chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child received dose of Act HIB that was mixed with sterile water instead of .4% saline/NoAE; Initial information was received on 07-Feb-2020 regarding an unsolicited valid non-serious case from nurse.  This case involves a 16 month old male patient who received HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) that was mixed with sterile water instead of 0.4 percent saline.  Medical history, medical treatment, vaccination and family history were not provided.   On 07-Feb-2020, the patient received 0.5ml of suspect HAEMOPHILUS INFLUENZA B Conjugate (ACT-HIB) VACCINE (lot UJ161AA and expiry date 26-Nov-2020) via an intramuscular route in the thigh NOS (not otherwise specified) for prophylactic vaccination.  It was an actual medication error due to wrong solution used in drug reconstitution.  Child received dose of Act HIB that was mixed with sterile water instead of .4% saline.  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.
Fatigue, fever, headache, and Lt arm sore and tender left axillary lymph node which began 6/19/07. Severity moderate RX Cephalexin 500mg 1 TID x 7 days.
Severe nausea for 6+ hours, followed by vomiting. Body aches and fatigue lasting 24 hours. Onset of symptoms began 3-4 hours after vaccination and lasted approximately 24 hours.
her doctor thought it was an autoimmune reaction to Pfizer COVID-19 vaccine; swollen, red arm (diagnosed as cellulitis); injection site pain that was really bad; lymph nodes were swollen; 101 degree fever; nausea; diarrhea; joint pain; back pain that felt like a burning sensation and was constant; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003909.  A female patient received BNT162b2, on 01Oct2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 Immunization. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "her doctor thought it was an autoimmune reaction to Pfizer COVID-19 vaccine"; VACCINATION SITE CELLULITIS (medically significant), outcome "unknown", described as "swollen, red arm (diagnosed as cellulitis)"; VACCINATION SITE PAIN (medically significant), outcome "unknown", described as "injection site pain that was really bad"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymph nodes were swollen"; PYREXIA (non-serious), outcome "unknown", described as "101 degree fever"; NAUSEA (non-serious), outcome "unknown"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; BACK PAIN (non-serious), outcome "unknown", described as "back pain that felt like a burning sensation and was constant". The patient underwent the following laboratory tests and procedures: Body temperature: 101, notes: degree.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Flu shot was administered too high in my shoulder. I am experiencing chronic shoulder pain & limited range of motion. I am attempting to reduce the discomfort with anti-inflammatory meds (Ibuprofen) and creams (Diclofenac Sodium Topical gel).
This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 26-MAR-2019, the patient was vaccinated with expired dose of VAQTA injection 50/1.0 U/ml (lot # N032753, expiry date: 23-MAR-2019) (dose and frequency were not reported) intramuscularly for prophylaxis (expired product administered). No adverse effects were reported. No product quality complaint was involved.
Received Varicella in left arm and first day had quartersize reddened swollen area by the next day the shoulder area was inflammed and injection site had blisters forming (4) red and could not touch the skin.  Got a migraine and Zomig did not help.
Fever, chills, body aches, joint pain mostly in hips, fatigue, headaches, nausea and pain at injection site started around 6 pm 2/28 and still ongoing.
Patient reported having fever, chest pain, palpitations after receiving vaccine. Fever improved with Tylenol. However cardiac symptoms persisted. Patient seen at the minute clinic on 8/30/21 and was noted to have elevated blood pressure readings 160/100, 156/104 respectively. He was referred to urgent care for further evaluation.   Of note: patient reported he received both doses and completed the series on 7/5/21
EDD-3/13/20 Painful arm, lump under the skin, red and hot to touch.
Itching arm for about two weeks after the injection. Was diagnosed with pneumonia.  Diagnosed with lungs that were scarred up.
