chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tachycardia; Caller says it makes her uncomfortable because it is an experimental drug.; Pericardial effusion; This spontaneous case was reported by a patient and describes the occurrence of PERICARDIAL EFFUSION (Pericardial effusion) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A, 068H21A and 010A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient had no known allergies. They were tested for pollen but it was not confirmed.  Concurrent medical conditions included Hashimoto's disease, Turner's syndrome, Hypothyroidism and Heart disease congenital (Visit cardiologist every 1 to 2 years.).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced PERICARDIAL EFFUSION (Pericardial effusion) (seriousness criterion medically significant). On an unknown date, the patient experienced TACHYCARDIA (Tachycardia) and FEELING ABNORMAL (Caller says it makes her uncomfortable because it is an experimental drug.). At the time of the report, PERICARDIAL EFFUSION (Pericardial effusion), TACHYCARDIA (Tachycardia) and FEELING ABNORMAL (Caller says it makes her uncomfortable because it is an experimental drug.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered TACHYCARDIA (Tachycardia) to be related. No further causality assessments were provided for PERICARDIAL EFFUSION (Pericardial effusion) and FEELING ABNORMAL (Caller says it makes her uncomfortable because it is an experimental drug.).    Concomitant medication was not provided.  It was reported that the patient had apprehensions because of patient's medical history. Patient had been visiting the doctor for past 34 years. Treatment information was not provided.  Company comment: This spontaneous case concerns a 34-year-old female patient with underlying Hashimoto's disease, congenital heart disease who experienced the unexpected serious (medically significant) event of Pleural effusion which occurred unknown days after receiving second dose of mRNA-1273 vaccine. She also experienced tachycardia on an unknown date. Investigation and treatment details are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report
Tinnitus - both ears; This is a spontaneous report received from a contactable consumer, the patient. A 71-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Mar2021 at 14:15 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergies to medications, food, or other products. Concomitant medication included trandolapril (MANUFACTURER UNKNOWN) 2mg per day for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested for COVID-19 since the vaccination. On 13Mar2021, the patient experienced tinnitus in both ears. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatments for the event. The clinical outcome of the event tinnitus in both ears was not recovered.   Information about lot/batch number cannot be obtained. No further information is expected.
Left shoulder pain Excessive tiredness not usually experienced (slept 11 hours on 2nd night)
Injection site pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number D924E, expiry date 8th March 2022) for prophylaxis.   On 22nd August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months 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 after vaccination experienced some pain at the injection site. This case has been linked with case US2019202821, reported by the same reporter.
patient said she suffered a low grade fever, sore arm, and flu like symptoms for 48 hours after receiving the vaccine.
Headache, Myalgia, Arthralgia, Fever, Diarrhea, NauseaVomiting, Fatigue, Chills Narrative:
headache; This is a spontaneous report from a contactable consumer (Patient) via medical information team. A female patient of an unspecified age received first dose of BNT162B2 (Pfizer BioNTech COVID-19 vaccine, formulation: Solution for injection, Lot number unknown, expiration date unknown), via an unspecified route of administration on 04Feb2021 as single dose for COVID-19 immunisation. Medical history included migraine. Concomitant medications included aspirin (ACETYLSALICYLIC ACID, strength: 81 mg) at 81 mg, daily for an unspecified indication. Historical vaccine included Aimovig. Patient was taking the injection called Aimovig 70mg once a month. She had her Aimovig shot 17 days before getting the Pfizer COVID-19 vaccine and she was scheduled again for her Aimovig shot 7 days before her second dose of the pfizer COVID-19 vaccine. She was concerned whether the Aimovig shot would make the Pfizer COVID-19 vaccine less effective. Patient also mentioned that she was taking 81mg aspirin everyday but on the day she got the Pfizer COVID-19 vaccine, she skipped the aspirin. Patient was taking Sumatriptan for her headaches. Twelve hours after the first dose of the Pfizer vaccine, she had a headache and took a pill of Sumatriptan. The outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Seizure like activity (full body convulsions) lasted less than 30 sec, eyes rolled back. No treatment. EMS transfer to ER for evaluation. No Hx of S2R or vaccine reaction.
only had sniffles the first night; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (only had sniffles the first night) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (only had sniffles the first night). At the time of the report, RHINORRHOEA (only had sniffles the first night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment medication was reported.   This case was linked to MOD-2021-260257 (Patient Link).
On 2/15/00, at 16:00, pt called doctor to see if soreness was normal and they said yes. On 6/12/00, went to doctor and he gave her home exercising to do. On 8/9/00, appt. with surgeon and he referred me to physical therapy. On 8/16/00 through 9/20/00, had therapy and didn't work so he sent me back to surgeon. On 10/4/00, met with surgeon and arranged an MRI and it was normal and was told to occasionally to stretch out my arm. I had very deep aching pain in my arm, very limited range of motion. Didn't sleep much from February to September. This was a terrible experience! (I found that when I called for the manufacturer and lot number, the nurse told me they no longer use that manufacturer; interesting!)
