chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A-fib (Atrial fibrillation); This is a spontaneous report from contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient experienced A-fib (atrial fibrillation) and was put on a heart monitor. It was further reported that the patient had the vaccine and she wound up in the hospital with A-fib on an unspecified date and she still had it. The outcome of event was not recovered.  Information on the lot/batch number has been requested.
Has warm reddened swollen area approx 2 in x 2 in to right back arm where injection was given. Just noted it today.
Initial solicited report received on 21 September 2017 from an investigator (Defense Health Agency) in the trial. This case involves a 24 year old male subject with no significant medical history. The subject received concomitant medication with Typhoid, Parenteral; japanese encephalitis - im (1); anthrax (1) on 05 May 2017. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 01 June 2017. On 11 June 2017, 10 days after vaccination the subject was diagnosed with I40.9 acute myocarditis, unspecified and on 14 June 2017, 13 days after vaccination the subject was diagnosed with I31.9 Disease of pericardium, unspecified. The subject's lab data included, Troponin I result abnormal 00.34, ECG- Abnormal both done on 11 June 2017 and Echocardiogram - Normal done on 12 June 2017. MRI of brain; spinal cord; heart; or Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the events I40.9 acute myocarditis, unspecified and I31.9 Disease of pericardium, unspecified; was not reported. Relationship to investigational product according to company: associated List of documents held by sender: none. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study.; Sender's Comments: This case involves a healthy 24-year-old male subject who developed acute myocarditis unspecified and unspecified disease of pericardium with favorable temporal association post vaccination with ACAM2000. Subject had confounding factors as concomitant administrations of typhoid parenteral, Japanese encephalitis and Anthrax vaccine. Myocarditis and pericardial disease are listed event for ACAM2000 vaccine. Alternative etiologies could be pulmonary edema, pulmonary embolism, aortic dissection, esophageal rupture and pneumothorax. History of allergies or trauma was not reported. Based on missing additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine can not be ruled out.
Local site reaction-left upper arm red, swollen, hot to touch; induration,erythema, itching, possible cellulitis. treated with keflex 500mg tid x7 days, hydroxyzine 25mg for itching
Myalgia, Arthralgia, Fever,  fatigue, light headiness, injection site tenderness Narrative:
Discomfort soon after receiving vaccine. Progressively worse. By 11/7 very limited range of motion and pain. Saw primary Dr. Referred to orthopedic. Received cortisone shots physical therapy medication, tried hot and cold to help pain. Both shoulders. Flu vaccine given in right arm. Left shoulder arm affected due to over use (compensating for right shoulder arm). To date, still problems with certain movements.
constant ring in ears; cannot sleep; cannot sleep or concentrate on the job , feel like you are loosing my mind; This spontaneous case was reported by a nurse and describes the occurrence of TINNITUS (constant ring in ears), INSOMNIA (cannot sleep) and DISTURBANCE IN ATTENTION (cannot sleep or concentrate on the job , feel like you are loosing my mind) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (constant ring in ears), INSOMNIA (cannot sleep) and DISTURBANCE IN ATTENTION (cannot sleep or concentrate on the job , feel like you are loosing my mind). At the time of the report, TINNITUS (constant ring in ears), INSOMNIA (cannot sleep) and DISTURBANCE IN ATTENTION (cannot sleep or concentrate on the job , feel like you are loosing my mind) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
This is in follow-up to report (s) previously submitted on 5/14/2007. Information has been received from a healthcare worker concerning a 15 year old female with no pertinent medical history or drug reactions/allergies, who on 19-FEB-2007 was vaccinated intramuscularly with GARDASIL. There was no concomitant medication. On 19-FEB-2007, with a few hours of receiving the vaccine, the patient developed hives. Unspecified medical attention was sought, and the patient took BENADRYL for the symptoms. The hives subsequently resolved. Additional information has been requested. No further information is expected.
