chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, Fever,Joint pain, irregular heart beat; Headache; Fever; Joint pain; This is a spontaneous report from a contactable consumer or other non hcp. A 76-year-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: en6200), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 at 13:30 (age at vaccination was 67 years old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included atenolol (ATENOLOL) taken for an unspecified indication, start and stop date were not reported; pravastatin (PRAVASTATIN) taken for an unspecified indication, start and stop date were not reported. Patient didn't receive other vaccines within 4 weeks prior to vaccination. Patient previously received first dose bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: el9264,) via intramuscular in Left arm, on 28JAN2021 13:30 (age at vaccination was 67 years old) as DOSE 1, SINGLE for covid-19 immunisation. patient had no allergies patient didn't had covid prior to vaccination and patient was not tested for covid to post vaccination. The patient experienced headache, fever, joint pain, irregular heartbeat on 19Feb2021 at 04:00. The outcome of the events heart rate irregular, headache, pyrexia, arthralgia was recovered on unspecified date.  Follow-up attempts completed. No further information expected.  FUP#1 (13May2021): Follow-up activities closed: Follow-up attempts completed.
Vaccine was stored after expiration date in the refrigerator; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator) and EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator) and EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications and treatment were reported.  No adverse events reported.   No temperature excursion of the product was reported.  There was no product complaint associated. Vaccine was refrigerated on 08-Nov-2021.
Swelling and erythema of right thigh at the injection site. Possible cellulitis with the spreading of the erythema. No fever. Treated with Keflex.
Very sick, almost lost her life was diagnosed with Type 1 Diabetes on January 1st. Does not run in family. I know vaccine triggered this, since she was perfectly healthy.
I was driving from my house going the speed limit (70 mph).  I left the house at 3:00 and felt fine.  I was hydrated, was not hungry and was feeling fine.  At 3:10 I got extremely hot and started to feel like I needed to throw up.  I pulled over 2 lanes to the side of the road but could not open my door because of the heavy traffic.  Once I pulled over I started seeing bright lights and then my body started to get really cold and I was shivering uncontrollably and my neck let my head roll back like I had no muscles.  I held onto my head and immediately called my daughter and said 911.  I started to breath really hard, not because I couldn't breath, but later to find that I may have been having an anxiety attack because of not understanding what was happening to my body.  I have never had an anxiety attack before in my lifetime.  Since there was an urgent care facility about 100 ft off the exit ramp, I drove myself in this condition to the facility and checked myself in.  This was not very smart as I was still having muscle issues and shaking and breathing uncontrollably.  I also had extreme pain in both of my arms and both hands went numb (apparently from the anxiety/breathing).  I experienced extreme body aches.
Initial misuse report received from a healthcare professional on 11 February 2014. A patient had received only the ACTHIB portion of PENTACEL reconstituted with ACTHIB diluent. It's an underdose of vaccine administered. No adverse event was reported. List of documents held by sender: None.
bad reaction; This case was reported by a consumer via interactive digital media and described the occurrence of adverse reaction in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Bexsero.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Bexsero and experienced bad reaction.
catastrophic side effects; Initial information was received on 23-Feb-2023 regarding an unsolicited valid  serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who experienced catastrophic side effects while receiving vaccine YELLOW FEVER VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 2020, the patient received a  dose of suspect YELLOW FEVER VACCINE produced by unknown manufacturer ) (dose, formulation, strength, lot and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date the patient developed a serious catastrophic side effects (catastrophic reaction) (unknown latency) following the administration of YELLOW FEVER VACCINE.   Action taken with YELLOW FEVER VACCINE (YELLOW FEVER VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (catastrophic side effects).  At time of reporting, the outcome was Unknown for the event catastrophic side effects.  This event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 28-FEB-2023: This case involves an unknown age female patient who experienced catastrophic side effects while receiving vaccine YELLOW FEVER VACCINE. Additional information regarding condition at the time of vaccination, concomitant disease or risk factor excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of suspect cannot be assessed.
