chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After almost 24 hours, there was fever 100.2F, headache, joint pain, redness pain and swelling at the injection site. The pain and swelling has continued  to grow every day until now my arm is swollen from the shoulder to the elbow and around to the inner arm. It is hot, hard to the touch, very swollen, and painful to any touch including clothing.  It is now 96 hours later.
Cardiac arrhythmia with palpitations.  Negative cardiac evaluation except frequent PVC's on Event Monitor.  Attributed to days autonomic likely from Guillain-Barre Syndrome. Poly neuropathy with numbness all extremities and face confirmed by NCV/EMG from post influenza vaccine GBS. High dose steroid therapy course failed to improve symptoms. Symptoms persist to this point without change.
Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Prostatic disorder NOS.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain) (seriousness criterion disability). At the time of the report, ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   At the time of the vaccination patient was received high blood pressure medication and a prostate medication as a concomitant medication. Treatment product was not provided by the reporter  This is a spontaneous case concerning a 65 years old, male patient with  no clinical history who experienced the unexpected event of ARTHRALGIA The event occurred unknown days after the first dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about first dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-387057 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 65 years old, male patient with  no clinical history who experienced the unexpected event of ARTHRALGIA The event occurred unknown days after the first dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about first dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Shortness of breath; COVID-19 pneumonia; COVID-19 infection; Hypoxic respiratory failure; sepsis; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of RESPIRATORY FAILURE (Hypoxic respiratory failure), SEPSIS (sepsis), COVID-19 PNEUMONIA (COVID-19 pneumonia), COVID-19 (COVID-19 infection) and DYSPNOEA (Shortness of breath) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart failure with preserved ejection fraction. Concurrent medical conditions included COPD exacerbation (On 2 liters of oxygen at baseline), Squamous cell carcinoma of lung, Schizoaffective disorder and oxygen.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criteria hospitalization and medically significant) and COVID-19 (COVID-19 infection) (seriousness criterion hospitalization). On 16-Apr-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization). On an unknown date, the patient experienced RESPIRATORY FAILURE (Hypoxic respiratory failure) (seriousness criteria hospitalization and medically significant) and SEPSIS (sepsis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized until 21-Apr-2021 due to COVID-19, COVID-19 PNEUMONIA, DYSPNOEA, RESPIRATORY FAILURE and SEPSIS. At the time of the report, RESPIRATORY FAILURE (Hypoxic respiratory failure), SEPSIS (sepsis), COVID-19 PNEUMONIA (COVID-19 pneumonia) and COVID-19 (COVID-19 infection) had resolved and DYSPNOEA (Shortness of breath) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Chest X-ray: abnormal (abnormal) multifocal pneumonia in the setting of chronic Interstitial changes..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information provided included 6L O2 Nasal cannula, Remdesivir for 5 days (stop date : 20 - Apr - 2021) ,Decadron for 6 days (stop date : 21 - Apr - 2021) . The patient was discharged on 21 Apr 2021 to rehabilitation on baseline 2L O2  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Case number PHEH2014US003834 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 16 year old male patient. Past medical history and concomitant medication were not reported. He vaccinated with FLUCELVAX (batch number: 010021A and expiry date: JUN 2014), at dose of 0.5 ml intramuscularly on 01 JAN 2014. No adverse event was reported following this administration error. Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
2 hr after MENACTRA vaccine RA pt c/o HA, N/V, arm & leg muscle aches.
Guillain Barre Syndrome, acute Inflammatory Demyelinating Polyneuropathy.
Had a massive stroke, was unable to move, communicate or function with out help. She was unable to recover from the vaccine induced stroke and died.
Pt reported feeling flu-like illness one day (3/30/21) post vaccination, subsequent loss of voice (4/1/21) . On 4/5/21 patient tested positive for Covid19.
(11-21-12) Red raised rash on left arm deltoid area. (11-28-12) - Dermatomal rash of vesicles erupted right dermatome. Dx'd with active shingles on 12-3-12.
Left upper extremity pain then swelling and redness that began about 4 days after receiving my 3rd dose of the Pfizer COVID-19 vaccine ("booster shot") at the hospital where I work.  I went to my primary care doctor 12 days after my 3rd vaccine dose because pain, swelling and redness were worsening and was started on aspirin and keflex and given an order for an upper extremity ultrasound.  I got the ultrasound done on 10/22/2021 which confirmed extensive LEFT upper extremity DVT.
The medication being available to clinicians occurred due to vaccines being left in the clinic or products being returned by the clinic and not appropriately segregated when returned to the pharmacy. This was a quick change, and we all worked to communicate as quickly as possible. Vaccine was given one day beyond date approved to administer.
