chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Inadvertently administered dose of the monovalent vaccines expiration date 13-Jul-2022 Date of administration of vaccine was 26-Jul-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the monovalent vaccines expiration date 13-Jul-2022 Date of administration of vaccine was 26-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 066F21A, 001A21A and 041L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the monovalent vaccines expiration date 13-Jul-2022 Date of administration of vaccine was 26-Jul-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the monovalent vaccines expiration date 13-Jul-2022 Date of administration of vaccine was 26-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the monovalent vaccines expiration date 13-Jul-2022 Date of administration of vaccine was 26-Jul-2022).    No concomitant product reported by reporter. It was reported that they inadvertently administered 51 doses of the monovalent vaccines of Lot number 004M21A, expiration date as 13-Jul-2022 and was administered on 26-Jul-2022 (40 doses), 04-Aug-2022 (1 dose), 19-Aug-2022 (1 dose), 30-Sep-2022 (1 dose). No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master Case
Dizziness; Headache; His son is still very ,very fatigued/feeling tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 33 year-old male patient received bnt162b2 (BNT162B2), administration date 27Apr2021 (Batch/Lot number: unknown) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mercury poisoning", start date: 2013 (unspecified if ongoing); "Chelation Therapy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 27Apr2021, outcome "not recovered", described as "His son is still very ,very fatigued/feeling tired"; DIZZINESS (non-serious), outcome "recovering", described as "Dizziness"; HEADACHE (non-serious), outcome "unknown", described as "Headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Minor was recieving vaccines, became lightheaded and had brief syncopal episode lasting approximatiley 30 seconds.  Minor sponteously woke, VSS after episode.
pt recv vax 21JUL98 & the next day devel an inj site rxn characterized by a 3inch by 4.5inch area of redness & induration @ the site of acel-immune administration;
Exhausted; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Exhausted) in an 80-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Exhausted). At the time of the report, FATIGUE (Exhausted) outcome was unknown. Not Provided           No relevant concomitant medications were reported.  No treatment information was provided.
8:30PM HEADACHE 1/6. 12:00AM 1/7 FEVER, CHILLS, HA, SORE THROAT, BODY ACHES. RESOLVED AT 9PM 1/7. Narrative:
Chills for a few hours. Fever reached a high of 102+ I think it finally broke and started coming down around 2-3 in the morning. Really sore neck muscles and muscles ached in back and legs as well. Very dehydrated from the fever I suppose so drank lots of water. Finally, the next morning around 9AM I did take some Ibuprofen for the still slight fever of only like around 99 and slight headache, maybe from dehydration. Slept most of the day after this and have been feeling fine since.
The morning after immunizations, he had a brief 5 second episode of pallor, shaking. Ok after 5 seconds. His temperature was 100F. He had a slight rash on legs increasing to his chest and all over on the same day. This lasted 5 days. Had pink spots with blisters.
ACUTE PULMONARY EDEMA  (Acute pulmonary edema, Acute pulmonary oedema)  FEVER  (Fever, Pyrexia) This spontaneous report received from a physician concerned a patient of unspecified age and unspecified sex.  The patient's weight, height, and medical history were not reported. The patient received JNJ78436735 (Ad26.COV2.S) (suspension for injection,  route of admin not reported,  batch number:  Unknown, expiry: UNKNOWN) dose was not reported,  administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. It was reported by HCP that the patient was admitted to hospital on MAR-2021, the patient experienced acute pulmonary edema with symptoms (shortness of breath(SOB) , questionable bloody sputum) and was intubated in emergency room (ER) where he developed troponin level of 65, ejection fraction of 30% baseline was 50 to 55%, and fever. Laboratory data included:  Body temperature 101.7 tympanic,  Echocardiogram ejection fraction of 30% baseline was 50 to 55%, and Troponin level of 65.  The  treatment of intubation was administered for acute pulmonary edema. The days of hospitalization was not known. The action taken with JNJ78436735  (Ad26.COV2.S)  was not applicable.  The outcome of the acute pulmonary edema and fever was not reported.  This report was serious  (Hospitalization Caused / Prolonged, and Life Threatening).
Have psoriasis and psroiatic arthritis. Have been on cimzia for 5 years. Psoriasis was well controlled. Had severe psoriasis flare. Psoriasis flare began after covid vaccine in September 2021. Improved then became severe spring of 2022. Doctor switched me to ilumya. Psoriasis has not improved. After first ilumya injection had severe anxiety and panic symptoms. Runny nose, sinus issues, diarrhea, night sweats, nightmares. Symptoms began 6 hours after injection and continue 3 weeks later
Meningococcal Conjugate, MCV4P and Meningococcal B, Recombinant. On the B side, large oval red "hot" spot. Painful, slightly raised bump
Lt. side facial palsy, treated with Valacyclovir 1gm x3 and prednisone 60mg/day for 10 days. Then Rt. side facial palsy on 02/01/2011, treated with Famcyclovir 500mg x3 and 80mg/day prednisone. then relapse on Rt side on 03/05/2011 also treated with Famcyclovir 500mg x3 and 80mg/day prednisone.
persistent nausea, h/a, intestinal pain & dizziness; 24DEC92 f/u final dx racoon bite, reaction to rabies prophylaxis; vax administered on 25AUG, 1SEP, 8SEP, 21SEP;
Pt reported that Monday 9/20 - 3 days after injection she began itching. She didn't notice hives until Tues 9/21 after getting out of shower. Today - Wed 9/22 hives are bigger - has some puffy and some pussy on back. Pt started BENADRYL at bedtime. Dr notified 9/22. Pt was started Prednisone 30mg daily for 4 days. Pt reported 9/24 hives had improved by yesterday evening - but awakened this AM with new breakout. To see allergist.
