chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; Sore throat; Swelling of the left side of his face; Ear infection; Rash on the side of his face, inside his ear, and on his scalp; Loss of hearing; Drooping of his left lip; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (Loss of hearing) and FACIAL PARALYSIS (Drooping of his left lip) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No recorded medical history). Concomitant products included AMOXICILLIN SODIUM (AMOXYCILLIN [AMOXICILLIN SODIUM]) for Laceration.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced DEAFNESS (Loss of hearing) (seriousness criterion medically significant), FACIAL PARALYSIS (Drooping of his left lip) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat), SWELLING FACE (Swelling of the left side of his face), EAR INFECTION (Ear infection) and RASH (Rash on the side of his face, inside his ear, and on his scalp). On 27-Mar-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, DEAFNESS (Loss of hearing), FACIAL PARALYSIS (Drooping of his left lip), HERPES ZOSTER (Shingles), OROPHARYNGEAL PAIN (Sore throat), SWELLING FACE (Swelling of the left side of his face), EAR INFECTION (Ear infection) and RASH (Rash on the side of his face, inside his ear, and on his scalp) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient went to urgent care center for the events experienced. Treatment for the events included ciprofloxacin 0.3%, dexamethasone 0.1% suspension and cefdinir. Treatment for shingles included valacyclovir 1mg, gabapentin 300mg, and prednisolone 4mg.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Significant follow up appended.; Sender'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.
20 something days prior to the second; Numbness in his biceps (in both arms)/numbness in his fingertips (in both arms); This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in his biceps (in both arms)/numbness in his fingertips (in both arms)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (20 something days prior to the second) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced HYPOAESTHESIA (Numbness in his biceps (in both arms)/numbness in his fingertips (in both arms)). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (20 something days prior to the second). At the time of the report, HYPOAESTHESIA (Numbness in his biceps (in both arms)/numbness in his fingertips (in both arms)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (20 something days prior to the second) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
After 2 h erythematous rash and small vesicles around vaccine injection with out any treatment rash cleared in 3 days with out any signs.
This spontaneous report as received from a medical assistant refers to a 2 months old patient of unknown gender. Patient's medical history, concurrent conditions and drug reactions/allergies were not provided. On 01-SEP-2016, the patient was inadvertently vaccinated with a pediatric dose of RECOMBIVAX HB (Concentration and dose were not reported, lot# and expiration date were unknown by the reporter),via intramuscular and a dose of PEDIARIX. The patent's concomitant medication was not reported. No adverse effects were reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
This is a vaccine administration error, not an adverse event.  Moderna vaccine was given to the wrong age patient.
He began flapping left arm and making vocalizations such as "ah, ah, ah" while flapping arm.
Pt stated the onset of severe pain in shoulder and inability to lift arm "as if it was heavy". Some tingling pain radiating down arm to hand. Nurse recommended applying ice to area and followed up next day. Pt stated that sx had improved however arm was still tender in one location.
Patient received  the first dose of covid vaccine on Nov 8. On Nov 16, 8 days following immunization for covid-19, Child experienced isolated fevers (103F)  body aches, fatigue and severe headaches., The fevers resolved after 2 days, however severe headache persisted and are ongoing on day 10 though continue to improve in severity.  Th firs 45 days headaches were so severe child could not move or get up and was screaming in excruciating pain.  Acetaminophen and Ibuprofen were given to manage fevers and pain. No neurologic symptoms were seen at any point. Viral meningitis was suspected however LP was not done as child showed continued improvement of the days. As of Nov 26, mild headache persists throughout the day however patient is able to manage without pain medication.
One week after vaccine, arm developed raised bump that grew, red ring started to spread. Also developed stuffy nose, cough, and some chest tightness, shortness of breath later that week. Symptoms continued, COVID test performed 1/23, positive. I did attend a funeral on 1/15 where I was masked, but several people have tested positive since.
Woke up in the morning with pain. Couldn't lift my arm up, had fever 101-102 for 4 days, headaches, hot flushes, nausea, vomited once and my whole body was sore. Have a rash on my arm.
Mother and child state (L) upper arm became painful and 2 cm x 2 cm area of redness over deltoid area. Child felt pain under (L) upper arm into (L) axilla. Denies any lumps. States was slightly swollen. No numbness or tingling.
