chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LITTLE DEPRESSED; PSORIASIS FLARE UP IN NOSE/HANDS/FEET; SORE ARM FROM COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (LITTLE DEPRESSED), PSORIASIS (PSORIASIS FLARE UP IN NOSE/HANDS/FEET) and VACCINATION SITE PAIN (SORE ARM FROM COVID VACCINE) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Alcohol use.   In February 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) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (SORE ARM FROM COVID VACCINE). On an unknown date, the patient experienced DEPRESSED MOOD (LITTLE DEPRESSED) and PSORIASIS (PSORIASIS FLARE UP IN NOSE/HANDS/FEET). In 2021, VACCINATION SITE PAIN (SORE ARM FROM COVID VACCINE) had resolved. At the time of the report, DEPRESSED MOOD (LITTLE DEPRESSED) and PSORIASIS (PSORIASIS FLARE UP IN NOSE/HANDS/FEET) was resolving.            Concomitant medication was not reported. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Muscle pain (up to 7 days after vaccination) Joints and body pain (up to 11 days after vaccination) Weakness and dizziness (after vaccination until now) Tiredness (after vaccination until now) Chills (after vaccination until now) Headaches (after vaccination until now) I took Tylenol  Eye pain (after vaccination until now) A blood vessel burst in my left eye on 7/7/21 and I still recovering from that.
p/vax pt exp vomiting & diarrhea;pt sought unspecified medical attention;
I am a medical doctor. Approximately 1 hour and 15 minutes after the injection I started feeling severely dizzy. My heart rate at that time was 85-90/min and BP was 140/90. Pulse OX was normal. The dizziness improved gradually and lasted for approximately 4 hours. I did not take any medication. Next day, on 1/5/2021 I still felt a little dizzy and I had muscular pain on my L arm. The symptoms completely disappeared on 1/6/2021.
I started to have pain in my chest. My son called an ambulance to come get me. I was transported to the hospital. They said I had pneumonia. They prescribed mw with levofloxacin 500mg 1xday for 14days. Off and on I still have slight pains.
6MAY92 8PM onset redness, t100 R; 11MAY92 swelling-rash onset; no exam; 3/4" x 1" rt thigh fine red rash, local rxn; appt w/MD 12MAY92 w/rash & irritiability; 13MAY92 MD dx hematoma viral exanthum;
Reports Anthrax (3rd out of 6) vaccine in left arm at 14:30 today with onset of several hours later of fever and chills, lightheadedness and cough. No nausea or vomiting. Reports similar illness after initial vaccination 2 weeks ago but symptoms had onset 3 days after vaccination, but he did not seek treatment. Alert but very dramatic, hyperventilating at times, crying out with discomfort of the chills. Shows poor effort asked to sit up. Feels better and is calm at 20:45. At 21:30, feels somewhat better but body aches persist. Systemic treatment with Motrin/naproxen for pain. F/U with PCM in 3 days or in ER sooner with worsening.
nurses administered ADACEL to a patient IV instead of IM with no reported adverse event; Initial information was received on 12-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 24 years old female patient who reported that nurses administered diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] to a patient IV instead of IM of with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine (Suspension for injection) (lot 2CA61C1, Expiry date : 06-Jun-2025, strength was unknown) via intravenous not otherwise specified route in unknown administration site for Immunization.  On an unknown date the nurses administered adacel to a patient IV instead of IM with no reported adverse event (incorrect route of product administration) (latency: same day) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event nurses administered adacel to a patient iv instead of im with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This initial spontaneous report was received from a medical assistant referring to an 18 year-old patient of unknown gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 23-DEC-2015, the patent was intramuscularly administered the first dose of both an adult formulation of VAQTA injection (50/1.0 U/ml; lot # L018499 with an expiration date 25-FEB-2017; dose was not provided) as well as a pediatric/adolescent formulation of VAQTA injection 25./0.5 (Lot # L027757 with expiration date 08-APR-2018; dose was not provided). This was an outside the labeled recommendations in the prescribing information. No adverse effect was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
PT RECEIVED A THIRD DOSE BY MISTAKE WANTED TO REPORT THE 3RD DOSE
Patient didn't have an adverse event, but did get 3 doses of shingrix instead of the standard 2 doses
1/15/2021 minor aches, Saturday 1/16 started with chills, fever, headache and low grade fever  around 6AM.  Body aches and fatigue on Sunday  1/17and Monday 1/18
i1/13/21 at about 2;45 pm, I had my second Covid vaccination. had pain on site on left arm  1/14/21 woke up feeling a little tired, went to work. went home early at 1:30 pm, feeling a little chilly. no fever.   1/15/21 in the morning noted pain on Left armpit ( injection site is left arm), pain from left shoulder blade to right shoulder blade. took advil. In the afternoon, about 4:00 pm, noted some swelling and soreness on left armpit. took Advil..  1/16/21, Called employee health to report this. Advised to take advil and monitor and call pcp if symptoms persists.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. In 2011 ("about 2 years ago"), the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose and route not reported). The pharmacist reported that the patient "recently" (in 2013) developed a case of "extremely painful" shingles on her scalp. The patient saw an unspecified healthcare provider, on an unspecified date, that prescribed unspecified antiviral medication and unspecified pain medication for her reaction. The patient was not recovered at report time. This is one of several reports received from the same source. Additional information is not expected.
