chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ischemic Stroke; This is a literature report for the following literature source(s): "Stroke in Patient With Controlled Preexisting Hypercoagulability After COVID- 19 Vaccine Booster:   A 55-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "factor V Leiden" (unspecified if ongoing); "protein C deficiency" (unspecified if ongoing). Concomitant medication(s) included: ENOXAPARIN taken for anticoagulant therapy. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE (Unknown Manufacturer )), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE (Unknown Manufacturer )), for COVID-19 immunization. The following information was reported: ISCHAEMIC STROKE (hospitalization, medically significant, life threatening), outcome "recovering", described as "Ischemic Stroke". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: revealed an acute left thalamic, left posterior, notes: internal capsule, and bilateral middle cerebellar infarcts. Therapeutic measures were taken as a result of ischaemic stroke.  Clinical course: On admission, she presented with acute-onset right-sided weakness and numbness. She received the BNT162b2 vaccine booster dose 27 days prior to admission. Prior to this incident, she was successfully maintained on the same dose of enoxaparin for 19 years without clotting event along with recent outpatient hematology monitoring. After medical stabilization, she was admitted to the acute inpatient rehabilitation facility where she regained full motor strength and gait, although numbness persisted. Following consultation with her outpatient hematologist, she was discharged at an independent level with unchanged enoxaparin dosing.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the  "Ischemic Stroke" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).  The same  was blamed as a possible trigger by the reporter, and it can possibly be explained by the mechanism as stated in the full article.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This case was reported by a consumer via call center representative and described the occurrence of itchy scalp in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On 17th June 2021, the patient received the 1st dose of Shingrix (intramuscular). In July 2021, an unknown time after receiving Shingrix, the patient experienced itchy scalp. On an unknown date, the outcome of the itchy scalp was not recovered/not resolved. It was unknown if the reporter considered the itchy scalp to be related to Shingrix. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine in the left arm and a month later experienced an itchy scalp. No further information was reported. The reporter consented to follow-up. For 2nd dose tolerance, refer linked case US2021AMR250604, reported by the same reporter for same patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR250604:same reporter.
hepatitis B vaccine 12/12/2021,02/04/2022, 09/12/2022; This spontaneous report was received from a Nurse referring to a 18-months-old female patient. The patient's pertinent medical history, drug reactions or allergies were not provided.   Concomitant vaccines included Hepatitis A Vaccine, inactivated (manufacturer unknown), rotavirus vaccine (+) live (+) oral (+) pentavalent (ROTATEQ), diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL), measles vaccine (+) mumps vaccine (+) rubella vaccine (MMR VACCIN), varicella vaccine (manufacturer unknown), and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13).  On 12-DEC-2021, 04-FEB-2022, and 12-SEP-2022, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection (strength, route of administration, exact dose, lot number and expiration date were not provided) for prophylaxis, respectively (inappropriate schedule of product administration for the second and third doses).   This is one of several reports from the same reporter. This is one of two reports for the same patient.; Sender's Comments:  US-009507513-2307USA009244:
Fever, dizziness, fatigue with some tenderness the first night. The second day, the site started to swell and be extremely tender, coupled with more fatigue and higher fever.
This spontaneous report was received from a pharmacist, referring to a 60 year old female patient with allergy to penicillin. The patient's concomitant medication included an unspecified "thyroid pill". On 15-JAN-2018, the patient was vaccinated with ZOSTAVAX 19400 PFU, subcutaneously in the left arm for shingles prevention, lot # N020943 and expiration date on 26-OCT-2018. On 17-JAN-2018, the patient began complaining of redness and itching throughout the entire body. The patient went to see her primary care doctor and was diagnosed with shingles. She was prescribed two weeks worth of an unspecified antiviral medication which did not relieve the symptoms. On an unknown date, the patient began using unspecified topical steroid creams and was using them by the time of the reporting, however, she was still experiencing the systemic reaction. The reporter did not assess the causal relationship between ZOSTAVAX and the event.
