chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was unknown if the doses are first, second or third doses for the patient.  The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration.  The vials was did not undergone any temperature excursions.  Concomitant medications were not reported.  Treatment information was not reported.
Reporting completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:1/09/2021.Moderna Lot#012L20A 2nd dose:02/06/21.Moderna Lot# 012M20A Diagnosed covid positive: 03/30/21 Exposure:Home Symptoms:SOB,Fatigue,Muscle aches,GI,HA
Patient received 1st dose Pfizer. Pt c/o of itching in post observation area to PA @1830 (15mins post vaccination). Pt escorted to triage area. Charge RN and on-site provider PA notified. Assessed by PA and RN. @1830   V/S:  BP 114/79  HR 95   RR 16   SpO2 98%  AOx4. Pt denies SOB, chest pain, headache, N/V.  PA recommended Benadryl. PA administered 25mg Benadryl PO @1840. Extended observation for 15 minutes.  @1855  V/S:  BP 118/82  HR 88   SpO2 99%   VSS AOx4. Pt denies SOB, chest pain, headache, N/V. Pt continue c/o of generalized itching. Per PA assessment, lungs and airway clear to auscultation, no wheezing.   PA recommended Benadryl. PA administered 25mg Benadryl PO @1856. Per PA, no immediate signs of anaphylaxis observed.  PA d/c patient with family to home at approx @1900. Patient educated to continue monitoring symptoms and to call 911/ER for symptoms of SOB, wheezing, chest pain, worsening itching. Pt verbalized understanding.
Flu shot (L) deltoid 10/09/12 progressive pain & decreased ROM started next day. No local redness or swelling. Now has frozen shoulder.
This spontaneous report was received from a registered nurse via a company representative referring to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date,  the patient was vaccinated with GARDASIL (dose, dosage number, route of administration, lot # and expiration date were not reported) it was also stated that the vaccine was administered with an improperly gauge needle. No concomitant medications were reported. No averse reaction was reported. No adverse effects and no product quality complain were reported. Additional information has been requested.
Headache, body aches, fatigue, 101.5 temp, sore arm,  Lasted about 24 hours from on-set, then went away
This case was reported by a nurse via call center representative and described the occurrence of nausea in a 18-year-old female patient who received BEXSERO. On 26th May 2017, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. In May 2017, less than a day after receiving BEXSERO, the patient experienced fatigue. On 26th May 2017, the patient experienced nausea, dizziness, injection site pain, headache, injection site erythema, injection site lump and injection site induration. On 27th May 2017, the patient experienced loose stools. On 28th May 2017, the patient experienced chills. The action taken with BEXSERO was unknown. On an unknown date, the outcome of the nausea, fatigue, injection site pain, injection site lump and loose stools were not recovered/not resolved and the outcome of the dizziness, headache, injection site erythema and chills were recovered/resolved and the outcome of the injection site induration was unknown. It was unknown if the reporter considered the nausea, fatigue, dizziness, injection site pain, headache, injection site erythema, injection site lump, loose stools, chills and injection site induration to be related to BEXSERO. Additional details were provided as follows: Immediately after receiving vaccination the patient experienced redness, a hard lump under skin and soreness at the injection site. It was reported that, the patient continues to have the hard lump and soreness at the site at the time of reporting. The patient also experienced nausea on the vaccination day's evening, a headache, fatigue within 24 hours and dizziness within 15 minutes of the injection itself. On 27th May 2017, 1 day after vaccination the patient experienced loose stools. On 28th May 2017, 2 days after vaccination the patient experienced chills. The patient was seen at the physician's office for continued issues with nausea, loose stools, and fatigue. The physician had recommended cool compresses to site, ibuprofen and rest. It was also being asked if the patient should receive the second dose of the BEXSERO vaccine, so she was transferred to medical information system. The call center representative forgot to ask lot number and expiry date of the vaccine.
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning 500 children of unknown gender. Neither the patient's medical history nor concomitant medications were reported. The original expiration date of the product was 20-Apr-2010 which was re-assigned to 08-Apr-2010. On an unknown date after 08-Apr-2010, the patients received the expired H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessment is not applicable, and the event was considered resolved.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 11-AUG-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L000454 with exp. 06-JAN-2017, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
I was working out months after my second dose and my heart rate spiked above 210 beats per minute and it felt as though my heart was incorrectly beating (palpitations), it took 30 minutes to somewhat stabilize, by the time I got to the hospital my blood pressure was high but all the other tests were inconclusive, so I was referred to a cardiologist for follow-up.
