chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A few sore arms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:.  An elderly female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "a few sore arms". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "A few sore arms". Additional information: The reporter stated both my wife (patient) and I (reporter) have receive our COVID-19 shots and boosters from this company and we have had practically no side effects to date; apart from a few sore arms for a day or two.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300149591 same reporter/AE, different patient;
Patient was given a booster shot of pfizer that was expired and out of the fridge for more than 24 hours. Patient currently has had no adverse reactions. Pfizer was called and it was recommended that patient needs to get another dose of pfizer. Patient has been notified.
Torn retina in my left eye; Hemerages in my right eye; This spontaneous case was reported by a patient and describes the occurrence of RETINAL DETACHMENT (Torn retina in my left eye) and EYE HAEMORRHAGE (Hemerages in my right eye) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced RETINAL DETACHMENT (Torn retina in my left eye) (seriousness criterion medically significant) and EYE HAEMORRHAGE (Hemerages in my right eye) (seriousness criterion medically significant). At the time of the report, RETINAL DETACHMENT (Torn retina in my left eye) and EYE HAEMORRHAGE (Hemerages in my right eye) outcome was unknown.            No concomitant medications were reported. On an unknown date, patient received Moderna COVID shots and boosters. It was reported that there was no price to put on loss of  site and have been seeing more and more issues going on about these covid shots.  No treatment medications were reported.  Company comment- This is a spontaneous case concerning a male patient of unknown age with no medical history reported, who experienced the unexpected serious (medically significant) events eye haemorrhage and retinal detachment. A dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine was administered on an unspecified date, hence latency cannot be assessed. Details of symptoms, clinical course, investigation reports and treatment were not provided. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-737177 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737177:Same Reporter
Seven  non epilepsy nocturnal seizures beginning 12 hours after injection and continuing for 18 hours.
This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 24-OCT-2014, the patient was inadvertently vaccinated with a expired dose of M-M-R II expiry date 18-OCT-2014 (dose, route and lot number were not reported). No adverse effects reported. Concomitant medications was not provided. The outcome of expired M-M-R II on 10/18/2014 was inadvertently administered to a patient on 10/24/2014 was unknown. Additional information has been requested.
Severe headache; psychosis; paranoia; resting heart rate 108; fever; extreme anger; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Er8729), via an unspecified route of administration in the right arm, on 17Apr2021 at 13:30 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN), zinc (MANUFACTURER UNKNOWN), and other unspecified medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took oseltamivir phosphate (TAMIFLU) and experienced allergy. The patient experienced severe headache, psychosis, paranoia, resting heart rate 108, fever, and extreme anger on 17Apr2021 at 19:00.  The patient underwent lab tests and procedures which included resting heart rate: 108 on 17Apr2021. The patient did not receive any treatment as a result of the events. The clinical outcome of severe headache, psychosis, paranoia, resting heart rate 108, fever, and extreme anger was recovered with sequel (reported as: recovered with lasting effects) in Apr2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Symptoms started around 11:30 am while pt was sitting in class. Started with itchy/watery eyes, increase in nasal congestion, then started having itching  on face, neck, and arms as well as itching in her mouth. Pt presented to health center at 1235 pm to be evaluated. Stated symptoms were still present, but also started having tingling in lower lip and tongue.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not provided. On 09-OCT-2018, there was an storage temperature excursion and on 12-OCT-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N035958 with expiration date on 18-DEC-2019 (strength, dose, anatomical location or route of administration were not provided), for prophylaxis; which was administered concomitantly with a sterile diluent (MERCK) that was not reported as improperly stored. The storage temperature of the vaccine was reported as 47 to 77 degrees Fahrenheit (°F) (58.5 °F) for a time frame of 13 hours and 20 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were being reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA012810.
Had it twice and once before the shots and once after/suspected vaccination failure; Had it twice and once before the shots and once after; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had it twice and once before the shots and once after/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had it twice and once before the shots and once after). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-JUL-2023 This case was reported by a patient via interactive digital media. The patient had shingles twice. The patient stated that once before the shingles shot and once after. The patient further stated that definitely easier time after the shingles shots. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
The patient called the pharmacy approximately 4 hours after vaccination to report pain, redness, and swelling in the arm. She was instructed to use an ice pack.
fever to 104 10 days p/vax x 2 days; devel macular faint erythematous exanthem over entire body x head @ 12PM vaccine;
After receiving the Moderna vaccine , I have had issues with broken vessels ( I assume capillary ) in my fingers and toes.  I hadn't experienced this before and it has occurred 10-12 times since receiving  the vaccine.  I will be using my hands and feel a sharp pain and notice a purple area in the palm side of one of my fingers that will last for 1-3 days.  These are not bruises .  I didn't think much about it but it kept happening over and over and I realized it has to be connected to the vaccine.  My fear is that this could happen internally and I wouldn't be aware.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 65-year-old male patient who received SHINGRIX. Concurrent medical conditions included diabetes. On 31st March 2018, the patient received the 1st dose of SHINGRIX. On 23rd April 2018, 23 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced painful rash, skin warm and pain in arm. On an unknown date, the outcome of the shingles and painful rash were not recovered/not resolved and the outcome of the skin warm and pain in arm were recovered/resolved. It was unknown if the reporter considered the shingles, painful rash, skin warm and pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by wife of the patient. The patient was continuing immunosuppressant and diabetic medication. Less than a week after receiving SHINGRIX, the patient experienced arm achiness and warm to touch which resolved within a week of vaccination. Less than a month after receiving SHINGRIX, the patient experienced rash described as achy and pinpoint in size. This is 1 of the 2 cases reported by same reporter.
