chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (blood pressure that is controlled.). Concomitant products included METOPROLOL and ATORVASTATIN for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported by the reporter.   This case was linked to MOD-2021-384436 (Patient Link).
3-5 minutes after vaccine administration, patient starting seizing (eyes rolled back, arms jerked rhythmically). This lasted approximately 1 minute. 2-3 minutes later, he started seizing again, which lasted 30-40 seconds.
This case was reported by a consumer via call center representative and described the occurrence of shivering in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 16th July 2018 13:30, the patient received the 2nd dose of SHINGRIX. On 17th July 2018, 1 days after receiving SHINGRIX, the patient experienced shivering, fever, worn out and feeling cold. On an unknown date, the outcome of the shivering and feeling cold were recovered/resolved and the outcome of the fever and worn out were not recovered/not resolved. It was unknown if the reporter considered the shivering, fever, worn out and feeling cold to be related to SHINGRIX. Additional details were provided as follows: The patient was the reporter. The patient experienced could not get warm and a wiped out feeling the morning.
Injection into left deltoid. 1min later felt "aura" (muscle weakening, light headed). Took two pumps of rescue inhaler and took out Epi Pen. 2 Mins later: called for help, nurse gave patient provided EpiPen (I was shaking too much to inject myself), additional Epi from crash cart, non rebreather O2. Symptoms included: convulsions; dizziness; bronchospasms; throat closure; difficulty breathing; dry heaving.
ACUTE RESPIRATORY FAILURE 2/24/2023 SYNCOPE HYPOXIA 2/25/2023 SYNCOPE ACUTE RESPIRATORY FAILURE 2/24/2023 CHRONIC DVT OF LEFT INTERNAL JUGULAR VEIN HYPOXIA 2/25/2023 CHRONIC DVT OF LEFT INTERNAL JUGULAR VEIN ACUTE RESPIRATORY FAILURE 2/24/2023 SYNCOPE HYPOXIA 2/25/2023 SYNCOPE ACUTE RESPIRATORY FAILURE 2/24/2023 FAILURE TO THRIVE SYNDROME, ADULT HYPOXIA 2/25/2023 FAILURE TO THRIVE SYNDROME, ADULT ACUTE RESPIRATORY FAILURE 2/24/2023 LARYNGEAL CANCER, SUPRAGLOTTIS HYPOXIA 2/25/2023 LARYNGEAL CANCER, SUPRAGLOTTIS ACUTE RESPIRATORY FAILURE 2/24/2023 LARYNGEAL CANCER, SUPRAGLOTTIS HYPOXIA 2/25/2023 LARYNGEAL CANCER, SUPRAGLOTTIS ACUTE RESPIRATORY FAILURE 2/24/2023 SYNCOPE HYPOXIA 2/25/2023 SYNCOPE
PATIENT WITH SEVERE LOCAL REACTION ON LEFT GLUTEUS  POST MMR VACCINE, DURATION 1 MONTH.
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received from a contactable Pharmacist. This Pharmacist reported for a male patient via medical information team. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 03Mar2021 as dose 1, single  for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the reporter was a pharmacist and stated he had patient who received his first dose of the Pfizer COVID-19 on 03March2021 and when it was time to get his second dose, he tested positive for COIVD-19 and was advised to wait 3 months before getting his second dose. The reporter would like to know how to proceed and can the patient receive the second dose of the vaccine. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unknown date in 2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the reported events and the suspect drug BNT162B2 cannot be excluded.
Sore arm; mild nausea; mild headache; low grade fever; an odd red mark on my left shoulder about 2 or 3 inches from the injection site; This is a spontaneous report from a contactable consumer (reporting for herself). A non-pregnant 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), via an unspecified route of administration in the left arm on to 14Jan2021 07:15 at a single dose for COVID-19 immunization.  Medical history included asthma, chronic obstructive pulmonary disease (COPD), known allergies: animals.  Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast sodium (SINGULAIR), lorazepam (ATIVAN), biotin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN).  The patient previously received a typhoid shot (MANUFACTURER UNKNOWN), for immunization and had very adverse reaction to third typhoid shot.  The patient experienced sore arm, mild nausea, mild headache and low-grade fever and an odd red mark on left shoulder about 2 or 3 inches from the injection site on 14Jan2021 21:00.  No treatment was received for the events.  The outcome of the events was recovering.
right sided facial palsy, consistent with Bell's palsy, grade 3 treatment with prednisone and valacyclovir for 7 days with improvement to grade 2 by 1 week
This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On 10-MAY-2017, the patient was inadvertently vaccinated with a dose of GARDASIL after its labeled expiration date (which had the lot # K010215, expiration date 05-MAY-2017) (dosage information, route and anatomical site of vaccination were not informed) for prophylaxis . Information regarding concomitant medication was not provided. No adverse effects were reported in the patient. Additional information has been requested.
