for 28 days.
Patient stated that after she got her vaccine she felt sick, then her arm started hurting pretty bad. Then, she started having sharp shooting pain from the left side of her shoulder down to her toes. When patient visited doctor she was told that it might be some inflammation, and that it would be fine in a couple days. But after a couple days, the pains started to get more aggressive. She was told by doctor that she may have Sciatica.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 19th August 2018, the patient received the 1st dose of SHINGRIX. On 19th August 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient reported that, it hurt at the injection site as she was getting the SHINGRIX vaccine, which went away almost immediately and before she left the pharmacy. The reporter consented to follow up.
Severe Nausea in stomach and abdomen for 12-18 hours.  This occured approximately 36-48 hours after injection.
terrible joint aches; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (terrible joint aches) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A, 023M20A and 045H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-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 ARTHRALGIA (terrible joint aches). At the time of the report, ARTHRALGIA (terrible joint aches) outcome was unknown.            No concomitant medication reported. No treatment medication details reported.   This case was linked to MOD-2022-554854, MOD-2022-554862, MOD-2022-554864 (Patient Link).
I woke up in the middle of the night with very loud ringing in both ears the night that I got the booster shot.  I have never had ringing in my ears before.  I continue to have ringing in my ears months later that interfere with ability to sleep and concentrate at work.  The ringing is constant but at time it bursts to very loud noise.
Local reaction - left deltoid was swollen, red, itchy and warm to the touch. No other symptoms.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse) from Regulatory Authority.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose number unknown, single (Lot number: FJ4991) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "Emphysema" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Flovent diskus, reaction(s): "Reaction: Allergy", notes: known allergies: Flovent Diskus. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) Positive, notes: Tested positive on 17May2022; (24May2022) Positive, notes: Retested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course- The patient previously receive COVID-19 Vaccine. There was list of other medications the patient received within 2 weeks of vaccination  No follow-up attempts are possible. No further information is expected.
worsening left arm pain Narrative: Reports that she had no pain for the first two hours after the injection. She then gradually developed pain in the left arm which worsened over time. She was evaluated in the employee health clinic on 9/3/21.
The patient received a dose from a vial more than 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided. HCP confirmed number of patients.   This case was linked to MOD-2021-368725 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Significant Follow up- HCP confirmed number of patients
Pregnant; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 30-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Idiopathic urticaria, Bell's palsy in October 2016, Subfertility, Anxiety and Alcohol use on 15-Aug-2020. Previously administered products included for an unreported indication: LETROZOLE from 2016 to 2018. Concurrent medical conditions included Sulfonamide allergy. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Prenatal care, PROBIOTICS NOS for Probiotic therapy, VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for Vitamin supplementation.    On 07-Jan-2021 at 4:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Jul-2020 and the estimated date of delivery was 24-May-2021. On 07-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy.  On 07-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Ultrasound foetal: abnormal (abnormal) concern regarding femur length. On an unknown date, Ultrasound foetal: abnormal (abnormal) At 20 weeks (concern regarding femur length) and normal (normal) At 8 weeks: everything was fine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. 17-Mar-2018: Patient had Miscarriage 02-Jul-2019: Patient had live-full time birth, infant's cord was wrapped around the neck and heart rate was dropping; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
a new finding of lymphadenopathy under left arm; This case was reported by a nurse via call center representative and described the occurrence of lymphadenopathy in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2022, the patient received the 2nd dose of Shingrix. On 3rd November 2022, 1 days after receiving Shingrix, the patient experienced lymphadenopathy. On an unknown date, the outcome of the lymphadenopathy was not recovered/not resolved.   It was unknown if the reporter considered the lymphadenopathy to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-NOV-2022 Reporter's Comment: The nurse practitioner reported that the patient received second dose of Shingrix into left arm and the patient underwent her routine high risk breast Magnetic resonance imaging screening and MRI report showed a new finding of lymphadenopathy under left arm. The patient did not have a history of cancer, but was high risk and therefore had the screening MRIs routinely.  The reporter did not have the vaccine lot number or expiration date information.  The reporter consented to follow up by phone.
Site of injection on R arm red, warm, sore, large blisters at injection spot. Cellulitis. Tx with LEVAQUIN and VALTREX.
first dose is over 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose is over 42 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose is over 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose is over 42 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received contains non new information.
Sore arm and shoulder - lifting and pressure were painful for about 36 hours Lack of appetite - lasting 36-48 hours Severe lower back pain, beginning 12 hours following shot, currently experiencing Low grade fever - resulting in fits of overactive sweating - 24 hours post shot Swollen arm pit resulting in severe pain in injection arm - iced and took acetaminophen- relieved superficial pain, but still very sore.
very warm; it became very sensitive; I had a fever for 2 days; my arm swelled up/it was the size of a golf ball; it was very red; it was painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (very warm), VACCINATION SITE HYPERAESTHESIA (it became very sensitive), PYREXIA (I had a fever for 2 days), VACCINATION SITE SWELLING (my arm swelled up/it was the size of a golf ball) and VACCINATION SITE ERYTHEMA (it was very red) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A, 013M20A and 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Renal disease and Heart disease, unspecified. Concomitant products included ATENOLOL, FELODIPINE, ESCITALOPRAM OXALATE (LEXAPRO), FISH OIL and DOXAZOSIN for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced VACCINATION SITE WARMTH (very warm), VACCINATION SITE HYPERAESTHESIA (it became very sensitive), PYREXIA (I had a fever for 2 days), VACCINATION SITE SWELLING (my arm swelled up/it was the size of a golf ball), VACCINATION SITE ERYTHEMA (it was very red) and VACCINATION SITE PAIN (it was painful). On 13-Sep-2021, PYREXIA (I had a fever for 2 days) had resolved. On 18-Sep-2021, VACCINATION SITE WARMTH (very warm), VACCINATION SITE HYPERAESTHESIA (it became very sensitive), VACCINATION SITE SWELLING (my arm swelled up/it was the size of a golf ball), VACCINATION SITE ERYTHEMA (it was very red) and VACCINATION SITE PAIN (it was painful) had resolved.            The treatment medication was unknown.
