chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to himself. The patient was vaccinated IM with single dose of ZOSTAVAX (lot# not reported) intramuscularly in the gluteus muscle in either February or March of 2012. No other co-suspects were reported. No adverse effects reported. No concomitant medications were reported. No treatment information was reported. Additional information has been requested.
patient states she felt nausea immediately after shot and was nauseous while waiting.  followed up with patient at night and she states she is still nauseous and probably more now than before
pt recvd vax;forearm swollen 2-3";itching all over w/ rash;eyes swollen;HA,dizziness,lightheadedness;shaky,n ;on 9feb96 dizzy,n,joints achy,diff concentrating;
No additional AE reported.; Physician was reviewing old records and noticed that back in 2007, patient was administered MMR and VARIVAX too close together.; This spontaneous report was received from an registered nurse and refers to a male patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-JUN-2007, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 19-JUN-2007, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  Physician was reviewing old records and noticed that back in 2007, patient was administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) too close together (Inappropriate schedule of product administration). This agent attempted to probe to inquire if nurse was referring to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), but nurse stated all that was documented is that is was Merck's measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine. No further information provided. No additional adverse event was reported.
The skin on my fingers and palms turned an orange colour. This happened 11 days after my first injection; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, deep vein thrombosis of left leg and COVID-19 exposure in Feb2020. Prior to the vaccination, the patient was diagnosed with COVID-19, on an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included rivaroxaban (XARELTO) started from an unknown date for deep vein thrombosis of legs and was ongoing and blood thinners (unspecified) started from an unknown date for clot and was ongoing.   On an unknown date, the skin on the patient fingers and palms turned an orange color. This happened 11 days after her first injection, and at day 13 after her  second dose, on 14Apr2021. The patient was currently being treated with Xarelto for a DVT that was in her left leg, likely due to a COVID exposure back in February of 2020. She went to the ER for the clot which was quite extensive and was still on the blood thinners. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event- skin on the fingers and palms turned to an orange colour was recovered on an unknown date Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
2 days post vax, the pt had a dystonic reaction which repeated over the following 6 days.
LT Breast Mass/Cyst; Received second dose more than 35 days apart from the first; This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (LT Breast Mass/Cyst) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 35 days apart from the first) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) from 03-Feb-2013 to an unknown date and AMLODIPINE MESILATE;OLMESARTAN MEDOXOMIL from 21-Mar-2011 to an unknown date for Hypertension.   On 07-Jan-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021 at 11:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 35 days apart from the first). On 21-May-2021 at 10:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BREAST MASS (LT Breast Mass/Cyst). On 26-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 35 days apart from the first) had resolved. On 06-Jun-2021, BREAST MASS (LT Breast Mass/Cyst) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Mammogram: incomplete additional imaging evaluation needed (Inconclusive) The focal asymmetry in the left breast is indeterminate. 3D spot compression imaging and possible ultrasound is recommended.. On 10-May-2021, Mammogram: ultrasound is recommended. (Inconclusive) The focal asymmetry in the left breast is indeterminate.. On 10-May-2021, Ultrasound breast: an ultrasound guided biopsy is recommended. (Inconclusive) The 1.4 cm oval mass in the left breast is suspicious of malignancy..         This case was linked to US-MODERNATX, INC.-MOD-2021-004328 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: No new information received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-004328:Dose 1
Tinnitus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "Tinnitus".  Additional Information: No reporter's contact information available to you or a sub-contracted party. Start and stop date was unknown. Patient was a consumer and verbatim and event description reported as tinnitus.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
4cm erythematous patch left mid deltoid. Vaccine given 06/03/02. Seen 06/17/02. T 98.4 po.
BODY ACHES; GENERAL LETHARGY; FEVER; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 not reported, batch number: Unknown) dose was not reported, administered on APR-2021 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 APR-2021, the subject experienced body aches. On APR-2021, the subject experienced general lethargy. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, body aches, general lethargy, and fatigue. This report was non-serious.
