chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients will complain about pain in the injection site following a dose of Bexsero; In general she has seen swelling in the arm; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site pain and swelling arm. On an unknown date, the outcome of the injection site pain and swelling arm were unknown.   It was unknown if the reporter considered the injection site pain and swelling arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. 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 reporter was an ARNP (advanced registered nurse practitioner). The age at vaccination was not applicable for this report. The reporter mentioned that in general she had seen swelling in the arm and the patients would complain about pain in the injection site following a dose of Bexsero. No specific patient information was available. The reporter did not consent to follow-up.
Patient was a Resident on our LTC wing.  Per the LTC Manager: Resident had hx of CVA with deficits in speech and extremities. Hx of decreased circulation to BLE's which resulted in wounds to bilateral feet on and off that needed treatment. Average meal consumption 25-50% of meals, started refusing more often in December and January. Would consume small amounts 60-120mL of fluids here or there. Vaccinated on 1/7/21. Stopped eating 1/18/21. Attempted bolus NS fluid 1/25/21. Resident refused all treatment afterwards. Went hospice on 2/3/21 and passed away on 2/7/21.
Pt received vaccine on 6/26/09. On 6/28/09 pt c/o chest tightness, shortness of breath, chest congestion & tightness. DX with asthma flare per ER MD.
Patient called PCP office 3/5 w/ c/o N/V/D, weakness and lightheaded when she stood up. Was advised to hold blood pressure medication. On 3/8, was feeling much worse and called 911. Upon arrival (8:55), patient A&O x 4 with poor oxygen saturation (O2: 88%). Given nebulized albuterol/ipratropium. BG: 247mg/dl. Patient has episode of dry heaving after which she vagaled down with HR in the 40s. Recovered on her own. Once the nebulizer treatment ended, she was place on nasal O2 at 3 liters/minutes. Given 4mg ondansetron. Lost consciousness and respirations became agonal. Pt was bagged via BVM and noted to be in PEA. CPR initiated, including intubation. Given 1mg epinephrine. NSR obtained after two rounds of CPR. Pt arrested again shortly after arrival to ED. ACLS initiated once more. Patient expired at 10:40 am.
This case was reported by a consumer via call center representative and described the occurrence of pain in a elderly male patient who received 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. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 74 or 75 years old. The patient received SHINGRIX and has no adverse reaction other than soreness. The reporter heard that many people get a bad reaction from 2nd dose. The reporter wanted to know was that likely.
Symptoms began September 12th with fever of 101 degrees F., severe headache, stiff/painful neck, fatigue, and body aches. Symptoms worsened and fever progressed to 104 degrees F on September 13th. Visited ED on September 15th where lumbar puncture was performed for suspected menigitis (negative). ED detected gram-negative bacteria in blood and possible inflammation of appendix on September 16th. Laproscopic appendectomy performed on September 16th (no inflammation found in appendix during operation). Blood results confirmed septicemia on September 17th with bacteria species Salmonella S. Chester. Hospitalized and started IV antibiotics on September 17th.. IV antibiotics continued for 7 days. Blood results negative for Salmonella 7 days later. Discharged from hospital on September 24th.
Information has been received from a nurse practitioner concerning an approximately 16 month old male with no known allergies or pertinent medical history who on 08-JAN-2003 was vaccinated SQ with a 0.5ml dose of VARIVAX vaccine (MERCK) (Lot # 643821/0865M). There was no concomitant medication. In February 2003, he had a rash with raised bumps that were not itchy which later subsided. He was not seen in the office. On 22-MAR-2004 he was seen in the office with clusters of vesicles and pustules with yellow fluid on his right hand and arm. He was seen the same day by a dermatologist with a diagnosis of Shingles. The patient was treated with oral acyclovir. The patient has completely healed and there were no isolates to collect for VZVID. Additional information has been requested.
It was reported that a female pt received a Menomune A/C/Y/W-135 vaccination on 9/29/00. Reportedly, on 9/30/00, the pt complained of severe headache, a temperature of 102F, nausea and vomiting and malaise. Further information requested.
