chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was reported that a 49 year old male received Fluzone 98-99. Reportedly sometime after the vax, the pt experienced systemic reactions of headache, general malaise, fever, and myalgia. From additional information received on 11/3/98 it was reported that the pt also experienced hoarseness and cough lasting 48 hours. Reportedly the pt recovered from this experience.
Information has been received from an office manager concerning a 6 year old female patient with asthma, no drug reactions/allergies, not immunocompromised, who on 13-OCT-2008 was vaccinated with intramuscularly with a 0.5 mL dose of PNEUMOVAX vaccine because according to the physician had risk of developing pneumonia. There was no concomitant medication. On 15-OCT-2008 the patient developed swelling, warmth and tenderness at the injection site of the left deltoid. The patient was seen in the office on 15-OCT-2008 and was prescribed OMNICEF. The patient had recovered. This is one case of several cases from the same source. Additional information has been requested.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a female patient of an unknown age (gravida 1) 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) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment medication information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received on 02-JUL-2021 and contains no new information.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this unidentified female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 23-May-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.
started with a cough, chills, headache came on around 9pm. left arm pain came on overnight, felt like it was broken but went away the next day. headache all day and cough worsening, heavy chest, felt like a filter in my chest and exhaustion.  albuterol inhaler, then Symbicort inhaler, then prednisone taper. took a month to feel better.  exhaustion , cough an breathing lasted 4 weeks.
I received the 1st booster on 10/30/2021. My adverse event started on 04/19/2022. I had sore throat and unproductive cough. I took 3 home test on 19/20/21 all came back negative. I tested positive on 04/24/2022. I am dealing with sinus infection and secondary infection after the booster. I went to my doctor who then prescribed me antibiotics.
Itching; Swelling; Redness; Bruising all over body, bruising on both ankles; Gums would bleed when she brushed her teeth; could not walk; Pain in tendons and ligaments in both feet, it felt like she tore her tendons and ligaments; Serious muscle and joint pain; Serious muscle and joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), SWELLING (Swelling), ERYTHEMA (Redness), CONTUSION (Bruising all over body, bruising on both ankles) and GINGIVAL BLEEDING (Gums would bleed when she brushed her teeth) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: Tetanus (Anaphylactic reaction). Concurrent medical conditions included Autoimmune disorder, Neurological disorder NOS, Gastrointestinal infection, Ulcer and Acid reflux (oesophageal). Concomitant products included FIDAXOMICIN (DIFICID) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PRURITUS (Itching), SWELLING (Swelling), ERYTHEMA (Redness), CONTUSION (Bruising all over body, bruising on both ankles), GINGIVAL BLEEDING (Gums would bleed when she brushed her teeth), GAIT INABILITY (could not walk), LIGAMENT PAIN (Pain in tendons and ligaments in both feet, it felt like she tore her tendons and ligaments), ARTHRALGIA (Serious muscle and joint pain) and MYALGIA (Serious muscle and joint pain). At the time of the report, PRURITUS (Itching), SWELLING (Swelling), ERYTHEMA (Redness), CONTUSION (Bruising all over body, bruising on both ankles), GINGIVAL BLEEDING (Gums would bleed when she brushed her teeth), GAIT INABILITY (could not walk), LIGAMENT PAIN (Pain in tendons and ligaments in both feet, it felt like she tore her tendons and ligaments), ARTHRALGIA (Serious muscle and joint pain) and MYALGIA (Serious muscle and joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medications included unspecified medicines for ulcer and acid reflux.   Treatment information was not provided.
After giving vaccines, pt looked pale and closed eyes,and slumped in chair. other nurse called in and and pt revived, pt felt nauseated and threw up. pt taked via wheelchair to exam table and laid down a few min, color came back to her lips and pt felt better. cold damp paper towels applied to neck and forehead. Pt given crackers and juice. no breakfast earlier. pt left feeling better no signs or symtoms and dad stated she would stay home and be watched today. no other complaits.
