chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE details or PQC.; PNEUMOVAX 23 was inadvertently administered after it's expiration date; This spontaneous report as received from a licensed practical nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.   On 24-JAN-2023, the patient was inadvertently vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe (lot # U010533 with expiration date: 29-OCT-2022; 0.5 milliliter, strength and route were unknown) for prophylaxis (expired product administered). No symptomatic side effects reported during time of report. No additional adverse event (AE) details or product quality complaints (PQC).
Hospitalized (11.9.21);  COVID-19 positive (11.3.21);  Fully Vaccinated  Admission Date: 11/9/2021 Discharge Date: Nov 13, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Syncope and collapse [R55] Debility [R53.81] Chest pain in adult [R07.9] COVID-19 [U07.1] BRIEF HISTORY OF PRESENTING ILLNESS: 78-year-old female with a past medical history significant for fibromyalgia who presents after suffering a syncopal event while going to the restroom at home.  Upon awakening, the patient states she felt some sharp chest pain.  She decided to present to the emergency department.   In the emergency department the patient was found to be hemodynamically stable.  Labs are obtained and remarkable for a white blood cell count of 12000. Cardiac enzymes were checked and found remained relatively flat at 27 and 28. CT of the head unenhanced shows no acute process.  CT of the cervical spine showed no acute process.  CT PE study showed no evidence of PE but ground-glass opacities were noted with some reactive adenopathy.  CT of the abdomen pelvis with IV contrast was obtained and this showed no acute intra-abdominal process but the patient was found to have a 7 mm low attenuating anterior pancreatic lesion concerning for cyst versus neoplasm.  Patient was thought to warrant admission to the hospital.  The patient was found culture positive had no symptoms and did receive monoclonal antibody therapy and remained on room air throughout her hospital stay. Patient had no recurrent syncopal or presyncopal events while hospitalized.  She had negative orthostatic vital sign and to evaluate for study likely posterior stroke, she did go for MRI of the head with and without contrast and this did not show any acute pathology. The etiology behind the patient's symptomatology was uncertain.  She did undergo further imaging in the form of echocardiogram and this did not show any evidence of shunt or any significant valvular pathology or focal wall motion abnormalities.  After being seen by PT and OT, the patient did not seem to have any requirements that would steer her toward subacute rehab facility placement, therefore she was thought to be appropriate for discharge home with outpatient physical therapy as desired. Of note, the patient did have an incidental finding of a pancreatic mass and MRCP suggested an intraductal papillary mucinous neoplasm.  Recommendation based on imaging was for the patient have 1 year follow-up imaging in the form of MRCP for surveillance.
I ate a normal breakfast with protein and carb and my normal dose of caffeine in the morning. Within 10 min of getting the vaccine my head was splitting and pounding so badly I talked to the nurse. I have had a migraine before, but this was different and unlike any headache I ever have had. Lights did not bother me, but sounds were harsher. The frontal lobe of my head is where it hurt, not in my temples and not anywhere else.  The pounding was so bad I was nauseous and dizzy feeling. I was told to go home and take tylenol and I did so. I use arthritis tylenol which is the strongest and I took 2 but it didn't help take away the pain. Sleeping helped some, which was surprising as I have never been able to sleep with any headache or migraine before.  The headache lasted throughout that first day, throughout the second day and mostly through the third day. It started to lesson around 9pm on the third day. By this time I had tried naproxyn, ibuprophen, and tylenol (i am allergic to asprin). Nothing helped what so ever.  On the fourth day the much milder headache still lingered and on the fifth day it was finally gone.  The nausea and dizziness lasted the entire first day and through part of the second day.  I am someone who walks on broken bones and stage 5 avascular necrosis without complaint. I am labelled someone who doesn't feel the same amount of pain as most people do. It is common for me to hurt myself and not even know it until someone points it out.  So pain I can normally handle, I also have techniques to lesson pain that I use every day, but nothing helped this headache.  As someone who dislocated her finger and popped it back in myself and went back to cooking immediately... The headache was not manageable. I tried Everything I know to do.  I actually felt like my brain was on fire and going to explode. I was concerned enough to talk to a nurse, which is also something I would not do if it did not feel like that.  When I get a migraine and the lights hurt my eyes, I pop on some glasses and continue onward. Not a big deal.   But with whatever happened to my brain that day, I'd say 90% would have ended up in the emergency room. But I prefer to handle things on my own.
