chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reported she had nausea, vomiting, diarrhea, fever102.0, chills, injection site pain, body aches at approximately midnight.  This nurse requested patient report to ER as soon as possible.  Admit to ER at approx 1810.  Labs ordered, zofran 8mg administered IVP per physician orders, Tylenol 1G administered, IV fluids given at time of visit.  Pt released at 11 p.m.
5min p/vax pt 02 sat dec 88% w/wheezing noted;total body redness also observed;pt c/o itching;DPH given & pt taken to ER where epi given;events resolved;no sequelae as of 18JUL f/u visit;
Pt recvd vax 30APR92 & lab eval on 30APR92 revealed that was anti-HBs pos; lab eval on 19OCT92 revealed that was anti-HBc pos; No further details were provided;
I had a low-grade fever, coughing, wheezing, tightness in my chest, body aches, earaches. I went to Urgent Care where they ran a RSV, PCR Rapid COVID-19, Influenza A and B tests that all came back negative. I was sent home and advised to use my inhaler. On March 31, I talked to an on-call physician from my practice and was given Doxycycline and Nabumetone. On April 3, I finally got to a telehealth visit with my primary care physician and was prescribed prednisone.
patient is 17 years old and received the Janssen vaccine, which is only approved for those 18 years of age or older
I received the 1st vaccine on 1/8/2021 and immediately my arm was very sore but was fine a few day after. however when i got my second vaccine on 2/4/2021 is when I began to experience more side effects. My arm was extremely sore for more than a week. I could barely fully extend my entire arm and I developed a lump in the pit of my arm pit. Both my tricep and  bicep mussels were tender. I also experienced headaches and tinnitus. The soreness of my arm and lump have gone away however I still have headaches and tinnitus to this day.
pt recv vax 8MAY98 & Friday evening t exp an elevated temp of 104.3;mom gave motrin & APAP;Saturday morning deltoid was pinkish purple radiating to elbow;taken to ER;ER told parent to f/u w/MD;
Received ZOSTAVAX 4/16/09. Developed herpes zoster 4/26/09 over T9 on right.
pt was immunized on 24SEP92 w/HBOC only; w/in 36 hrs p/vax pt thigh was bright red & swollen from the groin to the knee (twice the nl size); seen in office on 26SEP; MD believes it to be an allergic reaction;
blood clot in his left lower calf; pain in lower left calf; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (blood clot in his left lower calf) and PAIN IN EXTREMITY (pain in lower left calf) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced PAIN IN EXTREMITY (pain in lower left calf). On 20-May-2021, the patient experienced DEEP VEIN THROMBOSIS (blood clot in his left lower calf). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency and RIVAROXABAN (XARELTO) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DEEP VEIN THROMBOSIS (blood clot in his left lower calf) and PAIN IN EXTREMITY (pain in lower left calf) outcome was unknown.            No concomitant medications reported by investigator Action taken with mRNA-1273 in response to the events was not Applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Inside my hand hurts so bad. I feel like something touch the bone in in my hand. And when it hurts so bad, I feel it in my neck. Everyday it hurts. Right now I can feel it, like something is poking. It's in my left hand, the hand I got the vaccine in. I bare the pain, because it hurts bad.
I have had ringing in my right ear for several years.  About 6 weeks ago the ringing started becoming louder to the point I cannot sleep at night.  I wake up every hour or so from the ringing.  It is so bad I asked my ENT to make me lose my hearing in that ear because I am going crazy.  Of course he told me that would not help.
