chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen lymphs - neck; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03Sep2021 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received ibuprofen (MANUFACTURER UNKNOWN) and experienced drug allergy. On 05Sep2021 at 08:00, the patient experienced swollen lymphs - neck. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymphs - neck was unknown at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Right arm muscle, shot given. Mild at first. It settled in the muscle on the underside of the arm. Became very painful. Especially 1st thing in am. Went to doctor 12-13-06. Prescribed Ibuprofen 800 mg, didn't help. Prescribed Sanindoc 200 mg, did not help December 22 December 28 Methocarban 500 mg no help and then Hydrocol Apap 5 500 mg. On 1/2/07 went to orthopedic physician. X-rays showed nothing. Gave me a cortisone shot. It worked and pain went away. Will see him again 1/30/07. He could not tell me if the flu shot was to blame. I called the above service and asked what was in my shot. Have not heard back still would like to know. Do I get another shot next fall?
A little under the weather (After First Vaccine); This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (A little under the weather (After First Vaccine)) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced FEELING ABNORMAL (A little under the weather (After First Vaccine)). On 20-Mar-2021, FEELING ABNORMAL (A little under the weather (After First Vaccine)) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided. No concomitant medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-079320 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 24-MAY-2021. Patient stated that AEs resolved and no further information to report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079320:For second dose
polycythemia Vera; Metastatic breast cancer; This spontaneous case was reported by a consumer and describes the occurrence of POLYCYTHAEMIA VERA (polycythemia Vera) and BREAST CANCER METASTATIC (Metastatic breast cancer) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 032L20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included ANASTROZOLE (ARIMIDEX), INSULIN DEGLUDEC (TRESIBA), SEMAGLUTIDE (OZEMPIC), CELECOXIB (CELEBREX), GABAPENTIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POLYCYTHAEMIA VERA (polycythemia Vera) (seriousness criterion medically significant) and BREAST CANCER METASTATIC (Metastatic breast cancer) (seriousness criterion medically significant). At the time of the report, POLYCYTHAEMIA VERA (polycythemia Vera) and BREAST CANCER METASTATIC (Metastatic breast cancer) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, SARS-CoV-2 antibody test: low (Low) Low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.
Information has been received from a physician concerning a child who was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot # 649812/0492R) - The patient experienced redness and swelling at the injection site. It was unknown if medical attention was sought. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center of Biologics and Evaluation Research and was released by the regulatory agency. Additional information has been requested.
I received the vaccine in the afternoon and was fine until that evening. I started feeling a burning sensation in my hand that worsened through out the evening and by 1:00 am my hand felt like it was on fire. In the morning, the sensation had decreased but was still present. It worsened throughout the day until it felt like it was on fire again that afternoon. For the next few weeks, the burning sensation came and went, but never as bad as the first night.
Severe stomach pain, nausea, vomiting, and diarrhea for 24 hours then resolved then returned 72 hours later and lasted another 24 hours. Fatigue lasting 4 days starting day of vaccination. Low-grade fever for 24 hours after vaccination.
"Moderna COVID-19 Vaccine EUA"    Hypersensitivity & fleeting / flowing pains spread throughout left side of body from tip of nose across face, up and down neck and left side of head out through fingers of left hand, down left side of back, down left thigh / leg and out through toes of left foot.  It was as if the left side of my body was in a different time zone than the right side.  I called the nurse line; they suggested a visit to the ER.  My BP was way up, and I panicked just a little; but, tried to use my mindfulness practice to observe the unfolding events, rather than being consumed by them.  There was a CT of my skull wherein they found indications of "an old" stroke; so, they decided that it was possible I had a stroke.  I was transferred from the Medical Center to the Stroke Center at the Medical Center under the care of Dr.  Another CT with contrast and a MRI confirmed "OLD" stroke, but nothing new.  I was assured the vaccine had nothing to do do with my symptoms, and that I most likely experienced a Trans Ischemic Attack (TIA), and that the situation was merely a coincidence as they believe the vaccine had nothing to do with the TIA.  However, based on my personal experience of the events as they unfolded, it is my sincere belief that the vaccine was incidental to the effects as I experienced them.  I was kept overnight for further observation, released the next day, and had a follow-up with my primary care physician at the Med Center.  I am now taking an 81 mg aspirin, Plavix, and 80 MG Clopidogrel as a precaution, and my symptoms have been gradually fading away.
