chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a 8 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 01-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
This spontaneous report as received from a pharmacy technician referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug and allergy history were not reported. On 24-MAY-2017, the patient was vaccinated with an expired dose of VARIVAX injection, lot # L013068 and expiration date on 14-APR-2017 (dose and route were not provided) for prophylaxis. Additionally it was reported that the sterile diluent (MRK) injection used to reconstitute the vaccine was not expired (lot, batch # and expiration date were not provided), and the patient did not experience any adverse event. Additional information has been requested.
cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065D21A and 048F21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, TORASEMIDE (TORSEMIDE), POTASSIUM CHLORIDE (KLOR-CON M20), CLOPIDOGREL BISULFATE (PLAVIX), LISINOPRIL, METOPROLOL, APIXABAN (ELIQUIS) and LEVOTHYROXINE for an unknown indication.   On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold). At the time of the report, NASOPHARYNGITIS (cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 88.2 (Low) 88.2 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided by reporter.   This case was linked to MOD-2021-318405 (Patient Link).
A 14 year old male patient receive don 08 August 2007 a dose of Adacel (lot# C2730AA), intramuscular into the left deltoid. A day later, on 09 August 2007, he experienced severe headache for two days that was not improved with medications (Tylenol and Motrin). The injection site was swollen and red and he could barely move his arm. The patient had no other vaccine at the same time. The patient had no illnesses at vaccination time and had no pre-existing allergies or medical conditions. Concomitant medications included Zyrtec. The patient had no adverse event following prior vaccination. At the time of the report, the patient had not recovered.
Tummy ache/ gastric pain and then I threw up. This type of thing is still happening where I get the gastric/tummy pain, etc. Two days ago it happened again. I had a doctor appt with my doctor  Put me on Omeprazole. ( February 16, 2021)
Vaccine administration error.  Moderna Lot# 048F21A   expired on 01/22/22.  Administered as a booster dose to the patient on 01/24/22.
ACUTE NON ST ELEVATION MI  4/6/2022 & 3/9/2023  --  RECURRENCE OF SAME SYMPTOMS
rash on legs from hip through mid calf. Both sides. Onset was roughly 4-5 days after first vaccine shot.
Hospitalized 11/29/2021-still admitted currently; COVID-19 positive 11/24/21; fully vaccinated  ASSESSMENT Principal Problem:   Pneumonia due to COVID-19 virus Active Problems:   Emphysema   OSA (obstructive sleep apnea)   Type 2 diabetes mellitus with hyperglycemia, with long-term current use of insulin   Dyslipidemia   Essential hypertension   Depression with anxiety   History of ITP   Rheumatoid arthritis   Acute respiratory failure with hypoxia   Chronic, continuous use of opioids   Coronary artery disease involving native coronary artery of native heart without angina pectoris   Chronic diastolic heart failure  PLAN Cont O2 support, wean as able; currently on 2L Day of illness: 5 Cont Decadron x 10 days total Remdesivir - multiple high risk factors Cont other supportive measures CXR - no significant infiltrates Still at high risk of worsening as she reaches day 7 to 10 of illness 12/2/2021 note: Acute hypoxic respiratory failure-secondary to Covid infection vs COPD Sx start 11/24/21: weakness, fatigue, diarrhea, cough Covid + 11/24/21 CRP: 15 D-dimer: 950 BNP 370 CXR: no acute abnormalities Will cont remdesivir and decadron  Lovenox for DVT ppx Will continue supplemental oxygen to maintain SaO2>90% Cont mucinex and tessalon pearls The patient is on 1 L NC  Dispo: Will monitor respiratory status. Improvement in kidney function. PT/OT. Likely dc home in 2-3 days.