Breakthrough case admission after 3 vaccines Pfizer 3/30/21 Lot# EP7533;  Pfizer 4/20/21 Lot# EW0164;  Pfizer 10/21/21 Lot# FF8841
On 9/25/13, she was given Zostavax, flu shot and Pneumovax at the same time and on one arm. Now each arm was painful and swollen and "disabled".
I had my vaccination on 05/11/2021. I had body aches after vaccination, fatigue, arm was painful. My scalp started to burn and became achy. I contacted my dermatologist on 05/13/2021. I was diagnosed with dermatitis to the scalp, sensitivity to hair dye, and Neurogenic Rosacea. I was recently prescribed Gabapentin to help with the symptoms and it seems to be helping. I have been experiencing the symptoms to my scalp since the first vaccination on 05/11/2021 to presently 01/25/2023 with intermittent flare-ups.
Meningococcal MCV4 LOT# U3433AA - Exp. 08/02/11 vaccine administered 08/10/11, 8 days after expiration date. Dose not re-administered.
Right deltoid, red, swollen, tender and warm to touch, firm, temp of 100 at 330 pm. Now 98.7 after Advil. Treatment:  cool compress, contact physician today. MD treatment: Pedia Pred, Augmentin, Tylenol.
I started sneezing and runny nose.  I started to have aches and starchy throat.  I woke the next morning and was still feeling bad.  I took at a at home test, and it was negative.  I went to urgent care, and they did a COVID test, and it was positive they prescribed Lagevrio 200mg and cough medicine.  I have just been achy and runny nose and cough.  I have had no fever at all.  I also have extreme fatigue. Still not feeling all that great.
Received vaccines on 1-12-09.  Symptoms started on Sunday, 1-25-09, with a fever, "just not feeling well"  Took ibuprofen and slept.  On Monday, January 26, 09 noticed red, raised, "pimple like" rash on head, progressing to chest, back, arms and legs.  Rash was itching, blisters scabbed over.  Rash continued to appear for 2-3 days.  Saw Dr. on Wednesday, !-28-09.  Dr. gave pt. Claritan.  Dr. called Health Dept. asking this be reported to Vaers. Pt is feeling fine today.  Noted "I have a few scars from the rash".
Systemic: tingling eyes-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: called ambulance
ABOUT 13 MINUTES AFTER RECEIVING FLU VACCINE, PT REPORTED FEELING LIGHT HEADED; RPH WITNESSED PT ACTUALLY LOSE CONSCIOUSNESS BRIEFLY, BUT RECOVERED CONSCIOUSNESS ALMOST IMMEDIATELY. RPH HAD PT LIE DOWN AND HAD CUSTOMER SERVICE DIAL 911. RPH CHECKED PT'S BP AT 2 FIVE MINUTE INTERVALS (110/80 MMHG, 112/86 MMHG). PT REPORTED FEELING MUCH BETTER AFTER A FEW MINUTES LYING DOWN. WHEN EMS ARRIVED ABOUT 5 MIN LATER, PT SAID HE FELT MUCH BETTER, JUST OCCASIONAL LIGHT-HEADEDNESS. EMS TOLD RPH NOT TO ADMINISTER ANY EPINEPHRINE. EMS MONITORED PT ANOTHER 10 MIN OR SO; PT'S BP CONTINUED TO BE NORMAL, HR AND BG ALSO NORMAL. PT DECLINED BEING TAKEN TO ER AND EMS LEFT. RPH CONTACTED PT'S MD; NURSE SAID FOR PT TO GO TO ER IF HE FELT HE NEEDED TO, BUT IF FELT OKAY, THEN JUST TO F/U WITH OFFICE IF HE HAD QUESTIONS. PT STAYED IN STORE ANOTHER 1.5 HRS AS HE CONTINUED TO HAVE OCCASIONAL LIGHT-HEADEDNESS AND HEADACHE. HE HAD A GLASS OF WATER AND ATE A TURKEY SANDWICH TO SEE IF THAT IMPROVED HIS SYMPTOMS; SYMPTOMS REMAINED THE SAME. HIS OCCASIONAL LIGHT-HEADEDNESS CONTINUED AND PT OPTED TO HAVE A FRIEND DRIVE HIM TO THE ER TO MAKE SURE HE WAS OKAY. PT LEFT STORE ABOUT 12:15PM.
