chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RIGHT ARM NUMBNESS; NECK PAIN; SLIGHT HEARING LOSS; HEADACHE; NAUSEA; TIREDNESS; EAR FLUTTERING; TINNITUS; EYE LID TWITCHING; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight was 190 pounds, and height was 178 centimeters. The patient's concurrent conditions included seasonal allergy, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included patient had no pertinent medical history and did not had drug abuse or illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. Concomitant medications included for drug used for unknown indication.  On 24-MAR-2021, the subject experienced ear fluttering. On 24-MAR-2021, the subject experienced tinnitus. On 24-MAR-2021, the subject experienced eye lid twitching. On 24-MAR-2021, the subject experienced slight hearing loss. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced tiredness. On 31-MAR-2021, the subject experienced right arm numbness. On 31-MAR-2021, the subject experienced neck pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, tiredness, ear fluttering, eye lid twitching, right arm numbness, neck pain, and slight hearing loss, and the outcome of tinnitus was not reported. This report was non-serious.
ear inflammation; Delayed the second vaccine dose/2nd dose was given over 60 days; Got into a car accident; short of breath/shortness of breath; Chest pain; Chest tightness; This spontaneous case was reported by a nurse and describes the occurrence of DYSPNOEA (short of breath/shortness of breath), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest tightness), ACCIDENT (Got into a car accident) and INFLAMMATION (ear inflammation) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Anticoagulant therapy and Blood cholesterol. Concomitant products included TICAGRELOR (BRILINTA) and ASA for Anticoagulant therapy, CARVEDILOL for Blood pressure high, ROSUVASTATIN for Cholesterol.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced DYSPNOEA (short of breath/shortness of breath), CHEST PAIN (Chest pain) and CHEST DISCOMFORT (Chest tightness). On 22-Apr-2021, the patient experienced ACCIDENT (Got into a car accident). On 03-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed the second vaccine dose/2nd dose was given over 60 days). On an unknown date, the patient experienced INFLAMMATION (ear inflammation). On 03-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed the second vaccine dose/2nd dose was given over 60 days) had resolved. At the time of the report, DYSPNOEA (short of breath/shortness of breath), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest tightness), ACCIDENT (Got into a car accident) and INFLAMMATION (ear inflammation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Electrocardiogram: normal (normal) normal.     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.   Treatment medications included steroids for ear inflammation from 25-Apr-2021 to 23-May-2021.   This case was linked to MOD-2021-222715 (Patient Link).
This spontaneous report as received from a physician via a company representative refers to a 26 year old female patient. Information on patient's pertinent medical history was unknown. On an unspecified date in June 2016, the patient was vaccinated with GARDASIL 9 injection (strength, dose and lot number not reported). Information on concomitant medication was unknown. On an unspecified date in 2016, the patient experienced swollen lymph node in her neck (lymphadenopathy). The patient sought medical attention. It was unknown if any treatment or if any lab diagnostic tests were performed. The outcome of lymphadenopathy was unknown. Causality assessment was not provided. No product quality complaint (PQC) was filed. No other information was provided. Additional information has been requested.
Approximately 7 mins after her vaccine she started experiencing difficulty breathing, weakness/dizziness, and rapid heart beat. We immediately assisted her to the floor provided 0.3 mg of Epi and assisted with her albuterol.  Obtained baseline vitals and contacted the ambulance and provider on call. Maintained stabilization until emergency services arrived.
Patient had bilateral rejection of her corneal transplants in the time period immediately following H1N1 vaccination. Topical steroid therapy was initiated which improved the inflammation in her left eye. Her right eye is still being monitored for clinical response. 11;20/09 Medical records receoved for DOS 10/23 -11/09 Final DX: PK (corneal inplant)  rejection.  1 day s/p vaccine. Eye pain, swollen lids, discomfort, photophobia s/p vaccine. Rejection of corneal implants. Edema OD. Decreased visual acuity. Redness, edema OD initially improved. then increased swelling, painful to move. HA. OS stable.
