chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer reported for her daughter. A 22-year-old female patient received the 1st dose of TRUMENBA, (NDC # 00005-0100) via an unspecified route of administration as Injection in her left bicep on 30Jul2016, possibly at 14:00-16:00, for immunization (Prevention of meningitis B). The patient medical history was none. There were no concomitant medications.  No other Vaccines were administered on same date. No prior vaccinations within 4 weeks. The patient previously took DPT vaccine at the age of 10 months, possibly on 27Oct1994, for immunization and was lethargic and had a muted mechanical cry. On 30Jul2016 Immediately after receiving the vaccine, the patient experienced pain on administration with outcome recovered on 06Aug2016. On 30Jul2016 within 2 hours after receiving the vaccine, she started feeling ill and it worsened on 30Jul2016 with outcome of unknown.  On 30Jul2016 within 2 hours after receiving the vaccine, she experienced pain and swelling at the injection site, severe nausea, vomiting, severe headache, stiff neck, pain and swelling at the injection site, weak, shaky, dizzy, may have been running a fever, all with outcome recovered on 06Aug2016. On 01Aug2016, within 48 hours following administration,  the patient experienced pressure in her eyes, eye pain, eyelids seemed sore and swollen, and eyelids seemed sore and swollen, all with outcome recovered on 06Aug2016. No investigations performed. No event required a visit to ER or physician office. Course of events: On 30Jul2016, immediately upon receiving the injection, it was very painful. Within 2 hours after receiving the vaccine, she started feeling ill and it worsened. The most severe parts of the adverse events were the first 3-4 days. The patient may have been running a fever, but they did not have a thermometer to take a temperature.  About 48 hours after the vaccine injection on 01Aug2016, she developed the additional symptoms in her eyes. Consumer was wondering if there were any advice if her daughter should get the second dose or not. She queried whether these events could occur when she get the next dose and whether will they last as long.
Rash on left arm and right wrist 48 hours after first dose of Pfizer-BioNTech COVID-19 vaccine 0.3 mL IM in left deltoid. Patient tool cetirizine PO and used triamcinolone cream topically. Appears to have resolved, but no further details in the patient's chart.
Reported notability, poor feeding, lethargy and sev. min. of 1 y twitching.  T 100.3 F in office on 10/19/05, and nl exam.  Back to self by 10/20/05 per mom.
Redness, warmth, swelling around site of 2 injections.  Started 2 days after vaccines given.  No fever.  Prescribed oral antibiotics, BENADRYL, MOTRIN.
Drenched in sweat; Feels like there was an elephant sitting on her chest; Tremors; Head hurt; Every part of the body hurts; Fever at 101.6F at 3am - current temperature now is at 101.3F; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Drenched in sweat), CHEST DISCOMFORT (Feels like there was an elephant sitting on her chest), TREMOR (Tremors), HEADACHE (Head hurt) and MYALGIA (Every part of the body hurts) in a 50-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.     Concurrent medical conditions included Sulfonamide allergy (sulfa based drug).    On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Sep-2021, the patient experienced HYPERHIDROSIS (Drenched in sweat), CHEST DISCOMFORT (Feels like there was an elephant sitting on her chest), TREMOR (Tremors), HEADACHE (Head hurt), MYALGIA (Every part of the body hurts) and PYREXIA (Fever at 101.6F at 3am - current temperature now is at 101.3F). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 2 tabs and IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) ongoing since an unknown date for Adverse event, at a dose of 2 tabs. At the time of the report, HYPERHIDROSIS (Drenched in sweat), CHEST DISCOMFORT (Feels like there was an elephant sitting on her chest), TREMOR (Tremors), HEADACHE (Head hurt), MYALGIA (Every part of the body hurts) and PYREXIA (Fever at 101.6F at 3am - current temperature now is at 101.3F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2021, Body temperature: 101.3f (High) 101.3F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
pt devel redness, edema, warmth & pain shooting up shoulder & down arm, erythema from 15025mm reported by school nurse;
Rash 11/9/02 < 50 (papules, itchy & scabs). PCR - vax strain virus
Shortness of breath and breathing issues; fever and chills; muscular and skeletal issues; jaw pains from stress.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 16-APR-2015, the patient was vaccinated with a dose of improperly stored VAQTA (10Pk 50U/1 mL) lot number K008984, expiration date of 21-OCT-2015 (route of administration was not reported), which was stored 1 time with the following lowest recorded temperature: 34F (1.11 celsius degrees) for 88 hours. No highest reported temperature was reported. The type of storage was refrigerator. No concomitant therapies were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Patient has rheumatoid arthritis. He reported that after his Shingrix dose his arthritis pain was very great/apparent for about 3 days after.