An adult dose of Havrix was administered / to a pediatric patient.; An adult dose of Havrix was administered / to a pediatric patient; This case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 3-year-old female patient who received HAV (Havrix adult) (batch number G99R4, expiry date 20th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th March 2021, the patient received the 1st dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 9th March 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistant reported that an adult dose of Havrix was administered to a pediatric patient, which led to adult product administered to child and overdose. The reporter consented to follow-up.
myalgia; mild-fever; mild headache; This case was reported by a other health professional and described the occurrence of myalgia in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of myalgia (on 19th September 2019, received 1st dose For tolerance of 1st dose, refer linked case US2019AMR172657.).   On 17th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a day after receiving Shingrix, the patient experienced myalgia, fever and headache. Rechallenge with Shingrix was positive. On 19th February 2020, the outcome of the myalgia, fever and headache were recovered/resolved.   It was unknown if the reporter considered the myalgia, fever and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced myalgia, mild fever and mild headache. This case was linked with case US2019AMR172657, reported by the same reporter for the same patient.
The mother reports he developed erythema, induration on the left thigh at the vaccination site one day following the vaccine. At the time, it measured 5x3cm.
3" diameter red, hot, painful, swollen reaction at the injection site. Treated w/tylenol, advil, benadryl, ice. On 12/28/16, developed shoulder pain which was reported to provider on 1/3/16.
Sore arm after 1st dose; Headache after 1st dose; 13 year old received 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm after 1st dose), HEADACHE (Headache after 1st dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old received 1st dose) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old received 1st dose). On an unknown date, the patient experienced MYALGIA (Sore arm after 1st dose) and HEADACHE (Headache after 1st dose). On 27-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old received 1st dose) had resolved. At the time of the report, MYALGIA (Sore arm after 1st dose) and HEADACHE (Headache after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No concomitant medications provided. No treatment information provided.
Large bullseye rash on upper left arm - other side of elbow; This is a spontaneous report from a contactable consumer or other non hcp. A 75-years-old female non pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration, administered in Arm Left on 13Feb2021 10:30 (at the age of: 75-years-old) as dose 2, single for covid-19 immunisation. Medical history included systemic lupus erythematosus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.The patient previously took tetracycline, neurontin and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccine with in 4 weeks prior to covid vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 12Mar2021 the patient experienced large bullseye rash on upper left arm - other side of elbow. The event resulted in physician office visit. Therapeutic measures were taken as a result of large bullseye rash on upper left arm other side of elbow with antibiotics. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovered with sequelae.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I had a slight fever, the highest was a 100 it didn't last long. The site where I got the vaccine swell up and became very sore.
HYPOTENSION, ELEVATED HEART RATE, FATIGUE LASTING 2 WEEKS THEN RESOLVED ON ITS OWN
My child's teacher had covid. Then my kid got sick, and then I got sick as well. I took a covid test that day, and it was positive. I had a runny nose, sinus pressure, congestion, mild coughing, fatigue, an extreme sore throat, diarrhea, and I lost my taste and smell. My symptoms progressively got worse so I called my doctor. I got a prescription for Paxlovid. I had horrible side effects from it, and it didn't seem to help any of my covid symptoms. When I finished the medication I felt terrible, but today I feel much better. I got my smell back last night.
Pt called on 9/19/13 to report that she had developed pain on her Rt side with swelling of Rt knee and tenderness of Rt ankle that started the evening after she received her flu shot. Pt came in to see MD on 9/23/13 with continued symptoms. Pt cont having difficulty getting out of bed due to the pain. 10/3/13 pt called with c/o cont swollen joints and pain on the Rt side. 10/3/13 pt was given Rx for prednisone x 5d.
warm to touch injection site; itchy injection site; red injection site; This spontaneous case was reported by a nurse and describes the occurrence of   in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No conmeds were provided.  Treatment  information was unknown.    Reporter did not allow further contact; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Within in 10 minutes of receiving vaccine, pt complained of feeling itchy on stomach and throat. She was slightly coughing, but she was not having any difficulty breathing.  Administered 50mg diphenhydramine.  Pt then said she was generally not feeling well.
