chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He can't stand or speak; He can't stand or speak; Multiple Strokes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 76-year-old male patient received BNT162b2 (BNT162B2), in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (COVID19 Vaccine, dose 2, manufacturer unknown, Lot number unknown, not bivalent), for Covid-19 immunization; Covid-19 vaccine (COVID19 Vaccine, dose 1, manufacturer unknown, Lot number unknown, not bivalent), for Covid-19 Immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (caused and prolonged hospitalization, disability, life threatening) with onset Sep2021, outcome "not recovered", described as "Multiple Strokes"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (medically significant), APHASIA (medically significant), outcome "unknown" and all described as "He can't stand or speak". The event "multiple strokes" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of cerebrovascular accident. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a physician refers to a male patient of unknown age with no pertinent medical history and no known drug reactions or allergies. There was no concomitant medication. In "mid-April 2013" the patient was administered his one and only dose of VARIVAX (merck), subcutaneous. The patient then developed "breakthrough chickenpox" starting on 06-MAY-2013. The physician noted "the lesions started at the site of injection and then spread all over his body; the patient currently has 40 lesions." Mother of the patient called and spoke with the reporting physician. No treatment was given for the patient. No lab diagnostics studies were performed. At the time of the report, the outcome of breakthrough chickenpox was reported as not recovered. Additional information has been requested.
Pentacel was mixed with sterile diluent instead of the HIB component that it is supposed to be mixed with.
This spontaneous report as received from a registered nurse refers to a child of unknown age. On an unknown date, the patient was vaccinated with a dose of ROTATEQ (dose, route, lot number not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient developed severe diarrhea after receiving a dose of ROTATEQ. No treatment information was reported. At the time of the report, the patient's outcome of severe diarrhea was unknown. The relatedness for severe diarrhea was not reported for ROTATEQ. It was unknown if the patient sought medical attention. Additional information is not expected.
Muscle pain; muscle spasms; Problem moving, mobility problem; This is a spontaneous report from a contactable consumer (patient) and another contactable consumer (patient's sister). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in arm left on 01Apr2021 (Lot Number: EN620) as single dose for COVID-19 prevention. Medical history included diabetes from 2007 and ongoing, hypertension from 1998 and ongoing. The patient concomitantly took medicine and a whole lot, that was too much. The patient previously received first dose of BNT162B2 on 11Mar2021 (lot number EN620, it looks like 7). In Apr2021, the patient experienced muscle pain and muscle spasms and she had to go emergency room twice; had problem moving, mobility problem. She had never had this experience. It was very severe, very traumatic for her to go the emergency room twice. Treatment was received for events. For muscle spasms she was taking Ketorolac 10 mg. They take her blood and urine at emergency room, CT-scan, X-ray. It had been over a week, she had the vaccine second shot on 01Apr2021, and it was 14Apr2021. It was getting better by taking medications, medication was giving relief. The outcome of events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
It was reported that a 53 year old female received Fluzone SV '99-'00 at 11:00 on 10/25/99. The next morning, the pt experienced a "red, swollen area, 3" by 2" on her left upper arm that was hot and tender to touch". No further information is available at this time.
Chest pain. Took Tylenol and resolved within 30 min. Rest of day was normal.
No adverse event; Vaccine administered after beyond use date 07-Jul-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022).    No concomitant medication was reported. No treatment information was provided.  Reportedly, the vaccine BUD (beyond use date) was 07-Jul-2022.
