chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9OCT95 given vax;19OCT95 onset of h/a, fever;next day onset of pruritis rash & sore throat & lymphadenopathy
The vial was initially stored in refrigerator on 23-Dec-2022 and was administered on 26-Jan-2023; No adverse event; pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 23-Dec-2022 and was administered on 26-Jan-2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 26-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 23-Dec-2022 and was administered on 26-Jan-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 23-Dec-2022 and was administered on 26-Jan-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 23-Dec-2022 and was administered on 26-Jan-2023).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported. It was reported that the bivalent 6m-5y vial of size 0.4 ml was not exposed to temperature excursion.  Treatment medications were not provided.  This case was reported for patient 26 out of 42.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:(Patient no- 26 out of 42 patients)
pneumonia; Breathing difficult; Cold; lost her voice; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medically reported history).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced DYSPNOEA (Breathing difficult), NASOPHARYNGITIS (Cold) and APHONIA (lost her voice). On 17-Mar-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 17-Mar-2021 to 20-Mar-2021 due to PNEUMONIA. At the time of the report, PNEUMONIA (pneumonia) was resolving and DYSPNOEA (Breathing difficult), NASOPHARYNGITIS (Cold) and APHONIA (lost her voice) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment: Nebulizer, Hydrocodone, Antibiotics. Prednisone No concomitant product use was reported  Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Patient initially described not feeling well. She reported Dizziness, nausea,and painful breathing, shortness of breath, rapid heartbeat, feeling hot with shivers. One cold hand and one warm hand. vertigo, heavy eyes, tongue numbness no rash. Patient was offered and received 50mg Diphenhydramine as an oral suspension. As symptoms got worse, an epipen was administered to right outside thigh. Patient was given alcohol pad to self-swab before administration and a band aid to put on after epipen administration. Patient's symptoms improved dramatically within a couple minutes. Patient was picked up by sister and driven to primary physician after symptoms had largely cleared up.
Headache, Nausea, fever, chills, tingling/numbness in her fingers and toes, Neuropathy hands, feet and pineal area.
Caller stated that she received her vaccine on 02/23/21 and an hour later her face became numb and became lightheaded. She went home and took 2 benadryl liquigels and her light headedness went away, but was still feeling the numbness in her face. She denies fever, aches or chills. Patient advised to monitor and calll PCP if symptoms don't get better or call for help if experiencing SOB.
swollen lymph node on the left side of her neck (the size as that of a baseball); swelling and pain at the injection site; swelling and pain at the injection site; muscle aches; fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th May 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th May 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling, muscle pain and fatigue. On 15th May 2021, the patient experienced lymphadenopathy. On an unknown date, the outcome of the injection site pain, injection site swelling, muscle pain and fatigue were recovering/resolving and the outcome of the lymphadenopathy was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, muscle pain, fatigue and lymphadenopathy to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient herself. The patient received the Shingrix and that evening, reported muscle aches and fatigue, as well as swelling and pain at the injection site. The next day of vaccination, the patient continued to experience fatigue and muscle aches and noted the swollen lymph node on the left side of her neck. The patient described the size as that of the baseball. Till the time of reporting, the events were improving, but not resolved. The lymph node swelling, however only reduced in size very small amount. The reporter did not consent to follow up.
terrible reaction to the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (terrible reaction to the vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (terrible reaction to the vaccine). At the time of the report, VACCINATION COMPLICATION (terrible reaction to the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.
It started with a headache and blur vision, Then My chest was getting tighter. My oxygen dropped to 90 and that it what scared me, I was really short of breath and the cough that I cannot shake. I also had headache that it wouldn't go away. Yesterday 01/13/2022 I went to see the Pulmonology and basically I had a covid test on Monday which that was negative, I was checked my throat my nose and everything is inflamed and I told her it started after the booster, She gave me an Albuterol inhaler antibiotics and steroid Prednisone. She said to take my medicine and I have an Appointment next month for a recheck, She also advised that if my nose wouldn't feel any better to contact my ENT. She held any labs and EKG.
Accelerated heart rate up to 120 from 2 hrs after injection, called on-call doctor who prescribed 0ne Benedryl. Heart rate dropped to high 90's-101 for 3 hours. Current Heart rate after 46 hours is 83. Normal for me is 64. Raging headache that currently continues after 46 hours. Weakness in legs continuing. Soreness at injection site continues.  Slept for 20 hours from Saturday at 9:30pm to Sunday at 5:30pm.