Patient received vaccine and waited 15 minutes  in waiting room. Had no signs of negative reaction. No issues have been reported since that date.
Information was received on 11-OCT-2016 from a nurse. She reported that an unknown number of patients, names and demographics unknown, were administered one or more Merck vaccines following a temperature excursion to 62.7 degrees Fahrenheit for 9.5 hours and 53.1 degrees Fahrenheit for 2 hours for refrigerated vaccines; and a freezer excursion of 37.2 degrees Fahrenheit for 9.5 hours and 22.1 degrees Fahrenheit for 2 hours and 30 minutes. On an unknown date VARIVAX (Lot # M006156, expiration date 05-FEB-2018) was administered (patient age and gender unknown). No adverse effects were reported. No other information was available. Additional information is not expected.
mom reports:child crawling or crying & suddenly would seem to lose consciousness;pt would go completely limp, eyes rolled back in sockets, became very pale & lips turned blue;w/in 15-20seconds would become conscious w/blank stare
patient received her J & J covid-19 vaccine on 3/14/21.  She is a Pennsylvania school teacher, on 3/15/21 she developed a fever of 105F, headache, body aches, and vomiting.  She was seen in the ED and d/c to home without labs.  On 3/27/21 she started with unexplained bruising.  Was seen by PCP 4/12/21 for unexplained bruising throughout her entire body and dizziness and CBC revealed a platelet count of 5,000.  Patient was immediately advised to go to the ER for further evaluation of her symptoms.
Chills; Blue lips; Fever; Lots of shaking; Headache; Dizziness; Nausea; Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Apr2021 at 08:15 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC) from an unknown start date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;  Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Mar2021 at 08:15 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 20:00, the patient experienced fever, chills with lots of shaking, blue lips, headache, dizziness, nausea and exhaustion. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fever, chills with lots of shaking, blue lips, headache, dizziness, nausea and exhaustion was not resolved at the time of reporting.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented to emergency department on 12/3/2021 after getting positive COVID-19 test result earlier that day. He was shortness of breath, fevers, chills, nausea/vomiting, and loss of appetite. He was admitted for further management. He was treated with supplemental oxygen and dexamethasone. He was discharged home on 12/5/2021.
Patient complained about SOB, stridor and feeling of airway obstruction. Patient said she took her Albuterol inhaler right after she started feeling the SOB. Called 911 and arrived @ 1455. Noticed diminished voice when patient when talking, and directly administered 1st dose EpiPen @ 1446. Called for assistance, and EOA arrived @ 1447. BP taken @ 1447 156/100  with O2 sat 98%. Patient condition was not improving and per EOA, 2nd dose of EpiPen was given @ 1454. Took 2nd set of VS @ 1454 right after EpiPen administered BP 130/100 O2 sat 99. Patient stated of feeling better and noticed patient voice coming back to normal. AMR assessed patient. However, patient denied transportation to hospital stating to the AMR that she feels much better and her voice is coming back. AMR left and recommended patient to stay for an extra 30 min for monitoring. Patient finally left at 1540 with her partner, stable and walk steadily.
Had developed swelling of left eyelid soon after getting his vaccines, however also mentioned that he had some itchy eye before, then right eyelid also appeared swollen, and patient then c/o been cold, but had taken off his sweater before coming to office, and was cold before vaccine was given, but began to shiver. Also unclear if having swelling of lips, no difficulty breathing. Also c/o abd pain.
Pain; Nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) and NAUSEA (Nausea) in a patient of an unknown age and gender 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. On an unknown date, the patient experienced PAIN (Pain) and NAUSEA (Nausea). At the time of the report, PAIN (Pain) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information was provided.
