chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Guillain-Barre syndrome; Lost use of her arms and she had to be fed; weakness in legs; difficulty swallowing; headache; nausea; leg swelling; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On 18th May 2019, the patient received the 1st dose of Shingrix. On 27th May 2019, 9 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), arm paralysis (serious criteria hospitalization and GSK medically significant), lower extremities weakness of (serious criteria hospitalization), swelling of legs, headache and nausea. On 31st May 2019, the patient experienced swallowing difficult. On an unknown date, the outcome of the guillain barre syndrome, arm paralysis, lower extremities weakness of, swelling of legs, swallowing difficult, headache and nausea were not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome, arm paralysis, lower extremities weakness of, swelling of legs, swallowing difficult, headache and nausea to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's daughter. The patient expereinced weakness and swelling in her legs. On 28th May 2019, the weakness was so severe, and the patient was carried to the restroom. Within 24 to 36 hours, the patient lost use her arms and had to be fed. On 29th May 2019, the patient was admitted to the hospital. On 31st May 2019, 13 days after vaccination, the patient expereinced difficulty in swallowing. The patient had MRI and other scans and was diagnosed with Guillain barre syndrome. The reporter gave consent for follow up.
Had covid vaccine in morning. Developed fever up to 103, shaking chills, decreased sats (80%) later in the afternoon. Admitted for observation
EXACERBATED VERTIGO A BIT; CHILLS; SORE ARM; LOW GRADE BARELY FEVER.; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: vertigo. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced exacerbated vertigo a bit, chills, sore arm, and low grade barely fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from exacerbated vertigo a bit, chills, sore arm, and low grade barely fever. This report was non-serious.
About 10 hours after the vacinne I had shakes similar to coming out of anesthesia.  This lasted one hour.  I thought I was going to chip a tooth, I was shaking so badly.  I had no fever at this time.  About an hour later I had 102 fever which lasted about 12 hours. Body and headache also lasting about 12 hours.
Initial report received on 22/Sep/2006 from a healthcare professional. A five-year-old male patient with no current illnesses had received a fifth intra-muscular dose of Daptacel, lot number C2407AA, in the left thigh, an intra-muscular dose of IPOL, lot number Y0638-2, in the left thigh, and a concomitant subcutaneous dose of MMR II (manufacturer reported), lot number 0215F, in the right thigh on 13/Sep/2006. The next day, the patient experienced injection site redness and warmth on the left thigh. The reaction was reported as being five inches in diameter. A 25g one inch needle was used to administer the vaccines. The patient had no other symptoms. The patient was seen by the physician two days later for medical evaluation but the treatments received were not reported. At the time of this report, the patient had recovered from these events. Follow-up information received on 16 November 2006 from a health care provider. No diagnostic testing was performed.
Localized swelling, redness, pain 5cm, (L) deltoid. Symptoms started day after vaccination received. Evaluated the day after that (Immunized Friday 2-11-11, eval 2-13-11).
within two hours of the second dose, the patient experienced red skin in face and hands, muscle aches and fatigue.  After four hours the patient experienced swollen lymph nodes.  Although  his lymph nodes were swollen on his left and right side, the lymph nodes on the patients  left side (same side as the injection) were more swollen and sensitive to the touch.   The next day, joint pain and muscle fatigue persisted,    the patients   also experiences chills and small blemishes on his face and left arm.  On the night of 13 March 2021, patients   experienced fever of approximately 99.5 degrees  Fahrenheit (F).  After taking 1000mg of  Acetaminophen, the fever was reduced to 89.9 F.   Two hours later, patent's temperature  rose to 101.5 F.  Patent then took 800mg of Ibuprofen.  This brought the patient's temperature down  to 99.5.  Then he went to sleep.  The next day 14 March,  the patent experienced a sore throat and higher fever.  He went to the urgent Clinic for examination.