Generalized tonic/clonic seizure lasting 1-2 minutes while in bed with parents. No fever. Short postiltal phase. No prior history. Follow up on 12/10/03: "The seizure was generalized. The pt did not have a fever. Seizure lasted 1-2 minutes.  Neurologist putting on Trileptal. Medical records states viral infection, stupor. msv
This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported.  On 06-MAR-2017, the patient was vaccinated with an unspecified expired dose of PNEUMOVAX23  for prophylaxis (lot # L014458 with an expiration date of 11-FEB-2017) (dosage, route and  anatomical location were not reported). Other suspect and concomitant medications were not provided. No adverse effects were reported.       Additional information has been requested.
Pain in the Left calf and left leg  at nights after 2nd shot; Limping off and on after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the Left calf and left leg  at nights after 2nd shot) and GAIT DISTURBANCE (Limping off and on after 2nd shot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer (Radiation) since August 2020 and Blood pressure high. Concomitant products included VERAPAMIL, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE & HCTZ) and ANASTROZOLE for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in the Left calf and left leg  at nights after 2nd shot) and GAIT DISTURBANCE (Limping off and on after 2nd shot). The patient was treated with IBUPROFEN at an unspecified dose and frequency; MENTHOL, METHYL SALICYLATE (BENGAY [MENTHOL;METHYL SALICYLATE]) at an unspecified dose and frequency and CAMPHOR, MENTHOL (VICKS [CAMPHOR;MENTHOL]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in the Left calf and left leg  at nights after 2nd shot) and GAIT DISTURBANCE (Limping off and on after 2nd shot) outcome was unknown.
This is an initial spontaneous report by a contactable physician. This female Pfizer Sales representative reported on behalf of a male physician for patient who received PREVNAR 13 unknown dose intramuscular injection at an unknown time on arm as a single dose in Jun2013. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines given on the same day were unknown. Vaccines taken within the last four weeks were unknown. In Jun2013 after taking PREVNAR 13 the patient experienced redness in arm which was about seven inches at the injection site which the physician explained was a definite allergic reaction. The patient did not require an emergency room or doctor visit. Relevant lab was unknown. At the time of the report the patient was not taking PREVNAR 13 as it was a single dose. At the time of the report the patient had recovered from the above mentioned events in 2013. Follow-up-(09-AUG-2013) Follow-up attempts completed. No further information expected.
1 month old patient was administered VAQTA; there was "not a clinical reason" for the administration; no AE reported; This spontaneous report was received from a registered pharmacist and refers to a 1-month-old patient of unknown gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On an unspecified date, the patient was vaccinated at a hospital with hepatitis A vaccine, inactivated (VAQTA) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis (inappropriate age at vaccine administration). The pharmacist stated that there was "not a clinical reason" for the administration of the vaccine to the patient. No adverse event (AE) was reported.  The pharmacist was inquiring if there was data regarding hepatitis A vaccine, inactivated (VAQTA) administration to patients younger than 6 months of age. He said he was aware of reports of administering the vaccine to patients below 6 months old who may be at risk for infection due to travel.
I received my booster on 2/25 and a few days later my face was swollen.  Mostly the area around the eyes - eyelids and below the eyes.  I was also very red.  I do not have any allergies.  I also had not introduced any new products, food, medicine, etc.   The only new thing was the moderna booster.
Headache, Arthralgia, Fever, FATIGUE, CHILLS, PAIN/SWELLING ING SITE, Narrative:  Other Relevant History:
Within 24 hours of taking this vaccine my child was like a completely different person staring off into space. I reported this to his family doctor at the time. Pt. has since been diagnosed with autism spectrum disorder
Joint pain; Fever of 101; Tiredness; This is a spontaneous report from a contactable pharmacist. A 62-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via intramuscular route, in right arm, on 29Mar2021 11:00 (at the age of 62-years-old), at dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient had no allergies to medications, food, or other products. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via intramuscular route, in right arm, on 08Mar2021 11:00 (at the age of 62-years-old), at dose 1, single for covid-19 immunization. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 since the vaccination. The patient experienced joint pain, fever of 101, tiredness on 30Mar2021 10:00. The reporter assessed the case as non-serious. The patient underwent lab tests and procedures which included body temperature: 101 on 30Mar2021. Therapeutic measures were taken included Advil for the events. The outcome of the events was recovered on 30Mar2021.  Follow-up (01Apr2021): New information received from same contactable pharmacist which includes: the event awareness date confirmed on 30Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
eruption of wheels, then urticaria @ site of vax on lt deltoid;same on rt deltoid & torso;
possible abscess formation at injection site- redness/ warmth/ swelling/ tenderness. Cool compress, NSAID, PPI,  oral Antibiotic
At 24 hrs, warm, red, itchy spot appeared on arm. Disappeared into a bruise at 1 week post injection. Reappeared at the same size as a red, warm, itchy spot on arm with a hard bump on the middle.
