chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; chills; sweating; This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced fever, chills and sweating. On an unknown date, the outcome of the fever, chills and sweating were recovered/resolved.   It was unknown if the reporter considered the fever, chills and sweating to be related to Shingrix.  Additional details were provided as follows: The patient reported that, after vaccination with dose of Shingrix, had severe reaction as fever, chills and sweating. The patient had fever of 105 to 106 and went down to 100 by day 5. The patient had  chills and sweating for the period of 5 days. The patient ask to doctor, if he or she could receive the 2nd dose of Shingrix. The patient's doctor said, it was up to him or her( the patient).
Information has been received from a nurse at a medical center concerning a 40 yr old pt who on 10Aug05 got a splash of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) in her eye. Subsequently, the pt feels weird/does not feel right. Additional information has been requested.
Fever; chest pain; swollen arm; tired; swollen node; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 14-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0217 and Expiry date: Unknown), dose 2 intramuscular, administered in Arm Left on 05Jun2021 12:30 at the age of 14-years-old as DOSE 2, SINGLE for covid-19 immunization. Medical history included attention deficit hyperactivity disorder from an unknown date and unknown if ongoing Other medical history: ADD , drug hypersensitivity from an unknown date and unknown if ongoing Known allergies: Penicillin. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination. The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. Concomitant medication included methylphenidate taken for an unspecified indication, start and stop date were not reported.On 05Jun2021 23:45 the patient experienced fever, chest pain, swollen arm, tired, swollen node. Therapeutic measures were taken as a result of fever , chest pain , swollen arm, tired , swollen node. Treatment included Antibiotic and prevacid and ibuprofen and Tylenol.On an unspecified date in 2021, the patient had recovered from the events.  No follow-up attempts are needed. No further information is expected.
lymphadenopathy  Narrative: Patient received COVID-19 Moderna vaccine doses on 2/27 and  3/27/21. During both doses patient was observed for 15 minutes post-vaccination  and not noted to have any adverse events immediately following vaccination. On  4/19/21 , patient messaged provider to report that developed 2 lumps on his  collarbone area since receiving the 2nd dose of COVID-19 vaccine. Patient  denied any pain, redness, or other symptoms from reaction with the exception of  fatigue. Patient reported on 4/21 that smaller lump appeared to be dissipating,  while the larger nodule had no change unless he manipulated it. When patient  manipulated the larger lump he reported dull pain. Patient stated he is checking the  lumps daily and was advised to keep the clinic up to date with any changes. Lumps  were likely lymphadenopathy which is a known adverse effect from the COVID-  19 vaccine.
Information has been received from a medical assistant referring to one or two unspecified patients of unknown age and gender. Concurrent, historical condition and concomitant therapy were not provided. On unknown dates the patients were vaccinated with improperly stored VARIVAX (lot # L048465, expiration date 02-DEC-2017; dose and route were unknown). No adverse effects was reported. Additional information has been requested.
Redness approximately the size of a golf ball with swelling and warmth at the injection site. Onset within several hours. Pt. saw MD, diagnosed with cellulitis, treatment started with Amoxicillin.
received expired dose; This case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a 2-month-old female patient who received Hib (Hiberix) (batch number unknown, expiry date 8th August 2021) for prophylaxis.   On 17th August 2021, the patient received Hiberix. On 17th August 2021, unknown after receiving Hiberix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The reporter stated that, the patient received expired dose of Hiberix, which led to expired vaccine used. The reporter stated that, the dose was invalid as per Centre of disease guidance site to readministered dose. The reporter did not consent to follow up.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
01/12/2016-01/14/2016-FEVER. 01/15/2015-NEUROLOGICAL DEFICIT, INVOLUNTARY MOVEMENTS, WEAKNESS, INABILITY TO WALK.
