chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 79 year old female patient. Patient's pertinent medical conditions were not provided. Patient's previous experienced diarrhea with use of amoxicillin and itchiness due to BIAXIN and DEMEROL. On 09-MAY-2016, the patient was vaccinated with PNEUMOVAX 23 in her left arm, lot # M005287, expiration date 08-OCT-2017 (strength, dose, dose number and route was unknown). Concomitant therapies included diclofenac 50 twice daily, estradiol (manufacturer unknown) 1 mg, FLONASE and metoprolol 25 mg daily. On 11-MAY-2016, patient sought medical attention-she visited the office since she developed a red rash that was hot and swollen which was not just around the injection site but down around her elbow as well. Patient also experienced achiness and joint pain in her left arm. No fever was present. The patient was diagnosed with cellulitis (medically significant). Prior to returning to the physician's office on 11-MAY-2016, the patient self-administered BENADRYL (unspecified dose/ frequency) for treatment (hence onset date of cellulitis was approximately to May 2016). Patient was prescribed a MEDROL dose pack 4mg (unspecified frequency) and cephalexin 5mg three times daily for an unspecified number of days, as further treatment. The PNEUMOVAX 23 vaccine was administered by a new employee at the facility and "that may have played a role in the reason for the reactions". The outcome of the adverse event was unknown. Causality assessment was not provided. The reporter requested for a lot check for PNEUMOVAX 23 with lot # M005287, expiration date 08-OCT-2017. No product quality complaint (PQC) was reported. No further information was provided. Upon internal review, the event "cellulitis" was considered to be medically significant. This is one of the two reports received from the same reporter. Additional information has been requested.
A report has been received from a Physician concerning, subject of unknown gender, who had been receiving FLUMIST, 0.2 milliliters, yearly. FLUMIST started on an unknown date. The patient experienced loss of smell. The outcome of the event of loss of smell is unknown. The report was considered to be non-serious. 02-Dec-2011: Corrected report 02-Dec-2011: Case was suppressed.
knows others that have gained as well after receiving the Pfizer vaccine, one about 30 pounds; This is a spontaneous report from a contactable consumer. A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history included underlying thyroid condition. The patient's concomitant medications were not reported. The patient experienced weight gain and knows others that have gained as well after receiving the Pfizer vaccine, one about 30 pounds on an unspecified date. The outcome of the event was unknown.  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-202101097977 same reporter/product, different patient / event.;US-PFIZER INC-202101099308 same reporter/product, different patient / event.
No additional AEs; HBP with responsibility for vaccine storage calling to report a temperature excursion for MMR II, VARIVAX and PROQUAD. 1 dose of VARIVAX given. No additional AEs. No PQCs.    ?    Names of vaccines involved (including lot/exp) VARIVAX U025202 08/13; This spontaneous report was received from an other referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 16-MAY-2023, the patient was vaccinated with varicella virus vaccine live an improperly stored dose of (oka/merck)(VARIVAX) lot number U025202, expiration date 13-AUG-2023 (dose and route of administration not reported) for prophylaxis. Other vaccines involved in the temperature excursion were measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) however, these las t vaccines were not administered (product storage error). No adverse event was reported.  No information regarding the temperature excursion was reported.
complete liquid diarrhea / diarrhea is that bad, it's just complete liquid; chills; I am not throwing up but I do have nausea; hot flush type thing; I 'haven't thrown' 3 times, it's just like a dry heave or just a bit of saliva; it is taking every ounce of energy I have to hold this phone; I can't even work; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 (Lot number: ER2613) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "menopause" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset 22Mar2021 09:30, outcome "not recovered", described as "complete liquid diarrhea / diarrhea is that bad, it's just complete liquid"; CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "chills"; NAUSEA (non-serious) with onset Mar2021, outcome "unknown", described as "I am not throwing up but I do have nausea"; HOT FLUSH (non-serious) with onset Mar2021, outcome "unknown", described as "hot flush type thing"; RETCHING (non-serious) with onset Mar2021, outcome "unknown", described as "I 'haven't thrown' 3 times, it's just like a dry heave or just a bit of saliva"; ASTHENIA (non-serious) with onset Mar2021, outcome "not recovered", described as "it is taking every ounce of energy I have to hold this phone"; IMPAIRED WORK ABILITY (non-serious) with onset Mar2021, outcome "not recovered", described as "I can't even work". Therapeutic measures were not taken as a result of diarrhoea, chills, nausea, hot flush, retching, asthenia.  Additional information: It was further reported that the patient got her shot on Thursday morning (18Mar2021) and she was fine after that and didn't have any problems. Patient usually don't have any vaccines since she was not just 'here there' going out in public other than going to get her shot. On Monday (22Mar2021) started about 9:30 in the morning, the patient had complete liquid diarrhea and was still experiencing it. The patient had chills and she was not throwing up but she do have nausea. She had a hot flush type thing even though she was already menopause. Patient was not throwing up anything, when she 'haven't thrown' 3 times, it's just like a dry heave or just a bit of saliva. The patient just wanted to know if this was normal, she read online (not on Pfizer site) but she read that many people are experiencing diarrhea and that sometimes side effects can take up to 7 days to show and then can last for several days. Patient stated that it was huge for her, that she was concerned not only now but for her second dose too (on 08Apr2021). The patient said that this was bad since she can't even work. The patient was asking why severe diarrhea has not been on the sheet as one of the issues.   No follow-up attempts are possible. No further information is expected.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: ears felt like they were clogged and difficulty hearing-Medium, Systemic: Hypotension-Medium, Additional Details: Monitored for 45+ minutes. Paramedics came and observed vitals were normal & offered ride to hospital. Pt's mom declined and paramedics walked with patient to car. Called mom around 6:55pm & she said patient felt worse on drive home and she took her to Hoag. They were watiting to be seen. Called again Saturday around 10:30am with no answer.
