chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1/17/14 at 13:28 PM received varicella vaccination in right ventral gluteal area subcutaneously per request - refused arm injection. 1/18/14 about 18:00 noted soreness/pain at injection site and then later in evening redness/swelling extending into groin area which then caused pain with hip movement. 1/20/14 at 6:55 AM contacted Employee Health sent to office (Worker's Comp provider) for further evaluation and treatment. Placed on Medical activity for 24 hours and requested to take TYLENOL every 6 hours for 24 hours. Requested to follow-up on 1/27/14. Employee did not make appointment, however on 1/24/2014 stated area was less sore and healing.
Mother noticed on approximately 01/19/04 that child was switching left arm, no increased temperature, on approximately 01/24/04 reddened, raised area with small whelps appeared.  Mother gave Benadryl x1 and rubbed area with alcohol.  A few days later, mother noticed a fine rash across chest and back of neck (no itching).  Pt's mother in clinic today 02/04/04, left deltoid continues with dark skin color, raised 5.5cm area with small whelped spots inside dark circle  Dark sports present on upper chest/past neck where rash occurred.
Tues 4/13/21- Headache and dizziness started about 4p. Wed 4/14/21- Could not go to work because of headache and dizziness.  Made appt for 4/15 at 6:45a with Dr  Thur 4.15/21- Awoke with intense headache and dizziness. Ready to go to appt but emergency room called at 6:37 to switch to a Virtual appt.  I never received a call so I walked to the office.  They told me they would not see me as I had Covid 19 symptoms. Went to airport and received a Negative Covid test.  Went o Clinic and was diagnosed with fluid in the ears and a sinus infection.  Went to work and only stayed 2 hours.  Drove myself to the emergency room with weakness, shortness of breath and intense pain under the sternum.   Diagnosed with a blood clot in the right ventricle.  The cardiac cath lab removed it.  Was in intensive care Thur-Sat.
Patient reports no signs/symptoms or issues after receiving inactive influenza vaccine on 11/13/13 until 2 weeks later on 11/27/13 client complained of "raised, swollen, tender bump around area of injection site". Patient saw MD on 12/3/13 and given treatment of Advil and hot compresses. Patient reports the symptoms are getting better and will follow up with MD in one week if symptoms persist.
This spontaneous report as received from a registered nurse refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 07-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Swollen red and became tender the next day. Talked to patient and she said the area is about 4" by 5" and says it is getting better.
Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     Concomitant products included METFORMIN and SPIRONOLACTONE for an unknown indication.    On 01-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient experienced sore throat on 02-JUN-2021 and patient never had a sore throat in over 27 years prior to this incident. patient has not taken any medicine for treatment
Fever; Chills; Muscle aches; Injection site warmth; Injection site firmness; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no allergies to medications, food, or other products. Concomitant medication was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6203), via an unspecified route of administration in the left arm on 02Mar2021 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 24Mar2021, the patient experienced fever, chills, muscle aches, injection site firmness and warmth. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events.  The clinical outcome of the events fever, chills, muscle aches, injection site firmness and warmth were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Fever, lethargy, crying, refusing to walk, no eating or nursing, swollen at injection site on day 1 and 2, rash all over body started on day 4
This is a spontaneous report from a contactable physician reported via Pfizer employee. The physician reported that an 11 year old, female patient who started to receive PREVNAR since an unknown date at unknown dose and frequency. Relevant medical history and concomitant medications were unknown. It was reported that the patient experienced pneumococcal meningitis on an unknown date while being on PREVNAR therapy due to which she was hospitalized on an unknown date for an unspecified duration of time. Relevant laboratory data was unknown. Last action taken with PREVNAR was unknown. Therapeutic measures taken in response to the reported event were unknown. Clinical outcome of the reported event was unknown at the time of report. Follow-up (14JUN2013): Follow-up attempts completed. No further information expected.
3 inch red rash around injection site. Slightly raised, warm to the touch, and somewhat painful. No treatment.  Reaction went away on its own after 4 days.
