chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heart/chest pain; heart/chest pain; fatigue; weakness; pain in my limbs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single and administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANGINA PECTORIS (medically significant), CHEST PAIN (non-serious) all with onset 2021, outcome "not recovered" and all described as "heart/chest pain"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "fatigue"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "weakness"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "pain in my limbs". Clinical source as follows: the patient had two Pfizer shots (end of Apr and early May). The patient had not felt the same sense. Patient had had heart/chest pain, fatigue, weakness and pain in his/her limbs, among a variety of other troubling symptoms. The patient was working with his/her doctors to try to pinpoint exactly what was going on.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Swollen itchy feet, lethargy, feeling "sick". Next day - terrible pain in right ankle and left wrist, feeling sick.
5mmx5mm redness around injection site that lasted a week before getting better. Area was red and itchy. a day after vaccine was administered. Patient came back a week after vaccination and requested assistance to submit a VAERS report on her behalf and area looks like fading away and healing properly. No signs of infection.
Started off small itchy - almost like mosquito bite and is now swollen hard , warm have almost 2 inches big
I received Arrexy RSV vaccination on Thursday 10 19 2023. There was no immediate issues. My vaccination site on my upper left arm became very sore and swollen in the next 24 hours. It still aches today more than I have ever experienced with any vaccine. It itches very much. There is a hard lump and swelling remains although it has sibsided. The skin is pinkish and very sensitive. I can use my arm although it does ache. I have no other major symptoms, only slight fatigue that was much more on the 2nd day. I thought I should report what is happening.
first 3 days typical vaccine reaction of achy muscle in vaccine spot. went away totally then 7 days later large oval area of redness felt warm to the touch, and lasted about 5 days, a little tender, slightly itchy at first
pt developed swelling of the cheek and ear, was given prednisone and benadryl symptoms resolved, no shortness of breath.  originally thought it was related to another allergic reaction but given it was so long after her vaccination.  then she developed similar symptoms 10 days after her second dose of the moderna vaccine 8/18/21 and then swelling of cheek including lips this time w/o tongue swelling took prednisone and benadryl with resolution of symptoms
THAT EVENING PATIENT BEGAN STARTING TO NOT FEEL WELL. THE NEXT MORNING HE WAS ONLY ABLE TO STAY AT WORK FOR AN HOUR DUE TO FEELING ACHES, DIZZINESS, AND DROWSINESS. HE SAID HE WAS NOT EVEN ABLE TO SIT UP STRAIGHT. THAT DAY HE WAS COMPLETELY SICK. THIS SUBSIDED OVER THE NEXT TWO DAYS. LASTING 3 DAYS IN TOTAL.  THE PATIENT ALSO COMPLAINED THAT SINCE THE VACCINE HE HAS HAD SOME SYMPTOMS OF SHINGLES COMING BACK ON AND OFF. 1 MONTH AFTER THE VACCINE HE HAD THE WORST BOUT WAS 1 MONTH AFTER THE VACCINE HAVING CRAMPING AROUND HIS RIBS, ALONG WITH THE TINGLING AND BUMPS HE HAS BEEN GETTING AROUND HIS MIDSECTION. TODAY HE SAID HE HAD TINGLING ON HIS BACK ALONG WITH BEING ABLE TO FEEL 4-5 BUMPS WHICH HE BELIEVES ARE SHINGLES RASH.
This case was reported by a physician and described the occurrence of fever in a 2 months old female pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The pt's medical history and concurrent conditions were not reported. The pt received no concurrent medications.  On 17Nov2003 the pt received the first dose of Infanrix. On the same date the pt also received Haemophilus influenzae type b conjugate vaccine, poliomyelitis virus vaccine (IPOL), and 7-valent pneumococcal conjugate vaccine (Prevnar). At an unspecified time post-immunization, on 17Nov03, the pt experienced a fever and was examined at the physician's office. The event resolved the following day. The physician considered the fever to possibly be related to vaccination with Infanrix.
