chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Relapse of COVID symptoms and positive antigen test indicating larger viral load on day 11; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Relapse of COVID symptoms and positive antigen test indicating larger viral load on day 11) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     The patient's past medical history included Allergy (Name of drug not reported).    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2022 at 6:00 PM, the patient experienced COVID-19 (Relapse of COVID symptoms and positive antigen test indicating larger viral load on day 11). At the time of the report, COVID-19 (Relapse of COVID symptoms and positive antigen test indicating larger viral load on day 11) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 RNA: larger (High) Viral load on day 11. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         The Co Suspect drug reported as COVID-19 Treatment start date was 10-May-2022 and last date of administration was 14-May-2022. (Drug name was not reported)  No, patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Yes, patient previously receive a COVID-19 Vaccine. Device date: 21-May-2022. Concomitant medication list was not provided.  Treatment information was not provided.  Company Comment:  This spontaneous case concerns a 42-year-old female patient, with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest COVID-19 that occurred approximately 6 months after receiving mRNA-1273 vaccine given as third dose in the COVID-19 vaccination series.  Patient experienced Relapse of COVID-19 symptoms (documented by a positive antigen test) after completion of a 5-day course of an unspecified COVID-19 treatment. No information was provided on the previous 2 doses of COVID-19 vaccines prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 42-year-old female patient, with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest COVID-19 that occurred approximately 6 months after receiving mRNA-1273 vaccine given as third dose in the COVID-19 vaccination series.  Patient experienced Relapse of COVID-19 symptoms (documented by a positive antigen test) after completion of a 5-day course of an unspecified COVID-19 treatment. No information was provided on the previous 2 doses of COVID-19 vaccines prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
approx 2 1/2hr p/vax pt started vomiting small amount;no temp, no redness @ inj site;parents called MD & told them to put ice packs in the legs because the vax was absorbing too fast;parents had given APAP 1hr prior to vax;
This spontaneous case was reported by a physician and describes the occurrence of BONE PAIN (Deep long bone pain/His long bones were extraordinarily painful), CHILLS (Shaking chills) and PYREXIA (Fever of 101 F) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A, 041L20A and 025J2-02A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced BONE PAIN (Deep long bone pain/His long bones were extraordinarily painful), CHILLS (Shaking chills) and PYREXIA (Fever of 101 F). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, BONE PAIN (Deep long bone pain/His long bones were extraordinarily painful), CHILLS (Shaking chills) and PYREXIA (Fever of 101 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Body temperature: 101 (High) 101 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.  Patient received half dose booster shot.
No effects after first injection other than sore arm at injection site.  2nd injection at 11:30 a.m., onset of symptoms started at 9:30 p.m. - Chills, shakes ... lasted about 1 hour + - body aches, headache ..slower onset, about 10:30 p.m., lasted until midmornign next day, i.e., about 24 hours after injection.  - General fatigue and residual headache persisted until following morning, 2/15 - Fully recovered by 2/15 12:00 p.m.
disorientation, nausea, joint pain, chills, mild fever; rest and fluids
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), on 20Jul2021 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lumbar fusions" (unspecified if ongoing); "high liver panel results" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Normally patient had to take Oxycodone 20MG 4X a day, and experience withdrawal like symptoms when he did Not take a dose on time. He was taking Paxlovid for a case of COVID but noticed that he was sleeping a lot while taking the combination (Oxycodone does not make me sleepy regularly), but several times patient went 8-12 hours without taking my Oxycodone prescription. He had 0 withdrawal like symptoms that he normally experienced. Normally patient experienced Uncontrollable yawning, tears, jitteriness, more aches, and the anxiety feeling where he can't stay still. This was very abnormal for him to go 6 hours without seeing any of the symptoms, yet he was able to push taking half of his dose abruptly with 0 of the standard symptoms other than hurting.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2012, the patient was administered with a dose of GARDASIL at the age of 12 year old. Then, on an unspecified date in 2016, the patient received a dose of GARDASIL 9 (lot#, dose, frequency and route of administration were unspecified for both vaccines) for prophylaxis (interchange of vaccine products). No adverse effects were reported. no product quality complaint was involved.
RESPIRATORY SYMPTOMS; This spontaneous report received from a physician concerned a 69 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown expiry: UNKNOWN) dose was not reported, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 2021, the subject experienced respiratory symptoms.  The action taken with covid-19 vaccine was not applicable. The patient recovered from respiratory symptoms on 2021. This report was non-serious.
