chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in ears; Headache; Both ears itching; Lightheaded; Both ears red; Crawling skin and scalp; Constricted throat; No energy; Tender arm; This spontaneous case was reported by a consumer and describes the occurrence of EAR PRURITUS (Both ears itching), EAR PAIN (Pain in ears), FORMICATION (Crawling skin and scalp), THROAT TIGHTNESS (Constricted throat) and ASTHENIA (No energy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shellfish allergy.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced TENDERNESS (Tender arm). On 10-Feb-2021, the patient experienced EAR PRURITUS (Both ears itching), FORMICATION (Crawling skin and scalp), THROAT TIGHTNESS (Constricted throat), ASTHENIA (No energy), DIZZINESS (Lightheaded) and ERYTHEMA (Both ears red). On 11-Feb-2021, the patient experienced EAR PAIN (Pain in ears) and HEADACHE (Headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK UNK, bid and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 10-Feb-2021, DIZZINESS (Lightheaded) had resolved. On 12-Feb-2021, EAR PRURITUS (Both ears itching), EAR PAIN (Pain in ears) and HEADACHE (Headache) had resolved. At the time of the report, FORMICATION (Crawling skin and scalp), THROAT TIGHTNESS (Constricted throat) and ASTHENIA (No energy) had resolved and TENDERNESS (Tender arm) and ERYTHEMA (Both ears red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient symptoms happened a while ago. They lasted 2 days and went away. She was okay now   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Patient gender and events outcome was updated.
Could not roll over, sit up or get out of bed next morning; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 22Oct2021 (Lot number: 301558A) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No covid prior vaccination. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3302), administration date: 06Feb2021, when the patient was 78 years old, for COVID-19 immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: EK9231), administration date: 16Jan2021, when the patient was 78 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (hospitalization) with onset 22Oct2021, outcome "unknown", described as "Booster"; BEDRIDDEN (hospitalization) with onset 23Oct2021, outcome "not recovered", described as "Could not roll over, sit up or get out of bed next morning". The patient was hospitalized for immunization, bedridden (start date: 23Nov2021, discharge date: 27Nov2021, hospitalization duration: 4 day(s)). The event "could not roll over, sit up or get out of bed next morning" was evaluated at the emergency room visit. 911 had to be called and was taken to ER. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown results.  Follow-up attempts are completed. No further information is expected.
Coughing, Wheezing, Fever, No taste , No smell, hurting all over
I haven't gotten my periods since my first dose of vaccine which was 3 months ago; This is a spontaneous report from a contactable consumer (patient).   A non-pregnant female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Mar2021, as a single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that consumer stated, she has not gotten her periods since her first dose of vaccine which was 3 months ago, yeah, she was little bit concerned. It was further stated, it's the first shot and she was not pregnant, and have taken several tests. Outcome of the event was unknown.  Information regarding the lot/batch number has been requested.
I felt extreme fatigue afterwards and went home to sleep. Later I started feeling nauseous. Headaches started and have been feeling nauseous off and on for four days. Feeling malaise for 4 days. Sore throat started on 7/4/18. Waking up throughout night and early morning feeling stomach unsettled.
pt recvd vax 12MAY04 & on 13MAY94 mom called & stated pt had a t101.4; arm is red, swollen & very warm;
In first 15 minutes, no adverse reaction. In second 15 minutes, while driving home, my lips, throat, nasal passages began to go numb, tingle, swell. This lasted a day and a half. No breathing obstruction.
patient says her throat is tingly.  as precaution gave her benadryl.  she sat for 15 minutes.  we checked on her and before she left said she was feeling fine
WHOLE BODY SHAKING; FEELING HOT; SWEATING; WEAKNESS; TIRED; DIARRHEA; This spontaneous report received from a patient concerned a female of unspecified age. 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: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced diarrhea. On 11-APR-2021, the subject experienced whole body shaking. On 11-APR-2021, the subject experienced feeling hot. On 11-APR-2021, the subject experienced sweating. On 11-APR-2021, the subject experienced weakness. On 11-APR-2021, the subject experienced tired. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the whole body shaking, feeling hot, weakness, sweating, tired and diarrhea was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.
