chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a 67 year old female patient with cataracts and drug hypersensitivity to VIOXX. The patient's medical history included breast cancer and lymphadenectomy of one arm (dates were not specified). On 08-JAN-2014, the patient was vaccinated in the patient's arm where she had the lymphadenectomy with PNEUMOVAX 23 (lot number, expiration date, route of administration and strength were not reported). There was no concomitant medication. On approximately 09-JAN-2014 (reported as "a day or two" after vaccination), the patient noticed that the arm where she was vaccinated was swollen, and it looked bruised as she had a "blue and purple" discoloration of her arm. On 16-JAN-2014, the patient sought medical attention, and the physician put her on an unspecified antibiotic. On an unspecified date (reported as "a few months ago"), the patient felt a lump in the same arm, the lump stayed consistently. Therefore, she sought medical attention and the physician told her she should have it looked at. In September 2015, the patient went to an outpatient facility for surgery and had the lump removed from her arm. The pathology report described the lump as a "benign inflamed fibroid tissue and fat necrosis". At the reporting time, the outcome of peripheral swelling and contusion was reported as recovered on an unspecified date in 2014 (reported as "took about 2 or 3 months before she fully recovered") and benign soft tissue neoplasm was reported as recovered in September 2015. The reporter stated that any physician was sure if the benign soft tissue neoplasm was related to PNEUMOVAX 23. Additional information has been requested.
This case was reported by physician and described the occurrence of swelling of the left side of the neck in a 75-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline) for prophylaxis. The subject's medical history included gout. Concurrent medical conditions included asthma, degeneration joint disease, diabetes, gastrooesophageal reflux disease, hypertension, hypothyroidism and obesity. Concurrent medications included Lovastatin, Allopurinol, Thyroxine sodium (Levoxyl), Metformin hydrochloride (Metformin), Lisinopril, Fluticasone propionate+salmeterol xinafoate (Advir) and Mometasone furoate (Nasonex). On 27 November 2007 the subject received 1st dose of Fluarix in an unknown arm. On 17 December 2007, 3 weeks after vaccination with Fluarix, the subject experienced swelling of the left side of the neck. The subject was referred to an Ear Nose and Throat doctor. A biopsy was performed on an unknown date and the subject was diagnosed with lymphoma on 16 January 2008. The subject was referred to an oncologist. The outcome of neck swelling was not known. The lymphoma was unresolved at the time of reporting. This case was assessed as medically serious by GSK. The physician considered the events were possibly related to vaccination with Fluarix.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received SHINGRIX for prophylaxis. On 4th February 2019, the patient received SHINGRIX. On 6th February 2019, 2 days after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient experienced sore on the arm around the injection sight.
Left side of nose bleeding; This is a spontaneous report from a contactable consumer (patient's wife). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9267; Expiration Date: 31May2021), via an unspecified route of administration, administered in arm right on 01Mar2021 at 14:00 (at the age of 64-years-old) as dose 1, 0.3 ml single for COVID-19 immunisation. Medical history included high blood pressure (taking high blood pressure medication for a long time) from an unknown date. There were no concomitant medications. The patient experienced left side of nose bleeding on 02Mar2021. The reporter and her husband went and got COVID-19 Shot on Monday at 2PM. Her husband's nose started bleeding off and on. Is this a side effect? The reporter must go and get the second COVID-19 Shot. Nose bleeding started yesterday morning (02Mar2021) and it was off and on. The reporter found a paper towel with blood on it. She then saw her husband with a piece of paper towel up his nose in case it starts bleeding again. Nose is just bleeding from one side and thinks it is the left side. The outcome of the event was unknown.    No follow-up attempts are possible. No further information is expected.
Facial flushing and some blotching over cheeks and chin. Salmon rash on chest - classic drug rash. Gave 12.5mg of Benadryl with resolution of symptoms over the course of a couple of hours.
Given 0.25mL of Moderna Bivalent vaccine.  No apparent injury.