redness, with pimple like sore and burning x 1 week 1 day (only reported today 4-19-07) per patient, temp 98.4
4x4 slightly raised red area; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (4x4 slightly raised red area) and VACCINATION SITE ERYTHEMA (red) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE SWELLING (4x4 slightly raised red area) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE SWELLING (4x4 slightly raised red area) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment details were provided.
Pt recvd 2 doses of Hep B vax on 9MAY90 & 14JUN90 & on 25JUN90 pt devel enlarged salivary glands resembling mumps; pt seen by MD; 3JUL90 sx resolved; pt recvd 3rd dose of vax w/no problems;
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX lot # M033212 for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is VARIVAX.
Right arm had vaccine injected was swollen & painful. Pt. had fever and some heavy breathing. Pt took some TYLENOL and BENADRYL and got better the next day.
mother reports febrile seizure 48hours after the vaccines were administered.     He is sleeping a lot more than normal, not a big appetite, will still throw up if we don?t give him zofran and is not very interested in doing much.
PAINFUL LUMPS AT BASE OF HEAD AND BEHIND EARS, ITCHY RASH ON FACE.
Pt recvd 3 Hep B vax on 26JUL89, 30AUG89, & 23JAN90 following these titer was neg; pt was given a 4th dose of vax on 9AUG90; pt seroconverted p/4th dose; 5AUG91 1yr later, titer was neg;
After receiving the second dose of Moderna vaccine, the arthritis in my hands significantly reduced/after the second dose, more mobility in the joints of my hand/reduction in pain and swelling after second dose; After second dose have noticed very very little pain in the joints; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (After receiving the second dose of Moderna vaccine, the arthritis in my hands significantly reduced/after the second dose, more mobility in the joints of my hand/reduction in pain and swelling after second dose) and ARTHRALGIA (After second dose have noticed very very little pain in the joints) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis, Hypertension and BPH. Concomitant products included DICLOFENAC, AMLODIPINE, METOPROLOL and FINASTERIDE for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (After receiving the second dose of Moderna vaccine, the arthritis in my hands significantly reduced/after the second dose, more mobility in the joints of my hand/reduction in pain and swelling after second dose) and ARTHRALGIA (After second dose have noticed very very little pain in the joints). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (After receiving the second dose of Moderna vaccine, the arthritis in my hands significantly reduced/after the second dose, more mobility in the joints of my hand/reduction in pain and swelling after second dose) and ARTHRALGIA (After second dose have noticed very very little pain in the joints) outcome was unknown.            No treatment medication details provided by the reporter.
I received my vaccine and later around 11 pm I started feeling body aches and pain on the site of the vaccine around 4 am 02/02/2021 I started feeling chills  I checked my temperature it was at 101.1  I get col and at times I get hot and start sweating I have had a fever that comes and goes today . My stomach has been extra active since 11 pm 02-01-21 I have had to use the restroom about 5 times not watery but more than normal also I?m not hungry o force myself to eat  at 6pm today I started with a headache in the back of my head to the sides.
First Shingrix dose November 2019 and did not get my second dose (COVID); This case was reported by a consumer via call center representative and described the occurrence of coronavirus infection in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced coronavirus infection. On an unknown date, the outcome of the coronavirus infection was unknown.   It was unknown if the reporter considered the coronavirus infection to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself via chat function. The age at vaccination was not reported. The patient did not get her 2nd dose of Shingrix because of COVID infection. The patient mentioned that, a day before reporting, she received first dose (unspecified vaccine) and had the funky symptoms in a bad way which was myalgia, headache, pain and firmness at the site. Specialist attempted to gather further details and asked whether safety could follow up, but the patient disconnected the chat. Specialist unable to obtain additional information. Since the specialist had no way of knowing what other vaccine the patient was referencing thus it was in reference to an unknown, unspecified vaccine. The reporter did not consent to follow up. Note: Clarification was raised regarding "COVID". If this refers to COVID pandemic situation or COVID infection. However as per reply it was not clear that if patient referred COVID situation or developed COVID infection, thus considering worst approach COVID-19 was captured as an event as reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR070310:Same reporter
1/2 of left arm swollen and red; left eye feeling different. Ask patient to call her doctor.