10/31/22 presents to ED for "corona virus concern" "hypoxia cough and fever". PMHx of hypertension and CHF.
Entire body achy at midnight. Took total of 2 grams Tylenol,  HA and tired x24 hrs
Giant cell arteritis. I'm still being treated with high dose daily prednisone and also take Actemra. Treatment going on for two years.
Information has been received from a physician concerning a 3 year old male patient who was vaccinated. Concurrent conditions and medical history were not reported. On 07NOV2015 the same physician ordered that the patient should be vaccinated for pneumococcus and receives a dose of PNEUMOVAX. On the same date the patient was vaccinated. Despite that it is not sure if the patient received PNEUMOVAX23 (lot #, dose, frequency and route of administration were not provided) or PREVNAR. On an unspecified date the patient's chart showed that he received PREVNAR instead of PNEUMOVAX23. The reporter stated that he does not believe that the patient experienced a wrong vaccine administration as the product confusion. This information could not be verified. No adverse effects were reported. The outcome of the adverse event is unknown. The relatedness between the wrong drug administration is not related to PNEUMOVAX23. Additional information has been requested.
Breakthrough case admission after 3 vaccines Moderna 3/31/21 Lot# 010A21A;  Moderna 4/30/21 Lot# 043B21A;  Moderna 5/26/22 Lot# 038A22A
Patient began sweating, hyperventilating and "feeling bad like he might pass out"  about 5 minutes after vaccine.  He lost color in his face about 2 minutes after and asked if he could like down.  Paramedics were called and he was taken for care.
Information has been received from a health professional concerning a "11 or 12 year old" female who in November 2007, was vaccinated with her first dose of Gardasil vaccine. Concomitant therapy included influenza virus vaccine (unspecified). In November 2007, the patient experienced pain at the injection site going from her shoulder to her neck and ear almost immediately after getting the shot. That same night the patient also experienced a fever of 104 Fahrenheit. Subsequently, the patient recovered from pain at the injection site and a fever of 104 Fahrenheit. The patient sought medical attention the next day in the office and the doctor gave her Motrin. Information has been received from a healthcare professional concerning a 12 year old female who on 06-NOV-207, was vaccinated with her first dose of HPV vaccine (lot # 639435/1265U). On 06-NOV-2007, within 2 -3 minutes of receiving HPV vaccine, the patient exprienced pain at the injection site going from her shoulder to her neck and ear almost immediately after getting the shot. That same night the patient also experienced a fever of 104 F with a headache and back pain. Subsequently, the patient  recovered from pain at the injection site and a fever of 104 F. The patient sought medical attention the next day in the office and the doctor gave her (MOTRIN).
Symptoms began 24 days after flu vaccine given on 1/4/07.  02/27/2007 VAERS report received with medical records included. Patient initially presented to local ER with symptoms of diffuse generalized weakness beginning 26 days after receiving flu shot.  She was initially discharged from the ER but presented again the next day with worsening symptoms. 2 days prior to admission she noted tingling in her arm.  1 day prior she was unable to lift her arms above the shoulders. On the day of admission she noticed leg weakness and was unable to get up.  She was admitted. Initial PE showed Power in upper and lower extremities is 3 by 5.  Reflexes symetrically absent in all 4 limbs.  Touch greatly diminished. O2 Sat 94%. Somewhat depressed, otherwise WNL. Multiple consults.  Treated with hematoglobin with slight improvement initially, however still continued to have weakness and difficulty raising arms. Patient was transfered to another facility for continued treatment. Final Diagnosis:  1) Acute Guillain [[name]] Syndrome with diffuse weakness. 2) Dysphagia.  3) Worsening acute renal failure.  4) Hypoxia.  5) Degenerative Joint Disease 6) Increased Creatinine  7) Diabetes Mellitus Type II  8) Hypercholesteremia  9) Urinary Incontinence  10) Peripheral Neuropathy  11) Increased WBC  12)  Respiratory Alkalosis. Initial Admitting DX to 2nd hospital is: Probable Guillain [[name]] Syndrome.  Nuerology consult Impression:  Differential DX certainly includes acute inflammatory demyelinating polyradiculopathy, superimposed upon a baseline diabetic neuropathy.  Indeed the presence of "Guillain [[name]] Syndrome" can be difficult to make in the presence of baseline diabetic neuropathy as well as AIDP.  Primary myopathic process is included in the differential DX given her proximal weakness.  Dysfunction at the level of the neuromuscular junction is less likely. Rheumatology consult Impression: is consistant with polymyositis. 02/28/2007 Discharge Summary requested from 2nd hospitalization./pc 03/02/2007 D/C Summary received from above 2nd hospitalization.  Physical exam unchanged compared to admission, except pt. seems to have better strength in her legs and even in her arms.  She is now able to walk.  Patient was D/C'd to an inpatient rehab. D/C DX:  GBS vs. Myopathy.
