chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site sore; injection site red; injection site warm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site warmth. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injection site pain, injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient said the patient would apply ice to injection site.
vaccine that expired yesterday was inadvertently given today; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine that expired yesterday was inadvertently given today) in a patient of an unknown age and gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine that expired yesterday was inadvertently given today). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine that expired yesterday was inadvertently given today) outcome was unknown.        For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter  Treatment information was not provided   Reporter did not allow further contact
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 11:23 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:23 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 20.18. No concomitant medication was reported by reporter. Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 06-Apr-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-Apr-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken by using a Fisherbrand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.
is pregnant Yes; After dose 1: arm pain for 2 days; This is a spontaneous report from a contactable consumer (patient). A 31-years-old female patient received (BNT162B2, formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration, administered in Arm Left on 01Apr2021 10:00AM (age at vaccine 31-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient did not have any known allergies. It was reported that the patient was a pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced after dose 1: arm pain for 2 days on 23Apr2021 02:00AM and is pregnant yes on an unspecified date. The mother reported she became a pregnant while taking bnt162b2. The mother was 16 Weeks pregnant at the onset of the event. The mother was due to deliver on 30Sep2021. The clinical outcome of the events arm pain for 2 days was recovered other event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No follow-up attempts are possible.
Hard, bruise like spots appeared on legs. Continued to multiply on legs and existing spots darkened over the month. Erythema Nodosum was diagnosed 05/30/2012 with likely cause recent HPV injection.
pt recvd vax 18OCT94 & later in day devel fever 101 that contd through 19OCT requiring MD visit-fever 104, infant not eating or drinking;rx w/APAP suppository;21OCT fever contd, vomiting, crying cont-hospitalized;spinal tap, UA, blood
COVID 19 Positive; COVID 19 Positive; Interchange of vaccine products; This is a spontaneous report received from contactable reporter (Consumer) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31May2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 65 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Jan2021 as dose 1, single (Lot number: 026L20A), on 12Feb2021 as dose 2, single (Lot number: 006M20A), on 01Nov2021 as dose 3 (booster), single (Lot number: 039F21A) and on 26Sep2022 as dose 5 (booster), single (Lot number: A57163B) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "bronchiectasis" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: 15Sep2022, stop date: 04Feb2023; AMLODIPINE, start date: 01Sep2018, stop date: 04Feb2023; LEVOTHYROXINE, start date: 01Jan2010. Past drug history included: Tetracycline, reaction(s): "known allergies: tetracycline", notes: known allergies: tetracycline. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31May2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Home test was negative on Day 7; (Feb2023) Positive, notes: positive home test on Day 10 of original infection. Therapeutic measures were taken as a result of drug ineffective, covid-19; Patient took Paxlovid from 04Feb2023 to 08Feb2023.
Seriousness criteria other medically significant (OMIC). Initial report received on 6/5/06 from a health care provider. A 22 year old female pt, with a history of endometriosis and polycystic ovaries, had received an injection of Adacel, lot number not reported, on 5/23/06. Route and site of administration were not reported. It was later determined that the pt was pregnant. Date of last menstrual period was 5/28/06, and the pts estimated date of delivery is 2/2/07. Per the reporter, lab work showed a low progesterone. It was indicated that the pt was placed on progesterone 200 mg, two times a week, to maintain the pregnancy. The reporter was not aware of any adverse events related to vaccination. Follow up information received on 10/6/06. This case was upgraded to serious as based upon the new information received. It was reported that the pt received the Adacel vaccine as a requirement for work. The had been maintained on progesterone 200 mg IM from 5/31/06 to 6/2/06 due to placental insufficiency. A quantitative HCG level was decreased on 6/1/06. Her past obstetric history was reported as negative, although prior information noted she had one previous pregnancy which resulted in spontaneous abortion. The pt experienced a spontaneous abortion on 1/9/06. Her recovery status was not reported.
Initial reaction in first few days- muscle pain. 7 days post vaccination- neurological issue, disoriented, requiring > 2 weeks ICU testing, diagnosis, treatment-  No other indicators of any other cause.
Within 1-2 hours post vax, the pt experienced malaise and sleepiness which has persisted. He also complained of local swelling, warmth, pain and itching at site. No other symptoms were experienced.