Daptacel was inadvertently administered to a 10 year patient instead of Adacel/no AE; Daptacel was inadvertently administered to a 10 year patient instead of Adacel/no AE; Initial information received on 21-Aug-2019 regarding an unsolicited non-valid non-serious case received from a Physician.  This case concerns a 10-year-old male patient who received a single 0.5 ml booster dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) (lot: C5207AA/C5307AA) via intramuscular route in left deltoid instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) on 21-Aug-2019.  Patient's medical history and concomitant therapy were not reported.   It was of actual medication error case due to wrong vaccine administered and Inappropriate age at vaccine administration.  It was reported that no adverse event was experienced by the patient.  Information on the batch number was requested (for ADACEL).  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 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.
I had chills and High fever. When I tried to get out of bed I fainted and was completely pale and weak for an hour.
shingles; Information has been received regarding a case in litigation from a lawyer and consumers, referring to a patient of unknown age and gender. Information about concurrent condition, historical condition and concomitant medication was unknown.   In 2018, the patient was prescribed and administered with zoster vaccine live (ZOSTAVAX) (dose, frequency and route unknown) for the long-term prevention of shingles and zoster-related conditions, by the pharmacist at a pharmacy.   On an unknown date, subsequently, the patient was treated by a health care provider in the medical office for shingles.   As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of event was considered as not recovered/not resolved. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Swelling lower left arm and hand. Intensified to include entire left arm. Deep bruised ache feeling. Heaviness. Could not fit arm through sleeve. Became difficult to use hand due to swelling. Due to swelling now have carpal tunnel in left hand with numbness & painful tingling.
Fever, rigors, fatigue, injection site pain following morning after vaccine administration.   2 days after administration injection site pain, redness, pruritis, and angioedema, headache, and fatigue.
Child cried for 4 solid hours after vaccination. Could not bear weight on left leg for 4 days.
just sore left arm i was numb head to toe only on my right side. it's been 9 days i am not bck to 1005, my right side of my face doesn't feel rigth and still has numbness feeling.
Broken blood vessel and large painful swelling at base of right hand ring finger.  It resolved over a week into blue discoloration.  Applied ice to it. Did not contactdictor.  But same thing happened 3 days after the second shot but larger swelling and broken vessel at base of left wrist.  Also used ice.  Resolved over a week.  Have photo.
Vaccine(Dtap) was given to child @1430. Foster caregiver called @1843 stated that child had hives to extremities and vomited four times since immunization given.  Caregiver asked to return to clinic for evaluation Per Md. @1904 Caregiver called and stated she had given Benadryl and was going to hospital ER due to traffic congestion enroute to clinic.
Large knot at injection site; pain at injection site; skin redness the size of a half dollar along with itching; headache; nausea; malaise; skin redness the size of a half dollar along with itching; This is a spontaneous report from a contactable Nurse (patient). A 57-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6206; Expiration Date: Jun2021), via an unspecified route of administration in right arm on 07Mar2021 10:45 (at the age of 57-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included diabetes, sjogrens syndrome, HTN, mixed connective tissue and hyperlipidaemia. The patient was allergic to Amoxicillin. Other medications was received in two weeks. The patient previously received first dose of BNT162B2 (solution for injection, Batch/Lot number: EM9809; Expiration Date: Jun2021), via unspecified route of administration in right arm on 12Feb2021 at 11:00 as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 07Mar2021 at 12:00, the patient experienced large knot at injection site with pain at injection site, skin redness the size of a half dollar along with itching. That was still present 3 days post injection. A few hours post injection had headache nausea and malaise which resolved after a 3hour nap. Therapeutic measures were not taken. The outcome of all the events was reported as not resolved.  No follow-up attempts are possible information about lot/batch number cannot be obtained.