17 years old and was mistakenly given the Moderna vaccine; A spontaneous report was received from a consumer, concerning a 17 year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced product administered to patient of inappropriate age.  The patient's medical history was not provided. No concomitant medications were reported.  On 28 DEC 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown), in left non-dominant arm for prophylaxis of COVID-19 infection  Caregiver said that daughter got the vaccine at her workplace and now they refusing to give her the second dose because she is under 18 years old. The workplace had the second dose on 25Jan2021.  Action taken with second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event, product administered to patient of inappropriate age, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 17-year-old female who experienced nonserious unexpected event of Product administered to patient of inappropriate age for mRNA-1273 (lot # unknown) without associated adverse events.  The event occurred the same day as the first dose of mRNA-1273. Very limited information regarding this event has been provided at this time.  Further information has been requested.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On 03-APR-2012, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified). On 05-JUL-2012, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date, dose and route unspecified). On 30-AUG-2012, the patient was vaccinated with the third dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Patient describes left arm as being very sore and difficult to move. No longer constant pain, but unable to sleep comfortably. Patient states that she has a history of left shoulder injury. Has been using a heating pad. Advised to see personal MD
This report describes the occurrence of Lyme arthritis and/or Lyme disease in a 45 year old male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. The pt received injections of LYMErix on 4/2/99, 5/6/99 and 3/7/99 "according to the client." This represented an inappropriate schedule of drug administration, with LYMErix vaccinations given on a 0, 1, and 11 month schedule rather than the recommended 0, 1, and 12 month schedule. On 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "back pain and generalized joint pains." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited his employment options and opportunities." According to the attorney, the pt was under the care of a general practitioner, and received anti-inflammatory and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued through the litigation process and will be reported if obtained.
Swelling, redness, pain at site of injection (L deltoid/upper arm). 5 1/2cm down upper arm and 5 1/2. Ibuprofen 1 1/2 tsp Q 8 hours, Orapred 30mg x 5 d.
On Day 5: Left axillary lymphangitis: Redness, swelling, induration, heat, itching, pain in 6-inch diameter around smallpox vaccination site, and radiating to underderside of left arm.  Egg-sized lymph node swelling under left axilla.  No fever.  Mild fatigue.  Mild malaise.  Acute symptoms lasted 4 days.  Symptoms mostly subsided by Day 11.
According to mother on 3/5/08 evening, patient complained of nausea and was "exhausted".  The next morning, 3/6/08, he complained about a "very bad" headache and "very sore" arm.  Mom administered Ibuprofen on 3/6/06 & 3/7/08 for sypmtoms.  All sypmtoms resolved by 3/9/08. No hives, rashes, breathing difficulties, vomiting, loss of consciousness or swelling occured.  Mom reported to Health Department on 3/27/08.
Jittery, short of breath, and ?felt like my throat was closing? for 2 weeks after vaccination. States that shortness of breath has persisted for 3 weeks
Red area 6 cm at site of DTaP only.  Deltoid area and erythema and slight tenderness, slight edema. Treatment: Augmentin 600mg ES, 1 teaspoon per mouth
PATIENT EXPERIENCED INJECTION SITE REDNESS, SHORTNESS OF BREATH, AND CHEST PAIN AND WAS SEEN AT THE EMERGENCY DEPARTMENT.  REFERRED PATIENT TO SEE HEART DOCTOR AND ICE INJECTION SITE.
Pt recv vax on 1/26/99; on same day pt exp itching/ thick tongue & throat, vax site hot & erythemic w/ spasms
Swelling along roof of mouth and blisters/ulcers along the inside of the facial cheeks.
This spontaneous report was received from a licensed Practical Nurse refers to multiple patients of unknown age and gender. Concurrent conditions, medical history and concomitant therapies were not reported. Approximately in June 2016 (reported as "27-JUN-2016 or 28-JUN-2016"), the patients were vaccinated with improperly stored doses of (temperature: 28 F, time frame: 3 hours and 42 minutes) ROTATEQ (# lot L044476, expiry date 07-SEP-2017, dosing details not provided). No adverse effects were reported. Digital data logger was involved. There was no previous temperature excursion. No product quality issue was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Fever, NauseaVomiting, PAIN IN ARM, BITTER/TART THINGS PAINFUL IN MOUTH/PAROTID AREA Narrative:
Patient called into health department stating that within 30 minutes of taking influenza vaccination, developed hives.  RN who took call instructed to take Benadryl and call family MD.
