chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bell's Palsy temporarily  after receiving 1st dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of BELL'S PALSY (Bell's Palsy temporarily  after receiving 1st dose of the Moderna COVID19 vaccine) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bell's Palsy temporarily  after receiving 1st dose of the Moderna COVID19 vaccine) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's Palsy temporarily  after receiving 1st dose of the Moderna COVID19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient wanted to receive a second dose. HCP wanted to know which were the direction on whether the patient should get the second dose. HCP mentioned that the patient received the 1st dose on other facility and that she does not have further information. Patient was about 25 years old. No treatment information was reported.  Company comment: This case concerns a female patient around 25 years old with no medical history provided who experienced serious expected event of Bell's palsy. It was reported that the patient experienced Bell's Palsy temporarily after receiving the fist dose of mRNA-1273. No further information was provided. The precise temporal relationship cannot be determined, having in mind that the exact start date of the reported event was not provided. The outcome of the event was unknown at the time of the report and no information regarding the clinical course of the event was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient around 25 years old with no medical history provided who experienced serious expected event of Bell's palsy. It was reported that the patient experienced Bell's Palsy temporarily after receiving the fist dose of mRNA-1273. No further information was provided. The precise temporal relationship cannot be determined, having in mind that the exact start date of the reported event was not provided. The outcome of the event was unknown at the time of the report and no information regarding the clinical course of the event was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Got shot on Tuesday. On Sunday night had cough and congestion and little fever.  Going to do COVID testing this morning.  Is feeling better today.
Sore arm at the injection site; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 07Jan2021 at a single dose on the arm, with route of administration unspecified, for COVID-19 immunization. Medical history included acid reflux. The patient's concomitant medication included an unspecified acid reflux medication. On 07Jan2021, the patient had sore arm at the injection site. The outcome of the event, sore arm at the injection site, was unknown.  Information on the lot/batch number has been requested.
This spontaneous report as received from a pharmacist refers to a 65 year old male patient. The patient's current conditions included chronic obstructive pulmonary disease (COPD) and heart disease. The patient had no drug allergy. On 21-MAY-2013 the patient was vaccinated with ZOSTAVAX lot # J000429, exp. date 10-APR-2014, 0.65 ml, once, subcutaneous in the backside of the upper left arm. Concomitant therapies included SPIRIVA, SINGULAIR, PRILOSEC and ADVAIR. On an unspecified date in May 2013, after receiving ZOSTAVAX on 21-MAY-2013, he experienced a golf ball size raised area where the shot was given. The patient came in to see the pharmacist on 23-MAY-2013 to report the adverse event. The pharmacist did not know when the "golf ball size raised area" first appeared. No treatment was given. No lab test was done. The outcome of golf ball size raised area where the shot was given was reported as not recovered/not resolved. Additional information has been requested.
Several hours after became very tired, arm was very sore where the shot was given, had chills/freezing in bed and woke up every other hour, felt achy and neck hurt.
Swollen and stiff leg x 4 days after vaccines, very fussy - still has extra skin fold on (L) upper thigh. Possible DDH. Referred to orthopedics due to extra skin fold.
This case was reported by a pharmacist and described the occurrence of adverse event in a patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was received via web call. The pharmacist reported that the doses of SHINGRIX need to be restarted if the 2nd dose was not given within the 2-6 month time frame and asked that if the patient did not want to receive the 2nd dose due to side effects then what was the percentage of protection. It may sound like this pharmacist may had the patient who experienced an adverse event and did not want another shot.
This spontaneous report as received from a nurse manager refers to unspecified number of patients of unknown age and gender. On an unknown dates, since October 2014, the patients were vaccinated with a dose of VAQTA (doses, routes, lot numbers and expiration date were not provided) which were exposed to multiple excursions. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
On the morning 7/16 I experienced an episode of severe shortness of breath, chest pain and cold sweats. I called 911 and the ambulance came and was taken to the ER. The doctor notice clots in my right lung and said I had a pulmonary embolism and I was admitted for 3 days. During my stay I was given LOVENOX twice a day. They could not determine what the cause of the embolism was. I reached out to my PCP who advised that I would have to take blood thinners for the rest of my life. They prescribed me ELIQUIS.