Pain, headache, tiredness, loss of appetite for the  2 days after the injection (February 20th and 21st.   ON THE 22nd I WOKE UP TO A SEVERE NOSE BLEED THAT I COULD NOT STOP!  I NEVER RECALL HAVING A NOSE BLEED IN MY LIFE! I HAD MY SECOND SHOT ON FRIDAY, MARCH 12, AND WHILE SITTING WATCHING TV MY NOSE STARTED BLEEDING AGAIN EXCEPT, NOT SO PROFUSELY!   It seem very strange to me that this would happen days after having the Covid vaccine
See attached. Dr asked me to send my reaction to the pneumonia vaccine. As I didn't see an e-mail address for dr on the website. I knew you'd see that he received this. Friday, 11/30, 9:50 received inoculation and immediately felt more soreness than had ever experienced before with inoculations. Friday, 11/30, around 2:00 - upper arm lost range of motion, chills, aches throughout body. Friday, 11/30-evening-slept 14 hours. Saturday, 11/31 afternoon-upper arm from elbow to shoulder, inflamed and swollen, full range of motion compromised more than the day previous. Sunday, 12/1-aches remain, able to move arm a bit more. Monday, 12/2-AM, arm looked less swollen, and the color was not as vividly red. Monday, 12/2 PM-bright color and swollenness returned.
This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (she had the norms: fatique and vomiting) and VOMITING (she had the norms: fatique and vomiting) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (she had the norms: fatique and vomiting) and VOMITING (she had the norms: fatique and vomiting). At the time of the report, FATIGUE (she had the norms: fatique and vomiting) and VOMITING (she had the norms: fatique and vomiting) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported No Treatment medications reported   This case was linked to MOD-2021-404356, MOD-2021-406255 (Patient Link).
It was reported in a published article, title as stated above that an otherwise healthy, 8 year old male, who was active with no history, signs, or symptoms of any immunological problems that would place him at risk for development of herpes zoster opthalmicus at a young age, who, at 1 year of age, was vaccinated with a dose of varicella virus vaccine live. It was reported that the patient was seen by an optometrist for pain and subconjunctival hemorrhage in the right eye. The reporter speculated that the subconjunctival hemorrhage may have been caused by increased vascular fragility in the boys disease state. He was referred to a general ophthalmologist and diagnosed with allergic conjunctivitis and staphylococcal marginal keratitis in his right eye. He was given neomycin polymyxin dexamethasone eye drops, 4 times daily, and referred to a pediatric opthalomologist. On examination, the visual acuity was 20/20 in each eye. His pupils were equal and motility was normal. There was a diffuse subconjunctival hemorrhage and inferior punctate corneal staining in the right eye. The child and his mother were asked if there had been any recent peri ocular trauma that might explain the subconjunctival hemorrhage, but none was reported. The next day he was lethargic and nauseous. A characteristic vesicular rash erupted on the forehead above his right eye and on the tip of his nose, which lead to the diagnosis of herpes zoster opthalmicus. The patient was hospitalized for intravenous acyclovir. His ophthalmic regimen included ciprofloxacin ointment, 4 times daily, and cyclopentolate, 1%, three times a day. After 4 days, he was discharged home with instruction to take oral acyclovir, 400 mg, 3 times daily, for 1 week. The day after discharge he noted diminished vision in the right eye. Visual acuity was 20/80 and there were 3+ cells in the anterior chamber. The right optic disk showed modest edema. Hourly prednisolone acetate 1% and atropine, twice daily, were administered topically. It was noted that cultures taken during hospitalization were negative. Over the subsequent 2 months, the corticosteroid was tapered. Visual acuity in the right eye returned to 20/20, and both iritis and optic disk swelling resolved. Three months after the initial presentation of herpes zoster opthalmicus, the child experienced pain and photophobia in the right eye. He was found to have keratitis, which consisted of several discrete mid stromal opacities that rapidly resolved with topical corticosteroids. The boy remained asymptomatic at 7 months after initial presentation. It was reported that the only lingering effect was a slight mydriasis of the right pupil which was improving. It was reported that incidences of both wild type varicella and vaccine associated varicella, leading to herpes zoster outbreaks after vaccination, had been reported, which made either source a possible origin of herpes zoster opthalmicus in this case. Additional information has been requested. A copy of the published article is attached as further documentation of the patients experience.
The MA did not mix both required components and vaccinated patient with only the AS01B Adjuvant Component of Shingrix (Without the Lyophilized Antigen Component)
First shot (6/09)- no reaction Morning after 2nd shot (Saturday7/10) - woke up with pain down left leg from hip to toe - relieved with 1 Advil. That same evening into night 102 fever/wheezing /heart pounding - Did not take any further Advil. Next day (Sunday 7/11) continued fever/mild sore throat - by late afternoon (5:00 pm) noticed a very hot and hard arm with welts around shoulder area and swollen nodes near ear and throat. Took it easy for around 7 days as I felt tired and arm discomfort. Improvement shown by 7 days but arm continued to itch for around 10 days. All is good now.