History obtained. Client went to the ER on 11/18/2021 after being diagnosed with Covid on 11/15/2021 with hypoxia and a cough. Her sats were in the 60s on arrival on room air.
04/12/2022 I received 2nd booster shot, my adverse event started on the 04/16/2022. I noticed the back of my head on my hair line it was itchy and scaly it looked like psoriasis. I put Sarna anti itch cream, I put it on every 4hours. I also took Benadryl to help with this situation. I started getting better after 1 and a half weeks later. I did not go to see a doctor.
Vaccinee rec'd Engerix-B "early OCT90" & experienced "numbness of tongue; lightheadness/dizziness & tiredness" two or three wks later. Tx vaccinee is seeing a neurologist.
Supraclavicular swelling left side 2 days after injection. Self-diagnosis points to lymph node swelling.
pt recv vax 26JUL97 & pt exp chickenpox like rash w/less than 20 lesions & on 5SEP97 pt was seen by MD;tx w/DPH, APAP & colloidal oatmeal;
Severe headache, fatigue and nausea within 3-4 hours, lasting for 3 days. Fever (up to 100.7) lasting for 2 days. Muscle aches (in legs) lasting for 3 days so far. Very sore arm with pink, puffy splotches for 4 days so far.
Pt came in saying that her arm felt funny and that something was still in her arm on 10/1/17. Examined arm looked scabbed talk to her on 10/5/17 she says MD said she was fine as well. Says arm feels much better.
Moderna vaccine is approved for use in patients 18 year of age and older. The patient received both doses at age 17. At this time we have not been made aware of any adverse reactions.
shingles; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (shingles) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.  The first and second dose was given on Left.   This case was linked to MOD-2021-426367 (Patient Link).
Very fatigued. Slept all day after vaccine. Broke out in drenching sweats and then chills.
This case was reported by a nurse and described the occurrence of injection site reaction in a male pt in his fifties who received hep B vaccine recombinant (Engerix B). Medical history included diabetes, and the pt was described as "rather large." On 1/27/04 the pt received Engerix B (5465A6). At the time of vaccination, the pt experienced an injection site reaction characterized by injection site pain. While walking from the examination room, the pt complained of weakness and subsequently collapsed. The pt was moved by wheelchair to an examination room, where his blood sugar level was 199. A blood pressure was not taken because a blood pressure cuff could not be placed on the pt's arm. The pt developed a "pulse of 52 and skipping," pallor, sweating, SOB, coolness to touch, and nausea. He was transported by ambulance to the hospital and was admitted for "a couple of hours." He was discharged to rest at home. The following day, the pt continued to complain of nausea, dizziness, and weakness. On 1/29/04, the pt reported to the nurse that he was "doing fine." The events, which were described as having jeopardized the pt/ required intervention, were associated with a potential product complaint.  Follow up information received on 03/22/04 states: "He was discharged to rest at home. The following day, the pt remained off work for ordered rest, and continued to complain of nausea, dizziness, and weakness. On 01/27/04 the fatigue and injection site pain resolved. The events, which were described as life-threatening and as having jeopardized the pt/required intervention, were associated with a potential product complaint. The immunization series with Engerix-B was discontinued. The nurse considered the events to possibly be related to vaccination with Engerix-B.  Case Number A0495290A is a duplicate of A0496327A.  All future correspondence will be submitted to A0496327A."
Inflamed, sore gums Oral ulcer/blister with no history of cold sores Fatigue Fever Muscle aches
Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 09-Aug-2022; No Adverse Event; Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 09-Aug-2022).    No concomitant product use was reported. The number of doses/vials -around 50 doses from 5 vials. On 08-Jul-2022 the vials were initially stored in the refrigerator. The vaccines were administered from the 07-Aug-2022 until the 11-Aug-2022 Vial did not undergone any temperature excursions. The healthcare professional was not aware of any symptoms for any patient after the vaccine was given. No treatment information was provided.
7 year old male was inadvertently given 0.2mL of the Pfizer 12+ serum instead of the 5-11 serum. No adverse side effects noted same day.