10 cm cellulitis at injection site. Red, hot, and hard for 48 hours.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 03-DEC-2015, the patient was vaccinated with an improperly stored single dose of PNEUMOVAX 23 0.5 ml, which had a lot # of L014458 and an expiration date of 11-FEB-2017 (route and anatomical location of administration were not reported). The sum of hours in excursion was 8 hours and the lowest recorded temperature reported was 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
When nurse was administering the vaccine, some of the vaccine liquid leaked out on to the patient's arm; A spontaneous report was received from pharmacist concerning a 38-years old female patient who experienced underdose (when nurse was administering the vaccine, some of the vaccine liquid leaked out on to the patient's arm).  The patient's relevant medical history was not provided. Concomitant product use was not provided by the reporter.   On 25-Feb-2021, prior to the event onset, the patient received their second of two planned doses of mRNA-1273 (Batch number: 023M20A) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.   On 25-Feb-2021, the pharmacist reported, that a nurse injected a second dose to a female on her left upper arm, and during administration some of the vaccine liquid leaked out on to the patient's arm. Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event of underdose was unknown.  The reporter did not provide any causality assessments for the event of underdose.; Sender's Comments: This report refers to a case of accidental underdose for mRNA -1273 lot#  023M20A with no AEs reported
NECK PAIN; PAIN UP AND DOWN ARM/ARM PAIN; This spontaneous report received from a patient by a Business partner on 05-APR-2021 was received on 05-APR-2021 and concerned a female 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up tp request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced neck pain, and pain up and down her arm/arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain up and down her arm/arm pain and neck pain was not reported. This report was non-serious.
had both shingle shots/ it's shingles/suspected vaccination failure; hurtful side effect on my left side, NEUROPATHY; it's shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and Flu vaccine. On an unknown date, less than 6 months after receiving Shingles vaccine and Shingles vaccine and not applicable after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), neuropathy (serious criteria GSK medically significant) and shingles. The patient was treated with gabapentin. On an unknown date, the outcome of the vaccination failure, neuropathy and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, neuropathy and shingles to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the neuropathy and shingles to be related to Flu vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had both shingles shots and Flu vaccine this spring and ended up with the hurtful side effects on his/her left side, neuropathy. The patient was told it was shingles that never broke the skin. The patient enter Gabapentin which he/she was still taking. The patient was very worried about getting the Covid 19 and so he/she opted for the single dose brand vaccine. Now with all the variants he/she would had to wait and see how that turns out, never thought had get more vaccines now the when he/she was a child. This case was considered as suspected vaccination failure as details regarding, exact time to onset and laboratory confirmation were unknown at the time of reporting.
Day 1-9: fussiness and irritability, more than usual even for a toddler. Day 9&10: fever. Day 11: slept 5 hours longer than normal in a 24-hour period. Day 13&14: measles-like rash all over body, sent 10 photos and 2 videos to doctor, who confirmed it looked like the rash that is typical from MMR vaccine and is not contagious.
Hips, vertebrae (from head to hips) ached; Heart would race randomly; Exhausted; pulse was up to 129.; around 6 hours after shot, Joints started to ache; Chills; Trouble focusing and completing simple tasks; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 18Apr2021 at 09:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included juvenile rheumatoid arthritis (currently in remission) and 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 COVID vaccine. Concomitant medications included over the counter multivitamin (MANUFACTURER UNKNOWN) on an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 28Mar2021 at 09:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Patient had no known allergies to food, medication or other products. On 18Apr2021, about 6 hours after shot, the patient joints started to ache. She had trouble focusing and completing simple tasks. She experienced chills off and on but didn't actually have a fever. The next morning, on 19Apr2021, patient was exhausted and her hips, vertebrae (from head to hips) ached. Her heart would race randomly and just sitting up in bed to drink water made her heart rate alarm go off and notify her that her pulse was up to 129. The patient spent the day in bed but had her pulse alarm go off several times an hour. The patient started to felt better/more like herself after taking 800mg of MOTRIN about 34 hours after her shot. It was now two days (50 hours exactly) from when she received her second shot and she felt perfectly fine. Her heart was not racing randomly, either. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with 800mg of ibuprofen (MOTRIN). On 18Apr2021, the patient pulse rate was measured and the result was 129 (unknown unit). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events trouble focusing, heart racing, joint started to ache, exhaustion, pulse was up to 129, hips, vertebrae (from head to hips) ached and chills were resolved on 20Apr2021.    No follow-up attempts are needed. No further information is expected.