Red and swelling extending from left shoulder halfway down left arm. Dermatologist recommended Claritin, which did not help. Later that night, patient could not sleep due to pain in left wrist. Wrist pain worsened next day and not relieved from Norco or Neurontin. Patient never experienced respiratory symptoms and no fever was observed by daughter.
Redness at injection site and about 6 inches below site. Warm to the touch. Itchy.
Moderna 1/22/21, 2/16/21, 8/24/21, 5/17/22. Positive on 7/20/22
I smell like a newborn baby diaper. I have tiny water blisters on my neck, arms. What is going on??
Patient woke up coughing  blood tinged, mucus this morning. Denied fever, vomiting, and diarrhea. Patient was sent to the emergency department.
Swelling of lymph node under the injection arm.  Swelled to size of golf ball and lasted one week.  Fatigue lasted 2 days.
Patient tested positive for COVID-19 on 03/29/2021 via both antigen and PCR despite being fully vaccinated. She was subsequently hospitalized and then died on 03/30/2021. Symptom onset for COVID-19 was 03/23/2021, with symptoms of fever (101.8) and respiratory distress which required an increase in oxygen.   Per the death certificate, causes of death are as follows:  Part 1: Cause of Death: A. Multi organ failure B. COVID-19 infection  Part 2: Other Significant Conditions:  Congestive Heart Failure, Diastolic Heart Failure with Preserved Ejection, history of cerebrovascular accident, diabetes mellitus type 2, and morbid obesity
This spontaneous report as received from a consumer refers to a female patient of unknown age. The patient's medical history included arthritis and systemic lupus erythematosus. No drug allergies.  Approximately 2-3 years ago, the patient was vaccinated with ZOSTAVAX, intravenous for shingles prevention. Concomitant therapies included acyclovir (ACYCLOVIR). On 18-JUL-2017, the patient experienced herpes zoster although she received ZOSTAVAX (vaccination failure). She reached out to her health care professional (HCP) and pharmacist, and they prescribed antibiotics. No laboratory diagnostics/studies performed. The outcome of herpes zoster and vaccination failure is unknown. Causality was unknown. No Product Quality Complaint (PQC) was involved.
In same arm that previously in 2/05 a BCG was given, a 10 x 14 cm, red swelling with slight enduration at site of BCG - not at site of DTaP/IPB was vigorous (was above site of BCG).
Information has been received from a health professional concerning a 23 year old black/white female receptionist with asthma (diagnosed at the age of 5 year old) and outdoor allergies who on 19-APR-2007 at 01:15 (AM or PM not reported) was vaccinated IM in left arm deltoid with a first dose of Gardasil lot #655849/0263U. Concomitant therapy included montelukast sodium (MSD) loratadine (+) pseudoephedrine sulfate (LORATIDINE D) and albuterol sulfate (VENTOLINE (albuterol sulfate)). On 20-APR-2007, Friday night at 11:00 PM patient woke up with short of breath. Her rescue inhaler did not help so she used her nebulizer. On 21-APR-2007 she used her nebulizer again around 6:30 AM and through out that day 4 to 6x. On 22-APR-2007, Sunday she did 6 nebulizer treatment within one-two hours before being admitted at the hospital. In the hospital she had additional nebulizer treatment (10+) times and steroid injections. Patient stated that this was her worst asthma attack since being diagnosed. Patient recovered. Additional information is not expected.
This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions and drug reactions/allergies was not reported. On 14-DEC-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ, oral, lot # K020181 with expiration ate 24-JUN-2016. Concomitant medication was not reported. No adverse effect was reported. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unspecified dates, in a range from 01-APR-2015 through 30-APR-2015, the patients were vaccinated with improperly stored doses of ROTATEQ (Lot# reported as K006056, expiration date, 08-MAR-2016) (Strength, dose and route were not provided). Concomitant medications were not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sore arm; Vision problems; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VISUAL IMPAIRMENT (Vision problems) and HEADACHE (Headache) in a 71-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), VISUAL IMPAIRMENT (Vision problems) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), VISUAL IMPAIRMENT (Vision problems) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
Immediate Dyspnea, Difficult to Breathe, Clubbing of fingers. Pulmonary fibrosis    Severe dyspnea Hypoxia Pulmonary Fibrosis Immediately following COVID19 Vaccination No prior Lung disease Had Excellent Cardiopulmonary function Before Vaccine Lifelong Nonsmoker
ITCHING, WARMTH AND RED INDURATED AREA 9 X 14 CM.
