chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gave a patient typhim that expired 3 weeks ago,with no reported adverse event; Initial information received on 07-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Adult male patient who was administered typhim that expired 3 weeks ago and experienced no adverse event after receiving vaccine Typhoid VI Polysaccharide Vaccine (Typhim VI).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A Vaccine (Hepatitis A Vaccine); Hepatitis B Vaccine (Hepatitis B Vaccine), Tetanus Vaccine (Tetanus Vaccine) and yellow fever vaccine live (Yellow fever vaccine live) for prophylactic vaccination.  On 07-Oct-2022, the patient received a dose of suspect typhoid VI polysaccharide vaccine (lot T1E371M, expiry date 14-Sep-2022, administration site unknown) via intramuscular route for immunization.  On 07-Oct-2022 the patient experienced a non-serious gave a patient typhim that expired 3 weeks ago, with no reported adverse event (expired product administered)(latency same day) following the administration of typhoid VI polysaccharide vaccine.  Action taken: Not Applicable.  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 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.; Sender's Comments:  01312671:
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (005570). A male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had a rash, with outcome of unknown. Therapeutic measures were taken as a result of rash. Additional information: His dermatologist provided him with treatment regarding the rash; however he wondered how do we cure a long-term drug rash from the Pfizer COVID-19 vaccine. The batch/lot number for the vaccine, BNT162B2, not provided and will be requested during follow-up.
Bradycardia  (so bad turned blue), small red bumps all over face, swelling in face, fever, redness/splotty, and weakness.
Narrative:  COVID infection after COVID vaccine series 12/31/20 COVID vaccine dose #1 01/21/21 COVID vaccine dose #2 11/29/21 Seen in outside ED s/p fall with laceration 12/03/21 calls facility to report "he had a flu shot and since that he is weak and out of it;" reports fever of 102, c/o weak and lethargic, admitted to outside hospital, COVID hospital, COVID positive, no pneumonia 12/07/21 discharge from outside hospital 12/11/21 cough is resolved, fatigue improved, myalgia resolved, rhinorrhea improved, sore throat persists 12/10/21 COVID positive
Moderna COVID-19 Vaccine EUA. I had flu like symptoms for about 24 hours, headache, chills the 1st night, and pain in arm. But after that I started sneezing, and have a running nose. I dont have any other symptoms, just these too.
History of syncope and grand mal seizure 1 hr after influenza vaccine. Seen at hospital. Had complete recovery. Seen in office 48hr after. Asymptomatic normal physical.
04/10/23 presents to EC ED for "chest pain, nausea, vomiting". PMHx of "GERD, hypothyroidism, and migraines"
I had the second dose of my Moderna vaccine yesterday (first dose in January 2021).; I am 7 months pregnant.; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I had the second dose of my Moderna vaccine yesterday (first dose in January 2021).) and MATERNAL EXPOSURE DURING PREGNANCY (I am 7 months pregnant.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In August 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I had the second dose of my Moderna vaccine yesterday (first dose in January 2021).) and MATERNAL EXPOSURE DURING PREGNANCY (I am 7 months pregnant.). In August 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I had the second dose of my Moderna vaccine yesterday (first dose in January 2021).) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (I am 7 months pregnant.) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.
cold chills, low back pain, trouble sleeping, injection site pain, migraine, fever starting at 99.8 in pm and 101.7 in the AM.
Patient's right arm swelled up so large she could not use her hand to write or for daily function/activity; was admitted to the hospital for 6 days; fluid removed, antibiotics and steroids given and tests/exams run
Mild stroke about 9am. Fell on floor, needed help to stand up and walk, garbled speech, headache, temp. 98.0, 98.2, 98/3; not swallowing food, couldn't handle food. Could not hold cracker, bread or find mouth with hand. needed help to go  to bathroom, couldn't answer telephone, was dizzy, couldn't balance herself,  she fell 3 times on Feb. 3,  I took the top off a water bottle and handed it to her she kept trying to unscrew the lid even after I showed her I had the lid in my hand.  Feb. 4 she had the dry heaves all morning, she slept all afternoon.  I called the doctors office @ 8:00am and again later @ 8:30am.  He said he wanted her to have a CAT scan Medical Center. He said they would call
45 woman with depression, presented to ED on 8/29/21 with symptoms of  congestion, loss of sense of taste and smell starting on 8/25.she later developed mild shortness of breath, worse with exertion and  had adry cough but no fevers.  Had J&J vaccine 4/2021.  Patient tested COVID positive and came to ED, while in ED, desat to 91 while doing squats in her room and later 88% when walking and was admitted and started on decadron and remdesivir.  She received a few days of decadron and remdesivir, her CRP normalized, her DDimer remained normal.  She was only hypoxic with activity and the hypoxia resolved in about 2 days but she continued to have some symptoms of DOE and chest congestion or pressure.  She was monitored another day and was tried on an albuterol inhaler which significantly helped her chest symptoms.  On the day of discharge, her O2 sat was 97 on RA and she feels overall improved.     She is not continued on steroids since her hypoxia has fully resolved.  She is instructed to monitor her O2 sats at home and isolate.  She is ordered for a prn albuterol inhaler for home.
