chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left armpit pain; Feels like swollen lymph nodes; Nausea; Chills; Left arm pain; Dose 2 administration date 23May2021; Dose 2 administration date 23May2021; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received second dose of PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Batch/lot number: EW0185) via an unspecified route of administration in left arm on 23May2021 at 15:00 (at the age of 53-years-old) as single dose for COVID-19 immunization. Medical history of the patient included Hyperactive bladder from an unknown date and unknown if ongoing. Patient had no known allergies. Other medications (concomitant) in two weeks included mirabegron (MYRBETRIQ) taken for an unspecified indication, start and stop date were not reported; solifenacin succinate (VESICARE) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine in four weeks. Patient previously received first dose of PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Batch/lot number: unknown) via an unspecified route of ad-ministration in left arm on 31Mar2021 as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 23May2021 at 17:00, patient experienced left armpit pain, feels like swollen lymph nodes, nausea, chills, left arm pain. Treatment received in response to the events included Motrin. Outcome of the events Left armpit pain, feels like swollen lymph nodes, nausea, chills, left arm pain was not recovered.  Follow-up attempts are needed. further information is expected.
This spontaneous report as received from a public health, healthcare professional refers to unspecified patients of unknown age and gender. On an unknown date the unspecified patients might had vaccinated with improperly stored M-M-R II (lot #, dose, frequency and route unspecified), which were exposed to 53F for 12 hours and M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 54F for five hours. No adverse effects reported. Follow up information has been received from an office manager concerning a patient. On 05-AUG-2013 the patient was vaccinated with improperly stored M-M-R II (H018181 ,exp. 05-OCT-2014), which were exposed to 53F for 12 hours (date excursion ended 22-JUL-2013). This is one of several reports received from the same source (linked MARRS#: 1311USA007619, 1311USA011610, 1311USA011611, 1311USA011612, 1311USA011613, 1311USA011614, 1311USA011615, 1311USA011616, 1311USA011617, 1311USA011618, 1311USA011619).
temperature excursion involving punctured Ipol and administered to 3 patients after the excursion.; Initial information received on 23-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA192000(CLUSTER).  This case involves a 8 years old female patient with event as  temperature excursion involving punctured ipol and administered to 3 patients after the excursion. while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR); and hepatitis a vaccine (Hepatitis A).  On 09-May-2022, the patient received a  dose of suspect ipv (vero) lot T1E871M via intramuscular route in the right deltoid(formulation unknown, strength: standard and  expiry date : 10-Oct-2022)  On 09-May-2022 the patient was part of a non-serious event of "temperature excursion involving punctured ipol and administered to 3 patients after the excursion." (poor quality product administered) following the administration of ipv (vero).  Action taken with poliomyelitis vaccine (inactivated) (Ipol) was not applicable.  At time of reporting, the outcome was Unknown for the event "temperature excursion involving punctured ipol and administered to 3 patients after the excursion."  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 the 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.
Swelling /sore/arm stiffness at injection site - 10/29-11/1/2018; General fatigue/flu-like aches/ headache ; bed-ridden for 6 hr - 10/30/2018; Left arm redness/tenderness/excessively warm to touch/heat/pain- 10/31-11/1/2018.
PT COMPLAINED OF ITCHING AT INJECTION SITE.  DEFERRED IMMEDIATE TREATMENT.  STATED SHE WOULD TAKE A BENEDRYL WHEN SHE GOT HOME.  ADVISED TO SEEK ADDITIONAL MEDICAL HELP IF SYMPTOMS WORSENED BY  RN.
This literature report as received from the authors of a published literature article, refers to a 44 year old male patient with a recurring nasopharyngeal papilloma that was excised transorally at an outside hospital 4 months earlier presented to the authors' office with throat irritation. Endoscopic exam showed a papilloma on the left posterior nasopharyngeal wall, and surgical excision was performed with CO2 laser under transnasal endoscopic visualization. A 10 x 9 x 5 mm lesion on the nasopharyngeal surface of the soft palate was removed en bloc, and a second lesion on the posterior nasopharynx was also visualized and resected. Histopathologic analysis confirmed the lesion to be squamous papilloma, which was positive for HPV 11 on sequencing analysis. On an unknown date, on the follow-up 2 weeks after surgery, the patient was vaccinated with the three doses of GARDASIL administered at 0, 2 and 6 months, for recurring nasopharyngeal papilloma. Two months after surgery, the patient noted mild throat irritation, and endoscopic exam showed a 5 x 6 mm recurrent nasopharyngeal papilloma. It was recommended that the patient finish the vaccination with GARDASIL before further intervention. In the interim, the papilloma on the dorsal aspect of the soft palate shrank to approximately 3 x 4 mm in size. After the patient completed the course of GARDASIL, the lesion was excised with CO2 laser under a solely endoscopic approach. Final pathology of the 8 x 5 x 3 mm lesion confirmed the diagnosis of squamous papilloma. In the 33 months' follow-up since the last operation, fiberoptic exams showed no evidence of recurrence. This is one of the two cases from the same article (linked with MARRS # 1705USA009624). Additional information has been requested. Sender's Comments: US-009507513-1705USA009624.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Aug2022 as dose number unknown, single (Lot number: FP7137) at the age of 31 years for COVID-19 immunization. The patient's relevant medical history was not reported. The patient took concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19.  Clinical course: The patient started Paxlovid on 29Sep2022 and end date not provided for the treatment of COVID-19. Other medications in two weeks were taken by the patient.  No follow-up attempts are possible. No further information is expected.
