chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 5 (booster), single (Lot number: Gh9703) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "afib" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; AMLODIPINE. 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: (04Dec2022) Negative; (04Dec2022) Negative; (06Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Slightly elevated temp,  general body  ache, very sore injection site, restlessness for first several days.  Approx 7:30 PM on Aug 30, 2021, felt sharp pain in left side of neck while filling in reports..  Numbness in lip and left side of face.  Left eye felt very irritated and began watering.  When to bathroom to wash face and noted left side droop.  Consulted with on duty medic and confirmed assessment of possible stroke.  Transported to ER, a stroke destination hospital.  Initial assessment resulted in a CT scan which showed negative results for stroke.  MD assessed partial facial paralysis due to Bells Palsy.  Prednisone, Acyclovir, and eye drops prescribed with orders for follow up with internal medicine specialist and PCP.
Swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown , single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
w/in 1 1/2hrs of vax had entire body "shaking",reports mom;somewhat sleepy,hands & feet bluish;t103 w/in next few hrs;had APAP 1-1 1/2drops x 2 w/in 5hrs;fever & other sx;
Upon receiving Pfizer Bivalent, it was improperly stored in the freezer. This vaccine should have been stored in the refrigerator. Due to the incorrect storage patient received vaccine that was expired.  NO  ISSUES REPORTED
worst case of flu ever; Initial information received on 23-Nov-2020 regarding an unsolicited valid non-serious case from a patient via social media.   This case involves a patient of unknown demographic details who got worst case of flu ever (influenza), while being vaccinated with INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  On an unknown date, the patient received suspect INFLUENZA VACCINE (produced by unknown manufacturer) (batch number and expiry date were not reported) at an unknown dose via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (unknown latency) after starting the suspect vaccine therapy, the patient got worst case of flu ever (influenza). It was reported that when flu shots came out, they weakened virus to build resistance. Now all flu shots were based on dead virus, per the patient's doctor.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number for this case.
Significant soreness at injection site extending for two+ days. Redness at injection site. Injection site became black and blue.
As the client was exiting the vaccination hallway, the client informed a vaccinator that he felt tingling in his mouth, was experiencing an indescribable taste and his eyes hurt.  The client looked flushed.  The client was instructed to lay on a mat on the floor.  Client drank some juice and ate some pretzels.  After 20 minutes he reported that he was no longer experiencing any symptoms.  As the client was standing up he reported that he felt dizzy but this resolved as he walked around the room.  He then wanted to sit outside so two nurse's went with him .  After 40 minutes he reported that all of his symptoms had resolved.  We followed up with the client on 4/25/21 and the client reported that he had not experienced any additional symptoms.
Patient given 4 vaccinations.  10 days later, a blister appeared at the site of the varicella injection.  It progressed quickly to scattered vesicles on upper body.  Vesicles resolved over 7 days.  No specific treatment given for vesicles.  Pt. was put into respiratory/contact isolation.
At first I felt tired, sleepy, had a fever that would come and go, nauseas, extreme fatigue, and I had arm soreness. That didn't go away until about a week, but I still felt fatigued, exhausted, and was sleeping all the time. My Bechet's syndrome flared up. I had mouth sores so I went to an Urgent care on May 5th. I found out that I didn't have strep throat. The doctor noted that I had a flare up of mouth ulcers following the Covid vaccine. I had fatigue and myalgias. They prescribed triamcinolone cream that is supposed to be applied twice daily to mouth ulcers. I feel horrible after receiving the vaccine. I was feeling like I wanted to die. I went to dentist for them to look at my mouth. The doctor said that the vaccine triggered an immune response that created more mouth ulcers since I first noticed it. May 15th I had a fever of 99 degrees, body aches, and mild chills with sweating and fatigue. I was given a steroid cream and swabs for me to apply myself. I feel horrible and nauseated too. May 19th I had a sore throat, excessive runny nose, body aches, headaches, and fatigue. I did a Covid test that day that came back negative. Sometime after May 19th I finally started to recover and feel normal again.