I received dose 4, the bivalent, because I was advised not to get the second booster because of my health conditions.  After the bivalent dose in September 2022, I had some heart issues.  On October 13th I was at the doctor for a standard appointment.  I felt a pinching sensation under my arm pit.  It meandered towards my back and then filled my rib cage.  I returned to the front desk and told them I was having chest pains.  I was flushed.  It was 12:15 when I first started feeling the pain.  I called my GP.  The nurse told me to go to the ER.  I also had shortness of breath, minor.  When I was seen my blood pressure was elevated.  I had a CT scan of chest area to rule out embolism.  I was admitted for overnight observations.  I was sent home the following evening.  They ruled everything out that would seem to be an emergency.  They did not find out anything cardiac related for the pain.  In addition to this pain on October 13th, previously I had diarrhea before the bivalent shot.  But after the shot my diarrhea and other digestive issues got worse.  I have had diarrhea for over a month now and have lost 10 pounds.   I also would like to add that I have had shingles 4 times since December 2021 and my first vaccine for COVID-19 was 03/20/2021.
With in 3 hours of the injection, I had severe pain in my eyes.  When I examined them in a mirror, the whites of my left eyes was red within another hour it had crossed over to the right.  The pain was severe.  I had an eye antibotic that I started on Friday morning. My eyes were swollen in the eyebrow area and face below the eye by Friday night. Had severe pain until I saw Dr. on Monday.  He said my eyes were dry probably from swelling.  I took the antibotic thru Thursday as instructed.  and  used OTC eye drops  every 2 hrs. for the week following the antibotic.. The eyes are are more clear, but I still have some eye pain.  It has been 2 weeks today since  taking the covid vaccine.
Fatigue; muscle aches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Lot number: EW0150) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Product: COVID-19, Lot number: ER8735, Lot unknown: False, Dose number: 1, Vaccine location: Left Arm), when the patient was 39 years old, for Covid-19 immunization, reaction(s): "Dizziness", "Fatigue", "Nausea", "Body aches", "Tingling in left hand and left foot"; Bnt162b2 (Product: COVID-19, Lot number: ER8735, Lot unknown: False, Dose number: 1, Vaccine location: Left Arm, notes-(4 days early, started the day after the vaccine)), when the patient was 39 years old, for Covid-19 immunization, reaction(s): "Heavier Period". The following information was reported: FATIGUE (non-serious) with onset 05Apr2021, outcome "recovered" (2021), described as "Fatigue"; MYALGIA (non-serious) with onset 05Apr2021, outcome "recovered" (2021), described as "muscle aches". Therapeutic measures were not taken as a result of fatigue, myalgia.  Additional information-Patient had not taken any other vaccine in four weeks. Patient had no Covid prior vaccination and was not tested for Covid post vaccination  No follow-up attempts are possible. No further information is expected.
The patient reported that she could not get out of bed, felt achy, weak, diarrhea and headache behind her right eye.
pt recv vax & resulted in severe local reactions (redness, puffiness, warm to touch, etc) of long duration; one case devel into cellulitis; it is believed that all doses were fr the same lot
After 3rd dose of the vaccine lot 012H21B, the following adverse event happened. After 23 hours of vaccination, I lost the ability to read. All letters was in the wrong order, however all capital case was on the first letter. All numbers was in correct order, but not letters. I even open document written in my native language but the same story. I couldn't read anything. Feels like everything is presented in foreign language. When I open calendar, Month, Days was not readable, but day numbers was ok. I look on the clocks digital and analog to compare time and numbers on digital clock was equal to the time on analog clock. Two hours later the adverse event gone like it never happened to me. I feel lightheaded a while after the adverse effect gone, however the headache was following to end of the day. Today arm still hurt, but physically and mentally I am back to normal.
Parent reports patient woke with wide spread body rash, itches. Parent to administer Benadryl.