cardiomyopathy; This is a literature report for the following literature source(s):   A 42-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1). The following information was reported: CARDIOMYOPATHY (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Brain natriuretic peptide: 310; Catheterisation cardiac: no significant CAD; PCWP 15; PAP 33/16 (23 mmHg); mild pHTN; Echocardiogram: LVEF 2025%; LV dilatation; elevated LVEDP; Magnetic resonance imaging: dilated LV; no LGA; Red blood cell sedimentation rate: 17. Therapeutic measures were taken as a result of cardiomyopathy.  Clinical information: All patients commonly reported clinical symptoms of heart failure including fatigue, orthopnea, paroxysmal nocturnal dyspnea, and peripheral edema within 3 weeks from receiving the 2nd dose of the Pfizer COVID-19 vaccine. Patients had no prior known cardiac history or predisposing conditions. Diagnostic workup including a left heart catheterization showed normal coronaries. Echocardiograms showed significantly reduced left ventricular EF =25%. Patients were confirmed to have non-inflammatory cardiomyopathy via endomyocardial biopsy or cardiac magnetic resonance imaging which did not reveal either tissue edema or hyperemia. Since diagnosis, patients were started on guideline directed medical therapy or heart failure while being considered for advanced therapies. The relationship between the novel mRNA COVID-19 vaccine and cardiomyopathy is an area in need for further investigation. Whether or not the vaccine is a contributing factor remains to be unclear. Yet, the symptoms development following vaccine administration along with the exclusion of other potential etiologies, raises the question of whether they are truly related. Despite the unclear mechanism, management remains to be with guideline-directed medical therapy and advanced therapies, as indicated. EF recovery and improved clinical outcomes can be achieved in some patients.; Sender's Comments: The causal association between the event Cardiomyopathy and the suspect drug BNT162b2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient presents to ED 1/22/22 for reported seizure and confusion. Patient has history of seizure disorder. Positive for COVID-19. ED Differential Diagnosis (includes but not limited to): COVID-19, severe sepsis, breakthrough seizure, postictal state, pneumonia, other infectious source. Patient was confirmed to be febrile, tachycardic, tachypneic, has dyspnea and externally audible expiratory wheezes. On auscultation scattered rhonchi bilaterally with late expiratory wheezes. IV was initiated and seizure precautions instituted, pulseox was borderline and patient was put on supplemental oxygen via Oxy-mask. Patient required 6L Oxy-mask to keep sats 90%. Patient had Tylenol, fluid bolus, severe sepsis screening. This patient met institutional criteria for acute respiratory failure. Patient did not require intubation. Following initial stabilization and resuscitation, the patient's wife confirmed patient's history of brain cancer with seizure disorder. Multiple family members with confirmed COVID-19 recently. Patient had similar symptoms but did not test. Wife witnessed a seizure today before calling the emergency line.   Patient was diagnosed with Hypoxemic respiratory failure secondary to severe sepsis secondary toCOVID-19 pneumonia complicated with seizure and mental status alteration. Patient intubated urgently in the ICU. Diagnosed with severe sepsis source pulmonic. Broad spectrum antibiotics started in the ICU Zosyn/vanco Sepsis protocol. Patient became more lethargic and lower extremities appeared mottled. Patient with progressing Multi-system organ failure with COVID, on vent with worsening renal failure and hypotension admitted with covid positive, hypoxia, septic shock (lact>4, BP OK), breakthrough seizure, tachycardia. Patient intubated 1/22/22- 1/24/22- extubated. Patient required reintubation 1/29/22. Patient requires Continuous Veno-Venous Hemofiltration- no final decision prior to consult. Family decided on extubating with compassionate care and comfort measures. Patient died 2/1/22 at 12:17
104 fever for two days; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration, at the age of 74 years old and administered in left arm on 05Mar2021 14:00 at single dose for covid-19 immunization. Medical history included osteoporosis, penicillin allergy and COVID-19. In addition, the patient had COVID test via Nasal Swab with result Negative on Jan2021. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has been tested for COVID-19. The patient experienced 104 fever on 06Mar2021 06:00 for two days.  Treatment Tylenol was received. The outcome of the event was recovered with sequelae (reported as Recovered with lasting effects) on 08Mar2021 06:00. This case reported as non-serious.  Information on the lot/batch number has been requested.; Sender's Comments: The reported event hyperpyrexia was confirmed with temperature value below 106.7°F, a value which, from a medical point of view is not consistent with hyperpyrexia. The Company therefore coded this event as pyrexia.
