chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dry cough; fever of 102 Degrees Farenheight; chills; body ache; A spontaneous report (United states) was received from consumer, concerning a 38-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever of 102°F, Chills, dry cough and body aches.  The patient's medical history not provided by the reporter. Concomitant medications included tylenol, ibuprofen, singulair and allergy medication.  On 28 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced events, fever of 102°F, Chills, dry cough and body aches.  Laboratory details were not provided.  Treatment information not provided  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, fever of 102°F, chills, dry cough and body aches were unknown.
Information has been received from a registered nurse concerning a female in her 30's year old who on 19-MAY-2008 was vaccinated with a first dose of VARIVAX (Merck). Subsequently the patient developed an inner ear infection. The patient was placed on prednisone 60 mg daily for 5 days beginning on 22-MAY-2008 for the ear infection. On an unspecified date, the patient recovered from inner ear infection and appeared to be fine when she brought her child to the office for pediatric care. The patient sought medical attention. There was no product quality complaint. Additional information is not expected.
terrible headache; hurting; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (terrible headache) and PAIN (hurting) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (terrible headache) and PAIN (hurting). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (terrible headache) and PAIN (hurting) outcome was unknown. Not Provided      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 concomitant medication reported  Action taken with mRNA-1273 in response to the event was not applicable.
Moderna COVID- 19 Vaccine EUA Patient recieved first dose of COVID-19 Vaccine utilizing MODERNA Vaccine on February 9, 2021 at the current age of 17 years. Moderna EUA is for patients 18 years of age and older.
pt recv vax approx 830AM & pt pronounced dead on front steps of home;between 1:00 & 2PM 19OCT98 by medical examiner;
This spontaneous prospective pregnancy report as received from a nurse practitioner refers to a 26 year old female patient. The patient has medical history of seizure disorder, The patient is a tobacco user. The patient had last menstrual period (LMP) of 03-NOV-2015. Estimated date of conception (EDC) was 17-NOV-2015. The patient underwent urine screen for pregnancy prior to vaccination and it was negative on 11-JAN-2016 and was vaccinated with first dose of GARDASIL 9 lot # L011846 expiry date 16-JUN-2017, intramuscularly. The patient did not have any concomitant medications. The patient was exposed to the vaccine in first trimester. Patient then returned to the office on 11-MAR-2016 for her second dose (which was not administered) and a urine screen was again performed at which time it came back as positive for pregnancy. The patient sought medical attention. The patient did not receive any further doses of the vaccine and nurse practitioner stated that the patient was referred to an unspecified OB/GYN for prenatal care. The patient had estimated delivery date of 09-AUG-2016. The pregnancy outcome is pending (present status reported as not recovered). There was no product quality complaint. Additional information has been requested.
HAD SUPER MIGRAINE SINCE RECEIVING THE VACCINE EVERY COUPLE OF DAYS, SPECIFICALLY AT NIGHT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced had super migraine since receiving the vaccine every couple of days, specifically at night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from had super migraine since receiving the vaccine every couple of days, specifically at night on 2021. This report was non-serious.
The husband came in to Rx on 10/30/18 to ask if it was normal for both of them feeling shoulder pain and could not lift up the arm after the vaccination. The husband said the Patient was sitting beside the RPh when the vaccine was administered. However, they felt pain on the arm and could not fall asleep that night. They took OTC ibuprofen and used heat pads and ice bags. It had been 5 days, but they were not getting better. So the husband came in Rx to ask. When following up with the husband on the phone later, the Pt was by the phone. She stated that she had Ibuprofen for 3 days till Sunday. The husband was observed at Rx that he could not lift up the arm to 90 degree, and no side movement of the arm. The RPh advised the husband to talk with the Pt and they needed to find a way to get their arm function back first. An incident report was filed internally on 10/31/2018.
Raised red rash on chest. Across both collar bones, between and under both breasts.
Patient's agent reported a red patch (2 days after shot) extending from flu shot site halfway down the arm. It was reported warm to the touch with no pain. Patient was not present. Will follow up with patient for more details.