On 3/14/2023, my husband tested positive for COVID-19, and I tested negative. On 3/15/2023, I took a home antigen test and got a second negative result. I began having symptoms on 3/16/2023. I had a sore throat, a little bit of a headache, body aches, and nasal congestion. I called my doctor, who had already prescribed PAXLOVID to my husband two days before. Even though I had gotten a negative result on the antigen test, he also prescribed me PAXLOVID, which I began taking the evening of 3/16/2023. Before I could begin taking it, though, I had to go to the clinic to be examined prior to my getting the prescription. For the first couple of days, I still had some COVID-19 symptoms. By the third or fourth day, I was doing fine. At the time of this writing, I still feel fine.
double vision - onset 4/2/22 decreased vision left eye by visual acuity test  Seen by ophthalmologist Dr.  IV solu medrol - doses x 3 given in ED 3 successive days
This spontaneous report was received from a Licensed Practical Nurse referring to multiple unspecified patient of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # M005286 with expiration date of -8-OCT-2017 (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. It was also reported by the Licensed Practical Nurse, that the vaccine was exposed to a temperature excursion of 23.4 degrees C for a time of 2329 minutes. No additional temperature excursion was reported. Data logger was stated. Furthermore, no adverse events were reported and no product quality issues was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Maculopapular Rash through out body. Treatment: Cetirizine oral solution 2.5 ml daily Outcome: Stable  Date of visit 9/27/2022
pt. recvd 1st dose of hepatitis B vac & exp. h/a,fatigue,weakness,fever,malaise,nausea,diarrhea,& back,neck,& shoulder pain, neck stiffness, & pain & edema @ inject site.
WE HAVE CONTACTED PFIZER. THERE WAS NO ADDITIONAL SIGNS AND SYMPTOMS BROUGHT TO OUR ATENTION BY THE PATIENT.
pt recvd 1 hr p/vax exp fatigue, h/a & a flushed feeling;
NAUSEA AND LIGHTHEADEDNESS RESOLVED IN 20 MINUTES VS BP90/50, HR64, RR20 RESTED AND H2O GIVEN.
pt recvd vax & exp nausea;18JUN95 exp sever vomiting,h/a;
Patient was given a Moderna vaccine at 17 years old and it is not yet recommended by a nurse who was unaware. The patients father was notified and given information about what happened. It was recommended that the patient still receive the second dose of the Moderna vaccine if that is what the family/ patient wanted and it is. So the patient will come receive their second dose still.  The patient had a minor headache the day following her vaccine but she has not had any other side effects or issues since receiving it.
expired dose of PENTACEL was administered to a patient, with no reported AE; Initial information received on 22-Jul-2022 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 2 years old female patient who was administered expired dose of Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine [Pentacel] with no reported AE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine Conj 7V (CRM197) (Prevnar); Hepatitis A Vaccine Inact (HEP A in vac); HIB vaccine Conj (TET TOX) (ACT-HIB); and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Dtap) for Prophylactic Vaccination.  On 21-Jul-2022, the patient received a 0.5 ml (once) dose of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine (lot UJ473AA; expiry date; 09-Jul-2022, strength, formulation: unknown) via intramuscular route in the left thigh for immunization.  First time product used : Yes  The patient had last administration of vaccine on 21-Jul-2022.  On 21-Jul-2022 (latency: same day) the patient was administered expired dose of Pentacel with no reported AE (expired product administered).  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 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.
Tachyarrhythmia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TACHYARRHYTHMIA (Tachyarrhythmia) 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.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TACHYARRHYTHMIA (Tachyarrhythmia) (seriousness criterion hospitalization). At the time of the report, TACHYARRHYTHMIA (Tachyarrhythmia) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested..; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested..
No adverse event; VAQTA was administered after the expiry date; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.   The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 16-MAY-2022, Hepatitis A Vaccine, Inactivated (VAQTA) 1 mL, (which expired on 11-APR-2022) was administered to the patient as prophylaxis (expired vaccine used) (strength, route of administration, vaccination scheme, and lot number were not reported). No previous temperature excursion occurred. There was no adverse event reported.
At 10:05, post vax, pt looked pale and he's dizzy. I had his head down. At 10:10, had him lie down. BP 90/60; HR-66/min. reg. No SOB or chest pain. Pt diaphoretic. At 10:20, BP 90/70; HR-90/min. reg. Skin and lip color pink, pt states not dizzy anymore. Feeling fine and left stable.
Information has been received from a consumer concerning her 18 year old daughter with no medical history and no drug allergies, who, on an unspecified date, was vaccinated with a third dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). The patient had a miscarriage "a month and a half ago" in approximately February 2008. The patient sought unspecified medical attention. No laboratory diagnostics were performed. At the time of the report, the outcome of the patient was unknown. Upon internal review miscarriage was considered to be an other important medical event.  Additional information is not available.
Covid arm - injection site reaction, red, itchy, hot to the touch No treatment resolved on it?s own after about a week
This spontaneous report was received from a certified medical assistant, referring to unspecified number of patients of unknown age and gender. The pertinent medical history and concurrent conditions of the patients were not reported. On unspecified dates between 10-SEP-2015 and 18 SEP-2015, the patients were vaccinated with 7 improperly stored doses of (Merck) VARIVAX lot # L013827, expiration date 21-APR-2017 (dose, route and frequency were not reported). No concomitant medications were reported. No adverse symptoms were reported. No product quality complaint was involved. Additional information has been requested.
Injection site was red; Injection site was tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE PAIN (Injection site was tender to touch) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to sulfa, codeine and erythromycin).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE PAIN (Injection site was tender to touch). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE PAIN (Injection site was tender to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.