Information has been received from a physician concerning a female patient who on an unspecified date received a dose of MMR II (Lot # not provided) and subsequently developed negative measles titers after receiving the vaccine. At the time of this report, the patient's outcome was unspecified. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information is not expected.
two patients was given "diluent versus the vaccine" for Pentacel/no ae; Initial information was received on 22-Jun-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to case 2020SA162258. (same reporter)  This case involves a one year old male patient who had received "diluent versus the vaccine" for DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product preparation error).   Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received concomitant medication as HEPATITIS A VACCINE (HEPATITIS A).  On 19-Jun-2020, the patient received a 0.5 mL fourth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [carton: UJ230AAA, lot UJ315AA, expiry date: 04-Apr-2021] via an intramuscular route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to Active ingredient not added to diluent.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
The patient came in today on05 December 2014 with the large rash to upper left ams. Patient reports he has scratched at the upper left arm site a couple of times.
I received my second Pfizer booster for COVID-19 on 4/12/2022. On 9/25/2022, I had a dry cough throughout the day. Later that evening, I had body aches, possibly a fever, a scratchy throat, and fatigue in conjunction with the cough. I took a home test for COVID-19 and got a negative result. On the morning of 9/26/2022, I woke up feeling worse. I had a fever from when I woke up, and it gradually went up throughout the day and reached 101.1 or 101.2 at its peak. I took ALEVE, which helped relieve the fever and made me feel better. I also took another test that morning and got another negative result. When I woke up the morning 9/27/2022, I still felt bad, so I took another test and this time, I got a positive result. I called my doctor's office and made a telehealth appointment for 9/28/2022. At this point, my cough was worse; I coughed throughout the night, and this made it impossible for me to get any sleep. The other aforementioned symptoms also continued. I continued to take ALEVE during this time, and it helped reduce the fever and ease the body aches. On 9/28/2022, I had my telehealth appointment and I was prescribed PAXLOVID and albuterol. I began taking those that evening. I took the PAXLOVID for the prescribed 5 days and continued taking the albuterol afterwards, and for the most part, my symptoms gradually improved. However, my cough persisted and still made it impossible for me to sleep at night. I had a telehealth appointment with my pulmonologist on 10/6/2022, and he prescribed me a steroid inhaler to treat my cough. By this point, I had taken a couple of home tests around 10/4/2022 or 10/5/2022 and gotten negative results both times, though the cough still persisted. I began using the steroid inhaler on 10/8/2022, and it has definitely helped my cough. At the time of this writing, I am sleeping pretty well. Also, I was completely lacking an appetite during my illness, but since I've been on the steroid inhaler, I have regained it. I also lost some of my senses of taste and smell during my illness, but they are now gradually returning. As of now, I sort of have good days and bad days, because I still sometimes have bouts of fatigue. I'm trying to stay active, but I now tire very easily. The COVID-19 is gone, but the fatigue and the cough aren't.
red swollen arm 10 days post vaccination. Initiated on antibiotics for concerns of developing cellulitis.
Im now having dizzy spells and passing out and Seizures and I now have a left Bundle Branch Blockage that I know was not the December 31st when I had a hernia surgery. None of these symptoms showed up; Im now having dizzy spells and passing out and Seizures and I now have a left Bundle Branch Blockage that I know was not the December 31st when I had a hernia surgery. None of these symptoms showed up; Im now having dizzy spells and passing out and Seizures and I now have a left Bundle Branch Blockage that I know was not the December 31st when I had a hernia surgery. None of these symptoms showed up; Im now having dizzy spells and passing out and Seizures and I now have a left Bundle Branch Blockage that I know was not the December 31st when I had a hernia surgery. None of these symptoms showed up; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 22Mar2021 at 15:45 (Lot Number: EN6203) at the age of 58-year-old as single dose for COVID-19 immunization. Medical history included anxiety and depression. The patient didn't receive other vaccine in four weeks. The patient didn't COVID prior vaccination. The patient didn't perform COVID test post vaccination. The patient received medications in two weeks. Known allergies was none. Concomitant medication was not reported. On 03Apr2021 at 14:00, the patient had dizzy spells and passing out and Seizures and had a left bundle branch blockage that the patient was not the 31Dec2021 when he had a hernia surgery. None of these symptoms showed up till after the patient received the Pfizer shot. It was about two weeks after the first shot he started passing out. The events resulted in doctor or other healthcare professional office/clinic visit and hospitalization. Treatment included: Monitored heart and blood pressure took nitro. The outcome of events was not recovered.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 06Dec2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amox, reaction(s): "Known allergies: amox", notes: Known allergies: amox. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (23Sep2022) Negative; (24Sep2022) Negative; (25Sep2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Treatment was given from 15Sep2022 to 19Sep2022. Patient was experiencing a rebound case of COVID after completing 5-day course on 19Sep2022. Symptoms came back 23rd and 24Sep and multiple negative COVID tests until evening of 25Sep.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.