2nd dose >35 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose >35 days) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2021, 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 (2nd dose >35 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose >35 days) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported. Patient stated that patient was disabled and wanted to be vaccinated with the second dose. Patient's daughter got sick, and then Patient grandchild got sick and had not been provided with the second dose due to personal problems   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Follow-up document received contains no new information(NNI) On 06-Sep-2021: Follow-up document received contains no new information(NNI)
Initial report received from a health care professional on Aug 29 2005. A 20 year old female patient received an injection of Menactra, lot number U1750AA, in the left deltoid on Aug 28 2005. That same evening, she developed swollen eyes and a hive under one eye. She also had lip swelling. 24 hours post vaccination she developed swollen eyes and a hive under one eye. She also had lip swelling.  24 hours post vaccination she developed a fever of 103 degrees F and severe headache. She was treated with Benadryl.  At the time of this report the patient had not recovered from these events.  Follow up information received on Sept 23, 2005. The patient did not have any other vaccinations within the 4 weeks of the administration of the Menactra. The patient also did not have any adverse reaction prior to previous vaccinations.
Left arm has rash, burning, knot at injections site, diarrhea, burns when touched.  Started the day of the immunization.  Patient says she has been taking tylenol and benadryl and using a cold compress.  Also states that it does not appear to be getting worse at this point.  I will contact PCP on Monday.
PT received a Moderna booster dose lot #027H21B Exp 12/22/2021 at 0923am. The client denied history of allergies or previous vaccine reactions. The client reported a history of diabetes, ADHD, and anxiety and said she was taking metformin, trazadone, and guanfacine to treat these conditions. The client has a primary care provider at clinic.  The client completed her observation period after receiving her booster but returned to the nursing area at 1012am stating, ?My fingers feel numb and tingly. This didn?t happen with my other Moderna vaccines.? RNs asked the client to sit down.  She appeared pale and sweaty but denied feeling dizzy or faint. She denied feeling itchy. RN checked the clients left arm where the vaccine was given.  There were no signs of redness, rash, or swelling. The client said she felt ?nervous? but that the feeling was different than her usual anxiety symptoms.  At 1014 she said ?My chest feels tight like it?s hard to breath.  It feels like I have indigestion. It feels like I need to burp.?  Her respiratory rate was 16 regular and unlabored, SpO2 97%, HR 80 and regular, BP 130/90 and she rated her chest pain a 4 out of 10 on the pain scale. She was alert and oriented x 4. The client was given a snack because she said she had not eaten in 3 hours. At 1019 the client said the numbness and tingling in her left hand/fingers was ?gone,? and the pain in her chest decreased to a 2 out of 10 on the pain scale. She denied difficulty breathing and said the feeling of ?indigestion? was going away.  Her RR was 15 regular and unlabored, SpO2 96%, HR 78 and regular, BP 138/94. She remained alert and oriented x 4.  Her color returned to normal, her skin appeared dry, and she appeared calmer. At 1022 the client said her chest pain was ?not as bad as before? and rated it a 1 out of 10 on the pain scale.  At 1024 the client said her chest pain was ?gone? and she no longer had numbness or tingling in her left hand/fingers. Her respiratory rate was 16, BP 134/86, HR 83 and regular, SpO2 96%. Her breathing appeared regular and unlabored.  She was alert and oriented x 4. RNs observed the client until 1033, then asked her to try standing up.  The client stood up without symptoms. She walked away with a steady gait and returned to work on site with her colleagues.  The client was educated to call 911 if symptoms resumed.
The patient came in the day after the imz and the area that was the imz site was raised and red. I suggested cold and ibuprofen. She later called her md and he suggested the ibuprofen and warm packs. Spoke to her today and she is fine.