Starting 04/12/2022, I became short of breath. It was so severe that I was having a hard time catching my breath. I was taken to the doctor and they referred me to the emergency room. When I got there, they did a CAT scan and numerous blood tests. I was taken up to ICU and had the EKOS procedure the next day for a PE. I would remain in the hospital until 04/17/2022 when I was discharged after the catheter was removed. I was given blood thinner injections that I would need to inject myself. On 04/19/2022, I would be in so much pain in my abdomen that I ended up calling the ambulance to return to the ER. They did a CAT scan and more blood work and determined I had numerous large hematomas in my abdomen due to the removal of the catheter. They were so painful that it was hard to move or do anything. I would remain in PCU until 04/25/2022. They thought I might have a blood clotting disorder but ruled it out. They are unsure why I had this problem. Also, they did an ultrasound in the hospital of my legs and found numerous blood clots. They recommended that I have an IVC filter put in my chest to prevent the blood clots from moving into my heart. I had an identical Massive Saddle Pulmonary Embolism back in 01/2020 after having a severe cold with shortness of breath which is atypical for me. I have never had shortness of breath in my life until then. I would be discharged in 02/2020. In hindsight, I think I may have had COVID-19 but it was not talked about at that time and it wouldn't be until a month later they started having the COVID-19 lockdowns.
Left arm progressive edema and erythema, warmth Ceftriaxone qd x 2 given as well as Augmentin x 10days.
severe nausea and headache at 7pm when i returned home. Vomiting the day after the vaccination, fever and chills. Friday of that week lymph node swelled under left armpit. Numbing and burning in arm and hands and side of left breast. Rash onknees and continued left arm tingling and neck pain. Irregular menstrual cycle.
About 12 hours after the vaccine, I experienced a 102 degree temperature, all over body aches with the most discomfort in my lower back, knees, and hips, headache and general fatigue.  The next day all the symptoms went away except residual arthritic joint pain.  The pain is more extreme during sleep and in the morning.  My left knee has been swollen as well.  There is a general feeling of whole body arthritis and is lessened by NSAIDs.
got the shot for shingles/ got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional details were reported as follows: The age at vaccination was not reported. The reporter knew a lady who got the shot for shingles and got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
This spontaneous report as received from a medical assistant refers to a 16 year old male patient. The patient's pertinent medical history, drug reaction/allergies or concomitant information were not reported. On 27-JAN-2017, the patient was vaccinated with first dose of GARDASIL 9 lot # M028323 with expiration date: 26-SEP-2018, intramuscularly. Then, on 17-FEB-2017 with second dose of GARDASIL 9 lot # M036059 03-JUN-2019, intramuscularly for prophylaxis.   There was no product quality complaint (PQC) involved.   Additional information has been requested.
No additional AE; HCP states that multiple patients have accidentally been given PEDVAXHIB vaccine that was diluted. HCP states that the person administering the product was diluting the PEDVAXHIB with 0.5mL of normal saline and then drawing up 0.5mL and administering; administering the product was diluting the PEDVAXHIB with 0.5mL of normal saline and then drawing; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender.  On 19-AUG-2022, it was stated that the patient have accidentally been given the second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis, (lot # W002453 , has been verified to be a valid number; expiration date reported and established as: 24-JUN-2024), that was diluted with 0.5 milliter (ml) of normal saline and the drawing up 0.5 milliter (ml) and administered to the patients (product preparation error) (vaccine underdose).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA007866:
Woke up on 4/29 (3 days later after 2nd dose) with hives all over body. Consulted with Physician?s office and was advised to go to Emergency Room
