chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. experienced sensations of elevated temperature, "shaky vision", dizziness and "fullness" in her throat. Her pulse elevated moderately from 80 at resting to 100 during the event. She felt very anxious. She had no visible mouth or throat swelling and no difficulty breathing. All symptoms resolved except the throat "fullness" within 15-20 minutes. Continued to follow up with her intermittently for the next 6 hours and she reported all symptoms resolved except 10% of her throat sx remaining at 6 hours post vaccinations after 50mg diphenhydramine.
Symptoms started with low energy, loss of appetite, fever, tachycardia, and night sweats.  Went to the hospital, was admitted and diagnosed with viral cardiomyopathy (heart failure) and pulmonary edema.  Time course was 2/10/2022 - 2/15/2022. After spending 5 days in the ICU, was discharged and required to follow up with cardiologist and primary care physician.
Right facial numbness from cheek to jaw line.  Weakness to jaw.  Symptoms lasted 9 hrs and then reoccurred 9 days later.
pt recvd vax; rxn 5 days p/ immun, lasting 3 wks;
Within 24 hours post vaccination developed expected immune response - low grade fever, fatigue, myalgia, arthralgia - resolved within 48 hours.   On day 3, woke up with mild butterfly (malar) rash. Textbook in presentation - erythema to cheeks, bridge of nose up to forehead. Mildly raised and rough in texture. Day 4, facial erythema has improved with textural changes still present. No history of Lupus or other autoimmune conditions. No history of previous malar rash. Had sun exposure the evening before malar rash presented.
COVID-19 - Janssen ADR Come to ER on 4/8/2021 with chills, fever, weakness and dx with pneumonia after receiving COVID-19 vaccine 1 week ago and discharged on azithromycin.  On 4/13/2021, came back to ED with worsening SOB, weakness, nausea and now with right thigh and leg pain, ground glass findings on CT thorax, positive for acute DVT on right leg and negative COVID testing. 4/14/2021 - right femoral vein thrombectomy and right external iliac vein angioplasty
Lower limb edema; Ankles and toes inflammation; Ankles and toes inflammation; This is a spontaneous report from a contactable consumer (patient).  A 72-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration, in left arm on 26Apr2021 10:00 AM as dose 2, single for COVID-19 immunization. Medical history included hypertension and allergic asthma. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6206) via an unspecified route of administration, in left arm, on 04Apr2021 10:00 AM as dose 1, single for COVID-19 immunization. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Patient had no known allergies. Patient did not receive any other vaccines in 4 weeks. patient had not received any other medications in 2 weeks of vaccination. Prior to vaccination, the patient not had COVID-19 and was not tested for COVID-19 post vaccination. The patient experienced lower limb edema and ankles and toes inflammation on 27Apr2021 12:00 PM. Outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
At a bought 10:30 AM I felt the usual symptom shoulder aches. At around 12:30 PM my shoulder and scapula became sore then it quicly progressed to my left back thoracic side. It was painful to move my left side and it also hurt to inhale. I was scrubbed in surgery and 2 doctors noticed that there was something wrong. The surgeon asked me a couple of questions and stated that my words were slurring and that I needed to excused from my duties. The injection site was on my left upper arm. My right side was not affected at anytime.
I had a slight fever, fatigue and aches the following morning that lasted for the majority of the day of May 7th. The rest of the symptoms faded within a day or 2, but fairly severe fatigue with brain fog set in and has persisted ever since. This has caused great strain to my professional and personal life. Before the 2nd vaccine I was a more or less a type-a personality. Present day, I am struggling to get myself out of bed despite sleeping 10-12 hours. While awake , I constantly feel like I could fall asleep if I closed my eyes for a brief time. I have consulted a physician about the condition roughly a year ago and was met with skepticism and told to increase my vitamin B and D intake. No tests were performed, nothing further was offered, but the condition persists.
patient received the second dose of the Pfizer vaccine at 1618, ten minutes post administration, patient started to feel weakness, dizziness, chest pain
9 days after varicella developed 3 x 3.5cm indurated erythematous skin reaction at site of immunization.