About 1 pm soon after the pneumococcal vaccine shot, my arm began swelling in the same area. A rash formed within minutes and was red, tender and warm to the touch. The rash has continued to expand, and the size is now 5in x 6in with an irregular shape. I put ice on it and took ibuprofen as directed by the LP pharmacy clinic.
Immediately my face and leg and arm on the left side started tingling. The next morning my left leg was weak. Today which is two days later I feel pins and needles in my left foot, leg, arm, fingers. The muscles in my left leg are very fatigued and week. The muscles in my left leg are very fatigued and week.
Pt calling reports her son tested positive for covid on Saturday.  Pt reports she herself tested negative on Saturday.  Pt reports she is running fever daily as high as 100.5.  Reports cough is worse and she is having burning in her chest related to coughing only.  Pt reports productive cough with clear sputum and sometimes dry, barky cough.  Reports wheezing.  Reports is using inhaler with minimal relief.      09/01/2021 Advised ED ASAP, but definitely within the next 4 hours, unless she is having difficulty breathing or chest pain not related to coughing, then would recommend ED immediately.  Pt agreeable, will go to ED.   Reason for Disposition ? Wheezing is present  ED to Hosp-Admission Current  9/1/2021 - present (7 days) Pneumonia due to COVID-19 virus, Patient presents with ? Shortness of Breath  The patient in the ED has a productive cough with clear sputum Some slight wheezing.  labs include a normal CBC, normal BMP, normal ferritin, Normal LDH and negative troponin.  INR is 1.9.  Chest x-ray shows chronic elevation  of the right hemidiaphragm with lung parenchyma showing interstitial prominence scattered  Throughout with a respiratory infection.  ED the patient denies chest pain, pressure, palpitations, , Vomiting, diarrhea.  Has transiently needed 1 to 2 L of oxygen maintain saturations greater than 97% Per she has been 95% on room air.  Is now seen at the request of ED staff.
No adverse event; patients administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (patients administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 36-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (patients administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (patients administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster) 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 assessment was provided for ACCIDENTAL UNDERDOSE (patients administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster).    No concomitant medication was reported.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-662390 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662390:same reporter
Adverse event is HEARING LOSS in the left ear. Right now being treated with steroids orally. May have to get steroid injections in ear drum. Hearing is completely gone. No signs, just suddenly came on briefly.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 31-DEC-2015, the patient was vaccinated with expired dose of VARIVAX (Merck) lot # J012210 with expiry date of 28-SEP-2015. No adverse effects were reported. Additional information is not expected as the reporter denied consent for further contact.
Swelling of lips and face.  Tingling and burning of eyes, face, lips and throat.
Client was complaining of a tingling sensation on the same side as her vaccine administration.  Client stated that she began experiencing the tingling sensation several minutes after beginning her observation. Client denied any major medical history, past allergies or history of any previous vaccinations. Assessment revealed no bleeding, bruising, swelling or other signs of trauma on her left side vaccine site. Bandage was clean dry and intact. Client complained of tingling sensation that began behind her neck that was painless. Clients airway, breathing and circulation were intact. She was alert and oriented to person, place, time and event. Client was negative for hives, redness, severe sweating, shortness of breath or other signs of anaphylaxis. : Blood pressure 150/78, Pulse 66, O2 sat 100% room air, respirations were 16 and regular, eyes equal and reactive to light, Temperature 97,8* f and lung sounds clear bilaterally. She was given Oral Benadryl 50mg, water and observed for an additional 30mins.Vitals were taken every 5mins.  After 30mins of observation client stated that her tingling sensation was improving but still remained. She was offered to be transported to the hospital via ambulance for further observation or go home and continue observation and contact her primary Dr for further evaluation. She decided to go home to continue observation. She was recommended to make a follow up appointment with Dr. or seek emergency care if needed. She verbalized understanding. Left with husband.