This prospective pregnancy case was reported by a health professional and described the occurrence of vaccine exposure during pregnancy on a 26-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medications included Prenatal vitamins (Prenatal vitamin). On 16 June 2014, the subject received an unspecified dose of BOOSTRIX (intramuscular, administration site unknown). The last menstrual period was on 17 November 2013 and estimated date of delivery was 31 August 2014. The subject was exposed to the vaccine during 3rd trimester (29 1/7 gestation weeks). At the time of reporting the pregnancy was ongoing. Follow-up information received on 01 October 2014 from nurse: On 5th September 2014 after 41 weeks, the subject gave birth to a male neonate via vaginal delivery. The pregnancy resulted in a live neonate with no apparent congenital anomaly. The neonate weighed 3925 grams (8lbs 10oz) at birth, a height of 53 cm, a cranial circumference of 37.5 cm. APGAR scores were 8 and 9.
On 12/30/20, woke up with a swollen lymph node in right side of neck. Node appeared to increase in size  from 12/30/20 to 1/4/20, causing increasing pain in swallowing. On morning of 1/4/20, presented to local ER due to increasing size and pain in neck/ear canal, as well as concerns it may be blocking esophagus.
Pain in left fingers and elbow that occurred within 15 minutes of injection.  Numbness in left hand and forearm
patient got 1st dose of Twinrix on  Dec 2022  dint complete the series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 23-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose in December 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: patient got 1st dose of Twinrix on  Dec 2022  dint complete the series).  The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 31-Aug-2023 The pharmacist reported that the patient did not complete the series. The reporter asked need to restart. The reporter consented to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Twinrix, which led to incomplete course of vaccination.
PATIENT HAD PAIN IN SHOULDER IMMEDIATELY WENT TO HIS HEAD THEN TO HIS THROAT AND HE DEVELOPED PARALYSIS OF THROAT. PATIENT KEPT GOING TO DR THEY THOUGHT HE HAD COVID SO HE GOT DIAGNOSED ON FEBRUARY 8 2021
Arm pain greater than 2 wks after the vaccine. Have had the same problem with other AFLURIA shots.
Arthritis in both hands, joints, arms, elbows, shoulders, wrists; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis in both hands, joints, arms, elbows, shoulders, wrists) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included Amputation.   On 12-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Arthritis in both hands, joints, arms, elbows, shoulders, wrists). At the time of the report, ARTHRITIS (Arthritis in both hands, joints, arms, elbows, shoulders, wrists) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient reported that he was on pain management medications. No concomitant medications were reported.
Patient called pharmacy on 10-5-17 and commented that she had been experiencing a rash on her neck and a "hot" or "flushed" feeling on her face beginning about midday on 10-4-17, about 24 hours after I had given her the FLUZONE HD immunization. When questioned, she could think of no other "new" things (soap, medication, cosmetics) that could have been responsible. She had no shortness of breath or rash on her trunk or the arm that was immunized. She had not taken any diphenhydramine, nor did she feel that she needed to. She just wanted to make us aware. I have immunized her here at this location for several years previously without any similar problems.
Weak body, acting up heart. Traditional remedy and home care type of supplements. Vitamin C, D, B12, and healthy diet.
This spontaneous report as received from a physician assistant refers to a 21 year old non pregnant female patient. The patient did not have concurrent conditions, medical history, historical drugs or concomitant medication. On 19-JAN-2012, the patient was vaccinated with GARDASIL first and only dose (dose, route, lot number and expiration date were not reported) for prophylaxis. In September 2017, the patient had a "positive pap smear for HPV". The outcome of human papilloma virus test positive was reported as recovering/resolving. The causal relationship between the event and GARDASIL was not reported.
Six days after receiving the second vaccine . I developed  acute appendicitis with peritonitis. I had to have my appendix removed . Since my surgery I have two friends that each have a family member that also got appendicitis  and had to have their appendix removed .
Information has been received from a nurse concerning an approximately 8 year old male who "about 10 years ago" in approximately 1998 was vaccinated with VARIVAX (Merck). It was reported that the now 11 year old boy received VARIVAX (Merck). The nurse reported that "about 3 years ago" in approximately 2005 the patient experienced mild breakthrough chickenpox (some lesions on his back). On an unspecified date the patient recovered from mild breakthrough chickenpox. The patient sought medical attention; contacted Physician. There was no product quality complaint. Additional information has been requested.