DVT - Deep Vein Thrombosis; Blood Clot; was not feeling well; left leg was very swollen; left leg was very hard; he could not walk comfortably.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 18:00 (Lot number: 30145BA) at the age of 64 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "onion/garlic allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: 30145BA, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 19Oct2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: DEEP VEIN THROMBOSIS (hospitalization, medically significant, life threatening) with onset 03Dec2021 22:00, outcome "recovering", described as "DVT - Deep Vein Thrombosis"; THROMBOSIS (hospitalization, medically significant, life threatening) with onset 03Dec2021 22:00, outcome "recovering", described as "Blood Clot"; MALAISE (hospitalization, life threatening) with onset 03Dec2021 22:00, outcome "recovering", described as "was not feeling well"; PERIPHERAL SWELLING (hospitalization, life threatening) with onset 03Dec2021 22:00, outcome "recovering", described as "left leg was very swollen"; LIMB MASS (hospitalization, life threatening) with onset 03Dec2021 22:00, outcome "recovering", described as "left leg was very hard"; GAIT DISTURBANCE (hospitalization, life threatening) with onset 03Dec2021 22:00, outcome "recovering", described as "he could not walk comfortably.". The patient was hospitalized for deep vein thrombosis, thrombosis, malaise, peripheral swelling, limb mass, gait disturbance (start date: Dec2021, discharge date: Dec2021, hospitalization duration: 4 days). The events "dvt - deep vein thrombosis", "blood clot", "was not feeling well", "left leg was very swollen", "left leg was very hard" and "he could not walk comfortably." were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of deep vein thrombosis, thrombosis, malaise, peripheral swelling, limb mass, gait disturbance and included treatment with blood thinner and angioplasty. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. There were no list of any other medications the patient received within 2 weeks of vaccination. On 03Dec2021 (on Friday), 15 days after taking his second Covid Vaccine by Pfizer, the patient was not feeling well. By late evening, the patient's left leg was very swollen and hard and he could not walk comfortably. The patient was transported by ambulance to the hospital where he was treated for a DVT-deep vein thrombosis.
First noticed symptoms in my hands felt like they had been hit by a baseball bat extremely bruised feeling red hot and itchiness. The itching migrated to my feet scrotum and my head, That?s when the hives began I got them all over my body mainly on my arms legs and chest. I also experienced abnormal heartbeat I believe hypertension because I have a fitness watch that showed my heart beat above 150 while sitting still for over a half an hour.
Chest pain; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ept533) via an unspecified route of administration on 05Apr2021 at 06:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The relevant medical history was not reported. The patient had no known allergies to medications, food or other products. Concomitant medications included levocetirizine dihydrochloride (XYZAL) from an unknown date, for unknow indication and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08Apr2021 the patient experienced chest pain. No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event chest pain was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Shivering, Headaches, Nausea, Cramping, Diarrhea, Tiredness The above symptoms have subsided except for the fatigue. Still very sore at the injection sight with swelling and red, blotchy rash two days after the shot.
Woke up morning after receiving  vaccine (about 20 hours after vaccination) with my head feeling dense and heavy. Not a painful headache, but a strange fullness as if my head was solid. I took 2 Advil and went about my morning - yard work, cleaning, etc. The symptoms went away on their own approximately 4 hours later.
Abnormal mammogram detected. Follow up imaging reveals a solid mass that will require a biopsy.
Memory loss; Pressure in my head and right ear (not painful); Pressure in my head and right ear (not painful); Ringing in both ears; Constant lightheadedness with dizzy spells; Brain fog; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Constant lightheadedness with dizzy spells), FEELING ABNORMAL (Brain fog), AMNESIA (Memory loss), HEAD DISCOMFORT (Pressure in my head and right ear (not painful)) and EAR DISCOMFORT (Pressure in my head and right ear (not painful)) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Lisinopril) and Blood pressure high (Under control with medication).   On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 100 microgram. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced DIZZINESS (Constant lightheadedness with dizzy spells) and FEELING ABNORMAL (Brain fog). On an unknown date, the patient experienced AMNESIA (Memory loss), HEAD DISCOMFORT (Pressure in my head and right ear (not painful)), EAR DISCOMFORT (Pressure in my head and right ear (not painful)) and TINNITUS (Ringing in both ears). The patient was treated with MECLIZINE HCL ongoing since an unknown date for Lightheadedness, Dizzy spells, Head pressure, Sensation of pressure in ear and Ringing in ears, at an unspecified dose and frequency and PREDNISONE ongoing since an unknown date for Lightheadedness, Dizzy spells, Head pressure, Ear discomfort and Ringing in ears, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Constant lightheadedness with dizzy spells) and FEELING ABNORMAL (Brain fog) had not resolved and AMNESIA (Memory loss), HEAD DISCOMFORT (Pressure in my head and right ear (not painful)), EAR DISCOMFORT (Pressure in my head and right ear (not painful)) and TINNITUS (Ringing in both ears) outcome was unknown.            No concomitant medications were provided by the reporter. The patient did not get relief after treatment. Company comment: 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.; Sender's Comments: 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.
