chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Customer reported skin reaction including blisters, itching, burning, and some pain mainly around forehead, orbital area, and high cheekbones.    Some symptoms on and around the left elbow and left outer thigh from the knee to hip.    Symptoms around skin folds under both breasts.
Began with reddness, swelling, and pain on the left leg about 18-24hrs after vaccine (IPV and DTaP).
only flu like symptoms right after vaccine.  A year later I have been having veritgo and lightheadness problems. Diagnosis is Meniere's Syndrome.  I also have tingling in both hands.
2-4cm papules in R upper arm. Erythema, possible cellulitis. Prescribed dicloxicillin 250 6hr x 5d.
administered 1st dose on day 0 which is on 20Nov2022 but was not able to administer 2nd dose on day 7 as there is no vaccine available, with no reported adverse event; Initial information received on 28-Nov-2022 regarding an unsolicited valid non-serious case from other health professional.  This case involves an unknown age and unknown gender patient who was administered 1st dose on day 0 which is on 20nov2022 but was not able to administer 2nd dose on day 7 as there is no vaccine available, with no reported adverse event while receiving vaccine rabies (HDC) vaccine [Imovax Rabies].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 20-Nov-2022, the patient received a dose 1 of suspect RABIES (HDC) VACCINE at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for immunisation.  On an unknown date, was administered 1st dose on day 0 which is on 20nov2022 but was not able to administer 2nd dose on day 7 as there is no vaccine available, with no reported adverse event (routine immunisation schedule not administered) (unknown latency) for RABIES (HDC) VACCINE.  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Chills; Headache; Body ache; Dizziness; Nausea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E128734) via an unspecified route of administration in the arm left on 02Apr2021 at 13:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included dizziness which recovered with physical therapy and still patient felt like had a slight relapse in dizziness. Concomitant medications included vitamin B complex (B-complex), cetirizine 10 mg (MANUFACTURER UNKNOWN) and magnesium supplement (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient had no allergies to medications, food, or other products. 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 02Apr2021 the patient experienced chills, headache, body ache, dizziness, nausea and fatigue and reported that all the symptoms lasting 6 days post-vaccine. The patient also reported that she felt better on day 3, then worse on day 4, better on day 5 and worse again on day 6. The patient did not receive any treatment for the reported events. The clinical outcome of the events chills, headache, body ache, dizziness, nausea and fatigue were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
pt recv vax;shoulder discomfort;pain, fever 102;shoulder swelling; ER visit;purulent fluid;tx w/ meds;devel 7-100 chicken pox lesions; dx of septic arthritis;
Pt has burning pain in L LE & varicella rash in dermatome L5.
Starting around lunch time 4/1/2021....headache in the morning  Extreme fatigue , muscle and joint pain, hands hurt, chills, fever 99.1
Swollen Lips at first-then swollen tongue-then swollen jaw + rashes on left thigh and right thigh and on upper right arm.
Patient reported "I felt tingling under her left arm and mild rash on back at first. This progressed to throbbing under both arms (my heartbeat) and my left armpit was hot and swollen. I experienced lower back pain, tightness in my upper chest and waist areas." Day two 2/13/2016 "this developed into extreme itching under my left arm and swelling and it felt like ants were crawling under my left arm; they walked up and down my arm, across to the middle of my chest and back to my shoulder blades. My left rotator cup became inflamed along with my left shoulder blade right up to the back of my head. I had tremendous headache...and stabbing pain that hit on one spot on the right side of my head. The entire shoulder above and under was swollen and hot. I felt like someone knocked the wind out of me, I was exhausted."
Received influenza vaccine in right thigh on 10/25/16, leg became swollen from knee to groin, hard, red and warm to touch.