Delayed hypersensitivity eruption; Erythema multiforms; Rash on back and neck that itches; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA MULTIFORME (Erythema multiforms) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M20) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Coronary artery disease, GERD and Prostate cancer (Historyan of Prostate cancer). Concomitant products included GATIFLOXACIN, LOTEPREDNOL ETABONATE (LOTREL G) and POTASSIUM for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH PRURITIC (Rash on back and neck that itches). On 18-Mar-2021, the patient experienced ERYTHEMA MULTIFORME (Erythema multiforms) (seriousness criterion medically significant). On an unknown date, the patient experienced INJECTION SITE REACTION (Delayed hypersensitivity eruption). The patient was treated with TRIAMCINOLONE (topical) for Hypersensitivity reaction (NOS), at a dose of UNK dosage form and GRAMICIDIN, NEOMYCIN SULFATE, TRIAMCINOLONE ACETONIDE (KENALOG-S OPH.) (intramuscular) for Rash, at a dose of 60 milligram. At the time of the report, ERYTHEMA MULTIFORME (Erythema multiforms) and INJECTION SITE REACTION (Delayed hypersensitivity eruption) outcome was unknown and RASH PRURITIC (Rash on back and neck that itches) had resolved.            The action taken with mRNA-1273 in response to the event was not applicable.  It was reported that, the patient developed a maculopapular itchy rash on 10-Mar-2021 after 8 days after receiving second dose. He had no fever and chills. He was diagnosed with a delayed hypersensitivity eruption due to vaccine. Topical Triamcinolone was given for symptomatic relief, Later, he developed dusky erythema but itching improved. He was then treated with IM Kenalog 60 mg and improvement in rash was noted in 3-4 days.  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.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: The case was upgrade to serious as new event erythema multiforms added along with delayed hypersensitivity eruption, patient demographics updated along with HCP details.; Sender'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.
This spontaneous report as received from a consumer refers to her 5 years old daughter. The consumer called to reported that her 5 year old daughter received ZOSTAVAX (Lot# and route not reported) instead of VARIVAX (Merck) as a booster to her initial VARIVAX (Merck) injection. It was unspecified if the patient sought medical attention. Additional information has been requested.
Approximately a week after receiving the first dose of the Moderna COVID-19 vaccine, I developed a kidney-bean sized lump, believed to be a swollen lymph node, in my left axilla, the same side where the vaccine was administered.  The lump was mildly tender to palpation and gradually decreased in size over the next week until it was completely resolved.  When I received my second dose of Moderna, the same swelling returned within one day post-vaccine, along with other lymph nodes on that side extending to my neck and jawline.  These swellings took approximately five days to fully subside.
Patient said she had chills and lots of shaking and says felt like she probably had a fever although she did not confirm by taking temperature.
HEADACHE; JOINT PAIN; CHILLS; FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced fever. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 17-MAR-2021, and had not recovered from headache, and joint pain. This report was non-serious.
No additional AE reported; The injections were administered at 0, 2, and 4 months; This spontaneous report    was received from a nurse concerning     a 19 year-old female patient    The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On 12-AUG-2019 and 14-OCT-2019, the patient was vaccinated with the first and second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot# 1602283, expiration date 18-AUG-2021 (strength, dose and route were not provided)     for prophylaxis. On 16-DEC-2019,  the patient was administered with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot# E025729 (strength, dose, route and expiration date were not provided). The injections were administered at 0, 2 and 4 months. No additional adverse event was reported.  Lot Number E025729 is not valid for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1602283; expirationdate: 18-AUG-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This spontaneous report as received from a physician via Company Representative refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 27-AUG-2014 (reported as "a week ago"), the patient was vaccinated with second dose of GARDASIL (dose, strength frequency, route and lot number were not reported). On 04-SEP-2014 (reported as yesterday), the patient was vaccinated with third dose of GARDASIL (dose, strength frequency, route and lot number were not reported). Physician reported that an unspecified patient was administered the 2nd dose of GARDASIL "about a week ago" (on 04-SEP-2014) and was administered the 3rd dose of GARDASIL on 04-SEP-2014 (reported as yesterday). No adverse effects reported. Additional information has been requested.