This case was reported by a pharmacy via a pharmacy claims management company and described the occurrence of adverse reaction in a subject of unspecified age and gender who was vaccinated with FLUARIX Quadrivalent (GlaxoSmithKline). On 29 January 2014 the subject received a dose of FLUARIX Quadrivalent (unknown). On an unspecified date in 2014, within months of vaccination with FLUARIX Quadrivalent, the subject experienced adverse reaction. At the time of reporting the outcome of the event was unspecified.
Patient developed allegic hives in the hours following the administration of Hep A#2 and Varicella #2 (the third allergic-type reaction to that combo in our office this year)
Patient was given the wrong vaccines at the wrong time. Pt received PEDIARIX, PREVNAR and FLUZONE on 2/1/18. Pt had already received PEDIARIX and PREVNAR on 1/18/18. Pt did not display any adverse reaction on 2/1/18 or 2/2/18.
Physician notified on patient was not taking anything orally, lethargic, and very weak. She was sent to the hospital as these symptoms started within 12 hours of vaccine. She was admitted to the hospital with bilateral pneumonia. She is still hospitalized at this time.  Patient admitted to Hospital
No adverse effects were reported.; one dose of expired ROTATEQ (lot N030176 exp 6/17/2019) was inadvertently administered on 7/12/2019 to the patient; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.    On 12-JUL-2019, one dose of expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot N030176, expiration date 17-JUN-2019) was inadvertently administered to the patient. No adverse effects were reported.
Smelling smoky smells; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Smelling smoky smells) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historical condition reported).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAROSMIA (Smelling smoky smells). At the time of the report, PAROSMIA (Smelling smoky smells) outcome was unknown.
Made me sick for 2 weeks; Initial information received on 30-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who after treatment with influenza vaccine reported it made me sick for 2 weeks.     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 dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dose, lot number not reported) via an unknown route in an unknown administration site as prophylactic vaccination.  On an unknown date, the patient reported it made me sick for 2 weeks (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event made me sick for 2 weeks.
Several drops were seen rolling down the patient's arm, no AE; while pushing down on the plunger, about less than half came dripping down the patient's arm, no AE; while pushing down on the plunger, about less than half came dripping down the patient's arm, no AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 69 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE], lot no.: UJ292AA, expiry date: 10-Jun-2020, via unknown route in the left arm.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to underdose.  Also a case of exposure via skin contact and syringe leakage. It was reported that Pharmacist administered the vaccine into the muscle a large amount came out maybe about less than half came dripping down patients arm. while she was pushing down on the plunger, several drops were seen rolling down the patient's arm.  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.
PATIENT REPORTED DIZZINESS, LIGHTHEADEDNESS, NAUSEA W/O VOMITING, COLD SWEATS. LEGS WERE ELEVATED, CHECKED VITAL SIGNES (ALL NORAL RANGE), WATER GIVEN TO DRINK. PATIENT WAS SUPERVISED TO 15 MIN AFTER VACCINE ADMINISTRATION. PATIENT RECOVERED AND WENT HOME AFTER.
Patient reported tingling left side of tongue.  Paramedic notified for assessment. Symptoms resolved without intervention. Paramedic supervision continued during time in observation room. Pt left building at 17:45. VS stable;  BP 179/100;  P 100;  RR 14;  Pulse Ox 98% in RA. No medical intervention required.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-395985 (Patient Link).
No additional AE; patient who is 18 years old received a dose of PROQUAD yesterday, May 18, 2022; patient received their second dose of MMR on April 7, 2008 followed by their second dose of VARIVAX that was administered on April 16, 2008; a patient was administered their first dose of MMR on April 16, 2005 and their first dose of VARIVAX on April 27, 2005; This spontaneous report was received from a medical assistant and concerns an 18-year-old patient of an unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 16-APR-2005, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) subcutaneous injection (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis.   On 27-APR-2005, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration).  On 07-APR-2008, the patient was vaccinated with the second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) subcutaneous injection (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis.   On 16-APR-2008, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). The healthcare professional (HCP) was aware that the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) were administered less than one month apart from each other.  On 18-MAY-2022, the patient (who was 18-year-old at the time) was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection, lot number: U029296, expiration date 19-MAR-2023 (dose, route and site of administration were not reported) for prophylaxis (product administered to patient of inappropriate age) which was reconstituted by a sterile diluent. No additional adverse events were reported (no adverse event).