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: The patient had tingling above and below her lips. Benadryl was given after a few minutes of monitoring. After administration of Benadryl, patient started experiencing a tingling sensation in her hands. 1 dose of the 0.3 mg epinephrine injection was administered before 911 was called. Patient's vitals were taken by paramedics. She has fully recovered and is at home resting comfortably.
Severe pain in my chest when laying down. Repeated for about two weeks. Thought I was having a heart attack at first.  Pericarditis. Still feel tightness sometimes now.
Patient's husband called to report that his wife was in the hospital due to a blood clot that formed in her leg. He stated that she was having organ failure. Patient is currently being treated at a local hospital for blood clots that were moving and affecting her organs.
Pt developed hoarseness and cough 8 hrs after MMR given. Was given Albuterol and seemed to improve 7 hrs later, he developed a croupy cough and wheezing, ambulance was called. Pt brought to ED, given Duo-neb, Decadron and Vaporephin and admitted to hospital for 8 hrs. Then discharged home. Dx appear c/w croup but given timing allergic to MMR.  Additional term from Discharge summary was dyspnea.
The patient did not receive third dose of rabies vaccine; Case reference number US-BN-2021-000051 is a spontaneous case report initially received from a health care professional via Agency (reference number USBAV21-0050) on 08-Feb-2021, and concerns a 43-year-old male patient.   The patient's medical history included hypertension, autism, alcohol abuse, post-traumatic stress disorder and insomnia.  The patient's concomitant medication details were not provided.  On 25-Jan-2021, the patient received the first dose of RabAvert (Inactivated Rabies Virus Vaccine, Batch no. was not provided)  at a dose of 1cc (cubic centimeter), administrated intramuscularly for post-exposure-bite  On 28-Jan-2021, the patient received the second dose of RabAvert (Inactivated Rabies Virus Vaccine, Batch no. ARBA731B) at a dose of 1cc (cubic centimeter), administrated intramuscularly and for post-exposure bite.  On 01-Feb-2021, the patient was scheduled the third vaccine dose, but it was not administrated (inappropriate schedule of vaccine administered). The patient received antibiotic shot instead of RabAvert.  On 07-Feb-2021, the patient received the third dose of RabAvert (Inactivated Rabies Virus Vaccine, Batch no. ARBA731B) at dose of 1cc (cubic centimeter), administrated intramuscularly and for post-exposure prophylaxis.  It was not reported if the patient experienced any adverse events due to RabAvert.  It was stated by the reporter that the patient was immunized with the first dose of the vaccine, and that the patient realized that he did not received the third dose of RabAvert. The antibiotic shot was administrated. Those two events happened at a health care facility other than the reporter's.   No further information was provided.; Reporter's Comments: Inappropriate schedule of vaccine administered is listed by convention. The patient did not receive the scheduled third rabies vaccine which is considered inappropriate schedule of vaccine administered. No adverse events were reported. Inappropriate schedule of vaccine administered is not related to RabaVert, but to human action.; Sender's Comments: Inappropriate schedule of vaccine administered is listed by convention. The patient did not receive the scheduled third rabies vaccine which is considered inappropriate schedule of vaccine administered. No adverse events were reported. Inappropriate schedule of vaccine administered is not related to RabaVert, but to human action.
12:10 pm Rash on legs and then spread to body. Benadryl 12.5mg  4ml given
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, less than a month after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. In 2016, one month before the reporting date, the patient received 1st dose of BEXSERO. At the time of reporting, the patient returned to physician's (MD) office for receiving 2nd dose of BEXSERO. During office visit, the patient commented that the pain (specific to injection site) from the 1st dose had recently ceased. This case has been linked with case US2106153389, reported by the same reporter.
Pt had vaccine on 8-23 states rash on lower legs developed 2 days later. Denies being on any new meds. Pt came into clinic 9/6 and a red - petechiae rash noted over both lower legs.