Injection site pain, swelling and heat 8 days post injection.  Headache, nausea, fatigue
possible pericarditis; chest pain; feeling tired; harder to breath than normal; irregular heartbeat; fever hovering at 102 for 3 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 5 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 09:45 (Batch/Lot number: unknown) at the age of 5 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient was not diagnosed with COVID prior vaccination. There were no concomitant medications in two weeks. The patient did not receive any other vaccination within the four weeks before the vaccination. Facility where the most recent COVID-19 vaccine was administered: Doctor's office/urgent care. The following information was reported: PERICARDITIS (hospitalization) with onset 16Nov2021 14:00, outcome "recovering", described as "possible pericarditis"; CHEST PAIN (hospitalization) with onset 16Nov2021 14:00, outcome "recovering", described as "chest pain"; FATIGUE (hospitalization) with onset 16Nov2021 14:00, outcome "recovering", described as "feeling tired"; DYSPNOEA (hospitalization) with onset 16Nov2021 14:00, outcome "recovering", described as "harder to breath than normal"; HEART RATE IRREGULAR (hospitalization) with onset 16Nov2021 14:00, outcome "recovering", described as "irregular heartbeat"; PYREXIA (non-serious) with onset Nov2021, outcome "recovering", described as "fever hovering at 102 for 3 days". The patient was hospitalized for pericarditis, chest pain, fatigue, dyspnoea, heart rate irregular (hospitalization duration: 1 day(s)). The events "possible pericarditis", "chest pain", "feeling tired", "harder to breath than normal" and "irregular heartbeat" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: (unspecified date) irregular heartbeat; (unspecified date) irregular heartbeat; body temperature: (09Dec2021) 102; sars-cov-2 test: (09Dec2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of pericarditis, chest pain, fatigue, dyspnoea, heart rate irregular, pyrexia. Clinical course: Child was taken in ambulance to hospital. Emergency medical technician (EMT) found irregular heartbeat on Electrocardiogram (EKG)/ Electrocardiogram (ECG). Same was found in hospital. Released with possible pericarditis and request to follow up with pediatrician for chest x-ray and covid test (which was negative). A week later, he had a fever hovering at 102 for 3 days. The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient was shaky and pale during post-vaccination observation following her second Pfizer dose. Juice was provided to the patient. Per Mom, client has a history of "vagal" reactions following blood draws or other needle encounters. Onsite EMS evaluated client, took vital signs (below). Client's condition improved. Client was cleared by EMS to discharge home with her mother, and she left the facility of her own volition.
Patient found with hoarse voice, difficulty swallowing and lump in right neck.  Ct scan revealed retropharyngeal hematoma.  Required I&D of site with drain, speech therapy.
inj site red & swollen;feeling of fatigue & achy joints x 2 days;local symptomatic
PAIN (sore); INJECTION SITE INDURATION (Hard); Pain at injection site under the band aid; INJECTION SITE SWELLING (swollen); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (PAIN (sore)), VACCINATION SITE INDURATION (INJECTION SITE INDURATION (Hard)), VACCINATION SITE PAIN (Pain at injection site under the band aid) and VACCINATION SITE SWELLING (INJECTION SITE SWELLING (swollen)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 631B2A) for COVID-19 vaccination.  No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN (PAIN (sore)), VACCINATION SITE INDURATION (INJECTION SITE INDURATION (Hard)), VACCINATION SITE PAIN (Pain at injection site under the band aid) and VACCINATION SITE SWELLING (INJECTION SITE SWELLING (swollen)). At the time of the report, PAIN (PAIN (sore)), VACCINATION SITE INDURATION (INJECTION SITE INDURATION (Hard)), VACCINATION SITE PAIN (Pain at injection site under the band aid) and VACCINATION SITE SWELLING (INJECTION SITE SWELLING (swollen)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: reporter declined consent for further follow up.