Tiredness; Fever; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Nasal congestion (Nasal congestion and chest congestion). Concomitant products included DEXTROMETHORPHAN for Nasal congestion and Congestion pulmonary, FLUTICASONE, ATORVASTATIN CALCIUM (LIPITOR) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced FATIGUE (Tiredness), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches). On 23-Mar-2021, FATIGUE (Tiredness), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Second dose of mRNA-1273 vaccine scheduled for 18-Apr-2021.
throat tightening, shortness of breath, itching Narrative: Pt experienced throat tightening and itching following second dose of covid vaccine, leading to ED visit. Given epi IM and diphenhydramine IV. Throat tightening resolved and itching improved.
Severe tinnitis 06/16/2021 Inflammation and rash left upper arm next day and still continues
1.Small rash on axial line, one severely itchy wheal 2. Insomnia started the night of vaccine but appears to be improving . 3.Pain at injection site continues today but has started to wane as of today.
Pt was vaccinated for smallpox on his left arm on 11/1/07, pt had no reaction after 8 days, and was therefore revaccinated on his right arm on 11/8/07. On 11/9/07, one pox developed on his left arm at the original vaccination site. Over the course of the following week, he developed 3 additional pox on the left arm at the site of the original vaccination, and the single pox at the second vaccination site on his right arm. Otherwise, the patient has experienced no other complications.
Pt report pain (plus) fever like S/S on Saturday one after shot. Redness, tenderness all around vaccine site. Temp 98.9.
Intensive vomiting all night after receiving the vaccine, fatigue, chills, muscle aches
This spontaneous report has been received from medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided. On an unknown date, patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin)(PROQUAD), 0.5 milliliters (lot # U017138 has been verified to be a valid lot number, the expiration date was reported and established as 28-NOV-2022; strength, vaccination scheme, frequency, route of administration and anatomical site of vaccination were not reported)) for prophylaxis after a previously reported temperature excursion (product storage error) that was evaluated with a supported outcome. The vaccine was exposed to a temperature of 140F to 460F (16F), for a time frame of 15 minutes. There were previous temperature excursions of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) at temperature of 60F to 140F (9F) for 40 minutes and 60F to 140F (7F) for 30 minutes. No additional adverse event was reported.
Moderate to severe body ache, elevated temperature, 101 deg. F., lasting 36 hours
The patient became very nauseous; This spontaneous case was received on 01-Oct-2020 from a pharmacist via  (reference number: SEQW20-02768) and concerned a 79-year-old, female patient.    The patient's medical history and concomitant medications were not reported.   On 01-Oct-2020, the patient was vaccinated with Fluad Quadrivalent vaccine (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid) for protection against seasonal influenza. The batch number reported was 279805, expiration date reported was 30-Jun-2021.   On the same day, one hour after receiving Fluad Quadrivalent vaccine, the patient became very nauseous. The patient did not receive any corrective treatment.  At the time of initial reporting on 01-Oct-2020, the outcome of event nauseous was not resolved.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: Event 'nausea' is assessed as related to Fluad Quadrivalent vaccine.; Sender's Comments: Event 'nausea' is assessed as related to Fluad Quadrivalent vaccine.
Two days after pneumonia shot - right arm swelled, was red, warm adn painful.  Couldn't use it for three or four days.  Sweling was in the mid upper arm.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8732), in left arm and on 21Apr2021 as dose 2, single (Lot number: EW0164) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Nov2021 as dose 3 (booster), single (Lot number: O69f21a), in left arm, on 17May2022 as dose 4 (booster), single (Lot number: 03822a), in left arm and on 06Sep2022 as dose 5 (booster), single (Lot number: As7143c), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective which included paxlovid from 21Aug2023 to 25Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300291042 same patient, different drug, different event;
Fever - Motrin. Muscle aches and pain - Motrin, heating pad. Soreness at injection site.
Right arm tender at injection site. Tenderness spreading to arm pit. Right Axillary gland is tender along with the back of neck. Fatigue. Hasn't tried OTC meds.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 74 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 15Apr2022 as dose 4 (booster), single (Lot number: FK9894) for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EN5318), in right arm and on 02Mar2021 as dose 2, single (Lot number: EN6199), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient had no known allergies. Concomitant medication(s) included: ATENOLOL, start date: 01Aug2016. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included PAXLOVID (Lot number: GL3649) taken from 10Aug2023 to 14Aug2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Workforce member reports increasing pain and weakness in my arm at the injection site since  flu vaccine. Increasing pain and weakness.