She went to Urgent Care c/o swelling and pain while ambulating on 3/26/17 and was diagnosed as a rash and she was instructed to ice the area, use ibuprofen/TYLENOL as needed, and to encourage activity/walking.
Hives that burned and itched. Went to many different doctors with no treatment other than being told to take Claritin, Benadryl, antacids, and Zyrtec. I was finally sent to an allergist where they said it was demographic urticaria and to take 40mg of Zyrtec a day along with Benadryl. Symptoms subsided with the high amount of Benadryl and Zyrtec, and over time became less persistent. Today I still get hives when my skin is touched every now and then, but have random numbness in left side of my body that lasts for a few minutes along with a spider sensation down my back.
No adverse effects were reported; patient was inadvertently administered a dose of PNEUMOVAX 23 (unknown lot/expiration date) instead of a dose of Prevnar 13; This spontaneous report was received from a physician and refers to an almost 2-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in May 2019 (reported as unknown date last week), the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency, route of administration, lot# and expiration date were not reported) instead of pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (dose, frequency, route of administration, lot# and expiration date were not reported), for prophylaxis.The physician confirmed that this was not a product confusion. No adverse effects were reported.
presented to emergency department at hospital for shortness of breath and chest pain on 11/18/2021
Internal pain; Moves from neck; It moves from neck to hips; It moves from shoulder blades; No sores but feels like a knife in my back; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Internal pain), neck pain (Verbatim: Moves from neck), pain in hip (Verbatim: It moves from neck to hips), shoulder blade pain (Verbatim: It moves from shoulder blades) and back pain (Verbatim: No sores but feels like a knife in my back). The outcome of the pain, neck pain, pain in hip, shoulder blade pain and back pain were not resolved.   It was unknown if the reporter considered the pain, neck pain, pain in hip, shoulder blade pain and back pain to be related to Shingles vaccine.     It was unknown if the company considered the pain, neck pain, pain in hip, shoulder blade pain and back pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-JUL-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she got the vax 2 of them over 5 years ago now.  Patient stated he/she older and suffer from internal pain.  Patient stated it moves from neck to hips and shoulder blades.  Patient had no sores but he/she feels like a knife in back. The follow-up could not be possible as no contact details were available.
Dizziness; Chills; Exhaustion; Feeling unwell; Tightness in chest; Fast heartbeat; Shortness of breath/ trouble breathing; Headache; Stomach pain; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Sep2021 at 08:15 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included influenza vaccine (FLU) for immunisation on 26Aug2021. The patient received other medications (unspecified) within two weeks of COVID-19 vaccine. The patient received other vaccines within four weeks prior to the vaccination. On an unknown date in Sep2021, the patient experienced dizziness, chills, exhaustion, feeling unwell, tightness in chest, fast heartbeat, shortness of breath/ trouble breathing, headache, and stomach pain. The events resulted in emergency room/department visit or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness, chills, exhaustion, feeling unwell, tightness in chest, fast heartbeat, shortness of breath/ trouble breathing, headache and stomach pain were resolving at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
p/vax pt became very fussy;mom unable to settle baby;T103 R;mom very concerned as non of other child did this;
Pericarditis; Partially Collapsed Lung Resulting in Pneumonia; Partially Collapsed Lung Resulting in Pneumonia; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE , Batch/Lot No: EW0151), administration date: Apr2021, when the patient was 53 years old, for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE , Batch/Lot No: FH6204), administration date: Mar2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: PNEUMONIA (hospitalization), PNEUMOTHORAX (hospitalization) all with onset Nov2021, outcome "unknown" and all described as "Partially Collapsed Lung Resulting in Pneumonia"; PERICARDITIS (hospitalization) with onset Nov2021, outcome "unknown". The patient was hospitalized for pericarditis, pneumonia, pneumothorax (hospitalization duration: 3 day(s)). The events "pericarditis" and "partially collapsed lung resulting in pneumonia" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of pericarditis, pneumonia, pneumothorax.  Additional information: The patient had pericarditis & partially collapsed lung resulting in pneumonia. But the most concerning was pericarditis. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had been tested for COVID-19. The patient received the fourth dose of BNT162b2 (lot number: FM0173 9122) in Jun2022.  No follow-up attempts are possible. No further information is expected.
