chrisvoncsefalvay/vaers-outcomes huggingface dataset:
seemed infected; gave a red sore; gave a red sore; This case was reported by a consumer via interactive digital media and described the occurrence of infection in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   In February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced infection, localized erythema and ulcer. On an unknown date, the outcome of the infection, localized erythema and ulcer were not recovered/not resolved.   It was unknown if the reporter considered the infection, localized erythema and ulcer to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient had red sore that had not gone away and seemed infected.
Pt was given the concentrated dose of COVID 5-11y vaccine.  Spoke to parents & they stated that pt has no symptoms or signs of any side effects
Felt a little off the day after I received the first shot. Lost my hearing in my right ear only on March 22, 2021.
C/o immunization site hurting and swelling and c/o chest pain, adm to ICU on 4/25-4/27, echo on 4/28 normal. Labs CK 400T, CK-MB-4.2 increase, trop I 0.55 on 4/25/03 note did state he had shot on 16 2 days prior is prime position. EKG NSR at 68 hr, no STT WA.
right are was fine left arm (shingrix) - was red and swollen  elbow up to shoulder.  red and hot in appearance and touch.    patient stated really tired. some upset stomach and shoulder ached. no shortness of breath and no irregular heart rate. I recommended that patient contact doctor to see if he felt  medical treatment (meds) would be necessary and to see if doctor wanted to see him in the office.  patient had no taken any meds yet to treat this;
Information has been received from a physician's office manager concerning a 24 year old female, caucacic patient who on 06-Aug-2008 was vaccinated with second dose of GARDASIL single dose vial intramuscularly injection, left deltoid. Concomitant therapy included montelukast sodium (MSD), KLONOPIN and TOPICORT. In Oct-2008 when the patient was accompanying her sibling to an office visit she reported that she experienced a small nickel-sized divet left upper extremity (LUE) after she received her second dose of GARDASIL on 06-Aug-2008. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/12/2008. Follow up information has been received on 08-JAN-2009 from a physician who reported that the little impression in the patient's arm has gotten bigger has lost some pigment. Also the physician reported that the patient had a delayed injection site reaction that has progressively gotten worse over the past month. The "divot' in the patient's arm appeared on 20-OCT-2008. Currently the area was 2cm x 1 cm and lost pigmentation to the skin in that area. The depression in the skin was 1/3 - 1/2cm in deep. No further information is available.
Patient reported excruciating shoulder and arm pain from scapula to elbow on the left arm for 1 month after vaccination. Patient reported pain to be similar to having birth.
Redness and swelling at the injection site, starting in the evening of the day the vaccination was given. Cellulitis/Abscess
red slightly raised rash from top of legs about 4-5 inches down; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red slightly raised rash from top of legs about 4-5 inches down) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced RASH ERYTHEMATOUS (red slightly raised rash from top of legs about 4-5 inches down). At the time of the report, RASH ERYTHEMATOUS (red slightly raised rash from top of legs about 4-5 inches down) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Severe headache continuing for 7 days and rash red 2 in circle near vaccine site started on day 5.
Client seen here for pinpoint rash covering bilateral hands, front and back, and bilateral feet, extending to knees. Sent to MD's office without dx listed on receipt and without treatment requiring a prescription.
Pt developed diffuse papulomacular rash lasting two weeks and accompanied by fever 1 week after receiving measles vaccine.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-FEB-2018, the patient was ordered to receive PNEUMOVAX 23 for prophylaxis and inadvertently received a dose of PREVNAR 13 (lot 585205, Expiry date: December 2019) instead of PNEUMOVAX 23. There was no adverse event reported. No dose of PNEUMOVAX 23 was administered. There was no product quality compliant involved.
I diluted the MMR vaccine with the wrong diluent. I used lidocaine instead of the specific sterile water diluent.
Sore arm within a few hours of injection. Fever, chills, chest pain, shortness of breath, body aches, and lethargy around 24 hours after injection.
