chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10:35 received Flu vaccine L deltoid.  She states 20 minutes later her arm was becoming swollen with reddened skin and it felt hot to her.  These symptoms continued to develop over time with the emergence of a slight rash on both arms, and a hive on the Right arm and on her back.  Then she became itchy on her arms and across her brow, and in her throat.  She then went to the Emergency Room at 13:54.  She was examined and treated with Benedryl and Pepcid.  She returned to Employee Health after her ED visit and the rash and itching had subsided.  At 9:50 on 10/7/20 patient was seen again in Employee Health.  Her Left deltoid area was red, hot, and indurated in an area of 70 mm.
Needle disconnected from syringe when administering dose as patient jerked away during administration. Full dose was not received.
PATIENT REPORTS THAT SHE HAD A SINGLE SHINGLE COME UP ON LEFT SIDE OF FOREHEAD. SHE SAW TWO DOCTORS WHO HAVE CALLED IT A SHINGLE. THIS WAS REPORTED TO ME ON 5/19/2008.
itching; mild rash; 5-6 hives; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 11Mar2021 at 10:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoporosis and cystitis interstitial. The patient was not allergic to medications, food, or other products. Concomitant medications received within two weeks of vaccination included Citracal and vitamin D (MANUFACTURER UNKNOWN). Prior to 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 COVID-19 vaccine. On 19Mar2021 at 18:00, one week after the vaccination, the patient developed itching, mild rash and 5-6 hives. It was reported that the rash and itching were better and the hives were the same. The patient did not receive any treatment for these events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events itching and mild rash was recovering. The outcome of the event hives was not recovered at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
My upper left arm started to hurt almost immediately after the shot. About 1 1/2-2 hrs after I literally couldn't move my arm without severe pain. I had to use a sling the rest of the day & even at night. I couldn't sleep on it.
child became very lethargic & limp p/vax; pt will recv DT only from now on;
Numbness on left side of body; burning sensation on left side of body; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose at the age of 27-year-old for COVID-19 immunisation. Medical history included covid-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021 at 19:00 the patient experienced numbness and burning sensation on left side of body. No therapeutic measures were taken as a result of the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events numbness and burning sensation on left side of body were not resolved at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient is a 58-year-old retired female who recently received shingles vaccine and complains of lower extremity myalgias that developed the following day and lasted 24 hours -although myalgias are a known side effect with SHINGRIX and the package insert noted up to 57% of patient who receive this vaccine can report myalgias, I suspect that her previous days' activity (300 squats and 150 crunches) at least partially contributed to her symptoms, especially given myalgias were limited to her lower extremities with no complaint of a large local reaction or upper extremity myalgias -nonetheless, we will file a VAERS report for the AEFI -I do not feel these self-limited myalgias are a contraindication to the second dose of SHINGRIX -I would recommend avoid exercise the day before and for a couple days after SHINGRIX #2 -patient may also pre-medicate with TYLENOL or ibuprofen the day of and the day after vaccination to help mitigate any symptoms-Recommend delaying SHINGRIX #2 until after the first of the year due to the known shortage and patient's relatively young age (some data to support good efficacy with a single dose in this younger population) -Patient voiced understanding and agrees with plan, All questions were answered. -Patient to follow-up as needed or if she develops any adverse event following dose #2.
Bilateral ear pain.  Treated with a course of Augmentin, Mucinex, Sudafed.  No relief.  Now on a 12 day course of Prednisone
Pt came to our office on 9/3/2019 because his dad said he had come down with a rash the night before that was "very itchy". No other symptoms. No fever. Child did have the Varicella vaccine on 8/20/2019. Dr confirmed that it was chickenpox, probably from the vaccination on 8/20/2019.
Weakness and Pain in muscles and nerves in legs. Swollen lymph node in right arm pit.
sore arm; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unknown age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on an unknown date for Covid-19 immunization. Medical history was reported as "none". Concomitant drug was not provided. Patient had her vaccine, but had nothing but a sore arm. Patient stated that a sore arm was not a big deal. Outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient presented at off-site clinic site requesting influenza vaccine. When this nurse was entering vaccine into vaccine database, noted a previous dose of high dose quadrivalent influenza vaccine had been administered by a different provider on 9/17/2021.
1st set (PENTACEL, HVB, PCV7, Rota) resulted in wheezing, SOB, irregular breathing, fever 104 degrees; seen in ER. 2nd set (PENTACEL, Rota) resulted in no symptoms. 3rd set (HBV, Rota, PCV) resulted in rash and swelling on face requiring BENADRIL PRN
Noted orange sized, red, hard, warm area around injection site 24 hours after shot. 8/4/09. Reluctant to walk due to pain. On AM of 8/5/09 mom noted increased erythema extending to inner thigh - Now at medial, lateral and anterior thigh, sparing posterior, thigh measures 32 1/2 cm (2) and 28 1/2 cm on Rt. No other systemic Rx. Has been on ZYRTEC prior to infection and is on maintenances.  Area warm, red - no drainage.