Autoimmune disease due to the vaccine; Feminine bleeding; Myositis ossificans; Massive inflammation in her quad muscle.; Very painful in the quad; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (Autoimmune disease due to the vaccine), VAGINAL HAEMORRHAGE (Feminine bleeding), MYOSITIS OSSIFICANS (Myositis ossificans), MYOSITIS (Massive inflammation in her quad muscle.) and MYALGIA (Very painful in the quad) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A, 040A21A and 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN (NEURONTIN), MONTELUKAST SODIUM (SINGULAIR) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (Autoimmune disease due to the vaccine), VAGINAL HAEMORRHAGE (Feminine bleeding), MYOSITIS OSSIFICANS (Myositis ossificans), MYOSITIS (Massive inflammation in her quad muscle.) and MYALGIA (Very painful in the quad). At the time of the report, AUTOIMMUNE DISORDER (Autoimmune disease due to the vaccine), VAGINAL HAEMORRHAGE (Feminine bleeding), MYOSITIS OSSIFICANS (Myositis ossificans), MYOSITIS (Massive inflammation in her quad muscle.) and MYALGIA (Very painful in the quad) outcome was unknown.            Concomitant medication also included inflammatory drug and Neurontin at night. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.  One of the possible diagnosis was myositis ossificans and it was localized and would go away but would take 46 weeks. The worst version their doctors said was it might be autoimmune disease due to the vaccine and the doctor thinks it was unlikely, but it might be a potentially related. The patient also reported that they had feminine bleeding, which they no longer had at their age. Reportedly, all the symptoms started post 2-3 weeks after getting the vaccine and the two things happened at the same time.; Sender's Comments: This case concerns a 62 year-old female patient with no reported medical history, who experienced the unexpected non-serious event of  Autoimmune disorder. The event occurred an unknown number of days after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Manual override done to remove seriousness criteria of Medically significant from event of Autoimmune disorder based on medical judgement and review of source document that does not support seriousness criteria.
Very large triangular shaped very red area on her arm, around the injection site.; Injection site slightly itchy; Muscle at injection site is somewhat painful; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Very large triangular shaped very red area on her arm, around the injection site.), VACCINATION SITE PRURITUS (Injection site slightly itchy) and VACCINATION SITE PAIN (Muscle at injection site is somewhat painful) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Dec-2020, the patient experienced VACCINATION SITE ERYTHEMA (Very large triangular shaped very red area on her arm, around the injection site.), VACCINATION SITE PRURITUS (Injection site slightly itchy) and VACCINATION SITE PAIN (Muscle at injection site is somewhat painful). At the time of the report, VACCINATION SITE ERYTHEMA (Very large triangular shaped very red area on her arm, around the injection site.), VACCINATION SITE PRURITUS (Injection site slightly itchy) and VACCINATION SITE PAIN (Muscle at injection site is somewhat painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication also included for thyroid disorder. Treatment details not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: Possible NNI
Information has been received regarding a case in litigation from a lawyer and a female patient referring to herself. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The female patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2012, the patient was administered the ZOSTAVAX by a healthcare provider at a health center (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider at a health center for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to self and economic losses. The outcome of the shingles was unknown. Additional information has been requested.
Almost blacked out; Dizziness; Anxiety attacks; Vision was not all that well; Heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Almost blacked out), DIZZINESS (Dizziness), ANXIETY (Anxiety attacks), VISUAL IMPAIRMENT (Vision was not all that well) and PALPITATIONS (Heart palpitations) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PRESYNCOPE (Almost blacked out), DIZZINESS (Dizziness), ANXIETY (Anxiety attacks), VISUAL IMPAIRMENT (Vision was not all that well) and PALPITATIONS (Heart palpitations). At the time of the report, PRESYNCOPE (Almost blacked out), DIZZINESS (Dizziness), ANXIETY (Anxiety attacks), VISUAL IMPAIRMENT (Vision was not all that well) and PALPITATIONS (Heart palpitations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicines were not reported.
very little discomfort with that one; This case was reported by a consumer and described the occurrence of discomfort in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2019 (refer case US2020AMR095999)).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was unknown.   It was unknown if the reporter considered the discomfort to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 2nd dose of vaccine and had very little discomfort with that 2nd dose. The patient wanted to know that if other people experienced the same type of pain after vaccination.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR095999:same reporter
Vaccination of right deltoid developed swelling in and around immunization site within 2 hours.
Pain in left arm, stiff neck on left side and pain, and headaches on the left side.
Pfizer-BioNTech COVID-19 Vaccine EUA   12:00am - 3:30am Nausea, dizziness, lightheaded, feeling like throwing up, feeling like passing out, heart pounding, heart rate 130, abdominal pain and cramps   3:30am-5am - Extreme chills, lightheaded, heart pounding (not as bad), heart rate 125-130  Headache, body aches and stiffness   5am-7am- Lower back pain, body aches stiffness, headache/head pounding  Heat flashes  Temperature 100 degrees   Took Tylenol at 6am   8am And all day 3/31 - Temperature decreased to 98-99 degrees Main symptom fatigue, lack of appetite, mild nausea, lower back ache and cramping    Back cramping/aches subsided by 12:00am 4/1  4/1 daytime lack of appetite, mild nausea and body aches
Patient given 3rd dose monovalent and should have gotten bivalent. No adverse reactions reported.
