chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a female who was vaccinated with the third dose of Gardasil.  Subsequently, "a week post vaccination" the patient experienced joint pain in her upper shoulder opposite the arm she received her vaccination and then over time the pain moved to other joints in her body.  No further information was provided and no lot number was given.  Follow-up information: The nurse was called on 14-FEB-2008 for additional information on this case and stated that she did not have time to discuss the case.  The nurse was called again on 21-FEB-2008 and stated that she has not yet pulled the patient's chart.  Additional information has been requested.
heart rate suddenly increased; throat felt tight; felt very warm in the head and neck like was flushed; felt very warm in the head and neck like was flushed; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 41-year-old female patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL9265) via an unspecified route of administration in the left arm on 30Jan2021 10:30 am at a single dose as Covid vaccine. Medical history included known allergies to penicillin- anaphylaxis. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Approximately 5 minutes after injection, heart rate suddenly increased and throat felt tight, and felt very warm in the head and neck like was flushed on 30Jan2021 10:45 am. It passed after a minute or two, then happened again around five times within the hour after injection. No treatment was provided for the events. The patient had no Covid prior to vaccination and has not had Covid tested positive post vaccination. The outcome of the events was recovered on Jan2021.
L thigh red, swollen, hot, 7 1/2 cm x 10cm (area)
Cellulitis, fever, warmth to right back of arm, pain with movement.  Keflex 500 mg PO TID for 5 days.
I received the J&J vaccine on March 7, 2021, with no issues, except for body aches the next day. I also contracted COVID in September 21, 2021, and recovered quickly.  I decided to get the Moderna booster on Jan 7, 2021, the next day I woke up with a swollen eyes. I received fillers under my eyes 4 yrs ago, I suspect that was the issue related to this inflammatory response
Pt had vaccination between 1130 am - 330 pm on 10/26/23.  On 10/27/23 at 930 pm he reported to college staff nurse that he was running a fever of 104 degrees and having body aches.
Fever of 102 degrees for 18 to 24 hours. Red rash at injection site lasting several days. This was my second shot.
Sore arm; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient is a 48 y.o. male with a PMH of HCV, IVDU with a history of MSSA sepsis with TV endocarditis (11/2019) and L4-L5 OM and epidural abscess )7/2018), HTN, and HFrEF (~20% per pt) presents to ED with complaints of fever, chest, and back pain.  Pt is oriented x 3 but drowsy and falling asleep throughout exam.  Pt reports he used IV drugs prior to arriving in the ED and once while in the ED.  Pt is a poor historian, but he reports right sided chest pain that radiates into the back with dyspnea on exertion that has become progressively worse over the last 2 to 3 weeks.  Pt reports low back pain and bilateral hip pain that has become significantly worse over the last month.   Pt reports fever, max 102, on Sunday.  Pt reports that he was on Suboxone, but due to his increased pain, started using IV Fentanyl, about 1 gram daily, 3 months ago.  Pt denies nausea, vomiting, diarrhea, abdominal pain, dysuria, cough, congestion, sore throat, heart palpitations, travel, or known sick contacts. Pt initially with tachycardia at 110's and SBP 110's.  Pt afebrile.  Labs significant for WBC 19, CRP 209, and Na 124.  CXR shows bilateral opacities that could represent an atypical infection.  CT PE, MRI L spine and bilateral hips pending.   COVID 19 infection  - per IPAC recs , isolation lifted sept 10th   Respiratory: Positive for shortness of breath. Negative for apnea, cough, chest tightness, wheezing and stridor.    Discharge Disposition/Condition Disposition: Home Condition: Stable (s/sx potential problems absent or manageable)
pt recv vax & devel an inj site rxn characterized by a 10-40cm area of redness & pain;pt recovered;this is 1 of 11 pt from this facility to devel an inj site rxn p/flu vax w/lot# 4978296;
H1N1 vaccine 11-5-09. On 11-16-09, reported that on 11-6-09 developed sore throat, "terrible cough", fever to 103+ "never felt so terrible". States she had a slight red scratchy throat on day of shot - had a physical that a.m. and states her doctor said OK to get shot that day. Off work x 1 week. Fever 3 days.
RASH; FEVER; This spontaneous report received from a consumer concerned a 26 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 13-AUG-2021, the patient experienced rash. On 13-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from rash, and fever. This report was non-serious.