This spontaneous consumer report (initial receipt 13-Jan-2016) concerns a 60 year old female patient. The patient has a medical history of GERD, globus hystericus (reported as 'globus'), diphenhydramine allergy, amoxicillin allergy, hypertension and anxiety.  Prior vaccination with Afluria in Nov or Dec 2014 resulted in hives.  This reaction was treated with diphenhydramine to which she experienced an allergic reaction and was placed on prednisone which helped.  Concomitant medications include nebivolol, ranitidine, alprazolam, pravastatin and vitamin D. On 01-Dec-2015 at 09:30, the patient received Afluria (influenza virus vaccine polyvalent, batch number: unknown) via the intramuscular route for protection against the influenza virus.  On 01-Dec-2015 following influenza vaccination, the patient experienced headache and tiredness.  At 02:00 on 02-Dec-2015, the patient experienced pain in the back of her right leg and tingling on the right side of her face (also reported as occurring on 01-Dec-2015).  That same day, she went into work, was sent to ER/OT and was admitted to hospital for a mild/moderate allergic reaction.  Treatment comprised of prednisone (20 mg for 4 days) due to her diphenhydramine (Benadryl) allergy.  On 05-Dec-2015, the patient woke up with heart palpitations and called the ER doctor who told her to stop prednisone and take her alprazolam (Xanax).  On 11-Dec-2015, the patient returned to the ER for a rash that developed and palpitations.  The patient described it as hives.  The ER discharge noted acute anxiety and told her to continue alprazolam (Xanax).  She was also provided with an epinephrine which she has not used.  The patient stated white marks on her face and stomach but rash comes and goes.  The patient stated headache, tingling in face and leg pain comes and goes as well. The outcome was reported as not recovered. Linked case: 2016057877 (same patient). Reporter's Comments: n/a. Sender's Comments: Company comments: Seriousness criterion/criteria: Hospitalisation. Listedness: Unlisted. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information, acute anxiety and all other events are unlisted. Paraesthesia, headache rash and hives are listed. Causality: Possible. Time to onset is same day for headache and tiredness and next day for other events and 11 day for rash. Although the patient was treated with antihistamine and steroids events are not typical of type 1 allergic reaction. The case did not meet Brighton collaboration group definition for anaphylaxis due to delayed onset for rash and urticaria. History of anxiety was a probable factor in causation of palpitation rash and or events. Causality with vaccination cannot be completely excluded due to temporal association.
Total body shaking with abrupt onset at about 9:30 pm, followed shortly by low-grade fever 100.5 (my normal temp. is 97.3).   Took tylenol 1000mg. and Alprazolam 0.5 mg.,  drank some water, and immediately went to bed fully clothed.  Awoke at 8:00 am, with mild skeletal aches, took tylenol 1000mg., and within 2 hrs. I was back to normal.  No further symptoms.  I am a physician and did not feel need to contact my family doctor.
Narrative:  72yo male patient with esophageal cancer with metastasis to the liver died at home on 11/9/2021. Past Medical History: Secondary malignant neoplasm of liver (SHistory of antineoplastic chemotherapy (SCT 125211000119106) Iron deficiency anemia (SCT 87522002) Seen by palliative care medicine service (SCT 305824005) History of radiation therapy (SCT 429479Malignant tumor of lower third of esophagus (SCT 187727005) Hypertension (SCT 38341003) Nontraumatic AKI (acute kidney injury) (SCT 140031000119103) Prostatitis (ICD-9-CM 601.9) Abdominal aortic aneurysm (SCT 233985008) Bronchitis, not specified as acute or chChronic obstructive lung disease (SCT 13645005) Health Maintenance (ICD-9-CM V65.9) Dizziness (ICD-9-CM 780.4) Basal cell carcinoma - primary (ICD-9-CMHyperlipidemia (SCT 55822004) Occlusion and Stenosis of Carotid ArteryChronic obstructive lung disease (SCT 13645005) Gastro-esophageal reflux disease withoutBenign prostatic hyperplasia (SCT 266569009) Active problem list reviewed Pt received covid vaccines on 3/3/21, 3/31/21 & 9/7/21. This death from cancer, not related to covid vaccines.
expired dose of PENTACEL was inadvertently administered/no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional.  This case involves a patient with unknown demographics who inadvertently received expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ190AAA, expiry date- 22-Feb-2021 via unknown route in unknown administration site for prophylactic vaccination on 17-Mar-2021.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  It was a case of an actual medication error due to expired vaccine used (latency same day).  Office manager reporting an expired dose of PENTACEL was inadvertently administered. Caller did not have any patient data available, requested caller to call back to provide.  At the time of report there was no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a medical assistant concerning a 25 year old female with connective tissue disorder, thrombocytopenia, depression and allergy to ZITHROMAX who on 20-SEP-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) IM in the deltoid described as "pre-filled syringe one time." Concomitant therapy included escitalopram oxalate (LEXAPRO) and methylphenidate HCl (RITALIN). On 21-SEP-2006 the patient experienced fever of 100 degrees F. The patient sought unspecified medical attention. The patient's fever of 100 degrees F. persisted. Additional information has been requested.
