chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a patient who is a nurse, who "a few years ago" was vaccinated intramuscularly with a dose of 0.5 ml of PNEUMOVAX 23. The patient reported she experienced an injection site reaction when she received PNEUMOVAX 23. She was given the dose intramuscularly and she could not lift her arm within a few hours after receiving the dose. Her arm was red, very swollen and painful in the front of her arm near the bicep not exactly where she received the vaccine. The day after vaccination she ran slight fever and was tired. The patient recovered in a few days. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient with sickle cell disease. Developed high fever < 24 hours after vaccination, as high as 102.5 (verified in peds ED was 40.2F), leukocytosis to 35K. Was well prior, no other possible source of fever identified. Given h/o sickle cell disease, was admitted, started on IV ceftriaxone, required 2 day hospitalization. Fevers resolved within two hours of ED visit. Blood cultures no growth to date.
Per patient, pharmacist inserted needle, claimed to have hit the bone and broke the needle and took the needle out, got a new syringe and inserted in upper arm again.
received vaccine at 31 weeks pregnant; arm was mildly sore at the site of the injection; This spontaneous prospective pregnancy case was reported by an occupational therapist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (received vaccine at 31 weeks pregnant) and VACCINATION SITE PAIN (arm was mildly sore at the site of the injection) in a 39-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 28-Mar-2021. On 25-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (received vaccine at 31 weeks pregnant) and VACCINATION SITE PAIN (arm was mildly sore at the site of the injection). On 25-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (received vaccine at 31 weeks pregnant) had resolved. At the time of the report, VACCINATION SITE PAIN (arm was mildly sore at the site of the injection) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jul-2020, Pregnancy test: positive (Positive) positive. On an unknown date, Blood glucose: good (normal) good. On an unknown date, Blood test: good (normal) blood test to look for abnormalities- good. On an unknown date, Ultrasound antenatal screen: good (normal) good.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.
Extreme fatigue the day after the vaccine.  Swelling of the right knee.  Difficulty walking due to knee swelling.  Right knee cap developed "Golf ball" protrusion.  fatigue lasted about 24 hours, beginning 24 hours after the vaccine.   Knee swelling has slowly reduced in size over the course of the past six weeks.
patient received 0.25ml dose; A spontaneous report was received from a healthcare professional , concerning a female patient of 69 years of age, a prisoner , who received  Moderna's COVID-19 vaccine and she received only 0.25 ml of the dose.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 25-mar-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number  017B21A) via  intramuscular route on her left arm for COVID-19 infection prophylaxis.  On 25-mar-2021,the patient was administered 0.25m l doses of Moderna vaccine for prophylaxis under dose. Prison Nurses would like to know how to move forward and if another dose should be administered immediately.  Action taken with mRNA-1273 in response to the event was unknown  The outcome of the event, the patient received 0.25 ml dose was recovered and resolved.; Reporter's Comments: This report refers to a case of accidental under dose for mRNA-1273, lot # 027A21A with no associated AEs.
Extremes irritability, began crying uncontrollably the morning of June 6th and that lasted for weeks. Sometimes crying 15 hrs long during the day. He was then  later diagnosed with Transverse Myelitis on August 14, 2017
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On an unknown date the patient was vaccinated with PEDVAXHIB (strength, dose, route and lot number unspecified) which underwent a supported temperature excursion (Incorrect product storage). No adverse effects were reported. This is one of the 23 reports received from the same reporter. Additional information has been requested.
Muscle aches, fever, dizziness, lowered blood pressure; Symptoms persisted for more than 24 hours.
Dose 1 mild possible anaphylaxis lasting only minutes - 6 days severe normal side effects Dose 2 - Pretreated per Allergist recommedations - Extreme fatigue, cognitive impairment, lymphedema, peripheral edema, fluid retention, weight gain, loss of hearing in left ear
Pfizer-BioNTech COVID-19 Vaccine.  Headache and fatigue
Immediately following vaccines, flu like symptoms, fatigue, joint pain (especially knees) headache, disorientation and ringing ears. Elevated cholesterol, excessive sweating and chills,plantar fascitis, large muscle group fatigue. Treatment on going, dr's care.  Follow up:  Do not know lot numbers.  Vaccine administered by employee, do not wish to question unless required.
Inbound call from HCP who stated a patient received their second dose of GARDASIL 9 "about 6 months ago" and now has a complaint of chronic pain in her left arm where the vaccine was administered. No additional AE details or PQC.; This spontaneous report was received from a physician concerning a female patient who was 11 years old at time of vaccination. The patient's concurrent conditions included pain in knees, ankles and elbows. The patient's medical history and concomitant therapies were not reported.  On 05-JAN-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #1775808, expiration date: 20-AUG-2023), administered intramuscularly for prophylaxis (anatomical location and dose were not provided). In approximately August 2022 (reported as about 6 months ago), the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  On an unknown date, the patient had complaint of chronic pain in her left arm where the vaccine was administered. The patient sought medical attention but did not receive treatment for the event. She had a negative inflammatory work up (unspecified). At the moment of this report, the patient had not recovered from the event. No causality assessment was provided.
SHORTNESS OF BREATH AND FEVER UP TO 101.6 BEGINNING ABOUT 6 HOURS AFTER INJECTION.  SHORTNESS OF BREATH PERSISTED THROUGHOUT THE NEXT DAY.  USED INHALER AND IT IMPROVED AND EVENTUALLY SUBSIDED.
high blood pressure within 15 min post vaccination. BP 180/94/BP rose to 202/110; This is a spontaneous report from a contactable nurse. An adult female (age:18-64 Years) patient (pregnant: No) received first dose of BNT162B2 (Pfizer), intramuscularly in left arm on 05Jan2021 10:30 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was received other concomitant drugs. The patient experienced high blood pressure within 15 min post vaccination. BP (blood pressure) 180/94 rose to 202/110 on 05Jan2021 10:45. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The events were reported as non-serious. Recipient experienced high blood pressure within 15 min post vaccination. Went to hospital where her pressure was 202/110, vaccine given on 05Jan2021 at 10:30 am, by 10:45 am BP was 180/94, recipient refused hospitalization. Sister took her home but made her go to the hospital where her BP rose to 202/110. IV (intravenous) steroids given. The outcome of event was resolved in Jan2021. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The medications the patient received within 2 weeks of vaccination: Protein drink. Unknown whether was the patient diagnosed with COVID-19 prior to vaccination. Unknown whether the patient been tested for COVID-19 Since the vaccination. Unknown allergies to medications, food, or other products.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported event hypertension. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
I (the patient) woke up 2 hours after going to bed and could not seem to get warm (shaking uncontrollably) and I was too nauseous to get out of bed to check temperature or take medication. I had taken 2 Motrin at approximately 8pm. I had terrible pain in lower back, hips and legs and was unable to go back to sleep. The nausea subsided enough around 4am to allow me to take my temperature (101.9) and take Tylenol. Temperature was reduced to 100 by 6am. I was unable to get back to sleep after waking at 12:30am and suffered back and hip pain all day on the 23rd. On the 24th through the 26th I had a headache and was unable to sleep without taking a PM product (Tylenol PM). Symptoms continued to get better over the course of the next 3 days.