Second dose administered 2 weeks after first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 09Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Second dose administered 2 weeks after first dose". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Context: This consumer is the patient who reported after having been administered both doses of the Pfizer-BioNTech COVID-19 Vaccine he had a blood test performed that showed he has no COVID-19 antibodies. His second dose was administered 2 weeks after first dose of Pfizer-BioNTech COVID-19 Vaccine. First dose administered on 19Jan2021. Second dose administered on 02Feb2021. He asked for information on having no COVID-19 antibodies after having been administered both doses of Pfizer-BioNTech COVID-19 Vaccine; if there is any recommendations on what he should do regarding this test result.  Additional Lot/NDC/Expiry: Not provided, caller unwilling to complete report. PC filed. Caller was unwilling to complete report, further details for report and vaccine supplemental form not provided. Is there a Product Complaint: Yes  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt had febrile seizure 10 hours after flu shot administered. Pt. temp was 102.5 in the ambulance.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included rheumatoid arthritis. Concurrent medical conditions included back surgery. Concomitant products included MELOXICAM. On 5th June 2018, the patient received the 2nd dose of SHINGRIX. In June 2018, 2 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, tiredness, headache, fever and general body pain. On an unknown date, the outcome of the influenza-like symptoms was not recovered/not resolved and the outcome of the tiredness, headache, fever and general body pain were unknown. The reporter considered the influenza-like symptoms, tiredness, headache, fever and general body pain to be related to SHINGRIX. Additional details were provided as follows: No additional details about medical history provided. The reporter denied any other vaccines were administered at the time of the SHINGRIX. In between 15:00 hours to 17:00 hours, the patient received SHINGRIX in left arm. After 2 to 3 days (no exact date provided after injection), the patient experienced flu like symptoms. The patient had three bouts of two day flu like symptoms over the past sixteen days and she described flu like as tired, headache, fever, and aching all over. Flu like symptom bouts had not worsened or improved with each bout.  No hospitalization for treatment of flu like symptoms. The patient spoke with her primary care physician and pharmacist about her flu like symptoms. The reporter could not recall pharmacist who administered vaccine. The reporter did not have lot number, expiration date, dose, or strength of SHINGRIX. No addiitonal details were provided.
Caller states that she was feeling unwell; Discovered swollen lymph nodes; She also states that she had tiredness and a sore arm.; She also states that she had tiredness and a sore arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 12:00 (Lot number: EN6199) at the age of 74 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 18Mar2021, outcome "recovered" (21Mar2021), described as "Caller states that she was feeling unwell"; LYMPHADENOPATHY (non-serious) with onset 18Mar2021, outcome "recovering", described as "Discovered swollen lymph nodes"; FATIGUE (non-serious) with onset 15Mar2021, outcome "recovering", PAIN IN EXTREMITY (non-serious) with onset 12Mar2021, outcome "recovered" (15Mar2021) and all described as "She also states that she had tiredness and a sore arm.".  No follow-up attempts are possible. No further information is expected.
felling dizziness; Weakness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (felling dizziness) and ASTHENIA (Weakness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia stage 0 (under oncologist follow-up) and Blood pressure abnormal. Concomitant products included LISINOPRIL and AMLODIPINE for Blood pressure abnormal, IBRUTINIB (IMBRUVICA) for Chemotherapy.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021 at 11:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DIZZINESS (felling dizziness) and ASTHENIA (Weakness). At the time of the report, DIZZINESS (felling dizziness) and ASTHENIA (Weakness) outcome was unknown.            The reporter stated that patient did not seem to be in extreme distress, so she was driving the patient to nearby emergency room (ER) to have checked at the time of this report. The reporter also stated that when patient developed symptoms, patient contacted her oncologist who recommended, not to take chemotherapy medications for 2 days (on the day of vaccination and next day). No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable.
Rash and swelling, soreness at injection site 8 days AFTER vaccination.  Grew larger and worse over course of four days.  Resolved itself.
hands numbness/tingling, face flushing, water given, BP 144/83, P69, observed pt additional 10 minutes, feeling better, ambulated to exit with husband, and staff
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 concomitant medications, concurrent conditions or medical history. On or about 17-NOV-2012, the patient was inoculated with ZOSTAVAX by a physician at the physician's office as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 05-FEB-2016, the patient was treated by the same physician for a blistering outbreak that was diagnosed as severe herpes zoster or shingles.  She was prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
<24hr p/vax pt had rash eruption on all four extremities;the legs contained a heavy red, raised rash occurring in clusters;exp diff sleeping/resting the noc of vax;
headache, nausea,  fever of 101 with chills,  sweats and hives/rash  on arms and torso and private area, irritation around the injection site and soreness.
