chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs were reported.; The physician reported that a patient received improperly stored vaccine.; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies or reactions and concomitant medications was not provided.  On 14-SEP-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), lot number u024221 had been verified to be a valid number; expiration date 04-AUG-2023, and upon internal validation established as the same date, as prophylaxis (dosage, vaccination scheme, frequency, route of administration, and anatomical site of injection were not reported) following a temperature excursion of minus 12.5 degrees Celsius (C), during a time frame of 1 hour, it was stated that no previous temperature excursion occurred. No additional adverse event was reported.
Pt. c/o fever at 103.1-102.3 on 5/8/2021 p #2 dose Pfizer on 5/7/2021 . Pt is also cold & took dose of Motrin. 5/9/2021 c/o HA & fever at 100.8. 5/10/2021 better & no symptoms.
Vomiting; Diarrhea; She passed out; Woke up all achy; Tired; sore at the injection site; Felt like they hit a bone/ swollen; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Deltoid Right (reported as right shoulder/right arm) on 08Oct2021 between 10am to noon (Batch/Lot Number: EW0186; Expiration Date: Nov2021) at age of 67-years-old as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history was none. Concomitant medication included influenza vaccine (FLU SHOT) taken for immunization within 4 weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 19Dec2020 (Batch/Lot Number: EJ1685; Expiration Date: 31Mar2021) and dose 2 on 09Jan2021 (Batch/Lot Number: EL0142; Expiration Date: 31Mar2021) for COVID-19 immunisation. Vaccination facility type was hospital. No additional vaccines administered on same date of the Pfizer suspect. No AE following prior vaccinations. No family medical history relevant to AE. The patient experienced passed out on 09Oct2021 with outcome of unknown, woke up all achy on 09Oct2021 with outcome of recovered in Oct2021, tired on 09Oct2021 with outcome of recovered in Oct2021, vomiting on 09Oct2021 17:00 with outcome of recovered in Oct2021, diarrhea on 09Oct2021 17:00 with outcome of recovered in Oct2021, felt like they hit a bone/swollen on 2021 with outcome of unknown. AE require a visit to emergency room and not admitted to the hospital. Clinical course reported as follow: Patient had the Pfizer COVID booster shot on 08Oct2021 and the following morning she woke up all achy and tired, sore at the injection site. Then it went to vomiting and diarrhea and she went to the ER. First two shots went very smoothly. Felt like they hit a bone when she was given the booster injection, it was hurting, it was swollen and sore for a week. She passed out on 09Oct2021 and her husband called an ambulance and she went to ER and was kept till the morning. Confirmed she was not admitted, they kept her in the ER. 1700 was when vomiting and diarrhea started on 09Oct2021, it only lasted for a day or two. Put patient on iv something for the vomiting. No relevant tests.  Follow-up attempts are completed. No further information is expected.
48 hrs after 2nd shot  woke up to lemon size swelling in armpit of arm that was vacinated; 24 hrs after 2nd shot, vomiting; fever (102); This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Jun2021 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16May2021 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Jun2021 the patient experienced vomiting and 102 fever 24 hrs after 2nd shot, on 08Jun2021, 48 hrs after 2nd shot woke up to lemon size swelling in armpit of arm that was vaccinated. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events vomiting and 102 fever 24 hrs after 2nd shot, on 08Jun2021, 48 hrs after 2nd shot woke up to lemon size swelling in armpit of arm that was vaccinated were not resolved at this time of report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
pain in her arm that kept her awake half of the evening; stomach has been bothering; she developed a fever 101; red rash, swollen at the injection site; red rash, swollen at the injection site; flu alike; patient feels wobbling; headache; thighs and hips that are hurting; pain in her arm that kept her awake half of the evening/ arm still very sore/ arm was really sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (pain in her arm that kept her awake half of the evening/ arm still very sore/ arm was really sore), INSOMNIA (pain in her arm that kept her awake half of the evening), INFLUENZA LIKE ILLNESS (flu alike), FEELING ABNORMAL (patient feels wobbling) and ABDOMINAL DISCOMFORT (stomach has been bothering) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in her arm that kept her awake half of the evening/ arm still very sore/ arm was really sore). On 07-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu alike), FEELING ABNORMAL (patient feels wobbling), HEADACHE (headache) and MYALGIA (thighs and hips that are hurting). On 08-Apr-2021, the patient experienced PYREXIA (she developed a fever 101), VACCINATION SITE RASH (red rash, swollen at the injection site) and VACCINATION SITE SWELLING (red rash, swollen at the injection site). On 13-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach has been bothering). On an unknown date, the patient experienced INSOMNIA (pain in her arm that kept her awake half of the evening). On 16-Apr-2021, MYALGIA (thighs and hips that are hurting) had resolved. At the time of the report, PAIN IN EXTREMITY (pain in her arm that kept her awake half of the evening/ arm still very sore/ arm was really sore), INSOMNIA (pain in her arm that kept her awake half of the evening), INFLUENZA LIKE ILLNESS (flu alike), PYREXIA (she developed a fever 101), HEADACHE (headache), VACCINATION SITE RASH (red rash, swollen at the injection site) and VACCINATION SITE SWELLING (red rash, swollen at the injection site) had resolved and FEELING ABNORMAL (patient feels wobbling) and ABDOMINAL DISCOMFORT (stomach has been bothering) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information were not reported. Treatment information were not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Events added
I experienced sharp pain in my shoulder. I could not shower, stretch, and do normal activities. It was very limited movement from my shoulder. I went to go reach for something from my nightstand and that's when it was super painful. The first two months, I was tolerating the pain and tried not to use the arm that much. In April 2021 was when it was really bad. The pain was majorly sharp and would shoot up the side of my neck. I went to the doctor on June 21, 2021 and he sent me for physical therapy at a local hospital. I was discharged a month later on July 19, 2021 after having therapy twice a week. I started PT on June 25 and went on July 6, 8, 13, 15, and went for discharge on the 19th of July. My left was still hurting and I had to keep working on it, which I did. My left arm was never 100% after that.
This spontaneous case reported by a consumer, describes the occurrence of pain (arm aches), vaccination site pain (arm pain near injection site) and fatigue in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, (batch# unknown) for COVID-19 immunization. No medical history reported. On Feb 11, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 11, 2021, patient experienced pain (arm aches), vaccination site pain (arm pain near injection site) and fatigue. The patient treated with Tylenol (paracetamol) at an unspecified dose and frequency; and ibuprofen  at an unspecified dose and frequency. On Feb 14, 2021, pain (arm aches), vaccination site pain (arm pain near injection site) and fatigue resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments or concomitant medications.
my left ankle was lightly swollen yesterday and it's still swollen today; This is a spontaneous report from a contactable consumer (reported for himself). A 65-year-old male patient received second dose of BNT162B2 (Pfizer covid-19 vaccine, Solution for Injection, Batch/lot number and Expiration date were not reported), via an intramuscular route on the right arm on 01Jun2021 (age at vaccination: 65-year-old) as a single dose for covid-19 immunization. Medical history included high cholesterol and high blood pressure. Concomitant medications included amlodipine Besylate 10 mg for high blood pressure and atorvastatin, 30mg tablet for cholesterol. Historical vaccine included first dose of BNT162B2 (Pfizer covid-19 vaccine, Solution for Injection) as a single dose for covid-19 immunization. Family history included swollen ankle of patient father who is 95-year-old. Patient did not receive any other vaccine after the covid vaccine. On 05Jun2021 yesterday, patient mentioned that his left ankle was lightly swollen yesterday, and it's still swollen today. He wanted to know if that is something he should worry about as the side effect. The patient underwent lab test and procedure which included blood work up and it all came out good, his cholesterol was low, and his blood pressure was good. The clinical outcome of the left ankle was not recovered.  Information on the lot/batch number has been requested.
1 yr old male came in w/ hx of fever on and off x 1 wk averaging 103. Pt was given vaccine son 7/23/07 and per Mom's info. pt began w/ high fever 3d later. pt was treated w/ fever reducer.
I had a fever, achy and headache for two days from Thursday am to Saturday am, then a worse headache and very tired all day Saturday.   On Sunday, I started spotting as though I was getting my period.  I have been post-menopausal for three years, so this was a shock.  The spotting is slight but still there today (Tuesday).   I also had a very sore armpit on the side that I received my vaccine.