Day after vaccine arm was very very sore, with a hard lump on arm at injection site. He states he felt hot flashed and then cold flashes that continue to this day. States ' I feel like I have critters crawling up my skin starting at my legs and going through my body. Has headaches that start at the top of his head then pain radiates down the left side and then head feels very warm.  At times he feels "like I am in a tunnel " and "everything slows down (mental/cognitive)" Continues s to this day to feel like there are "lumps within soft tissue areas on inner thigh, back and burning sensations.  Chills on and off daily Exceptionally tired, no energy, feels drained. No changes in blood pressure
s/s Right thigh red, swollen and warm to touch. Swelling from area of injection postierior and down towards the knee. Mother states redness noted the evening of the injection, child did not want to walk on the leg.  She does walk on it ok now.  Leg still painful to touch. Mother provided Tylenol and warm baths for comfort.
myocarditis; shortness of breath, dizziness, light-headedness, racing pulse at times, uneven cardiac rhythm, heartburn
Screaming spells, lethargy, fever of 99.8 X 4 days. (possible reaction to pertusis)
Breakthrough case admission after 5 vaccines Pfizer 3/11/21  Lot# En6199;  Pfizer 4/1/21 Lot# ER8733;  Pfizer 8/19/21 Lot# FC3181;  Pfizer 1/21/22 Lot# FJ1614;  Pfizer 9/19/22 NO LOT #  PLEASE DO NOT CONTACT ME FOR LOT #; NOT AVAILABLE TO ME
Moderna Dose 1 2/4/21 (016M20A) Moderna Dose 2 3/4/21 (013A21A) COVID Positive 1/10/22  1/10/22: This is an 80-year-old male with history of chronic obstructive pulmonary disease on home oxygen of 2 L, essential hypertension, tobacco use and chronic kidney disease stage 2 who presented with shortness of breath. Patient reports that he has been having worsening dyspnea for the past 3 days. He wears 2 L of O2 at home.  He currently has no chest pain, abdominal pain, nausea, vomiting, fever or chills. Patient was last admitted on 03/05/2021 and was discharged on 03/07/2021 for acute hypoxic/hypercapnic respiratory failure secondary to pneumonia and chronic obstructive pulmonary disease exacerbation.   In the emergency department, patient was found to be hypoxic and was initially put on BiPAP and then was put on 4 L of O2. Labs showed a creatinine level of 2.35, troponin level of 0.03, hemoglobin of 12.5.  Chest x-ray showed bibasilar ground glass opacities. Patient was given nebulizer treatment, IV Solu-Medrol and a dose of IV Rocephin.  1/20/22: Patient is a pleasant 80-year-old male with past medical history of COPD chronically on 2 L of oxygen, hypertension tobacco use, and chronic kidney disease who was admitted on 01/10/21 after presenting to the emergency department with shortness of breath.  Patient was found be hypoxic and initially placed on BiPAP therapy.  Patient was admitted with acute on chronic hypoxic hypercapnic respiratory failure.  Patient was found to be COVID positive, there was also concern for possible superimposed community-acquired pneumonia and exacerbation of COPD. Patient with treated with courses of doxycycline and remdesivir as well as steroids.  Patient had an AKI which improved over the course of his admission.  Patient responded well to treatment and gradually wean down on supplemental oxygen, patient now is at his baseline 2 L of oxygen nasal cannula.  Will discharge home with short taper of prednisone. F/u w/ pulmonology and PCP outpatient.
PATIENT RETURNED TO PHARMACY AND SAT ON BENCH, REPORTED COLD SWEATS AND DIZZINESS.  TOOK BLOOD PRESSURE, 100/54. Sent associate to get pillow to prop up feet, took 2nd read before pt lay down: 95/56.  Patient elevated feet.  Took 3rd read: 124/72.  Had patient remain sitting for several minutes, took a 4th read 120/74.  Patient reported feeling much improved, color better, sweats and dizziness gone.  Patient elected to return to shopping and was advised to return to pharmacy or seek help if dizziness returns.