Patient is a 67 y.o. male patient of, MD with history of COPD/emphysema with chronic respiratory failure with hypoxia on 4 L nasal cannula, who presented to Doctors Hospital with worsening shortness of breath..  He was found to be COVID-positive on 11/20   Acute on chronic respiratory failure with hypoxia and hypercapnia Concern for volume overload on imaging Respiratory acidosis-resolving on repeat VBG Chronically on 4 L nasal cannula at home Initial VBG showed pH 7.26 with PCO2 80.5 and bicarb 36.  He was placed on BiPAP in the ED.  Pulmonology consulted in ED   Repeat ABG at that time showed improvement with pH 7.34, PCO2 down to 58.1 with bicarb 31.7 and O2 saturation 98.6% CXR with mild?moderate CHF with moderate pulmonary vascular congestion with diffuse edema and small effusions ECHO showed  EF of 70% Lasix 20 mg IV x1 given 11/20.  Monitor daily weight.  Strict I's/O Procal - normal, cefepime and vancomycin discontinued Patient transitioned from BiPAP to Heated high flow nasal cannula  Weaned to nasal cannula 4 liters Pulmonology signed off   Covid-19 Virus Infection Date of onset of symptoms: 1 week prior to admission Symptoms present on admission: Shortness of breath, diarrhea Date of covid positive test: 11/20 Vaccination status: vaccinated?Johnson & Johnson times 17/13/2021 Imaging: CXR with moderate pulmonary vascular congestion and diffuse edema with small effusions with large heart size concerning for mild?moderate CHF Oxygen requirements on admission: BiPAP Current oxygen requirements:  Medical therapy: remdesivir and steroids?started on Decadron and remdesivir 11/20 Consultants following: Pulmonology, ID Anticipated special isolation end date: TBD possibly 11/30 (or 10 days from positive test) CRP 22.9 on admission.  Lactic acid was 1.1   COPD exacerbation Received multiple albuterol and DuoNeb's.   on azithromycin  Albuterol and Symbicort Decadron for COPD and COVID infection   Polymicrobial Enteritis  Stool pcr postive for C diff, campylobacter and Ecoli  Initiated on po vancomycin continue  HIV Positive  HIV-1 quantitation pending T-helper at cells CD4 count  - 453 Does not want to discuss about HIV positive status   f/u with Dr  ID
Had Covid back in January. We all three did; Had Covid back in January. We all three did; Arm is real sore; He did not feel good; sick at home; This is a spontaneous report from a Non-contactable consumer reporting on behalf of her husband consumer (patient).A male patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunization. The patient medical history included COVID-19. The patient concomitant medications were not reported. On unspecified date, the patient experienced arm was real sore and he did not feel good, sick at home. Reporter stated that "my arm hurts and I had ran fever, I had a diarrhoea, I was so sick I could hardly get out of my chair. I was sick for 3 days and that my arm is still sore, my husband's arm is real sore, but he did not feel good. My daughter got the shot same day we did, Friday. Her arm had swollen, her lymph node underneath her arm was swollen and she can hardly move her arm. She is in lot of pain. And it says if we had any side effects to report it. This was our first shot. I had Covid back in January. We all three did (Further clarification unknown). But I had to be hospitalized because I had the Covid, it was scary, it was like I will die. I had pneumonia with it. My husband and daughter were sick at home. I lost, my brother passed away due to Covid and my brother-in-law had Covid. But we did have a side effect. I usually run like a low grade temperature 96 or a 97 and I ran 99.2." The outcome of the events was unknown.  QR Comment: MI concern acknowledged in First case.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Shortly after being vaccinated, I noticed a ringing-like noise in my ears.  Its more like static than ringing. I later heard on the news that this could be a side effect of the Covid 19 vaccine.  Its mild and does not disrupt my day -to-day.  I dont intend to seek treatment at this time but thought it should be reported.
Initial misuse report received from a healthcare professional on 05 August 2013. An 11-year-old patient was administered DAPTACEL in error. No adverse event was reported. List of documents held by sender: none.
Soreness at injection site; Small cough at night; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site) and COUGH (Small cough at night) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 41L20A) for COVID-19 vaccination.     The patient's past medical history included Coronary artery disease, Pneumonia, Immune system disorder and Peripheral artery surgery.   On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose.   On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site) and COUGH (Small cough at night). At the time of the report, VACCINATION SITE PAIN (Soreness at injection site) and COUGH (Small cough at night) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It is reported that patient had other health conditions as 22 stamps and currently taking infusions for low immune system. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: No specific follow-up information recorded.