Later that night I felt very fatigue, I had sweats, chills, body aches.
Pulmonary Embolism Requiring hospital stay; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 2021 (also reported as Mar2021) at 50 years old as dose 2, single for COVID-19 immunization. Medical history included blood pressure abnormal, atrial flutter, heartburn, and penicillin allergy from an unknown date. Concomitant medications included ciclosporin (CYCLOSPORIN) taken for an unspecified indication, start and stop date were not reported. Other concomitant medications include unspecified blood pressure meds, and atrial flutter meds. The patient previously received the first dose of bnt162b2 (lot number: EW0169) on 16Apr2021 at 50 years old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 11Jun2021 16:00 the patient experienced pulmonary embolism requiring hospital stay. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care visit and was considered by the reporter as serious for requiring hospitalization for 4 days and life-threatening illness (immediate risk of death from the event). The patient was given an unspecified blood thinner as treatment. The outcome of the event was recovered with sequelae (lasting effects).  Information on the lot/batch number has been requested.
Pleural effusion NOS on 2012-12-05, clinician comment: Patient notes brief episode of feeling like she had a viral illness with mild pleurisy and was found to have very small pleural effusions on CXR. This could be an unrelated viral illness as well.
I had tightness in my chest my heart felt like it was beating rapidly and I felt sharp pain in my chest.  I felt extremely dizzy also where the room felt like it was spinning but there was nothing I could do about it to really make it stop; laying down, sitting up, or standing did not help with the pain or dizziness. I also had a headache much of like the one you have when you actually have covid-19. I along with the symptoms listed above I have also had a sore throat. After not being able to deal with the dizziness and chest pain I went to my local ER around 6pm 8/22/21. They treated my symptoms and release me the same day. They diagnosed me with Benign Positional Vertigo and Nonspecific Chest pain. The throat pain still continues today to as of 9/7/21 along with some chest pain and dizziness.
Patient developed a septic knee (history of arthroplasty) need for immediate surgery, hospitalization and months to years of antibiotics in his future now.
vaccinated for varicella 8/7/07. presented to ER 8/17 with chickenpox seen by PMP 8/17-dg prob. atentuated II varicella
Information has been received from a nurse, via a company representative, concerning a female patient (age not specified), who in October 2007, was vaccinated in her deltoid region, with the first dose 0.5 ml, of GARDASIL (lot # not specified). The following day, she developed a rash on her buttocks. She sought the medical advise of her physician. The patient refused to continue the series, because of the rash. At the time of this report, the outcome of the event was unknown. No further information is available.
Patient received Moderna COVID vaccine on 2/1/21 and 2/27/21. On 1/21/22, patient admitted to our inpatient facility (med/surg unit) with acute hypoxemic respiratory failure and pneumonia due to COVID-19. As of today (1/24/22), patient is still admitted in our med/surg unit.