Myalgia, Fever, Swollen lymph nodes to left side of body, pain at injection site  Narrative:    Other Relevant History:
Hives, shortness of breath, chest tightness within 5 minutes of receiving vaccines. Right arm had redness at the injection site the left arm site did not. He states he does not have an egg allergy that he is aware of. He received PO benadryl 50mg and pepcid 20mg and was given a shot of decadron/depomedrol 4/40mg IM once in office. EMS was called and he was transported to the ER.
pain swelling redness at injection site, sore as soon as it was given, headache, fatigue, mild body aches
Tested positive for COVID-19; Extreme nausea; Fatigue; Headache; Head spinning; Numbness in arms and hands; Severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Severe diarrhea), VERTIGO (Head spinning), HYPOAESTHESIA (Numbness in arms and hands), SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) and NAUSEA (Extreme nausea) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced DIARRHOEA (Severe diarrhea). On 04-Jan-2021, the patient experienced VERTIGO (Head spinning), HYPOAESTHESIA (Numbness in arms and hands), NAUSEA (Extreme nausea), FATIGUE (Fatigue) and HEADACHE (Headache). On 05-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). At the time of the report, DIARRHOEA (Severe diarrhea) was resolving and VERTIGO (Head spinning), HYPOAESTHESIA (Numbness in arms and hands), SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), NAUSEA (Extreme nausea), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included baby aspirin, ibuprofen and aspirin, sodium bicarbonate, anhydrous citric acid. Concomitant medications were not provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, other than testing positive for Covid-19 , a causal relationship cannot be excluded.  Testing positive for Covid-19 is unrelated to receiving COVID-19 vaccine (mRNA-1273)
pt recv vax & approx 10-12 days post vax pt exp fever of 104 & gen rash (it was noted may have been roseola);medical attention was sought;
Breastfeeding; raised hives all over; itchy on my knees, palms, arms, and elbows; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchy on my knees, palms, arms, and elbows), URTICARIA (raised hives all over) and EXPOSURE VIA BREAST MILK (Breastfeeding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included Maternal exposure during breast feeding.    MEDICAL HISTORY (Patient): The patient's past medical history included No adverse event (No medical history was reported.).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced PRURITUS (itchy on my knees, palms, arms, and elbows). On 02-Jan-2021, the patient experienced URTICARIA (raised hives all over). On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (Breastfeeding). At the time of the report, PRURITUS (itchy on my knees, palms, arms, and elbows) and URTICARIA (raised hives all over) was resolving and EXPOSURE VIA BREAST MILK (Breastfeeding) 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.   No relevant concomitant medications were reported. Treatment medication included Benadryl and topical steroid cream.  Company Comment: This is a case of product exposure during breastfeeding. 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. Patient will continue to be contacted for further monitoring of AEs.; Reporter's Comments: This is a case of product exposure during breastfeeding. 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. Patient will continue to be contacted for further monitoring of AEs.
pt recv vax 18JUL96 & since that time pt reports that has had a reduced ROM, spasms & loss of feeling in the inj site arm when it is moved in certain positions;
Fluvirin w/ Thimerosal given to OB pt. LMP = 8/15/2009. EDC = 5/22/2010. Pt does NOT have an OBGYN. Pt notified on 11/09/09.  Denies any adverse effects. Pt NOT hospitalized after receiving H1N1 vaccine.  11/17/09:  Prenatal visit record received from date of service 11/2/09. Dx:  Pregnancy. Assessment:  IUP at 11 wks. 2 days.  No AE reported.
Vertigo or Dizziness lasting over a week now. Metallic taste in mouth starting around the same time but now dissipated.
Monday, June 14 11:30am received Shingrix #1 shot in left arm.   Tuesday, June 15 1:30am woke up with very sore arm, chills, shivering ...  Tuesday, June 15 8:00am chills and shivering symptoms were gone.   Very sore arm.   Mild headache Wednesday, June 16 Arm still sore (not as bad).  Mild headache. Thursday, June 17 8:00am  Got a migraine headache.  Injection site starts to feel itchy and redness Friday, June 18  woke up to injection site very warm to the touch.  Redness and swelling (approx 5" diameter).  Injection site very itchy.  I called my primary care provider that morning (Fri. 6/18) to report side effects (was told these were all normal)  and to ask if I could take Benadryl for the itchiness (was instructed to not take Benadryl)
Red, swollen, itchy rash on and around injection site starting on day 8 and lasting 3 days. Worst on the second day.