A non-serious spontaneous report of FLUMIST given to a female greater than 49 years of age was received from a licensed practical nurse concerning a 63-year-old female. On 11-Sep-2009, the patient received FLUMIST. On 06-Oct-2009, the reporter confirmed that the subject did not experience any adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 06-Oct-2009 and incorporated into the narrative: included confirmation that the patient did not experience any adverse events associated with the vaccination error.
Looks like a sunburn; Itchy around the injection site; Rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Looks like a sunburn), VACCINATION SITE PRURITUS (Itchy around the injection site) and VACCINATION SITE RASH (Rash around the injection site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant concomitant medications reported. No relevant medical history was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 23-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy around the injection site) and VACCINATION SITE RASH (Rash around the injection site). On 01-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Looks like a sunburn). At the time of the report, RASH ERYTHEMATOUS (Looks like a sunburn), VACCINATION SITE PRURITUS (Itchy around the injection site) and VACCINATION SITE RASH (Rash around the injection site) outcome was unknown.            patient did not take medication as treatment.   Reporter did not allow further contact
This spontaneous report was received from a healthcare worker referring to an unspecified number of patients. On an unknown date, the patients were vaccinated with ZOSTAVAX that was improperly stored (lot# K014835; Expiration date 14-DEC-2015) (lot# K016324; Expiration date 24-DEC-2015) (lot# K018172; Expiration date 02-DEC-2015) (lot# K020186; Expiration date 27-JAN-2016) (lot# K023622; Expiration date 02-FEB-2016) (lot# L000450; Expiration date 09-MAR-2016) (lot# L006379; Expiration date 25-MAY-2016) (lot# L011535; Expiration date 03-JUL-2016) dose and route of vaccination were unknown. No adverse events reported. This is one of two reports from the same reporter (1507USA001144). Additional information has been requested.
Anaphylactic shock, unspecified, initial encounter on 2022-11-02, Adverse effect of other vaccines and biological substances, initial encounter on 2022-11-16.
1. Vaccine reaction, initial encounter      Discharge Instructions    As we discussed, I do think that this is a localized reaction and immune response to the vaccines that you received on Wednesday.  This does appear to be resolving.  I have outlined the area of inflammation today please look at this once per day.  If you have redness that is spreading outside the marked area especially if you have any red streaking running up or down your arm, or if your symptoms worsen again such you have return of fevers body aches, chills etc. this may indicate a developing infection and antibiotics may be needed.   You may take acetaminophen and/or ibuprofen if needed.  I do recommend trying to keep your arm elevated at least at heart level when at rest.   Please advise your primary care provider of the reaction.     Differential diagnosis considered include local reaction to vaccine, cellulitis.   Patient notes that he was experiencing symptoms of body aches, malaise fatigue and fever the symptoms have all resolved.  He states initially he did not notice the redness and first noticed this yesterday.  He states that it did seem to be more swollen yesterday but has improved today.   Patient does have an erythematous area with well-defined edges, this area is warm to palpation not hot and swelling is very mild at this point.  As patient describes symptoms of improvement I do think that this is a local immune response to either the shingles vaccine or the pneumonia vaccine both of which she received in the same arm.   At this time I do not think that this is a cellulitis and did not recommend for antibiotics.  The area was outlined with date and time.  Patient is to monitor to the area and return if he has worsening redness including red streaked or worsening symptoms such as fevers, chills or body aches returning.   I did recommend that he contact his primary care provider and advised them of the reaction.  Aftercare follow-up and return precautions reviewed he verbalized understanding is agree with this plan.   This document was made with voice recognition software.  Although every effort was made to edit the content, transcription errors may occur.