Breakthrough case admission after 4 vaccines Pfizer 2/16/21 lot# El9267;  Pfizer 3/8/21 lot# En6206;  Moderna 11/19/21 lot# 069F21A;  Moderna 7/25/22 lot# FP7139
Myalgia, NauseaVomiting, Chill, irritability, mild sore throat Narrative:
6:30 am next day after vaccine, patient developed hallucinations and became confused.  Lasted till 1 pm and then patient returned to normal with no other episodes. Patient and ex wife state that patient has had these episodes before when he had VRE and do not feel related to vaccine.
11-22-08 - Scratchy throat, fatigue. 11-23-08 - Fever 100-101 degrees, headache. No N/V/D.
Patient reported left hip pain approximately 30 minutes after receiving flu shot one month ago. She stated pain has been constant for one month.
1/12/21 at 08:00 am patient started having intense itching throughout body which worsens at night, rash to abdomen, chest, bilateral lower legs. Pt. states that she started taking zyrtec which helped patient sleep better. Pt. states that symptoms have not resolved and are still there.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXIA
NDC Number:  58160-0823-11  Approximately 10 hours after receiving the second vaccine in the series I developed a headache.  An hour after that point I developed chills, a fever, body aches , fatigue , nausea and a headache that lasted approximately 18 hours.  After the first vaccine there were no issues.
Injection site inflammation. Injection site warmth. Injection site edema. Injection site redness. Injection site pain. Injection site nodule. From initial information received on 21/Apr/2003 from the patient's parent regarding an adverse event occurring in the USA, it was reported that a 5 year old male patient received his fifth dose of DAPTACEL, lot number C1245AA, given in the right deltoid on the morning of 17/Mar/2003. That evening, the patient developed a raised, warm, red area measure 3.5x3.5 inches in diameter at the injection site. The area was also painful to touch. The symptoms lasted for two and a half weeks. The patient then developed a small pea-sized nodule at the injection site, which is still present at the time of this report and the patient has not fully recovered. Per the patient's mother, he was seen by a physician on an unspecified date. Treatment was not reported.
pt recv vax 26MAR97 & mom reports swelling & redness @ inj site on 26MAR97 & had spells of staring off that lasted about 1-2min & on 27MAR97;28MAR97 erythema @ 4.5cm from inj site w/induration;
Woke up the following morning vomiting and sweating profusely with heart racing. Followed by intense fatigue for 24 hrs.
Pt. had a local reactions 2 days post vaccine. Pt. right thigh, where immunization was given, was swollen, red, and warm to touch.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment medications was given to the patient.  The vaccines was stored in freezer, take out one to two vials and place in fridge each day as needed.
This spontaneous report was received from the referral coordinator of the physician's office and refers to a male 13 month patient. The patient has had an unknown reaction to MOTRIN. No other information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 10-FEB-2017, the patient was vaccinated with (wistar ra 27-3) M-M-R II lot # M011666, expiration date 08-MAR-2018, intramuscular for prevention of measles, mumps and rubella  (dose and anatomical location were not reported). On an unknown date, after the administration the patient was diagnosed with Autism spectrum disorder. The outcome of the event autism spectrum disorder and the causal relationship between the event autism spectrum disorder and therapy with M-M-R II (wistar ra 27-3) were not reported. Upon internal review the event autism spectrum disorder was considered to be medically significant.
Headache, myalgias, lightheadedness, severe fatigue, weakness, squeezing chest and upper back pain, nausea, chills, sweats, abdominal discomfort. Had to miss 2 days of work. 6/15/17 at 10:30 AM mostly improved but not yet at baseline.
Felt sore in the afternoon. At 4am had pain in arm it became more hot and sore as the day progressed eventually it became bumpy, sore all around all the way to arm pit. Low grade fever 100.9 by night. Today called doctor who recommended cold compresses and Motrin for fever. Fever is down but still area is red and lumpy. Separate lumps have grouped together into one large one, feels swollen tired.
12/12/22 diagnosed with unprovoked Pulmonary Embolism and Iliac DVT. survived. On blood thinners for life.
Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experinced sore arm For 2nd dose refer case US2021000525. Did not consent to follow-up. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021000525:Same reporter