1 dose: tightness of chest and pain in lungs for 28 hours; 1 dose: tightness of chest and pain in lungs for 28 hours; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Lot number: FK4175) at the age of 23 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: seafood" (unspecified if ongoing), notes: known allergies Seafood, shellfish, pineapple; "known allergies: shellfish" (unspecified if ongoing), notes: known allergies Seafood, shellfish, pineapple; "Known allergies: pineapple" (unspecified if ongoing), notes: known allergies Seafood, shellfish, pineapple. The patient's concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (non-serious), PULMONARY PAIN (non-serious), outcome "unknown" and all described as "1 dose: tightness of chest and pain in lungs for 28 hours".  Additional information: No covid prior vaccination. Patient did not tested post vaccination for covid. Patient did not receive any other vaccine within four weeks. Patient did not receive other medications in two weeks. Patient did not received treatment for adverse events.
Flu-like symptoms the day after vaccines administered (approx 10-12 hrs), low-grade headache, nausea, chills, slight fever, weakness throughout body. All symptoms gone the following day.
"The shot itself was very unpleasant,  the vaccine stung.  The nurse was concerned about this since it shouldn?t cause any discomfort at all.   Other than immediate onset of a painful injection site no other symptoms occurred until later in the evening.  I started feeling kind of yucky before I left work but nothing specific.  By the early evening I was running a low grade fever and having muscle and joint pain.   I didn?t sleep very well due to  body aches and severe organ pain.  At one point I woke up because my heart was beating so hard and fast I could feel it in my forehead.  My lips and eyes were swollen and my neck was visibly swollen as well, I think due to the lymph nodes in my neck.  My throat was some swollen but not enough to cause a breathing issue.  The heartbeat issue didn?t last terribly long.  I took a Benadryl to try and stop the reaction.  I ran fever of a 102 give or take a few degrees either way for 2 ½ days.  In addition, the injection site and whole shoulder area was swollen and  hot with redness that wrapped around the front of my arm."
Patient presented himself for COVID19 Vaccine administration on 04/05/2021 at 4:10pm. Upon checking in for his appointment, he was provided with Conviva?s COVID19 vaccine screening and consent form in which he denied the following:  ? Having allergies and reactions to any medication, foods, vaccines, or latex.  ? Carrying an Epi-pen for emergency treatment of anaphylaxis.  ? Having had a severe reaction to previous dose of this vaccine or to any of the ingredients of this vaccine.  After the vaccine administration, patient was guided to the observation area for a 15-minute observatory period.  At approximately 4:25 pm- patient, while in the observation area, expressed to the clinical staff member monitoring the area, that he felt lightheaded and needed to lay down, he leaned forward, and the clinical alert team was activated.  Patient was lowered to the floor; a pillow was placed under his head and his feet were elevated.  Vitals reported were taken in the presence of registered nurse while patient was laying on the floor.  Vitals ? Glucose 97 ? Blood pressure 120/77 ? Oxygen saturation level 97% ? Pulse 72 Register nurse reports that patient was laying on the floor, alert, oriented to place, time and person. Patient never lost consciousness and within approximately 5-7 minutes he was sitting up, drinking water. At this time, patient was asked the following series of questions: ? How do you feel? As per patient, he was feeling nauseous, dizzy, and anxious.  ? Are you allergic to any medications or have you had any allergic reactions to a vaccine? Patient denied having had a history of any adverse or allergic reaction to any medication or vaccines in the past.  Several minutes later patient stated that he was feeling better and he was assisted to sit up. Patient stated that he was feeling fine, and able to drive. Patient was kept in the observation area an additional 15 minutes.   At approximately 4:40 pm- After patient was considered stable by doctor, he was checked out. Patient was given phone numbers in case he had any clinical or general questions.   At 6:00 pm- (Center Administration) called patient, he stated that he was still driving and felt fine.  At 6:21 pm- Patient sent a text to Center Administrator, stating the had arrived home and was feeling fine.