PATIENT WAS GIVEN THE COVID 19 VACCINE-JANSSEN BUT SHOULD HAVE RECIEVED COVID 19-PFIZER PT RECEIVED 1ST DOSE OF COVID 19 VACCINE PFIZER ON 5-4-21 AND SHOULD HAVE RECEIVED THE 2ND DOSE OF COVID 19 PFIZER ON 6/4/21 BUT ACCIDENTALLY RECEIVED COVID 19 JANSSEN
Malaise, pain at the injection site, fever, and sore throat. The fever and sore arm lasted about 24 hours, and the malaise about 48 hours. I am STILL experiencing the sore throat. I took tylenol alternated with advil for the fever and made sure to stay hydrated.
Breakthrough menstrual bleeding began night after vaccination continuing 24-36 hours despite continuous hormonal contraceptive use
Acute Appendicitis; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received the first dose of BNT162B2 (lot number: EW0151), via an unspecified route of administration in left arm on 09Apr2021 12:30 at single dose for COVID-19 immunisation. Medical history included anemia, depression, anxiety, obsessive-compulsive disorder (OCD), endometriosis, and known allergies: Cashews, pecans, and pistachios. Concomitant medications included topiramate (TOPAMAX), bupropion, buspirone, and doxycycline. The patient experienced acute appendicitis on 09Apr2021 20:45. Immediate laparoscopic appendectomy (surgery removed appendix) was required by the emergency room (department or urgent care). The patient was hospitalized for acute appendicitis for 2 days. Patient was recovering. Patient also received the second dose of BNT162B2 (lot number: EW0165), via an unspecified route of administration in left arm on 30Apr2021 12:30 at single dose for COVID-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.
Fever and chills the night of 5/13 when shot was received, severe lethargy the immediate days following and minor lethargy since received. Impacts basic activities that were not an issue prior. Such as yard/house work, any physical activity is more strenuous and exhausting than prior to the second dose of the vaccine
Patient received MCV4, Tdap and HPV 9. Patient was standing by with window with by his father while I began to immunize patients brother. After I administered the first vaccine. Patient went pale and appeared to be having a seizure like event.  Dad grabbed him to stablize while I went to get Dr. for assistance. Had patient lie down on the exam table.  Vitals were performed as well as glucose and EKG. Got the patient some juice and crackers until stable and until Dr. okayed him to leave.
Pt reports having SOB, increased heart rate, pain and swelling at the site of injection. Pt also describes FLU like Sx, chills and congestion.
Patient received vaccines then later that day noticed itching as well as right sided abdominal pain and feeling flushed. Patient called and discussed this with care manager then was scheduled to follow up with provider on 9/14/18. After visit, provider stated that the Hepatitis A vaccine caused the reaction of itchiness.