red area that got larger and larger; felt inflamed; peeling; being very itchy; burning; icky; area that was red at the beginning of the symptoms is now dark and warm; area that was red at the beginning of the symptoms is now dark and warm; the dark part as if someone had hit punched her; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 05Apr2022 as dose number unknown (booster), single (Lot number: FM0698) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer, Caller on the line got the 2nd booster of the Pfizer COVID-19 Vaccine.), for Covid-19 immunization; Covid-19 vaccine (First Booster, Manufacturer unknown, Caller on the line got the 2nd booster of the Pfizer COVID-19 Vaccine.), for Covid-19 immunization. The following information was reported: SKIN DISCOLOURATION (non-serious), FEELING HOT (non-serious) all with onset 06Apr2022, outcome "unknown" and all described as "area that was red at the beginning of the symptoms is now dark and warm"; PRURITUS (non-serious) with onset 06Apr2022, outcome "unknown", described as "being very itchy"; BURNING SENSATION (non-serious) with onset 06Apr2022, outcome "unknown", described as "burning"; INFLAMMATION (non-serious) with onset 06Apr2022, outcome "unknown", described as "felt inflamed"; MALAISE (non-serious) with onset 06Apr2022, outcome "unknown", described as "icky"; SKIN EXFOLIATION (non-serious) with onset 06Apr2022, outcome "unknown", described as "peeling"; ERYTHEMA (non-serious) with onset 06Apr2022, outcome "unknown", described as "red area that got larger and larger"; FEELING ABNORMAL (non-serious) with onset 06Apr2022, outcome "unknown", described as "the dark part as if someone had hit punched her".  Additional information: Caller on the line got the 2nd booster of the Pfizer COVID-19 Vaccine on 05Apr2022 from lot number FM0698. On 06Apr2022 she had a red area that got larger and larger and felt inflamed. She stated it started peeling and being very itchy. Besides the peeling and itchy, caller also described as if it had been burning, icky. She said that she could tolerate the other symptoms but that it was really itchy. The area that was red at the beginning of the symptoms is now dark and warm. Caller later described the dark part as if someone had hit punched her. Caller's inquiry was if this side effects have been reported. Caller also stated she would consult with his physician whether or not to get her next dose if a 3rd dose is ever required.  No follow-up attempts are possible. No further information is expected.
Information has been received from a health professional concerning a pt who on 04Feb1997 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 02Apr2003 the pt experienced breakthrough chickenpox which was described as a small fluid filled rash all over the body with itching. The reporter indicated that 2 other patients were vaccinated with a dose of varicella virus vaccine live and developed breakthrough chickenpox on 02Apr2003. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was vaccinated with an expired 0.5 ml dose of live (Merck) VARIVAX (lot # reported as 1040Z, exp date 11-AUG-2012), subcutaneously on 09-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. She reported that the patient was seen to receive a dose of live ZOSTAVAX today 09-JAN-2013, but instead received live (Merck) VARIVAX, which had expired. No adverse effects reported. Additional information has been requested.
didn't feel good; diarrhea; nausea; shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself) received via Pfizer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced diarrhea, nausea, shortness of breath on an unspecified date in 2021; didn't feel good on 14Mar2021. Patient got the first shot yesterday 13Mar2021. Patient didn't feel good the night after. Patient experienced diarrhea, nausea and shortness of breath. Patient wants to know if it is normal or if she should see her doctor. Outcome of the events was unknown.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Migraine within 30 minutes of vaccine. I thought I was going to have to go to the hospital it was so bad. I had to work from home for a few days. I got tested by my neurologist (the Wed or Thursday following the vaccine -she prescribed a couple of new medications for me. the meds may have helped make the migraine more manageable but it was still there. It lasted 8 days. I generally get two or three a month and they last a day. This one would not go away. I was fine with the second dose on 2/5/2021 - I didn't get  a migraine until after 10 days after second dose.
C/O increase palpitation/hear racing. VSS. hx of experiencing the same reactions post vaccination. Provider at bedside and evaluated. extended obx addtional 30 mins. sx improved and sent home.
Patient received their booster dose of Moderna only 4 months after their 2nd dose of Moderna.
T- 101.3 after imms. observe, TYLENOL as needed. Call if sx. change/worsen.
Sore to touch in area of vaccination reported on 08/08/11 by resident via telephone call. No fever or swelling reported at site. Resident denies drainage at site of vaccination.
