chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Difficulty breathing; Ear was hurting inside for several hours; Back pain; Lip was itching; Bottom lip swelled; 1-2 hives on her lips; Dizzy spells; Vertigo; Migraines/ low grade headache; Coughing up dark mucus; Not feeling well; Itchy, 2 inches in diameter of a red circle at vaccination site; Respiratory infection; Bronchitis; Side of her neck was hurting; Itchy, 2 inches in diameter of a red circle at injection site; Congestion; Shoulder pain; A spontaneous report  was received from a  consumer concerning a 73-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchy arm, 2 inches in diameter of a red circle at the injection site, pain going up her shoulder, congestion, bronchitis, difficulty breathing, side of her neck was hurting, ear was also hurting inside for several hours, back pain, lip was itching, bottom lip swelled, 1-2 hives on her lips, dizzy spells, like vertigo, migraines, low grade headache, coughing up dark mucus, respiratory infection, and not feeling well.  The patient's medical history, as provided by the reporter, included chronic fatigue syndrome, respiratory infection. Concomitant medications were not reported.   On 10 Feb 2021, approximately same day prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unspecified date in Feb 2021, prior to receiving mRNA-1273, the patient felt covid arm around 7 days later where it was itchy, 2 inches in diameter of a red circle at the injection site, pain going up her shoulder, congestion, bronchitis, difficulty breathing, side of her neck was hurting, ear was also hurting inside for several hours, back pain, lip was itching, bottom lip swelled and had 1-2 hives on her lips, dizzy spells, like vertigo, migraines, low grade headache, coughing up dark mucus, respiratory infection. The event respiratory infection was considered medically significant.  Treatment for the events included antibiotics and steroids.  Action taken with mRNA-1273 in response to the events was not reported.   The events, itchy arm, 2 inches in diameter of a red circle at the injection site, pain going up her shoulder, congestion, bronchitis, difficulty breathing, side of her neck was hurting, ear was also hurting inside for several hours, back pain, lip was itching, bottom lip swelled and had 1-2 hives on her lips, dizzy spells, like vertigo, migraines, low grade headache, coughing up dark mucus, respiratory infection, and not feeling well, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
7/29/13 about 7 pm feeling "achy" and c/o's stiff neck. Chills and nausea -temp 101 degrees. Vomiting at 2 am; Next day 7/20 tem 100 degrees. Left work early; 7-31-13-> developed cough and some dizziness -> better later that same prn (7/31/13) advised to go to ER or her provider-had appt scheduled with her provider but canceled apt.
Immunization Dtap 3/21, rash 3/24-vesiculopapular. Prescribed Benadryl 3/26/07.
Information has been received from a physician concerning a 37 month old male with no medical history and no allergies, who on 14MAr03 was vaccinated with a 0.5ml dose of varicella virus vaccine live (lot 0936). There was no concomitant medication. It was reported that the pt came into the office on 26Apr05 with a mild case of varicella. He had a rash and no lesions. The pt's status was reported as not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Patient reported: "Unbearable throbbing" the night of getting vaccine. Pt went to ER and was found to have "low BP" of 103/71 mmHg and was given saline (NaCl 0.9%).
Flu like symptoms; Nausea; Mild Headache; Big red circle on arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE ERYTHEMA (Big red circle on arm), NAUSEA (Nausea) and HEADACHE (Mild Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Big red circle on arm). On 27-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), NAUSEA (Nausea) and HEADACHE (Mild Headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE ERYTHEMA (Big red circle on arm), NAUSEA (Nausea) and HEADACHE (Mild Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient had unspecified thyroid medication as concomitant medications.