Blood pressure 170/120; Fast heart rate; Rash on her arm that spread across her body, rash felt itchy and hot; Rash felt itchy and hot; Headache; A spontaneous report was received from a consumer concerning, a 48-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fast heart rate, BP:170/120, rash spread from arm to her body, rash felt hot and headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Jan 2021, 1 day prior to onset of the events fast heart rate, BP:170/120, rash spread from arm to her body, rash felt hot and headache, patient received their dose of mRNA-1273 (lot/batch: 029L420A) intramuscularly for prophylaxis of COVID-19 infection.    On 22 Jan 2021, the patient had medically significant events of increased heart rate, BP:170/120, rash spread from arm to her body, rash felt itchy and hot and non serious event of headache.  The patient stayed at the ER (emergency room) for 3 hours.  Treatment included diphenhydramine.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of events increased heart rate, BP:170/120, rash spread from arm to her body, rash felt itchy and hot was recovered on 22 Jan 2021. The outcome of the event headache was not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient called pharmacy specifying that as of 9/19/18 he has dizziness, headaches, body aches, shivers and shortness of breath. We recommended a doctor visit.
Information has been received from a nurse concerning a female (age not reported) with pertinent medical history and drug reactions/allergies reported as none who in July 2007 ("a little over two months ago"), was vaccinated with the first dose of Gardasil, injection, 0.5 ml.  Concomitant medication was not reported.  In July 2007 ("day after vaccination"), the patient experienced stomach flu-like symptoms which included nausea and vomiting for three days after her first dose of Gardasil.  The patient sought unspecified medical attention (phone call).  It was reported that the patient does not wish to continue the series of Gardasil.  Subsequently, the patient recovered from stomach flu-like symptoms, nausea and vomiting three days after stopping therapy with Gardasil.  Additional information has been requested.
Mild fever, severe chills and shaking, tingling skin. Treatment: Tylenol and rest. Symptoms eased and ended next day.
The next day after the vaccine I started feeling lethargic. On the second day I was running a low grade fever. I went to the ER on October 7, 2021 I started exp Afib.
Passed a kidney stone.  Symptoms began in the am, prior to going for the vaccine.  Urinating blood, pain, et.  Elected to get the shot, then pain became too intense, so I went to the ER.  Was on antibiotics for ~10 days post episode.
Mother and patient reports directly after injection patient experienced chills and shaking. That resolved within 3-4 hours. The next morning he woke up with a sore throat that felt swollen that persisted through today 4/10/21.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2021 as dose 1, single (Lot number: EP7533), in left arm, on 25Apr2021 as dose 2, single (Lot number: EU 0170), in left arm, on 27Nov2021 as dose 3 (booster), single (Lot number: FH8030), in left arm and on 21Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 64 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, latency 2 days 30 min after the suspect product(s) administration, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course included: Treatment of COVID-19 included Paxlovid from 7May2022. On 9May2022 the patient experienced muscle cramps. No known drug allergies.  No follow-up attempts are possible. No further information is expected.
Bronchitis. Sinusitis. Information regarding Flumist 2003-2004 formula influenza virus vaccine live intranasal 2003-2004 formula nasal solution frozen was received from a consumer regarding a male patient who experienced sinusitis and bronchitis. The patient received the first dose on an unspecified date. See related case HQWYE879510FEB04 (adverse event, non-expedited). No additional information was available at the time of this report.
Received MMR vaccine on 10/13/2005 on approx 10/20/2005 began to have arm pain and swelling in left arm have pain and swelling in arm that radiates into forearm and behind shoulder, left arm swollen from upper arm to elbow, no redness, pain radiated down arm and behind shoulder denies numbness.
Fever 100-101 began 16 hours after vaccination and lasted approximately 24 hours. Tylenol did not reduce fever. Injection site warm to touch and on day two developed an irregular, circular shaped red rash about the size of a half dollar.