This case was reported by a pharmacist via call center representative and described the occurrence of local reaction in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced local reaction, pain in arm, swelling and flu like symptoms. On an unknown date, the outcome of the local reaction, pain in arm, swelling and flu like symptoms were unknown. It was unknown if the reporter considered the local reaction, pain in arm, swelling and flu like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. No further information was reported regarding to the event. The healthcare professional preferred not to provide further information.
When patient and mother arrived at site, patient's birthday was mistakenly charted, which would make her a year too young to recieve the Pfizer vaccine for youth. Reportable error found in data mining. RN contacted patient mother who stated she would provide child's birth certifcate for DOB proof, never submitted to RN and could not get ahold of after that.
20 minutes after injection states itchy at injection site & then wrist & down thumb. Short narrow red line seen. BP 108/70 P 84. No Resp distress. 1540BP 104/70 Decreased itching. 0 redness seen. 1545 sent home with instructions
pt recvd vax;had sz;to MD;v;T 102;slept p/ sz;chest x-ray,CBC done;observed till 3:30pm;apap,motrin,loribid given;12am,2nd sz identical to 1st one;T 101;
L FA - 3 cm x cm erythematous papular tender area with increased local temp. Rx: Tylenol, Benadryl, local heat and three days of periopred (?)
Had 5 Pfizer injections for Covid, clarified and confirmed had 5 doses of the Pfizer COVID-19 vaccine.; Had 5 Pfizer injections for Covid, clarified and confirmed had 5 doses of the Pfizer COVID-19 vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: BJ3342) at the age of 67 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: EL9261), on 06Feb2021 as dose 2, single (Lot number: EL9264), on 25Sep2021 as dose 3 (booster), single (Lot number: FF2588) and on 02Apr2022 as dose 4 (booster), single (Lot number: FJ4991) for covid-19 immunisation. The patient's relevant medical history included: "heart surgery" (unspecified if ongoing); "quadruple bypass" (unspecified if ongoing), notes: He added that he's been on atorvastatin because he had a heart surgery due to blockages. Concomitant medication(s) included: ATORVASTATIN taken for surgery, start date: May2020, stop date: 11Apr2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had 5 Pfizer injections for Covid, clarified and confirmed had 5 doses of the Pfizer COVID-19 vaccine.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Mar2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient took Paxlovid from 03Mar2023 to 09Mar2023.  Clinical course: Had 5 Pfizer injections for Covid, clarified and confirmed had 5 doses of the Pfizer COVID-19 vaccine. Indication: Had tested positive on 02Mar2023 for Covid symptoms, very mild, like a mild cold, runny nose, congestion, coughing, low grade temperature also. Called primary care, did video appointment and doctor thought for caller to try Paxlovid and made the recommendation to stop Atorvastatin while taking the Paxlovid and to lower the Eliquis.
Case number PHEH2013US005293 is an initial spontaneous report received from a medical assistant on 28 FEB 2013 and a follow up received on 25 MAR 2013. This report   refers to an adult male patient. He was vaccinated with MENVEO (batch numberM12006 and expiry date: 31 OCT 2014) intramuscularly at a dose of 0.5 ml on 30 JAN 2013. This vaccine had undergone temperature excursions. The first temperature excursion took place on 23 JAN 2013 and the vaccine reached 54 degree Fahrenheit for less than four hours. MENVEO was not re-constituted at the time of excursion. Reporter stated that the MENVEO had a temperature excursion but the patient did not experience any adverse events as a result of the temperature excursion. It was reported that the patient will be revaccinated.   Follow up information received on 25 MAR 2013: Confirmed that the patient did not experience any adverse event and will be revaccinated.
Patient has a rash on the back of her neck.  She went to her doctor who prescribed a steroid cream which has improved the rash but it is still there.  Her doctor ok'd the 2nd dose of the vaccine which she got today and waiting 30 minutes in case of severe reaction.