This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. On an unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (dosing regimen unspecified) (lot # L048237, expiry 08-MAY-2017). Excursion details are as follows: which were exposed to the following conditions, were administered to unspecified patients: temperature 31.55 F, Time frame: 45 seconds, there was no previous temperature excursion. It was a call because of a data logger. No adverse effect reported. No further information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Felt exhausted and tired; Injection site soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 44-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 09Apr2021 at 10:30 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), liothyronine (MANUFACTURER UNKNOWN) and hyoscyamine (MANUFACTURER UNKNOWN); for an unknown indication since an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 10:30, 24 hours after shot, the patient experienced mild injection site soreness. On 10Apr2021 at 22:30, 36 hours after shot, the patient felt exhausted and tired. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site soreness and felt exhausted and tired was recovered on 12Apr2021, 72 hours after shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had her flu shot on 9/21/10 and came back to the pharmacy on 9/30/10.  She showed her arm where she had her vaccination and it was quite bruised or discolored (purple/yellow/blue) around the injection site as well as below the injection site (approximately 2-3 in. long and 1-2 in. wide) She had no other effects besides the bruising.
Wheezing, Coughing, Hacking, Runny Nose, Difficulty Breathing, Sore Throat
uncontrolled shaking of hands and arms; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (uncontrolled shaking of hands and arms) and CHILLS (Chills) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced TREMOR (uncontrolled shaking of hands and arms) and CHILLS (Chills). At the time of the report, TREMOR (uncontrolled shaking of hands and arms) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Information has been received from a physician concerning a 16 year old male who was vaccinated with the 1st and 2nd doses of MMR II on 14-OCT-1994 and 13-JUL-1998, respectively.  On 15-DEC-2009 the patient developed mumps on the left orchitis without fever.  On 18-DEC-2009, lab test revealed mumps immunoglobulin M antibody < 1:10, mumps immunoglobulin G antibody 7.2 and amylase 368.  On the same day, the patient was diagnosed with right parotitis and was afebrile.  At the time of this report, the outcome was unknown.  No further information is available.
Patient reported feeling fine after 15 minute observation post vaccination.  She returned immediately after being cleared stating she felt sweaty, hot, and dizzy.  Was given Gatorade and immediately transferred to health services.  She was released an hour later.
This is a spontaneous report received from a contactable Physician via Pfizer sales representative. This Physician reported for a female patient (Daughter). A female patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain at injection site, fatigue, flu like symptoms for 3 days on an unspecified date. She had to call in sick to work until she felt better. The outcome was unknown.
Numbness on the Left side nose, face and lips; Numbness on the Left side nose, face and lips; Tinkling in right side of lip; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness on the Left side nose, face and lips), HYPOAESTHESIA ORAL (Numbness on the Left side nose, face and lips), PARAESTHESIA ORAL (Tinkling in right side of lip) and CHILLS (Chills) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness on the Left side nose, face and lips), HYPOAESTHESIA ORAL (Numbness on the Left side nose, face and lips), PARAESTHESIA ORAL (Tinkling in right side of lip) and CHILLS (Chills). At the time of the report, HYPOAESTHESIA (Numbness on the Left side nose, face and lips), HYPOAESTHESIA ORAL (Numbness on the Left side nose, face and lips), PARAESTHESIA ORAL (Tinkling in right side of lip) and CHILLS (Chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication list was not provided. Treatment information was not provided.    This case was linked to MOD-2021-066587, MOD-2021-065932 (Patient Link).
Joint Pain/Swelling, Rash still continues despite treatment with 2 dexamethasone dosepaks, 1 prednisone dosepak and continuing daily prednisone dosing at this date. 11/25/20 Dr. performed labs including sed rate, CRP (which was elevated) and other blood work. Rhematoid Factor negative.  Referred to Dermatology. Appointment 1/14/21 where biopsy of rash was performed. Outcome unknown at this time. Also saw PCP for swelling of right supraclavicular and neck lymph nodes in December (29th).  Labs performed included Covid testing, mono, strep, and autoimmune markers. These were normal.
p/vax pt devel an inj site rxn characterized by redness, swelling, warmth & pain;
After my vaccine, I passed out. I went to the hospital for three days and they told me I had an ocular migraine. I also had a post concussion syndrome and was out of work till 04-12-2021 with nausea and severe migraine headaches.   I still have headaches today and I am on migraine medication.
Right shoulder sore, pain, radiated up to neck unable to turn head to do normal activities.
I got the shot, later that evening/night I had a fever (100.4), muscle aches, chills, diarrhea and vomiting. I only took TYLENOL to help with the fever and aches. I didn't go to the doctor until the week after, I didn't have any testing. I had blood drawn for my chronic issues, but I did mention the adverse event to my doctor.
itchy rash; swollen lymph node in the groin; This is a spontaneous report from a contactable nurse.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced itchy rash and swollen lymph node in the groin on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.