The patient reported into the urgent care center here and he said that he did not know if he had contacted his left eye after coming into contact with the immunization site.  He received the vaccine 1 week ago today and said that the eye became progressively irritated over the past two days.  On exam the patients left eye on the lower lid margin was erythematous and mod edematous with a small 1mmx1mm early pustular formation.  The sclera was minimally injected and the cornea was clear PERRL EOMS intact.  I call our oph on call and spoke with DR who agreed that the symptoms were probably consistent with auto-inoculation.  He was sent up to Dr this morning and will see him in the office.  We will put him on viroptic 9x/d until resolution of symptoms and will also put him on a oph antibiotic to cover for any secondary bacterial infrections that will be applied tid for the next week.
Please help me with obtaining records. My daughter was given shots and the medical facility lost them. Complaint filed and documented with the Health Department. My daughter was later re-immunized by another facility I will look for this information however I believe its available on the public vaccination system. She contracted chicken pox as a result of the shot the break out was SEVERE, I have only ever seen a break out like this in other countries never on anyone I know in use.  We returned to the doctor and they advised to treat like chicken pox & measles. Healing time was around 6 weeks.  I believe this damaged her development. After the 'overdose of shots she never responded the same. I need help with understanding what happened. All medical records have been documented.
Swelling, redness, pain entire upper arm and spreading down to forearm - lasted 3 days - no fever; Took Benadryl, chlor-Trimeton and antibiotic cephalexin and ice
Numbness and tingling on the injection site and the left side of your face. Also reports a metallic taste in her mouth
Information has been received from a medical assistant concerning an unknown number of patients; names and demographics were unknown to the reporter. The patients' medical history, concurrent conditions, drug reactions and allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX for prophylaxis, lot #M040144 and expiration date: 26-DEC-2017 (dose, frequency and route of administration were not reported), reconstituted with sterile diluent (manufacturer unknown). The sterile diluent was not involved in the temperature excursions. No adverse effects were reported. It was reported that on an unspecified date, the vaccines were exposed to a temperature between 15 Farentheit degrees and 46 Farentheit degrees for 1 hour and 18 minutes. The vaccines were also exposed to a temperature between 15 Farentheit degrees and 46 Farentheit degrees for 1 hour, a temperature between 6 Farentheit degrees and 14 Farentheit degrees for 30 minutes and finally, a temperature between -50° Celsius (C) and -15° C for 54 minutes. The medical assistant reported that there was no previous temperature excursion. The call was placed because of a Digital Data logger report. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA006803.
Approximately 2-3 minutes after vaccine administration patient turned very pale and had a pre-syncopal episode.  She was able to respond to commands with a sluggish response.  Complained of abdominal pain.  Patient placed supine, vital signs stable.  Patient recovered spontaneously within 5 minutes.  No LOC, no nausea or vomiting.
COVID+ 12/13/22.  Vaccination status - moderna x3 + Moderna BIVALENT Discharge Summary (Physician) ? ? Hospitalist  BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider:  MD Admission Date: 12/13/2022 Discharge Date: 12/16/2022     Active Hospital Problems   Diagnosis Date Noted POA ? Pulmonary embolus, right (HCC) 12/13/2022 Yes ? Acute deep vein thrombosis (DVT) of right tibial vein (HCC) 12/14/2022 Yes ? COVID-19 virus infection 12/14/2022 Yes ? Pulmonary infiltrates 12/14/2022 Yes ? Obstructive sleep apnea 02/09/2021 Yes ? Coronary arteriosclerosis in native artery 03/13/2003 Yes ? Right bundle branch block    DETAILS OF HOSPITAL STAY:   Clinical Narrative: This is a 71-year-old female who in October had travel and also had tested positive for COVID in October.  She presented to emergency room with right lower chest pain which was worse with inspiration.  She was found to have pulmonary emboli in the right lower lobe as well as bilateral DVTs.  Chest x-ray also showed right lower lobe infiltrates concerning for pneumonia.  She screen positive for COVID once again but it was unclear if this was related to her original infection on October.   For her pulmonary emboli she was treated with apixaban 10 mg twice daily during her hospital stay.  At discharge her insurance red flag apixaban is not covered, and she is therefore transitioned to Xarelto at discharge 15 mg twice daily for 21 days, then 20 mg once daily.  She was also treated for possible pneumonia with Rocephin and doxycycline.  She completed 3 days by discharge, and will receive 4 more days of Ceftin 500 mg combined with doxycycline 100 mg 2 times a day.
Chest discomfort & headaches. times vary for both systems. deep breathing seems to help with the pain in chest. headaches don't last very long. they hit hard and leave.
Mom states day after inj., pt. with red, hot, raised area. Today area still red, warm to touch & pt. states itchy. 7x14cm area
This spontaneous report was received from a registered nurse regarding a 16 Months old patient unknown gender. The patients' medical history, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patient was vaccinated with improperly stored doses of M-M-R II  lot # N024696, expiration date 07-APR-2019 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 9 to 25 (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA000142: