chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Systemic: Nausea-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Medium, Additional Details: hypotension 102/74. symptoms resided after pt laid down with feet/legs elevated. after 30 minutes additional observation, patient felt back to baseline.
I82.409 ACUTE DVT, UNSPECIFIED VEIN 2/5/2022 ACUTE DVT, UNSPECIFIED VEIN J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/19/2022 ACUTE DVT, UNSPECIFIED VEIN
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Fever-Mild
Patient claims that after the flu shot in his left arm he had sudden shooting  pain sensation down his arm starting almost immediately after his shot. Also has started a rash on his back only on the left side as well by where the arm is. Patient was instructed to go see primary care physician to determine the cause of the rash and the pain in the arm.
Muscle aches; This case was reported by a consumer and described the occurrence of muscle pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st December 2020, the patient received Shingrix. On 4th January 2021, 4 days after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, after vaccination the patient had muscle aches. The reporter did not consent to follow up.
This spontaneous report was received from a pharmacist and refers to a 73-year-old female patient. The patient had no pertinent medical history. The patient's concurrent condition included unspecified reaction to angiotensin-converting-enzyme (ACE) inhibitors. On 11-JUL-2014, the patient was vaccinated with the first dose of ZOSTAVAX (lot # L046893, expiration date: 23-FEB-2017), subcutaneously. Concomitant therapies included simvastatin (manufacturer unknown), Losartan potassium (manufacturer unknown), hydrochlorothiazide, BYSTOLIC, Loratadine, clopidogrel and meloxicam. On 03-OCT-2016, the patient developed an unspecified symptom. On an unknown date in approximately 2016, the patient was diagnosed with shingles (an unspecified location of the body), by unspecified healthcare professional. No treatment was given for the adverse events. The outcome of the events was reported as recovering. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Patient developed severe nausea and vertigo as well as generalized weakness, which started May 5.  Progressed to the point that she  was unable to ambulate on her own at home and family called ambulance on 5/8/21 to take her to  Health Care facilty. She received IV fluids, meclizine and ondansetron with gradual improvement.  Still required walker and assistance by the time of discharge on May 13, 2021
Pt noticed red lump that went around arm the day after vaccine. Swelling resolved and still feels twinges once in a while.
I got really sick the next day with a slight fever, body aches, and a mild headache . And a itch a lot for a couple of hours and was fine the next morning.
Client had reaction after vaccination- client became light headed and sweaty, water was given, VS were taken, P60, BP110/70, SPO2 97%. Client recovered and left after sitting 15 minute in waiting area.
Meningococcal was given/administered as a third dose. Vaccine was administered, 04/28/2023, extra as third dose when she had already received her second dose and was fully vaccinated for her age.
Administer 0.5ml dose to the patient instead of the indicated 0.3mL dose. Patient noted typical injection site pain and swelling, perhaps more pain the previous. No residual symptoms.
Injection site swollen to softball size, hard, red and warm to touch.  Went to ER and was discharged to home with prescriptions for Crphalexin 500 mg TID and Methylprednisolone 21 day dose pack.
Extreme high fever, severe joint pain several days (7 days later). Followed by muscle weakness. Called Dr. and they said it was OK. Possible arthritis diagnosed but not confirmed. Muscle weakness for few mnts.
Burning in arm, joint aching, loss of deltoid muscle strength, loss of strength in right arm, dropping things. Approximately 5 days of exhaustion and memory confusion. Some aching in leg muscles. Initial swelling (really big) for about 10 days.
Patient broke out in a rash and went to the dermatologist.  The dermatologist confirmed it was eczema.  The rash occurred after both doses of Shingrix and resolved with the application of steroid cream prescribed by her dermatologist for the eczema break-out.
HEADACHES; FATIGUE; NUMBNESS IN ARM; NUMBNESS IN LEG; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced numbness in arm. On APR-2021, the subject experienced numbness in leg. On 10-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, and had not recovered from headaches, numbness in arm, and numbness in leg. This report was non-serious.