Transient throat tightening; 1 dime sized hive on injection arm; Injection arm tenderness; Feeling tired; This spontaneous case was reported by a nurse and describes the occurrence of THROAT TIGHTNESS (Transient throat tightening), VACCINATION SITE URTICARIA (1 dime sized hive on injection arm), VACCINATION SITE PAIN (Injection arm tenderness) and FATIGUE (Feeling tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included LEVOTHYROXINE, CLONAZEPAM (KLONOPIN) and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced THROAT TIGHTNESS (Transient throat tightening), VACCINATION SITE URTICARIA (1 dime sized hive on injection arm), VACCINATION SITE PAIN (Injection arm tenderness) and FATIGUE (Feeling tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) 04-Mar-2021 for Prophylactic, at an unspecified dose and frequency. On 05-Mar-2021, THROAT TIGHTNESS (Transient throat tightening) had resolved. At the time of the report, VACCINATION SITE URTICARIA (1 dime sized hive on injection arm), VACCINATION SITE PAIN (Injection arm tenderness) and FATIGUE (Feeling tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Blood pressure measurement: 132/80 (High) Elevated Blood pressure (132/80) 2-5 minutes after vaccine. On 05-Mar-2021, Heart rate: 140 (High) Elevated heart rate (140s) 2-5 minutes after vaccine.     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.   Other concomitant product  include Bioidentical hormone cream.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up received- Event outcome provided.
Pt was given combination vaccine containing Hep B while pt had already completed 3 doses of Hep B; This case was retrieved during monitoring on 11-APR-2022 with the following reference number: 2194500-1. The original narrative is as below.  Pt was given combination vaccine containing Hep B while pt had already completed 3 doses of Hep B. Vaccine made Hep B #4
Numbness and tingling of left pinky and ring finger and extending to left wrist. TX: Physical Therapy.
7cm on left later thigh at site of DTAP and IPV redness, induration, with slight inepular borders, and tenderness.
Cramping in stomach constantly; normal at first but as of 16Sep2021 she still menstruating/moderate to heavy bleeding; blood clots, bright red blood; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Fd8448), dose 1 via an unspecified route of administration, administered in Arm Left on 26Aug2021 19:00 (at the age of 48years) as dose 1, singe for Covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. There were no concomitant medications. There was no vaccine in four weeks. There were no other medications in two weeks. The patient reported that she had first vaccination shot on 26Aug2021 and she started my period on 01Sep2021. Everything was normal at first but as of 16Sep2021 she still menstruating. She had moderate to heavy bleeding and cramping in her stomach constantly. She had blood clots, bright red blood. She stated that she can't get a doctor appointment until next month but can't wait that long. There was no treatment received for the events. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Pt. had an episode of fainting in the observation hall 5 mins after receiving the pfizer biontech covid-19 vaccine.  he regained full consciousness after 15 seconds, was verbal. V/S - bp 131/87, rr 14, hr 64, temp 96.3, pulsox 99% RA. He was assisted to a wheelchair and wheeled to a cubiclePt where he was asked to lay down on a cot for further observation and monitoring  Pt was offered water and apple juiced - 625 mls  and he finished the fluids. The ambulance team called when the incident occurred arrived but left soon after when the pt. refused to be taken to the hospital At 2:35 pm pt walked out of the premises unassisted. no c/o pain or any injuries resulting from incident noted at the time.
I was watching tv and noticed that my heart beat started to beat really fast for a little bit then slow down and do that again (this went on for approx 30 to 45 mins). I have an apple watch so I looked at my heart rate at the time of one of the fast episodes and it was at 102. My resting heartrate is usually in the 60's. I monitored it for a little bit, took note and then it was time for bed, When I woke up in the morning I didn't have those symptoms again except for sore arm at the injection site.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 07-OCT-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) with lot number: L026728, expiry date: 15-JAN-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Initial within 10 minutes, redness and burning pain at site. Ice was applied and this went away, then about 25 minutes, itchy throat, trouble swallowing, mild confusion. Oral benadryl 50mh and solumedrol IM. Once again this dissapated after 30 minutes. 3 hours later, trouble swallowing, felt as if something was in my throat, redness and flushing all over.fluid bolus, epinephrine  I'm, iv benadryl, pepcid oral,  and claritin oral, fluid bolus. 12 hours after getting the vaccine blurry vision, ringing ears, headache, benadryl, steroid, claritin all oral
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), CHILLS (chills), FATIGUE (tired) and NAUSEA (nauseous) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 18-Mar-2021, the patient experienced CHILLS (chills), FATIGUE (tired) and NAUSEA (nauseous). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 10-Mar-2021, PAIN IN EXTREMITY (arm pain) outcome was unknown. At the time of the report, CHILLS (chills), FATIGUE (tired) and NAUSEA (nauseous) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter.
