chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021 at 2:48 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Mar-2021 at 2:28 PM, 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. Age of patient was reported as 59.68 for dose administered on 02-Mar-2021. No concomitant medications were reported. Batch number 014M20A administered on 02-Mar-2021 underwent temperature excursion with temperature range of 27 to 33 degrees Fahrenheit from 09:00 AM to 12:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 02-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period 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 using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported
Reports that the child has a rash on her arms and is itching. Instructed to use BENADRYL and Calamine lotion for itching. Instructed to seek medical attention if condition becomes worse.
Post vax, the pt developed redness, swelling, and warmth to the touch on right upper arm from shoulder to elbow.
Severe swelling at site severe arm pain with no relief.  Being put on benadryl and prednisone.
Information has been received from a physician concerning a 12 month old Caucasian male with no past medical history who on 19APR2004 was vaccinated with a third dose of hepatitis B virus vaccine + Hib conj vaccine in the left leg. There was no illness at the time of vaccination.  There were no concomitant vaccinations administered. On 28APR2004 the patient presented with "raging" urticaria. There were no other symptoms. The patient was treated with diphenhydramine HCL and antihistamines. The patient recovered. No product quality complaint involved. There were no relevant diagnostic tests. It was also noted that the patient did not experience any adverse events following prior vaccinations. No further information is expected.
A report has been received from a Pharmacist concerning a patient born on 20-Dec-2004, female subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. It was reported by the pharmacist that patient had administration of only a half dose of FLUMIST in one nostril. The outcome of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
All of the patient's teeth became extremely sensitive, and eating was painful.  Taking Tylenol made the condition tolerable.  The duration of symptoms was 3 days.
This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with (Merck) VARIVAX vaccine (strength, dose, route, lot number and expiry date were not reported), which were improperly stored. No concomitant medication was reported. The (Merck) VARIVAX vaccines were exposed to a maximum of 9.9 degree F, for a total of 188.5 hours, on multiple occasions. No adverse effects were reported. The outcomes of the events was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
On the morning of February 17th I woke in the middle of the night with a burning itching sensation over parts of my body.  My arms, abdomen and back had broken out in a rash.  I went to the dermatologist the same same day and was diagnosed with Pityriasis Rosea which is seen predominately in very young children and young adults.  The doctor was bewildered as to why someone my age would get the disease.  He did some research and found there were a few reported cases of this condition with people who had COVID and asked that I report this.
So much pain in my left arm that it became immovable by the next day.  It felt like my arm was broken and needed to be in a cast.  I finally had to put my arm in a sling to keep it from moving around.   I could hardly sleep and basically lost the next day (03/17/21), being in pain and sleeping on and off throughout the day.  This even through taking Motrin and/or Aleve.  Today is day 2 after the injection.  My arm is still very sore, but I can let it hang down.  I cannot raise it though.  I am taking Aleve twice daily and feel tired even though I slept for 12 hours last night.
PATIENT REFERS THE DEVELOPMENT OF HIVES (ALLERGY-LIKE) IN TRUNK AND ARMS 48 HOURS AFTER VACCINATION. WAS TREATED WITH CLARINEX 5MG AND ORAL STEROIDS.
Patient developed severe arm pain. I believe within a few hours of the vaccination. Her husband took her to the emergency room where they examined her and took x-rays. They could find no structural issue. She was sent home with a pain prescription and instructions to ice for 3 days and then alternate ice with warm. Patient saw her family physician, I believe the next day. He referred her to orthopedic for exam. He scheduled patient for an MRI this coming Saturday, 12/09/2017. I talked to patient today...she is getting better, but, still experiencing pain.
Lymphadenopathy, anterior cervical chain. Comment: cervical node swelling and tenderness x 7 days. Headache, general. Fatigue, Malaise <60 Days, Erythema, Edema at injection site 50-120 mm , Tenderness, Lymphadenopathy axillary, Blurred Vision: visual changes including blurring intermittently; describes as black out. ...couldn't see; lasted < 1 minute.