Experiencing hands getting cold; Forehead gets warm; This is a spontaneous report from a Pfizer-Sponsored program, received by two contactable nurses.   This 90-year-old female patient started to receive palbociclib (IBRANCE, formulation: film coated tablet, Lot number not provided and Expiration Date 30Jun2022), orally, at dose of 100 mg cyclic (3 weeks on/1 week off) from Sep2020 for an unspecified indication. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not provided), via an unknown route, in Feb2021 (2 weeks ago, as reported), at single dose for COVID-19 immunisation. Relevant medical history included asymptomatic menopausal state. No relevant concomitant medications were provided. In Feb2021 (at start of 2nd week), the patient experienced hands getting cold and forehead gets warm. This happened mostly at night. Advised to inform MD. No action was taken with palbociclib in response to the events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recvd vax; devel a purulent inject site rxn w/ erythema & swelling approx .5" diam;seen by MD;approx 2cm fluid drained fr site;culture neg for bacterial growth;tx w/ augmentin;
Very slight acheyness starting around 11:00am the next morning and ending same day around 8pm.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0179), via an unspecified route of administration in the right arm on 13May2021 at 15:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient was allergic to amoxicillin (MANUFACTURER UNKNOWN). Concomitant medications included fluoxetine hydrochloride (PROZAC), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate and dexamfetamine sulfate (ADDERALL), vitamin d nos (VITAMIN D) and electrolytes nos (MANUFACTURER UNKNOWN); all for unknown indications since unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0179), via an unspecified route of administration in the right arm on 22Apr2021 at 15:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14May2021 at 11:00, the patient experienced very slight acheyness starting around 11:00 the next morning and ending same day around 20:00.The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as the result of the reported adverse events. The clinical outcome of the event very slight acheyness was recovered on 14May2021.   No follow-up attempts are needed. No further information is expected.
Patient first experienced painful tingling sensation in upper left arm on approximately 07/20/2021 which lasted for about 1 minute and again about 2 days later.  On 08/07/2021, patient noticed a red rash on upper abdomen (no pain or itching).  On 08/09/2021, patient, who is participating in a clinical drug trial for development of an oral medication to treat Alpha-1 Antitrypsin Protein Deficiency at Medical Center, went to scheduled check-up visit.  Patient reported the rash on her abdomen. Doctor observed the rash and diagnosed it as Shingles.  Doctor prescribed Valacyclovir HCL 1 MG. Tablet to be taken by mouth 3 times a day for 7 days.
Initial misuse report received from a healthcare professional on 22 October 2013. The cases were received on 21 March 2014. A 64 years old patient had received unknown dose of FLUZONE HD (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Vaccines given on 12-13-06, patient returned to clinic 12-15-06. Complain of reddened areas on arms, 2 on right arm, one on left arm. Approximate size 1 to 10 mm. Child states they are "itching". I told father take child to MD immediately. I am an RN, no MD at this site.
Rheumatoid arthritis/Rheumatoid arthritis attack; herpes outbreak- blisters in her mouth; wound on leg started to get worse, leaking a lot of fluid; back is hurting; felt like a tetanus shot in her arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EM9809), intramuscular in left arm on 10Feb2021 14:30 at single dose for covid-19 immunization. Medical history included high blood pressure, rheumatoid arthritis and kidney issues. Concomitant medication included insulin. The patient had the first COVID-19 vaccine. She had a lot of issues wrong with her, however she did not have them hit her at the same time. It was currently the 9th day since she had her first shot. About 4 or 5 days into it, the wound on her leg started to get worse. She had rheumatoid arthritis and she had an RA attack. She had herpes, but she did not had an outbreak in a couple of years. She got blisters in her mouth, and this also hit her. She explained everything hit her all at once. She was now on antibiotics for each one of the things. Her doctor figured out that her body just couldn't handle it. She clarified putting the vaccine into her body, she couldnt fight off everything. Like whatever in in the vaccine and how the vaccines works, her body was just not strong enough to fight off everything at the same time. The patient did not went to the emergency room. It was reported that the patient would receive her second dose on 03Mar2021. The outcome of the events was unknown.      No follow-up attempts are possible. No further information is expected.
patient is experiencing pinkish inflammation at the injection site down to his elbow and muscle soreness....no swelling
onset of sleepiness, irritability, generalized tonic sz approx 14 hrs p/vax;
high temperature (102.3 F) with  flu like symptoms in the joints for 16 hours . disappeared after. swallen area where the injection was adminstred - for 2 days mild pain under the arm for less than 1 day