This spontaneous report was received from a physician and support services director and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-NOV-2015, the patient was vaccinated with an improperly stored dose of PUEUMOVAX 23 0.5 ml prefilled syringe (lot # L022795, expiration date: 05-NOV-2016; dose and route of administration were not provided). The dose of the vaccine was exposed to the following separate temperature excursion (dates unspecified): one lasting for 24 hours, with the lowest recorded temperature of 8.3 degree Fahrenheit, the second one lasting for 24 hours, with the lowest recorded temperature of 8.4 degrees Fahrenheit, the third one lasting for 24 hours, with the lowest recorded temperature of 8.1 degrees Fahrenheit, the fourth one lasting for 24 hours, with the lowest recorded temperature of 8.5 degrees Fahrenheit. The vaccine was stored in a refrigerator No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
passed out 10 mins p/vax, took 30sec to respond; 1 hr later lightheaded, hot ambulance called; MD called did not see pt;ill for 2 days; swelling lt arm & under arm
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    No concomitant medication was reported. No treatment medication was reported.
Significant pain in the shoulder started a few hours after vaccination and continued as severe for 2 days; the pain never went away and several weeks later I have developed a deltoid bursitis with significant pain and reduced ability to move my left arm. The pain is most significant when attempting to raise my left arm and also when sleeping ( unable to apply any pressure on that arm)
Fever of 102. Continued to spike fevers of 102 for a week and had shortness of breath. Personal family doctor ordered blood work which showed anemia and a chest x-ray which showed pneumonia.
Information has been received from a registered nurse concerning a 25 or 26 year old female who was vaccinated IM with GARDASIL vaccine.  Subsequently that patient experienced abnormal Pap test with high risk human papillomavirus (HPV) "after completing the series" of GARDASIL.  The patient sought medical attention: office visit.  No further information is available.
No adverse reactions noted. Vaccine was administered after beyond use date. Patient and manufacturer both notified.
The injection site reaction on right arm was 3 inches in length and 2 inches in width, raised, red, and hot to touch. Patient experienced dull pain radiating from wrist to shoulder.
in nursing home due to Alzheimer; diagnosed positive for COVID; since this diagnosis she has gradually declined; stopped eating and drinking; comfort meds were given; pt passed away in the nursing home; pt was 100 years old
Pt reported event on 10-30-15. The patient stated she got a Flu shot on 10/27/15 around 1400. She stated the next morning she woke up with diarrhea and stomach pain. She stated the S/S lasted throughout the day and resolved on 10-28-15 in the evening.
Patient may have received a cloudy vaccine; Patient may have received a cloudy vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of SUSPECTED PRODUCT CONTAMINATION (Patient may have received a cloudy vaccine), SUSPECTED PRODUCT QUALITY ISSUE (Patient may have received a cloudy vaccine) and NO ADVERSE EVENT (No adverse event) in a 21-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Dec-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced SUSPECTED PRODUCT CONTAMINATION (Patient may have received a cloudy vaccine), SUSPECTED PRODUCT QUALITY ISSUE (Patient may have received a cloudy vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, SUSPECTED PRODUCT CONTAMINATION (Patient may have received a cloudy vaccine), SUSPECTED PRODUCT QUALITY ISSUE (Patient may have received a cloudy vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for SUSPECTED PRODUCT CONTAMINATION (Patient may have received a cloudy vaccine) and SUSPECTED PRODUCT QUALITY ISSUE (Patient may have received a cloudy vaccine).    Concomitant and treatment medications were not reported.  Patient had no allergies and unknown for diseases.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Pharmacist was not sure if the vaccine administered was cloudy. The next 2 vials from that box have been cloudy once thaw form the freezer. Patient may have received a cloudy vaccine.
Complains of swelling, redness, itching, soreness since 2/25/21. Evaluated by MD on 02/26/21 and Rx  Doxycycline 100 mg BID x 7 days, Loratadine prn itching, warm compresses.
Patient  (24 year-old male) vaccinated with his 2nd dose of COVID-19 Pfizer (Lot#FK9896) vaccine on 02/12/2022 at 1740 by RN in the right deltoid. While waiting in post-vaccination observation the patient reported to the post-vaccination nurse  LPN at around 1749 that he was feeling ?cold and shaky?. Patient was escorted safely with his friend to medical cot area by wheelchair to lay down. This Charge RN was notified about the incident by the Site Supervisor  while scribing for another RN in the Pfizer vaccination area. Sit supervisor had already responded and came and asked this Charge RN to take over the incident response to assist with other clinic staff concerns, and Charge RN responded and visually assessed that patient was visibly sweating profusely and reported to this RN that he felt cold and shaky. Patient was able to drink some apple juice without difficulty following staff assist. Patient vitals checked by LPN at 1752 and were all within defined limits and stable (BP: 119/70, HR: 66, SPO2: 99%, Temp: 98.3 F, and RR 14). Patient was still visibly sweating profusely on his forehead and when assessed by the Charge RN he continued to say he felt cold and shaky. Patient said that he had a fear of vaccinations and that he only had a very small amount to eat the day of vaccination. His vaccinator, RN also came to medical cot area and assisted staff with patient intervention. Patient was able to sit up with staff assist after a few minutes and stated he could drink more juice. No difficulty drinking fluids or swallowing noted. Patient then stopped sweating and stated he was no longer cold or felt shaky and denied any weakness or dizziness while sitting. Patient safely stood at side of medical cot. Patient Denied feeling weak or lightheaded, stable gait noted by this Charge RN, patient was accompanied by his family member who would escort the patient home as he safely walked out of the clinic.