chrisvoncsefalvay/vaers-outcomes huggingface dataset:
classic varicella lesions-sl coryza  rt wrist, rt ankle, forehead-no temp-otherwise nl activity-no other classic sx;
pt recv vax & varicella lesions 17DEC97;pt had +varicella exposure @ school prior to vax;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: EK4176), in left arm, on 06Feb2021 as dose 2, single (Lot number: EL9265), in left arm, on 13Sep2021 as dose 3 (booster), single (Lot number: FP2588), in left arm and on 03Apr2022 as dose 4 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bradycardia" (unspecified if ongoing), notes: other medical history: Bradycardia; "been on CPAP for 4 months" (unspecified if ongoing), notes: other medical history: Been on CPAP for 4, months; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: VERAPAMIL, start date: Sep2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The event "treatment of covid-19" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 107/73 mmHg, notes: BP 107/73 with 70 pulse; Heart rate: (unspecified date) 70, notes: BP 107/73 with 70 pulse; (unspecified date) 68, notes: 68/97 pulse/ox; Oxygen saturation: (unspecified date) 97 %, notes: 68/97 pulse/ox; SARS-CoV-2 test: (27Jun2022) Positive; (03Jul2022) Negative; (04Jul2022) Negative; (05Jul2022) Negative; (07Jul2022) Negative; (09Jul2022) Negative; (10Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Tested positive for covid on 27Jun emergency room. Prescribed the Paxlovid/Ritonavir regimen which was started on 27Jun2022 and completed on Saturday morning of 02Jul. Tested negative on 03Jul, 04Jul, 05Jul, 07Jul. On 09Jul awoke congested, puffy eyes, cough but again tested negative. 10Jul awoke with 99.9 temp and tested positive. 68/97 pulse/ox. BP 107/73 with 70 pulse. Adverse event start date 09Jul2022, 06:15 AM. Another course of Paxlovid starting on 10Jul.
10/18 - woke up with severe diarrhea, felt achy, flushed, and feverish, little energy or appetite, increase in arthritis pain
Felt nauseous, woozy, low grade fever, sweats, no appetite x36 hrs.
Pt. walked to the front of the Pharmacy from the post vaccination waiting area  (4 feet) asking for help because he was dizzy. He was sweating  and having shortness of breath. Pt. was taken to the seat where he fainted. Pt. was laid on the floor with his legs up in a step. He gained consciousness in less than 1 min.  Pt was pale. Pt. was given an alcohol swab to smell. 911 was called. First responders took his blood pressure again and blood sugar. Uncle's pt. was called and came to the Pharmacy to pick him up to avoid pt. having to drive his car back home.
Pruritus - Benadryl given at COVID vaccine area. Relieved. Symptoms advanced after the caregiver went back to work. Called vaccine provider. Went to ED. Received Solu-medrol and Epinephrine. Released in stable condition
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age who on an unknown dates, were vaccinated subcutaneously with a doses of ZOSTAVAX (dose and lot numbers not reported). On an unknown date ,the patients were diagnosed with shingles after being vaccinated with ZOSTAVAX. At the time of the report, the patient's outcome was unknown. The relatedness for shingles and ZOSTAVAX was unknown. Additional information is not expected.
Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves unknown number of patients over 65 years of age (demographics unknown) who received vaccine ADACEL (lot number not reported) via unknown route in unknown administration site on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was reported that the patients experienced no adverse events. 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 and Module VI of the 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.
SPOKE TO PATIENT AND DAUGHTER, THEY WERE OK . PATIENT WAS NOT COMPLAINT ANYTHING AND GAVE PATIENT THE RIGHT VACCINE.
Fever, chills, fatigue, muscle aches, sore throat, knot on arm noted approx 48 hrs after shot with red rash approx the size of a mandarin orange
Few minutes after the vaccination, patient seemed very tired and weak. Upon approaching the patient, she was crying. She seemed in distress. She started turning pale and slowly losing consciousness and balance while seating on the chair. Patient did not fall off the chair because I was holding her.  It seemed like a syncope like reaction until her face started drooping and she started convulsing for few seconds. She came back to conscious within few seconds and complains her head hurts. One dose of Epipen 0.3mg was administered to the patient and EMT came and took the patient away.