March 11 & 12 overnight didn't get to sleep until 5am due to all-body itching.   Same thing happened overnight March 29.  For 2 or 3 weeks after second vax shot I didn't do much but stay in bed.  When I started to feel better I could hardly walk due to hip pain. X-rays showed I had bad hip joints, but that wasn't caused by lying around a couple weeks. I slowly have gained strength but was set back in that improvement about a month after my booster on Oct 12. I'm getting a referral for physical therapy but haven't started yet.
pt recvd vax; mom states pt stopped breathing for a few secs then gasped for air; mom denies fever or v or sz at this time;
Whelpy rash developed the next day-on trunk and legs, after receiving swine flu vaccine. Resolved quickly with 1 dose of BENADRYL. No further rash appeared.
Applicant had soreness as anticipated 2 hours post injection. Then noticed some limited range of motion of left arm around 5:30PM the same day Pfizer Bivalent was given. By 06/29/2023 around 0530AM, patient, observed swelling over the front neck surface area, around where the lymph nodes are, extending to the right breast and some of the right arm pit. Also observed some stiffness and pain when turning neck towards the right side. Today 06/30/2023, patient notified vaccine administrating facility about her reactions. Range of motion seem to be improving, but with observed tenderness on areas mentioned upon touch. Advised to seek medical care if described symptoms worsen.
IM vaccine was given SubQ - Large, quarter sized, red bump appeared within an hour after vaccine was given to back of upper, left arm.  Today is 8 days later, bright redness has disappeared but the LUMP is still the same size. I was given a Tdap and a Hepatitis A vaccine on 8/20/14; The nurse told me Tdap was given in left arm and Hep A in the right, however she documented this information backwards.
Patient began to feel flushed, hot.  No nausea or vomiting.  No shortness of breath or light headed ness.  O2 sat 100%, resp 18, BP 140/76, heart rate 67.  Symptoms resolved and patient discharged from clinic
First day: Warm Next day: Soreness on left arm at injection site Body Aches
Patient had wanted to receive the Tdap vaccine. We accidentaly gave her the moderna vaccine. She had already received both doses of the pfizer vaccine back in april. We followed up with her doctor, they said just to monitor her for side effects. I followed up with her later today, she said she was only experiencing a headache. I will continue to follow up with her over the next couple days and also next week to see if she is experiencing anything else.
received the second dose 21 days after the first; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose 21 days after the first) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose 21 days after the first). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose 21 days after the first) had resolved.            No concomitant medications reported. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Vaccine details:  "Pfizer-BioNTech COVID-19 Vaccine EUA"  Numbness and constant tingling sensation in left foot, left hand and fingers, and left side of face including mouth and tongue.  Swollen feeling (no visible swelling) in face.  Drooping sensation to left side of mouth.  Numbness and tingling sensation only on  side of body where vaccine was administered (left arm).
chills about 15-16 hours later, lasted around 4 hours; This is a spontaneous report from a contactable pharmacist. A 57-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: E112B3), second dose intramuscular, administered in left arm on 25Jan2021 09:00 as SINGLE DOSE for covid-19 immunisation. Patient was 57 years old at the time of vaccination. Medical history included diabetes mellitus, hypertension, glaucoma and back pain, all from an unknown date and unknown if ongoing. The patient had no known allergies. On 04Jan2021 at 2pm patient received first dose of Bnt162b2 (lot number=EJ1686, intramuscular in left arm). On 26Jan2021 at 2:00 the patient experienced chills about 15-16 hours late and lasted around 4 hours. Therapeutic measures were taken as a result of the event. Outcome of the event was recovered.
Rec'd Dtap - within 24 hours - had redness over entire deltoid muscle - swelling & warmth - itching - no c/o pain.
Pt received vaccine, 5 minutes later pt's brother reported pt was having seizure. Arrived and found pt awake and alert on the ground. Bystanders reported was running and fell, hitting face on ground and chipping tooth. Bystanders reported pt was unconscious and twitching. Mother of pt denies any allergies or medical conditions, reported older brother had epilepsy. Pt remembered event, had not vomited. EMS arrived and took pt to hospital.