1st dose of Moderna vaccine on Thursday April 1. Side effects for one week following 1st vaccination ranging from low grade fever, headaches, chills, and overall aches. During well visit on Tuesday April 20 discovered small swelling on right thryoid area. No previous history of thyroid issues. Blood work revealed positive TPO antibodies and regular thyroid hormone levels (TSH and T4). An ultrasound was scheduled for Friday April 30. Second dose of moderna vaccine scheduled for Thursday April 29 at 8:40am. By 5pm had 102 fever that lasted 8-10 hours. Friday April 30 receded to low grade fever and overall minor aches. Thyroid ultrasound completed on Friday April 30.   On Saturday May 1, neck area was extremely inflamed. It felt like someone was applying "icy hot" on my neck every 5 minutes. Higher temperature. Relief with ice packs on neck and last through Sunday night (May 2). Extreme fatigue on Sunday. Thyroid was extermely inflamed and swollen. Monday May 3 swelling slighly receded and no longer having the icy burning feeling. Low grade fever remains with overall body aches. As of Wed. May 5, thyroid is still very swollen. Had a follow up with general practicioner with ultrasound revealing 7 thyroid nodules measuring 1.5-2 cm in size. Thyroid swelling easily visualized externally. Will follow up with an endocrinologist.
pt recvd vax; was found to be non-responder; total of hep A screen neg;
She got her vaccine, she got very weak and tired and slept the first day and a half as she was so weak and tired and had a headache.  The headache went away after the 3rd day, but the tiredness lasted for about a month or so.  She found it more difficult to breath.  Prior to this she had some problems breathing, but it got worse after she received the vaccine, pretty much right away.  She went to her doctor who sent her to a pulmonologist.  The pulmonologist sent her for a pulmonary function tests, and had a test that her oxygen dropped to 86 when she was walking.  In November she was having problems, and had a chest x-ray and did not get back to her until 2/8/21 and that she had an enlarged heart, but it got worse after the vaccine.   She was placed on oxygen on 3/26/21.  This has helped her.  She was not put on any nebulizers as they did not help much and is on Oxygen 24/7.   The tightness in her chest have gone away but does have occasional headaches possibly due to not using her oxygen at times.
pt recv vax 5MAY97 & 19MAY97 pt exp intractable h/a extending  from frontal lobes to back of head;it was noted pt did not have an adverse exp following 1st dose;
Patient said she was not able to lift her left arm. The area at the injection was tender and she experienced a burning sensation that spread from the injection site to her chest. After 5 days she has been able to lift her arm a little more but she still does not have full range of motion.
Local swelling VS infection at site entire arm, required ER treatment two night IV antibiotics and 2 courses of oral. Took 1 week 12/08/06 to recover.
pt recv varivax 4/7/98 & 4/21/98 devel approx 7 vesicles
Information has been received from a registered nurse via field representative referring to a 65 year old male patient. There was no medical history or concurrent condition reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dosage, strength, route and lot # were not reported). There was no concomitant medication reported. On an unknown date, the patient presented with a excessive swelling, redness, pain and tenderness in an unspecified arm 1 week after receiving the PNEUMOVAX 23. The patient also had body aches and a temperature. He went to the emergency room due to these symptoms. It was not known if he was admitted into the hospital. At the time of the report, the outcome of the events was unknown. Additional information has been requested.
Patient given expired dose of Twinrix. Twinrix expired on 02/20/2022.No Adverse event took place for the patient that day besides the patient recieveing an expired dose of Hep A/B Twinrix.
Since my 2nd Pfizer vaccination, I have been experiencing consistent fatigue, weakness, body aches, chills, headaches, brain fog, and an itchy cough.
HEAD BURNING; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced head burning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of head burning was not reported. This report was non-serious.
Pt. called out to me that she was starting to itch in her arm, quickly spread full body round 5:25 pm. I provided a bottle of water and 2 (25mg) benadryl. She then started she was hot, so we grabbed ice packs which she stated felt cooling on the itching. I called 911 at 5:33 from my personal cell so I could stay near by. One of me techs is pre-med. I stationed him next to the patient while I looked into protocols. Once EMTs arrived they escorted her out of the building after asking if her breathing was okay. She was speaking to us the whole time.
vaccine administered 4/29/20/22 expiration date was 5/31/2022 but beyond use date was 4/18/2022
patient passed out at the front end of the store after receiving vaccine. Did get up and father was contacted (who is a nurse) and agreed she was fine. and she left with the mother
Tingling in feet, cold feet, weakness in both hands, fatigue, then weakness in lower legs, and headaches.
Pt sat down in waiting room for observation. After about 5 minutes pt was noted to be unconscious. Pt did respond to stimuli and woke up after about 30 seconds. Pt stated she was fine did not need additional care.  Had pt state for another 15 minutes of observation and she was feeling fine.
On the date of vaccines given child was at check out window and fainted. O2 level checked 98% Heart Rate 45 Blood Pressure 88/44 - rested O2 100% HR 72 patient sent home with mom. 6/2/11 patient with swelling of left thigh allergic reaction.