I thought I had allergies, but my Nasacort and Allegra were not relieving my symptoms. I took a rapid test on the 15th, and I spoke to my doctor who recommended that I take the monoclonal antibodies which I did. The symptoms were congestion body ache, headache, runny nose and watery eyes. I was symptom free within 18 hours.
After the shot, I was feeling a little weak wanted to throw-up. Next felt a little better, Saturday felt sick sick in my stomach and throw-up when I got home.
This case was reported by a pharmacist via call center representative and described the occurrence of blurred vision in a 41-year-old female patient who received BOOSTRIX (batch number EC9A9, expiry date 22nd January 2019). On 30th January 2017, the patient received BOOSTRIX 0.5 ml. On 31st January 2017, 1 days after receiving BOOSTRIX, the patient experienced blurred vision. The patient was treated with vitamins nos. On an unknown date, the outcome of the blurred vision was unknown. The reporter considered the blurred vision to be unrelated to BOOSTRIX. Additional details were provided as follows: On 30th January 2017, the patient received BOOSTRIX vaccine around approximately 7pm and upon awaking on the morning of 31st January 2017 experienced the blurry vision and had difficulty for focusing on objects (visual disturbances). The patient received vitamins and herbs and the symptoms went away. Edit (not further specified), pharmacist who took the escalated call and told that the health care professional stated that two weeks ago the patient drank out of a cup from someone who had Guillain Barre Syndrome.
hectic Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (hectic Tinnitus) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (hectic Tinnitus). At the time of the report, TINNITUS (hectic Tinnitus) outcome was unknown. Not Provided          No concomitant medication provided. No treatment information provided.   This case was linked to MOD-2021-092206 (Patient Link).
This spontaneous report as received from a pharmacist refers to a 21-year-old non-pregnant female patient. The patient did not have any pertinent medical history or drug allergies. The patient did not take any concomitant medications. On 21-NOV-2015, the patient was vaccinated with the first dose of RECOMBIVAX HB 10 Microgram in 1 ml, intramuscular, lot # L013051, expiration date 15-APR-2017 for prophylaxis. On 20-JAN-2016, the patient was vaccinated with the second dose of RECOMBIVAX HB 10 Microgram in 1 ml, intramuscular, lot # L025377, expiration date 15-APR-2017 for prophylaxis. On 20-JUL-2016, the patient was vaccinated with the third dose of RECOMBIVAX HB 10 Microgram in 1 ml, intramuscular, lot # M032653, expiration date 31-MAY-2016 for prophylaxis. In approximately 2017 (reported as recently), the patient had a negative hepatitis B antibody titer. The patient sought medical attention and she was not given any treatment for the event. The outcome of the event was reported as not recovered. The relatedness between RECOMBIVAX HB and the event was not provided.
Mom called on 5/5/00 and states she noticed that  on 5/4/00 the child's leg was swollen, hard, red and warm to touch at the injection site and up the leg. She took the child to the ER and the pt was prescribed Keflex for an infection. Follow up on 5/11/00 states child is using leg.
very big pain down my arm, from elbow to hand; also in shoulder blade; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very big pain down my arm, from elbow to hand) and PAIN (also in shoulder blade) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PITAVASTATIN CALCIUM (LIVALO) for Cholesterol, VITAMINS NOS for Nutritional supplementation.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (very big pain down my arm, from elbow to hand) and PAIN (also in shoulder blade). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and TRAMADOL at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (very big pain down my arm, from elbow to hand) and PAIN (also in shoulder blade) outcome was unknown.
Rash at injection site one week after vaccination. Cold and flu like symptoms 15-20 hours after injection.