Itchy rash at injection site; Itchy rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash at injection site) and VACCINATION SITE REACTION (Itchy rash at injection site) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROXYCARBAMIDE (HYDROXYUREA EURECO PHARMA), GLIPIZIDE, CARVEDILOL (CARVEDILOL +PHARMA), LISINOPRIL and ATORVASTATIN for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced RASH PRURITIC (Itchy rash at injection site) and VACCINATION SITE REACTION (Itchy rash at injection site). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Itchy rash at injection site) and VACCINATION SITE REACTION (Itchy rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Presented with rash 5/29/06. Child had fever 5/24/06. No fever since Pt now had >30 lesions.
body itching, at 9:30pm covered in hives armpits, stomach, underwear line, growing, rapidly spreading
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies were reported. On 18-JUN-2015, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot number L005295 and expiry date 17-AUG-2016) (dosing, regimen, route were unknown). No concomitant medications were reported. No adverse effects were reported. There was no product quality issue reported. Follow up information was received on 10-JUL-2015. It was reported that lot number L005295 with an expiry date of 17-AUG-2016 is a valid lot number for PROQUAD (Merck). On 03-AUG-2015, a phone call was made to the certified medical assistant. The phone call went directly to voice mail. A voice mail message was left requesting that the certified medical assistant return the phone call. Additionally, a request was made for patient identifiers, lot number, expiration date and date of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. Follow up information has been received from the reporting Certified Medical Assistant (C.M.A.) during a phone call on 05-AUG-2015. The C.M.A. reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 4-year-old patient of unknown gender. On 22-JUL-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) lot # L005295. This is one of several reports received from the same source. Additional information has been requested. Patient's details, product, event information and narrative were updated.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 25-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of Refrigeration was 7-MAY-2021.  No concomitant medications were reported. No treatment details were provided.   This case was linked to MOD-2021-365189 (Patient Link).
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (for 1st dose refer case US2019023148). On 30th January 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm, fatigue and sleepiness. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm, fatigue and sleepiness were recovered/resolved. It was unknown if the reporter considered the pain in arm, fatigue and sleepiness to be related to SHINGRIX. Additional details were provided as follows: The case was reported by patient's wife. The patient received SHINGRIX on an unknown arm. The patient experienced some fatigue, was sleepy and arm soreness.
By mid-afternoon, headache, body achy, and "felt miserable." By 6 PM, having nausea, vomiting "a few times." Pt says "it was not sour stomach as it did not have that sour taste." Began having chills but did not take temperature. Went to bed around 9:30 PM "feeling miserable." Pt was reportedly up by 5 AM on 9/27/10 feeling better but still fatigued. Had reportedly taken 2 Tylenol last evening. No chills, nausea, or emesis reported this AM.
After receiving the Gardasil shot for the 2nd time- my son fainted, presented seizure like activity, lost consciousnesses, urinated o himself. These symptoms presented were more extreme the second time.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was received regarding medical history, concurrent conditions, or concomitant medications. On or around 15-APR-2013, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX, the patient suffered exacerbation of congestive heart failure, cellulitis, vertigo, and sensorineural hearing loss. As a direct and proximate of the Company's defective ZOSTAVAX vaccine, the patient's symptoms resulted in physical limitations not present prior to using the Company's product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient suffered severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not resolved. Causality assessment was related. The lawyer considered exacerbation of congestive heart failure, cellulitis, vertigo, and sensorineural hearing loss to be disabling. Upon internal review, exacerbation of congestive heart failure, cellulitis, and sensorineural hearing loss were considered to be medically significant events. Additional information has been requested.