INSIDES SHAKY LITTLE IN THE BEGINNING; HEADACHE; SUBJECTIVE FEVER; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety issues, environmental allergy, allergy to bee stings, and anaphylactic reactions. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 208a21a, expiry: 21-JUN-2021) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAY-2021, the subject experienced insides shaky little in the beginning. On 17-MAY-2021, the subject experienced headache. On 17-MAY-2021, the subject experienced subjective fever. The action taken with covid-19 vaccine  was not applicable. The patient recovered from insides shaky little in the beginning on MAY-2021, headache on 18-MAY-2021, and subjective fever on 17-MAY-2021. This report was non-serious.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored ZOSTAVAX (unknown strength) both subcutaneously and intramuscularly. Concomitant medications were not reported. The nurse could not confirm if intramuscular injections were standard practice for administering these vaccines at the facility. No adverse effects were reported. The outcome of the events was unknown. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 16 to 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F an 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Loosing weight; Received second Moderna Covid-19 injection on 03Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Loosing weight) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second Moderna Covid-19 injection on 03Mar2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second Moderna Covid-19 injection on 03Mar2021). On an unknown date, the patient experienced WEIGHT DECREASED (Loosing weight). On 03-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second Moderna Covid-19 injection on 03Mar2021) outcome was unknown. At the time of the report, WEIGHT DECREASED (Loosing weight) outcome was unknown.            No concomitant information was reported. No treatment information was reported.   Reporter did not allow further contact
Patient called in on 1/4/19 stating that her vaccine was administered too high in her arm and has caused her severe pain. She states that the pain went from her arm to her neck and she did not have this reaction with the first injection in the series. She said that she went to the ER where they did x-rays and stated to her that it looks that it was administered too high. Patient states that she cannot move her arm and that it is in a sling. She was given a prescription for the pain/muscle and is to follow up with her primary care provider. The administering pharmacist recount of the event of the vaccination. Prior to administering the vaccination I informed the patient that redness and pain near the injection site is common following this vaccination and reviewed the screening questionnaire for immunization and consent and asked the patient if she had any questions about the vaccine. I asked the patient to lift her right arm and palpated to feel for the deltoid muscle. I then advised the patient to put her arm down and relax her arm as much as possible. I then cleansed the injection site with an alcohol swab and administered the vaccine intramuscularly in the patients right deltoid per Meijer vaccination protocol and covered the injection site with a Band-Aid. The patient's arm was thin, but nothing else was atypical or of note when the vaccine was given. We reviewed how to find the deltoid muscle and then where in the deltoid muscle to make the injection.
Information has been received regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about late 2015, the patient was inoculated with ZOSTAVAX (route of administration, site of administration, lot number and expiration date were not reported) for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient developed a painful rash on her left arm, which was accompanied by pain, weakness, and fatigue. In response to these complaints, the patient presented to her primary care physician and was diagnosed as suffering from herpes zoster, neuropathic pain, pain syndrome and actinic keratosis. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This initial spontaneous case, was received on 13-Oct-2017, from a pharmacist, concerning a 70-year-old female patient. The patient's medical history and concomitant medications were not reported. On 27-Sep-2017, the patient received FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular: anatomical location: left deltoid, batch number: 178623 (as reported) and expiry date: Apr-2018). On 28-Sep-2017, the patient had dark redness (3 inches in diameter) and warmth around injection site. It was reported that, the patient did not receive any medications as a treatment. On an unspecified date (reported as within 2-5 days), the patient had recovered from the events. The reporter considered this case as non-serious. Follow-up received on 23-Oct-2017: The event outcome was changed from not reported to recovered (within 2-5 days). Narrative amended accordingly.
Erythema and induration 10 cm around injection site.  No tenderness.  Site is itchy.  No treatment except to monitor site.
Migraine on day 3. Started around 5 pm the first time, took ibuprofen and hydroxyzine to sleep until it passed. Day 6, another migraine. Ibuprofen and caffeine. Day 7 I went to get a haircut thinking the migraines may be caused by heavy long hair. Day 8 extremely painful migraine, can?t open eyes as light made it worse, nausea, vomiting. Called my PCP, they recommended going to urgent care after I vomited. I couldn?t get a ride so I took ibuprofen, Tylenol, and hydroxyzine to help me sleep until it?s gone.
ligament in injection shoulder snapped; This spontaneous case was reported by a consumer and describes the occurrence of LIGAMENT RUPTURE (ligament in injection shoulder snapped) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 020B21A) for COVID-19 vaccination.     The patient's past medical history included Shoulder operation NOS (Shoulder surgery in right shoulder) in 2015.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced LIGAMENT RUPTURE (ligament in injection shoulder snapped). At the time of the report, LIGAMENT RUPTURE (ligament in injection shoulder snapped) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other medications were cholesterol medication, blood pressure medication, prostate medication.  The treatment information was not given.
pain in all of left arm the day of injection, red swelling hives around injection site, pins and needles sensation in hands and feet, joint pain. Benadryl gave no relief