This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  An adult female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 4 (booster), single (Lot number: CJ6742) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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) all with onset 27Dec2022, and all described as "got covid from daughter sx 27Dec and positive AG 27Dec mild sx". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Dec2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. Outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.
ARM VERY RED AND SWOLLEN. AREA AROUND INJECTION RAISED AND SWOLLEN AND EXTENDED DOWN THE ARM TOWARD THE HAND AND UP TO THE ARMPIT LYMPH NODE AREA.
patient was administered a vaccine on 10/18/2021 that expired on 10/13/2021
After 12-18 hours: pain in right arm, shoulder, shoulder blade, neck. Headache. Fatigue. After 24 hours: fever of 100.6, headache (right-sided)
right axillary lymphadenopathy developed 3/15/22, started to decrease in size per patient report 3/16/22. Right axillary soft, mobile, non tender enlarged lymph node about 8cmx7cm on exam.
Reported 11-2-13 arm red, swollen, warm to touch from shoulder to elbow. Called family doctor prescribed cephalexin 500mg tid x 10 days and BENADRYL 25 mg every 6 hours. Itched originally not real painful.
Upper respiratory infection. Sore throat, coughing, sinus. I had a virtual visit with the doctor. They gave me a z-pack and that did the trick.
Fever,headache, severe shaking, headache,lightheadedness , nausea, redness at injection sight, fatigue
Site: Itching at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Tested positive for COVID-19 after being fully vaccinated. Symptoms began on 4/18/21. Symptoms included; loss of smell, headache, runny nose, loss of taste, congestions, and sinus pressure.
On January 26th around 9am she was very lightheaded it lasted 15-20 minutes. Called the ambulance took her to the hospital and she got every test done, she included that she had a mild bnp.
This spontaneous report as received from a female patient of unknown age refers to herself. On an unspecified date in August 2014 (reported as "on an unspecified date a month ago"), the patient was vaccinated with a dose of ZOSTAVAX, 1 single shot (route and lot # unknown). A little while after receiving ZOSTAVAX the patient developed an ugly raised rash of big dark itchy blisters on the side of her leg. The patient was experiencing joint pain in her arms which she was going to physical therapy for. The patient sought medical attention. The patient's physician gave her an unspecified cream to put on it but it did not work. The outcome of events was unknown. The causality was not reported. Additional information is not expected.
Chest pain and heart palpitations that progressively got worse over the course of 5 days until I had to go to the emergency room on 5 May 2021. I still have chest pain and mild heart palpitations.
After the 2nd dose vaccine, I started getting abdominal pain, vaginal pain and menstrual bleeding. I have a history of endometriosis and these symptoms have been exacerbated. I went to see a doctor, did an MRI and was diagnosed with deep infiltrating endometriosis, which the cells in my uterus grows outside the uterus. I had a hysterectomy in 1/2019 and I should not have any uterine cells. This abnormal growth of endometrium cells is causing extreme pain and painful menstrual cycle. My doctor initially put me on birth control and that did not help. I then got an hormonal implant Nexplanon on 6/30/2021, this seems to be helping. It has stopped my bleeding and the pain has improved.
Pt vaccinated with DTP/OPV cried 2 1/2 - 3 days & almost cont, no sleep night of shot & altered sleep. Small local rxn, marked fussiness, no sleep except dozing . Lg local rxn, now sleeps fitfully & shudders occasionally.
Came down with Covid on 7/21.  Very sore throat, headache, cough, thick sinus mucus and cough.  Slight fever.
I woke up with congestion, cough, sore throat, headache, and sneezing. I felt like I had a bad cold. I tested for COVID-19 at home. The result was positive. I called my doctor the following Monday. I take Xyzal regularly. I continued to take it while I was sick. He told me to take a decongestant. He prescribed a Z-Pak and Tessalon Pearls for the cough. He called in a prescription for an antiviral, but the stores didn't have it in stock. By the time they called me, I was feeling better, so I didn't take it. By Tuesday, I was feeling much better.