Patient fainted approximately 2 minutes after receiving the vaccine. He sat down to wait for the 15 minutes but fell forward and off of his chair. He recovered quickly, but stated he felt nauseous as well as "weird".  Ambulance was called for precaution and while waiting for arrival we got a cold compress, water, and some crackers for him to eat as his father stated he did not eat any breakfast before he came in. Anxiety seemed to be the most prevalent cause of the fainting, but father insisted he normally does well with shots. His breathing was normal, and color was retuning quickly after eating the crackers. EMT's arrived, took blood pressure, blood sugar and stated eveyrthing was normal. However it was mentioned that the patient takes medication for anxiety and EMT's stated it was most likely fainting from anxiety as all tests were normal. We kept him for observation for another 30 minutes, and will follow up to check in on patient.
Vomiting and fever started 36 hours after first dose. Vomiting persisted for 4 hours. Fever persisted for 24 hours.
About 3 inches down from the injection sites, patient experienced redness, swelling, and tenderness. Patient took tylenol and benadryl for home care after experiencing those symptoms. Redness and tenderness improve.
Information has been received from a mother, for the Pregnancy Registry for GARDASIL vaccine (yeast), concerning her 15 year old daughter with a history of latex allergy and tonsillectomy who on 24-APR-2008 was vaccinated with her first dose of GARDASIL vaccine (yeast) (Lot #, size, and route not reported). There was no concomitant medication. On 24-APR-2008 the patient "became pale, and she was nauseous and sick for one day". On an unspecified date, the patient took a pregnancy test which was positive (not further specified) (LMP approximately 05-FEB-2008, "estimated date of conception is 27-Feb-2008"). On 25-APR-2008, the patient fully recovered from paleness, nausea and being sick. The patient sought unspecified medical attention. No additional information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/13/2008.
I was starting to not feel well, and I was congested, coughing, and I had a bad headache. I ended up going to my doctor after three days of this and they did a COVID-19 Test and it was negative. There was an influenza bug going around and they treated me for that. I was given four prescriptions to take and after about a day or two I was doing much better.
15 year old given Adult Hep A vaccine; 15 year old given Adult Hep A vaccine; This case was reported by a consumer via call center representative and described the occurrence of overdose in a 15-year-old patient who received Hepatitis A vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis A vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 07-OCT-2022 Reporter's Comments: The reporter stated that a patient was given the Adult Hepatitis A vaccine and the patient wanted to know any guidance. The reporter did not have any patient information.
Patient initially experienced muscle soreness and then developed itchiness in the arm injection was given. This progressed into hives, sore throat, cough, and headache.  He also complains of chest tightness.
A report has been received from a Health Professional concerning a 58 year old, Female subject, who had been received Nasal FLUMIST (intranasal), 0.2 Millilitres, Unknown for INFLUENZA. FLUMIST (intranasal) started on 28-Sep-2015 for INFLUENZA. The patient who was 49 years of age was administered FLUMIST on 28-Sep-2015. FLUMIST (intranasal) was discontinued on 28-Sep-2015. The outcome of the event over OVER 49 YEARS OF AGE and MISUSE/FLUMIST WAS ADMINISTERED OVER THE AGE OF 49 YEARS is unknown.
Rheumatoid arthritis flare up; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Relevant concomitant medication was not reported.  On an unknown date of 2021, patient received first and second dose of Moderna COVID-19 vaccine and on 22-Dec-2021, patient received booster dose of Moderna COVID-19 vaccine.  On an unknown date, the patient experienced rheumatoid arthritis flare. On an unknown date of 2021, she had Moderna COVID-19 vaccine and experienced fever and chills.  Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  The reporter causality for the event of triggered rheumatoid arthritis flare, fever and chills with RINVOQ was not provided.  CC: This spontaneous case concerns a 63year old female patient, with a relevant history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) adverse event of special interest Rheumatoid arthritis flare up, which occurred unknown days after the third dose of mRNA-1273 vaccine administration. The outcome was reported as unknown. No diagnostic results or treatment information were not provided. Underlying  history of rheumatoid arthritis could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 63year old female patient, with a relevant history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) adverse event of special interest Rheumatoid arthritis flare up, which occurred unknown days after the third dose of mRNA-1273 vaccine administration. The outcome was reported as unknown. No diagnostic results or treatment information were not provided. Underlying  history of rheumatoid arthritis could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.