dry heaves, uncontrollable dry heaves; sick to my stomach; chills; fatigue; headache; nausea; fever; redness at the injection site and going down the arm; swelling the size of an orange; A spontaneous report was received from a 72-year-old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Retching ( dry heaves and uncontrollable dry heaves), abdominal discomfort (sick to my stomach), chills, fatigue, headache, nausea, pyrexia (fever), vaccination site erythema (redness at the injection site and going down the arm) and vaccination site swelling (swelling the size of an orange).  The patient's medical history was not provided. Concomitant medications reported were omeprazole, simvastatin and vitamins.  On 25-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 26-JAN-2021, the patient developed redness at the injection site and down her arm as well as swelling the size of an orange.  She also reported that she experienced  nausea, dry heaves, headache, fever, chills, fatigue and she was sick to her stomach.  She reported that she went to the emergency room (ER) for over four hours due to the uncontrollable dry heaves.  Admission to the hospital was not described in the initial report.    Treatment for the events included diphenhydramine and ondansetron.  Action taken with mRNA-1273 in response to the events was unknown.  The outcomes of events, redness at the injection site and going down the arm, swelling the size of an orange, nausea, dry heaves, headache, fever, chills, fatigue and sick to my stomach, were considered unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore shoulder) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer (throat cancer) on 01-May-2019. Concomitant products included TAMSULOSIN and FINASTERIDE for Enlarged prostate, XYLITOL (XYLIMELTS) for Mouth dry.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ARTHRALGIA (sore shoulder). On 28-May-2021, ARTHRALGIA (sore shoulder) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Electrocardiogram: abnormal (abnormal) premature atrial contraction. On 05-May-2021, Heart rate: low (Low) bradycardia was diagnosed more than 1 time and 36 (Inconclusive) The patient normal pulse rate is in the low 50s. On 27-May-2021, Heart rate: 47-48 (Inconclusive) 47-48,which is closer to his normal pulse rate.         No Treatment information was reported.
Fever 102, chills, aches, severe headache.  Alternated ibuprofen & Tylenol at dosage frequencies.  Fever has resolved but still have body ache and severe headache as of Nov 20th 9 am.  Will try to rest to see if headache resolves.
Acute pain when given. Took ibuprofen & heat/cold. Prednisone then PT. Ultrasound. Dr. noted shot was misplaced PT started Jan. 1, 2014. 4 months for recovery.
everyone I know that got the Shingrix had only an arm sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-Jun-2022 Reporter's Comments: The reporter reported the case via interactive digital media. The reporter reported that it's very strange that everyone he/she knew that got the Shingrix had only an arm sore. Additional Supportive  The follow-up would not possible, as no contact details were available. This case is linked to the case US2022AMR088928, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR088928:same reporter
Elevated heart rate, it is slightly elevated like adding them is overall hundred but it would be in the low, in the mid 90s; Heart rate is increased like in 90 like 91, 92, 93 like that mid to low 90s; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer Covid-19 vaccine, Solution for injection, Batch/Lot Number: EL9266; Expiration Date: 31May2021), via an unspecified route of administration on an unspecified date as Dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced elevated heart rate, it is slightly elevated like adding them is overall hundred but it would be in the low, in the mid 90s; heart rate is increased like in 90 like 91, 92, 93 like that mid to low 90s on an unspecified date. When asked about the concern, consumer stated, the heart rate is increased like in 90 like 91, 92, 93 like that mid to low 90s. Patient just wanted to know is that something that other people have reported. Consumer was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department and provided with the number and website link as (website withheld). Further probing couldn't be done because consumer was unwilling to further answer any questions. Reason of delay was spike of incoming calls due to COVID19 vaccine. The patient underwent lab tests and procedures which included heart rate: elevated heart rate. I felt like elevated heart rate, it is slightly elevated like adding them is overall hundred but it would be in the low, in the mid 90s, which is usually not resting. This is usually not for me, it went up to like 90 and my heart rate is usually in the high 70s and 80s."The heart rate is increased like in 90 like 91, 92, 93 like that mid to low 90s. The patient received treatment reported as unknown. The clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected
had the flu 1 time; Initial information received on 05-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient).  This case involved an adult patient of an unknown age and gender who had the flu 1 time(Influenza) after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date and other dosing details were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient reported that patient knew a woman got hers every year -sick as dog for 6 weeks EVERY time !!!!!! no thanks ----in 50yrs patient have had the flu 1 time(Influenza) No relevant laboratory details were provided. It was not reported if the patient received a corrective treatment.  Outcome of the events were reported as unknown.  There will be no information available on the batch number for this case.