11:37 initally slightly lightheaded, arm tight feeling, 11:39 L arm starting to itch, refused benadryl a few times. 11:41 starting to feel a little dizzy, offered to lay her down, she was sitting, refused. Headache beginning, dizzy, a little hard to focus. states she suffers with panic attacks on occasions. Arm more itch and throat a little itchy - Administered diphenhydramine liquid orally 25mg at 11:46pm.  11:53 itching , redness on L arm and throat improving - feeling sleepy. 11:53 BP 113/80, pulse 88.  offered another dose of diphenydramine; declined due to drowsiness. She insisted on going home to rest- her father came to get her aprox 12:30am.  She has family to keep an eye on her also. Has a migraine, sleepy, tightness in Left arm. I advised seeking emergency treatment if symptoms get worse and to update the pharmacy after she is feeling better. I will also follow up with her as discussed.
Shot given too high in shoulder - extreme pain while receiving. Could not move arm or use arm immediately after shot. Doctor visit 10/3 & 10/17 - referred to orthopedic surgeon. Surgeon - 10/20, MRI 10/24, & surgeon f/u 10/31 - Surgery 11/1/11 due to extreme inflammation. PT f/u.
CHILLS, FEVER AROUND 100 degrees TERRIBLE Headache lasted  all 3 Days SICK TO STOMACH - vomited SO SICK WAS Right down in bed 3 DAYS
Reportedly had a seizure and fainting episode in the evening after receiving a vaccine in the afternoon (hours later)
Patient is fully vaccinated and boosted on 12/6/2021.  COVID + 1/4/2022 at ED visit.57-year-old female presents to the ED complaining of cough, generalized body aches, chest pain, subjective fever, generalized weakness and malaise. Her chest pain is worse with coughing. Her cough is productive of green sputum. Her chest pain is anterior and nonradiating. She has mild dyspnea. No leg pain or swelling, denies history of DVT/PE.BP 105/78  | Pulse 102  | Temp 97.8 °F (36.6 °C) (Oral)  | Resp 14  | Ht 170.2 cm (5' 7")  | Wt 89.4 kg (197 lb)  | SpO2 98%  | BMI 30.85 kg/m² EKG normal.  CXR: No acute cardiothoracic process.She was given IV fluids, Toradol, Robaxin, Zofran. Discharged home.
Day after vaccine was given patient complained of soreness to arm, with decreased range of motion, and increased pain.  Patient did have an approximately 1 cm by .75 cm bruise to area, no redness, or swelling.  One week later patient demonstrated continued decreased range of motion.
I experienced the all the symptoms that are commonly known to happen after taking the vaccine (fatigue, fever, chills, and swollen at the site of the injection). I overcame those symptoms but then on 03/29/2021 the onset of anxiety came on four weeks after receiving the vaccine and became progressively worse. I sought care from my doctor on 05/25/2021 and am currently seeing a counselor (tried medication but I experienced severe side effects) who decided that therapy would be the best option moving forward.
Per daughter, patient died the next day after receiving the shot. Patient didn't have any issues with 1st shot and she went to check on her and she was dead.
Significant red, mildly raised area, tender when pressure is applied on 05/23/2017 at 10PM and 05/24/2017 at 10AM. On 05/25/2017 at 9:30AM there redness and swelling spread. Pt stated it had gotten better the night before prior to worsening. She denied any systemic reactions. Pt was advised to take OTC Benadryl and Ibuprofen PRN.
Redness, swelling, fluid filled blister at injection ste. MD started course of SEPTRA DS 1 PO BIX x 14 d on 11/9/13. Swelling measured 6x6 cm. Blister filled with clear yellow fluid measuring 4x3 cm.
Pain in jaw after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (Pain in jaw after 2nd dose) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016b21a and 001b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN JAW (Pain in jaw after 2nd dose). At the time of the report, PAIN IN JAW (Pain in jaw after 2nd dose) outcome was unknown. Not Provided
This case was reported by a consumer via patient support programs and described the occurrence of feeling unwell in a 68-year-old female patient who received influenza vaccine unspecified. Co-suspect products fluticasone propionate, ADVAIR inhalation powder (batch number 5ZP9982, expiry date 2016). Concurrent medical conditions included allergy (the patient can hardly talk and thinks that, that was may be from allergies). On 25th November 2015, the patient received influenza vaccine unspecified. In 2015, the patient started ADVAIR at an unknown dose and frequency. In 2015, less than a month after receiving influenza vaccine unspecified and an unknown time after starting ADVIAR, the patient experienced feeling unwell and speech disorder. On an unknown date, the outcome of the feeling unwell and speech disorder were unknown. It was unknown if the reporter considered the feeling unwell and speech disorder to be related to influenza vaccine unspecified and ADVAIR. Additional details were received as follows: This case was received from the healthcare provider vis program for ADVAIR. The patient called for the re-enrollment in the program. After vaccination the patient had not felt well. The patient stated that she could hardly talk and that she thought that may be because of the allergy, which she was having on and off for years. The reporter was unable to provide exact start date of ADVAIR, but was started in early 2015.