Fever, chills, nausea, fatigue, joint pain, headaches, weakness, muscle pain - they have not gone away yet. Missed a little bit of work. I talked to doctor - with a visit. My auto-immune diseases started flaring a lot.  I was in so much pain - never felt it in my entire life.
No pregnancy adverse events. Delivered baby 3/12/21. While in hospital for routine postpartum monitoring, given polyethylene glycol prophylactically as part of routine postpartum regimen. I have no medication allergy history and have not previously taken polyethylene glycol. When taken in hospital, had immediate reaction of sneezing, scratchy throat and hives on back, chest and face. Symptoms all self resolved in about 10-15 min (offered benadryl but did not take).
ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/6/2022,  11/28/2022,  11/26/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Information has been received from a nurse concerning a 14 year old female who was vaccinated with the second dose of the Gardasil (Lot # 658094/0524U) on an unspecified date. It was reported that the patient experienced seizure like activity after receiving the vaccine. Her eyes rolled back in her head and briefly lost consciousness. The patient sought unspecified medical attention. She recovered 40 minutes after injection. The nurse also reported that the refrigerator where the vaccine was stored was "4 degrees colder than it should have been". Upon internal review, seizure-like activity was considered to be an other important medical event. This report is one of two reports from the same source. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a 7 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 09-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally (incorrect product storage). The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Pain under my arm. Feels like a swollen armpit gland in the arm that received the vaccine. My boss said that she and her daughter experienced the same thing and it went away in a couple days.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On multiple unspecified dates, the patients were vaccinated with improperly stored VAQTA (dose and route unknown, lot# L023232, expiration date: 25-FEB-2017. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
grandma called Am of 27JAN94 stating pt had elevated temp of 105 & sz;
Mom called at 2:45 pm stating child had his shots that morning and is screaming, has given 2 doses of Tylenol and is inconsolable.  He cried for 1-2 hrs.  We suggested Tylenol every 4 hrs and a warm bath.  Call if further complications or continues.
I got my vaccination yesterday (Sunday, 03/10/19) at about 4 p.m. Today (3/11/19), I woke up at 5 a.m. freezing. I was not able to get warm all day until after 6:30 p.m. (11 1/2 hours after waking up) despite cranking up the heater, bundling up, and staying under thick comforters all day. As the morning progressed, I got a headache, felt achy all over, got a slight fever, and severe chills. All of these symptoms lasted all day. I also had some diarrhea after breakfast, but it hasn't recurred. By 10 a.m. I couldn't get out of bed I felt so awful. It took until 7:00 p.m. before I started feeling slightly better. The chills seem to have subsided but I still have a slight headache and I'm still achy.
Increased blood glucose, arm soreness, redness at injection site, swollen injection site, fatigue, headache, muscle aches, low grade fever
pt reports severe reaction to site, pain & swelling, swollen lymph nodes; whole arm swollen evening of the shot, swelling has subsided today;
Runny nose; Body was hurting; Temperature was little bit warm than normal; Little bit tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), MYALGIA (Body was hurting), PYREXIA (Temperature was little bit warm than normal), FATIGUE (Little bit tired) and HEADACHE (Headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A.) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form  On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.  On 05-May-2021, the patient experienced RHINORRHOEA (Runny nose), MYALGIA (Body was hurting), PYREXIA (Temperature was little bit warm than normal), FATIGUE (Little bit tired) and HEADACHE (Headache). At the time of the report, RHINORRHOEA (Runny nose), MYALGIA (Body was hurting), PYREXIA (Temperature was little bit warm than normal), FATIGUE (Little bit tired) and HEADACHE (Headache) outcome was unknown. Not Provided          No concomitant medications reported. No treatment information provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was not applicable.
Increase of Pulse, Fatigue, chills, Headache, Palpitations, Body Pain
Very bad taste in mouth (happened within a minute) that is lasting.  Overwhelming tiredness within 5-10 minutes.