8pm -chills/shakes/fever started and lasted for 6 hours. Hovered around 101.  8pm --lips and backs of hands turned dark purple. This lasted for about 20 minutes.  8pm - fingertips became numb, like precursor to frostbite. Lasted for 4 hours. Headache- 7am the next morning (4/9/21)
Chest pain and pressure, back pain and severe shortness of breath.  Weakness and brain fog.  The shortness of breath has lasted 2 weeks and caused me to not be able to do activities.
Headache, Myalgia, NauseaVomiting, Major body aches and severe nausea, chills, HA, shooting abdominal pains Narrative: Although did not seek medical care, she states she was very sick, which is why I coded it as "Moderate"
Pfizer-BioNTech COVID-19 Vaccine   Employee complained of feeling hot, tongue felt swollen, and weak. Patient was taken to Clinic for evaluation at onset of symptoms, approx 12 minutes after distributing vaccine.  At Clinic, patient states her symptoms have improved. She states she thinks she got a little anxious and feels comfortable driving home at this time. Patient denies oral/throat/tongue/lip edema. No headache, vision changes, difficulty swallowing, difficulty handling oral secretions, chest pain, palpitations, shortness of breath, nausea/vomiting. No pruritus. Patient is siting comfortably in the chair and drinking water without difficulty. Discussed ED precautions. Patient verbalized understanding. Advised patient to follow up with her PCP to discuss the second dose of the covid vaccine. Patient agreed to the plan. Patient ambulated out of clinic without difficulty.  1/1/21: Pt received 2nd dose of vaccine. Experienced some dizziness and slightly high BP. Both symptoms resolved within 30 minutes and patient was discharged home.
pain in stomach / pit in stomach; Dizziness; Nausea; Vomiting; cardiac issues that lasted for approximately 1.5 hours heart rate was really fast; Heart skipping beats; Heart pounding; soreness in arm; pulse was trickety; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 6th February 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 7th February 2020, the patient experienced stomach pain, dizziness, nausea, vomiting, heart rate increased, heartbeats skipped, pulse abnormal and heart pounding. On 7th February 2020, the outcome of the dizziness, nausea, vomiting, heart rate increased and heartbeats skipped were recovered/resolved. On 9th February 2020, the outcome of the stomach pain was recovered/resolved. On an unknown date, the outcome of the pain in arm, pulse abnormal and heart pounding were recovered/resolved.   It was unknown if the reporter considered the pain in arm, stomach pain, dizziness, nausea, vomiting, heart rate increased, heartbeats skipped, pulse abnormal and heart pounding to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and had soreness in arm that evening.  The patient wakes up early with pain in stomach described as a feeling of eating something that may have set too long. The caller also described feeling like a pit in stomach. Stomach pain reportedly lasting throughout the weekend. The caller reported drinking a little coffee but the stomach pain became worse.  The patient had dizziness, followed by nausea, and then vomiting.  The caller reported vomiting cleared everything out, and dizziness, nausea and vomiting resolved. The consumer then reported cardiac issues that lasted for approximately 1.5 hours heart rate was fast, pounding, skipping beats, and pulse was trickety. All symptoms had already resolved and one would be unable to tell the reactions she experienced.  The reporter consented to follow up.
This spontaneous report as received from a certified medical assistant refers to an unknown number of patients of unknown ages and gender. On an unknown dates the patients were vaccinated with a dose of PNEUMOVAX23 (lot #, expiration date, dose, route unspecified) stored as high as 53F and as low as 26F for unknown periods of time. No adverse effect was reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports from the same source. Additional information has been requested.
Hospitalization  9/11 symptom onset covid positive.  COVID 19 pneumonia with hypoxic respiratory failure.