Client was seen in UC on 04/14/2003 in the afternoon. Had right sided weakness, neck pain, as well as droopy eye lid. The vaccine site was tender according to the client. Client verbalized she was Dx with Bell's palsy
woke with fever of 100.1, headache, left arm soreness at the injection site
Fever; Fatigue; Vomiting; Dizziness; This is a spontaneous report from a non-contactable consumer. A female patient of unknown age received 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 09May2021, as a single dose for COVID-19 immunisation. It was unknown whether the patient was pregnant at the time of vaccination. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. On 10May2021, the patient experienced fever, fatigue, dizziness and vomiting. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of fever, fatigue, dizziness and vomiting which included treatment with paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, fatigue, dizziness and vomiting were resolved on an unspecified date in May2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This 72 year old man with stage 4 pancreatic cancer was admitted with covid pneumonia.  He did not require remdesivir but did receive steroids.Today he is not hypoxic.  He has advanced disease with last CT showing progression of disease.  He is doing poorly and wishes to go home with hospice care.  He will go home this evening.  Hospice involved He will complete empiric antibiotics
I have small bumps in the palm of my hand and I have a small rash on the inner left side  of my left arm
C/o pain in right deltoid when raising arm to adduction or rotating arm internally. Very painful at night, wakes me up at night hurting.
Extreme severe nausea lasting 48 hours, fever 101.9, chills, extreme weakness, chest pressure.  Arm extremely red, bruised, hot and swollen.  I did not seek medical care although I truly feared I was perhaps experiencing an heart attack.  I am my husband's sole caretaker and cannot leave him unattended.
Patient received the flu shot for the first time and was advised to remain on site for 15 mins. After 5 mins, She experienced dizziness and vomitted for 5-10 mins. She remained sitted for another 15 mins, drank some water and was feeling fine afterwards. She denied any difficulty breathing.
This spontaneous report was received from a healthcare worker concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number and expiry date were reported as H015749 and 08-JUN-2014 respectively, dose and route unspecified). No concomitant therapy was reported. On an unknown date, the patient developed cellulitis after receiving one dose of PNEUMOVAX 23. It was unspecified if the patient sought any medical attention. The outcome of cellulitis was unknown. The relatedness for cellulitis was unknown for PNEUMOVAX 23. The healthcare worker requested lot check on behalf of physician. This is one of the two reports from the same source. Additional information has been requested.
At aprox 10Pm on 8/20/21, I started to feel anxious but in a daze at the same time. From there and very quickly I began to at first feel my legs getting very hot, then my ears, I then felt tingly, weak, and very anxious, I was driving home and had to pull over, I became very thirsty, I went into a gas station to get Gatorade, I then began sweating as much as if I had just completed a spin class, it was dripping down my face, I then thought I was going to vomit, felt very dizzy and thought I was going to pass out. I started to panic as my breathing got heavier. My side effects went from zero to full blown hot flashes, vomit and dizzy in a matter of maybe an hour, it was very quick, I literally felt my body getting worse ans worse minute by minute, I got home, laid down and tried to relax .. after about 20 mins of being home, the dizzy went away, I was exhausted and then my body became so sore, i did not want to move. The soreness lasted about24 hours. I did not seek medical treatment because It all happened so fast, I'm a single mother, I had my children home with me and I did not want to leave them or scare them .
VZV2, Menactra, Tdap admin on 1/23.  1/24 noted redness to right arm and sore.  1/25 came in with 20 cm erythematous area cm right port 3mm with 5 cm indurated tandem.  No fluctuant area in location of Varicella.
This spontaneous report was received from a pharmacist refers to a unknown number patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of ROTATEQ (lot number, expiry date was unknown) which had been stored as high at 47 Fahrenheit for up to 63 hours and no adverse effect was reported. This is one of the two reports received from the same reporter. Additional information is not expected.
S/P 12 admin on 4/4/14 with KINRIX, MMR, VZV IN on 4/.7/14 with c/o lg reddened area to (L) thigh measuring 10x11cm. KINRIX, VZV was given in (L) thigh. Back in on 4/10/14 with improvement. Red induration improving as of 4/10/14. Pt given BENADRYL and Prednisolone.