Information has been received from a physician concerning a 10 year old male patient with no known drug reactions/allergies who on 28-JUN-2008 was vaccinated with a dose of VAQTA inactivated (manufacturer unspecified) and on 02-FEB-2010 was vaccinated with a pediatric dose of 0.5 ml of VAQTA inactivated intramuscularly (Lot # 665164/1100Y). It was reported that on 22-FEB-2010, the patient was seen at the office and he was lethargic, had abdominal pain, fever and was not jaundiced. On the same date, 22-FEB-2010, a serum hepatitis A antibody test was performed and the result was positive. At the time of the report the patient's outcome was not specified. Additional information has been requested.
The pt experienced fussiness, fever and vomiting. then the pt experienced a rash on the face, neck, and trunk and body. No known exposure to chicken  pox.
There was an excursion from the freezer; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported.On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 12-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medication information was reported.No Treatment medications were provided. There was an excursion from their freezer on 01Oct2021.This case was linked to -MODERNATX, INC.-MOD-2021-387730, -MODERNATX, INC.-MOD-2021-387762 (E2B Linked Report). This case was linked to MOD-2021-383439, MOD-2021-387536, MOD-2021-387782, MOD-2021-387795, MOD-2021-387929 (Patient Link); Sender's Comments: -MODERNATX, INC.-MOD-2021-387762:MASTER FILE. US-MODERNATX, INC.-MOD-2021-387730:MASTER FILE.
expired Bexsero administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 4th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 04-AUG-2022 Reporter's Comment: The reporter was a pharmacy intern. The reporter reported that the patient was received expired Bexsero vaccine. The reporter did not had the patients gender, date of birth and the lot at the time of report. The reporter did consent to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
After approximatley 4 hours after vaccination, pt. c/o of chest tightness.  Pt. self administered epinephrine injection and later took benadryl.  She stated she was fine after the treatments. (pt. is allergic to Bee Stings therefore she carrys epinephrine injections in case of an emergency).
Lump the size of a small chicken egg Throbbing pain in armpit Boby aches
Several hours after receiving the vaccine I started to break out in hives and felt incredibly fatigued. Symptoms gradually improved over the next two days. Last night the vaccine injection site became hot, swollen, and incredibly itchy. Symptoms have not worsened but have not improved since taking 50mg of Benadryl at 3:30 PM today
tired; Body aches; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to the company on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired), MYALGIA (Body aches) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced FATIGUE (tired), MYALGIA (Body aches) and PYREXIA (Fever). At the time of the report, FATIGUE (tired), MYALGIA (Body aches) and PYREXIA (Fever) outcome was unknown.            No concomitant medication were reported No treatment medication were reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
Lethargy, inc temp, no appetite presented to hosp ER 22JUL91 admitted x 72 hrs; mom did not report rxn until immun of 14JAN92;
Approximately 30 mins post vaccine patients left hand ring finger began to be painful and a hematoma began to form. Patient Hx of Factor v Leiden. Patient felt lightheaded and dizzy. Patients hands were turning blue hue while in the ED triage. Color of hands resolved, but still has a noted hematoma to ring finger.
Shingles; Rash/red spots shortly after the vaccine and then got them on his chest; Allergic reaction to an influenza vaccine; This spontaneous case was received on 08-Nov-2021 from other non-health professional (consumer) via Agency (reference number: SEQW21-05187) and concerned a 55-year-old male patient.  The patient's concurrent condition included diabetic and high blood pressure. The patient's concomitant medications included Metformin (metformin hydrochloride), Diltiazem (diltiazem hydrochloride), glimepiride, all for unknown indication, and unspecified blood pressure medication.  On an unspecified date in Oct-2020, the patient was vaccinated with Afluria Tetra (brand name unknown; dose, route of administration, indication and anatomical location: not reported). The batch number was not reported.   On an unspecified date in Oct-2020, an unknown amount of time after vaccination, the patient developed red spots (bumps) on his right arm, the outside and inside of his bicep as well as on the right side of his chest and hands. As reported, the rash subsided after three weeks. The patient sent pictures to doctor and then was advised to take Benadryl (diphenhydramine hydrochloride).   On an unspecified date in 2020, the patient recovered from the event rash.  On an unspecified date, later in the year after, the patient was vaccinated with non-company co-suspect Covid shot (brand name unknown), and the patient looked like something like shingles, as reported.  The outcome of the events 'allergic reaction NOS' and shingles was not reported.  The reported did not provide causality assessment.  Company comment: A 55-year-old male patient developed rash after vaccination with Afluria Tetra. Posteriorly, after receiving non-company co-suspect Covid-19 vaccine, the patient developed something like shingles. Besides, the patient developed an allergic reaction. Time elapsed between vaccination with the suspect product and the onset of the events is unknown. Due to this lack of information regarding chronology, causality for the reported events is unassessable.; Sender's Comments: A 55-year-old male patient developed rash after vaccination with Afluria Tetra. Posteriorly, after receiving non-company co-suspect Covid-19 vaccine, the patient developed something like shingles. Besides, the patient developed an allergic reaction. Time elapsed between vaccination with the suspect product and the onset of the events is unknown. Due to this lack of information regarding chronology, causality for the reported events is unassessable.
