chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter.  No treatment medications were reported.
This is not bad, just unusual. My arm still has a little pain after 4 weeks. I was reporting daily and said I was fine so stopped reporting because I don't notice the discomfort all the time. Just when I move it some certain ways in feels like I have a charley horse that is resolving.
I haven't been able to taste and smell anything; I haven't been able to taste and smell anything; soreness in my left arm; slight muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (I haven't been able to taste and smell anything), ANOSMIA (I haven't been able to taste and smell anything), PAIN IN EXTREMITY (soreness in my left arm) and MYALGIA (slight muscle ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H21A, 002E21A and 023C21A) for COVID-19 immunisation.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient experienced AGEUSIA (I haven't been able to taste and smell anything), ANOSMIA (I haven't been able to taste and smell anything), PAIN IN EXTREMITY (soreness in my left arm) and MYALGIA (slight muscle ache). At the time of the report, AGEUSIA (I haven't been able to taste and smell anything), ANOSMIA (I haven't been able to taste and smell anything), PAIN IN EXTREMITY (soreness in my left arm) and MYALGIA (slight muscle ache) had not resolved.            Patient was taken allergy pill as treatment drug for unknown indication.  These were injected IM one in the left arm and the other in the right arm.   No concomitant medication was reported.  Company comment: This is a spontaneous case concerning a female patient of unknown age, with no reported medical history, who experienced the non-serious unexpected, according RA, AESI of ageusia and anosmia. The event occurred approximately 1 day after the booster dose of mRNA-1273 vaccine. The outcome of the events was reported as not recovered. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age, with no reported medical history, who experienced the non-serious unexpected, according RA, AESI of ageusia and anosmia. The event occurred approximately 1 day after the booster dose of mRNA-1273 vaccine. The outcome of the events was reported as not recovered. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot # 670616/0617AA) on 02-AUG-2012 after its expiration date. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient has sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Extreme vertigo occurred suddenly around 9:00 pm. Continuous dizziness continues. Unable to walk straight lines. Wobbling and loss of balance when I walk.  I have eaten and been drinking fluids. Side effect still continues.
Anthrax given - (R) deltoid. Red /warm, and has a lump - 20 x 25 " - c/o shooting pain and tingling.  Recommend IM next inj.
heart conduction abnormality; inflammation in heart; heart beats at a lower rate after exercising/ there are periods where her heart rate is over 100 bpm/heart is not relaxing/ causing both parts of the heart to beat at the same time; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONDUCTION DISORDER (heart conduction abnormality), MYOCARDITIS (inflammation in heart) and HEART RATE IRREGULAR (heart beats at a lower rate after exercising/ there are periods where her heart rate is over 100 bpm/heart is not relaxing/ causing both parts of the heart to beat at the same time) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONDUCTION DISORDER (heart conduction abnormality) (seriousness criterion medically significant), MYOCARDITIS (inflammation in heart) (seriousness criterion medically significant) and HEART RATE IRREGULAR (heart beats at a lower rate after exercising/ there are periods where her heart rate is over 100 bpm/heart is not relaxing/ causing both parts of the heart to beat at the same time) (seriousness criterion medically significant). At the time of the report, CONDUCTION DISORDER (heart conduction abnormality), MYOCARDITIS (inflammation in heart) and HEART RATE IRREGULAR (heart beats at a lower rate after exercising/ there are periods where her heart rate is over 100 bpm/heart is not relaxing/ causing both parts of the heart to beat at the same time) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 100 (abnormal) 100 bpm.         Concomitant products included hormone replacement therapy and OTC medication for an unknown indication. Treatment included 800 mg of Ibuprofen twice a day for reduction of inflammation.  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.; 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.
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The female consumer reported for herself and her female friend, this case is for her female friend.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 22Sep2021, outcome "recovering", described as "Sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme irritability starting 5 hours post vaccine and lasting until about 24 hours post vaccine.
Painful, swollen lump (L) delt found on day 7 after immunization given. Rx'd ice packs, TYLENOL, watchful waiting & to call office if worsens.
Fully vaccinated with Covid19 Pfizer EUA 05/03/2021-05/24/21
Dysfunctional uterine bleeding causing symptomatic anemia requiring hospitalization and transfusions.  Onset of menarche 4/2021. Received first shot 5/18/2021 and 2nd shot 6/8/2021.  Third menses onset 6/7/2021. Started becoming symptomatic with DOE, lightheadedness, and pallor 6/17/2021 (day 10 of menses). Hospitalized on 6/19/2021. Still bleeding as of date of this form (7/1/2021)
Patient complained of left arm being warm to the touch and redness around injection site. Patient visited doctor to get checked out. Doctor was not concerned. Redness had started to diminish and patient was feeling better.
annoying itching / itchiness appear on many old chickenpox scars; burning; tingling; creeping under the skin side effects; red dots; This case was reported by a consumer and described the occurrence of pruritus in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox.   On 11th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 11th January 2021, 2 hrs after receiving Shingrix, the patient experienced pruritus, burning sensation, tingling, skin discomfort and erythema. On an unknown date, the outcome of the pruritus, burning sensation, tingling, skin discomfort and erythema were unknown.   It was unknown if the reporter considered the pruritus, burning sensation, tingling, skin discomfort and erythema to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 1st dose of shingrix on 11th January 2021, intramuscularly. After 2 hours, patient experienced itching, burning, tingling, creeping under skin, including red dots and itchiness appear on many old chicken pox scars. Events were not resolved. The reporter consented to follow up.
