chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash; itchy rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number XJ57B, expiry date 18th October 2019) for prophylaxis.   On 28th July 2019, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced rash and itchy rash. On an unknown date, the outcome of the rash and itchy rash were recovered/resolved.   It was unknown if the reporter considered the rash and itchy rash to be related to Shingrix.  Additional details were provided as follows: The pharmacist stated she was told the information by a patient's husband. He described the rash as itchy. Pharmacist believed the rash had resolved at the time of report. The batch number was reported as SJ57B from the reporter; however, based on safety batch number review, the batch number was corrected to XJ57B.
hypotension and bradycardia. iv placed with 1 liter saline b olus sent t0o hospital via paramedics
approx 30min p/vax pt c/o abd pain, chest pain, throat feeling funny, nose running & red eyes;BP 120/82;rapid pulse;911 called taken to ER;given IV & 02;SOB, nausea;redness to chest, arm;cough, sneezing;dx acute allergic rxn;wheezes;
fever; chills; red; swollen; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced fever, chills, erythema and swelling. On an unknown date, the outcome of the fever, chills, erythema and swelling were recovered/resolved.   The reporter considered the fever, chills, erythema and swelling to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported.  After receiving dose of Influenza vaccine Quadrivalent unspecified season, the patient experienced fever, chills, so red and swollen for about a week. The patient had bad reaction to  Influenza vaccine Quadrivalent unspecified season vaccine. The reporter did not consent to follow up. This case has been linked with US2020AMR249292, reported by same reporter for same patient for Shingles vaccine..; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR249292:same reporter
Initial unsolicited report received from a Physician on 16 October 2014. A 5-year-old female patient, who had medical history of seasonal allergy and allergy to cat and dog, and concomitant medications were not reported, had received an intramuscular dose of FLUZONE QIV (Batch number, expiry date and site of vaccination not reported), on 06-NOV-2014. On an unspecified date, after vaccination the patient had swelling at the injection site, induration, and hot to touch at the injection site. The patient had no illness at the time of vaccination were unknown. Laboratory data were not reported and patient had received FLUMIST as corrective treatment. At the time of this report, the patient was not recovered. List of documents held by sender: none. Follow up information received from a physician on 06 March 2015. It was reported that the lab tests were not performed. The patient did not receive any concomitant vaccines. List of documents held by sender: none.
.  I started my first job as an RN, and on June 16,  I was sent to employee health to be given the first of the series of HepB vaccines. I informed them of my reaction to the tetanus vaccine and they insisted Hep B vaccines did not have serious adverse side effects and it was required because I was in a high risk category as a health care worker.  Two days later on the afternoon of June 18, I began experiencing severe stomach cramping and projectile vomiting and diarrhea simultaneously, and I knew this was not the norm for stomach bugs, my heart rate was increasing and we took my blood pressure which was somewhere around 80/50, very low for me. (It was even lower upon arrival to the hospital).  The vomiting and diarrhea and cramping was continuous and I knew it was delayed gastrointestinal anaphylaxis from the vaccine.  My husband took me to the nearest hospital ER, and we were told the HepB vaccine would not cause this.  I was given IM phenergan and observed for several hours.
Indication-Treatment of COVID-19; Indication-Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 12Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Indication-Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Treatment included nirmatrelvir/ritonavir (PAXLOVID) from 19Jul2022 to 23Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
hot feeling; pressure between shoulder blades; sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot feeling), DISCOMFORT (pressure between shoulder blades) and VACCINATION SITE PAIN (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 an unknown date, the patient experienced FEELING HOT (hot feeling), DISCOMFORT (pressure between shoulder blades) and VACCINATION SITE PAIN (sore arm). At the time of the report, FEELING HOT (hot feeling), DISCOMFORT (pressure between shoulder blades) and VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Information has been received concerning a male who on 11-SEP-2010 was vaccinated with PNEUMOVAX 23 (lot # 663889/0632Y). There was no concomitant medication. On 11-SEP-2010 the patient experienced a reaction to the pneumonia vaccination. The customer's arm became swollen and red. Follow-up information has been received from a lawyer and medical records concerning a 66 year old male who had what was reported as a severe reactions to a 0.5mL PNEUMOVAX 23 (lot #0632Y) on 11SEP2010. He has sustained damages as a result. On an unspecified date, the patient had an office visit and had a CBC (results not provided). He was also given ROCEPHIN 1 gram injection and a prescription for BACTRIM DS/KEFLEX. The patient was instructed to return in two weeks. All available medical records will be provided upon request. Additional information has been requested.