Day of and following day swelling over large area of upper arm and discoloration area very hot to touch, 2nd day after intense chest and back pressure
red/bruise mark @ 3" in diameter beginning PM 9/18/2023;  by end of day 9/19/2023, I was having difficulty using my arm - PT appointment was cancelled; 9/19/2023 - site was @ 4" in diameter. unable to sleep on affected side. by 9/24 the site had grown to the top of my shoulder blade and was approximately 5" in diameter with bruising descending down arm; 9/25: deep red/black bruising w "regular" bruising @ 2/3 of way down arm; 9/27: original round mark extends above should; rash has developed; woke me up at 4:00 AM with a pain level of @ 8-9 9/30: round mark is approximately 1" over shoulder; bruising is solid 2/3 of way down arm
arthritis, joint swelling, tendereness, sleplessness, headaches, mood problems, sensitivity to light, hearing loss, stomach problems (ulcer), lethargy, fatigue, concentration and memory impairment, cloudy thoughts, local pain at the injection sight,
Patient developed shortness of breath, dizziness, tachycardia 10-15 minutes after vaccination. Taken to ER by wheelchair. Patient had 2 more episodes of tachycardia, shortness of breath. Given Benadryl and lorazepam through a saline lock/IV. Patient returned to ER later that evening. Blood was tested. Given lorazepam again, decreasing heart rate from upper 130s to 110. Patient was sent home. Patient visited walk-in clinic the next morning and was prescribed vistaril and metoprolol.
On 29Dec2022. the vial was initially stored in the refrigerator and administered on 16Feb2023; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (On 29Dec2022. the vial was initially stored in the refrigerator and administered on 16Feb2023) and NO ADVERSE EVENT (No adverse event) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19.     On 16-Feb-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 16-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 29Dec2022. the vial was initially stored in the refrigerator and administered on 16Feb2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (On 29Dec2022. the vial was initially stored in the refrigerator and administered on 16Feb2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (On 29Dec2022. the vial was initially stored in the refrigerator and administered on 16Feb2023).    No concomitant medications were reported.  Dosage text was reported as Additional Booster.   This was their 5th Moderna vaccine.  Clinic Manager reported that 4 doses of the Moderna Bivalent 6yrs and older vaccine was administered after 30-day Use by Date. Dose administered after 30-day Use by Date or after manufacturer date of expiry. Patient received Bivalent 6yrs and older vaccine was administered. individual vials stored in carton. Vial size was reported as 2.5 mL. On 29Dec2022. the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.  No treatment medications were reported.
Chills (mild); Headache (mild); Fatigue (mild); Injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 03Mar2021 at 13:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19 . The patient did not take concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Mar2021 at 13:15, the patient experienced injection site pain (mild). On 04Mar2021, the patient experienced injection site pain (mild), chills (mild), headache (mild) and fatigue (mild). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain (mild), injection site pain (mild), chills (mild), headache (mild) and fatigue (mild) were resolved on an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Pt recv vax on 11/5/98; post vax pt exp erythema (circular)  of LA & left axial lymphadenopathy
Papules form head to toe no blistering, with scarring (pt seen in office 1 week after onset of rash)
Headache/head feels heavy; Very Dizzy; Threw up; Couldn't breathe well/heavy; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), HEADACHE (Headache/head feels heavy), DIZZINESS (Very Dizzy), VOMITING (Threw up) and DYSPNOEA (Couldn't breathe well/heavy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 02-Apr-2021, the patient experienced HEADACHE (Headache/head feels heavy), DIZZINESS (Very Dizzy), VOMITING (Threw up) and DYSPNOEA (Couldn't breathe well/heavy). At the time of the report, PAIN IN EXTREMITY (Arm was sore) had resolved and HEADACHE (Headache/head feels heavy), DIZZINESS (Very Dizzy), VOMITING (Threw up) and DYSPNOEA (Couldn't breathe well/heavy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Macular/Papular rash on right wrist and patient complained of general itching. Gave diphenhydramine 25mg PO, and symptoms resolved after about 25 minutes.
Started 7/12/12 at date of vaccination, felt sore & bruised over night began swelling & turned red. Today pt began not feeling well. Treated with ice, BENADRYL.
SkinRash, Rash, rash - minimally raised, warm to the touch Narrative:
Pt vaccinated in MAR area due to autism.  Observed pt for 15 minutes, pt asymptomatic & stable, d/c'd home with father
Medication error occurred whereby the nurse administered the influenza vaccine from the prior flu season (2009-2010). No significant adverse event noted at time of reporting (5 days after administration), but final outcome is still unknown.
Fever of 100.9 for two days, could not get out of bed due to muscle and joint aches, could not move left arm, had dizziness and vertigo for 24 hours, hallucinating dreams, severe night sweats, could not eat due to dizziness for two days.