Abnormal EKG; high troponin; Hospitalized at (with held) with Myocarditis; Chest pain began overnight Monday heading into Day 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 15-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Feb2022 15:00 (Lot number: FK9729) at the age of 15 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0185, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular), administration date: 05Jun2021, when the patient was 14 years old, for COVID-19 immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0176, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM, Route of Administration: Intramuscular), administration date: 15May2021, when the patient was 14 years old, for COVID-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization) with onset 28Feb2022, outcome "not recovered", described as "Hospitalized at (with held) with Myocarditis"; CHEST PAIN (hospitalization) with onset 28Feb2022, outcome "not recovered", described as "Chest pain began overnight Monday heading into Day 3"; ELECTROCARDIOGRAM ABNORMAL (hospitalization) with onset 01Mar2022, outcome "not recovered", described as "Abnormal EKG"; TROPONIN INCREASED (hospitalization) with onset 01Mar2022, outcome "not recovered", described as "high troponin". The patient was hospitalized for myocarditis, chest pain, electrocardiogram abnormal, troponin increased (start date: 02Mar2022, discharge date: 04Mar2022, hospitalization duration: 2 day(s)). The events "hospitalized at (with held) with myocarditis", "chest pain began overnight monday heading into day 3", "abnormal ekg" and "high troponin" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test (Blood test for COVID): (02Mar2022) negative, notes: covid test type post vaccination (blood test); electrocardiogram (EKG): (01Mar2022) abnormal; troponin: (01Mar2022) high. Therapeutic measures (ibuprofen) were taken as a result of myocarditis, chest pain, electrocardiogram abnormal, troponin increased. Additional information: The patient received the most recent COVID-19 vaccine in a pharmacy or drug store. The patient was under monitoring and was scheduled for MRI and repeat EKGs.   No follow-up attempts are possible. No further information is expected.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021 at 9:04 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 9:32 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Mar-2021 at 9:04 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 32.62 The age of patient was provided as 32.54   Concomitant products were not provided.  On 02-Mar-2021, Excursion time was 9A, 10A, 11A, 12P, 2P, 3P temperature was 27, 29,32, 33,35, 36 total doses given for the day was 177, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 02-Mar-2021. 16 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  On 30-Mar-2021, Excursion time was 9A temperature was 33 total doses given for the day was 173, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 30-Mar-2021. 3 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Strong Abdominal Pain. High Blood Pressure and increased heart rate CT angiography Scans revealed segmental arterial mediolysis and / or Fibromuscular dysplasia of the superior mesenteric artery and left renal artery. pseudoaneurysm in the neck area.  Prescribed: Losartan 50mg., Clopidogrel 75mg. until (unknown at this time). Restrictions: no lifting, pushing, or strain of any kind until (unknown at this time). Lost 1 week in wages, reduced hours, and medical bills. Blood pressure 3 weeks prior to second covid shot was normal.
Information has been received from a nurse practitioner concerning a 15 year old female patient with no pertinent medical history and no known drug allergies/reactions who on 17-MAR-2009 was vaccinated with the first 0.5 ml IM dose of GARDASIL (lot # 0250X). Concomitant therapy included ORTHO-CYCLEN. On 17-MAR-2009 the patient experienced restless, shortness of breath and anxiety around the bedtime. No lab diagnostics studies were performed. At the time of reporting, the outcome was unknown. The patient sought medical attention via calling nurse practitioner. Additional information has been requested.
4-5 days after receiving vaccine, developed intermittent unproductive cough with mucous taste; 8 days after receiving vaccine, developed moderately high fever (101.5 orally) which lasted approximately 12 hours until it was lowered to 99.5 with 2 Advil.  Fever remained at approximately 99.5 - 100 for next 24 hours, then broke.  Back pain developed during fever, still moderately present.  Neck pain developed at end of fever, still quite painful and causing headaches.
Information has been received from a male dentist who on approximately 01 Nov 2006 was vaccinated with one dose of Zostavax. On approximately 01 Dec 2006 the patient developed 3 herpetic like lesions on his tonsil area. He was scheduled to have an appointment with and ENT physician on 01 Dec 2006. There was no product quality complaint involved. No further information is available.
Pt recv vax on 11/17/98; on 11/18/98 pt exp erythema, swelling, warmth, itching at vax site of Rt arm
I haven't had a menstrual cycle  in over 2 years. I had a full week heavy menstrual cycle 2 weeks after receiving the 2nd vaccination. I had read that this has been a side ef; This is a spontaneous report from a contactable consumer (patient herself). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0164), via an unspecified route of administration in Left Arm on 29Apr2021 at 13:45 as single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8729) via an unspecified route of administration in Left Arm on 06Apr2021 at 12:30 for COVID-19 immunization. It was reported that, patient was in menopause age at time of vaccination and haven't had a menstrual cycle in over 2 years. No known allergies. within 2 weeks of vaccination and patient had not received any other vaccines 4 weeks prior to the COVID vaccine. On 16May2021, she had experienced full week heavy menstrual cycle, 2 weeks after receiving the 2nd vaccination. It was stated that, she read that this was a side effect for many women and wanted to report it so it can be investigated as being a side effect from the vaccine. Unspecified treatment was taken for the adverse event. It was reported that the event was non-serious. Patient visited physician office for the event. The outcome of the events was unknown.