Immediately after receiving vaccine, while waiting in observation area, patient started to feel "weak in the knees" and "tingling" in legs. patient admits history of dizziness in the past with blood draws. No prior history of allergies. No history of COVID, Last meal/snack/drink 24 hours prior. Patient was advised to lay supine- also given snacks/water. Symptoms resolved with rest. BP 133/75, Pulse 66.
This spontaneous report was received from an office manager via a company representative and refers to a 56-year-old female patient. No information concerning patient's concomitant medication, pertinent medical history, drug reactions or allergies was provided. On 15-FEB-2017, the patient was vaccinated with first single dose of ZOSTAVAX, subcutaneous injection (dose, lot number and expiration date were not provided), for prophylaxis. The order was for PNEUMOVAX23 (dose, lot number and expiration date were not reported) and ZOSTAVAX to be given in a 30 day window, but instead, on 22-MAR-2017, the medical assistant gave the patient the second dose of ZOSTAVAX. No adverse effects were reported. Additional information has been requested.
Tired; Sweating; Vomiting; Can't open your eye; Excruciating pain all over the body; Chills; This spontaneous case was reported by a non-health professional and describes the occurrence of VOMITING (Vomiting), ASTHENOPIA (Can't open your eye), PAIN (Excruciating pain all over the body), CHILLS (Chills) and FATIGUE (Tired) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025620A and 072A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. On 07-Feb-2021, the patient experienced VOMITING (Vomiting), ASTHENOPIA (Can't open your eye), PAIN (Excruciating pain all over the body), CHILLS (Chills) and HYPERHIDROSIS (Sweating). On an unknown date, the patient experienced FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form and HYDROCODONE for Adverse event, at a dose of UNK dosage form. At the time of the report, VOMITING (Vomiting), ASTHENOPIA (Can't open your eye), PAIN (Excruciating pain all over the body), CHILLS (Chills), FATIGUE (Tired) and HYPERHIDROSIS (Sweating) outcome was unknown.            No concomitant medications reported.
By the afternoon felt very dizzy and had nausea. Similar to prior year. Decided to go to sleep to not feel dizzy. Woke up in the morning fine.
No additional AE details; Nurse states that the vaccine was administered to patient during the excursion; This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.   On 08-DEC-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 milliliter (mL) orally for prophylaxis, lot number reported as 1684157 and expiration date as 26-JUN-2021 (formulation, strength and vaccination scheme were not provided).   The administered vaccine had a temperature excursion below 2 degrees Celsius (°C) (1.3°C) for a time frame of 24 minutes on an unspecified date, and the data was recorded by a digital data logger. It was also reported a previous temperature excursion below 2°C (1.6°C) for a time frame of 24 minutes. No additional adverse events were reported.  This is one of several reports received from the same reporter.
This spontaneous report as received from an other health professional refers to an unknown number of patients of an unknown age. On unknown dates in 2017 (reported as starting on or after 11-MAY-2017), the patients were vaccinated with GARDASIL 9 for prophylaxis. On unknown dates, the patients experienced incorrect product storage. No adverse effect was reported. The outcome of incorrect product storage was unknown. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1708USA011804: US-009507513-1708USA011803:
No Adverse event occurred, vaccine dose #2 given earlier than the 4 year old age recommendation. No concern or issue after vaccination.
covid vaccine breakthrough  dose 1 Moderna 3/24/21 047A21A dose 2 Moderna 4/21/21 040B21A
Hands are always tingling; Rash, pretty much every where except face and legs; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Hands are always tingling) and RASH (Rash, pretty much every where except face and legs) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE and IRBESARTAN for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced PARAESTHESIA (Hands are always tingling) and RASH (Rash, pretty much every where except face and legs). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Hands are always tingling) and RASH (Rash, pretty much every where except face and legs) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-043765 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-043765:Same patient, 1st dose
Reddened large round spots on back and on upper chest after vaccines approximately 7 minutes.
Information has been received from a physician concerning a 10 year old male, with no known medical history or allergies, who on 6/27/96 was vaccinated with a dose of varicella virus vaccine live (lot # 616998/1658B). There was no concomitant medication. On 9/27/04, the patient developed a mild case of chicken pox, including 25 scattered lesions. It was reported that he was afebrile. The patient was seen in the office on 9/30/04 and no treatment was required. There was no product quality complaint involved. Follow up information from the physician indicated that he had forgotten the details concerning this. No further information is available.
Patient had received his first dose of Gardasil and his second dose of Menactra approximately 6:40 PM, July 28, 2015.  He was sitting with his father at a table in the clinic.  All adolescents are requested to wait 15 minutes following immunizations for safety. At about 6:45 PM, I observed the pt. sitting in his chair and then falling from to the right onto the floor. I rushed to him and found him to be unconscious for a few seconds.  He was conscious again and seemed dazed, but said he was "fine".  Other nurses and I assisted him by applying a pillow under his head, a cold pack behind his neck and elevated his extremities.  His vital signs and neuro signs were monitored.  It is uncertain whether or not he bumped his head in the fall. He did not think he had. After approx. 10 minutes he was assisted to a sitting position and reported no dizziness.  Instructions were given to father for signs to watch for, to which he replied he was well versed in concussion care, as he is a local football coach.  Pt. left clinic in the company of his father.