I have been nauseated since I took the shot and have been real tired and fatigue, on 9th my arm was just little bit sore but on the 10th till today I have been real fatigue and having nausea; I have been nauseated since I took the shot and have been real tired and fatigue, on 9th my arm was just little bit sore but on the 10th till today I have been real fatigue and having nausea; I have been nauseated since I took the shot and have been real tired and fatigue, on 9th my arm was just little bit sore but on the 10th till today I have been real fatigue and having nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), FATIGUE (non-serious), outcome "not recovered" and all described as "I have been nauseated since I took the shot and have been real tired and fatigue, on 9th my arm was just little bit sore but on the 10th till today I have been real fatigue and having nausea"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I have been nauseated since I took the shot and have been real tired and fatigue, on 9th my arm was just little bit sore but on the 10th till today I have been real fatigue and having nausea". Patient call the Primary Care Physician to make an appointment with him and they find and said  the people they gave the shot to patient. So, patient took the shot on job premises they were issuing the shot."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client received flu shot on 10/8/10 at approx 309PM. Later that evening she developed blotchy rash to (L) arm where shot was administered and traveling down to wrist area. By 10/9/10 client developed temp of 104degrees and rash spread across chest and throughout rest of her body. Developed chest tightness and SOB. While taking MOTRIN every 4 hrs temp decreased to 1010 and then would go back up to 104degrees. Started on BENADRYL and kept up with MOTRIN q 4 hours. Saw MD on 10/11/10. All temps and rash subsided by 10/12/10. Has had flu shots in past but had never received H1N1 before.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 28-SEP-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 22-OCT-2015, the patient was treated at a hospital for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Reddened rash around face, neck, on right arm. Stated she felt flushed. Having anxiety
Pt recvd 1st dose of Engerix-B & exp 3 day episode of flu-like synd w/jaundice & body aches; The exact date of event is unk, & there was no treatment;
Shortness of breath, extreme achiness, fever, chills.   Body aches started the night of 01/19/2021, fever and shortness of breath started the following morning on 01/20/2021 with body aches continuing.  Had to be seen by a ER physician on 01/20/2021.  Was given motrin and ice pack to put on right arm (sight of injection).  Body aches continued until early afternoon on 01/21/2021.  Last fever reported on 01/21/2021 at 4:18 am CST.
45min after injection had started with fever Nausea and vomiting, abdominal pain, tmax 104
Paroxysmal atrial fibrillation 4 hrs after vaccine administration. Symptoms: palpitations, dyspnea, throat tightness, fatigue
full dose instead of booster; feel a little bit out of it; have sore arm; fever; This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (full dose instead of booster), FEELING ABNORMAL (feel a little bit out of it), MYALGIA (have sore arm) and PYREXIA (fever) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Asthma and COPD. Concurrent medical conditions included Overweight.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (full dose instead of booster), FEELING ABNORMAL (feel a little bit out of it), MYALGIA (have sore arm) and PYREXIA (fever). At the time of the report, ACCIDENTAL OVERDOSE (full dose instead of booster) had resolved and FEELING ABNORMAL (feel a little bit out of it), MYALGIA (have sore arm) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No lab data was provided. has a history of asthma/ copd as well as pots   Most recent FOLLOW-UP information incorporated above includes: On 13-Nov-2021: Significant follow-up appended medical history   added asthma,COPD.
This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 28th August 2018, the patient received the 1st dose of SHINGRIX. On 29th August 2018, 1 days after receiving SHINGRIX, the patient experienced injection site warmth, injection site pain and sweating. On an unknown date, the outcome of the injection site warmth and sweating were recovered/resolved and the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the injection site warmth, injection site pain and sweating to be related to SHINGRIX. Additional details were provided as follows: The patient reported that a day after receiving SHINGRIX, she experienced skin being hot to touch around the injection site, sweating and extreme pain at injection site.
Sore arm, nausea,  with in an hour of vaccine. fever 100.6  started couple hours later  treated with Tylenol
localized swelling, redness & pain in lt deltoid, fever, malaise;tx Cefadroxil, ice, DPH, Ibuprofen;
localized rxn swelling-hard & red @ inj site-rt deltoid w/in 10min;
She is experiencing hives; chest tightness; clearing her throat a lot; This is a spontaneous report from a Pfizer Sponsored Program. A contactable female consumer (patient) received bnt162b (BNT162B2 , Formulation : Solution for injection, Batch/Lot number : Not reported) dose 1, Via an unspecified route of administration on 07Apr2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced  hives, chest tightness and clearing her throat a lot on Apr2021. She would like to know if she can take a benadryl for "non severe allergic reaction" or see a medical professional.  The outcome of the events were unknown.  No follow-up attempts are needed. No further information is expected.