Headache, Myalgia,  FATIGUE; "PULLING SENSATION IN CHEST" Narrative:
Approximately 24 hours after the vaccine, I felt a rash on the back of my neck. It is red, dry, flaky skin. It is very dry and leathery feeling and itches and burns occasionally. The rash is contained to the back of my neck and has stayed the same since first appearing - it hasn't gotten better or worse. I am using a cream given by a dermatologist to try to heal the rash.
Information has been received from a physician concerning a pt who was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt developed a full blown severe case of chickenpox. No other complications were reported and the pt was still recovering at the time of the report. Additional information has been requested.
rash and itchiness at site of injection; itchiness at site of injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number GB429, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date.).   On 22nd September 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 22nd September 2020, 1 hr after receiving Shingrix, the patient experienced injection site rash and injection site itching. On an unknown date, the outcome of the injection site rash and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash and injection site itching to be related to Shingrix.  Additional details were reported as follows: The reporter asked how common the duration and intensity for an event in patients was that received Shingrix. The patient had developed a rash and itchiness at site of injection soon after vaccination. The reported batch number 6B429 for Shingrix did not exist and was updated to GB429 as per the sales database. On the day of reporting the patient still had the rash and itchiness present. The reporter consented to follow up.
Reaction began 4 days post injection:  Severe red itchy rash initially on legs from knees to hip; both hands and entire arms.    Rash spread to both feet, parts of calves and and to waist on day 2 of adverse reaction.  Doctor instructed me to take a Zyrtec at night for 2 nights and to decrease dosage to 1/2 pill each night until rash disappeared.  He also instructed me to take Claritin during the day until rash disappeared.   I used initially a topical cortisone cream without much success in stopping the itching.  Rash was first noticed Thursday morning, January 21,  4 days after the injection on January 17.   By Sunday, January 24 it was nearly gone and by Monday, January 25 it had disappeared.
24 days p/vax pt had 3 days of t103 oral, very painful joints; reluctant to walk;
migraine/headache; migraine/headache; chills; myalgia; arthralgia; sensitive skin; flank pain; This case was reported by a physician via call center representative and described the occurrence of migraine headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain. On an unknown date, the outcome of the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain were unknown.   It was unknown if the reporter considered the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter believed that the adverse events were much more severe after 2nd dose compared with the 1st dose. No additional demographic information of patient was provided. The reporter consent to follow up. This is 1 of the 6 linked cases reported by the same reporter.
Pain in left shoulder, lack of motion, pain when reaching up, lifting, movement, lack of sleep. Orthopedic DR, medication, physical therapy, and now trying acupuncture. No treatments have provide relief or restored motion.
PATIENT RECEIVED PNEUMOVAX (LEFT ARM) AND FLUZONE (RIGHT ARM) ON SUNDAY 10/21/07 AROUND 3:00. PATIENT REPORTS SHE BEGAN TO EXPERIENCE REDNESS AND PAIN IN LEFT ARM LATE THAT EVENING. SAW A VISITING NURSE TUESDAY 10/24/07, WAS REFERRED TO EMERGENCY ROOM. PATIENT DIAGNOSED WITH CELLULITIS AND GIVEN ANTIBIOTIC TREATMENT FOR 10 DAYS.
Patient given Hep B vaccine on 02.06.08 (L deltoid).  On 02.07.08, arm became swollen, red, warm to touch, painful from shoulder to elbow.  Treated on 02.08.08 with Cephalexin 500-One every eight hours; cool compress; Advil/Tylenol.
This spontaneous report was received from a pharmacist referring to a 13 year old male patient with asthma and an unspecified allergy treated with medication (no further details were provided); additionally, the patient had no drug reactions. On 19-APR-2018, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported). On 20-APR-2018, the patient vomited. The patient did not seek medical attention, no treatment was given for the adverse event and no laboratories or diagnostic tests were carried out. The outcome of vomiting was reported as recovered on an unspecified day in April 2018. Causality assessment was not provided.