Pt developed sudden left eye partial vision loss on 4/6/2021, 5 days after 2nd dose of COVID vaccine. Saw Dr on 4/7/2021 and diagnosed with left branch retinal artery occlusion, admitted to the hospital on 2nd day of symptoms. No treatment indicated. Evaluation undergoing. Imaging negative for acute stroke. Pt continues to have visual field deficit on 4/15/2021 when she was seen for follow up in PCP office.
This case was reported by a physician via call center representative and described the occurrence of white blood cell increased in a adult patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included lymphocytic leukemia (chronic). On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced white blood cell increased. On an unknown date, the outcome of the white blood cell increased was unknown. It was unknown if the reporter considered the white blood cell increased to be related to SHINGRIX. Additional details were provided as follows: The patient's age group was taken based on the product indication as no other patient details were provided. The physician who adminsitered the vaccine to the reporting healthcare professional, stated another patient also discovered their WBC count increased after SHINGRIX vaccination. No additional information was provided. This case has been linked with case US2018103115, reported by the same reporter. Lab Comments: On an unspecified dates, before receiving the SHINGRIX, white blood cell (WBC) count was normal and WBC was increased after receiving the SHINGRIX.
Client presented to the COVID-19 Vaccination Clinic on 1/20/2022 for her first COVID-19 vaccine, but she is documented as having received the adult formulation of Pfizer with the lot number FJ5683, which would be an inappropriate vaccine type for her age. This error was one of several found as part of a routine audit, the majority of which were determined to be simple documentation errors and not vaccine administration errors. However, the client?s guardian was unable to be contacted in order to determine which vaccine was actually received (please see below for an outline of attempts to reach the client?s guardian). The possibility of a vaccine administration error cannot be ruled out at this time. Attempts to contact: ? Called with voicemail left on 2/24/2022 ? Called with voicemail left on 2/25/2022 ? Called with voicemail left on 3/8/2022 ? Emailed on 3/28/2022 ? Physical letter sent on 4/13/2022 ? Called with voicemail left on 5/8/2022 All staff at the COVID-19 Vaccination Clinic have been educated on a procedure designed to reduce vaccination and/or documentation errors: vaccination staff ask clients to confirm their name and DOB and then respond by speaking the client?s age aloud and verbally confirming which vaccine the client is receiving. They will also verbally confirm the vaccine type aloud when they choose the vaccine type from the drop-down menu. The staff member who made the preponderance of the documentation errors was also individually coached regarding the accuracy of their vaccination recording practices.
pt recv vax 8MAY97 & 1JUN97 macular papular varicella like rash started;pt seen in hosp on 4JUN97;had vesicle under chin;progressed to face, back, chest upper arms, abd & upper legs lesions in various stages;
Vaccination site pain; chills; body aches; Feeling hot; Breathing difficult; Gait shuffling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), CHILLS (chills), PAIN (body aches), FEELING HOT (Feeling hot) and DYSPNOEA (Breathing difficult) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Kidney disorder and Bipolar disorder.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain), CHILLS (chills), PAIN (body aches), FEELING HOT (Feeling hot), DYSPNOEA (Breathing difficult) and GAIT DISTURBANCE (Gait shuffling). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 22-Mar-2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved. On 25-Mar-2021, CHILLS (chills), PAIN (body aches), FEELING HOT (Feeling hot), DYSPNOEA (Breathing difficult) and GAIT DISTURBANCE (Gait shuffling) had resolved.        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.   Patient was taking number of unspecified medications. On the day of the administration, patient  had soreness at the site of the injection. On 23Mar2021, he had chills, body aches, was warm to touch and had a hard time breathing. He took Tylenol for these symptoms. In the early morning of 24Mar2021 (4:15am), he was noted to be shuffling while walking then when he went to the bathroom his leg locked (like paraplegic legs) and he could not walk. Patient was  now back to normal. They called his doctor and were advised to bring him in in case the symptoms recur. They were also advised to proceed with the 2nd dose of the vaccine. Consent to follow up obtained.