Three to four inch wide by three to four inch long redness, itchy area. Noted 2 weeks after injection and lasted 2 days. Used cortizone cream, went away.
Highest temp measured 106; rash on stomach & back; duration of illness 3 days; 4DEC89 conjunctivitis w/matting & purulent URI; BOM; cervical nodes pea-size; 6DEC89 exam - TM is injected, pharynx sl injected; impression: respiratory infect;
Headache, sweating, headache, "feels hot thn cold all over" Narrative:
Debilitating joint paint. All joints, started out worse in hands. I couldn?t make a fist, then affected my ankles, knees, wrists and shoulders. Needed a cortisone injection in my shoulder and have been taking anti inflammatories regularly to help with the pain so that I can work. I regularly use ice and also regularly do physical therapy exercises to help with the pain.
Outpatient positive COVID test on 7/19/21 after receiving Pfizer two-dose series
ADMINISTERED 0.3ML PFIZER BOOSTER INTO THE LEFT ARM OF 16-YR OLD PATIENT. (PT REQUESTED PFIZER)
24JAN94 mom noticed twitching mostly of upper body pt was awoke fell asleep & wake up w/twitching which lasted about 7 mins; t100.6;
Vibrating from my waist to my neck; Atrial fibrillation; Really tired; Felt lousy; Extreme thirst; I've lost 8 lbs from the last month or two; A spontaneous report was received from an consumer concerning a 70 years old, female patient who experienced atrial fibrillation, tired out, vibrating from waist to neck, felt lousy, extreme thirst and lost 8 lbs last month.    The patient's medical history was not provided.    Concomitant product use was none by the reporter.   On 01 Feb 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 027L20A) in left arm for prophylaxis of COVID-19 infection. On 01 Mar 2021, prior to the onset of the symptoms, the patient received the second of two planned doses of mRNA-1273 (Batch number not provided) in left arm for prophylaxis of COVID-19 infection.     The patient experienced the events tired since an unknown date in Feb 2021; vibrating from my waist to my neck, atrial fibrillation, felt lousy, extreme thirst and lost 8 lbs last month all since 06 Feb 2021. The patient was hospitalized on 06 Feb 2021 and was discharged on 07 Feb 2021.  Laboratory investigations included echocardiogram which "turned out ok" and EKG "was ok" both performed on an unknown date in Feb 2021.  Treatment for the event included diltiazem and Eliquis both since an unknown date for an unknown indication.    The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events felt very tired, vibrating from my waist to my neck, atrial fibrillation, felt lousy, extreme thirst and lost 8 lbs last month were unknown.; Reporter'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.
Confusion; Unproductive cough/ Some Cough; A rash along neck; Low grade fever; Diagnosed with covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with covid), CONFUSIONAL STATE (Confusion), COUGH (Unproductive cough/ Some Cough), RASH (A rash along neck) and PYREXIA (Low grade fever) in a 70-year-old female patient 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. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jul-2021 at 1:00 AM, the patient experienced COVID-19 (Diagnosed with covid). On an unknown date, the patient experienced CONFUSIONAL STATE (Confusion), COUGH (Unproductive cough/ Some Cough), RASH (A rash along neck) and PYREXIA (Low grade fever). The patient was treated with PARACETAMOL (TYLENOL) in July 2021 for Fever, at an unspecified dose and frequency and AMYLMETACRESOL, DICHLOROBENZYL ALCOHOL (ROBITUSSIN [AMYLMETACRESOL;DICHLOROBENZYL ALCOHOL]) in July 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (Diagnosed with covid), CONFUSIONAL STATE (Confusion), COUGH (Unproductive cough/ Some Cough), RASH (A rash along neck) and PYREXIA (Low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Body temperature: 101.8 f (High) low grade fever (highest recorded temperature). On 21-Jul-2021, Body temperature: 101.0 f (High) low grade fever. On 21-Jul-2021, Oxygen saturation: 92 (Inconclusive) 92 %. On 23-Jul-2021, Body temperature: 101.7 f (High) fever.   No relevant concomitant medications were provided.