pt reported suffered permanent neurologic & ophthalmic injuries (of an unspecified nature) as a result of vax on 10MAR94;
A red, swollen and tender area around the injection site; A red, swollen and tender area around the injection site; A red, swollen and tender area around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (A red, swollen and tender area around the injection site), VACCINATION SITE ERYTHEMA (A red, swollen and tender area around the injection site) and VACCINATION SITE SWELLING (A red, swollen and tender area around the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN and IBANDRONATE SODIUM (BONIVA) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE PAIN (A red, swollen and tender area around the injection site), VACCINATION SITE ERYTHEMA (A red, swollen and tender area around the injection site) and VACCINATION SITE SWELLING (A red, swollen and tender area around the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (A red, swollen and tender area around the injection site), VACCINATION SITE ERYTHEMA (A red, swollen and tender area around the injection site) and VACCINATION SITE SWELLING (A red, swollen and tender area around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional event treatment included ice.
This case was reported by a physician via call center representative and described the occurrence of shingles in a adult female patient who received SHINGRIX for prophylaxis. Co-suspect products included dTpa vaccine for prophylaxis and PREVENAR for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX, dTpa vaccine and PREVENAR. On an unknown date, 2 days after receiving SHINGRIX and dTpa vaccine, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX and dTpa vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX, along with PREVNAR, and a TdaP vaccine. The patient broke out in shingles. The patient was given Acyclovir and symptoms resolved within 72 hours. The patient then had recurrent shingles and given acyclovir once more and again resolved within 72 hours. The vaccines were administered at a pharmacy, so healthcare professional had no information on the vaccines.
THE PATIENT WAS DIZZY AND LIGHTHEADED AFTER SECODN DOSE OF MODERNA COVID VACCINE ADMINISTRATION
Developed diffuse blanching pink maculopapular rash on scalp, torso, prox extremities; some urticarial, has a ring of rash around the site where she got the Tdap with cluster of fine vesicules/papules.
Expired booster dose administered to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered to a patient) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A, 027A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered to a patient). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported. No Concomitant medication reported. Patient taken other medications, names were not specified. Initial date of refrigeration of third dose of vaccine  was 02-OCT-2021 and  it was packed appropriately.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Follow-up received contain significant information contain   Batch number, Route of administration, Anatomical location of first and second dose, Start of drug of first dose, Event verbatim updated, new reporter added. On 08-Nov-2021: Follow-up received contain significant information: Reporter  added, initial date of refrigeration received added in  I narrative.
This spontaneous report was received from a health care worker (clinical assistant) refers to unspecified number of patients. On an unknown date the patient was vaccinated with MMR II injection, lot # J003623; expiry: 22-MAR-2015. On an unknown date clinical assistant stated that an unspecified number of unspecified patients may have been administered improperly stored MMR II on unspecified dates. No adverse effect reported. Outcome of the medication error was unknown. Additional information has been requested.
Fever of 103 for 36 hours.  Dizziness, fatigue, muscle pain at site, and muscle pain throughout body.  Slight wheezing of chest throughout 2 nights.
I was fine the day of vaccination. The next day, my eyes felt puffy and strange, so I looked in the mirror and saw it was irritate and swollen. I called my doctor who prescribed antihistamine medication and cream to take and within 24 hours, the swelling had reduced and the puffiness around the eyes had gone down. It happened after my first dose but was much milder.
After taking the 2nd dose of the vaccine, a few days later, father was taken to the ICU with fluid in his lungs. He had never gone to the ICU with this issue prior to the vaccine. He has since been in the ICU for fluid in his lungs 6 times over a span of 4 months. Again, he had never had to go to ICU before the vaccine was given. It may have caused adverse effects in combination with his other medications.
The site where I received the shot is still giving me pain when I raise my arm.  It has created a weakness or damage to my muscle perhaps.
On 11-7-09 received H1N1 vaccine in office at approximately 10am. That evening approx. 6pm, patient started wheezing, coughing and had post tussive emesis. Patient presented to office today was prescribed Prednisone and instructed to continue Albuterol.
Patient was brought in by her mother and father. Reported redness and size of a 50 cent piece with swelling, mild pain. The area was hot to touch with a dime size knot in the middle approximately 30 hours after the injection. This occured on the right arm, the site whre the prevnar was given IM. Is currently still taking tylenol for symptoms. The nurse encouraged warm compresses to the area and benedryl . To return to the PMD or NCHD if symptoms persist or worsen.
Patient was administered 3rd dose of Moderna vaccine, but it turns out he did not meet criteria for severely immunocompromised. He tolerated the dose well with no adverse reaction, but I am filling out this report as patient did not meet criteria outlined by FDA EUA and ACIP recommendations for 3rd dose Moderna vaccine.