Routine visit to cardiologist on Nov. 4 . Cardio gram  indicated very erratic heart rate of 130 and irregular. Digion .25 mg prescribed. No symptoms. No previous heart trouble. Repeat visit 4 days later reported perfectly normal heart as shown by cardio gram and sonogram tests.  Diogenes reduced to .124 mg On Nov.4 my home monitor indicated rate of 115. All measurements on home monitor before and after the 4th indicated normal rates in the 70s  and  90s. Some in 80s. A repeat testing on December 7 confirmed normal heart.
Well exam and shots at 4:30pm - to ED for redness and wheals 5 hrs later.  Generalized.  Diagnosed with allergic reactions - treated with Orapred and Prednisone PO.
pt recv vax 20SEP95 & 2APR97 pt devel chickenpox w/less than 30 lesions;The pt recovered from exp;
Low grade temp; Achy; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade temp) and MYALGIA (Achy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy and Allergy to antibiotic (clindamycin).   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PYREXIA (Low grade temp) and MYALGIA (Achy). On 26-Mar-2021, PYREXIA (Low grade temp) and MYALGIA (Achy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Body temperature: low (Low) Low grade fever.         No concomitant medication was reported  No treatment medication was reported
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2016, the patient was treated at a health care facility (by an unspecified healthcare professional) for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Had upper arm pain later the same day as is typical. However it never dissipated. I began having sudden severe pains in shoulder once in a while when grabbing /using left arm. Then started having more constant arm pain. Saw PA at ortho clinic on 1/4/23 who said I had bursitis from the flu vaccine being administered incorrectly most likely. Received a steroid injection.  And a handout for exercises, which I did daily.  While this helped I was still having pain and trouble using left arm. Returned on 4/23/23 to ortho clinic and saw Dr.  He said I had frozen shoulder, gave me another steroid injection and referred me to PT.  PT is ongoing, I do exercises daily, but still have limited motion in my left shoulder, and it clearly does not move the way it should.
The lot number Lot# 029K20A it was expired; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The lot number Lot# 029K20A it was expired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The lot number Lot# 029K20A it was expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The lot number Lot# 029K20A it was expired) had resolved.            No concomitant medication reported.  No treatment information was provided.
Discharge Provider:  MD Primary Care Provider:  MD Admission Date: 2/13/2023 Discharge Date: Feb 16, 2023  PRESENTING PROBLEM: Acute respiratory failure with hypoxia  [J96.01] Community acquired pneumonia of right lung, unspecified part of lung [J18.9] COVID-19 [U07.1]   HOSPITAL COURSE:   58 y.o. female with a pertinent past medical history of asthma, hx asplenia and nephrectomy 2/2 trauma, chronic pain, HTN, who presented with cough, SOB. Admitted for AHRF.   CTA chest was negative for PE.  Did show multifocal right pneumonia with small areas of cavitation.  Pulmonology evaluated.  Cavitations thought to be infiltrates superimposed on emphysema.  Clinical presentation was consistent with COVID-19 pneumonia with respiratory bronchiolitis.  Was recommended for outpatient follow-up and signed off.    Patient's history was also not suggestive of cavitary pneumonia such as TB.  She denied any history of incarceration or recent travel outside the country, or any hemoptysis.   Patient was initially started on Unasyn and azithromycin for antibiotics.  Also started on Decadron and remdesivir.  DVT prophylaxis had been held in the setting of a possible bronchoscopy with pulmonology which patient eventually did not have.    Infectious Disease followed.  Strep and Legionella were negative.  Sputum culture with no result.  Blood cultures were not collected.   Patient initially required 4 L nasal cannula, remained hemodynamically stable throughout her admission.  She progressively improved and was weaned to room air.  She was discharged on a course of Augmentin to complete 5 day course for CAP, as well as continued Decadron to continue total 10 day course. Case was discussed with ID who was in agreement.