This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 30Apr2021 (at the age of 41-years-old) as a 0.3 mL single dose for COVID-19 immunisation. Medical history was not reported. On 15Jan2021, the patient underwent nasal swab test and the result was negative. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), escitalopram oxalate (LEXAPRO) and levothyroxine (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the arm left on an unknown date at 17:00, as a 0.3 mL single dose for COVID-19 immunisation. The patient previously received morphine (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Apr2021 at 22:00, after second dose, the patient experienced tinnitus in both ears- constant and increasing. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event after second dose began getting tinnitus in both ears - constant and increasing was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
LEFT ARM BECAME PAINFUL, INFLAMMED, RED, WARM TO TOUCH WITHIN 12 HOURS AFTER VACCINATION. MUSCLE PAIN TRAVELED DOWN CHEST WALL AND THRU SHOULDER BLADE BY DAY 2 FOLLOWING VACCINATION. PT WENT TO PHYSICIAN 24 HOURS AFTER VACCINATION AND WAS PUT ON NUPIRIN FOR INFLAMMATION. TWO DAYS LATER SYMPTOMS ARE RESOLVING.
Severe migraine, sinus migraine, all over head migraine. Slight nausea overall feeling of not well.
Numbness / tingling of right leg. Inside of leg from hip to ankle. Started within minutes of shot. Has not gotten better as of 8/24/2021
had a high fever for 4 days w/no appetite; was not seen by a MD & the temp was not recorded; recommended to parents to consult MD prior to future immun;
PATIENT REPORTED SWELLING AND REDNESS AT BOTH SITES, HOWEVER, TDAP SITE LOOKED OK UPON EXAM TODAY. PCV13 SITE TO RIGHT ARM WAS SWOLLEN WITH ERYTHEMA APPROXIMATELY 10CMX10CM AND WARM TO TOUCH. PATIENT HAS KEPT A HEADACHE INTERMITTENTLY WITH BODY ACHES AND LOW GRADE FEVER OF 100 INTERMITTENTLY AS WELL.
congestive heart failure; Stroke; Herpes zoster ophthalmicus; Other serious neurological problems; Cardiovascular event; Anxiety; Balance issues; Depression; Postherpetic neuralgia; Vision problems; herpes zoster; Death; Information has been received from a lawyer regarding a case in litigation and concerning to a patient (pt.) of unknown gender, who would be approximately 80 years old. On 03-DEC-2008, the patient was vaccinated at a pharmacy with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, lot number, and expiration date were not reported). On an unknown date, reported as subsequent to the vaccination, the patient was treated for herpes zoster, post herpetic neuralgia, herpes zoster ophthalmicus (ophthalmic herpes zoster), stroke (cerebrovascular accident), cardiovascular event (cardiovascular disorder), congestive heart failure (cardiac failure congestive), vision problems (visual impairment), balance issues (balance disorder), anxiety, depression and other serious neurological problems (nervous system disorder). On 07-MAR-2018, the pt. died. It was not reported the cause of death and it was unknown if an autopsy was performed. Damages were claimed as a result of injury to the pt., wrongful death, loss of consortium, loss of services, and economic losses. The outcome of herpes zoster, postherpetic neuralgia, herpes zoster ophthalmicus, stroke, cardiovascular event, congestive heart failure, vision problems, balance issues, anxiety, depression and other serious neurological problems were not reported. The reporter considered the aforementioned events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, ophthalmic herpes zoster, cerebrovascular accident, cardiac failure congestive and nervous system disorder were determined to be medically significant events.  Information regarding the events herpes zoster, post herpetic neuralgia, ophthalmic herpes zoster, cerebrovascular accident, cardiovascular disorder, cardiac failure congestive, visual impairment, balance disorder, anxiety, depression and nervous system disorder was already reported in MARRS#1812USA001687. But upon internal review it was determined that the information should be captured in MARRS#2107USA008942.
57 y.o. received MMRV - not recommended to patients 13 years and older.  Pt was also given VARIVAX.