Pt presented in our ER on 11/16 with chief complaint of facial swelling and tongue thickening, had a flu vaccine on 11/12/20. Same type of co after last flu vaccine 10/11/2018. Was admitted that time overnight as observation, felt it was allergy to Lisinopril  REceived Benadryl, solu-medrol, claritin, and pepcid in our ER and discharged home
Swollen, reddened, feverish knot with redness going to axillary area. Itchy 3 1/2X2 " knot redness 7 1/2" X 4 1/2"  no streaking down arm (bubbly looking similar to cellulitis)  however 7 1/2 X 4 1/2 reddened area.
Patient received the pneumococcal vaccine on 12/26/2001. They then experienced erythemia and warmth on the upper part (shoulder to elbow) of the arm which the vaccine was administered.
Injection site reaction - Information has been received from a dermatiologist's office concerning an 16 month old male who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation.  subsequently the patient experienced a large reaction around the injection site.  It was reported that the circular pattern around the injection site was at least 6cm.  in diameter.  It was indicated that the dermatologist received this information from the patient's mother.  No other information was available at this time.  unspecified medical attention was sought.  Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA: During post-vaccination observation period, vaccine recipient became dizzy. They were attended to by EMS with no intervention.
Heart racing, clenching heart, random beats, significant vo2max drop on stress test for cycling despite same power output and body weight. Went from elite vo2max to normal.  BOTH SHOTS had heart racing.
fever; chills; headache; tiredness; This case was reported by a consumer and described the occurrence of fever in a 56-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th July 2019, the patient received the 2nd dose of Shingrix. On 17th July 2019, 1 days after receiving Shingrix, the patient experienced fever, chills, headache and tiredness. On an unknown date, the outcome of the fever, chills, headache and tiredness were unknown.   It was unknown if the reporter considered the fever, chills, headache and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced fever, chills, headache and tiredness. The patient inquired, how long do the side effects would last.
SUFFER THE CONSEQUENCES WITH A TERRIBLE PERIOD FOR 15 DAYS; DISCOMFORT; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced suffer the consequences with a terrible period for 15 days, and discomfort. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suffer the consequences with a terrible period, and discomfort. This report was non-serious.
I was administered 1st shot of Pfizer covid vaccine on March  25, 2021, 6:30 PM at Walgreens Pharmacy. However on April 22, April 2021 6:30 PM, I was mistakenly administered the Moderna vaccine as 2nd dose (instead of Pfizer 2nd dose) by Pharmacist at Publix Pharmacy.    Should I go ahead and take 2nd shot of Pfizer manufacturer or Moderna? How can I be assured that I am 100% protected from Covid and have covid anti-bodies generated my body?  Should I worry about contracting Covid in the future because of mismatch and I didn't get vaccinated properly?  What should I do now?  Should I go for a serology report to make sure that I have enough protection in my body to fight against the corona virus?
I was positive for COVID-19 on 10OCT2022, I had vertigo and I was so dizzy, sore throat and headache. I was also having body aches and no fever.  I was fatigued and I was moody and unhappy. I did contact my doctor, but I didn't take any medication. I started feeling better few days later.
Chest pain, elevated heart rate, fatigue, headache. Took Ibuprofen. Symptoms have resolved.