A report received on 10/9/02 from a consumer, concerning a 29 year old female vaccinee who experienced severe pain and swelling in the big toe after receiving a Fluvirin vaccine on 10/1/02. On 10/3/02 the pt experienced severe pain and swelling in the big toe after receiving one dose of Fluvirin vaccine IM on 10/1/02. The pt was seen by a physician in an emergency room. The physician took blood samples and suspected gout. The following day the pt was seen by her primary physician who also suspected gout. On 10/5/02 the pt was seen by a rheumatologist and states that the preliminary diagnosis appears to be gout, even though the pt's age, medical history and life style were not typically associated with gout. The rheumatologist checked the uric acid levels, which were not elevated. The physician prescribed oral anti-inflammatory medication and injected an unknown drug into the affected joint at the time of the appointment. The physician has not diganosed the pt with gout. It was unknown if the pt received flu vaccines in the past. At the time of reporting the pt had recovered. On 11/1/02 a follow up report was received. It was reported that the onset of symptoms began on 10/2/02. On 10/3/02 the vaccinee went to her doctor who suspected gout and took blood for uric acid levels. A foot x-ray was performed and was negative. The affected joint was injected on 10/5/02 and the pt experienced relief by the 10/6/02. The pt was concomitantly receiving the oral contraceptive pill orally. On 11/22/02 a follow up report was received confirming that the Fluvirin batch number was this manufacturer's batch number.
felt muscle twitching; This is a spontaneous report from a Pfizer-sponsored program COVAX Support. A contactable male consumer (patient) of unknown age reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 12Feb2021 as dose 1 single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in Feb2021 the patient felt muscle twitching. The event outcome was unknown.  Information on lot/batch number has been requested.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 12-APR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (injection, lot # L044058, expiration date 02-MAY-2017) (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
ED to Hosp-Admission Discharged 8/2/2021 - 8/6/2021 (4 days) Hospital  Hypoxia Dyspnea, unspecified type Hospital Problems        POA    * (Principal) Pneumonia due to COVID-19 virus Yes         Diastolic dysfunction Yes         Hypercholesterolemia Yes         Hypertension Yes         Type 2 diabetes mellitus (CMS/HCC) Yes         COPD (chronic obstructive pulmonary disease) (CMS/HCC) Yes         PVD (peripheral vascular disease) (CMS/HCC) Yes         Hypoxia Yes
On the day of the vaccination, March 27, 2021, I had a sore arm and a headache. The next day I was lethargic and felt mild chills. These seemed like flu-type symptoms. On the third day, March 19, I felt fine during the day, but by 10 pm, my breasts were warm and hurting. Over the next 5 days they got much worse. My nipples were noticeably swollen, hot to the touch, and so sore that I couldn't wear a bra or a blouse that pressed on my skin. Overnight I had discharge from my left nipple (about 1/4 teaspoon worth on my night clothes); this occurred again on the next night. By the 5th day, my breasts felt mostly back to normal.
Tingling and pain at site, numbness in arm, general malaise, bump at site.
product storage error temperature too low/ reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes with no reported adverse event; fluzone administered to adult patient after product experienced an excursion with no reported adverse events; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA057733, 2023SA069712,2023SA069466,2023SA052709,2023SA054981,2023SA069475 (CLUSTER).  This case involves Adult and unknown gender patient to whom influenza quadrival A-B vaccine [Fluzone QIV] was administered after product experienced an excursion with no reported adverse event and product storage error temperature too low/ reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes with no reported adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was administered unknown dose of suspect influenza quadrival A-B vaccine, suspension for injection (dose, strength: not reported; lot UT7683NA; UT7682JA: expiry date: 30-Jun-2023) via unknown route in unknown administration site for immunization after product experienced an excursion with no reported adverse events (product storage error) (poor quality product administered) (unknown latency).  Action taken : not applicable.  Outcome was Unknown.   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.