Information has been received from a 53 year old female registered nurse with diabetes and thyroid disorder who on 10/12/2006 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (0.5 ml), IM in the left deltoid. Concomitant therap0y included insulin and Synthroid. Subsequently, her left arm was in a lot of pain and she could not move her entire arm or lift the arm on the evening of 10/12/2006. The nurse was told by the physician to ice the arm and take medication for the pain. The nurse took Motrin 800 and two tablets of Vicodin. The nurse was very scared that there was a lot of pain with her arm and that she could not move her arm. The nurse mentioned on 10/13/06 the arm was achy but she could move it, but it was swollen and sore. At the time of the report, the pt had recovered. The nurse considered her experience to be an other medical event (OMIC)( and disabling. Additional information has been requested.
Vaccine administered 3/5/2009 3 pm. Friday am 3/6/09 individual noted site to be tender only, no erythema, but by Friday evening was experiencing erythema and tenderness. By Saturday am, 3/7/09 the area was elevated,tender, itchy, hot to touch, pink and rosier center near the injection site (approximately 5 1/8" longitudinally and 3 1/4" transversally). Individual took Ibuprofen and Benadryl as comfort measures. On Sunday, 3/8/09 the area remained the same size but intensity of symptoms increased. Individual contacted  PHN and was advised to go to ER for evaluation and individual declined. Advised to  continue comfort measures (cool compresses, Benadryl po and Ibuprofen or Tylenol po for pain), mark boundaries of erythema and contact PCP or see PHN 3/9/09.  Seen in PHN office 3/9/09 am, site less tender, erythema reduced to light pink, slightly warm to touch ,area reduced to approximately 1 1/2" logitudinally and 1 5/8 " transversally overall. Individual is continuing comfort measures.  At no time did she experience SOB, LOC, or s/s of anaphylaxis.
Patient presented on 8/27/09 with redness and blistering over left upper arm.  Mom reports the redness began on 8/26 and began to spread, the blisters formed on the evening on 8/26.  She received Rocephin for possible cellulitis.  Mom called and the redness was spreading with swollen elbow that afternoon.  she was sent to UK Children's ER for evaluation.  She was begun on Vancomycin and then detremined to be adverse reaction with beginning resolution.  9/17/09 Hospital records received DOS 8/27/09 to 8/28/09. Assessment: Arthus Reaction. Patient was admitted with swollen left upper arm progressing in size and redness. Soft-tissue swelling. Pustule lesions area of injection site. The following morning the lesion was erythematous and warm but nontender to touch and located from shoulder to elbow on left upper extremity. Heart rate elevated. Respiratory rate elevated.  9/14/09 ICD-9 Codes Received: 999.5 Other serum reaction, 682.3 Cellulitis of arm, E949.9 Adverse effect of other and unspecified vaccines and biological substances.
pt recv vax 28AUG98 & over the weekend pt had flu like sx w/fever, chills & pain all over body;pt lt arm from shoulde to below elbow was red & swollen;the redness was about 6 inches long & 3 inches wide;red streak line ran below eblow;
09 April 2021 10:00 ? While administering single dose of J&J COVID-19 Vaccine medical personnel were able to draw a full 0.5ML 6th dose from a 5 dose vial. The extra 6th dose was administered to the individual listed. PT exhibited no immediate adverse reaction and was monitored for 15 minutes post vaccination with no adverse reaction or symptoms.  10 April 2021 ? Follow up with PT and he stated experiencing no significant side effects, only minor body aches which are listed as a common side effect. PT was instructed to follow up if any significant side effects occur.
PATEINT RECEIVED VACCINE AT 7:40 PM THEN SAT AND WAITED IN OBSERVATION AREA FOR 15 MINUTES. SHOPPED IN STORE FOR FEW MINUTES THEN A BAGGER ALERTED ME THAT CUSTOMER HAD FALLEN WHEN LEAVING THE STORE WHO HAD RECEIVED THE VACCINE. 911 WAS CALLED IMMEDIATELY AND PATIENT REMAINDED CONSCIOUS ENTIRE TIME AND NEVER SHOWED SIGNS OF ANAPHYLATIC REACTION
Within a couple hours of receiving the 1st shingrix vaccine patients arm, the injection site, started swelling and it was swollen for 5 days thereafter. Hives started to develop below the injection site all the way down the arm to mid-forearm. He developed a bad sore/boil on the edge of his elbow and another sore/boil in the middle of his forearm. He said the hives caused severe itching which kept him from sleeping at night. The hives were there for about 2 weeks. Now, 2 months post the injection, the patient still has a scab at the site where the vaccine was administered.