Initial report received from a healthcare professional on 23 July 2013. A 38-year-old female patient, had received first intramuscular dose of ADACEL vaccine (Lot number: U4586AA and site of administration was not reported) on 23 July 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period was on 14 November 2012. The patient's estimated date of delivery was reported as 21 August 2013. At the time of this report, the patient had not experienced any adverse events. The patient's health during pregnancy, concomitant medications, medical history and specific risk factors (e.g.: alcohol, tobacco or recreational drugs) were not reported. At the time of this report, the patient's outcome was unknown. Documents held by sender: none.
Severe migraines 2 days after receiving the vaccine.  Unable to focus. Went to primary care then to neurologiest. Completed CT brain scan. Cleared of any abnormalities. Given Topamax to help with migraine symptoms. Drug cause difficulty focusing on day to day activities. Quality of life is negatively impacted by vaccine reaction. Still having migraines as I type this 7 months after receiving the vaccine.
Arm pain; Arm pain that reflected also in the back; Arm pain that reflected also in the left hand.; Fever below 100; headache; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient 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 04Jun2021 at 20:00 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and hypothyroidism and penicillin allergy. Concomitant medications included metformin (MANUFACTURER UNKNOWN), semaglutide (RYBELSUS), empagliflozin (JARDIANCE), glipizide (MANUFACTURER UNKNOWN) and simvastatin (SEVERAL). The patient previously took Codeine on an unspecified date for an unspecified indication and experienced drug allergy. 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. On 05Jun2021 at 01:00, the patient experienced arm pain that reflected also in the back and left hand, fever below 100 and headache. No therapeutic measures were taken as a result of the events. The clinical outcome of the events arm pain that reflected in the back and left hand, fever below 100 and headache was resolving at the time of this report.    The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Muscle pain mostly on left side, shoulder pain.  Pain radiates from shoulder through back all the way to the buttocks. Been bruise on left leg at site of injection, swelling (1ml up) and white dots.  General aches and pains, no fever or temperature.
shingles; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix. On an unknown date, several months 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 information received were as follows: This case was reported by the Physician's Assistant (PA). The age at vaccination was not reported. A couple of months after receiving Shingrix, the patient experienced shingles. The reporter consented to follow up.  The reporter reminded of 24 hour time frame to report.    The reporter stated an MSL spoke with the PA on Wednesday.
Narrative: Patient received Pfizer COVID 19 Vaccine on 17 February 2021. The patient experienced shortness of breath that required the use of his albuterol inhaler four times and then improved per note on 27 June 2022 originally reported by doctor on 27 June as historical. The patient did not go to the hospital.
Pain and burning to (L) deltoid. Severe swelling and discoloration in surrounding 4 in of vaccination site. Swollen, red lesions and several welts at periphery. Warm to the touch. Naproxen 500 mg bid, ATARAX 25mg , rest, fluids.
Patient experienced a  slight tightness in her throat, explained as a slight difficulty in swallowing, similar to a sore throat during a cold.  She didn't present any other symptoms, and stayed a total of 45 minutes from time of injection as a precautionary measure.  We gave her some oral diphenhydramine to help with the itching/scratchy throat.
This non-serious spontaneous case, was initially received on 18-Oct-2017 from other health professional (nurse), concerns a patient of an unspecified age and gender. On 09-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 09-Oct-2017, employees were given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided for was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However, a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. Narrative amended accordingly. Non-significant case correction received with IRD 18-Oct-2017: The verbatim of the event 'product leakage' was corrected and the lead sentence in narrative was amended.
Generalized aching/ body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Generalized aching/ body aches) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    The patient's past medical history included COVID-19 on 12-Nov-2020. Concurrent medical conditions included Psoriatic arthritis.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In February 2021, the patient experienced MYALGIA (Generalized aching/ body aches). At the time of the report, MYALGIA (Generalized aching/ body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication information was provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was provided.   This case was linked to MOD-2021-621454, MOD-2021-621451 (Patient Link).
This spontaneous report as received from a medical assistant refers to a 16 year old patient of unknown gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 21-NOV-2017, the patient was inadvertently vaccinated with PEDVAXHIB 0.5 ml, intramuscularly, (lot # L035878, expiration date: 11-AUG-2018). There was no adverse event reported.
A non-serious, spontaneous report of "patients got a full dose of FLUMIST in each nare" was received from a nurse practitioner concerning 16-20 adult patients. The nurse practitioner discovered that an office assistant was administering two doses of FLUMIST per patient, one in each nostril. The patients received the doses from 24-Sep-2009 through 16-Oct-2009. There were no adverse events associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable.
PT CALLED TODAY C/O ALL OVER BODY ACHES. RIGHT BREAST REALLY SORE BUT THE INJECTION SITE IS NOT SORE. DID NOT SLEEP VERY GOOD LAST NIGHT. THIS STARTED APPROXIMATELY 10:30PM.  PT ASKED WHAT SHE COULD TAKE. I ADVISED HER TO TAKE IBUPROFEN.