Initial case received from a pharmacist on 25 September 2009. A 67-year-old patient, with no reported history, presented to the hospital with "acute coronary" and possible autoimmune hemolytic anemia six days after receiving FLUZONE SV (lot not reported) on 12 September 2009. The patient presented to the emergency department on 18 September 2009 with acute coronary, and at the time of the report was being assessed for autoimmune hemolytic anemia. The reporter did not provide any additional information.
pt recvd vax on 7DEC92 & on 8DEC92 had sudden onset fevers, chills, nausea & vomiting; h/a later approx 3 days; devel significant local tenderness;
It's very hard to describe, but in late February, I began to have a strange sensation in the middle of my chest. It felt almost like and anxiety type feeling when you lose your keys or wallet. I was concerned it was heart related. I saw my doctor for an existing appointment and described my symptoms. He advised that I take one of three over the counter acid reducers. I went with a 14-day course of lansoprazole. Tomorrow is my last day. It seems to have helped, but the sensation is not entirely gone.
Felt left side of face was swollen in less then an hour after injection. Redness/swelling ( slightly greater then 5cm)at injection site still present 48 hours later. Mild fever  since injection, still persisting. Chills, tired, slight headache and slight achiness.
Treatment of COVID-19; Treatment of COVID-19; Dose Number: 1 Moderna; Dose Number: 2 Moderna; Dose Number: 3 Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received bnt162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster), single (Lot number: F12593) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Jan2021 as dose 1, single (Lot number: 013L20A), in left arm, on 18Feb2021 as dose 2, single (Lot number: 011M20A), in left arm, on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm, on 03Oct2022 as dose 5 (booster), single (Lot number: 055F22B), in left arm and on 05Jun2023 as dose 6 (booster), single (Lot number: A571858), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "ADD" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 01Jan2019, stop date: 07Sep2023; ROSUVASTATIN, start date: 01Jan2019, stop date: 07Sep2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Nov2021, outcome "unknown", described as "Dose Number: 1 Moderna; Dose Number: 2 Moderna; Dose Number: 3 Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from  12Sep2023 to 16Sep2023.
Sore arm at injection site; Joint pain in my knees; Tiredness and fatigue.; This is a spontaneous report from a non-contactable consumer, the patient. A 28-years-old male patient received the second  dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3247)  via an unspecified route of administration, administered in Arm Left on 12Feb2021  at 11:30 (at the age of 28-years-old) as SINGLE DOSE for covid-19 immunization. Facility in which vaccine was administered was a Workplace clinic Medical history included Known allergies: Penicillin. Concomitant medication included paracetamol (TYLENOL). Historical Data includes  BNT162B2 Dose 1,  Lot number: EL3247,  Administered on 22Jan2021 at 12:00, in the Left arm for covid-19 immunization. No other vaccines were given within 4 weeks.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 12Feb2021 at 16:00 The patient experienced sore arm at injection site,  joint pain in my knees,  tiredness and fatigue. The events were considered non serious. No treatment was given for the events.  The clinical outcome of the events sore arm at injection site,  joint pain in my knees,  tiredness and fatigue were recovering.     No follow up attempts are possible. No further information is expected.
My son is 11 and received the Tdap shot on 8/29/18. He was fine day of shot. Next day (8/30)his arm sore and a red circle became obvious near injection site. By mid afternoon he had 101.9 fever, very lethargic and his arm was swollen very bad. Fever next morning (8/31)of 100.9. Pain continues next day. Still swollen and red area very obvious. Took to doctor to check - he said yes, it's a reaction to the vaccine. It was not infected and he should be better by Tuesday (which is 6 days from the shot!). Last night (8/31) he had diarrhea and today (9/1) he has a terrible headache and can't sit up or stand without throbbing pain. He has now missed 2 days of school because of this vaccine.