Pfizer COVID Vaccine treatment under Emergency Use Authorization(EUA): Vaccination received 3/2/2021. On 3/16/2021, maternal cardiac arrest, terminal fetal bradycardia, emergent C-section. Likely amniotic fluid embolism and DIC.
Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 13-year-old female patient who experienced diarrhea, abdominal pain and cramping and nausea. At 13 years of age, the patient received a dose on 08-Dec-2003. Medical history: The patient has no relevant medical history. Product details: Indication for Flumist (2003-2004) was immunization. Product was administered on 08-Dec-2003. Dose regimen was 1 dose (intranasal). Concomitant therapy: Patient was not taking concomitant therapy. Event details: the patient experienced diarrhea (diarrhoea), abdominal pain and cramping (abdominal pain) and nausea (nausea) on 14-Dec-2003. As of 15-Dec-2003, her frequent bowel movements have continued. No additional information was available at the date of this report.
swelling in armpits bilaterally. Reports started about the 26th of October in the right and a couple days later in the left. Denies fevers, chills, unusual sweats, n/v/d.  Reports 3 small red bumps near swelling on right side. Red bumps are insect bites, not related.
Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C; Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Pfizer (Dose-1) on 07-Jan-2021, Pfizer (Dose-2) on 28-Jan-2021 and Pfizer (Dose-3) in October 2021. Past adverse reactions to the above products included No adverse reaction with Pfizer, Pfizer and Pfizer.    On 15-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Date and time vial was first punctured was on 15 Jun 2022 at 9.15 AM, the vial undergo temperature excursions of plus1.9C to plus 6.4 C. Total amount of time the vial was exposed to room temperature range 8° to 25°C= 46° to 77°F.  No treatment medication were reported.   Reporter did not allow further contact
Patient (DOB 4/19/1991)  received the COVID vaccine at 1405. At 1407, she reported dizziness and EMT and RN  responded. She complained of lightheadedness and was clammy and pale. Vital signs were as follows: heart rate of 112, respiratory rate of 12, and O2 of 99%. The client has no allergies, takes no medications, and has no medical conditions that she is aware of. She was alert and oriented, and her pupils were equal and reactive to light. At 1415, the client had another set of vitals taken: blood pressure 100/palpable, heart rate 102, and O2 99%. The client was unable to keep her arm still and stated the blood pressure cuff was too tight, so the blood pressure was difficult to obtain. The client refused water at this time and stated her last meal was at 1330. At 1420, the client stated she felt more calm and EMT attempted a repeat blood pressure, which was 104/60. At this time, the client's color had returned and she was less clammy. At 1425, the client's repeat vital signs were as follows: blood pressure of 100/80, heart rate of 104, respiratory rate of 16, and O2 of 98%. The client was again offered water, which she refused. At 1430, the client stated that she would rate the severity of her symptoms at an 8/10 and she was now rating her symptoms of dizziness and lightheadedness at 2-3/10. At this time, the client accepted a bottle of water and started to drink it, no complaints of nausea. At 1435, the client's repeat blood pressure was 110.80 band her heart rate was 100. She stated her symptoms were resolved. Benadryl was refused. At 1442, the client's vital signs were as follows: her blood pressure was 108/82, heart rate of 98, respiratory rate of 14 and an O2 of 98%. The client was educated regarding system, emergency response and when to activate , and to follow up with her primary care provider. The client was escorted out to her car by EMT , ambulating with a steady gait, and was driven home by her girlfriend.
Information has been received from a registered nurse referring to a 1 month old infant of unknown gender. The patient's concurrent conditions and medical history were not reported. On 11-SEP-2015, the patient was intended to receive an unspecified hepatitis B vaccine, was inadvertently administered VAQTA (dose, strength, lot # and route were not reported). No adverse effects reported. Additional information is not expected as the reporter did not wish further contact.
This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 23 year-old female patient. On 09-Oct-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5mL. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.