Patient experienced syncopal episode after receiving Jynneos Vaccine 0.1 mL via the intradermal route. Client was assisted to the floor.  Vitals: 1st attempt BP 154/77 P 54. Client recovered, was given water and monitored for 30 minutes.  Repeat vitals: BP 127/70 P 60. Client left clinic at 3 pm alert and oriented.
Patient presented to second dose mass Moderna vaccination drive through clinic. Patient did not have an appointment but reports they were supposed to return for second dose. Paperwork given to complete which was checked off that patient had received Moderna previously. Patient did not mark through this or make any comment to the nurse administering that they had not received Moderna originally. The nurse gave immunization appropriately based on paperwork that patient filled out and per patient request. Upon coming back to the department and entering in the shot in CVMS it would not let us enter as it reports that the first dose was Janssen vaccination. Upon going back through paper records we found that patient was given Janssen vaccination on 3/12/2021. Verified with nurses working the clinic on 3/12/2021 where Janssen and Moderna were both being administered and they reported that they were sure that paperwork was correct in the fact that they ask everyone a second time which vaccine they wanted and confirmed before administering. Unfortunately some who received Janssen overheard the instructions that were being given to those who received Moderna in the same building and chose to come back to the second dose clinic.
This spontaneous report as received from medical assistant refers to a patient of unknown age and gender. No information received regarding medical history and concurrent conditions. On an unknown date the patient was vaccinated with VARIVAX (Merck), 0.5 ml, subcutaneous (lot# not reported). No concomitant medications reported. The medical assistant has reported that over the last 30 days (approximately from the 09-NOV-2014) an unknown number of doses of VARIVAX (Merck) which underwent a supported temperature excursion had been administered to the patients. No adverse effects reported. No treatment was given for the adverse event. Product quality complaint was not reported. This is one of the several report received from the same source. Additional information has been requested.
Information has been received concerning a pt who developed chickenpox like lesions on the trunk post vaccination. The pt denies itching and had no complaints. the pt was recovering on 06/13/00 and it was indicated he did recover.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 19-DEC-2016, the patient was vaccinated with improperly stored VARIVAX, subcutaneously, lot # M023382, expiry date 11-MAY-2018 (dose and site of administration were not reported) for prophylaxis. No adverse effects were reported. The administered vaccine underwent temperature excursion between 6 and 14 degrees Fahrenheit for 2.5 hours and between 15 and 46 degrees Fahrenheit for 12 hours. Previous temperature excursion was reported as between 6 and 14 degrees Fahrenheit for 2 hours and between 15 and 46 degrees Fahrenheit for 15 minutes. Data logger was involved. Additional information has been requested.
Clinic medical assistant presented to room and administered Rotavirus, Pediarix, Hib, PCV immunizations. Reportedly patient was crying robustly after immunizations and then suddenly stopped breathing and became unresponsive, hypotonic and pale. Medical assistant pulled me from neighboring room and rapid assessment confirmed that patient was hypotonic, unresponsive and had circumoral cyanosis. I placed baby on exam table and began chest compressions. Patient became alert and began to cry after about five chest compressions. He was consoled by mom and returned to baseline during a 10 minute observation in clinic.