Left side of face below the eyes and on top of eye lid is heavily swollen, resolved spontaneously after few days
Client experienced itching at site of injection, tightness and swelling of throat 30 mins after 2nd injection of Japanese encephalitis client declined to stay in clinic. 30 min post injection. Had to call for  help in freeway. Was sent to clinic was tx with ephinphine and prednisone then sent home.
Improper holding and equipment malfunction.  Dr and parent talked and parent advised to come back for another dose in 30 days.
Developed tinnitus shortly after second dose/tinnitus came on gradually/tinnitus intense at first, then backed off/tinnitus comes and goes, it flares back up sometimes; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Developed tinnitus shortly after second dose/tinnitus came on gradually/tinnitus intense at first, then backed off/tinnitus comes and goes, it flares back up sometimes) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 008B21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced TINNITUS (Developed tinnitus shortly after second dose/tinnitus came on gradually/tinnitus intense at first, then backed off/tinnitus comes and goes, it flares back up sometimes). The patient was treated with GINKGO BILOBA (GINGKO BILOBA) for Adverse event, at an unspecified dose and frequency. At the time of the report, TINNITUS (Developed tinnitus shortly after second dose/tinnitus came on gradually/tinnitus intense at first, then backed off/tinnitus comes and goes, it flares back up sometimes) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: result not reported Result not reported.         Patient went to an ENT physician and had undergone MRI (Magnetic resonance imaging) scan, went through bunch of testing and the physician thought the adverse event was vaccine related.  Treatment medications included steroids and Gingko.
had fine hives on my forehead and also under neath my right eye and cheeks; Initially, while waiting posterior neck muscle soreness/ache from of ears downward to top of shoulder, but not affecting shoulder. only neck.; My BP 160s; repeat 1288/60; rash on my forehead; This is a spontaneous report from a contactable Nurse. A 54-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW5318), via intramuscular route, administered in Arm Left on 26Jan2021 at 16:15 as single dose for COVID-19 immunization. Medical history included seasonal allergy, eczema, sinus disorder. Known allergies: PCN, Biaxin, Avelox, shellfish, salmon, latex. Concomitant medications included Gabapentin, levocetirizine, Multi-betic, Zetia, Crestor, Zinc, Super B complex, Biotin, D3. On 26Jan2021 at 16:30 patient experienced Initially, while waiting posterior neck muscle soreness/ ache from of ears downward to top of shoulder, but not affecting shoulder only neck. We waited over 30min. BP is 160s and repeat 1288/60, HR-66, and Sat100% per EMT. Left after over 30min being watched. Upon returning home, Dad noted that I had a rash on forehead. I removed my face mask noted in the mirror that I had fine hives on my forehead and also under neath my right eye and cheeks. On 26Jan2021 Lab data was noted as BP with 1288/60, Heart rate as 66 and oxygen saturation as 100. Treatment have been taken with Benadryl and applied cortisone to face and neck rash that developed. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. The outcome of the events was recovering.
RINGING IN MY EARS BEGAN THE  NIGHT FOLLOWING  THE INJECTION.  STILL PERSISTS
Client was given MMR Varicella 10-12-2007 & given again 12-19-2007 due to vaccine was not put on hard copy immunization record-only computer record.
Patient reported fever, chills, pain in fingers and toes. Arm extremely sore. Body feels extremely weak.
Ear Ringing daily since vaccine Called facility that administrated twice and no one has called me back.
Complete Placenta Previa diagnosed at 20 weeks, cleared at 28 weeks, otherwise normal and healthy pregnancy. Delivered 1 week early with a postpartum hemorrhage. Birth weight was 8 lbs 5 oz. Adverse event: Frozen shoulder/Severe pain for 2 months after the injection. Could not lift arm above hips. Pain with active and passive range of motion with severe limitations. AC glide test was negative.