24 hours after shot child with wheals through at skin, arms, legs, abdomen pruritic.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Headache-Mild, Additional Details: pt disclosed that she had not eaten all day. injection given at 5pm. she also reported she usually feels faint when she goes to doctors office for bloodwork usually. checked BP 111/85 HR 88. gave her water and 3 candy, she felt better a few minutes after.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 2/10/2023 Discharge Date: 2/15/2023  PRESENTING PROBLEM: Hypoxia [R09.02] Acute on chronic respiratory failure with hypoxia [J96.21]   HOSPITAL COURSE: Patient is a 59 y.o. male with past medical history significant for intracerebral hemorrhage who is currently bed-bound and nonverbal, has a trach and PEG.  He has  hypertension, chronic anemia, CKD stage 3b, depression and has been under hospice care at facility.   Patient apparently has been having increased sputum secretions and unsuccessful attempts to replace his trach by the nursing home facility after it fell off.  He was needing 15 L of oxygen via non-rebreather hence transferred to Hospital.  A chest x-ray done initially in the emergency room showed concerns for pneumonia and with leukocytosis he is treated with IV antibiotics for potential pneumonia.  A CT scan of his lungs showed no pulmonary embolism and chronic scarring.  He completed 5 days antibiotic therapy and he did very well after the tracheostomy is replaced in the ER.  Very minimal secretions and suction needed.  RT has followed him every day and was happy for him to go back he was on 28% FiO2 at the time of discharge.   Patient threw up a couple of times during this hospitalization his tube feeds were held in the CT scan was obtained CT did not show any obstruction he is restarted on tube feeds at a slower rate and within 24 hours he reached goal.  He was doing very well on tube feeds.   Throughout the hospital stay the guardian was updated.  At this stage the guardian is not planning on restarting hospice care at the facility.  I explained to her that patient has high risk of rehospitalization and declined given his the severely chronic comorbidities and encouraged her to consider hospice in future.   COVID test done prior to discharge toward out to be positive.  This is considered incidental as he was recently tested positive for COVID.   He has been on sublingual morphine which seems to have been helping him with contractures we will continue that eventually if he is not on hospice scheduled sublingual morphine could be discontinued and we could discontinue it as as needed.
Approximately 15 minutes after the shot patient became confused and anxious.  I did not see her do this but her family members said she was in and out of consciousness.  No signs of anaphylatic shock just fainting and confusing.  Ambulance took her to area hospital I do not know any more information at this time.
Arm pain forever; Bursitis; Sick; injection site pain; Some fatigue; COVID positive / just getting over COVID; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain forever), BURSITIS (Bursitis), ILLNESS (Sick), COVID-19 (COVID positive / just getting over COVID) and DRUG INEFFECTIVE (Lack of drug effect) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shoulder replacement. Previously administered products included for an unreported indication: FLU. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and ALENDRONATE SODIUM (FOSAMAX) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced COVID-19 (COVID positive / just getting over COVID) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain forever), BURSITIS (Bursitis), ILLNESS (Sick), INJECTION SITE PAIN (injection site pain) and FATIGUE (Some fatigue). At the time of the report, PAIN IN EXTREMITY (Arm pain forever), BURSITIS (Bursitis), ILLNESS (Sick), COVID-19 (COVID positive / just getting over COVID), DRUG INEFFECTIVE (Lack of drug effect), INJECTION SITE PAIN (injection site pain) and FATIGUE (Some fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Sep-2021, SARS-CoV-2 test: positive (Positive) COVID positive.         No Treatment were reported. Patient mentioned flu shot caused bursitis and tendonitis.   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: follow up received on 29-SEP-2021 includes Event was added On 04-Oct-2021: follow up received contains medical history , events for flu shot; Sender's Comments: This case concerns a 71-year-old, female with reported history of Flu vaccination and shoulder replacement, who experienced the unexpected AESI event of Drug ineffective because of COVID 19 infection more than 15 days after the second dose of the vaccine within a correct interval with the first dose. The event occurred approximately 7 months and 26 days after the first dose and 6 month and 27 days after the most recent dose (second dose) of mRNA-1273 Moderna vaccine (Spikevax). The rechallenge was unknown since the patient is planning on getting the booster. Several other non serious or AESI events were reported, such as pain in extremity, tendinitis and bursitis that could be confounded by the history of shoulder replacement and the co suspect of flu vaccine. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report
This spontaneous report was received from a healthcare professional referring to a 12 months old female patient. Information about the patients' medical history and concurrent conditions was not reported. On 06-JAN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Approx. 2 days, post vax, had extreme bad cold accompanied by fever, chills, difficulty breathing and coughing with fluids which persisted for 6 days after.
Patient started with arm pain and swelling following the vaccine administration that evening. She treated with IBU to help resolve the pain and ice for the swelling. The next morning she woke up with hives down her whole arm. On 2/15 contacted me for advice and recommendations. She will continue IBU every 4-6 hours and ice, but will also take BENADRYL in the evening to help with the allergic reaction.