Patient called on 9/9/10 @ 9:20 am to report soreness and fever.  Patient stated she had soreness in left arm that started the evening of 9/8/10 and began taking Advil.  Patient woke this morning with fever and called her primary physician.
no known adverse events; a patient received less than a full dose of PROQUAD because the plastic syringe leaked; a patient received less than a full dose of PROQUAD because the plastic syringe leaked; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's pertinent medical histories, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 22-JUL-2019, the patient was vaccinated with less than a full dose (incorrect dose administered) of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (POQUAD) rHA, Lot No. R008203 has been verified to be a valid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, expiration date reported as 05-JUL-2020, but upon internal validation established as 16-SEP-2019 (dose, frequency, strength, route of administration were not reported) for prophylaxis. It was reported that the plastic syringe leaked (product leakage) and it was unknown exactly how much of a dose the patient actually received. No known adverse events. The outcome of product leakage was unknown.  The causal relationship between product leakage and therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (POQUAD) was not provided.
upper arm burning, increased warmth, purpura; rest of the symptoms abated now, except purpura still visible lower forearm today
I received the vaccine at about 4:45pm on the 31 of May in my left arm.  the arm was sore but nothing out of the usual.  I woke up the next morning with pain in my left chest, going into my left armpit, my left shoulder and arm.  This pain lasted all day until I went to bed.  I tried not to let it interfere with my activities..  It lasted until I went to bed that night.  I took tylenol , 500mg during the day and naproxen 220mg when I went to bed that night.  The next day I woke up feeling better and less pain.  today I am feeling better with no noticeable pain.
Clammy, tingling in bilat hands, anxiety. Pt stated she fainted before - feels cold, clammy beforehand. She felt this way w/ bilat tingling & called for nurse. A&O x4. Vitals stable. Gave water - hasn't drank since 10 AM. After drinking water, pt stated she is feeling better. Offered w/c for exit, declined. Vitals still stable. Pt left Yahoo in stable condition. BP 123/63; HR 72; RR 18, SpO2 97%
Case number PHEH2012US006254 is an initial spontaneous report received from a consumer on 16 Mar 2012. This report refers to a female patient whose age was unspecified. Her medical history, past drugs, current conditions and concomitant medications were not reported. She was vaccinated with H1N1 pandemic influenza vaccine (manufacturer and batch number: unspecified) intramuscularly on 13 Nov 2009 (site and dose was not reported). On Dec 2009, it was reported that she lost her balance and fell down. Her right foot went numb along with other sensory nerves in her body. On an unspecified date she experienced frostbite as she could not sense the cold from the ice and underwent shoulder surgery. She was tested by three neurologists. An electromyogram (EMG) was performed which revealed that her sensory nerves were abnormal; however transverse myelitis and multiple sclerosis were ruled out. The only possible causes were two brain elisions and an abnormal signal from her brain stem to her extremities and the latter was confirmed by another electrical test. She also experienced leg spasms and tingling and numbness in the extremities. It was stated that her reflexes were hyper-reflexive; hence Guillain-Barre syndrome was ruled out. On an unspecified date she experienced spasm, fatigue, pain and loss of muscle endurance. She was treated with NEURONTIN which relieved her from spasm but it did not help with joint pain and fatigue and she also became very depressed mentally. On an unknown date she was switched to baclofen which was ineffective. It was reported that she could not lift her arms. Her foot had been broken twice but she was walking on it for weeks because she did not know that it was broken. The outcome of the events reported as condition unchanged.
Diarrhea, frequent bowel movements, abdominal cramping all of which will not go away a week after the injection, no blood noticed in stool as of yet (Ulcerative Colitis symptom). Joint pains in knees, hands, feet. Muscle pain. Sore inside mouth
This spontaneous report as received from approximately 63 year old female consumer regarding herself. The patient had none pertinent medical history and drug reactions/allergies to SULFUR, epinephrine and unspecified steroids reported. On 16-JUN-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous 1 single shot for the prevention of shingles. Concomitant therapies included CORGARD. The consumer reported that on 17-JUN-2014, one day after receiving ZOSTAVAX her arm swelled to the size of a grapefruit, it was red and she developed elbow pain. No laboratory diagnostic studies performed. The patient sought medical attention and was treated with oxycodone and PHENERGAN. The events were recovering at the time of the report. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history included shingles. A few months ago, the patient was vaccinated with ZOSTAVAX (lot # not reported) dosing details unspecified. No concomitant medications were reported. The reporter stated that a patient was administered ZOSTAVAX by him at an unspecified time a few months ago and experienced a 2 inch patch of redness at injection site but no other adverse effects. Outcome of the reported event was unknown. No further information provided. Additional information is not expected.
shoulder injury - pain in upper shoulder joint began a few hours following shot and continues one week later. Feels like a frozen shoulder...in the morning cannot lift arm above my head without pain. I have pain at injection site after second shot but this is much more severe
Skin rashes mostly in the abdominal area. Few found on my arms. Slightly itchy. Red bumps.