This case was considered medically important (OMIC). Information regarding FluMist nasal solution was received from a pediatrician regarding a 13 year old male who developed pneumonia. Relevant medical history was not provided. Indication for FluMist was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. The pediatrician reported that the child had a fever on the same day as the FluMist administration. One hour post-immunization, his fever was 104 degrees F. Two days post-immunization, he was diagnosed with pneumonia. No additional information was available at the time of this report. Follow UP: The reporter considered this event medically important. Follow-up information received from the physician on 16-Dec-2003 provided patient identifiers, immunization date, onset date, test results and outcome. Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a pediatrician regarding a 13 year old male who develooped penumonia. At 13 years of age, the child received the first dose on 11-Nov-20003. The pediatrician reported that the child developed a fever 4 hours post -immunization. The fever ranged from 102 deg. F. to 104 deg F and persisted for 2 days. On 13-Nov-2003, the child was seen by the pediatrician and diagnosed with pneumonia. The child recovered. The pediatrician noted that she did not consider this event related to vaccine administratiion.
Felt fine for the first 18 hours post-dose then woke up at 3am and had a violent episode of vomiting
Bell's Palsy; administered in the left leg; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727, expiry date: unknown), via an unspecified route of administration, administered in the left leg, on 21Mar2021 09:45, as single dose, for COVID-19 immunization. The patient medical history was not reported. The patient did not have COVID-19 prior to vaccination. There were no concomitant medications (no other medications in two weeks). The patient did not receive other vaccines in four weeks. On 22Mar2021, the patient experienced Bell's palsy. This event required hospitalization for 2 days (unspecified dates). Treatment included steroids. The patient underwent COVID Nasal Swab and tested negative on 22Mar2021. The outcome of the event Bell's palsy was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
shingles post vaccination series/ Suspected vaccination failure; 3-4 Breakthrough shingles/  7 breakthrough Shingles; uncomfortable with PHN; This case was reported by a pharmacist via sales rep and described the occurrence of suspected vaccination failure in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included pneumonia bacterial. Previously administered products included Hizentra with an associated reaction of immunoglobulin therapy (received Hizentra on an unknown date), IVIG (received IVIG on an unknown date) and pneumovax with an associated reaction of pneumonia viral (received Pneumovax as late as July 2015 and experienced viral pneumonia twice.). Concurrent medical conditions included immunodeficiency.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix and an unknown time after starting Valacyclovir, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the vaccination failure, shingles and post herpetic neuralgia were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix  Additional details were provided are as follows: The age at vaccination was not reported. The patient was having immunodeficiency. The patient received 2 doses of Shingrix in the fall of 2018. Since the vaccination, she had 7 breakthrough Shingles infections.  The patient's physician had her on a maintenance dose of 500mg Valacyclovir QD, increasing to BID and TID if improvement not seen. Last episode, about two weeks ago, she had to use valacyclovir 1g TID x1 week, then 500mg TID along with Prednisone, refer case US2021AMR217819. Given that these were happening so often, she wondered if a third dose of Shingrix would be advisable. She was quite uncomfortable with post-herpetic neuralgia. Her physician said the usual 2 shots was the maximum. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR217819:same reporter
Heat appearing rash on stomach & back; Inc to cover entire body, face, & extremities by following day; Afeb; Seen by family MD 28MAY91;
1st shot:  3/31/2021- within 5 minutes drenching sweat, rapid heartbeat, dizziness; in the evening body aches 2nd shot:  4/22/2021:  fatigue, body aches, chills, fever, headache, loss of taste and smell, weakness
Reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction). At the time of the report, VACCINATION COMPLICATION (Reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Hair loss. Started noticing hair strands on pillow. Then when running hands thru hair and brushing. Noticeable hair loss when in shower.