I started having pain in my underarm and on my side of my left breast not really swollen but a lot of pain. Pain is mostly around my rib cage on my left side, like a constant ache but sometimes sharp.
doesn't hurt but can feel it; large pink area/feeling like a pressure; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (doesn't hurt but can feel it) and VACCINATION SITE PAIN (large pink area/feeling like a pressure) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced FEELING ABNORMAL (doesn't hurt but can feel it) and VACCINATION SITE PAIN (large pink area/feeling like a pressure). At the time of the report, FEELING ABNORMAL (doesn't hurt but can feel it) and VACCINATION SITE PAIN (large pink area/feeling like a pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Follow-up information received on 09-MAY-2021 contains no new information.
12 hours after injection, leg pain, fever. 24 hours later, pain thigh, refusing to walk. 48 hours, redness, tachycardia.  Received medical record which revealed a 4 yr old with c/o leg pain, fever, refusal to walk, redness and tachycardia beginning 12 hours after Pneumococcal vaccine. Pneumovax and Flu given on October 18, 2006.  The following day he developed a  fever (102') and chills and c/o thigh pain at the pneumovax site which prevented him from bearing weight. Admitted to hospital with DX: of Left Thigh Cellulitis and high fever, sepsis.  Discharge 10/22/06 on 2 antibiotics with DX: Leg cellulitis or immune reaction to injection. F/U on 10/25/06 reveals pt. walking better with DX Immune reaction to pneumo vaccine.   Follow-up states - patient recovered.
rash on her right leg below the knee; hives on her right leg below the knee; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on her right leg below the knee) and URTICARIA (hives on her right leg below the knee) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. OV1B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-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 RASH (rash on her right leg below the knee) and URTICARIA (hives on her right leg below the knee). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (rash on her right leg below the knee) and URTICARIA (hives on her right leg below the knee) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Pt    reports   pain/aches,   fever (~101.5 F) , malaise referred to MD
A week after the vaccine I had pain in my arm and it lasted 1 month and it went away on its own. I couldn't work or move. Now the pain has returned, but stronger. I am taking pain pills (Naproxen).
Deep vein thrombosis. It started Friday night (10/9/2020) with leg pain (felt like a charley horse) in lower right leg muscle. Continued through the weekend.
18 yo patient received Engerix-B 1 ml dose; 18 yo patient received Engerix-B 1 ml dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 18-year-old patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B 1 ml. On an unknown date, unknown after receiving Engerix B, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK receipt date: 2-Aug-2022 Reporter's comment: The nurse reported that they had a patient that received 1ml of Engerix-B dose but the insurance rejected because of the age. The reporter did not consent to follow-up. The case was linked with case US2022AMR114586, reported by same reporter. Additional supportive information: The patient received 1ml dose of Engerix-B, which led to overdose and adult product administered to child. As per local schedule, 1ml dose was administered to adult patient and if check it out the patient was 18 years old and above 19 years patient was considered for adult dose as per schedule, therefore adult product administered to child was coded as event.; Sender's Comments:  US-GSK-US2022AMR114586:Same reporter
Information has been received from a health care worker concerning unspecified number of patients, who on unspecified dates were vaccinated with the second dose of GARDASIL (Lot # not reported) late. No adverse reactions were reported. Attempts are being made to obtain additional information to distinguish individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
See attached forms: DD Form 2766C Vaccine Administration Record. Standard Form 600 Health Record Chronological Record of Medical Care.
Chills, arm pain (@ injection site), tiredness, nausea during the first few days after vaccination then resolved but today 2/22/21 all symptoms returned-except arm pain.
rt arm very sore starting early AM 25OCT97 progressed to shoulders across back to lt arm;chills on Saturday;Sunday pain under rt arm until Wednesday;
Initial unsolicited report received from a non health care professional on 07 Oct 2016. This case involves a 62-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose and site was not reported) on an unspecified date. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and concomitant medications was not reported. On an unspecified date, within two hours post vaccination, the patients had experienced headache (reported as continue to today 07 Oct 2016). On an unspecified date following the vaccination, the patient had extremely painful arm and also had bruise. Lab data and corrective treatment was not reported. Patient's event outcome was reported as unknown. List of documents held by sender: none.
SYMPTOMS OF COVID-19; This spontaneous report received from a consumer concerned a 29 year old female. The patient's weight was 165 pounds, and height was 65 inches. The patient's concurrent conditions included: alcohol non-user, and non smoker, and other pre-existing medical conditions included: The patient did not have any drug abuse/illicit drug use. The patient experienced drug allergy when treated with amoxicillin, and clarithromycin for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A and expiry: unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-AUG-2021, the patient experienced symptoms of covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from symptoms of covid-19. This report was non-serious.
Initial report received from physician on 29 Dec 2009: This patient was vaccinated with FLUVIRIN, intramuscular on unknown date. Approximately 2 weeks ago (approximately 15 Dec 2009), a 3.5 years old boy received one dose of the FLUVIRIN vaccine. The vaccine was injected into the deltoid. No adverse effect were noted after administration. The outcome of event was not reported.