chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Weird numbness in right leg, right above knee; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 08Apr2021 at 15:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included sickle-cell anemia, blood clot and high blood pressure. The patient did not have any allergies to food, medications, or other products. Concomitant medications included apixaban (ELIQUIS), morphine sulfate ER (MANUFACTURER UNKNOWN) and oxycodone (MANUFACTURER UNKNOWN), all taken for unspecified indications from unknown dates. The patient previously 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 an unknown date at 03:45 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021, the patient underwent COVID-19 test (nasal swab) and the result was negative. On 11Apr2021, the patient experienced weird numbness in right leg, right above the knee. The event resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event weird numbness in right leg, right above the knee was not resolved at the time of this report   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Large rash on arm of vaccination. Red, raised, warm, itchy, sore.  Monitoring size and taking action if it gets bigger.
SCIATICA,  GIVEN STEROIDS  AND, STRECHI NG PHYSICAL THERAPY,,PAIN RETURNED
This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (first bout of shingles was over 5 years ago). Concurrent medical conditions included post herpetic neuralgia. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving 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. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got first bout of shingles over 5 years ago and still had post herpatic neuralgia. The patient had received all the Shingles shots and had three lesser flare ups of shingles in the 5 years. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
I would like to say that the beginning of my problem started with the first vaccine, with second it intensified tremendously  and now with a booster I am having exactly the  same thing. I started getting numbness in my face, mainly on my left side. Pins and needles and tingling. It would spread to my right side not as constant as with left side.  After the second vaccine it became so persistent  and disruptive . I told myself maybe it is from cold, from running, maybe it was dental issue. Once we started going back to doctors I eliminated all these things and with my primary physician we decided to do MRI of the brain. That came back ok and with the time my numbness never disappeared but it was not as constant or I perhaps learned to live with it.   I knew all along it must have been from the vaccine, the way it just started out of nowhere. Now that I got my third dose and  I am back at the beginning. Same sensation, same numbness, pins and needles on my left side of the face. Its again as constant as it was before.  I wanted to report it first time it started happening but than I figure maybe it was something else.  .
Headache, bilateral knee pain and swelling, purple discoloration of legs.  Headache started within minutes of immunization.  Severe pain x 2 days, but still having daily headaches.  Knee pain started 7/19/2021 and is now improving.  Had one day of purple discoloration of legs, but that has resolved.
PATIENT STATES THAT AFTER HE RECEIVED SHINGRIX SHOT HE FELT STRANGE LATER THAT AFTERNOON BUT HE HAD TO CALL HIS WIFE THE NEXT DAY AT 10:15  TO PICK HIM UP FROM WORK BECAUSE HE WAS FEELING BAD.  HE EXPERIENCED FATIGUE, DIZZINESS, SHORTNESS OF BREATH,  REDNESS AT INJECTION SITE, A LITTLE SWELLING , AND INCREASED HEART RATE. HE ENDED UP IN EMERGENCY ROOM DUE TO PAST HEART ISSUES.
About 5 mins after the shot I received on Sunday, I got a cooling effect in my chest and began to feel a bit off with an elevated HR of 132. I raised my hand to talk to a nurse and she said I was probably just nervous, got me a water, and said to continue to monitor symptoms. Then, after 15 minutes were up with no other symptoms I left the facility where I got the vaccine. The rest of the day I began to get a burning and cooling effect all around my sternum. It persisted through the day despite Tylenol 500 mg and worsened at night, keeping me up along with a slight fever and chills. The next morning I awoke with slightly lowered symptoms but the sternum pain would flare up on and off through the day and again was worse at night on Monday. So, I took a Benadryl and a 500 mg Tylenol and slept great. I woke up Tuesday feeling great with no fever and minimal chills and no sternal pain. I thought since I hit the 48 hour mark everything was going fine and I was recovering. I ran some errands and even went to the gym to do a mild workout. Then at about 6pm all the symptoms of the sternal pain flared up and was just as bad as Monday night. I took another 500mg Tylenol and 1 Benadryl again and they did not seem to work or help nearly as much as the night before. I woke up this morning with some pain in my sternum again and did not sleep much last night due to the pain as well. I have not taken any further medications at this time and I am also experiencing the worst fatigue I have so far today.
Red, swollen, itchy arm.  Redness and swelling wrapping around arm.
