chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness which started on 04/05/2021 over a week after the 2nd dose and still happening on 04/11/2021. Could be positional vertigo which I had once before about 8 year ago. But as dizziness is being reported as a COVID vaccine side effect .; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GP7533) via an unspecified route of administration in the right arm on 25Mar2021 at 18:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included positional vertigo which the patient had once before about 8 years ago. The patient had no known allergies to medications, food or other products. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 04Mar2021 at 18:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 05Apr2021, the patient experienced dizziness which started over a week after the 2nd dose and still happening on 11Apr2021. It was also reported that it could be positional vertigo which the patient had once before about 8 years ago but as dizziness was being reported as a COVID vaccine side effect, the patient thought to report this. On 27Mar2021, the patient underwent lab test and investigation which included PCR Oral Swab (Other) test and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of dizziness was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse refers to a 4 year old patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 09-SEP-2016, the patient was vaccinated with M-M-R II lot # L036851 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with public funds. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1609USA014830: US-009507513-1610USA004339.
GOT SHINGLES, (BAD RASH AND EXTREME PAIN IN CHEST AND BACK), TREATMENT VALACYCLOVIR HCL 1 GRAM 3 TIMES DAY FOR 7 DAYS.
Received booster (3rd Moderna dose) 12/10/21.  Evening of 12/21/21 began to feel itchy. Had raised red welts/hives. Clothes and heat irritated skin.  Condition, diagnosed dermatographia, has continued since 12/21/21. If skin is scratched or irritated it will begin to produce raised red hives/bumps that itch.   Taking two antihistamines daily to prevent symptoms since 1/6/2022
Pt had fever the first night after getting the second vax but it went away by the next day.   Pt stated that he developed severe sweats so bad that he has to change clothes about two times per night.  These symptoms lasted several weeks.  Pt had been to the doctor after getting the first covid dose for having these same symptoms.  He had blood work that showed SED Rate was 101 and C reactive was 33.  The doctor wanted to rule out cancer so he ordered a head, chest, abdominal xray, abdominal US and abdominal and pelvic CT w/ Contrast.  These test did not show anything.  He had a small bowel test that was negative.  He had more blood work on 4/1/2021 that was normal.  SED Rate was 20 C Reactive was 2.  His doctor seem to think that he had some type of reaction to the vaccine.
sore arm; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 78 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administration date unspecified (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. Relevant medical history included: "Diabetic type-2", start date: Mar1995 (ongoing), notes: Also reported as Diabetic type-2 for 30 years; "Stroke", start date: Jul2017, stop date: Jul2017. The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Lot/Batch number: EL9261, Anatomical location: Arm left), administration date: 30Jan2021, when the patient was 78 years old, single for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: No other illness at the time. Have never had reaction to any medication of vaccine before.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021122264 same reporter, patient, suspect product, different event and dose
Sore arm; This is a spontaneous report from a contactable healthcare professional (patient). This non-pregnant 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3247) intramuscularly in the left arm on 24Feb2021 at 09:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR DISKUS 250/50) and eletriptan hydrobromide (RELPAX 40 mg), both from unknown dates for unknown indications. The patient previously received the first dose of BNT162B2 on an unknown date for COVID-19 immunisation. The patient had not received any other vaccines in the 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced sore arm. The event was reported as non-serious and did not require hospitalization. No treatment was provided for the event. The clinical outcome of sore arm was unknown. It was also reported that since vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
PT RECEIVED SHOT 10/28/14 EARLY AFTERNOON. Patient called 10/30/14 9:10 am to report that she felt "weird" and somewhat sick the night of 10/28 and then the morning of 10/29 she broke out in hives and had redness around the site of injection.  Patient reported taking 2 Benadryl on her own at that time.  She then called pharmacy next day to report how she was doing (2 days later). Pharmacist called patient primary physician Dr's office to report the incident and also told patient to call them as well to let them know what had happened and what she should do.  Patient was not experienceing any difficulty breathing though she stated her neck was a "little itchy."  will continue to call patient and monitor for next 3 days.
Achy; fever; fatigue; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 16-year-old male patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Achy"; PYREXIA (non-serious), outcome "unknown", described as "fever"; FATIGUE (non-serious), outcome "unknown".  Additional information: the event took place after the use of the product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Anaphylaxis (throat tightening) EPIPEN and BENADRYL given taken to ER. Patient received FLUCELVAX in left deltoid muscle and approximately fifteen minutes later she presented with a lower voice, indicating that her throat was beginning to swell. I administered the EPIPEN 0.3 mg in her right thigh but had to readminister it since she jumped the first time and it didn't inject. Her symptoms diminished and her blood pressure was monitored every five minutes. She was given two BENADRYL 25 mg capsules and taken to the ER.
CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes type 2 (non-insulin dependent).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: Unknown) .5 ml, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced confirmed covid-19 infection. On 05-APR-2021, Laboratory data included: Pharyngeal culture positive viral (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection was not reported. This report was non-serious. This report was associated with a product quality complaint; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
moderate to severe pain and swelling in middle knuckles of right middle and ring fingers. Started a few days after vaccine second dose and is still persisting now 8 months later.
The pt experienced idiopathic thrombocytic purpura. Symptoms included bruise, petechiae, nose and mouth bleed. Platelets less than 5000. Treated with IV globulin 2 times.