lack of oxygen; numb left hand; heaviness of head and back; very high pressure in the chest; circulatory issues in the legs with varices; sinusitis; has lymph nodes in the neck , such a big ball t; weakness; joint and muscle pains; joint and muscle pains; feeling tired; A spontaneous report was received from a consumer concerning a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following event: numb left hand, joint and muscle pains (arthralgia), feeling tired (fatigue), weakness, has lymph nodes in the neck , such a big ball that did not go away and lasted almost 2 weeks, heaviness of head and back, lack of oxygen, very high pressure in the chest, high range of beats per minute (84), circulatory issues in the legs with varices, sinusitis.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24-FEB-2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 001A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 24-FEB-2021, the patient experienced the event(s) numb left hand, joint and muscle pains, feeling tired, weakness, has lymph nodes in the neck , such a big ball that did not go away and lasted almost 2 weeks, heaviness of head and back, lack of oxygen, very high pressure in the chest, high range of beats per minute (84), circulatory issues in the legs with varices, sinusitis.  Treatment details included antibiotics.  Action taken with mRNA-1273 in response to the events is unknown.   The outcome of event(s), numb left hand, joint and muscle pains, feeling tired, weakness, has lymph nodes in the neck , such a big ball that did not go away and lasted almost 2 weeks, heaviness of head and back, lack of oxygen, very high pressure in the chest, high range of beats per minute (84), circulatory issues in the legs with varices, sinusitis was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
HIGH BLOOD SUGAR LEVELS; FELT ACHY; CHILLS; This spontaneous report received from a patient concerned a 59 year old female.  The patient's weight was 145 pounds, and height was 65 inches. The patient's concurrent conditions included: type 1 diabetes, non smoker, and alcohol use (4 glasses of wine a week), and other pre-existing medical conditions included: Patient had no known allergies, no drug abuse or illicit drug usage. The patient was not pregnant at the time of reporting.  On 11-MAR-2021 15:00, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported (dose number in series 1), 1 total, administered for prophylactic vaccination on left arm. Concomitant medications included insulin aspart for type 1 diabetes, and ramipril for type 1 diabetes.  On 11-MAR-2021, the patient experienced sore arm. (dose number in series 1)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from sore arm on 12-MAR-2021.  On SEP-2021, Laboratory data included: Laboratory test (NR: not provided) everything was within normal range.  On 01-NOV-2021, Laboratory data included: Laboratory test (NR: not provided) within normal range.  On 10-NOV-2021 11:30, The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213021A expiry: UNKNOWN) dose was not reported (dose number in series 2), administered for prophylactic vaccination on right arm.  On 10-NOV-2021, the patient experienced high blood sugar levels, felt achy, and experienced chills. Laboratory data included: Blood sugar abnormal (NR: not provided) 250 mg/dL, 301 mg/dL, 200 mg/dL. On 11-NOV-2021, Laboratory data included: Blood sugar abnormal (NR: not provided) 125 mg/dL, High, 240 - 250 range.   On 12-NOV-2021, Laboratory data included: Blood sugar abnormal (NR: not provided) 250-300 range, 323 mg/dL.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from felt achy, and chills on 11-NOV-2021, and had not recovered from high blood sugar levels.  This report was non-serious.  This case, from the same reporter is linked to 20211129839.(husband case)
Patient (12yr old female) was due for 2nd adult Pfizer dose (.3ml) but was given pediatric dose (0.2ml).  No ill affects.  Parents notified of dosage error with no concerns.  Nursing supervisor notified, CDC called for instructions also.   Per CDC, nothing to do for incident at this time. Patient will return for adult booster at appropriate time.
Leg pain, couldn't walk ER assumed it was transient synovitis Motrin  Went away and then pain returned 8 days later. Naproxin for 3 weeks after hospitalization
I went to lunch on 7/25/21 at 12:00PM and after eating, stood up, felt faint, had a seizure. Heart was constricting   I have never had a seizure before.
This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose not received about 2 months after First dose) in a 19-year-old male 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) (Intramuscular) 1 dosage form. On 16-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not received about 2 months after First dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose not received about 2 months after First dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant drugs were reported. No treatment drugs are not provided by reporter.
VERY SWOLLEN, V. INFLAMED, LEFT ARM. SAT. STILL RED AND INFLAMED FROM SHOULDER TO ELBOW. SAT - WENT TO URGENT CARE. DOCTOR SAID IT WAS A BACTERIAL INFECTION, GAVE ME AN INJECTION IN THE TUSH, PRESCRIPTION FOR 7 DAYS ANTIBIOTICS. STILL RED & SWOLLEN BETWEEN ELBOW AND SHOULDER.  Sunday: still red and swollen, but not as much as Friday. I THINK IT IS AFFECTING THE R. SIDE OF MY FACE. SUNDAY. STILL INFLAMED AND SWOLLEN.