Patient presented with their legal guardian requesting booster dose be provided. Primary series completed with Pfizer 6/8/2021. Booster administered prior to identifying patient's age. She was too young for the booster. Patient and parent educated about risks and to notify primary care provider. No adverse event during observation period, patient left without acute distress. Verbalized understanding of education and instructions.
I FELT AN UNUSUAL FEELING IN MY ARM WHEN THE INJECTION OCCURRED AND SAID THAT DID NOT FEEL RIGHT. LATER I FELT KIND OF SICK LIKE AS IF I WAS COMING DOWN WITH SOMETHING. TWO DAYS LATER I VOMITED. I HAD A FEVER AND WAS IN BED FOR 7 DAYS. I AM NOT SURE WHAT DAY THE PAIN IN MY ARM INCREASED BUT IT HAS BEEN HURTING SINCE THEN AT THE SITE OF INJECTION AND WHEN I STRETCH OR RAISE MY ARM. IT TAKES MY BREATH AWAY
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: METFORMIN. Vaccination history included: COVID-19 vaccine (dose 1, single; manufacturer unknown), for COVID-19 immunization; COVID-19 vaccine (dose 2, single; manufacturer unknown), for COVID-19 immunization; COVID-19 vaccine (dose 3 (booster), single; manufacturer unknown), for COVID-19 immunization; COVID-19 vaccine (dose 4 (booster), single; manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, COVID-19 which included Paxlovid (lot number: GK2916) starting on 25Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Seen on 7/29/04: was developing abscess at site of HIB injection given on 7/27/04. Treated with Augmentin. Seen patient again on 8/2/04. Redness subsided, small area of induration still present at site of injection. Advised to complete 10 days of antibiotic.
Information regarding PREVNAR was received from a healthcare professional regarding a 12-month-old male patient who experienced fever of 100.5 degrees F. and hives on trunk and arms. At 12 months of age, the patient received the fourth dose on 02-Mar-2010. Medical history: Patient born at 38 weeks gestation; induced due to low fluid; mother 29 years of age. Product details: Indication for PREVNAR was immunization. Product was administered on 02-Mar-2010. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced fever of 100.5 degrees F. and hives on trunk and arms in Mar-2010. The reporter stated that the lot of PREVNAR administered was recalled. The outcome of the events is resolved. No additional information was available at the time of this report. Physical examination (results: head circumference 47 cm; language/speech within normal range; emotional/social within normal range; fine/gross motor skills within normal range; cognitive thinking within normal range; has not failed to meet developmental milestones since starting medication; physical growth normal but in low percentiles-weight 24%, length 20%) was done in Mar-2010. No additional information was available at the time of this report. Following the integration of the legacy safety adverse event reporting databases, this case has been migrated from the legacy company database into the current safety database for processing follow-up information. As a consequence of the migration, the follow-up CIOMS I, Medwatch or VAERS may indicate in the appropriate field that it is an initial report. Follow-up (08Mar2011): This is a spontaneous report from a contactable physician. The patient recovered from the events, however, the developmental milestones of language/speech is not within normal range; there is an ongoing "expressive speech delay". Emotional/social; fine/gross motor skills; and cognitive thinking were all within normal range. The child's physical growth has been normal.
Information has been received from a physician concerning a 11-year-old male with no medical history, who on 27-JAN-1997 was vaccinated with a first dose of Varivax. There was no concomitant medication. On 14-MAR-2007 the patient experienced a breakthrough case of chickenpox, over 200 lesions. Unspecified medical attention was sought and the patient was placed on acyclovir. It was reported that the patient's mother recently developed shingles and the patient's father developed a case of chickenpox. No outcome was reported. No product quality complaint was involved. Additional information has been requested. 05/16/2008 As of 05-APR-2007 it was reported "the patient cleared up just fine". Additional information has been requested.
Fatigue, headache, followed by chills and fever of 101.4.  Lasting about 24-30 hours.  I recovered quickly, by staying hydrated., although I did not want to eat. Since my fever didn?t reach 102 I avoided taking an medication.  This reaction was to my FIRST shot so I was wondering about my second shot which is scheduled for 2/25/2021... six days from now.