injection arm itchiness; injection arm redness; injection arm bruising; chills; fatigue; headache; body aches; injection arm sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection arm sore), FATIGUE (fatigue), HEADACHE (headache), PAIN (body aches) and CHILLS (chills) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.  Concomitant products included FLUOXETINE and ETHINYLESTRADIOL, NORELGESTROMIN (XULANE) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (injection arm sore). On 21-Jan-2021, the patient experienced FATIGUE (fatigue), HEADACHE (headache) and PAIN (body aches). On 27-Jan-2021, the patient experienced CHILLS (chills). On 28-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection arm redness) and VACCINATION SITE BRUISING (injection arm bruising). On 29-Jan-2021, the patient experienced INJECTION SITE PRURITUS (injection arm itchiness). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. On 25-Jan-2021, FATIGUE (fatigue), HEADACHE (headache) and PAIN (body aches) had resolved. On 26-Jan-2021, VACCINATION SITE PAIN (injection arm sore) had resolved. On 27-Jan-2021, CHILLS (chills) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (injection arm redness), VACCINATION SITE BRUISING (injection arm bruising) and INJECTION SITE PRURITUS (injection arm itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a registered nurse refers to a 30 years old patient. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) on 14-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that possibly a 30 year old patient received a dose of ZOSTAVAX instead of influenza virus vaccine (manufacturer unknown) due to a human error. No adverse effect was reported. Additional information has been requested.
Initial symptom was weakness of left side of mouth. Diagnosed with Bell's Palsy. Left-sided facial weakness increased over two days. About 8 days after initial symptom, facial tone improved. Muscle strength gradually increased. Treated with prednisone 60 mg x 5 days, then 40 mg x 5 days.
Left shoulder injection 3/16/12, arm redness and pain developed on 3/17/12 area reddened and indurated 8 x 5 cm.
Chills fever aches and pain in joints. Took Tylenol and cold compresses.
Reactive lymph node swelling (2) in left side of neck lasting 15 months and appearing 3 days after vaccination.  3rd full dose of Moderna COVID-19 vaccine.
pt recv vax 22JUL95 & pt exp shingles on forearm & shoulder;
Content right hip pain, walking sitting,  laying, etc; This is a spontaneous report from a contactable consumer (Patient). A 61-years-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: Er8733), via an unspecified route of administration, administered in right arm on 02Apr2021 13:00 (at the age 61-years-old) as dose 2, single for covid-19 immunisation. Medical history included thyroid removal/ cancer and drug hypersensitivity (allergic with Penicillin) from an unknown date and unknown if ongoing. The patient received unspecified concomitant medication in two weeks. The patient previously took Synthroid, daily for an unspecified indication. She did not take any other vaccine in four weeks prior COVID -19 vaccine. She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: Eke199) via an unspecified route of administration, administered in right arm on 12Mar2021 16:00 (at the age 61-years-old) as dose 1, single for covid-19 immunisation and experienced headache, hands were cold, nauseous, swollen face. On 09Apr2021 at 14:30 patient experienced content right hip pain, walking sitting, laying. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken with Chiropractor adjustment. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
7cmx4cm erythema and swelling right deltoid at site of Pneumovax. Treated with Keflex 500mg QID for 10 days.
pt recv vax & devel a small, red raised area @ the inj site;It was unk whether this was the pt first or second dose of vax;
Patient described for 8 days after receiving shot she had sore arm that radiated up thru her neck. After several days she is fine.
Patient asked for her second shingrix shot- pharmacist went over all the paperwork w/ the patient and administered the shot- it was patient third dose and not the second one.
Employee stated the day she received her last vaccination and acknowledged it had been 28 days. After submitting to NYSIIS we noticed that she was incorrect and it had only been 15 days since her 1st dose. (1st Dose given on 1/4/21). No adverse reactions at this time just error.
Patient contracted COVID after being fully vaccinated 9/11/2021 - Cough congestion, and fatigue