SARS-CoV-2 pneumonia with secondary bacteremia; anemia; SARS-CoV-2 pneumonia with secondary bacteremia; hemoptysis; Initial information received on 22-Feb-2023 by health care professional regarding an unsolicited valid serious case issued from a literature article. This case is linked to cases 2023SA063143, 2023SA063145, 2023SA063146, 2023SA063147, 2023SA063148 and 2023SA063144.  This case involves a 74 years old male patient (table 1) who experienced sars-cov-2 (severe acute respiratory syndrome coronavirus 2) pneumonia with secondary bacteremia while receiving vaccines PFIZER BIONTECH COVID-19 (coronavirus 2019) VACCINE and INFLUENZA VACCINE (QUADRIVALENT).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect PFIZER BIONTECH COVID-19 VACCINE not produced by lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect high dose INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a serious sars-cov-2 pneumonia with secondary bacteremia (covid-19 pneumonia) (bacteraemia) with symptoms of anemia (anaemia), hemoptysis (haemoptysis) (latency: 11 days). This event was assessed as medically significant. The patient was hospitalized for this event for 13 days.  Action taken with QUADRIVALENT INFLUENZA VACCINE (INFLUENZA VACCINE (QUADRIVALENT)) and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown Reporter's causality: Related; Sender's Comments: Company comment dated 28-FEB-2023: This case involves a 74 years old male patient who experienced sars-cov-2 pneumonia with secondary bacteremia while receiving vaccine and INFLUENZA VACCINE (QUADRIVALENT). Based on information received the causal role of VACCINE cannot be excluded due to compatible temporal relationship of ADR to the VACCINE. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of vaccine cannot be assessed.
This spontaneous report was received from a medical assistant via company representative regarding a female patient of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. The medical assistant reported that her cousin after receiving GARDASIL or GARDASIL 9 (medical assistant could not confirm if it was GARDASIL or GARDASIL 9) dose developed facial twitches. It was unknown if the patient had completed GARDASIL or GARDASIL 9 series. No product quality complaint (PQC) was involved. Outcome and causality of the event was not reported. Additional information is not expected as there is no consent to contact the reporter.
Narrative:  12/28/22 - Pt brought to triage with c/o confusion, weakness, pt. states he has been sick with sore throat, ear pain, diarrhea, family states he tested + Covid with home test. Pt currently hypotensive with HR 40-50s SBP 89. 1L LR stated as ordered. HPI: He was at home this morning and began to feel very lightheaded and dizzy. He did not have a syncopal episode. He denied nausea vomiting chest pain shortness of breath. 2 days ago he developed a cough had a fever at home with an earache and sore throat. He had a positive home Covid test. He denied having a headache but he did report change in taste. He has been fully vaccinated. MEDICAL DECISION MAKING (MDM): Hypotension bradycardia due to cardiac effects of COVID-19. Pt given 1L LR fluid. His BP was 121/81 and HR improved to 53. Sats remained 92 - 97%. Repeat EKG showed sinus bradycardia with a rate of 53 and a first-degree AV block. DIAGNOSIS: Primary Diagnosis: Hypotension Secondary diagnoses: Bradycardia 3) COVID-19 upper respiratory infection Pt admitted to SDU on 12/28/22. Pt treated with remdesivir while inpatient and discharged 12/30/22.
The patient experienced pain and soreness in the left upper arm and shoulder. Over the next several days, patient experienced a tingling feeling in the fingers of her left hand as well as worsening arm pain with motion. On 08/02/12, the patient returned to the healthcare facility and was prescribed nabumetone (500mg); on 08/21/12, was advised to take ADVIL. Follow-up received 10/23/12: Patient recovered.
I first noticed the symptoms on  15NOV20222 mild symptoms but by 16NOV2022 a very scratchy throat and coughing . The next week I tested and it was positive. I had a scratchy throat headache diminished loss of taste and smell.  I was prescribed an antiviral.  What was  really bad was the side of my face was very painful like a sinus infection eventually I got over it but the congestion and pressure on my left side remains with stuffiness. I got a nasal spray which helps a lot, Azelastine.
red, swollen, painful lump the size of a peach.  she stated the reaction is an inch below the injection site.  She said the reaction is still growing in size. Suggested the customer reach out to her provider tomorrow if not improved.