Had a cold after first vaccine/ Reports a cold and took antibiotics, after the first vaccine; This is spontaneous report from contactable consumer (mother) reported for her daughter via medical information team.  A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration date: Unknown), via an unspecified route of administration on an unknown date as 1st dose, single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Consumer stated that her daughter has a cold, later reclarified as a common cold and had tested negative, later reclarified as tested negative for Covid. Consumer said that her daughter's doctor had started her on an antibiotic and last dose was finished today (on reported date). Consumer stated that she was also due for her second dose of vaccine today (on reported date) and wants to know whether it is alright for her to get the second vaccine. Consumer was with her daughter, was waiting to be called, to get the vaccine and clarified that her daughter's antibiotic was a Z-Pak. Consumer stated that her daughter did not get a cold until weeks after the first vaccine. Patient underwent lab test included SARS-CoV-2 test with result: Negative on an unknown date. The event was considered as non-serious by the reporter. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
This spontaneous case reported by a consumer, describes the occurrence of COVID-19 (positive for COVID-19) and inappropriate schedule of product administration (second dose may be greater than 36 days) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 040B21A) for COVID-19 immunization. No medical history reported. On Apr 7, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 29, 2021, patient had COVID-19 (positive for COVID-19). On an unknown date, patient experienced inappropriate schedule of product administration (second dose may be greater than 36 days). The patient treated with Tylenol (paracetamol), at an unspecified dose and frequency; and ibuprofen, at an unspecified dose and frequency. At the time of the report, COVID-19 (positive for COVID-19) and inappropriate schedule of product administration (second dose may be greater than 36 days) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medications not provided.
Itching; Round red rash at the injection site/ COVID arm; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE RASH (Round red rash at the injection site/ COVID arm) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE RASH (Round red rash at the injection site/ COVID arm). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itching). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Vaccination site rash and Vaccination site pruritus, at an unspecified dose and frequency and TRIAMCINOLONE for Vaccination site rash and Vaccination site pruritus, at an unspecified dose and frequency. On 21-Jan-2021, VACCINATION SITE RASH (Round red rash at the injection site/ COVID arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information not provided.     Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Updated patient demographics and reported COVID arm; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient called pharmacy on 7/2/2018 to report that she had a reaction to the SHINGRIX booster vaccine that she received on 6/29/2018. She stated that her arm had a very large red and raised area around the area where she received the injection almost immediately after receiving the vaccination. It was very sore to touch and was somewhat itchy. She described that it looked like someone punched her in the arm. She had no problems whatsoever with the first injection. She had already been taking a daily dose of CLARITIN for seasonal allergies. I advised her to take  BENADRYL to see if it would help with the reaction. I also told her that if the reaction got worse or did not improve in the next 24 hours to contact her physician.
Was shaking so bad; Nauseas; Fever up to 103.6F; Felt tired; Sore left arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore left arm), TREMOR (Was shaking so bad), NAUSEA (Nauseas), PYREXIA (Fever up to 103.6F) and FATIGUE (Felt tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included TRAMADOL for Arthritis, CLONAZEPAM for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm) and FATIGUE (Felt tired). On 07-Feb-2021, the patient experienced TREMOR (Was shaking so bad), NAUSEA (Nauseas) and PYREXIA (Fever up to 103.6F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore left arm), TREMOR (Was shaking so bad), NAUSEA (Nauseas), PYREXIA (Fever up to 103.6F) and FATIGUE (Felt tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 103.6f (Inconclusive) fever up to 103.6F.     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 further information is available; The patient second dose of VAQTA was 0.5ml when the patient was 19 years old; This spontaneous report was received from the administrator in the physician's office, concerning a 19-years-old female patient. The patient's concomitant medications, concurrent conditions, historical conditions, and drug allergies were not reported.   On 22-JUN-2020 (at the age of 17-years-old), the patient was vaccinated with first dose of hepatitis a vaccine, inactivated (VAQTA) prefilled syringe at the dose of 0.5 milliliter (ml); lot number S037574 has been validated to be a valid lot number, expiration date reported and validated as 10-APR-2021 (strength, route of administration, and anatomical location were not reported).   On 16-AUG-2021 (at the of 19-years-old), she received the second dose of hepatitis a vaccine, inactivated (VAQTA) prefilled syringe at the dose of 0.5 milliliter (ml); lot number T035721 has been verified to be a valid lot number, expiration date reported and validated as 15-APR-2022 (strength, route of administration, and anatomical location were not reported) (incorrect dose administered). No adverse event reported, nor product quality complain involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: S037574; expirationdate: 10-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Pfizer product on 12/30/2020 (at the Pharmacy), 01/20/2021 (at the Pharmacy) and 10/19/2021 at Clinic.   They were tested  via antigen test twice on 02/17/2022 at the long term care facility at which they were a resident. One result was positive and one was negative.  They died on 03/06/2022. COVID-19 is listed on the death certificate.
1st dose 18Jun2022, 2nd never; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 42-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received first dose on 18th June 2022 of batch number 4F3YY and expiry date 1st January 2023).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16-Dec-2022 Reporter's comment: The reporter consented to follow-up by postal. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Twinrix, which led to incomplete course of vaccination.