PT FELL AFTER HEAVILY DRINKING. FELL BACKWARDS FROM 5-6 STEPS AND HIT HEAD ON CEMENT. UNRESPONSIVE, MOANING. BLEEDING FROM BILATERAL EARS
Vertigo, equilibrium started day after vaccine still continuing to present 10 days later. Also mild headaches and fatigue.
In the evening - I had a mild headache and chills; And had generalized joint pain and soreness on the arm on Saturday and Sunday. Those all continued for a few days and then that resolved. Shortness of breath and chest pain started 10 days after - they lasted for about a week and they resolved simultaneously. I went to my doctor and he did some tests. Everything was normal. No treatment except diet and exercise.
Client received the 1st dose of COVID vaccine Moderna lot #041B21A and expiration of 5/6/2021 at 11:00AM. At 11:11  AM client reports nausea to EMT 4 minutes before her 15 minutes of observation were up. EMT gave client emesis bag. Client went to the restroom and vomited x1.  Client reports vomiting and feeling better-no nausea or headaches reported, EMT gave client water bottle.  At 11:16 am vitals were as follows: blood pressure: 110/50, pulse: 83 and oxygen 98%. PHN notified and found patient sitting upright alert and oriented x 4.  Client was asked to stay another 30 minutes.  Client reports eating breakfast.  Client reports no history of any medical conditions. She takes no medications, no allergies. No history of any reactions to vaccines prior to this vaccine.  No complaints, client states she"feels fine."  Client is not driving but taking the bus home.  At 11:20 AM vitals were as follows: blood pressure: 120/100, pulse: 77 and oxygen 98%, repeat blood pressure. Client alert and oriented and feels fine, having a conversation with PHN.  At 11:35AM vitals were taken blood pressure 120/80, pulse: 76 and oxygen: 97%.  Client reports no symptoms. At 11:46AM vitals were as follows: blood pressure: 130/90, pulse: 74 and oxygen 97%, client reports feeling fine.  At 11:50AM client walked out of facility with a steady gait.
Large rash (redness, swollen) ~8-10cm diameter around injection site. Minor itchiness. Occurred at the 8th day post 1st dose, rash is lighter in color today (9th day) but spread ~1 cm.
Patient developed extreme fatigue x 12 hours on 10/302021.  Took tylenol and started feeling okay, at 5pm she started having chills and fever of 102.  Had fatigue after this that lasted the whole weekend.  She called her doctor on 11/1, fever subsided, but she was exhausted.  On 11/3 she had a cough with cold symptoms and she went to Urgent care to be evaluated.  11/4 she had a loss of appetite with 3 "weird" bowel movements, metallic taste.  She was advised to go to Health Center and get a COVID-19 test.  Had history of COVID 19 in 2020.  11/5 results of Covid Test were positive/detected for the virus.  Advised to stay home for isolation period, call doctor about symptoms and test results.  Got pulse oximeter- 97-98%.  11/10 Dr. prescribed prednisone medication because she was still coughing.  11/12 started feeling better
Elevated heart rate, 25 BPM. Trouble Breathing, Headache, wheezing. Laid down made it easier to breath, almost went to emergency room.