received the second dose of the vaccine 6 weeks apart from the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose of the vaccine 6 weeks apart from the first vaccine) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose of the vaccine 6 weeks apart from the first vaccine). On 24-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose of the vaccine 6 weeks apart from the first vaccine) had resolved.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided
flushing, wheezing, tachycardia about 30 minutes after receiving vaccines. Went to the ED and received albuterol updraft, IV benadryl and solumedrol with marked improvement and sent home on oral prednisone and benadryl. Has had 5Dtap's previously and all her immunizations without any previous adverse reactions.
Information was received from a nurse concerning a first grade student who on 17 NOV 1998 was vaccinated with a dose of Varicella.  On mid DEC 14 2004 the student developed chickenpox.  According to the school nurse there were 58 other elementary school students and 34 of them had previously been vaccinated with a dose of Varicella.  Unspecified medical attention was sought.  There was no information regarding the present status of the first grade student.  No product quality complaint was involved.  Additional information was requested.
Normal muscle aches within the first 24 hours.  After that, creeping anxiety and panic attack similar to one that happened while I was positive with Covid in December of 2020.  Had anxiety including increased heart rate and impending sense of doom requiring a trip to counselor.  During Covid positivity, had severe anxiety and panic attack--also some hallucinations and severe paranoia.  However, I was too ill at home to be fully aware of the extent of the problem and was too anxious to seek help.
SEVERE HEADACHE; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: non-smoker, and non-alcohol user. The patient had no known drug allergies and no medical history of chronic illness. The patient was not pregnant at the time of reporting The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on an unspecified date in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was unspecified whether patient experienced any adverse events following the administration of covid-19 vaccine ad26.cov2.s (dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable The patient received non-company suspect vaccine mrna 1273 (Moderna, dose number in series: 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 06-NOV-2021 for prophylactic vaccination. On christmas eve, following mrna 1273 vaccination, it was reported that patient had a close contact with a person who had flu like symptoms prior to christmas eve, and that he was tested positive for covid-19 thereafter. On 26-DEC-2021, the patient experienced severe headache. (Dose number in series: 2) The action taken with mrna 1273 was not reported. The patient had not recovered from severe headache. This report was non-serious
From initial information received on 11/05/2003, from a health care professional regarding an adverse event occurring in the USA, it was reported that a 32 year old female patient received a dose of Fluzone SV '2003-'2004 USP (lot number U1102AA, expiration date 6/30/04) administered on 10/04/03. The route and site of administration were not reported. Within 24 hours, the patient developed a fever of 102 degrees Fahrenheit with malaise, fatigue and cervical lymphadenopathy. The next day, the patient still had a fever of 100 degrees Fahrenheit and was seen by a physician, who recommended Motrin 600mg, every 6 hours. the patient reportedly has received numerous influenza vaccines in the past. Her recovery status is unknown. From additional information received on 02/11/04 from a health care professional, the county of vaccination was reported. The vaccine was administered intra muscularly in the left deltoid on 11/04/03, not 10/04/03, as initially reported. The adverse event onset date was 11/05/03. the symptoms lasted for 72 hours. Reportedly, the patient purchased the vaccine with private funds. No relevant diagnostic tests were preformed. The patient did require a doctor's office visit due to the symptoms. She did not have any illnesses present at the time of vaccination. Reportedly, the patient recovered from these events. Her full address and telephone number were also provided. No further information is anticipated, this case is considered closed.