HCP reported an improperly stored administered ROTATEQ; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 23-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 1 dosage form, orally, lot number 1684163, expiration date 26-JUN-2021 for prophylaxis.  The vaccine had a temperature excursion from 0.92 Celsius degrees (°C) to 13.3°C for 43 hours and 45 minutes. There were no previous temperature excursions.
benign proximal positional vertigo; sick; This is a spontaneous report from a contactable consumer. This 69-year-old female consumer reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0182) via an unspecified route of administration on 10May2021 09:30 on arm left (at 69-year-old), as dose 2, single for COVID-19 immunization. Medical history of the patient included stroke. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0170) via an unspecified route of administration on 19Apr2021 at 09: 30 AM on left arm at 69-year-old), as dose 1, single for COVID-19 immunization. Caller reported that she received both doses of the Pfizer Covid-19 vaccine and later, on an unknown date she was sick. She went to an Urgent Care, and Ear, Nose, and Throat doctor, who diagnosed her with benign paroxysmal positional vertigo on 06Jun2021. On an unknown date in 2021 the patient underwent lab tests and procedures which included blood test: her bloodwork, computerized tomogram head, electrocardiogram and urine analysis were normal. Her question was could the vaccine have caused this condition. Therapeutic measures were taken with a full course of Prednisone prescribed by the Urgent Care for benign proximal positional vertigo (vertigo positional). The outcome of event benign proximal positional vertigo was not recovered and for sick was unknown. The patient reported that she had no health insurance and does not like or take drugs. She was normally a very healthy person, who did not have a vaccine pressure, but peer pressure got her to take this vaccine.  No further details were provided.
R arm hot to touch; R arm hurts; R arm she has like a chicken egg/Swelling in arm after 2nd dose; side effects from the 2nd dose. She says it was like she had duck eggs all up and down her arms; she says picking things up has been a nightmare; R arm of injection red; Knots in arm after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (R arm hot to touch), PAIN IN EXTREMITY (R arm hurts), PERIPHERAL SWELLING (R arm she has like a chicken egg/Swelling in arm after 2nd dose), SKIN DISORDER (side effects from the 2nd dose. She says it was like she had duck eggs all up and down her arms) and MUSCULOSKELETAL DISORDER (she says picking things up has been a nightmare) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (Breast cancer survivor). Concurrent medical conditions included Allergy NOS (Allergies to medicines) and Idiopathic thrombocytopenic purpura (turned black, Says the radiation caused her body to attack its own cells and cause the ITP). Concomitant products included ELTROMBOPAG OLAMINE (PROMACTA), POTASSIUM CHLORIDE, METOPROLOL TARTRATE, LOVASTATIN, PANTOPRAZOLE SODIUM ANHYDROUS and VITAMIN D NOS for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE WARMTH (R arm hot to touch), PAIN IN EXTREMITY (R arm hurts), PERIPHERAL SWELLING (R arm she has like a chicken egg/Swelling in arm after 2nd dose), SKIN DISORDER (side effects from the 2nd dose. She says it was like she had duck eggs all up and down her arms), MUSCULOSKELETAL DISORDER (she says picking things up has been a nightmare), INJECTION SITE ERYTHEMA (R arm of injection red) and MYALGIA (Knots in arm after 2nd dose). At the time of the report, INJECTION SITE WARMTH (R arm hot to touch), PAIN IN EXTREMITY (R arm hurts), SKIN DISORDER (side effects from the 2nd dose. She says it was like she had duck eggs all up and down her arms), MUSCULOSKELETAL DISORDER (she says picking things up has been a nightmare), INJECTION SITE ERYTHEMA (R arm of injection red) and MYALGIA (Knots in arm after 2nd dose) outcome was unknown and PERIPHERAL SWELLING (R arm she has like a chicken egg/Swelling in arm after 2nd dose) was resolving.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: significant followup On 08-Jul-2021: Follow up included no new information.
Information has been received from an office manager referring to multiple patients of unknown age and gender. the patient's concurrent condition, medical history or concomitant therapy was not provided. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (lot# M006729, expiration date 08-FEB-2018, dose ad route unknown). the vaccine had been stored under the temperature of 21.7 Fahrenheit. There was no previous temperature excursion and no date logger involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was administered Flucelvax on 11/05/2022. Patient was overdosed on Flucelvax 11/21/2022, 12 days before she was eligible for a second dose of Flucelvax. Father called on 11/22/2022 to confirm timing was correct and the error was caught. The child is asymptomatic currently.