Information has been received from a nurse practitioner concerning a 14 and a half year old female patient who on unspecified day was vaccinated with a second dose of VARIVAX. Subsequently the patient developed varicella like rash after getting the second dose of the vaccine. Lot # was not provided. The patient had sought unspecified medical attention. At the time of this report, the patient had not recovered. Additional information has been received from a nurse practitioner who reported that the patient received the second dose of VARIVAX (Lot # 664724/0927Y),  subcutaneous injection given in the right arm, on 26-AUG-2009 at 6:00 PM. The patient on 27-AUG-2009 at 7:00am experienced injection site reaction-large (8"), the red induration very pruritic and painful. Additional patient experienced generalized sparse vesicular eruption also pruritic. The patient recovered from AEs on 29-AUG-2009. No further information is available.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 02-DEC-2012, the patient was inoculated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 20-JUN-2016, the patient was treated at a medical center for the onset of a severe vesicular rash, which was diagnosed as shingles. On or about 22-JUN-2016, the patient sought subsequent treatment from a physician assistant for the onset of a severe vesicular rash, which was diagnosed as ongoing herpes zoster. On or about 13-JUL-2016, the patient sought additional treatment at medical center for ongoing and worsening symptoms of zoster outbreaks and pain, which was diagnosed as complicated herpes zoster and facial nerve palsy involving the partial paralysis of facial muscles. The patient has been prescribed hydrocodone/acetaminophen (NORCO), valacyclovir (VALTREX) and prednisone for management of her pain and chronic symptoms.  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. Upon internal review facial nerve palsy involving the partial paralysis of facial muscles was considered medically significant. Additional information has been requested.
syncopal episode during observation period, patient regained consciousness after seconds, provided water and support, patient was able to exit the premesis under his own control, denied any further needs
Didn't feel good; headache; fatigue; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MALAISE (Didn't feel good), HEADACHE (headache) and FATIGUE (fatigue) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Didn't feel good), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, MALAISE (Didn't feel good), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   patient said her send dose schedule on 05 feb,2021. no concomitant and treatment provided
RECEIVED 2ND DOSE OF SERIES AT DAY 14 INSTEAD OF DAY 21
Initial information received on 10-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 57 years old female patient who experienced severe shoulder pain and shoulder immobility and frozen shoulder, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. In June 2018, the patient received a 0.5 ml single injection dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5771AA via intramuscular route in the right deltoid. The patient developed a non-serious experiencing severe shoulder pain following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient developed a non-serious shoulder immobility and frozen shoulder following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. (Other relevant tests included No lab data). Final diagnosis was shoulder immobility and frozen shoulder and experiencing severe shoulder pain. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Recovered/Not Resolved on an unknown date for experiencing severe shoulder pain and as Not Recovered/Not Resolved on an unknown date for shoulder immobility and frozen shoulder.
Information has been received from a nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a 20 year old female with no pertinent medical history and no known drug allergies who on 07-NOV-2007 was vaccinated in right arm with a first dose of GARDASIL. There was no concomitant medication. On 04-AUG-2010 the patient received the second dose of GARDASIL. In addition to this prolonged dosing interval the patient was also determined to be pregnant after the second dose of GARDASIL was administered. Gestational age was approximately 4 weeks. In addition to this, the patient fainted in the office 5 minutes after receiving the GARDASIL shot #2 on 04-AUG-2010. The patient was unresponsive for 60 seconds. When she became arousable the patient was offered food and was subsequently discharged from the office with no perceived ill effect. On 04-AUG-2010, the patient recovered from fainted and unresponsive. The patient sought unspecified medical attention. Unspecified pregnancy test was performed but no result reported. The patient's last menstrual period (LMP) was approximately 06-JUL-2010. The estimated delivery date (EDD) would be on approximately 10-APR-2011. The patient was planning to terminate the pregnancy. Follow up information has been received via telephone call from the nurse practitioner, indicating that the patient voluntarily elected to terminate her pregnancy. The date of elective abortion procedure was unknown. The nurse stated that the patient's decision to terminate her pregnancy had nothing to do with vaccine exposure; that the patient was going to terminate her pregnancy anyway. At the time of the report the patient's outcome after elective termination was unknown. Upon internal review voluntary elected to terminate her pregnancy was considered to be an other important medical event. Additional information has been requested.
Initial report received from healthcare professional on 8 September 2014. A 5-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of DTaP which might be DAPTACEL (batch number, dose number, route and anatomical site of administration were not reported) on an unspecified date of 2007. It was reported that on an unspecified date of 2007, after receiving DTaP or DAPTACEL vaccine, the patient experienced "severe" local reaction. The patient's corrective treatments and laboratory investigations were not reported. On an unspecified date, the patient was recovered. Documents held by sender: none.