Pt came back approximately 30 minutes later saying that she was very cold & feeling sleepy, but otherwise ok. Approximately an hour later patient stated no change. Still cold & sleepy.
Pt. noticed (R) deltoid was tender to touch after receiving TDaP (within minutes). Area became swollen with a lump on 7/1. Continues to have swelling, pain at site. No numbness or paresthesia. Advised warm pack, OTC analgesics.
Pt reported itching sensation 1 hour after getting her injection.  The itching sensation is on her chest (front and back), arms, hands and both legs.  Pt called her PCP and left a message to his nurse.  PCP will return her call.  Pt stated she will take Benadryl at home.
I received my vaccine at 1:10pm. As I was waiting afterwards, I started getting really itchy around 1:25pm. I have a lot of medicinal allergies and this is my normal response when I have a reaction. The itching gradually got worse and some swelling started as well. Around 1:45pm my throat started swelling and I was having trouble swallowing. This continued to get worse, so I stopped at the ER on my way home. I was given Benadryl in an IV and observed for 2 hours. The swelling in my throat went down by 2:45, but the itchiness continued until around 5pm. That evening, the only symptom left was fatigue.
Missed 2nd dose.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose.) had resolved.        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.   No concomitant medications were provided.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow up information received contains significant information. Added suspect start date. Added Reporters Email id from the initial Source document.
Pt left pharmacy and returned about an hour later and eyes were puffy and swollen, arms and throat were itchy. Patient took BENADRYL (a few doses) to get rid of the symptoms.
was very tried at 1:30 after lunch. Had to take a nap around 3:30pm so I could do my my evening events.  Went to bed very tiered at 9pm that night then woke up to go to the bath room about 3am next morning and I got dissey, I felt like  I was spinning I also was hungry than normal and had to eat before I could go back to bed, this is not usual. when I woke up the next day I was okay but I found hives on my neck so I took a Benadryl for Allergies and Called my health clinic.  Also feel vary tiered for the next 3 days after like one would have from an Allergy reaction,  still trying to find my energy mostly really tiered after lunch and dinner feel like I need to go to bed.  Been really hungry as well after vaccination but that is probably due to Vaccine +  cold weather+  Daily work and Activities; letting you know about that cause it is happening around the same time and seems like I am more hungry than was before the vaccination.
Chronic urticaria with dermatographia, trouble swallowing (substernal esophageal discomfort even with saliva), and moderate to severe asthma with poor control, both ongoing even after 10 day oral steroids, first time in patient?s life needing inhaled corticosteroids and frequent bronchodilator use
I developed a COVID-19 Test-Positive 19DEC2022  I developed shortness of breath 21DEC2022 and went to the ER at hospital and was diagnosed with RSV and started on Oral Steroids on 22DEC2022 Predezone.  On 25DEC2022 my shortness of breath and cough worsened and so  went back to the ER at hospital where I was given two inhalation treatments of Steroids as well as 120 mgs of Prednisolone through an IV.  On 30DEC2022 I developed Hemoptysis  which was diagnosed as Bronchitis. On 08APR2023 I was diagnosed with COVID-19. 02SEP2022 Moderna Bivalent vaccine was taken.