A non-serious spontaneous report of stuffy nose has been received from a non-health professional concerning a 34-month-old male, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST on 16-Nov-2010. On 17-Nov-2010, one day after vaccination, the child developed a stuffy nose. The outcome of the event was unknown.
The next day, I felt like someone hit me with a sledgehammer.  I had a fever of 102. I had trouble breathing. I had a cough and congestive. I was lethargic. I had bad headaches. Both of my knees swelled up where I could not move around. I been on antibiotic because my doctor was worried that my knee was going to have an infection in it because I just had a knee replacement. I went to the urgent care. They did a quick exam and put me on a lot of medicine. I have never felt so sick in my life.
Patient reports noticing erythematous, itchy area in site of left upper arm anthrax vaccine administration day after it was administered. The area was larger in size the next day. Denies constitutional symptoms.
I have a large red, swollen circle on my arm, close to where I got the shot.  It's hot and sensitive to the touch.  It seemed to get bigger the second day, but it looks like it has stayed the same size since then.  It almost looks like hives.
Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. Concomitant medications were not provided.
Parent of patient returned to clinic 2 days after vaccination to have right arm evaluated.  Raised reddened area 9 cm X 6 cm right upper posterolateral arm.  Denied  pain, numbness or tingling in arm.  No systemic reaction evident.  Recommended child be evaluated by their personal pediatrician.
Hallucinations, severe nausea, abdominal pain, dizziness, headache, body aches, cold sweats, uncontrollable shivering.
Patient was given dose 1 of Moderna series on 2/21/2023  from a vial which was placed in refrigeration on 2/1/2023, meaning it was stable until 3/3/2023 (30 days).  It was discovered after administration that the manufacturer expiration of the vial was 2/21/2023.  Moderna was contacted to assist in determining if vaccine was to be considered valid or if revaccination was needed.  Moderna completed an analysis and determined that "The vaccine administered on February 23, 2023  from lot number AS1420B maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. "   A physician reviewed the scenario  and Moderna analysis and determined that the dose was to be considered valid, and the series was to be completed per Moderna guidelines.  Family was alerted to this incident and was in agreement with plan, and did not note any symptoms, or adverse reactions.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 34-year-old male. Neither medical history nor concomitant medications were reported. On 24-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
She had the vaccine at 0700 and at 0800 she developed Lightheadedness, sore throat, body aches, chills, headache, nausea. She was not having these symptoms before the vaccine.
Itchy rash on palms of hands and fingers. Rash more widespread on left palm, with smaller rash on right palm
Experiencing headache and shortness of breath every day, for the last 5days.  Using albuterol; had not been necessary for months.
31y.o. G4P3013 presents for routine postpartum incision check. She delivered via primary cesarean section for non-reassuring fetal heart tones with intraoperative findings concerning for placental abruption. Postpartum course has been uncomplicated. She denies fever, chills, nausea or vomiting and pain at incision site is well controlled. Baby doing well. Patient denies headache, visual disturbances, chest pain, shortness of breath, RUQ/epigastric pain. Is not currently taking her blood pressures at home but is agreeable to doing so.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date 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 ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date later in 2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster. The outcome was unknown. 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. Additional information has been requested.
Sore arm, tingling sensation slightly numb, tingling numb sensation also in left 3 outside fingers (pinky, ring, middle).  That started about 15 min after injection.  The next day on 12/24, increased pain at site, redness, swelling and hard lump in area of vaccine. It is about 2 inches diameter round spot. Pain in arm continued. Fingers feel slightly improved as of 12/25. The injection site is the same as yesterday.
muscle pain in shoulders, hips, lower mid back, finger joints, chills, nausea, uncontrollable shivering, upset stomach, breathing difficulties.
severe swelling which radiated down her arm; This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. A 65-year-old female patient started to receive pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced severe swelling which radiated down her arm 5 months ago on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
This case was reported by a physician via call center representative and described the occurrence of autoimmune disorder in a 80-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included heart disease, unspecified and polymyalgia rheumatica.  In November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced autoimmune disorder (serious criteria GSK medically significant), arthralgia, myalgia, creatine phosphokinase increased, peripheral edema, inflammatory reaction and synovial disorder. SHINGRIX was discontinued. On an unknown date, the outcome of the autoimmune disorder, arthralgia, myalgia, creatine phosphokinase increased, peripheral edema, inflammatory reaction and synovial disorder were unknown. It was unknown if the reporter considered the autoimmune disorder, arthralgia, myalgia, creatine phosphokinase increased, peripheral edema, inflammatory reaction and synovial disorder to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX at a local pharmacy. The reporter did not know the product details or exact date of immunization. The reporter thought, this was the 1st dose of SHINGRIX vaccine for patient. After vaccination, the patient experienced as an adverse reaction with autoimmune symptoms. The patient further described it as a diffuse inflammatory reaction, involving arthralgia's, myalgia's, increase in creatine phosphokinase (CPK), synovial fluid retention and peripheral edema. The reporter did not have patient's chart with him. The patient had seen two physician, including a rheumatologist, regarding this reaction. The patient told did not get the 2nd dose of SHINGRIX. The reporter consented to follow up. Lab Comments: On an unknown date, the creatine phosphokinase was increased.