Son said in car he didn't feel good. Felt yucky. Came home and he played and ate. Later that evening he threw up in bed and told me that he saw people walking around his room. Later in the evening he threw up again. Next morning he was ok. Later that day he spiked a fever after his nap. Called Physician and told him about night before and then. Told to give Tylenol, fluids and rest. Next day broke out in hives which continued a few days. Called physician, told to watch what he eats. Hives left in few days then a dry hacking cough started. Only at night when sleeping. Then post nasal drip. Month later received 2nd shot, no reaction. Four days later return to doc for cough, son has sinus infection and given antibiotic (first time ever) for 14 days. My son has been sick for a month now and this is a child that is NEVER sick, and I believe it stemmed from the flu shot. This was his first time getting it due to nursery school.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 16May2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS, start date: 01Mar2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) contracted COVID; (Jun2022) Negative; (Jun2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient was given Paxlovid from 03Jun2022 to 07Jun2022 for the treatment of Covid-19. The patient recovered after five days and was negative by antigen test. Three days later, the patient felt ill again and tested positive by antigen test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vomiting,  Diarrhea, night sweats, chills, low grade fever, fatigue, nightmares
Patient developed severe sore arm and went to her physician,who diagnosed her with a hematoma in her vaccinated arm.  The patient went to her doctor several days later. Patient states the prescriber told her that she should not be getting vaccines in her right arm and she has had  right side breast cancer and lymph nodes removed in the past.
patient fainted after receiving vaccine - her dad was with her here in the pharmacy and stated that this was typical of her when getting blood drawn/needles
ON DAY OF - EXTREME EXHAUSTION DAY AFTER - FEVER, NAUSEA, VOMITING, EXHAUSTION, FATIGUE, HEADACHE 2 DAYS AFTER - FATIGUE, HEADACHE, NAUSEA 3 DAYS AFTER - PRONOUNCED HEARTBEAT AND INCREASED HEARTRATE LASTING FOR EIGHT HOURS SPORADICALLY SINCE THEN - DAYS OF PRONOUNCED HEARTBEAT LASTING FOR HOURS
shingles; she received her first Shingrix vaccine series at age 45; Suspected Vaccination failure; shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles 4 times a year).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular, unknown arm) .5 ml and the 1st dose of Shingrix (intramuscular, unknown arm) .5 ml. On 14-AUG-2023, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). On an unknown date, the patient experienced shingles (Verbatim: shingles) and inappropriate age at vaccine administration (Verbatim: she received her first Shingrix vaccine series at age 45).     The outcome of the vaccination failure and inappropriate age at vaccine administration were unknown and the outcome of the shingles was not resolved and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 18-AUG-2023 The patient wanted to receive the Shingrix vaccine because since the age of 16, she had shingles 4 times a year.  The patient reported that her shingles always appears in the same exact spot on her face, right outside her left eye.   The patient reported that after receiving the Shingrix 2 series dose in 2018, she went three years without a case of shingles.  In 2022, she had just one mild case of shingles.  This week she had another mild case of shingles, again by her left eye.  The patient's reason for calling was to get a booster of Shingrix. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. The patient received 2 doses of Shingrix vaccine at inappropriate age, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Following day of vaccine overall feeling of weakness fatigue chills body aches. Day 3 4 and 5 perfectly fine. They 6 woke up feeling like my extremities were not attached to me. I was looking at my legs and arms move and walk but it didn't feel like they were attached to my body. I couldn't believe that my brain was communicating with them. When my arms are on the steering wheel they feel like they want to fall off while I'm walking my legs feel like they want to buckle. They don't I just can't believe it. I feel so weak that if somebody were to push me with one finger I would follow over somehow or another I keep moving. Weird sensations in all extremities little bit of numbness a little bit of tingling but overall I feel like I have sea legs I feel like I made of jello. My brain communicates with my extremities but it's almost like a sensation that an amputee goes through. I feel like when you hit your funny bone and your arm goes limp and that type of feeling it's all over my body. My first ER visit that's why I went My second year a visit I started to feel it in my abdominal area and my tailbone and my legs I have excruciating electric shocks that go for my abdomen tailbone clear down to my feet. All of this is new since vaccine. 2 visits to the ER so substantial findings an EMG is ordered can't do until the new year
Initial and follow up information has been received from a physician concerning an approximately 59 year old white male retired pharmaceutical executive with an allergy to Penicillin who on 13-OCT-2005 was vaccinated in the right deltoid with a 0.5 ml intramuscular dose of pneumococcal 23v polysaccharide vaccine (Lot#650453/0791P).  Concomitant therapy included glyburide, atorvastatin calcium (LIPITOR), lisinopril (ZESTRIL), hydrochlorothiazide (manufacturer unknown), levothyroxine Na (SYNTHROID) and Allopurinol.  It was reported that on 14-OCT-2005, the patient developed a severe local reaction at the injection site including, redness, swelling, and pain.  Follow up information from the physician confirmed that the patient developed fever (>103), severe pain, swelling in his right arm and lightheadedness and was seen by his doctor or in the emergency room.  There was no illness at the time of vaccination.  The patient was reported to have recovered on 21-OCT-2005.  The reporter expressed concern about the lot#650453/0791P) for pneumococcal 23v polysaccharide vaccine.  Additional information has been requested.  A lot check has been requested.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.