12/12 Received booster shot at around 4:15-4:30pm.  12/12 Starting 2 hours post vaccine 6:30pm: mild arm pain, nausea began 12/12 Starting 4 hours post vaccine8:30: severe arm pain, moderate nausea, and moderate fatigue *Went to sleep at around 10pm, woke up at 6:30am. Sleep was regularly interrupted by arm pain.* 12/13 14 hours post vaccine: severe headache, nausea, severe pain in right arm, hot flashes mixed with chills (on and off), dizziness, severe fatigue, body and muscle aches (mostly in joints). Tylenol did not help.  *Symptoms caused me to leave work at 12:00pm 12/13, slept most of 12/13. Tylenol did not help any of the symptoms.*  12/14 ~36 hours post vaccine: moderate headache and arm pain, pain in armpit lymph nodes- Tylenol helped.  12/14 ~42 hours post vaccine: mild pain in right arm, pain in armpit lymph nodes. *Went to bed at 10:30pm, slept through the night with zero issues* 12/15 ~60 hours post vaccine: woke up @6:30am with zero side effects, felt back to normal.
Severe fatigue  High fevere Sore throat Severe headache  Nauseous Severe dehydration
rash on inner thigh of rigtht leg/rash test positive for shingles; This spontaneous report has been received from a pediatrician, referring to a 6-year-old male patient. The patient's medical history included hydrocele repair. The patient had no current condition and concomitant medication. The patient had no known allergy. The patient never had chickenpox, herps zoster or herps zoster ophthalmic before.  On 20-MAR-2014, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # and expiration date not available; dose, route, strength and frequency unknown) for prophylaxis. On 17-AUG-2018, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # N035175 with expiration date: 09-JUN-2019, therapy type: recombinant human albumin (RHA); dose, route, strength and frequency were unknown) in the right anterior lateral thigh for prophylaxis. Other suspect therapies included sterile diluent (manufacturer unknown) (lot# M022416). There was no rash occurred at the site of injection following the vaccination.   On 20-JAN-2020, the patient developed a rash on inner thigh of right leg. There was no fever and the patient's temperature was 36.67 (units not provided). There was no other systemic symptoms. On 24-JAN-2020, the patient sought for medical attention and was seen by the another health care professional (HCP). The sample of the vesicle/lesion was collected and test was positive for shingles. The herpes zoster was on the dermatome of right groin and leg (near knee and above ankle), L2-3 and L3-4. On the same day, the patient was treated on acyclovir ointment (also reported as oral suspension x 7 days). Physician stated that the samples on swabs was in transport media and he did not have any dry samples. Also the patient's skin was healing and unfortunately there was no way to obtain any other sample. The outcome was considered as recovering. The causality assessment of events was unknown.
The patient reports their shoulder is locked up and cannot move it. This occurred 4 hours after the shot was given. The patient had no issues before this and was able to move his arm fine from the time he received the shot until about 4 hours after. He was at home and noticed it started feeling sore and hurting and he was unable to move it.
On April 21, 2021, this patient received their first doses of vaccinations during medical in-processing into basic training. On April 27, 2021, the patient received their first dose of the Moderna COVID-19 vaccine. The recruit answered ?No? to receiving any vaccine in the past 14 days on the immunization screening form so he was not screened further nor flagged and continued to receive their Moderna COVID-19 vaccine. Patient was discharged without complications and tolerated vaccine well prior to discharge.
This spontaneous report as received from a medical assistant, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 30-AUG-2018, the patient was vaccinated with a improperly stored PROQUAD recombinant Human Albumin (rHA) (which had a lot # of R006747 and an expiration date of 03-SEP-2019; however, dosage number and route of administration were not reported), for prophylaxis and was reconstituted with properly stored sterile diluent (MERCK). Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion on an unknown date: 6° F to 14°F for 6 minutes. Reportedly, there had been no previous temperature excursions and the aformentioned one was identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1809USA004794: US-009507513-1809USA006756.