4 hours after receiving my booster I arrived home from walking my dog and the room began spinning. I almost dropped. My sister came to my assistance and assessed that I was having an irregular pulse and that I was very pale. We attended ER at hospital. I was very dizzy, nauseous and felt very unwell. ECG revealed multifocal PVC's. Blood work was normal. Troponin levels were normal and when repeated in 6 hours, remained normal. ECG continued to show same multifocal PVC's. I was dizzy. They discharged me, with only advice to go home, rest, no caffeine or alcohol, no exercise. I followed the advice. On Jan 9th I experienced 10/10 headache and went to ER at  hospital. Head CT normal. ECG confirmed multifocal PVC's, covid swab negative, medications were given through IV to treat the head pain and nausea. Discharged with same advice to rest and that it is the body's  inflammatory response to the vaccine. I am still experiencing an irregular heart rhythm. I am dizzy when I exert myself, even walking my dog. I have not returned to work. I am seeing my GP on Monday January 24th.
Loud, high pitched sound startled me awake approximately 17 hours after vaccination.  This same reaction occurred after each of the first three moderna vaccine doses  (3/30/21, 4/27/21, 12/8/21) but resolved within a few days and was not listed as a side effect that I could find online at the time.   I knew it was related though as I have never had tinnitus before or since and all three doses had a startling high frequency sound begin approx 10-17 hours after vaccine.  No real other side effects other than sore arm.  This fourth vaccine has a much louder case of tinnitus that still has not resolved nine days later and seems to be getting worse.  Interrupting sleep, etc.  I have emailed my primary physician who has told me to wait a few weeks to see if it resolves.
concomitant administration of PROQUAD with VARIVAX in a 12 month old female patient./the patient was intended to receive MMRII and VARIVAX; concomitant administration of PROQUAD with VARIVAX in a 12 month old female patient./the patient was intended to receive MMRII and VARIVAX; no additional AE; This spontaneous report has been received from a nurse concerning to a 12-month-old female patient. The patient's medical history, current conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the patient was concomitant vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliter (ml), (strength and route of administration were not provided; lot number W028567 that was verified to be valid,expiration date reported  and established as 06-MAR-2024); and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, at a dose of 0.5 milliliter (strength, route of administration, and indication were not provided; lot  number W022294 that was verified to be valid, expiration date reported an established as 13-JUL-2024). Both administered for prophylaxis (wrong product administered) (extra dose administered).  The caller reported that the patient was intended to received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (strength, dose, oral route, indication, lot number and expiration date were not provided) for prophylaxis, and varicella virus vaccine live (oka/merck) (VARIVAX).  The outcome of the events was not provided.  No additional adverse event.
06Dec90 pt vax w/ MMR; 14Dec90 devel 3 cm mobile non-tender right inguinal node + other shotty nodes in both groins.
On 12/4/21  at 4 pm  about one week after the COVID vaccine  experienced severe chest pressure,requiring Nitroglycerine,and aspirin, taken to hospital  ED by EMT ,noted to have  bundle brunch Block on EKG, and found to have up trending Troponin levels ,diagnosed with NSTEMI started on blood thinners, had cardiac Cath with stent placement  on 12/5   and noted to have 100% block of LAD . Monitored in the ICU overnight and was discharged home in stable condition on 12/7  on blood thinners and close cardiac follow up.
PATIENT BECAME DISORIENTED AND FAINTED  ABOUT 1 MINUTE AFTER BEING VACCINATED. PATIENT WAS LEANING AGAINST A TABLE AND SLUMPED OVER AND WAS CAUGHT BY RPH . PATIENT DID NOT HIT OR INJURE HERSELF. PHARMACIST HELPED PATIENT LIE ON THE FLOOR. PATIENT WAS DISORIENTED, BUT BECAME AWARE OF HER SURROUNDINGS IN ABOUT 1 TO 2 MINUTES. PATIENT WAS HELPED TO A CHAIR AND GIVEN WATER TO DRINK. PATIENT WAS HELPED TO WALK AROUND THE PHARMACY ASSISTED AND UNASSISTED . SHE ATE A COOKIE,  AND SAID SHE WAS OK TO DRIVE HOME. SHE CONTACTED HER HUSBAND  TO INFORM HIM OF WHAT HAD HAPPENED. SHE WAS ESCORTED TO HER CAR AND DROVE AROUND THE PARKING LOT TO VERIFY HER ABILITY TO DRIVE. PATIENT WAS IN THE PHARMACY FOR 40 MINUTES AFTER SHE FAINTED. THE PATIENT CALLED THE PHARMACY WHEN SHE HAD ARRIVED SAFELY HOME
frontal, photophobia, h/a w/nausea; more if bending, abdo pain, anorexia, fever 103, fatigue x 1 wk;
pt recvd vax 230PM & 1 hrs later started feeling nausea & faint; arm began to get somewhat sore; had fever;
Upper left side of lips began swelling 3x the normal size on the opposite side of injection site. Was diagnosed with angioedema by healthcare provider.