She states that she had written an order for Bexxero, a Men B vaccine, however when the order came across the front desk, they interpreted it as Menactra and that is what was given in error without any reported adverse event; Initial information regarding an unsolicited valid non-serious case was received via physician via Medical Information (Reference number- 00693586) and transmitted to Sanofi on 22-Jul-2021.   This case involves a 16-year-old female patient who states that she had written an order for bexxero (a men b vaccine), however when the order came across the front desk, they interpreted it as MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and that is what was given in error (wrong product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 02-May-2016, the patient received a dose 1 of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination (wrong product administered).  On 22-Jun-2021 she also received a dose 2 of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot number: U6920AB and expiry date: 15-Apr-2022] via an unknown route at an unknown administration site for prophylactic vaccination (wrong product administered).  On 22-Jul-2021 she also received a dose 3 of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination (wrong product administered).  It was a case of actual medication error due to wrong vaccine administered.  At the time of report, no adverse event was reported.  It was reported that "a patient, was given Menactra vaccines 3 times with the last 2 Menactra vaccines being exactly 1 month apart at age 16. The physician asks what can happen as a result of this. She states that she had written an order for Bexxero, a Men B vaccine, however when the order came across the front desk, they interpreted it as Menactra and that is what was given in error. The Physician also asks if it is acceptable for the patient to go ahead and get the Men B vaccine as that is the vaccine that she was supposed to get in the first place. "  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Improvement of rash (that was present for years); itching; The rash completely disappeared; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and RASH (The rash completely disappeared) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Leukemia and Rash (Rash from the leukemia for several years. After he received the 1st dose of the Moderna Covid-19 vaccine, the rash started to improved and stop itching. The rash completely disappeared 4 - 5 days after receiving the 2nd dose of the vaccine.).   On 04-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) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PRURITUS (itching) and RASH (The rash completely disappeared). At the time of the report, PRURITUS (itching) and RASH (The rash completely disappeared) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up information received  21-JUN-2021 contain Race information of patient.
vaccine has been diluted to a regular sterile water instead of the diluent associated with the vaccine with no reported adverse events; Initial information received on 17-Mar-2022 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age and unknown gender patient who was administered Haemophilus type B (HIB) vaccine [ACT-HIB] which has been diluted to a regular sterile water (water for injection) instead of the diluent associated with the vaccine with no reported adverse events.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose, of suspect HIB (PRP/T) vaccine, once (with an unknown formulation, strength (standard) and route) (lot number: UJ573ABA and expiry date: 20-Sep-2022) diluted with sterile water in unknown administration site for immunization.  On an unknown date the patient was administered HIB (PRP/T) vaccine which had been diluted to a regular sterile water instead of the diluent associated with the vaccine with no reported adverse events (product preparation error) (same day latency).  Action taken was not applicable with both the suspects.  Outcome: Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Mother states, On way home from (shot clinic) daughter started "growling" and did not respond to verbal stimuli- approx. 20-30 seconds in duration. Within 1 minute, daughter was answering all questions appropriately'.  She returned to (shot clinic) where daughter was evaluated by a paramedic. She was found to be pale in color; incontinent to urine; but was awake, alert, and appropriately oriented. Patient was placed supine and local EMS was summoned. Mother denies any other altered mental state.  EMS arrival found patient's condition to be as described above. Patient was tachycardic at 130 bpm with steady pulse. All other vital signs were within normal parameters. Blood sugar was 100 mg/dL. Pulse on departure of EMS was 108 strong and regular.  EMS advised mother to allow ambulance transportation to local ER. Both ambulance and ER treatment were refused. Mother stated that she would "keep an eye on her tonight".  Mother also advised to monitor daughter for any unusual color, complaints, or changes in behavior.  Phoenix Fire Department Immunization Coordinator subsequently contacted parents at approximately 2030 that same night. Father stated, "Oh, she's fine. She ate some dinner; had a shower; and is now playing on the Internet."   Father was advised by Coordinator, of the same precautions, as was the mother.
incorrect product storage; no adverse effect; administered 1 dose of MMRII intramuscularly; This spontaneous report was received from an office manager refers to a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On 21-MAY-2019, the patient was vaccinated with 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # N020927, expiration date 01-AUG-2019) intramuscular route (incorrect route of product administration). It was unknown whether if the Sterile diluent was properly stored (incorrect product storage). On an unknown date the patient experienced no adverse event. PQC (product quality complaint) was not reported.
PATIENT WAS VACCINATED AT AGE 16. AGE REQUIREMENT FOR MODERNA IS 18 AND OLDER.
started with a headache in early morning.  Then a stomach ache with some dizziness.  It is now 6pm, and some of the symptoms have lessened.