Patient had itchy, scaly bumps on the arm that was vaccinated and her upper chest. They were mildly bothersome but required no treatment. The bumps persisted for about 3 days.
Twenty four hours after the shot I had a high fever ,body aches and nausea which lasted 48 hours. I felt better for a few days and five or six days after the shot I started to get headaches again. The headaches got progressively worse and more frequent. I don't normally get headaches. It was pain at the lower back side of my head which was dull but got worse and throbbing in periods. My pain level was an eight or nine. They lasted most of the day. I am still getting a few headaches after three weeks. I have been taking Tylenol and Ibuprofen and it is starting to get better. It is still every day and the mornings are worse before I take a pain reliever. My pain level with the headaches is more like a 3-5 range level of pain.
3hr p/vax pt c/o severe soreness & redness @ site;nurse assessed 5FEB98-area of swelling as big as tangerine;heat @ site;ASA given today & topical analgesic applied to site;
Information has been received from a physician concerning her daughter who was vaccinated with a dose of varicella virus vaccine live at 15 months old. Subsequently, two weeks after vaccination, the patient developed a rash. She was noted to have recovered. No fever was noted. Unspecified medical attention was sought. It was also noted that the patient was vaccinated with a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) and developed a rash (WAES0505USA01839).
get itchy; a rash; really tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (really tired), INJECTION SITE PRURITUS (get itchy) and RASH (a rash) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included Chickenpox.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced FATIGUE (really tired). On 05-Apr-2021, the patient experienced INJECTION SITE PRURITUS (get itchy) and RASH (a rash). At the time of the report, FATIGUE (really tired), INJECTION SITE PRURITUS (get itchy) and RASH (a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Steroid and eczema cream.
Redness; Swelling; Itching; This spontaneous case was received on 07-Jan-2021 from Med Communications (reference number: SEQW21-00089), reported by other non-health professional (consumer) and concerned a female patient of unreported age.  The patient's medical history included allergy to polyethylene glycols (PEG). The patient's concomitant medications were not reported.   On an unspecified date in Nov-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; anatomical location, dose, route of administration: not reported) for flu prevention. The batch number was not reported.   On an unspecified date, 30 hours after receiving Flucelvax Quadrivalent, as reported, the patient developed swelling, redness and itching.   The outcome of the events was not reported.  The reporter assessed the events as related to Flucelvax Quadrivalent. As reported, the patient had mild adverse reaction to Flucelvax Quadrivalent.  The reporter assessed the case as non-serious.  Company comment: A patient of an unreported age was vaccinated with Flucelvax Quadrivalent. On an unspecified date, 30 hours after receiving Flucelvax Quadrivalent, the patient developed swelling, erythema and pruritus. Causal role of the suspect vaccine is assessed as possibly related.; Reporter's Comments: Consumer inquires if Flucelvax Quad contains PEG. She wants to know because she is allergic to it, but on November she got Flucelvax Quad and she only had a mild adverse reaction (swelling, redness and itching).; Sender's Comments: A patient of an unreported age was vaccinated with Flucelvax Quadrivalent. On an unspecified date, 30 hours after receiving Flucelvax Quadrivalent, the patient developed swelling, erythema and pruritus. Causal role of the suspect vaccine is assessed as possibly related.
REDNESS; WARMTH; SORENESS; ARM SWELING; FEVER; INJECTION SITE REACTION; EXPLOSIVE DIARRHEA; This spontaneous report received from a patient 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 on left arm, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2021, the subject experienced explosive diarrhea. On 13-MAR-2021, the subject experienced injection site reaction. On 14-MAR-2021, the subject experienced redness. On 14-MAR-2021, the subject experienced warmth. On 14-MAR-2021, the subject experienced soreness. On 14-MAR-2021, the subject experienced arm swelling. On 14-MAR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from explosive diarrhea on 13-MAR-2021, and fever on 15-MAR-2021, had not recovered from arm swelling, redness, warmth, and soreness, and the outcome of injection site reaction was not reported. This report was non-serious.