missed 2nd dose appointment due to surgery/ over 42 days since dose 1; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed 2nd dose appointment due to surgery/ over 42 days since dose 1) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed 2nd dose appointment due to surgery/ over 42 days since dose 1). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed 2nd dose appointment due to surgery/ over 42 days since dose 1) 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 was reported.  Treatment information was not provided.
Varicella received 8/23/11. 5 cm x 3 cm area erythema & induration left upper arm, positive pruritus, & pain over site. No fluctuant or streaking noted.
Bony pain; night sweats; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection), dose 1 via an unspecified route of administration, administered in Leg Left on 20Feb2021 12:45 (Lot Number: EN6201) at the age of 60 years old as single dose for covid-19 immunisation. Medical history included Covid prior vaccination, Hypertension, Diabetic, No Known allergies.  The patient's concomitant mediations received in two weeks included medications for Hypertension and Diabetic Medication. Facility type vaccine was Hospital. No other vaccine in four weeks. The patient experienced Bony pain and night sweats on 21Feb2021 at 11:45 AM. No treatment received for the events. No covid tested post vaccination. The outcome of the events was recovering. The report was serious per the reporter.
Some injection site pain, felt okay until 04:00am 06/23. Woke with a screaming migraine (head, eyeballs, neck) with an extreme sensitivity to light, sound, or movement; joint swelling, chills, fever, muscles aches and spasms, dizziness, weakness in the muscles, nausea, and an inability to ingest sustenance. Lastly, a very large feeling of unwellness.
Nausea; vomiting; muscle aches; 99.5 temp x24 hours; This is a spontaneous case from a contactable Nurse. This 45-Year-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: Solution for injection, Lot number: EL9269), via intramuscular, administered in left arm on 15Feb2021 10:30 at SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and known allergies: sulfa, bananas, avocados, honey. Concomitant medications included propranolol, lisinopril, fioricet, calcium/magnesium/zinc, VIT C, VIT D and potassium. On 21Feb2021 04:00 the patient experienced nausea, vomiting, muscle aches, 99.5 temp x 24 hours. No treatment was given for the events. No other vaccine in four weeks. No covid tested post vaccination. No covid prior vaccination. The outcome of the events was recovering.
This is a spontaneous report from a contactable medical assistant calling on behalf of a physician. A 74-year-old male patient received PREVNAR 13 (lot: R75238, expiry date: May2018, NDC number: 0005197101) on 18Jul2017, at 0.5 ml single, intramuscular, in left arm, for immunization. Medical history and concomitant medications were none. On 22Jul2017 the patient experienced fever (102 degrees Fahrenheit), was tired, headache, joint and muscle pain and stiff neck. The patient did not have any coughing, respiratory or GI issues to report. The doctor prescribed TYLENOL 500 mg QID to the patient who had not yet recovered at the time of report.
positive COVID-19 infection with hypoxia, admitted to hospital further management of COVID-19 pneumonia, acute respiratory failure with hypoxia. Labs: D-dimer 1.49 CRP 6.4 Ferritin 257 CXR clear;  Treated with steroids, bronchodilators, Vit C, Vit D3, Lovenox, singulair, zinc:  Rec'd 2 doses of Remdesivir but Out of window for remdesivir, so it was discontinued. symptoms improved. Hypoxia resolved;  stable on room air at rest and after ambulation with pulse ox greater than 93%