Body aches and pains and (L) arm pain starting 10/1/07. 10/3/07 - chills, fever, body aches and (L) arm pain. 10/8/07 - all symptoms resolved.
This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age and gender. Pertinent medical history was unknown. On an unknown date unspecified number of patients were vaccinated with RECOMBIVAX HB (dose, route of administration, anatomical location and lot number was unknown) that were improperly stored. Concomitant medications were unspecified by reporter. No adverse events were reported. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
Received flu shot on 10/27/16. Pt noticed rash to arms, trunk, back of chest upon awakening 10/28/2016. Seen by work comp MD on 10/28/16. Dx: hypersensitivity to flu shot.
on 2/1/21 patient started have redness and swelling; says the swelling is about 3 inches down the arm. Arm is painful, warm and tender to the touch. Patient continues to take Ibuprofin for pain.
In the evening after getting vaccine, I experienced lightheadedness, and was "woozy." Woke up with  dizziness the next morning, and symptoms lasted until mid-day the following day. So a little more than 48 hours of feeling woozy/dizzy. Never before had a reaction to a vaccine, so thought I'd report it. Began full vegetarian diet eight months prior.
7 days after the injection, I developed hives and redness (about the size of a quarter) on my left arm, directly below the injection site.  My arm also felt itchy. I applied Calamine lotion at night. The next morning on Day 8, the red, swollen area had grown to the size of a baseball. By afternoon, the red inflamed area below the injection site had grown to the size of a softball.  The area no longer itched but it hurt, & was swollen, distended, hard, hot to the touch, with increased redness
10 days p/vax pt devel a fever of 105 &  a rash;pt recovered p/4 days;this report was recv from MD dept of hlth & mental hygiene;
This non-serious consumer report (initial receipt 16-DEC-2014) concerns a 57 year old female patient. In DEC-2014, the patient received a flue shot (manufacturer and batch number not reported). The patient was also taking Berniert. After receiving the flu shot, the patient experienced a severe sore throat, fever and aches throughout the body. Outcome was not reported. Linked to 2014047394 (Berinert case). Reporter comments: The reporter stated the events were not serious.
Patient Called in today and stated that after she got the  2nd shot of shingrix on 10/12/2020 and as the same day at night time she had vomiting and chilling, shaking for few hours but she did not take any medication for those symptoms .  She got better by next day.
severe stomach pain; vomiting; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (reported as "77", unit unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) dose number 1, via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient felt fine for the first 5 days after receiving the vaccine then he developed severe stomach pain and vomiting in Jan2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Felt lightheaded like she was going to pass out; chills; fever; cold sweat; Feeling like she was beaten with brass knuckles / Sore / Pain; unable to go to work; eeling like she was beaten with brass knuckle; This case was reported by a consumer via call center representative and described the occurrence of light headedness in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 20th October 2020, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2020-2021 season (intramuscular). On 21st October 2020, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced light headedness, chills, fever, cold sweat, pain, inability to work and feeling unwell. The patient was treated with ibuprofen. On an unknown date, the outcome of the light headedness, chills, fever, cold sweat, pain, inability to work and feeling unwell were unknown.   It was unknown if the reporter considered the light headedness, pain, inability to work and feeling unwell to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. The reporter considered the chills, fever and cold sweat to be related to Shingrix. It was unknown if the reporter considered the chills, fever and cold sweat to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient received Shingrix intramuscularly in the left deltoid and also received the flu shot intramuscularly in the right deltoid.  It was reported as the patient was unable to go to work because she woke up feeling like she was beaten with brass knuckles. The patient said she was sore. When she got up (to use the bathroom) she felt lightheaded like she was going to pass out.  The patient also experienced cold sweat and fever and chills. She took ibuprofen for the pain and fever. The patient still had a fever of 101.5 She was attributing these side effects to Shingrix.   The patient wanted know how long the side effects would last. The patient stated that she does did have anaphylaxis). The patient stated that her doctor warned her that she might experience a fever after the Shingrix shot and not to worry as this was normal). She also said that she read about the possible side effects that Shingrix could cause but she wasn't expecting them to be so intense. The reporter consented to follow up.