5 hours after vaccination, I started feeling dizzy and nausea at the same time. It came quickly, and I needed to lay down. I couldnt even talk, it was very stressful. I couldnt have gotten in the car to go to the doctor for about 2 hours. My husband brought me some water. I couldnt vomit, i felt like I had to. I had a small bowel movement, and I drinked a little water, and I started to feel better. This morning, I had a hangover feeling and I am able to function a little. I never had this happened before, so I thought I report it.  note: I have not been to the hospital or ER , or pcp for any of my adverse events.
Patient hospitalized for diarrhea, mucinous adenocarcinoma within 6 weeks of receiving covid vaccination. Patient died on 2/27/22.
Strong joint pain in right arm at the elbow, upper shoulder blade and collarbone.; Pain has subsided, but still feeling the effects; unable to lie down on my right side or lift/carry light; This is a spontaneous report from a contactable consumer and other non-health care professional. A 68-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER2613, Expiry date not reported) via an unspecified route of administration, administered in right arm on 03Apr2021 at 12:15 (at age of 68-years-old) as dose 2, single for COVID-19 immunisation. Medical history include Spinal osteoarthritis and Covid-19. There are no known allergies. Patient did not receive any other medication within two weeks. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,Solution for injection, Lot Number: EN6199, Expiry date not reported) via an unspecified route of administration, administered in Right arm on 13Mar2021 (at age of 68-years-old) as single dose for COVID-19 immunisation. On 06May2021 at 05:00 (1 month 2 days 16 hrs 45 min after vaccination), Patient experienced strong joint pain in right arm at the elbow, upper shoulder blade and collarbone. Pain has subsided, but still feeling the effects. I am unable to lie down on my right side or lift/carry light items. If I do, I experience the pain. Patient did not receive any treatment for the events. The Outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
On 9th day: Stiff neck, sore throat, body aches, pain and tenderness in left wrist and near left knee  On 1st and 2 day: Fever and fatigue  On 3rd or 4th day onwards: pain and tenderness in armpit which started to decrease after 2 days
a leakage at her injection site occurred where she noticed that a clear liquid with blood leaked and dripped down her arm at about 5 inches; a leakage at her injection site occurred where she noticed that a clear liquid with blood leaked and dripped down her arm at about 5 inches; This is a spontaneous report from a contactable consumer (Caregiver). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on Mar2021 as SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On Mar2021, the patient experienced a leakage at her injection site occurred where she noticed that a clear liquid with blood leaked and dripped down her arm at about 5 inches. The seriousness reported as non-serious. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Patient mistakenly received a COVID Moderna vaccine which is not approved for 12 year olds.  Should have received Pfizer.  No adverse reactions noted.  Followed up with patient's Mother the next day and pt continued to do fine.  Scheduled for a Pfizer for his 2nd dose 30 days after initial dose.
fatigue; felt like she was going to have a stroke; hives; two seizures; rash from head to toe; wrap around headache; sore muscles; This is a spontaneous report from a contactable other healthcare professional (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6208), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history included seizure, high blood pressure, and atrial fibrillation with rapid ventricular response on 03Feb2021, all ongoing. The patient's concomitant medications included metoprolol tartrate (LOPRESSOR) taken for blood pressure measurement, lisinopril taken for an unspecified indication, valproate semisodium (DEPAKOTE) taken for seizure from 2017 to an unspecified stop date, and hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) taken for an unspecified indication. The patient experienced two seizures on 27Mar2021. Patient felt like she was going to have a stroke on an unspecified date. The patient experienced hives on 27Mar2021, fatigue on an unspecified date, rash from head to toe on 27Mar2021, wrap around headache on 26Mar2021, and sore muscles on 26Mar2021. The outcome of the events wrap around headache and sore muscles was recovered on 28Mar2021, for hives and rash from head to toe was recovering, and the outcome of the rest of the events was unknown. Events relatedness was reported as related.; Sender's Comments: Other than a close temporal association, there was no other evidence or argument in support to causality for BNT162B2 in the serious events, Seizure and Cerebrovascular accident. Seizure was consistent with underlying medical condition, still on treatment with VALPROATE SEMISODIUM. Chronic hypertension may have increased the risk of vascular accident, despite the poly-medication with different type of antihypertensive agents. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.     No treatment medications were reported.