past the expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (past the expiration date) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) 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) (Intramuscular) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (past the expiration date). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (past the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information provided by the reporter No treatment information provided by the reporter
A report has been received from a literature source concerning a patient of unknown age and gender, enrolled in an unsponsored/ non-interventional/post-marketing study. The study was conducted in 6 large integrated health care organizations participating in the Vaccine Safety Datalink (VSD). Trivalent LAIV safety was assessed in children who received LAIV between 01-Sep-2003 and 31-Mar-2013. Based on prior reports and biologic plausibility, 18 medically attended health outcomes were examined, including allergic, autoimmune, neurologic, respiratory, and infectious conditions. Using self-controlled case series analyses, incident rate ratios (IRRs) were calculated for each outcome.  During 2003-2013, 396173 children received 590018 doses of LAIV. For 124529 (21. 1%) of LAIV doses, other vaccines were administered on the same day. Five outcomes (anaphylaxis, non-anaphylactic allergic reactions, Stevens-Johnson syndrome (SJS), syncope, and respiratory failure) met criteria for manual medical record review. For the remaining 13 outcomes, there was no significant increase in risk after LAIV. After manual medical record review, most cases were excluded because diagnoses were ruled out or clearly attributable to other causes. One case of medical record-confirmed anaphylaxis was observed following FLUMIST: Wheezing, facial swelling, and hives occurred 2 hours after LAIV vaccination, in someone known to be egg-allergic (observed rate 1. 7 cases per million LAIV doses). In individuals who received LAIV only, and no other same-day vaccines, two cases of medical record-confirmed syncope were observed (3.4 cases per million LAIV doses). This case belongs to one of two patients who experienced syncope after receiving LAIV. The outcome of syncope was unknown.   The company physician considered syncope as important medical event. The reporter considered syncope to be related to LAIV.  ; Sender's Comments: Syncope is not listed in the company core data sheet of FLUMIST. Due to limited information on details of syncope (type), exact onset date of event, start date of suspect drug along with its indication, underlying comorbidities, past medical history, concomitant medications, age and gender of the patient, lab details ( complete blood tests, blood glucose values), detailed clinical and diagnostic workup (imaging studies, cardiological and neurological workup), it is not possible to make a conclusive assessment of the causal relationship of syncope with FLUMIST.
developed fever 101 degrees  12 hrs following vaccine without other symptoms. Resolved 24 hrs.
redness and warmth on top 1/3 of arm, developed to cellulitis in area on 09/24/2011
Vaccine was administered in left arm on Sunday. Rash/bruising occurred 2 days later on Tuesday morning on opposite right arm. There is no pain or itching to the impacted area, Resembles bruising or a birth mark.
Really hurt my arm, very sour and uncomfortable/shot in the arm hurt; Lot of achiness; I'm still very sour and uncomfortable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Lot number: Unknown) at the age of 74 years as 2nd dose, 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: 04Mar2021, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "Really hurt my arm, very sour and uncomfortable/shot in the arm hurt"; PAIN (non-serious) with onset Mar2021, outcome "recovered with sequelae", described as "Lot of achiness"; DISCOMFORT (non-serious) with onset Mar2021, outcome "not recovered", described as "I'm still very sour and uncomfortable". No follow-up attempts are possible. No further information is expected.
pt receeved the bivalent booster dose for the 2nd dose in the primary series instead of the primary vaccine dose; pt had no reaction to the vaccine
I though I am gonna pass out; Dizzy; Heart was counting very fast; Heart was stuck; Right that had a allergic reaction at the center where I had it; This is a spontaneous report from a contactable consumer (the patient).   A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Jul2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced I though I am gonna pass out, dizzy, heart was counting very fast, heart was stuck, right that had a allergic reaction at the center where I had it. It was reported that the patient had the first dose yesterday and within a minute might have had a reaction that was very dizzy, patient got dizzy, heart was counting very fast. So, the patient had to sit there for longer time. So, that was considered as an allergic reaction. The patient wanted to know was that an allergic reaction?" Consumer stated, "Right that had a allergic reaction at the center at the (pharmacy name) site where I had it, you know my heart was stuck and I would not get the second shot. As I want to put that on record that I am afraid to get the second dose. I though I am gonna pass out." The patient stated that she cant take the chance of having the second shot and must have some immunity with the first shot. Consumer asked that how long was immunity good for? Is it a year? On an unspecified date, the patient underwent lab tests and procedures which included heart rate: heart was counting very fast. The outcome of events was unknown.  The lot number for the vaccine  was not provided and will be requested during follow up.