Patient is a 51 year old female with PMH HTN, DM2 who presents for low back pain. S/p Moderna COVID booster 4 days ago. Felt fatigued the first two days with some arm soreness. These were similar symptoms to previous vaccinations with Moderna. Fatigue and arm soreness have improved. Yesterday onset of low back pain, worse today. Midline low spine. 5/10. Trying ibuprofen, heating pad with moderate relief. Denies trauma, falls. No saddle anesthesia or change in baseline stress incontinence of bladder. Denies change in BMs, bowel incontinence, extremity weakness/numbness. Denies burning/frequency of urination.
Left deltoid area 9cm diameter, indurated, red, hot, swollen occurred the next day after shot given.  Treated with Orapred.
General fatigue and mild flu-like symptoms the following day, 4/2.  Mild dizziness/brain fog every day since: 4/2-4/13 (today). It ebbs & flows throughout the day, and seems exacerbated by movement. My doctor thinks it may be vertigo.
Patient is a 67 y.o. female patient of, MD with history of HFpEF, HTN, IDDM2, OSA, metastatic breast cancer, cancer related pain presented to Hospital with leg swelling, shortness of breath, cough, found to have COVID and acute on chronic HFpEF.   Acute on chronic HFpEF On torsemide 20 mg BID at home as well as spironolactone Last TTE in April 2022 with normal LVEF, grade I diastolic dysfunction Volume overload on admission with pulmonary edema, lower extremity swelling BNP is falsely low due to obesity Repeat TTE with normal LVEF, grade II diastolic dysfunction Significantly improved with IV diuresis Discharged on increased home torsemide dosing on discharge to 40 mg qAM and 20 mg qPM   Acute on chronic respiratory failure with hypoxia/hypercapnia Chronic CO2 retention in setting of likely OAHS, baseline using O2 intermittently, requiring 3L on admission, respiratory failure in setting of heart failure and COVID CXR with mild fluid overload with cardiomegaly COVID positive on admission Down to room air by discharge Continue home BiPAP nightly   COVID-19 virus infection Date of onset of symptoms: 10/1 Symptoms present on admission: shortness of breath, cough, sore throat Date of covid positive test: 10/3 Vaccination status: vaccinated without recent booster Imaging: CXR with mild fluid overload Oxygen requirements on admission: 3L Current oxygen requirements: room air Medical therapy: given high risk for severe disease, treated with remdesivir while admitted as well as steroids, plan to continue dexamethasone on discharge for 3 more days Consultants following: n/a Anticipated special isolation end date: 10/11 IDDM2 with hyperglycemia Follows with facility endocrinology Home regimen of Levemir 50 units BID with Novolog 12 units TID AC with SSI and Trulicity Glucoses elevated with steroid use Resume home regimen on discharge   HTN On carvedilol, torsemide, spironolactone at home Continue carvedilol and spironolactone, resume torsemide on discharge with increased dosing   CKD3 Baseline Cr in the 1.2-1.5 range, admit Cr of 1.48 Below baseline by discharge   Pancytopenia Acute on chronic in setting of chemotherapy with Ibrance, recently completed 3 week course WBC 1.26 (ANC 0.35K), Hgb 10.2, platelets 101K on admission Improved since off of Ibrance Will need to follow up with oncology before resuming   Metastatic breast cancer Follows with facility oncology, with mets to bone, initially diagnosed ~10 years ago On Ibrance and letrozole Resume Ibrance as outpatient pending CBC, can continue letrozole   Chronic pain syndrome Cancer related pain Follows with palliative care at facility, pain due to cancer and RA Home regimen of methadone 10 mg q8h with oxycodone 15 mg q6h PRN for breakthrough Continue home regimen   OSA Morbid obesity BMI 53.71, on BiPAP at home Continue BiPAP nightly and at naps Rheumatoid arthritis Continue home hydroxychloroquine   Right leg cellulitis Chronically on penicillin for suppression of cellulitis with known ulceration, currently on ciprofloxacin and amoxicillin given recent worsening Continue ciprofloxacin and amoxicillin, improved, plan 10 day course
fever; feeling shaky; tiredness; body aches; chills; This case was reported by a consumer and described the occurrence of tremor in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 2nd December 2020, the patient received the 2nd dose of Shingrix. On 2nd December 2020, less than a day after receiving Shingrix, the patient experienced tremor, tiredness, general body pain and chills. On 3rd December 2020, the patient experienced fever. On an unknown date, the outcome of the tremor, tiredness, general body pain, chills and fever were not recovered/not resolved.   It was unknown if the reporter considered the tremor, tiredness, general body pain, chills and fever to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient experienced body aches, chills, tiredness, and feeling shaky on the same day the vaccine received. One day after receiving vaccination, the patient awoke with a fever. The reporter stated that, all events have not resolved.  The patient also mentioned that had every side effect listed, but did not go into specific details other than those reported. The reporter did not consent to follo w up.