No other AEs reported.; Vaccine administered after expiration; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 08-SEP-2021, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot number T017385 with expiration date 01-SEP-2021 (dose, route and anatomical location were not reported) for prophylaxis (expired product administered). No other adverse events were reported.
PATIENT EXPERIENCED RASH ON FACE AND HAS NOT BEEN TREATED. RASH IS STILL PRESENT, BUT IMPROVING (PER THE PATIENT) ON 11/18/05. ADVISED TO TREAT ALLERGY WITH BENDADRYL TABLETS ON 11/18/05.
pt recvd 2nd dose of vax & devel high fever of 103.8, severe muscle cramping & malaise; poss cat scratch fever;
dizzy, feels drugged cannot move arms or legs well cannot open eyes well, very weak, laughing, crying observation to treatment given;
day p/vax pt exp blurred vision, dizziness & flue like sx lasting 2days. pt felt as though he was suffocating
No additional adverse effects reported; patient was administered improperly stored M-M-R II; This spontaneous report was received from a nurse and refers to a 20 year old patient of unknown gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 08-JUN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # S010706 and expiration date 08-APR-2021 for prophylaxis (dose strength, frequency and route of administration were not provided). The vaccine was reconstituted with properly stored sterile diluent, lot# R006906 and expiration date 18-DEC-2020.     It was reported that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) had a temperature excursion above 47°F: 58 F for 1 hour. No previous temperature excursions were reported. Digital data logger was involved.
This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 47-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 13th June 2018, refer case US2018155246). Concurrent medical conditions included rheumatoid arthritis. On 20th August 2018 17:00, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 21st August 2018, 1 days after receiving SHINGRIX, the patient experienced activities of daily living impaired. On an unknown date, the patient experienced pain in arm, muscle pain and muscle spasm. On an unknown date, the outcome of the pain in arm, muscle spasm and activities of daily living impaired were unknown and the outcome of the muscle pain was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, muscle pain, muscle spasm and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: This case was reported by physician for himself. The patient received 2nd dose of SHINGRIX on left deltoid and experienced a pain during administration. The night after receiving the vaccination was horrible because of the pain. The patient went into work the next day but had to leave because of the arm pain, he stated that there was muscle spasms and muscle pain. The patient said the pain went away for a little bit of time but restarted on the day before reporting. The patient said, he was experiencing the same pain as he felt last week. The patient had denied permission to contact their physician.
patient complained of headache at check out desk and then had syncopal episode in which she hit back of her head. During observation after event, her initial blood pressure was normal but then her blood pressure began to drop. She complained of feeling hot. Her blood pressure continued to drop and eventually was sent to ER via EMS
pt recv vax;pt noted to be pale & limp p/ vax;no cyanosis noted; better now;
exacerbated neck/shoulder pain; exacerbated neck/shoulder pain; coughing (more during the day); felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (exacerbated neck/shoulder pain), COUGH (coughing (more during the day)), FATIGUE (felt tired) and ARTHRALGIA (exacerbated neck/shoulder pain) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy, Neck pain and Shoulder pain.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced COUGH (coughing (more during the day)) and FATIGUE (felt tired). On 15-Feb-2021, the patient experienced PAIN (exacerbated neck/shoulder pain) and ARTHRALGIA (exacerbated neck/shoulder pain). On 12-Feb-2021, COUGH (coughing (more during the day)) had resolved. On 13-Feb-2021, FATIGUE (felt tired) had resolved. On 19-Feb-2021, PAIN (exacerbated neck/shoulder pain) and ARTHRALGIA (exacerbated neck/shoulder pain) had resolved.            Concomitant medications were not provided.  Treatment included antihistamines (unspecified).   This case was linked to MOD-2021-048098 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Reporter contact information updated .
Patient states she was vaccinated with the Pfizer two dose series both in March 2021.  Patient states she received the Moderna booster in May 2021.  Patient was unable to provide exact dates nor place of vaccinations. Patient presents to ED with complaints of generalized malaise, headache, cough, SOA, fatigue, and fever.  Admitted due to patients transplant status.
20Nov90 pt developing back pain /w radiation down legs, weakness & some paralysis developed.  Was evaluated @ Hosp. DX of Guillian Barre made Dec90. Was allowed to return to full duty @ work 4Feb91