Patient complaints of difficulty breathing, SOB, chest pain, numbness in extremities and back pain 5 mins after Tdap vaccine given.
Tinnitus in right ear, saw ENT for tests in January 2021, no treatment prescribed, tinnitus continues until now,
Information has been received from the authors of the literature article entitled as stated below, concerning to a healthy 3-year-old immunocompetent boy with a 4-day history of a progressive, mildly pruritic, painless rash on his right thigh. He was afebrile and otherwise asymptomatic. Despite the use of hydrocortisone 1% cream, the rash had spread. On an unknown date, he had received a single dose of the VARIVAX at 12 months of age. On physical examination, his rash showed clusters of clear vesicles on an erythematous base. The rash extended from the lower back, wrapped around the right lateral and anterior thigh, and ended on his lateral pubis in an L2 dermatomal distribution. The varicella zoster polymerase chain reaction (PCR) performed on specimen from his right thigh lesions was positive for vaccine-strain zoster. On the day of the visit, he started a 7-day course of acyclovir 45 mg/kg three times a day. Within 4 days the lesions were crusting over and the rash subsequently resolved without sequelae. This report is linked to MARRS 1710USA013161 from the same literature article. Sender's Comments: US-009507513-1710USA013161.
13 month old received Patient received a dose of Flublok Quadrivalent vaccine/No AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case from a consumer/non-HCP.  This case involves a 13-month-old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Nov-2019, the patient received first 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA1952, expiry date- 30-06-2020) once via unknown route in the left thigh.  It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Headache; tiredness; nose bleeding; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248, expiration date was unknown), via an unspecified route of administration in the left arm on 20Jan2021 01:30 at a single dose for COVID-19 immunization. Medical history included chronic migraine from an unknown date and unknown if ongoing. Concomitant medication included citalopram and trazodone. The patient was not pregnant. The patient had no other vaccine in four weeks prior vaccination. She had no covid prior vaccination nor was she tested post vaccination. The patient experienced headache, tiredness, she had a nose bleed and added that most of the time, if she had a headache, her nose will bleed. The events occurred on an unspecified date in Jan2021 at 03:00 AM with outcome of recovered in Jan2021. No treatment received for the events.
Mild tension headache and mild pain behind the eyes for 24 hrs. Also, general fatigue for 18 hrs.
Suspected COVID-19 virus infection  Cough  Acute non-recurrent maxillary sinusitis
Numbness & tickling in face from tip of nose to under chin.. started 2 days after injection & has not charged( or gotten any better) since.
Pfizer-BioNTech COVID-19 Vaccine EUA  initial IM caused intense pain at site, then through evening into night pain radiated to shoulder and neck, experienced sweats/chills during night, site swollen but not red, recovered next day but exhausted.
w/in 24hr pt parents reported that  child acting differently & did not appear to be feeling well;devel severe diarrhea & dehydration & was hosp;resp distress & intubated;enlarged liver & elevated liver function studies;varicella-like rash;
This spontaneous report as received from a registered nurse refers to a 3 year old patient (gender was not reported). On 12-AUG-2015, the patient was vaccinated with a dose of improperly stored (Oka-Merck) PROQUAD lot # K020754 (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Mild, Additional Details: Patient stated that she last ate around 10 am and had no extensive activity prior to vaccine at 6 pm. Per vaccinating pharmacist, patient had been fasting and fainted 5 minutes following vaccine administration.
Mom describing red, raised, hard, swollen area with a rash at injection site, approx size of quarter. Fever 101.1. Left thigh.
I developed site redness that has grown and is now a hot red rash that extends 3 inches in width and 2.5 inches below the injection site.
my temperature keeps rising; This case was reported by a consumer via interactive digital media and described the occurrence of body temperature increased in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than a day after receiving Shingrix, the patient experienced body temperature increased. On an unknown date, the outcome of the body temperature increased was not recovered/not resolved.   It was unknown if the reporter considered the body temperature increased 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 was selected as per the vaccine indication. The patient received the 2nd dose of Shingrix vaccine last night and the patient's temperature keeps rising.  The patient ask what was a normal range of fever with the vaccine.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The reporter stated that on 11-FEB-2013 the patient was vaccinated with ZOSTAVAX (lot # 1716AA, 0.65 ml, subcutaneous route) with an expiration date of 02-FEB-2013. No other co-suspects or concomitant medications were reported. Also it was reported, that the patient was not experiencing any known symptoms. Additional information has been requested.