I am feeling a little bit of pain in just one knee; my left knee and today I cannot even move it. It is so swelled up; my left knee and today I cannot even move it. It is so swelled up; This is a spontaneous report from a contactable consumer (patient). A 67-year-old patient of an unspecified gender received first dose of bnt162b2 (Pfizer covid-19 vaccine, solution for injection, Batch/lot number: EN6205, Expiry date: unknown), via an unspecified route on 25Feb2021 and second dose of bnt162b2 (Pfizer covid-19 vaccine, solution for injection, Lot number: EN6206, Expiry date: unknown), via an unspecified route on 18Mar2021 (age at vaccination: 67-year-old), as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had the vaccine on Thursday and on an unknown date on Friday patient was feeling a little bit of pain in just one knee, left knee and today patient cannot even move it. It was so swelled up and it was just left knee. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Approximately 10 min after receiving the Moderna vaccine the employee reported her throat began to feel scratchy and had itchiness.  Employee has a history of allergic reactions.  Patient was given diphenhydramine 25 mg in the ED and discharged home.  No respiratory issues noted in ED, symptoms resolved.
Patient states that the evening after receiving vaccine in the office, her arm was sore and she was a little dizzy. The following morning she woke up more dizzy and lightheaded and had to stay home from work. She was back to baseline by the following day.
Swelling of neck from chin down the middle of neck.  About 1 1/2 inches wide.  Both sides of jaw muscles got tight from each ear to the chin.
put me out for the next day with all over body aches; headache; fever; muscle soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 18:00 (Lot number: ER8727) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "bipolar disorder (type I)" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: CLONAZEPAM; OXCARBAZEPINE; LOVASTATIN; LEVOTHYROXINE. Past drug history included: Codeine, reaction(s): "allergies", notes: allergies: Codeine and Ultracet are meds that affect me badly; Ultracet, reaction(s): "allergies", notes: allergies: Codeine and Ultracet are meds that affect me badly. Vaccination history included: Bnt162b2 (dose number=1, lot number=EN6208, administration time=02:00 PM, vaccine location=Left arm, Minimal effects first dose), administration date: 09Mar2021, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 31Mar2021, outcome "unknown", described as "put me out for the next day with all over body aches"; HEADACHE (non-serious) with onset 31Mar2021, outcome "unknown", described as "headache"; PYREXIA (non-serious) with onset 31Mar2021, outcome "unknown", described as "fever"; MYALGIA (non-serious) with onset 31Mar2021, outcome "unknown", described as "muscle soreness".   Additional information: The patient had no covid prior vaccination. The patient had not tested to covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Aching,tingling,burning muscle went to Dr Diagnosed with Brachical Neuritis given prescription for steroids Referred to Neurologist on 6/20/08
Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; swelling and redness; swelling and redness; Nausea; I just feel very, just uneasy; Diarrhea; I threw up earlier today/I even it throw up; not feeling good right now; my blood pressure going up; This is a spontaneous report from a contactable consumer or other non HCP (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2 Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EP7533) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, swelling and redness, nausea, patient threw up earlier today/even it throw up, the patient just feel very, just uneasy, and diarrhea on an unknown date. The patient stated that after the first dose, had some side effect and just, the patient knowing that it was normal for the first 24 hours but like having like every single one on here except that one reaction and the patient don't have a rash. The patient had diarrhea as well which was not on here but threw up earlier today. The patient wanted to know even though it on here and does not go by certain time then the patient need to consult with physician. The patient felt like blood pressure going up, hence took unspecified blood pressure medication (further clarification unknown). The patient stated that on an unknown date, really not feeling good right now and think can't get on phone call for 8 to 10min. Therapeutic measures were taken as a result of event Blood pressure increased. The outcome of events reported as unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
2 weeks after second Covid-19 vaccine, a severe shingles outbreak (confirmed by PCR) appeared on the left side of the scalp and face.  The outbreak was causing severe nerve pain for 2 months, now managed with medication but still present.