6 hours after injection - sore arm/tenderness 24 hours after injection- very mild malaise, body aches, fever (took Tylenol and slept) these subsided by morning 9 days after injection- small red rash on arm at injection site, very mildly itchy, slightly warm, not raised.
This is a spontaneous report received from a contactable nurse through a Pfizer sales representative. A 17-year-old female patient of an unspecified ethnicity received TRUMENBA (lot number M95612, expiration date 30Jul2017), intramuscular on 23Jun2016 12:22 as single dose for immunization/ preventive vaccination. Medical history included dysmenorrhoea from 24Jan2013, treated with ethinylestradiol, norgestimate, anxiety from 24Oct2015 to an unknown date treated with vortioxetine hydrobromide. Concomitant medication included DOXY from 20Jun2016 till 23Jun2016 for upper respiratory tract infection (URI), BRINTELLIX from 240ct2015 and ongoing for anxiety, ORTHO TRI-CYCLEN for dysmenorrhea from 01May2013 and ongoing and  TRINTELLIXfor anxiety 24Oct2015 and ongoing. The patient experienced hives all over/ severe hives on 24Jun2016. Therapeutic measures were taken as a result of hives all over/ severe hives; patient was administered CELESTONE; batch 511700, expiration date Sep2017 at 6 m given intramuscular for hives and the hives went away patient got better. The patient recovered from hives all over/ severe hives on 24Jun2016. Per the reporter, the Pfizer product maybe had a casual effect to the adverse event. Follow-up (01Oct2016): Follow-up attempts are completed. No further information is expected. Follow up (28Nov2016): New information reported from a contactable nurse (reported on behalf of physician) includes: patient data, suspect product data, medical history, concomitant medication, detailed event description, treatment received and causality. Follow-up attempts are completed. No further information is expected.
Report 20020005581 describes possible rheumatoid arthritis in a 43 year old male who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received from the vaccinee and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not provided. The vaccinee reported that he received his first and second injections of LYMErix in October 1999 and September 2000 (exact dates not provided), respectively. In the year 2000, an unspecified time following receipt of the second injection of LYMErix, the vaccinee reported that he experienced achiness "for a couple of months that (he) thought was the flu." The achiness resolved. In December 2001, 15 months following receipt of the second injection of LYMErix, the vaccinee reportedly began to experience joint pain. His body was "stiff and sore," and he found it "difficult to walk due to arthritic feeling." He was seen by a general practitioner, who reportedly told the vaccinee that he "may be developing rheumatoid arthritis" and reffered the vaccinee to a rheumatologist. The rhematologist saw the vaccinee on 01/11/2002. The rheumatologist reportedly was "not ready to label (him) as developing arthritis. The rheumatologist prescribed rofecoxib (Vioxx), and advised the vaccinee to exercise and watch his diet. As of 01/11/2002, the joint pain, body stiffness, and body soreness persisted. The vaccinee stated that his facility's healty unit considered the events to be possibly related to LYMerix administration. The LYMErix immunization series was discontinued. The adverse events 'possible rheumatoid arthritis' and 'joint pain' do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
This spontaneous report as received from a healthcare worker, who reported that ZOSTAVAX was exposed to 40F for an unspecified amount of time longer than 72 hours. Healthcare worker was unsure if any doses were administered. No adverse effects reported. Additional information has been requested.
Fainted while waiting in the waiting area. She was sweating also. She gained conscious after few minutes and left the store. Asked to call ER but she refused.
Shingles; Cold sore on lip; "Festering under skin like pimple"; Acne on shoulder; Exacerbation of eczema; Skin is tender; Itch; Rash/ Pain with rash; Pain with rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included eczema.   In January 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th January 2020, 2 weeks after receiving Shingrix, the patient experienced pruritus, rash, pain, skin tenderness and eczema aggravated. On an unknown date, the patient experienced shingles, cold sores lip, subcutaneous abscess and acne. The patient was treated with steroids nos (Steroids). On 11th February 2020, the outcome of the cold sores lip, pruritus, rash, pain, subcutaneous abscess, skin tenderness, acne and eczema aggravated were recovered/resolved. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles, cold sores lip, pruritus, rash, pain, subcutaneous abscess, skin tenderness, acne and eczema aggravated to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. This case was reported by patient himself. The patient received first dose of Shingrix sometime in mid January. The patient reported that about 2 weeks later he started developing symptoms of what he thinks was Shingles. The patient went to the emergency room and received steroid cream to treat affected areas. The patient expereinced itch, rash, pain, festering under his skin like a pimple, tender skin on affected areas, cold sore on his lip, acne on his shoulder and exacerbation of his eczema. The patient was being treated by his health care professional. Provided him with phone number for Medical Information department so his health care professional can call for further information. The reporter consented to follow up. Emergency visit required.