ringing in ears; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program.  A 55-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot no: ENU204), first dose via an unspecified route of administration, administered in right arm on 30Mar2021 11:00 as single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient took the first Covid vaccine on 30Mar2021 and had Covid virus back before then on the 07Mar2021. On an unknown date in 2021, the patient experienced ringing in ears (tinnitus). The patient stated that the ringing in ears was worsened. Dates for has not had second dose; was at day 42 and wants to take it. Since patient has had the vaccine, he noticed ringing in the ears or either it made it worse and is not sure if it's side effect or not. patient has not had the second dose and is at day 42 and wants to take it but wants to know if there is any information about a short term flare up about the ringing in ears or anyone else reporting ringing in ears. At the time of this report event outcome was not recovered.   No follow-up attempts are needed. No further information is expected.
I am cold; Ache; Soar throat; I have sore lymph node in injection arm pit; Chills; This spontaneous case was reported by a pharmacist and describes the occurrence of NASOPHARYNGITIS (I am cold), PAIN (Ache), OROPHARYNGEAL PAIN (Soar throat), LYMPH NODE PAIN (I have sore lymph node in injection arm pit) and CHILLS (Chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (I am cold), PAIN (Ache), OROPHARYNGEAL PAIN (Soar throat), LYMPH NODE PAIN (I have sore lymph node in injection arm pit) and CHILLS (Chills). At the time of the report, NASOPHARYNGITIS (I am cold), PAIN (Ache), OROPHARYNGEAL PAIN (Soar throat), LYMPH NODE PAIN (I have sore lymph node in injection arm pit) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Product temperature excursion issue; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 29-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided.
Initial report from a health care professional (medical assistant) on 27 Apr 2010: This child was vaccinated with expired S-OIV FLUVIRIN, (batch no: 102046p1, with a expiration date of 31 Mar 2010), (dose: 0.5 ml) intramuscularly on 26 Apr 2010. No adverse reaction had occurred.
Pt became pale, diaphoretic p/immun extremely nervous prior to immun; arm & legs weak; Pt layed down w/feet elevated; c/o stomach aching & throat soreness;
T- 102, achiner, fatigue, chills, pounding HA, dizziness
Systemic: Seizure-Mild, Systemic: Shakiness-Mild
No additional AE/PQC.; HCP calling to report AE for expired dose of PNEUMOVAX 23 PFS that was administered to a patient on 25OCT2023. Product expired 29JAN2023. Product did not have any previous temperature excursions. No side effects were reported. No other medical inform; This spontaneous report as received from a physician refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 25-OCT-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # U022984, expiration date 29-JAN-2023 (dose, route of administration and anatomical location were not reported) for prophylaxis (Expired product administered). The suspect vaccine did not undergo temperature excursion. No side effects were reported (No adverse event).
The affected individual donated a unit of plasma and then, shortly thereafter, received the TENIVAC vaccine. After receiving the vaccine, the individual had a syncopal episode the lasted approximately 10-15 seconds. The individual recovered quickly and had no further symptoms.