Nine days after receiving the Moderna shot, I woke up on 2-21-2021 with my arm itching like a hundred mosquito bites.  As the day progressed, a large red circular rash appeared and the area was hot to the touch.  The tissue beneath the red area felt firm, like a large disc-shaped lump.  These symptoms continued for over a week, but gradually subsided.  Today, on March 1, 2021, the area looks much better.  Most of the redness is gone, but there is still itching at times,  and  the skin appears bruised.   I applied anti-itch lotion, ice, and warm showers.
Approximately 20 - 30 minutes (12:40) after receiving injection, she returned to clinic with complaints of "throat tightening up". Face sl. flushed.  No signs of respiratory distress.  Could talk.  Forwarded to emergency room.
Patient came in for a varicella vaccine and instead was given the shingrix shot which she is not eligible for because of her age below 50 years.  The pharmacist on duty thought that shingrix was the indicated vaccine for varicella in error and administer to patient.  In follow up questions she seems to have a typical response to the vaccine as those that are 50 and older do including achiness, chills, headache.  Patient also said she had an increase in respiration but no rash, hives, swelling of tongue or lips were present.  The increased breathing may have been due to the stress of knowing she received the incorrect vaccine.
No additional AE reported; First dose of GARDASIL 9 was administered on May 20, 2022. Second dose of GARDASIL 9 was administered three weeks later on Jun 3, 2022; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On 20-MAY-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis, lot #U035286 and expiration date reported as 21-OCT-2023 (strength, dose, frequency and route of administration was not provided). On 03-JUN-2022 (also reported as three weeks later) the patient was accidentally vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) also for prophylaxis lot #U035286 and expiration date reported as 21-OCT-2023 (inappropriate schedule of product administration). No additional adverse event was reported.
Information has been received from a 10 year old male consumer who on 01-NOV-2000 and on 18-AUG-2004 was vaccinated with the first and second doses of MMR II, respectively. On 06-DEC-2009, the patient experienced mumps (he was diagnosed on 06-DEC-2009). The patient was afebrile and had R parotitis. It was reported that there was exposure in the same household to a sibling with mumps. There were no lab diagnostic studies performed. At the time of the report the patient's outcome was unknown. No further information is available.
Flu-like symptoms for 48h after vaccination. Arm pain at site of injection with erythema and swelling. Remains painful to touch at 6d after injections. Flu and PNEUMOVAX given concurrently.
Initial case received from a healthcare professional on 29 May 2014. It is part of a cluster of six patients who were diagnosed with pertussis after receiving either DAPTACEL or ADACEL. The other patients are captured in case numbers 2014SA071241, 2014SA071253, 2014SA071260, 2014SA071266, and 2014SA071268. A 16-year old patient (gender and date of birth not reported) received ADACEL and/or DAPTACEL and subsequently developed a mild cough and was tested positive for pertussis (positive PCR). According to the reporter, there was currently a pertussis outbreak in the county where the patient resided. Lot numbers, dates of vaccination, and event onset dates, and outcome were not reported. Additional documents held by sender: None.
Patient was given flu vaccine in the breathmobile on 1/16/2013. Called 1/17/2013 in the morning to report pain not relieved by Tylenol and sleeplessness due to discomfort. Stated there was no swelling. Never had a reaction to influenza in past.
After 8 hours, flu like symptoms began and worsened over the next 24 hours. 100 degree temp, severe joint aching, severe malaise, severe swelling and pain at injection site. Also redness and heat at injection site. The symptoms were very flu-like. I was 'in bed" for 48 hours and stayed home from work but not in bed on day 3. Injection site remained painful and swollen until day 4.
I had a Pfizer booster on 11/09/2021 at 11:15 am. By the afternoon my arm became sore and hurt down to my elbow. Later I started to run a temperture and in the middle of the night I woke up freezing and had severe vomiting and diarrhea. I had a second round of the same and then the room started to spin rapidly, I laid down and closed my eyes and stayed still until this passed.  The next day I ran 103 - 104 degree tempature with aches. I felt that my balance was off and I would bounce on the hallway walls. The next morning my fever broke, but felt weak and nauseated, light headed.
Body ache; Chills; Fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (headache) in a female patient of an unknown age 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 MYALGIA (Body ache), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (headache). At the time of the report, MYALGIA (Body ache), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-184726 (Patient Link).
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 37-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was reported that there have been no power outages that would have impacted the Moderna vaccine. However, reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download for the months of DEC2021, JAN2022, and FEB2022. Reporter said that they are filling out a temperature excursion assessment with the State at this time and she was calling in to report the same to Moderna.  Reporter confirmed that patients have been administered doses while the temperature excursion assessment has been ongoing. It was reported that no adverse reactions were reported by any patients.