My arm is swollen; Arm is red; Arm is hot to touch; Arm is very itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (My arm is swollen), ERYTHEMA (Arm is red), FEELING HOT (Arm is hot to touch) and PRURITUS (Arm is very itchy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concomitant products included METOPROLOL SUCCINATE (TOPROL), AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3), LISINOPRIL and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PERIPHERAL SWELLING (My arm is swollen), ERYTHEMA (Arm is red), FEELING HOT (Arm is hot to touch) and PRURITUS (Arm is very itchy). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) in March 2021 for Swollen arm, Feeling hot and Redness, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (My arm is swollen), ERYTHEMA (Arm is red), FEELING HOT (Arm is hot to touch) and PRURITUS (Arm is very itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Presented to the ED 2/6/2022 due to left upper extremity erythema, swelling and tenderness. Similar episode of cellulitis in the past. Admitted for sepsis and cellulitis. COVID-19 PCR positive. Patient is asymptomatic on room air; no respiratory symptoms; no indication for COVID-19 treatment. Previously vaccinated 4/8/2021. Discharged 2/10/2022.
syncopal episode,  pt was observed passing out and was taken from chair to floor in trendelenburg  position.  Upon laying pt onto floor pt regained consciousness  but was very weak.  Administered low flow oxygen, B/P 104/66 pulse 106 skin cool and damp.  Pt relates that she had not eaten prior to being vaccinated and was nervous about getting the vaccine.  Patient kept on floor in trendelenburg for 17 minutes and B/P now  106/66 pulse 68 skin warn and dry.  Pt. relates that she feels much better now and is ready to go home with her husband.
This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 23-Nov-2021 and second dose received on 4-Jan-2022) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066H21A and 018F21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Nov-2021 at 2:41 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 04-Jan-2022 at 10:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 04-Jan-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 23-Nov-2021 and second dose received on 4-Jan-2022). On 04-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 23-Nov-2021 and second dose received on 4-Jan-2022) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2021, SARS-CoV-2 test: positive (Positive) Saliva Test. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications was provided by the reporter. No treatment information was provided by  the reporter. Reportedly, there was no adverse reaction observed. This case was linked to MOD-2021-403089 (Patient Link).
Poor pneumococcal and HIB vaccine response was noted.; This literature marketed information has been received from the authors in a published article title as stated below.  The authors describe a case from a 71 years old male patient whose concurrent conditions included chronic lymphocytic leukemia (CLL) (11q deletion, immunoglobulin heavy chain unmutated, Rai stage III). Patient was clinically asymptomatic until 2017, when he developed thrombocytopenia and he started infusions with obinutuzumab for two months and went into remission.   On an unknown date the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (lot #, expiration date, strength, dose, route of administration and anatomical location of vaccine were not reported)  and with a dose of  pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (Lot #, expiration date, strength, dose, route of administration and anatomical location of vaccine were not reported); both vaccine were administered for prophylaxis. On an unknown date, poor pneumococcal and HIB vaccine response was noted. At the reporting time, the outcome was unknown.    A copy of the published article has been requested.
Numbness around her mouth, specifically on the "corner of her right mouth and extending down into her right chin". It feels "kind of like when NOVOCAINE is wearing off". BP 125 systolic by report which is "high for (her)". HR 105. No dizziness or nausea. Reported rash that resolved. Seeking medical attention from PMD for evaluation 10/18/16.
Initial information received on 21-Jan-2019 regarding an unsolicited valid non-serious case received from a Pharmacist via phone. This case is linked to case 2019SA020397. This case involves an 90 years old male patient who had sore arm, while she received vaccine FLUZONE HIGH DOSE. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and Expiry date unknown, site and route not reported). On an unknown date, the patient experienced non-serious  sore arm (Pain in extremity) (Other relevant tests included No lab data.) Final diagnosis was sore arm. It was not reported if any corrective treatment was recieved. The patient had recovered from the event. List of documents held by sender: none.