I received vaccine at 8:00AM I had large amount of blood clots vaginally around 10:00AM that day. I wasn't sure if I was hemorrhaging called 911 transported to the ER. Once I got there the bleeding stopped later that day I was discharged. I was prescribed Progesterone to stop the bleeding.
His body has been achy / generalized aching throughout his whole body; Myalgia; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, less than a week after receiving Shingrix, the patient experienced general body pain and myalgia. On an unknown date, the outcome of the general body pain was not recovered/not resolved and the outcome of the myalgia was unknown.   It was unknown if the reporter considered the general body pain and myalgia to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and body had been achy, myalgia.  The reporter said no pain at the injection site, just generalized aching throughout his whole body and did not wish to provide HCP information. The reporter did not consent to follow up.
5/28/03: Nasal swelling. 5/29/03: Facial swelling, rash, hives, itchy. 5/30/03: Came into clinic - above symptoms continue, advised to take Benadryl 25 mg  BID for 3 days.
Child woke with high fever 103.1 complained of body aches.  Day of 10/10/13 cough started, nasal drainage, sore throat, fever continued. 10/11-10/14 Wheezing, cough, vomiting, continued fever between 101.0 to 103.2 No appetite, sore throat, continued wheezing, shortness of breath.  Child taken to hospital 10/17/13.  Was instructed side effects can last 5 - 10 days after Flumist was administered.
broke out in hives on legs wrist and belly area. following day around neck armpits and back of knees.
transcient cerebral ischemic attack; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 26-OCT-2016, patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose# and route of administration were not specified) for routine health maintenance an for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), patient experienced left-sided hemiparesis. The patient was hospitalized and diagnosed with possible transient cerebral ischemic attack, left facial droop, left hemisensory loss and left sided weakness. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of transient cerebral ischemic attack was reported as not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of transient cerebral ischemic attack was considered to be disabling. Upon internal review, the event of transient cerebral ischemic attack was considered do be medically significant.
Increased heart rate, numbness (right area of throat), difficulty talking. BP 190/109 (HR 130); repeat BP 172/102 (HR 123). Epi-Pen given, then taken to the ED. ED progress note - MD doubted anaphylactic reaction. Patient stabilized after observation in the ED and was discharged.
fever of 101; This is a spontaneous report from a contactable consumer reported for herself. A 28-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284 and expiration date unknown), via an unspecified route of administration on left arm on 17Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that she had the second dose of Pfizer Covid 19 vaccine yesterday on 17Jan2021, and has had 101 fever for 8 hours on 18Jan2021. Wanted to know if she can take fever reducing medication. No treatment received for the event. Outcome of the event was recovering.
Pfizer was mixed as directed at 1046am. Called COVID attending MD line to ask if dose could still be given at 420 and approval given. Pt remained in clinic for 15 minutes with no adverse reaction.  However clinical director later clarified that  dose was given after its 6 hours expiration and needed to be considered an adverse event and pt rescheduled for new immunization
I had the two dose shot 3: years ago and I have the shingles/suspected vaccination failure; I have the shingles right now for the 2nd time; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the 2 shots of Shingles 3 years prior to the report and had the shingles right now for the 2nd time and not as bad as of the 1st time. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
This is a spontaneous report from a non-contactable nurse. This report was received via a sales representative.  An elderly male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The Elderly male patient was showing signs of COVID. A COVID test was run and results were negative. Patient received COVID vaccination. Patient later admitted to hospital and died. Event took place after use of product. The patient died on an unspecified date.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported events.The event will be confirmed with autopsy reports.  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; Reported Cause(s) of Death: died
After first 6 hours, major Left arm stabbing pain in Deltoid.  Migraine HA symptoms developed.  Trigeminal neuralgia symptoms started.  Left face, jaw, eye, and ear pain and numbness.  After 10 hours, Left axillary lymphoid node swelling occurred, full body rigors with body sweeting, no fevers.  Muscle contracting happened after 14 hours.  This included upper and lower extremities and ABD. muscles.  Injection site swelling continued into day 2, large erythema area developed.  Hard, skin shinny, painful to touch or clothing touching area.  Symptoms of muscle contracting stopped after 2 full days.  Today is 3/1 and left deltoid still swollen, hard redden, shinny.   Lymphoid node still swollen in axially area.  Trigeminal symptoms still present.  Migraine HA symptoms resolved.
Fatigued 24 hours later, weakness in muscles.; Fatigued 24 hours later, weakness in muscles.; This is a spontaneous report from a contactable healthcare professional, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0153) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) (reported as Ogmenton) for unknown indication on unknown date and experienced drug allergy. 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. The patient felt fatigued 24 hours later, weakness in muscles on 07Apr2021. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events felt fatigued 24 hours later, weakness in muscles was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
mild shingles rash; This case was reported by a physician via sales rep and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by the physician (MD). The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The reporter stated that, the patient experienced mild shingles rash following first dose of shingrix. The reporter stated that did not recall specifics regarding the patient but wanted to share with GlaxoSmithKline(GSK). The physician did not agree to be followed up. This case has been linked with case US2019AMR172649, reported by the same reporter.
hives on neck and trunk, erythema of ears, face and legs in 30 min. after immunization, was given Benadryl PO, took to MD office with difficulty breathing and coughing, has given Epi shot. Steroids and Albuterol NEB ambulance called, transported from MD office to med. center by ambulance