Pt had red spot and itching immediately after injection.  Returned the following day with an 11X 12 cm red swollen area on his ledft deltoid.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On multiple unspecified dates the patients were administered with doses of improperly stored M-M-R II (lot # was reported as L003858, expiration date was reported as 05-FEB-2017; lot # was reported as L01528, expiration date was reported as 03-APR-2017; therapy type, dose and route were not reported). Concomitant drug was not reported. This is one of several reports from the same reporter. Additional information has been requested.
dizzy; cramping in stomach; hard to swallow solid food; body shook; chills/teeth chattered; BP rose to 170/89; felt jittery; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported that a 78-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EN6200), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 14:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing high BP Onset date: 5+ years Stop date: Ongoing Pertinent details: Controlled; ongoing acid reflux disease Onset date: 10+ years Stop date: Ongoing Pertinent details: Controlled. There were no concomitant medications. On 20Feb2021, the patient experienced BP rose to 170/89; felt jittery; chills/teeth chattered; body shook; On 21Feb2021, dizzy; cramping in stomach; hard to swallow solid food. The patient underwent lab tests and procedures which included blood pressure measurement: 217/105 mmhg on 28Jan2021, blood pressure measurement: 170/89 mmhg on 20Feb2021, pyrexia: 103 on 28Jan2021. It was reported that patient took 2nd shot on Wednesday 17Feb. On Saturday 20Feb BP rose to 170/89 felt jittery. On Sunday 21Feb become jittery, dizzy, BP high and had cramping in stomach. Hard to swallow solid food. Went on until doctor ordered Dicyclomine. It helps. On Saturday 20Feb had chills for 2and half hours. Teeth chattered and body shook. Stomach was still cramping after 2and half weeks and solid food is hard to swallow. I have an appointment with a gastrologist. The clinical outcome of all events were unknown.  No follow-up attempts are possible. No further information is expected.
This literature report (initial receipt 02-Oct-2012) concerns a 9-month-old male patient. The patient received flu vaccine (manufacturer and batch no. were not provided). The patient's activity and oral intake decreased. He had an oral temperature of 38.3 degrees Celsius and a one day history of runny nose. 2 weeks after vaccination he was admitted to hospital. On admission, the patient was afebrile and lethargic with a weak cry. He had decreased movement in all extremities. His musculature showed decreased tone. A sepsis workup was done and during the lumbar puncture the patient had an episode of bradycardia and was intubated. The patient was admitted with presumed sepsis and acute respiratory failure. The patient was noted to not have spontaneous movement of arms or legs to painful stimuli. Deep tendon reflexes were absent in the arms but preserved in the lower extremities. A magnetic resonance imaging (MRI) showed a non-enhancing signal abnormality in the medial thalami and midbrain extending into the dorsal pons and an expansile, non-enhancing cord lesion centered at C4 with edema/signal abnormality was noted. An inflammatory or demyelinating process, acute disseminated encephalomyelitis (ADEM), was considered most likely. The patient was started on IVIG and high dose dexamethasone for a two week period without clinical effect. The patient was started on IVIG and high dose dexamethasone for a two week period without clinical effect. The patient was subsequently started on five courses of plasmapheresis (alternating days). Intravenous immune globulin (IVIG) was discontinued and dexamethasone was gradually tapered. The patient showed improvement, including spontaneous respiration, oral feeding and some movement of the extremities. He was subsequently discharged to a subacute center.