Tinnitus in both ears - began 3 days after first dose, persistent 24/7  Heavier menstrual flow and increased cycle duration
THERE IS A RED RAISED ZONE IN THE RIGHT DELTOID MEASURING ABOUT 65 MM AROUND, WARM TO TOUCH AND CHILD COMPLAINS OF SIGHT BEING PAINFUL
I started developed a cough and my fever was 99.7 and a headache and body was hurting and felt nauseous. I did a home COVID-19 test and it was positive.
pneumonia; acute encephalopathy; sepsis; shingles; myopathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 23-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for the routine health maintenance and for its intended purpose: the prevention of singles(herpes zoster). Shortly after the on an unknown date, the patient suffered weakness, altered mental status, dysarthria, hallucinations, fever, chills, cough and blíster like lesión on her hip, buttocks and leg. The patient was diagnosed with acute encephalopathy, critical illness, myopathy, pneumonia, sepsis and singles. As a direct and proximate result of the patient's receipt of zoster vaccine live (ZOSTAVAX), symptoms had resulted in physical limitations not present prior to vaccination. Further as a tragic consequence, the patient suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering mental anguish, emotional distress, los of enjoyment of life, physical impairment and injury. The outcome of the events was unknown.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered all the events to be disabling.  Upon internal review, the events pneumonia, sepsis and encephalopathy were considered to be medically significant.
Neck pain, malaise, myalgias, fever, redness over site. Illness last two days.
This is a spontaneous report from a contactable consumer. A 48-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 22Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. The patient experienced headaches, chills, "loose stomach" i.e. diarrhea, all on Mar2021. The event outcome for events was unknown.  No follow up attempts are possible; Information about lot/batch number cannot be obtained
Employee reports arm pain after flu vaccine administration, after receiving the vaccine noticed arm weakness that has not improved since 10/2023. Employee has appointment with her PCP .
This spontaneous report was received from a nurse regarding unspecified patients of unspecified age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. The nurse reported that between 11-DEC-2018 and 20-DEC-2018 unspecified patients received improperly stored RECOMBIVAX HB, intramuscular injection for prophylaxis, (Lot: R001084; Expiration date 07-NOV-2020) (dose, strength, anatomical site of vaccination and frequency were not reported). No adverse effects reported. It was also reported that temperature was: 9 degrees C to 25 degrees C (15.4 C), the time frame was 30 Minutes. A digital data logger was involved.
Information has been received from a female concerning her older sister who was vaccinated with MMR II. The younger sister reported that her older sister developed the same reactions as she did after she was vaccinated with MMR II (WAES0211USA00312). The older sister also developed severe ulcerations in the mouth and was diagnosed with ulcerative colitis. Upon internal review, ulcerative colitis was considered an other important medical event (OMIC). Additional info has been requested.
Swelling at injection site for 4 weeks. After one week of swelling had it evaluated and was prescribed Kalflex. Swelling went down but there was some pain and swelling for a month.
Developed flu like symptoms, dizziness, nausea, headache, fatigue, malaise.
extreme fatigue/ exhausted/ tired; always sleepy; terrible depression; feeling sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team The reporter is the patient.  A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: Jun2022 (not ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization. The following information was reported: SOMNOLENCE (non-serious) with onset Oct2022, outcome "not recovered", described as "always sleepy"; FATIGUE (non-serious) with onset Oct2022, outcome "not recovered", described as "extreme fatigue/ exhausted/ tired"; MALAISE (non-serious) with onset Oct2022, outcome "not recovered", described as "feeling sick"; DEPRESSION (non-serious) with onset Oct2022, outcome "not recovered", described as "terrible depression". The event "feeling sick" required physician office visit.  Additional information: She got the bivalent vaccine on 06Oct2022 and has been exhausted for 2 weeks (as reported). She had to go to the dentist and that's when she started feeling sick. After that, she had a nurse come in and is in touch with her doctor. She is exhausted, tired and sleepy and has had terrible depression with it. It has lasted a long time. She was feeling a little better "yesterday" (31Oct2022) but "today" (01Nov2022), she is back to worse. Was wondering if maybe she got a bad batch of Pfizer vaccine. The events were assessed by the reporter as not serious.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
shot was given around 11am and around 1-2 she began to get chills and body aches worse than covid, exhausted, several weeks later she began to having issues with walking, she will get pains in her knees and legs, its hard to walk she begins to walk like a penguin, she is now using a cane.
Severe Headache, Loss of appetite, Mild Fever, chills, severe fatigue, swelling at shot site.
Hives/rash at injection (L) site to shoulder and rash on (R) shoulder also. No SOB, abd pain or other symptoms. Patient given 50mg Benadryl PO phone call to mother. Patient rash resolved.
Pt had a sore arm, fever and his arm was swollen from top of his shoulder to his elbow. Pt's arm felt warm and hard to the touch. This happened a few hours after the vaccine was given on 9/21. Parents called our office on 9/22 to inform us. Parent was told to use Tylenol/ Motrin/ Benadryl and a cold compress to help.