Right distal ureteral calculus. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Initial unsolicited report received from nurse on 13-Oct-2016. This case involves a female patient (unknown age) who was vaccinated with 0.5 ml dose of Fluzone QIV (batch number: UI625AA, expiry date: 30-JUN-2017, site of administration was not reported) via intramuscular route on 03-Oct-2016 at employee health room. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions, other vaccinations within 4 weeks and concomitant medications were reported as unknown. On 03-Oct-2016, within 10 minutes after receiving the vaccination, the patient became tachycardic with heart rate was greater than 130 bpm, Systolic blood pressure was 160, diastolic blood pressure was greater than 100 and patient also had flushing at chest and neck, felt tightness in chest and throat felt swollen. It was also reported that patient had no respiratory compromise. It was reported that the patient required emergency room or doctor visit and patient was seen by a physician in employee health. Laboratory investigations were reported as unknown. Corrective treatments includes 8 mg. of Decadron IM, and 50 mg. of Benadryl, followed by an additional dose of 50 mg. of Benadryl 6 hours later, and another 50 mg of Benadryl 6 hours after the second dose. On 04-OCT-2016, patient recovered from the all events within 48 hours of duration. Upon internal review, the case was considered as serious due to important medical event tachycardic with a heartrate greater than 130 bpm, flushing of her chest and neck, Systolic B/P was160, diastolic pressure was greater than 100, felt a tightness in her chest and throat felt swollen. Documents held by sender: none. Sender's Comments: In this case, the reported events and rapid onset of symptoms are consistent with hypersensitivity reaction. Time to onset is compatible with the role of vaccine. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), immune status at the time of vaccination, medical history including allergies, concomitant medications, complementary investigations ruling out alternate etiology and allergy testing to identify the culprit allergen are needed to further assess this case. Based on the information available, the role of vaccine cannot be excluded.
No additional AE reported; a 15 year old patient received their 3rd dose of the GARD ASIL 9 series today (04MAR2022) and their second dose of the series was administered in 2019; This spontaneous report as received from a medical assistant refers to a 15-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date in 2019, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). On 04-MAR-2022, the patient received third dose of this vaccine, lot # U008900, expiration date: 12-AUG-2021, 0.5 mL (route of administration was not reported) for prophylaxis. No adverse event was reported.
Arm hurt; Ache in the side of the back; Miserable; Body aches; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), BACK PAIN (Ache in the side of the back), FEELING ABNORMAL (Miserable), PAIN (Body aches) and HEADACHE (Headaches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt), BACK PAIN (Ache in the side of the back), FEELING ABNORMAL (Miserable), PAIN (Body aches) and HEADACHE (Headaches). At the time of the report, PAIN IN EXTREMITY (Arm hurt), BACK PAIN (Ache in the side of the back), FEELING ABNORMAL (Miserable), PAIN (Body aches) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Additional information received regarding second dose and events of 2nd dose
Information has been received from a health care professional concerning an 11 year old female who on 9/27/99 was vaccinated IM with one dose of Hep B vaccine. On 9/27/99 the pt experienced neck and shoulder pain and was dizzy. Subsequently, the pt recovered from the neck and shoulder pain and dizziness.  No further information available.