My left hand, the following three fingers: middle finger, ring finger and pinky are completely numb/When I touch them it's a dull pain; My left hand, the following three fingers: middle finger, ring finger and pinky are completely numb/When I touch them it's a dull pain; dose number: 2 vaccine date: 22Mar2021/ Dose number: 1 Administration date: 22Mar2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 (Lot number: EP7534) at the age of 58 years as dose 1, single and administered in arm left, administration date 22Mar2021 (Lot number: EW0170) as dose 2, single for covid-19 immunisation. Relevant medical history included: "seasonal allergies" (unspecified if ongoing); "allergies:animal fur and dust" (unspecified if ongoing); "allergies:animal fur and dust" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS]. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 22Mar2021, outcome "unknown", described as "dose number: 2 vaccine date: 22Mar2021/ Dose number: 1 Administration date: 22Mar2021"; HYPOAESTHESIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 06May2021, outcome "not recovered" and all described as "My left hand, the following three fingers: middle finger, ring finger and pinky are completely numb/When I touch them it's a dull pain". Therapeutic measures were not taken as a result of hypoaesthesia, pain in extremity.  Additional Information: Patient was not tested covid prior and post vaccination. No other vaccines were taken in four weeks. Other medical history: None.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unspecified date in 2007 the patient received the first dose of GARDASIL (Lot #, dose and route not reported). On an unspecified date in 2013, the patient received a second dose of GARDASIL (Lot #, dose and route not reported) and two months later received the third dose of GARDASIL (Lot #, dose and route not reported). Concomitant therapy was not reported. No adverse effect reported. Additional information has been requested.
Shingles diagnosed on April 8, 2021 Valtrex was prescribed and taken for 7 days - resolved.  Currently PVC's, appointment scheduled for May 17, 2021. Not resolved.
Episode of apparent vasovagal syncope a few minutes after receiving the vaccine.  This was witnessed by myself.  She appeared to have loss of consciousness and collapsed onto the pavement striking her posterior head on the pavement (fortunately, she did not strike it with great force).  She regained consciousness within 2-3 seconds.  She had a small "knot" on her posterior scalp, but no break in the skin.  No other apparent injury.  She initially complained of a headache, but this resolved over the course of about 10 minutes.  She initially was mildly diaphoretic and had a rapid pulse and mild hypotension, but these also resolved over the course of several minutes.  A chemical ice pack was applied to the posterior scalp and neck.  She had a completely normal neurologic and musculoskeletal examination.  She was provided oral fluids (water and kool aid) and a snack (chewy granola bar) and kept under close observation by medical personal for about 30 minutes.  Transport to the emergency room via ambulance was offered, but declined. Her boyfriend was called and came to drive her home after she had made an apparent complete recovery.  Both he and she were extensively counseled regarding signs and symptoms to be on the lookout for that would indicate the need for further medical evaluation and they both expressed complete understanding and agreement. Of note, she reported that she has had episodes of syncope in the past when having blood drawn for laboratory tests, but decided not to disclose this to on site personal prior to the vaccination thinking she would probably not have a problem.
Information has been received from a family nurse practitioner concerning a 24 year old female with no drug allergies and a history of BCG vaccination with a PPD skin test positive who on 13-AUG-2002 and 16-SEP-2002 was vaccinated with her first and second dose of MMR II. There was no concomitant medication. ON 31-JUL-2002 and 10-AUG-2007, lab diagnostic studies confirmed that the patient had measles titer drawn which showed negative titers and no immunity to measles. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Experiencing aching pain on injection site side of body( right); tender and moveable lump on collarbone; tender and moveable lump on collarbone; This is a spontaneous report from a contactable consumer, the patient. A 25-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 on 29Apr2021 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to penicillin. The patient did not receive any medication within two weeks of vaccination. 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 29Apr2021, the patient experienced aching pain on injection site side of body (right) and at night after the vaccine, the patient noticed a tender and moveable lump on collarbone. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events aching pain on injection site side of body(right), tender and moveable lump on collarbone were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sat. - site of injection was red and swollen - very light & hot to the touch.  Sun. - redness covered all of upper arm - down to the elbow, pulsating & hot - itching was unbearable.  Mon. & Tues - Continued as on Sunday.  Wed. Swelling lessens, but itching remains. Thurs. still redness at injection site & itching. Fri - better, but still red.