Per vaccinator, while administering the vaccination, the needle separated from the syringe. It occurred at the end of pushing the dose and the patient received the full dose. No replacement dose needed or given. Patient continued to observation with no issues.  Syringe/needle was Haiou brand
COUGH, HEADACHES,FATIGUE  Pneumonia due to COVID-19 virus   HOSPITAL COURSE   Admitting Diagnosis: Altered mental status, unspecified altered mental status type [R41.82] Pneumonia due to COVID-19 virus [U07.1, J12.82] Hospital Course (2 Days) YOU presented with fever, nausea, altered mental status, generalized body aches and incontinence of stool, the symptoms of which came on after he received his 2nd Covid vaccine yesterday.  Per report of the patient's daughter, he received his 1st Covid vaccination approximately 21 days ago.  Ten days ago he tested positive for COVID-19.  Despite this, the patient was instructed to proceed with securing a 2nd Covid vaccination after which his symptoms came on.  Upon presentation here, the patient was noted to be quite febrile to a temperature of a 103.2°.  On diagnostic workup, he did have a chest x-ray done which demonstrated vascular and alveolar congestion.  Fluid overload or cardiac decompensation.  No other suspicious acute abnormality identified. NO CHF HAS COVID   It is not recommended to take the covid vaccine within 30 days of covid infection due to increasing infammation and symptoms and should have immunity for at least 90 days from the infection with covid We did walk you and you do not require any oxygen .
fatigue, anxiety, chest tightness Narrative: severe pain in both temples and across the forehead blurry vision lasting less than 5 seconds occurring four times a day chest tightness, feeling anxious and "wiped out"
Allergic to wine; Flare up/occasional break out on face; Sore arm after vaccines; Fatigued after injection; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO CHEMICALS (Allergic to wine), RASH (Flare up/occasional break out on face), VACCINATION SITE PAIN (Sore arm after vaccines) and FATIGUE (Fatigued after injection) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis and Psoriatic arthritis.    No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ALLERGY TO CHEMICALS (Allergic to wine), RASH (Flare up/occasional break out on face), VACCINATION SITE PAIN (Sore arm after vaccines) and FATIGUE (Fatigued after injection). At the time of the report, ALLERGY TO CHEMICALS (Allergic to wine) and VACCINATION SITE PAIN (Sore arm after vaccines) outcome was unknown and RASH (Flare up/occasional break out on face) and FATIGUE (Fatigued after injection) had not resolved.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The patient did not agree to have physician contacted.  The reporter's causality for the event of flare up/ occasional break out on face and fatigued after injection with SKYRIZI was reported as reasonable possibility and for allergic to wine and sore arm after vaccines was no reasonable possibility.  No treatment medications were reported.
Patient was unknowingly given Dose #3 with expired vaccine.  Once realized the patient was contacted by his provider
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age. The patient's medical history, concurrent conditions and concomitant medication were not reported. On an unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot # L009203, expiry date 17-MAR-2017; lot # K018961, expiry date 15-OCT-2016; and lot # L011084, expiry date 01-APR-2017, (dose, frequency and route of administration not provided). No adverse effects reported. No product quality complaint (PQC) was involved. There was no additional information to report. Additional information has been requested.
Case number PHEH2013US022847 is a combined initial and follow-up spontaneous report received from a consumer on 28 Oct 2013 and 04 Nov 2013 respectively. This report refers to a 36-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1308501) intramuscularly on 15 Oct 2013. It was reported that on 15 Oct 2013, beginning night after vaccination, she experienced achy joints, muscle stiffness, chills, sweats, weakness, fatigue, shortness of breath and nausea. The outcome of the event was reported as condition unchanged. The seriousness and causality were not reported.
In a retrospective chart review that was conducted in 2 HIV primary care clinics, Patient 9, is an HIV positive patient, at least 18 years of age, with documented history of HBV vaccination administration prior to November 2017, and negative for both HBsAg and anti-HBs after previous HBV-vaccination. Baseline laboratories included HIV RNA undetectable, CD 4 count 228 cells/uL, CD 4 24%, positive for anti-HBc and positive for HCV co-infection. On an unspecified date, the patient received and completed both doses of HEPLISAV-B vaccine. On an unspecified date, the patient was noted as not having achieved seroprotection. Company comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.