"Cold". Looked run down within few days of vaccination. Oct. 2, 2012 - first mild "spells", increasing in frequency and intensity. Oct. 26 - 17 seizures/24 hrs., day and night.
This child had a fever, precipitating status epilepticus. ICU admission , not intubated.
Patient came to the pharmacy 3/20/21 complaining of Gas, uncontrollable diarrhea, fatigue and headache for the last 5 days. She stated that the symptoms started 3/16/21 the day after vaccination.  Anti-diarrhea medication was unsuccessful at stopping the symptoms.
Open wound; Abscess; This is a spontaneous report from a contactable consumer. A 75-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 14: 30 (Batch/Lot number was not reported), at the age of 75-years at vaccination, as SINGLE DOSE for covid-19 immunisation.  Medical history included black lung and COPD, he fell about three weeks before they got the vaccine. He was swollen in his back with infection where he fell on a rock, back was hurting in the hip area due to the fall. Family history includes: Sister has had an abscess 20 years ago. The patient's concomitant medications were not reported. Reports he fell about three weeks before they got the vaccine. He was swollen in his back with infection where he fell on a rock. He received the first dose of the Pfizer COVID 19 vaccine on 5MAR2021 at 1430 in the left arm. On the 12MAR2021, there was a knot across his back. The doctor said the bruise didn't come to the outside; it started bleeding inside and turned his back red across the bottom. He went to the doctor who put him in the hospital and they drained out all the infection from the wound. Patient was admitted to the hospital 12MAR2021 and discharged 16MAR2021. Mentions you have to check in at the front and then they send you around to the ER to see the doctor. When he was admitted they diagnosed an abscess. They cut it and lanced it and put in a drain tube that is still draining. Now the wound is still an open wound. He has an appointment with the surgeon and his regular doctor soon. The swelling is gone now and the wound was actually in the hip. Adds he had the infection when he got the first shot but he never ran a fever. Adds they are treating him with the generic for Levaquin and he has four more days. Adds when he was in the hospital he was given two types of strong IV antibiotics but she does not know the names or anything else about them.  The outcome of the event abscess was recovering with sequalae; open wound was recovering.  Information on the lot/batch number has been requested.
EXTREME TIREDNESS AND FATIGUE; This spontaneous report received from a parent concerned a 37 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced extreme tiredness and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extreme tiredness and fatigue was not reported. This report was non-serious.
Patient was given the Pfizer covid vaccine in left deltoid at 3:25 pm. At 3:32 pm patient c/o jaw-throat-tingling. Also reported, "Buzzing like a tuning fork." Patient reports hx of panic attacks and tremors. At 3:45 pm Benadryl 50 mg PO was administered. Patient questions, "Do you have anything stronger?"  She also instructed, "Crush up the pills to make them work faster." Vitals signs were monitored:  At 3:32 pm BP 156/85, at 3:42 pm BP 158/91, HR 72, at 3:48 BP 178/92, HR 85, Resp 15, O2 Sat 98% room air. Patient advised she needed to call her sister and was talking on the cell phone with full/complete sentences. No shortness of breath observed. No wheezing noted. DC BP was 167/79, HR 68. Sister arrived and assisted with decompression of symptoms. Discharged alert and oriented x 4.
Blisters on the arm where vaccine was given, swelling of the lymph nodes under arm pit all the way up to my neck, fever of 102.5, chest felt tight of tough to breathe, rapid heartbeat. Sweating, one week later lymph nodes still some swelling, and new fever 1 whole week later.  101.
4" x 4" in diameter. Redness, warmth to touch. Parent thinks its the DTaP vaccination that was given on that leg (Right leg) circular shape.
About 3 hours after having the vaccine, heart started racing, couldn't get it to slow down. Called 24 hr nurse hotline, she was told to call 911 and go to the ER. Observation for 3 days, given medication to get it under control. Test came back normal. She is now on blood thinner medication. No problems before having the vaccine.
This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medications were reported.  No treatment information was reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Company comment: Very limited information regarding this patient's death has been provided at this time.; Sender's Comments: Very limited information regarding this patient's death has been provided at this time.; Reported Cause(s) of Death: Death
Light headed, dizzy, hard to focus/confusion, elevated heart beat, elevated blood pressure, slight shaking started 30 minutes after injections.  I immediately took a Benadryl 25mg to counteract the symptoms and prevent body tremors (previous histamine attack symptom).  Normal symptoms of having a histamine attack later presented, e.g. extreme fatigue, insomnia, occasional dizziness.
Had Menactra (.5ml) on 5/1/07. On 5/5/07 around 8pm he c/o itching. It gradually increased with hives over entire body. No trouble breathing so mom call ER they suggested 2 tab Benadryl Q 4 hrs throughout night. Within 48 hrs all hives were gone.