Admission Date: 6/9/2022  PRESENTING PROBLEM: Atrial fibrillation with RVR [I48.91] Acute on chronic respiratory failure with hypoxia [J96.21] Acute on chronic congestive heart failure, unspecified heart failure type [I50.9] COVID-19 virus infection [U07.1]  HOSPITAL COURSE: The patient is a 96 yo female with PMH which includes HTN, HLD, DM II, hypothyroidism, osteoporosis, arthritis and chronic back pain, b/l cataracts, recent bouts of community-acquired pneumonia and recently diagnosed (5/4/22) Atrial fibrillation with RVR, started on diltiazem and Eliquis the day prior to presentation. She came in with a chief complaint of worsening back pain and shortness of breath/respiratory distress.    Patient was found to have severe sepsis and acute on chronic hypoxic hypercapneic respiratory failure likely secondary to acute COVID 19 infection, A fib with RVR, and concern for acute heart failure (no prior history, but elevated BNP). Patient tachycardic, tachypneic (initially, now some intermittent apnea/bradypnea), worsening confusion/AMS with periods of lethargy/minimal responsiveness, consistent with severe sepsis at the time of admission. Mental status improved, although still some mild intermitt confusion. Continued to require increased respiratory support with HFNC/Non-breather at times with CXR showing worsening effusions and colidations.Patient had some intermittent improvement with IV steroids and lasix. However, CTA thorax was obtained on 6/11 due to concern PE with worsening chest pain, tachycardia, and elevated D-dimer (b/l doppler US negative). CTA showed no evidence of PE, but worsening bilateral pleural effusions, including her chronic complex R pleural effusion with thickening and concern for possible exudative process. Bilateral lower lobe consolidations were significantly worse as well, especially on the left.  On 6/12/22, patient asked to stop aggressive cares and transition to hospice. Team spoke with patient's activated DPOA (son) and he was in agreement with patient's desire to become comfort care/hospice. Palliative care was consulted, active treatment was discontinued and comfort meds initiated.    Paged by nursing that patient had passed on evening of 6/14. On my evaluation, patient not responsive to verbal stimuli or sternal rub. Pupils fixed and nonreactive. No heart or lung sounds heard after a full minute of auscultation. Peripheral pulses not present. Death pronounced at 7:25pm. Personally notified patient's son and DPOA, of death. All questions answered.
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 years old unknown gender patient who was vaccinated with a 0.5 ml dose of IPOL (Batch number: N1K93IM, expiration date: 18-Nov-2019, route: subcutaneous and site of administration: right arm) on 23-Oct-2018. The patient also received dose of KINRIX (route: intramuscular and site of administration: right deltoid) on 23-Oct-2018. The patient's medical history medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration (IPOL was administered to 5 year old patient/No AE), Extra dose administered (administered KINRIX that contains 0.5mL of polio vaccine, as well as IPOL/No AE) and inappropriate route of vaccination (IPOL was administered subcutaneously/No AE). No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
On an unspecified date, the child received an injection of DTPA; it was not reported if the child had received prior injections of DTPA. An unspecified time, post vax, the child developed stridor. It was not known if the child received medical attention. It was reported that the child did not die. No further information was available at the date of this report.
patient under-dosed. Patient given 0.25 ml of Pink cap bivalent Moderna and was supposed to receive 0.25 mg of GRAY cap bivalent moderna due to having one monovalent dose already.
90y.o. male with a past medical history of HTN, BPH, Dementia, CLL (Diagnosed 10 years back, never received treatment, followed with Dr per wife) was brought to local Hospital with shortness of breath.  He had runny nose 10 days ago but was doing okay at home.  Initially taken to urgent care where he was advised to watch his oxygen saturation.  His oxygen saturation at home was measured in the mid 80s when he complained about some shortness of breath and high heart rate he was brought to the hospital and was later diagnosed with COVID. We are consulted because of the history of CLL.  CLL was diagnosed roughly 10 years back and he followed with Dr. at the HCF  Never received treatment for CLL was monitored only for his wife. On admission, vitals stable and has been saturating well on 2 L nasal cannula, normal electrolytes, WBC count 31.5, normal hemoglobin, platelet 147.  Differentials showed normal neutrophil, 27.3% lymphocytes.  D-dimer 3970.  CTA chest showed no pulmonary embolism, small right-sided pleural effusion, diastolic and hilar lymphadenopathy.  CT abdomen pelvis showed tensive intra-abdominal and pelvic adenopathy within the retroperitoneum and left common iliac region, mild splenomegaly. Discharge to: Home with Home Care/Medical Equiment and/or Supplies
On 9/11/2019 patient reported to mother that since the day after vaccination she has had mild diarrhea and jaw pain.
Patient passed out, fell out of the chair and hit his head within seconds of receiving vaccines. Patient lost memory and was vomiting. He was sent to the ER for treatment and observation.
30 seconds after giving shot pt felt lightheaded and nauseated. Told to sit with head between knees. Two minutes later got up to go to sink because he felt like he was going to vomit and passed out on floor. Was given cool towel for head. Later moved to exam table to lay down. Improved. Became normal in 10 minutes. Sent home.
headache - pt reports she will take Tylenol , reports head is ongoing  tingling between shoulders - resolved
After 48 hours post-vaccine, I developed pain in the left shoulder blade region. After an additional 24 hours (72 hours post-vaccine), the pain had spread to the chest area and so I took aspirin. After an additional hour, there was no relief and it felt like I was having a heart attack so I went to the emergency. I was admitted to the hospital and they found elevated troponin levels which indicated inflammation of my heart. Additional tests confirmed this. I was released after one day and prescribed NSAIDs to treat inflammation events. I am still experiencing issues with chest pain whenever I walk for more than five minutes or do normal household tasks.
Began vomiting- woke him up.   I have no clue if this is related to the vaccine, but wanted to report it because it was unusual and the night of the vaccine