Case completed Covid vaccine primary series, then was hospitalized for Covid in AUgust 2021. He was hospitalized at the hospital for 4 days, then at the Medical Center for 20 days.  * Pneumonia due to COVID-19 virus Assessment & Plan Sent to the ER from urgent care 8/13. Progressively more ill, F, diarrhea, fatigue, myalgias, altered taste, cough, sob, and very poor appetite (limited oral intake 48 hours).  Fully vaccinated in Feb 2021- exposed by unvaccinated son and grandson on Aug 2 and has been ill since Aug 4, so he was treated with both dexamethasone + remdesivir.  8/13 with a fever of 101 but has since improved. CXR initially with patchy infiltrates but mild. CRP was 14 and improving daily. He continues to improve clinically as well and expresses desire to d/c home today. He is now ambulating independently in the room and doing squats. He is tolerating a diet, though still has no appetite or taste. Is aware he needs to eat and drink more. Continues on oxygen, was on 5L for the last 72 hours which hasn't changed. I suspect a large part of this is atelectasis as he was so immobile the first few days of his hosp stay. Fatigue and weakness have improved sig per patient report. RT did arrange for home oxygen.    Case was admitted to hospital severall days after being discharged from the other hospital. He was on BiPap x 5 days,  then O2 on nasal canula, and underwent repeat dexamethosone treatment, and was discharged to home after 20 days in (Privacy).
Very nervous about getting shots. Mother was in the room by her side. Patient sitting on end of exam table. Injection given. Bled moderately. I was holding a cotton ball on the site and she looked over. When I removed the cotton ball she saw the blood. She immediately passed out. I eased her to a laying position on the exam table. Was only seconds and she fought to sit back up. She was confused for about 5 seconds and then remembered she was getting shots. Placed a cool washcloth on her head. Encouraged deep breathing. After 10 minutes mom wanted the rest of her shots given. She received a Men B in right deltoid, HPV in left deltoid and LAIV 4 in left deltoid. Also completed a TB skin test. Patient had no difficulties with the rest of the injections. She remained laying down with the cool washcloth on her head for 15 minutes. Then I had her sit up for 5 minutes. Denied any side effects. Left clinic ambulatory with her mother. Encouraged good hydration and rest. Mom states during the incident that she has passed out when getting her blood drawn previously. States if she looks at her own blood she gets lighted.
Day 7, April 21st, I woke up feeling chilly but also sweating, no fever. Very tired, headache.   Day 8, spent the night shaking and sweating in my sleep, no fever. Injection site very swollen, red, and itchy. Very tired, headache
Nausea, dizziness, weakness, sharp painful headache left side behind eye/forehead, sensitivity to light,  small bursts cold sweat, icy feeling across chest
Confusion, Palpitations, Hypertension, syncope, flushing, not thinking clearly, chills/clammy  Narrative: Immediately post vaccine, had facial flushing/redness, dizzy and c/o brain fog. Recovered after lying down/resting. Returned to work, 2 hours post vaccine again felt like not thinking clearly, chills/clammy, palpitations and felt like she was going to pass out. 911 activated/paramedics transported to ER.
my taste and smell has changed. Foods taste and smell horrible/It has a metal smell and taste; my taste and smell has changed. Foods taste and smell horrible/It has a metal smell and taste; my taste and smell has changed. Foods taste and smell horrible/It has a metal smell and taste; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 04Oct2021 17:00 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Relevant past drug history: No. Reaction: Allergy. There were no concomitant medications. The following information was reported: DYSGEUSIA (non-serious), PAROSMIA (non-serious), TASTE DISORDER (non-serious) all with onset 11Oct2021, outcome "not recovered" and all described as "my taste and smell has changed. Foods taste and smell horrible/It has a metal smell and taste". Therapeutic measures were not taken as a result of dysgeusia, parosmia, taste disorder.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Reported Event: A week after taking the shot, my taste and smell has changed. Foods taste and smell horrible. Such as bacon. Patient did not have relevant medical history and concurrent conditions, Relevant past drug history, Family medical history and Relevant tests. Patient had no Known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient received dose 2 BNT162B2 on 25Oct2021, Time: 18:00, Anatomical site of injection: (name) arm, Route of Administration: Intramuscular for covid-19 immunisation. Specific Relevant Test for Thromboembolic events with Thrombocytopenia: None. Comments/Narrative: Since Recalling my first shot. A few days later Food has smelled and tasted horrible. It has a metal smell and taste. Some foods are worse than others. This has still not gone away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.