Day 1: moderate arm pain. Day 2: fatigue, headache for half a day in the am and started developing heavy breathing and sudden changes in cardiac rhythm (mild). Days 3-6 heavy breathing and changes in cardiac rhythm continued increasing, particularly at night. Took ibuprofen, increased liquid intake, rested. Days 7-8: Symptoms were a bit milder. Day 9: Tachycardia at night, sensation of fainting. Day 10 to 19 (today): dizziness that varies from lightheadedness to vertigo to nausea every single day.  I went to the pharmacy on Day 16 and got Sea Band Accupressure bands, ginger Dramamine and ginger gum which have helped a little.  As a side note, I am a very healthy person who has never suffered a side effect like this one from any vaccine. I haven't even had a cold in the past year. I had to google the symptoms online and found a thread at VEDA (vestibular.org) with a very long list of people who are suffering from the same thing.
Approx 48hr p/immun, pt experienced a non-pyretic maculo papular rash over the entire body & an episode of diarrhea four hrs later; On exam had mild erythematous throat; No tx; Pt has sinus congestion 1 wk prior to immun;
On 5/12/21 (one day after first vaccine) I got a bullseye rash on my face.  First test for lyme was positive, but no tick was found. Subsequent tests for lyme were inconclusive. I completed doxycycline treatment for Lyme. In July, I started suffering from migraines and fatigue. I also experienced an increase in ADHD symptoms despite being on medication that had been effective for 5+ years. I sought treatment from my infectious disease doctor(thinking it was lyme related and he assured me it wasn't) who suggested I try antihistamines as I had fluid in my inner ear. I tried antihistamines with no success.  I went to my  my primary care doctor about the headaches and earaches, who referred me to a neurologist. After my November vaccine, I got another malar rash. The rash and inconclusive neurological testing led my neurologist to refer me to a rheumatologist. No autoimmune issues were found, but given the pattern of autoimmune symptoms after the vaccine, the rheumatologist mentioned she has seen quite a few patients who had strong immune responses to the vaccine that mimicked autoimmune disease.
L sided facial (Bells) palsy.  tx with prednisone & Valtrex.
Patient experienced feeling of anxiousness after receiving vaccine and taking albuterol inhaler.  Patient allowed EMS to take vital signs and felt better after 20 minutes of rest.  Refused transport to hospital.
Extreme cold/flu symptoms but also a blinding headache for approximately 10 hours despite taking 1300mg of Tylenol.
August 21st positive for COVID-19 - lingering symptoms: joint pain, LUQ pain, random headaches, sore muscles in legs.  September 11th first dose of Pfizer (EW0191) sore arm, headache/tired next day. Worsening joint pain. Around 11:30am October 2nd received second dose of Pfizer. By 11:45 pm rigors, blue lips/fingers, elevated heart rate. Took scorching hot shower and bundled up. Fever followed 100.8, headache, took extra strength Tylenol 1000mg total. Relieved symptoms. October 3rd around 3:00pm had same symptoms , same treatment.  Relieved fever. October 4th happened again around 4:15pm same treatment.
Woke up to a Severe fever of 102.8 F. Proceeded to use cold compresses and take 2 Tylenol 500mg tablets. Fever stared to go down after an hour.
Information has been received from a medical assistant concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot# not reported) that after delivered, had sat on the counter overnight and for half the next day before it was refrigerated. Subsequently, the patient complained of muscle soreness at the injection site and painful arm. The patient mentioned it on their next office visit. It was unknown if the patient sought medical attention. On an unspecified date the patient recovered. The medical assistant contacted during telephone follow-up could not supply the following information: patient name, date of birth, date of vaccination, lot number or date of event. Follow up information was received from an office manager indicating that there was no specific patient and no specific information that they wanted to provide. This is one of several reports received from the same source. No further information is available.
pt recv vax FEB98 & 8-10 days post vax pt exp a local inj site rash;the rash was a red raised wheal, non-tender;
pt recv vax 19DEC96 & 21DEC96 pt exp a 1/2 inch induration @ the lt arm inj site;no tx was given;
Generalized Aches/Pain; Hot Sensation; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized Aches/Pain), FEELING HOT (Hot Sensation), NAUSEA (Nausea) and VOMITING (Vomiting) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M2O and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (Generalized Aches/Pain), FEELING HOT (Hot Sensation), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Generalized Aches/Pain), FEELING HOT (Hot Sensation), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.            No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.