Nausea, vom and headaches 2-3 hrs after immunizations. Sx better at 11:00am 9/5/18.
My father recieved 0.5 ML of MODERNA covid-19 in his right arm Sept 6, 2022 at 4pm.  On Sept 9 at approxm. 5pm my sister discovered my father in bed with right side droop and no mobility and non verbal. She called the ambulance he was brought to hospital were he was attended too with a catscan of the brain and she was told he had suffered an L1 stroke. Upon this knowledge his cardiac dr was called and he had my father transfered to a different hospital for a thrombectomy. THe clot from my fathers brain was removed in whole. My father has limited memory (he comes and goes as far as knowing me but does not really reckognize my sister. He has little speech that comes and goes if given commands but spontaneous talk has halted. He cannot eat solid whole foods yet only thickend liquids.  He cannot spell or reckognize letters and or numbers. His right side continues to heal but is still rather weak.
red,itchy, burning inflammation about the size of  between a quarter and half dollar in my upper chest about  an inch below clavicle. Center was white, with very rough inflamed skin,white bubble type areas, lasting over a month ( still red and inflammed)
This patient comes to us with history of Varicella vaccine on 9/28/2018. He presents with rash that has been verified as Chicken Pox on 1/21/2021
patient developed a 2 in. x 3in. red, raised rash on upper arm where injection was administered. Rash developed 8 days after vaccine. No pain, no itching
Headache, Myalgia, Fever, Mild site discomfort, fatigue, chills Narrative:
Starting in the afternoon of 11/20/2022, I had a tickle in my throat from sinus drainage and congestion/sneezing. It felt like I was coming down with a regular respiratory virus. I had a headache as well. Later that evening, I developed chills and body aches but never became febrile. The next day, I still had upper respiratory infection symptoms and if I didn't have a combination of TYLENOL and ibuprofen in my system I would have severe body aches and chills. Also, my asthma was acting up more and I needed to use my rescue inhaler more frequently. By 11/22/2022, I was coughing and needing my rescue inhaler more frequently and was experiencing severe body aches, chills and a headache. By that afternoon, I needed to nap and I wasn't able to work or take care of my child. On 11/23/2022, I was still coughing and had chills, body aches and fatigue. When I was cooking, I noticed I was experiencing hyposmia which prompted me to test for COVID-19. I tested myself that day and was positive. By 11/24/2022, I was feeling a little better and was able to prepare food. I still had chills/body aches, coughing, wheezing, headache and fatigue. The hyposmia was still present but the congestion was slightly improving. I had a telehealth visit on 11/23/2022 and they were going to put me on antibiotics for continued infection but decided not to. They decided against PAXLOVID due to breakthrough symptoms and it being close to the 5 day mark. I gradually improved after that day. My brain fog and mental fatigue got better. My only lingering symptom to this day is the asthma exacerbation. One week prior to contracting COVID-19 I was being treated for a sinus infection.
Redness of approx. 2 inches, induration of unknown size and warmth at site.
Tested positive for COVID; Tested positive for COVID; 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 male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive.  Clinical information: He has a question about Paxlovid. He just found out yesterday that he is positive for COVID. His first shot was J&J COVID Vaccine, and booster was Pfizer COVID vaccine. His only concern is, he was looking at paperwork for FDA approved medication. He read that there is a possibility in future that if someone gets HIV, that some medications won't work properly or would not work at all. He is at higher risk of getting HIV because he is gay. He took it last night and a dose this morning. He stopped taking it after reading this. He would like to know if something will happen if he stops taking it. There was a product complaint to report.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt came in on 9-14-12 with glands swollen - and fever. He was seen at 9:30 am - He returned to the office at 4:30 pm with his glands doubled in size and red streaking from them. We sent him to hospital.