Right arm and forearm swollen 3 times normal size. Arm is tight, warm and red, also experiencing severe pain, fever, headache, dizziness, marked weakness and muscle spasms. Symptoms were severe enough to require bed rest for 10 days and antihistamines for 3 weeks.
I experienced a sore inside my left nostril, my entire nose got swollen and red on the outside and they described the sore in my nose as herpes.
URI, cough, sore throat, expectorating blood by 6th day; lethargic-rapid pulse 120-tires all time; tx w/Erythromycin;
1-2 day after vaccination site with increased erythema, swelling, then purple/bruise hue and tenderness, limp.
Pt developed an injection site reaction with pain radiating down the arm and weakness of the arm. Follow up states patient recovered.
Throwing up, fever, shortness of breath, sore arm at injection site, rash on arm of injection, elevated heart rate, ringing ears, swollen and sore armpit, sore heart.
At first arm was sore, then entire upper arm became red, swollen and hot to the touch.  Then I developed hives, headache, nausea and fatigue.
Patient with history of COPD and dementia. He was brought to the ED by EMS on 12/29/22 for evaluation after a fall at home. His wife noted he has been more weak than normal. COVID PCR test performed in the ED resulted positive. He was admitted to the hospital 12/29/22 - 1/9/23. Discharge diagnoses included acute hypoxic respiratory failure due to COVID-19 pneumonia, among other diagnoses. Patient was on 2L O2 and was able to be weaned off to room air during his admission. Patient has received the primary COVID vaccine series and one booster.
No additional AE/PQC reported at this time; Assistant called in a temperature excursion on PROQUAD. Caller stated PROQUAD had been administered to three patients; This spontaneous report was received from a medical assisstant and refers to a patient. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 19-APR-2021, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD)  (dosage regimen and route of administration was not reported), lot # T029099 rHA and expiration date 23-FEB-2022 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of -58 degree fahrenheit (°F) and 5°F for 6 hours and 30 seconds and -58°F and 5°F for 7 minutes and 30 seconds; previous temperature excursions were reported with no details.  The call was made due to a digital data logger. No adverse symptoms were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2104USA008088: US-009507513-2104USA008219: US-009507513-2104USA008302:
Bell's Palsy; Can't blink or close your eye; mouth wandering all over your face; This case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In October 2022, less than 2 weeks after receiving Shingles vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant), eyelid function disorder and mouth movement impaired. On an unknown date, the outcome of the bell's palsy, eyelid function disorder and mouth movement impaired were unknown.   It was unknown if the reporter considered the bell's palsy, eyelid function disorder and mouth movement impaired to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine and 2 weeks ago after taking Shingles shot the patient reported that could not blink or close your eye and mouth wandering all over your face. The patient reported that it's time to wake up to the risk of having Bell's palsy if you take the Shingles shot. Additional Supportive Information: Follow-up would not possible as no contact details were available.
This spontaneous report was received from a registered nurse and refers to an unknown number of patients of an unknown age and gender. The patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unspecified dates in April 2016, (reported as since 16-APR-2016), the patients might had been vaccinated with improperly stored PEDVAX HIB (lot # L042257, expiration date: 17-AUG-2018; dose and route of administration were not provided). The vaccine was exposed to temperature of 6 degrees Fahrenheit for 7 hours. No previous excursion was reported. No adverse effects were reported. There was no product quality complaint. This is one of several reports received from the same reporter. Additional information has been requested.
Lingering low grade fever 99.9 - 100.1 for 11 days post vaccine
I am experiencing tinnitus and pressure in my ears and it started soon after getting my second dose of the Moderna vaccine. I have no prior history of ear problems and confirmed it is not due to ear wax buildup. I am healthy and have no chronic health conditions.
pt recv vax 9AUG96 & 13FEB97 pt devel a light case of chickenpox;pt given DPH;pt recovered from sx;