Syncope; Body aches; This case was reported by a nurse via sales rep and described the occurrence of syncope in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced syncope (serious criteria GSK medically significant) and general body pain. On an unknown date, the outcome of the syncope and general body pain were unknown.   It was unknown if the reporter considered the syncope and general body pain to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient went to the emergency room for treatment.
Symptoms began late evening/night day of vaccine and continued throughout next day: Headache, left-sided neck pain, loss of taste, loss of appetite, bilateral pain in kidney area along with inability to control urine (times three episodes), and intense backache.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Delayed allergic reaction. Itchy rash on chest, neck and eyelid. Eyelids moderately swollen.
Employee states feeling  lightheaded and stomach ache and pallor noted one hour post vaccine administration. Employee was taken into office to be monitored. Medical staff recorded employee temperate of 99.0 , Blood pressure of 112/75, heart rate of 84. Staff noted employee skin is pink, warm and dry. Employee advised to rest and if symptoms persist or worsens follow up with a healthcare provider.
6+ months later I developed bloating, sensation that food was not passing through my GI tract at  normal speed. No vomiting or signs of obstruction, no pain or tenderness.
Information has been received from a registered nurse concerning a 17 year old female who on 14 Feb 2007 was vaccinated IM in the left deltoid with a 0.5mL dose of Gardasil vaccine. There was no concomitant medication. On 22 Feb 2007 the patient "developed a painful lump underneath the arm pit of the same injection arm". The nurse reported that the patient was told to follow up with the physician as soon as possible. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Resident was inadvertently given a bivalent booster vaccine when she had not yet been vaccinated with their primary series. No adverse reaction was noted, and she tolerated the injection.
HEADACHE-2 HOURS,   FEVER,CHILLS,DYSPNEA,TIGHT FEELING IN THROAT-6 HOURS     EDEMA & ERYTHEMA OF FACE-12 HOURS   EDEMA OF FACE AND HANDS-ONE WEEK    HYPOTENSION-12 HOURS             TREATMENT--IV FLUID, STEROIDS, BENADRYL, CARDIAC MONITORING 01/22/07-records received and reviewed for DOS 01/03-01/05/07 DC DX: Allergic reaction to influenza vaccine:Tachycardia Present illness:two hours after flu shot developed headache and subsequent fever, chills, fast heart rate and funny feeling in her neck. No difficulty breathing. Only prior symptoms in past were a midsternal intermittent tightness for past 3 weeks.  TX: Solumedrol and Benadryl in ER
lt eye & cheek turned red w/in 1hr; temp ranged from 102.8-103.8-101.6 fr 24hrs; given APAP; screamed x 1hr;
bruising at injection site, severe headache, difficulty sleeping, Per patient: "felt like someone socked my arm"
My right eye started it water and itch. It?s still doing it and it?s red, like I have pink eye. It started the following day after shot.
it is also affecting the shoulder joint, is now having pain in other joints - right shoulder and the knees; have been experiencing pains on their left shoulders (injection site), kinda hurts where it was administered; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (it is also affecting the shoulder joint, is now having pain in other joints - right shoulder and the knees) and VACCINATION SITE PAIN (have been experiencing pains on their left shoulders (injection site), kinda hurts where it was administered) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A and 014F21A) for COVID-19 prophylaxis.     Patient had no medical history or conditions, allergy, concomitant diseases and risk factor.  Previously administered products included for Product used for unknown indication: J and J (1st dose). Past adverse reactions to the above products included No adverse event with J and J.   On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (it is also affecting the shoulder joint, is now having pain in other joints - right shoulder and the knees) and VACCINATION SITE PAIN (have been experiencing pains on their left shoulders (injection site), kinda hurts where it was administered). At the time of the report, ARTHRALGIA (it is also affecting the shoulder joint, is now having pain in other joints - right shoulder and the knees) and VACCINATION SITE PAIN (have been experiencing pains on their left shoulders (injection site), kinda hurts where it was administered) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Patient stated that since the 2nd booster dose patient have been experiencing pains on their left shoulders (injection site). Patient stated that they never got sick before they got the shot. The pain started shortly after they got the shot. For the patient, initially the pain was coming and going, but now it been there all the time. It was kind of hurting where it was administered but it was also affecting the shoulder joint. No treatment information was provided by the reporter.