Expired Hep A vaccine administered; This case was reported by a other health professional via interactive digital media and described the occurrence of expired vaccine used in a patient who received Hepatitis A vaccine (batch number unknown, expiry date 9th August 2022) for prophylaxis.   On 3rd November 2022, the patient received Hepatitis A vaccine. On 3rd November 2022, unknown after receiving Hepatitis A vaccine, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's Comment: This case was reported by a reporter via interactive digital media. The reporter asked could GlaxoSmithKline give him/her the proper steps to take when mistakenly administered Hep A vaccine that was expired on 9th August 2022. The reporter also asked would patient need to be revaccinated and if so how many days should wait before doing so. Additional supportive information: The patient received a dose of Hepatitis A vaccine which was already expired, which led to expired vaccine used. The follow-up would not possible, as no contact, details were available.
This spontaneous report was received from a nurse and refers to a currently 12-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # N032284, expiration date: 22-SEP-2020 (dose and route of administration were not provided) for prophylaxis. Temperature and time frame were reported as: below 0 degrees Celsius (-0.6 degrees Celsius) for 7 hours and 38 minutes and 9 degrees Celsius to 25 degrees Celsius (13.3 degrees Celsius) for 1 hour and 14 minutes. Previous temperature excursion was reported as: 9 degrees Celsius to 25 degrees Celsius (11.7 degrees Celsius) for 3 hour and 53 minutes and 9 degrees Celsius to 25 degrees Celsius (23 degrees Celsius) for 11 hours and 21 minutes. Digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1811USA007952: US-009507513-1811USA001303: US-009507513-1811USA007949: US-009507513-1811USA007950: US-009507513-1811USA007951: US-009507513-1811USA007946: US-009507513-1811USA007945: US-009507513-1811USA007947.
On 5-10-07 @ 3:30 a.m., client's wife states her husband was sleep & awakened c/o abdominal cramping, chills, nausea & vomiting x2. No temp. was taken but wife states husband was warm. Denies redness and swelling at the injection site. Wife states at 9:30 a.m. husband was able to drink water & have a popsicle without having an emesis. Wife states husband's private physician was not notified.
ITP- /w clinical signs evident by approx. 1 mon. /p vaccination.  Bruises, petechiae, No frank bleeding
Patient history: Lyme disease and pork allergy. Vaccine given at 0912. At 0925 patient experiencing throat tightness, scratchy throat, cough, and chest tightness. Initial oxygen at 98% pulse 70. Patient denied shortness of breath, dizziness, or feeling lightheaded. Patient escorted to the back area for further assessment. At 0931, 25 mg (10 ml) of benadryl administered orally; no difficulty swallowing. VS: BP 160/98, pulse 75, respiration 18, temp 97.2, oxygen 99%. At 0937, patient verbalizes "throat feels better, scratch still there but no chest tightness. I can breath better." At 0939, patient reports symptoms of throat tightness. Patient auscultated, negative wheezing. Bilateral lungs clear. Benadryl 25 mg (10 ml) po administered without difficulty. 0941 VS: BP 180/114, pulse 74, respiration 18, temp 96.2, and oxygen 98%. Patient continues with symptoms but negative for labored breathing, tachypnea, cyanosis, or swelling. At 0952, BP 170/119, pulse 82, respiration 20, temp 95.9, oxygen 96%. At 0955, symptoms continue of throat tightness and hoarse voice; EMS (911) notified and en route. At 0959, 0.3 mg epinephrine (auto-injector) administered IM via left thigh. At 1006, EMS arrived and patient evaluated. Per patient, "still feel scratchy throat". At 1011, patient transported via stretcher with EMS to hospital for evaluation. At 0957, Medical director made aware and in agreement with transport to hospital for further evaluation.
Information has been received from a physician concerning a patient who was vaccinated PO with the first dose of rotavirus vaccine (human-bovine). The patient subsequently developed rotavirus gastroenteritis. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
When I got the shot or at least the next day I fatigued and tired. I didn't pay too much attention but a week later it was still there. I reported to my doctor because I was out of breath very easily. Sitting to do gardening I was having difficulty breathing. This problem just never went away. Even though I could exercise heavily, the smaller exercises caused me to breathe as if I had done heavy exercise. Walking up stairs was very difficult but would have to stop and sit down half way up to rest. I was too out of breath. Even now I still get out of breath way too fast. It also seems that my diabetes may have gotten worse, but I cannot be certain of numbers. I have been able to control it with medication, but I wasn't taking the medication as often before the vaccine.