-Minor shingles outbreak -Menstrual change. Bled during ovulation, only second time in my life. First time was after 2nd COVID vaccine dose.
A 12-year-old patient was accidentally given 0.25 ml of the Moderna COVID 19 vaccine, which is not FDA-approved for those under 18 years of age. Follow-up monitoring was completed 24 and 72 hours after injection. The patient experienced fatigue and mild injection site pain. No fever or other adverse effects were reported.
Temp 101.6 4/24/03 14:00. Arthralgia left shoulder; unable to lift arm, decreased range of motion, pain radiates to neck, elbow and wrist 4/24/03 14:00.
Sudden onset fatigue, chills, piloerection approximately 10 hrs post vaccine: temp 100.7 initially 102.9 this AM afebrile; no cough.
pt recvd MR vax on 1OCT91 & 12 days following vax pt devel a maculopapular rash; no further details were provided;
EXCRUCIATING PAIN IN LEFT DELTOID, THREE RAISED PLAQUES ON BICEP, SWELLING AT THE INJECTION SITE WAS APPROX 3" IN DIAMETER AND 1" IN HEIGHT, LOSS OF STRENGTH DUE TO PAIN IN DELTOID, LOSS OF RANGE OF MOTION DUE TO PAIN, AND UNABLE TO SLEEP ON BACK, SIDE, AND STOMACH DUE TO PAIN IN SHOULDER.  SYMPTOMS LASTED THREE DAYS.  TREATMENT WAS INTENSELY PAINFUL STRETCHING, HEAT THERAPY, AND NSAIDS.
She got the vaccine, and then had headache, fever and slight fatigue.  No she has welts all over her body, very itchy, they get warm to the touch and it started in a couple of spots and now are everywhere.  When she wakes up she gets more, and feels like she's in a horror movie.  Notified her doctor and he wants her to take Benadryl at night and using Benadryl cream, but it's not completely alleviating the symptoms.   The patient states that she is miserable.
HPI: The patient is a 37year old right handed woman referred for evaluation of Left hand numbness. Symptoms first occurred four months ago. Symptom frequency is usually constant. On March 2, 2021 she received the first Pfizer COVID vaccine in the left arm. She had some soreness around the left shoulder associated with left neck and shoulder pain, stiffness. She was treated with myofascial release and her symptoms improved. She received a second Pfizer COVID vaccine in the left arm March 26. The following day her entire left arm felt numb associated with tingling sensation. Over the next few weeks the numbness would improve but she was left with residual numbness affecting the first through fourth digits of the left hand. The symptoms have been constant. Numbness in the left hand is worse at night, when gripping or using her hand. No loss of strength. She tried wrist splinting but this did not help her symptoms. She denies Lhermitte symptoms. No right upper extremity numbness. Past medical history includes VACTERL association for which she had right thumb surgery for duplicate thumb 1984. She has had multiple surgeries associated with that hand. She also has renal malformations, T-E fistula treated at birth, heart murmur at birth which resolved with time. She has mild scoliosis and had surgery to the left hip in 2012. She has a malrotation of the small bowel currently being followed. She remains quite active working in insurance for a bank. Recent labs were normal.  PROBLEM LIST: ? Brachial plexus disorders : Type: Condition. Recorded on 07/29/2021. Diagnosed on 07/29/2021. Updated on 07/29/2021. ? Carpal tunnel syndrome, left upper limb  Type: Condition. Recorded on 07/29/2021. Diagnosed on 07/29/2021. Updated on 07/29/2021.  Impression: 37-year-old woman with history of left upper extremity numbness following second Pfizer COVID vaccine in the left arm March 26 now with residual numbness secondary to carpal tunnel syndrome. Neurological examination demonstrates normal strength, normal reflexes and reduced sensation to light touch along the median nerve distribution of the left hand. Electrodiagnostic testing reveals findings compatible with moderately severe carpal tunnel syndrome. She had numbness of the entire arm after the second vaccine the following day. I suspect she had mild brachial plexus inflammation that would subsequently resolved. She now has residual carpal tunnel syndrome which is not improving with conservative measures. Plan: We reviewed the results of this evaluation. Given the severity of her symptoms and nerve conduction abnormalities, I recommended she proceed with carpal tunnel surgery consultation.