Information has been received from a registered nurse concerning a 57 year old caucasian female with badrim, vancomycin, ciprofloxacin hydrochloride (CIPRO) and ceffin allergy and no medical history who on 24-MAY-2007 at 9:00 AM was vaccinated SC on right arm with first 0.5 ml dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 655410/1469F). There was no concomitant medication. There was no illness at the time of vaccination. It was reported that on 24-MAY-2007 at 12:00 noon the patient developed fever, diarrhea, nausea and sore throat after vaccination. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. On 28-MAY-2007 the patient had recovered. A product quality complaint was not involved. Additional information has been received from the registered nurse who stated that the patient experienced fever, nausea, diarrhea, difficulty in swallowing for 3 days. On 28-MAY-2007 the patient recovered. No additional information is expected.
Itchy rash when pt approached after 30 minute waiting period. No shortness of breath. Blood pressure and heart rate within normal limits.  Given 37.5 mg liquid diphenhydramine and to continue dosing this med every 6 hours for next day or two. Called pt 3 days later was feeling fine rash disappeared next day.
Difficulty walking; Tingling all over body; A spontaneous report was received from a consumer who is an unidentified patient that received Moderna's COVID-19 vaccine and experienced tingling all over the body and difficulty walking.   The patient's medical history was not provided. No relevant concomitant medications were reported   On an unknown date in Dec 2020, the patient received their first of two planned doses of mRNA-1273 via unknown route for prophylaxis of COVID-19 infection.   On an unknown date in Dec-2020, the patient reports having tingling all over the body, one week after receiving the vaccine. The patient also reports difficulty walking since 28-Dec-2020.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, tingling all over the body and difficulty walking, was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
This spontaneous report was received from a registered nurse referring to two patients of unknown ages and genders. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (Lot # M013156, expiration date 15-OCT-2017) dose, route and frequency were not reported. The temperature and time frame were unknown (thermometer was not calibrated). There was no previous temperature excursion reported and data logger was reported as yes. No adverse effects were reported. This is one of two cases received from the same reporter. Additional information has been requested.
Child received the Flu vaccine between 9am & 10:30AM left the building with her mother and in the parking lot c/o being itchy and scratchy all over inside and out, even the mouth. Mother gave benedryl which she always carries and she got better within 20-30min. Mother stated no allergies, including eggs except bug bites. The father however has severe allergies to many things and she knows what an allergic reaction is. She called her PCP and he was going to note it in her chart so she does not get another Flu shot.
Urinary Tract Infection Symptoms Burning and pain when urinating Blood in urine Urgent sensation to urinate Extreme Fatigue Headache  Waiting to see Doctor for urology appointment
patient developed itchy rash with vesicle that contains clear fluid on top of an erythematous base-rash located on left wrist/forearm
Patient had a rash (red area with some pain) in the same arm as the PREVNAR injection but did not start until after 1 week from injection.
Large red rash lasted 1 1/2 wks itching. Swollen. Hot to the touch.
Vaccine given in am. Early evening arm had "bumps" all over, fingers numb. Later on face started swelling. Lips swelled. No difficulty breathing. Dx-Angioedema.
high blood pressure; fever of 101F; headache; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 01Feb2021 as single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller got the first dose of the Pfizer vaccine on 01Feb2021. Her second dose was scheduled on 19Feb2021 which was only 18 days after. She would like to know whether there be a problem. Caller said she also experienced high blood pressure, fever of 101 F, headache from her first dose. She said that she had already reported this in DSU (possible duplicate AE). Caller was worried about her second shot of the vaccine since she had adverse events with the first shot. She wanted to know what to do. Outcome of the events was unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.