This spontaneous report was received from a patient's mother via company representative and refers to her 4 year old male son with Kawasaki's disease. The patient did not have drug reactions or allergies. On 28-AUG-2015, the patient was vaccinated with the first dose of PROQUAD (Merck) (lot#, expiration date, dose, site and route of administration were not reported) as preschool vaccinations. Concomitant therapies included IPV (unspecified) and Hep A (manufacturer unknown). On 03-SEP-2015, the patient experienced headache. Then on 06-SEP-2015, he had a temperature of up to 103.5 (units not provided), was sent to an unspecified emergency room (ER) and released on the same day. On 08-SEP-2015, the patient complained of leg weakness. Unspecified blood work was performed and it was reported that the "UBC" was low (on unknown date). On 08-SEP-2015, the patient complained of leg weakness. The treatment was given and included MOTRIN, TYLENOL (also reported as "Tylernol") and unspecified intravenous (IV) antibiotic. The outcome of the events was reported as not recovered. The relatedness between the events and PROQUAD (Merck) was not reported. Additional information has been requested.
HEP B injection given on Monday. Wednesday morning noted rash to arms. Late evening it spread to legs. Rash is red blotchy and itches. Rash on arms ongoing per Pt.
On 4/29/03 @ 5:55 pm patients mother called reporting patient has moderate amount of redness and swelling to RAT.  Hot to touch.  Mother states pating acting fine, no fever, no N/v.  Mother was told to apply warm compresses and keep an eye on swelling, redness
Pt never had flu vaccine. So she did not answer q #3. Upon adminins. she immed. developed "bubble" on her L arm and 5 minutes a/f that she became lightheaded and dizzy. I called EMT.
Swollen Lymph nodes thought-out mu entire body. Under left and arm are the worst with my stomach area being the second worst area; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the left arm on 05Apr2021 at 09:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included blood clot in spline in Jan2021 and allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included apixaban (ELIQUIS), metformin (MANUFACTURER UNKNOWN), calcium citrate (CITRACAL), magnesium (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received neomycin (MANUFACTURER UNKNOWN) and oxybutynin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the left arm on 15Mar2021 at 09:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 07Apr2021 at 11:00, the patient experienced swollen lymph nodes thought-out her entire body. Under left and arm was the worst with stomach area being the second worst area. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event swollen lymph nodes thought-out her entire body; under left and arm was the worst with stomach area being the second worst area was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
03Mar98 pt recv 1 dose vax. 06Mar98 pt devel "approx 100 generalized varicella-like lesions, pt was afebrile".
Mother reported redness on injection site beginning and noticed it the day after injection. No fever, pain or limp. Seen in office on 4/3/02; erythema, mild edema left anterior thigh. No tenderness or temperature. Dx'd with inflammation. Warm soak and Benadryl.
Left supraclavicular and left axilla lymphadenopathy, pain.  Then started with right supraclavicular and right axillae lymphadenopathy and chills the next day. Now having increasing pain in lymphatic areas
2X3 cm area of muscle tightness: left lateral thigh with an area of 5x7cm area of red macule of overlying skin, No swelling noted in neck after vaccination.
Right foot developed 'drop foot'. Noticed when leaving vaccine location but did not taken seriously. Cannot raise front of right foot at heel (dorsiflexion) as before vaccine and when comparing to other foot. Front of right foot drops when trying to stand on right heel only. Cramps in the right exterior ? muscle about twice a week.
L deltoid area red, swollen, temp 102 x 3 days post injection. Today arm is still red.
This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX23 lot # N011491 with expiry date: 04-NOV-2018 (dosing details, route and anatomical location were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 32 degree Fahrenheit to 35 degree Fahrenheit for a duration of 23 days. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. Follow up information has been received from a medical assistant on 26-SEP-2017. The reporter stated that she had faxed the patient identifiers and dates of vaccination a month ago after she made the call. The medical assistant stated that she would refax them. Follow up information has been received on 04-OCT-2017. On 11-AUG-2017, an 88 years old patient of unknown gender was vaccinated with improperly stored PNEUMOVAX23. This is one of 8 reports received from the same reporter. Sender's Comments: US-009507513-1708USA011337: US-009507513-1710USA008711: US-009507513-1710USA008712: US-009507513-1710USA008713: US-009507513-1710USA008714: US-009507513-1710USA008715: US-009507513-1710USA008716.