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2021 at 14:00 as dose 1, single (Lot number: EL3248), in right arm, on 08Mar2021 at 14:00 as dose 2, single (Lot number: EL3248), in right arm and on 17Nov2021 at 10:00 as dose 3 (booster), single (Lot number: FF2590) at the age of 48 years, in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21May2022 at 11:00, outcome "recovered with sequelae" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21May2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient had not had COVID prior to vaccination.
Information has been received from a 69 year old female consumer with sulfa allergy concerning herself who on 17-AUG-2010 was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) (lot# not reported). Concomitant therapy included VALTREX, acyclovir and DARVOCET-N. On 24-AUG-2010 the patient was not feeling well. The consumer had joint pain, fever and nausea; now she had Shingles. The consumer also stated, "I have been having outbreaks since the 80's, and those symptoms always proceed before my outbreaks." She stated that she has used VALTREX (manufacturer unspecified) for treatment. The patient also mentioned that she thought the therapy route was done intramuscularly rather than subcutaneously. No medical attention was sought. Blood work was performed with no results reported. At the time of this report, the patient had not recovered. Additional information has been requested.
Pt c/o lightheaded while sitting in 15 min waiting area.  2nd mask removed & taken to Observation area per w/c.  Vomited x2, shaky, pale & diaphoretic.  BP125/87 R16 Legs elevated on cot & rested.   4:20 PM Sitting up & eating juice & crackers.  Color improved 4:42 Released after walking around & stating he feels better.  BP 125/87 R 16
Upper arm, around injection site, became swollen, red, and warm on 1/22/21-one week after the vaccine;  I took 250mg acetaminophen and put ice pack on arm.  Occasionally the site itches very slightly; ice reduces itch.  Upper arm was sore to touch on Friday night/Saturday morning, but has not been such since then.  No loss of function and all affect to activities of daily living.
had titers drawn/ did not present enough antibodies for measles; Information has been received from a physician via a field representative referring to a 14 years old female patient without pregnancy. Information about medical history, concurrent condition and concomitant medication was unknown.        On an unknown date (reported as "year ago"), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, frequency, route, lot# and expiration date were unspecified) for prophylaxis. On an unspecified date in 2019 (reported as "recently"), the patient had titers drawn and did not present enough antibodies for measles. The patient did not seek medical attention and it was unknown if treatment was given for the event. The outcome of titers drawn/ not present enough antibodies for measles and the causality were unknown.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA002177: US-009507513-1905USA006157:
light headedness, claminess, parasthesias of the hands and feet, worked night shift and day shift. no treatment
08/26/22 presents to Triage for "planned induction of labor". PMHx of "anxiety disorder, depression"
Initial redness and discomfort in arm. Two days afterward, runny nose and temperature to 100.3. Extremely red rash on arm, measuring approximately 4 and 1/2 x 5 inches. Had eye surgery today and the nurses strongly encouraged me to report the rash.
Pt c/o left side HA, c/o tooth pain and nausea. Pain from HA on temporal lobe so severe pt felt dizzy. s/s lasted x 5 days. Had tooth extracted and was prescribed oxycodone which states did not take. Took Tylenol 3 x 1 1/2 days.