Head ache, dizziness, tiredness, nausea, & diarrhea.
patient had 1 minute febrile seizure with full recovery over 15 minutes. Was taken via EMS to the pediatric emergency Department where he was seen to be back to normal and discharged with return precautions
Narrative:  Patient is a 79 year old MALE with PMH significant for HTN. DM2, DLP, CAD s/p inferior wall STEMI c stents x2 RCA & OM in 08/2017, OA of the knees s/p Rt TKA and Lt TKA scheduled for 7/7/21 s/p complete vaccination of Pfizer Vaccine 2/7 and 2/27/21 comes to ED for ongoing loose diarrhea x 3 days associated with weakness, nausea but no vomiting. Has been having loose and frequent diarrhea every 1-2 hrs progressive and accompanied by weakness. He even was unable to control bowel this evening (and soiled his dress) and too weak to stand and shower. No fever, no unusual coughing, no SOB but has some anterior discomfort breathing deeply. No sick contacts reported. He is better following fluid bolus. HOSPITAL COURSE: The patient was admitted to the hospitalist service. He was started on dexamethasone. The patient had no pulmonary complaints nor was he hypoxic during his hospital stay. In regards to entereitis/diarrhea patient reported no episodes on the day prior and day of discharge. Patient requested discharge home and was told to return if diarrhea worsened or if he had any pulmonary issues.
sore arm; This case was reported by a other health professional and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. Age at vaccination was not reported. The patient stated that with her 1st Shingrix shot she had a sore arm which was not a big deal. No contact details were reported. For tolerance in 2nd dose refer case US2021AMR186215.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR186215:same reporter
1. Fever lasting 30 hours.  It began approximately 11 hours after my shot, and ended 30 hours later.  Fever ran about 102 degrees most of the time.   2. Chills 3. Loss of appetite and body aches lasting approximately 3 days  4.  Hives in armpits, worse on the side of the injection.  I noticed it 48 hours after the injection, and I still have them 1 week later.  They are much better, but still visible and itchy. 5.  Sensitive and painful gums
hives noted to arms & legs, cheeks flushed @ 4PM-w/in 5 mins of vax; pt seen by MD & MD ordered Adrenelin-hives cleared up in 5 mins then ordered DPH;
pt recvd vax 730AM approx 12-1PM pt had near syncopal episode knes buckled; c/o weakness-sweaty & warm became flushed & very tired went home to bed noted some chills-?temp;
Arm is red approximately 4 inches by 4 inches. Pt is monitoring and taking BENADRYL. She is going to contact provider.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2 NOS), on 29Sep2022 at 14:30 as dose number unknown, single (Batch/Lot number: unknown) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient had no known allergies.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 for which patient received PF-07321332, ritonavir (PAXLOVID) from to 09Feb2023 to 14Feb2023. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
(translated fr Spanish by FV)nurse rptd that immed p/vax pt became pale & cyanotic, SOB, & weak & as if he had seizure;
a little pain in my arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little pain in my arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 PAIN IN EXTREMITY (a little pain in my arm). At the time of the report, PAIN IN EXTREMITY (a little pain in my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        AE submitted  I received my first vaccine of moderma 2 days ago and I only noticed a little pain in my arm. Yes
Patient had fever, jaundice, arterial venous clotting of the upper and lower extremities. Admitted to the ICU severely ill. Intubated for acute hypoxemic respiratory failure.
Headache (severe), muscle aches (mild), chills (mild), and fatigue (mild). Symptoms lasted approximately 48 hours after onset. Could not work/bedridden for approximately 36 hours. Tylenol did nothing to help, ibuprofen effective to  lessen the headache so I could sleep.