immediate shoulder pain; mild inflammation and soreness; approximately day 7 and persistent to date is a dry, nontender, pruritic, raised patch at the site of the injection, 3-4in square, scattered follicular lesions--raised, pink--on left forearm > right arm
big knot under arm, it hurt; shot spot has a scab on it, is still red around it, about the size of a dime. Right below the shot site, pain starts about the size of a soft ball; itchy spot, hives on arm around injection site; itchy spot around injection site; shot spot has a scab on it; shot spot has a scab on it, is still red around it, about the size of a dime. Right below the shot site, pain starts about the size of a soft ball; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 68 old female patient who experienced big knot under arm, it hurt (nodule), shot spot has a scab on it, is still red around it, about the size of a dime, right below the shot site, pain starts about the size of a soft ball (inflammation), (vaccination site reaction), hives on arm around injection site (vaccination site urticaria), itchy spot around injection site (vaccination site pruritus) and shot spot has a scab on it (vaccination site scab), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Oct-2019 (or as reported 27-Oct-2019), the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the left arm.  On an unknown date, the patient developed a non-serious hives on arm around injection site (vaccination site urticaria), itchy spot around injection site (vaccination site pruritus) after about a week or more following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date, the patient developed a non-serious big knot under arm, it hurt (nodule), shot spot has a scab on it, is still red around it, about the size of a dime. right below the shot site, pain starts about the size of a soft ball (inflammation), (vaccination site reaction) and shot spot has a scab on it (vaccination site scab) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was shot spot has a scab on it, is still red around it, about the size of a dime, right below the shot site, pain starts about the size of a soft ball, shot spot has a scab on it, itchy spot, hives on arm around injection site and big knot under arm, it hurt.  The patient was treated with (Benadryl [Diphenhydramine Hydrochloride]) and Ibuprofen for Product used for unknown indication.  The outcome of the event was Unknown for all the events.
4/5/2021 patient received 1st shot on 4/10/2021 noticed that she was lethargic, we thought that is might be her blood sugar but it was in normal range.  we continued to check blood sugar daily thinking that was causing her to be lethargic and voice to be slow.  4/23/2021 my son and I spent the day with her noticing and she was getting worse but had also noticed that she was getting winded easily and would need to sit down.  4/26/2021 canceled 2nd covid shot.  4/30/2021 at about 1:30 pm she called me and said something was wrong something just happened she was scared!  She called her Dr. and spoke to the the nurse PA.  My sister was with her at the time so they checked for stoke signs none were found.  Spoke to my mom through out  the day on 5/1 & 5/2/2021 and she sounded out of breath and very lethargic.  5/3/2021 the Nurse PA called mom and said that she needed to go to the hospital where she stayed until she passed away on 5/15/2021.  She had passed blood clots to her lungs then kidney and liver failure.
THE INJECTION SITE ARM WAS TENDER FOR 11 DAYS ,  ON THE 12TH DAY, THE SITE SWELLED  TOT HE SIZE OF A HALF DOLLAR. I WENT TO MY PRIMARY CARE AND HE SAID THAT IS WAS A HEMOTOMA AT THE INJECTION SITE I  WAS TOLD TO TAKE BABY ASPRIN TO HELP DISSOLVE IT. I AM ON DAY 27 AND THERE IS STILL A MSALL KNOT AT THE INJECTION SITE.
Itchy rash on inner aspect left ankle. Erythema and erythematous papules at injection site (SQ tissue of right arm)
Received Td 9/29 c/o red swollen arm 10/2, Unable to make office apt to ER.
Mid back numbness.  Like my back fell asleep.  Happens 5 times per day
1/28 c/o hot flushes, sweating, neck pain, tiredness, chills, inability to focus.   Narrative:
Shortly after administration of Tdap, pt experienced disorientation/dizziness/SOB with crying for no reason. Went to ED. No treatment given, bloodwork drawn.
Formication of right shoulder, neck, face, and ear all on the right side. Happens about 30 times a day, no pain, just the feeling of ants crawling in the area. MRI done at this time they have not found anything out of the ordinary but have scheduled me for a Clavicle MRI and a brain CTI and a revisit to the Doctor on Nov 11 2021.
Chills, shaking, coughing when inhaling Used rescue inhaler Took tylenol
Received flu shot on 11/10/06 in the morning, was fine all day, at approximately 345pm developed bad headache, sweating, vomiting and chills. no neck pain or stiffness. took tylenol. did not go to the emergency room.
shingles; This spontaneous report has been received on 03-APR-2020 from a lawyer, regarding a case in litigation and refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for the long-term prevention of shingles and/or zoster-related conditions as prescribed and/or administered by a healthcare provider. Subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, on an unknown date, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, 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 shingles was not reported. The reporter considered the shingles to be related to zoster vaccine live (ZOSTAVAX).