0845 received vaccine  1900 onset moderate headache  0100 felt feverish and nauseous  0400 nausea resolved  0700 feverish sensation resolved  1800 headache resolved
pt recvd vax 6OCT94 & parent called MD that evening to report child had high pitched cry for many hrs; no report of fever/listlessness;tx w/APAP q 4 hrs; parent called 7OCT to report pt slept well & was fine;
soreness on her arm; she felt very cold; heart rate went a little fast, recorded at 110-112; felt a weird sensation which she can't fully explain. It was like electrical impulses all over her body started appearing and like her blood is running inside all over her body; could not sleep because of this; This is a spontaneous report from a contactable consumer. A contactable Female Nurse reported for patient. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date, as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date It was reported that the patient received the 1st dose of the Pfizer vaccine. She was fine afterwards but experienced some soreness on her arm so she took Tylenol. When she got home, she felt very cold but did not have a fever and had a normal temperature. As she was laying down, she felt a weird sensation which she can't fully explain. It was like electrical impulses all over her body started appearing and like her blood is running inside all over her body. Her heart rate went a little fast, recorded at 110-112 while her normal is 100-110. She could not sleep because of this. She woke up and mentioned that her symptoms are lessening, not as intense as they were last night, and there is a little improvement. She took Tylenol for her symptoms and did not go to work. She is glad that it did not get worse. She is concerned because she received the vaccine amidst having a previous COVID Diagnosis last thanksgiving, 27Nov2020. She mentioned that she stayed home and was not hospitalized for it, but experienced intense symptoms for 5 days like the aggressive fever. She went to the CTMD and was given albuterol, tylenol, and mucinex for her symptoms She is glad she survived it but is concerned that she may still have antibodies from her infection and that the vaccine might be interacting with it. She knows that the Pfizer vaccine was not tested in people with previous COVID Diagnosis and just followed the CDC's recommendation to get vaccinated after 90 days after the infection. She is asking for information Pfizer may have on these topics and if she should receive the 2nd dose on 22Mar2021. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
My symptoms started on 12/14/2022. On 12/16/2022 I tested positive for COVID-19. I had a mild fever and high blood pressure. I went to the hospital on 12/17/2022 I had to see a cardiologist. I also tested positive for COVID-19 12/17/2022. My lungs were clear.
Ten days post vax, the pt experienced fever of 102.2 after treatment with aspirin, chills, swollen lymph glands, severe headache, and joint pain. The pt reported that she would have gone to the ER on the 14th day had she not been a nurse. Additionally, she called the hospital that administered the vaccine to question the dosage she received.
Pt reacted to 1st dose DTP @ 2mos fever, vomiting @ 3yrs had lst dose of ped DT-had fever, joint pain; 28AUG91 had ped DT & OPV devel fever 102, vomited, taken to ER & then to pvt MD; Both felt rxn was vax related; poss allergic to tetanus;
This literature marketed report was received from a physician regarding a female patient in her 80s. Patient was considered immunocompetent on the basis of an absence of immunodeficiency, history of opportunistic infection, autoimmune disease, systemic malignancy, or treatment with immunomodulatory medications. The patient received 3 doses of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown) at 0, 2 and 6 months in 2013 for prophylaxis (dosing details not reported). The vaccines were well tolerated by the patient and had no adverse effects. Prior to vaccination, patient 2 had a total of 5.5 new sees (100% SCC in situ) and 0.92 new BCCs per year. After vaccination, the patient developed 1.84 SCCs (100% well-differentiated SCCs) and 0 BCCs per year, representing a 66.5% reduction in sees and a 100% reduction in BCCs during the observation time of 13 months before and 13 months after the first dose of the qHPV vaccine (Therapeutic response unexpected). Outcome of the event was unknown. Causality of the event was considered to be related. This is one of 2 reports 1707USA005911 (Same literature link). Additional information has been requested. Sender's Comments: US-009507513-1707USA005911.
This literature marketed report has been received from the authors of the published article, and refers to a 15-year-old female patient with genetically diagnosed Pitt Hopkins syndrome. The patient's concurrent conditions included humoral immunodeficiency, persistent hypogammaglobulinemia (immunoglobulin G (IgG): 398 mg/dL, immunoglobulin A (IgA): 21 mg/dL, immunoglobulin M (IgM): 40 mg/dL), and recurrent sinopulmonary infections. The patient was placed on chronic antibiotics for approximately two years prior to presentation. On an unknown date, the patient was administered PNEUMOVAX 23 as a booster vaccination (dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient had non-protective titers to streptococcus IgG antibody (6/23 titers protective greater than 1.3 mcg/mL) despite vaccination with PNEUMOVAX 23. She also had borderline tetanus (0.18 IU/mL) and diphtheria titers (0.11 IU/mL). Given this laboratory evaluation and her recurrent illness, immunoglobulin replacement therapy (IGRT) was started. She continued to have infections despite therapeutic IGRT. Chronic antibiotic treatment was initially tapered, however needed to be reintroduced as intravenous immunoglobulin treatment alone was not stopping her infections, despite a IgG level over 1000 mg/dL. At the reporting time, the patient remained healthy with the combination of IGRT and prophylactic antibiotics. The outcome of the event "non-protective titers to streptococcus IgG antibody" was not reported. The reporter considered the event to be related to PNEUMOVAX 23.