Information has been received from a health professional concerning a 44 year old white female with no past medical history and no known drug allergies who received the complete series of Hepatitis B vaccine recombinant (yeast) "sometime in the past". The medical assistant reported that in approximately July 2001, a titer did not detect seroconversion. On 26 JUL 2001, the patient received an additional dose of Hepatitis B vaccine recombinant (yeast) (Lot # 638713/1820K) IM in the left arm. There were no illnesses at the time of vaccination. On 27 JUL 2001, the patient experienced an injection site reaction of redness, tenderness and swelling. The patient also experienced nausea and fatigue. Unspecified medical attention was sought. The medical assistant reported that the patient put aspirin crushed up, mixed with water on her arm "to take the fever out." The patient also put ice on her arm. The patient's pain and redness lasted approximately five days. Additional information has been requested.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 08-AUG-2017, the patient was inadvertently vaccinated with PNEUMOVAX 23 lot # L048265, expiration date 10-JUN-2017, single dose, intramuscular for prophylaxis (expired product administered). No adverse events reported.
Adverse systemic events for the duration of March 17-March 27: Swollen lymph glands (mild) Fatigue (severe) Brain "fog" (severe)  Sensation of overheating / burning  Fever (few mild elevations) Loss of Appetite /Indigestion (resolving as of March 26)
Per patient statement - 30 minutes after reciving vaccine  patient reports that he started to feel congested.  AT that point the thought it was allergies from the day before.  His wife dropped him off aat work.  He had someone take him to healthcare center.  Was given Epinephirne at 1045am.  He was discarged by ED,  with Epinephrine Rx.   At 230 his wife injected him with another epinephrine due to congestion and diffculty breathing, speaking, it felt like his througfht was getting tight.  EMS gave himanother dose of Epineprine  and was taken to ER again.  6pm on February  25  nebulizer , had complaints of difficulty breathing speaking was taken to healthcare center  and admitted.   Discharged on  February 26, 2020 Saturday  730 Difficulty breathing, wheezing, speaking could not swallow  Horse, abdmen pain, lethargic,
From patient's medical record: "Patient called and patient has complaints of after she received the shingrix vaccine on Friday 2/21 she went home and felt very chilled, she then developed fever and sweats (she did not check temp.). The next day she still did not feel well and felt like her heart was racing. She then passed out and fell down in her hallway. She is unsure how long she was out for. She hit hear elbow and her head.  She feels fine today, c/o bruise on elbow and small bump on head. Offered appointment and pt refused. She said she doe not like coming to the doctor and only sees the doctor once a year. She said she is a healthy person and is not sure why this happened. She said she no longer wants to receive these types of vaccines.    She reported this to the number on her VIS sheet and was told to notify her PCP. She would like this added to her allergies on her file.  She was told that PCPs office should also report this reaction. "
At 15 minutes past vaccination patient is crying. When asked if she is ok, she doesn't speak just keeps crying.  Then her eyes roll back in her head and she proceeds to pass out.  She comes in and out repeating this process for 5-10 minutes. Patient is non verbal during event.  Once  Patient  came to, she knew her name, year, and president but did not know what day it was.
Call is regarding a possible reaction to the first moderna vaccine in an 84 year old.; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (Call is regarding a possible reaction to the first moderna vaccine in an 84 year old.) in an 84-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Call is regarding a possible reaction to the first moderna vaccine in an 84 year old.). At the time of the report, VACCINATION SITE REACTION (Call is regarding a possible reaction to the first moderna vaccine in an 84 year old.) outcome was unknown. 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 relevant concomitant medications were reported.  No treatment information was provided.