Called to patient room by nurse who reported that a few minutes after vaccines patient complaining of worsening throat pain and difficulty breathing. Went to see patient and he reported that he was mostly having severe throat pain. His respiratory exam was normal except for tachypnea; no stridor was noted. Per mom and nurse, patient was quite anxious during shot. A Rapid Strep test was done since patient was complaining of severe throat pain. He was able to drink water. He calmed and breathing slowed down.
Patient developed dizziness within five minutes of booster vaccination.  RN encouraged PO fluids, as patient had not had any water today.  Symptoms progressively worsened and patient experienced tightness in her chest, then tingling in her legs.  Within 30 minutes, patient was unable to lift her legs or ambulate.  RN called a code and patient was transferred to ED.  Unsure of details of care in ED, but according to discharge note, patient regained ability to walk and left on her own accord.
fever 105.2 WED PM, 104 Thursday, 102 Friday, rash following;
Day1 of vaccine 1/25/21-at 7 pm started having chills fever, body aches and severe headache.  Day 2-1/26/21-all same symptoms as day 1 took Tylenol and Excedrin with no relief or help.  Day 3-1/27/21-nothing, no symptoms.
Myocarditis. Chest pain, shortness of breath, pain when leaning over or increasing heart rate, referred pain in left shoulder
This case was reported by a consumer via call center representative and described the occurrence of ophthalmic zoster in a 61-year-old male patient who received SHINGRIX. The patient's past medical history included ophthalmic zoster (in April 2017), migraine headache and corneal lesions. Concomitant products included gabapentin. On 11th April 2018, the patient received SHINGRIX. On 11th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 13th April 2018, the patient experienced ophthalmic zoster (serious criteria GSK medically significant), migraine headache, tingling, neuralgia and eye symptom. The patient was treated with ZOMIG. On an unknown date, the outcome of the ophthalmic zoster and eye symptom were unknown and the outcome of the migraine headache, tingling and neuralgia were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved. The reporter considered the ophthalmic zoster, migraine headache, pain in arm, tingling, neuralgia and eye symptom to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient reported that he experienced some arm pain after his injection, which had resolved. The patient reported the he experienced a migraine headache 2 days after vaccination. He reported that ZOMIG usually would treat the migraine and the migraine symptoms, such as photophobia, phonophobia, head congestion, and watery eyes, but since the SHINGRIX, the ZOMIG had no effect. After the SHINGRIX vaccination, it felt like he was getting those zoster and ophthalmic symptoms back again which he had experienced in last year. The patient reported that he was experiencing some neuralgia and tingling. The physician contact details were provided.
Patient returned to pharmacy on 9/10 stating that she was diagnosed with cellulitis in the injection arm (this was per physician). Upon examination, arm appeared red and swollen.  Patient states that she was experiencing pain in the arm and that she was feverish.  Patient received prescriptions for methylprednisolone dose pack and amoxicillin-clav antibiotic.
pts right arm had swelling, and a rash to the vaccine site. pt was seen by pcp on 3/8/2023 and was given and antibiotic and steroids, for possible allergic reaction, and infection.
10 hours post vaccine - chills, fatigue, headache, sweats. Arm a bit sore but not as bad as dose 1.  sx subsided within 36 hrs
PT complaining of cramping LLQ abdominal pain and nausea appx 8hr after receiving injection lasting until appcx 36hr after injection
This spontaneous report was received from a nurse regarding approximately 175 unspecified patients of unknown age and gender. There was no information on medical history and drug reactions or allergies. On an unknown date, the patients were vaccinated with PROQUAD (Merck) (strength, dose, route not reported) that were exposed to temperatures outside of the recommended storage range. No adverse effect reported. There was no product quality complaint involved. The outcome of the events was unknown. This is one of the several reports from the same source. Additional information has been requested.
Initial vaccination site reaction with swelling, redness, for several days. Then a delayed immune reaction across the chest and opposite shoulder that included redness, swelling and some discomfort. Given Prednisone in the urgent care.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 12:19 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 12:19 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 41.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 09 AM and 10 AM, temperature was 34 and 37 respectively, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.