This is a spontaneous report from a contactable pharmacist communicated to a Pfizer sales representative. The pharmacist reported same event for 2 patients. This is the second of two reports. A patient of unspecified age, race and gender received PREVNAR 13, via an unspecified route of administration at 0.5 ml, single on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swollen arm in Jul2016 with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016561730 Same product/event/reporter, different patient.
left arm throbs when weather is going to change,    Arm goes numb from neck to middle two fingers  Can not touch spot of injection , Can no longer get any shots in left arm as it is to painful ,  Right after I got shot I developed a rapid spreading skin cancer at 5 locations on arm onew of which had to be surgically removed four were frozen off ,  It is now almost a year and nothing has changed still have pain and it still throbs                                              NEVER SHOULD HAVE GOTTEN SHOT
6 DAYS POST VACCINATION , PATIENT REPORTED EXPERIENCING 6 HOUR BOUT OF NAUSEA, VOMITING, HEADACHE AND DIZZINESS
Case number PHEH2017US000832, is an initial spontaneous report from a pharmacist received on 04 Jan 2017. This report refers to a 25 years old female patient. Past medical history was not reported. Current condition included as egg allergy. Concomitant medications was not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: 185284 and expiry date: Apr 2017) at a dose of 0.5 ml, intramuscularly on 04 Jan 2017. On the same day after vaccination, the patient experienced rash (unspecified location), arm rash and swollen lips. Pharmacist instructed the patient to take BENADRYL, which the patient said helped ease her symptoms. The outcome of the events was reported as condition improving. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sinus issues, possible infection, sore right eye, possible infection, or stress continues after antibiotic.
Local reaction, left deltoid surrounding area, red, warm, tender, swollen to touch. Cold compress applied. Given appt to see MD for further eval.
Temp of 103oral and 103.5oral. Usually temp is 101 after vaccines.
Patient received Moderna vaccine as second dose in primary series instead of Pfizer Covid Vaccine by error.  Patient received the first dose of Pfizer vaccine on 12/14/2021.
1.RASH AND ITCHING ON UPPER EYELIDS 12:30 PM 2. ONGOING FRONTAL HEADACHE PAIN RADIATES TO BASE OF NECK AND SKULL AT PAIN LEVEL 10+ /GREATER @ 4PM, ONGOING BODY RASH WITH ITCHING, AND REDNESS UPPER EYELIDS,  FACE, CHIN, CHEEKS,  LOWER FOREARM, BACK, AND ENTIRE BODY. 3. THROAT FEELING THICK AND ABNORMAL 4.FACIAL SWELLING NECK AREA UNDER CHIN, BACK OF NECK, UPPER ARMS AND LOWER ARMS, UPPER BACK ACROSS SHOULDERS, AND ENTIRE BODY TENDER TOUCH. 5. BILATERAL SWELLING OF THIGHS AND LOWER LEGS CALF AND ANKLES 6. BREATHING FELT LIKE RECOVERING FROM AN ASTHMA ATTACK 7. BLURRED VISION, VISION FELT WEAK 8. FATIGUE TREATMENT OF CARE:  WENT TO  URGENT CARE FACILITY LOCATED IN  ON  .  RECEIVED IM INJECTIONS OF BENADRYL 50MG IN BUTTOCK AND SOLUMEDROL (STERIOD) INJECTION IN OPPOSITE BUTTOCKS.   ON 08APRIL21: PT RECEIVED ZYRTEC PO, BENADRYL 50MG AT BEDTIME FOR ITCHING AND RASH, PREDNISOID   08APRIL202: PATIENT EXPERIENCED NAUSEA AND VOMITING AT 8PM,    ON 09APRIL2021 PT C/O ZONING OUT MEMORY FOGGY AND FEELS LIKE SHE IS NOT WITH IT. 10APRIL: RASH CONTINUES TO SPREAD ON FACE, CHIN, UNDER CHIN AND NECK.  FRONTAL HEADACHE CONTINUES, NECK SWOLLEN AND SHARP PAIN ON RIGHT SIDE OF NECK AND LOWER JAW.  LYMPH GLAND FEELS SWOLLEN ON RIGHT SIDE OF NE``