Worsened tinnitus; Hearing is pertinently impacted; I am unsteady; stepping backwards; Body aches; Flu like symptoms; Fell ill; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), TINNITUS (Worsened tinnitus), BALANCE DISORDER (stepping backwards), PAIN (Body aches) and MALAISE (Fell ill) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ulcerative colitis (Pandemic Ulcerative colitis) in 1992, Migraine in 2016, Sinusitis in 2016, Tension in 2016, Osteopenia and Hiatal hernia. Concurrent medical conditions included Fibromyalgia (Tinnitus worse), Allergic reaction to drug (Prednisone) and Tinnitus aggravated (Tinnitus worse) since 1992. Concomitant products included CYCLOBENZAPRINE HCL from 2000 to an unknown date for Fibromyalgia, DIAZEPAM from 1980 to an unknown date for Fibromyalgia and Headache, FAMOTIDINE from 2017 to an unknown date for Hiatal hernia, LEVOTHYROXINE SODIUM (L THYROXINE) for Hypothyroidism, AZATHIOPRINE (IMURAN [AZATHIOPRINE]), FOLIC ACID from 2017 to an unknown date and MESALAMINE from 2017 to an unknown date for Ulcerative colitis, BIOTIN, VITAMIN E NOS, UBIDECARENONE (COQ10 [UBIDECARENONE]), ACETYLSALICYLIC ACID (ASPIRIN 81), COD LIVER OIL [COD-LIVER OIL], VITAMIN D3, MAGNESIUM and PROBIOTICS NOS for an unknown indication.   On 21-Jan-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 10:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and PAIN (Body aches). On 03-Mar-2021, the patient experienced BALANCE DISORDER (stepping backwards). On an unknown date, the patient experienced TINNITUS (Worsened tinnitus), MALAISE (Fell ill), HYPOACUSIS (Hearing is pertinently impacted) and GAIT DISTURBANCE (I am unsteady). On 22-Feb-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) and PAIN (Body aches) had resolved. At the time of the report, TINNITUS (Worsened tinnitus) and BALANCE DISORDER (stepping backwards) had not resolved, MALAISE (Fell ill) had resolved and HYPOACUSIS (Hearing is pertinently impacted) and GAIT DISTURBANCE (I am unsteady) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 100-101 (High) body temperature 100-101 degrees.         No treatment related information has been reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Sig followup - Reporter's contact details updated i.e. email address. Patients demographics added, race and ethnicity updated, relevant medical history updated, Concomitant products added, Vaccine facility information updated, New events added, Narrative regenerated.
Seizure 11/1/10. Seizure 11/27/10 - Hospitalized 11/26-11/29. Repeat seizure 12/8/10.
Couple of minutes after injection flushing, complaining about closed throat feeling, difficulty breathing/stridor. Nurse left room, instructed to call EMS and doctor was called in. Doctor administered 1ml 1mg/ml Epinephrine. Immediate response regression of symptoms. Squad took patient to ER when they arrived. ER administered Famotidine IVPB 20mg, Methylprednisolone, Diphenhydramine 25mg inj, patient to continue prednisone 2 days. Scheduled office visit 12/27/17 for follow-up and to complete annual.
lt side numbness w/o other signs or sx;pt had never had flus hot until 1977 (this was second);pt still has numbness sin hand & face (12 days);pt had lt side face & tongue numbness, lt hadn't from wrist down;
Patient has a localized injection site reaction (redness and edema).; Patient has a localized injection site reaction (redness and edema).; A COVID-19 vaccine is given subcutaneous and not intramuscular as recommended.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) subcutaneous for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE EDEMA (non-serious), outcome "unknown" and all described as "Patient has a localized injection site reaction (redness and edema)."; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "A COVID-19 vaccine is given subcutaneous and not intramuscular as recommended.".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extended interval between dose 1 & 2; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Extended interval between dose 1 & 2) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 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 experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Extended interval between dose 1 & 2). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Extended interval between dose 1 & 2) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
She had covid once in Jan2023; She had covid once in Jan2023; Dose 1/Dose 2/ Dose 3: Moderna Covid-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Lot number: 6H9703) at the age of 68 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Jun2022 as dose 4 (booster), single (Lot number: FM7553) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Dec2020 as dose 1, single (Batch/Lot number: unknown), on 21Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Jun2022, outcome "unknown", described as "Dose 1/Dose 2/ Dose 3: Moderna Covid-19 Vaccine"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "She had covid once in Jan2023". Clinical course: She had COVID once in Jan2023. Had no symptoms and was able to continue working. Felt a little tired maybe, but had no symptoms. Vaccination Facility Type: Pharmacy, Prior Vaccinations (within 4 weeks): None. Family Medical History Relevant to Adverse Events (AEs): None and relevant Tests: None.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300254758 Same patient, different event/dose;
No adverse event experienced, however, the vaccine was inadvertently administered on 09/13/2021 when the vaccine expired on 09/11/2021.