Chills; shakiness; headache; joint pain; tiredness; nausea; metallic taste in mouth; injection site pain; redness; This is a spontaneous report from a contactable other health professional (patient). A 47-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8730) via an unspecified route of administration, administered in Arm Right on 24Mar2021 at 15:00 (at the age of 47-year-old) as dose 2, single for COVID-19 immunisation. Medical history included rhinitis allergic, hypertension, diverticulum and Penicillin allergy. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Historical vaccine included bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration, administered in Arm Right on 03Mar2021 at 15:00 (at the age of 47-year-old) as dose 1, single for COVID-19 immunisation. On 25Mar2021 at 02:00 the patient experienced Chills, shakiness, headache, joint pain, tiredness, nausea, metallic taste in mouth, injection site pain, redness. Patient visited emergency room for the events. Patient was treated with antibiotics. The patient underwent lab tests and procedures which included sars-cov-2 (Nasal swab): negative on 28Mar2021. Since the vaccination the patient been tested for COVID-19 and results were negative. Outcome of the events was recovered on unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
pt recv vax 18DEC95 & LMP 9NOV95 & pt was found to be pregnant;estimated date of delivery 15AUG96;ultrasound were performed on 4JAN96, 3MAR96, 19APR96, 8JUL96 & 27JUL96 (results not reported);pt dx w/PIH;labor induced delivered nl male;
Information has been received from a Doctor of pharmacy concerning a 76 year old female patient with hypothyroidism and hypertension and no allergies or drug reactions who on 14-APR-2011, was vaccinated with a dose of ZOSTAVAX (Merck) 0.65 ml, subcutaneously in the left arm (lot number 670385/0232AA, Exp. 16-MAY-2012). Concomitant therapy included LIPITOR, nifedipine, furosemide and SYNTHROID. The pharmacist reported that 10 minutes following the injection, the patient started to experience a headache and the patient's face became "flushed". The pharmacist reported that the patient's blood pressure was elevated at 142/80. The patient was given a cup of cold water and the patient has been observed in the pharmacy. The pharmacist mentioned that if the patient's headache and facial flushing did not resolve, the pharmacist "will refer the patient for medical evaluation". The patient did not receive any treatment for the event. There was no laboratories performed. At the time of the report the outcome of the patient was unknown. Additional information has been requested.
PATIENT HAD PFIZER COVID VACCINE  Dose 1 date: 01/19/2021,  Dose 2 date: 02/09/2021, AND TESTED POSITIVE TO COVID ON 8/31/21.
This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a receptionist for the practice. The age at the vaccination was not reported. The patient experienced flu like symptoms for 1 to 2 days. The reporter agreed to receive follow up from GlaxoSmithKline. This case was linked with the cases US2018GSK205481 and US2018GSK204598, reported by the same reporter.
I have COVID -- I had headache, chills, cough, loss of taste and smell, body ache, stuffy nose, soar throat. My worse symptoms (chills body ache tiredness) lasted for one night. Next day I had headache and stuffy nose. Day after that loss of taste and smell at night. Now today loss of smell and stuffy nose.
First event 4 days after vaccine (2nd) dose...vaginal lesions, nausea,vomitting, headache -E.R visit diagnosed with herpes, all subsequent tests negative - 6/7/09 headache, fever, lesions: mouth and vaginal, aspetic meningitis, hospitilized for 5 days- diagnosed with Behcets disease  7/16/09 Medical records received DOS 7/25/07 to 7/08/2009. Assessment: Meningitis, viral unspecified. Behcet's Syndrome. Patient presents with papular lesion on outer vaginal opening. Vulva - White papular lesions. Vulvovaginitis. Increasing painful multiple ulcers vaginal area, purulant discharge, pain with urination. Genital herpes. Wart right hand. Vulvovaginitis. Hospitalized for viral meningitis. Rash: torso and arms -hyperpigmented patches, legs - flesh colored nontender papules. Consultation note: Oral-genital ulcers with papular rash and meningeal symptoms.  7/16/09 Hospital discharge summary DOS 6/14/09 to 6/17/09. Assessment: Behcets Patient presents with 3 days of severe frontal headache. 2 oral ulcers on tongue and 4 genital ulcers. Intermittant raised rash on torso and extremities. Nausea and vomiting. Not taking adequate PO.
chills; fever; body soreness; headache; feels like a truck is sitting on top of me; still feel weak; runny nose; A spontaneous report was received from a consumer, concerning a female patient of 74 years, who received Moderna's COVID-19 vaccine and experienced chills, fever, body soreness, runny nose,and headaches,awful feeling,feel weak,feels like a truck is sitting on top of me.  The patient's medical history was covid-19 in mar-2020. Concomitant product use was Zocor, Ambien,Premarin by the reporter.  On an 01-mar-2021, prior to the onset of events, the patient received their first of two planned dose of mRNA-1273 (lot number 010A21A ) via intramuscular route for COVID-19 infection prophylaxis.  On an 2-mar-2021, after first dose of vaccine, the patient experienced ongoing chills, fever, body soreness, runny nose,and headaches,awful feeling,feel weak,feels like a truck is sitting on top of me. No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events was considered to be unknown at the time of this report.