Shivering; high fever of almost 103 degrees Fahrenheit; acid reflux; arm sore at injection site; Fever; chills; minor body aches; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), VACCINATION SITE PAIN (arm sore at injection site), PYREXIA (Fever), CHILLS (chills) and MYALGIA (minor body aches) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), VACCINATION SITE PAIN (arm sore at injection site), PYREXIA (Fever), CHILLS (chills), MYALGIA (minor body aches) and HEADACHE (slight headache). On 05-May-2021, the patient experienced CHILLS (Shivering) and PYREXIA (high fever of almost 103 degrees Fahrenheit). On 05-May-2021, PYREXIA (Fever) and HEADACHE (slight headache) had resolved. At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), VACCINATION SITE PAIN (arm sore at injection site), CHILLS (chills), MYALGIA (minor body aches), CHILLS (Shivering) and PYREXIA (high fever of almost 103 degrees Fahrenheit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided Treatment medication include Ibuprofen .  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events were not applicable.
A non-serious, spontaneous report of flu-like symptoms and Influenza A has been received from a licensed practiced nurse concerning a six-year-old female patient, subsequent to receiving FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 16-Oct-2009. On 16-Oct-2009, the patient experienced flu-like symptoms manifested as a fever of 103.1F, cough, sore throat, a runny nose. On an unknown date, the patient tested positive for Influenza A. On an unknown date, the events of flu-like symptoms and Influenza A resolved.
Pt's significant other called nurse triage line on 3/14, stated that patient had not been eating since his second dose of the COVID vaccine and was having severe abdominal pain and was "doubled over in a fetal position and sweating profusely." Triage advised them to call EMS. Patient presented at the emergency department an hour later, was diagnosed with acute appendicitis, and was admitted to general surgery. Laparoscopic appendectomy was completed on 3/14 with successful removal of "acute gangrenous, perforated appendix" and patient was discharged home the same day with no complications.
I had slight soreness in right arm and a low grade fever of 101.4 for 12 hours. I also had slight fatigue for 2 days.
This spontaneous report was received from a physician a nurse and the patient's mother referring to her son, an 11 years old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unspecified date in February 2018, the patient was vaccinated with the first dose of pediatric VAQTA (lot # reported as: N023953, expiration date 05-NOV-2018) (route not provided). On 22-MAY-2018, the patient was supposed to be vaccinated with ADACEL, but instead was inadvertently vaccinated with a dose of adult formulation of  VAQTA (lot # R009799, expiration date 02-JUN-2019) intramuscularlly for prophylaxis. The nurse stated that the two vaccines were similar in color. The patient's mother stated that her son received a VAQTA injection early. No adverse effects were reported. Lot number N023953 is an invalid lot number for hepatitis a vaccine, inactivated.
Within 40 minutes I began to feel weak, followed by nausea and severe headaches.  A few hours later acute abdominal pain that left me doubled over and lasted for 8 hours and 40 hours of stomach pain that left me unable to eat.
20 min. following inj. pt felt shortness of breath with chest tightness. At 3:00 PM, pt sought ER care for continued chest tightness. Breathing at that was good.
Information has been received from a nurse practitioner, via a company representative, concerning a female patient, who on 05-MAR-2007 was vaccinated with the first dose, IM, of Gardasil. Concomitant suspect therapy included Tdap. The nurse practitioner reported that "a patient who received the 1 Gardasil in one arm and the Tdap vaccine in the other arm, fainted within a few seconds after being vaccinated." The nurse practitioner states that "the patient was fine after a minute or so." The patient sought unspecified medical attention. Additional information has been requested.
5 minutes after administration of vaccine, patient bean to report feelings of dizziness, lightheaded, nausea and anxiety. Pt was prompted to lay down and did so. Vital signs were taken again and pt was instructed to take deep breaths. Patient described feeling a lump in her throat. Throat was visualized and no swelling was noted. Patient was given cold pack, Gatorade, and granola bar. After 30 minutes patient was able to sit up and stated that she was feeling much better. Within this time patient's vitals were taken every 5 minutes and all vitals were  WDL. Patient was monitored for 1 hour in total after shot administration before leaving the clinic. On 9/16, two days after vaccine administration, patient called clinic to report that she had to leave work early due to feeling "nauseated, dizzy, faint, and looking pale." She requested that the vaccine be listed under her allergies. Patient was informed that side effects can last 2-3 days, instructed to hydrate and eat bland food, and to go to acute care if she continues to feel unwell or if symptoms worsen.
significant neck pain on same side as inj site arm w/some diff swallowing;taking maximum pain medication;
Pt received Janssen Dose on 3/12/2021- given by pharmacy. pt answered VAR form stating he had received another product already. He was not appropriately counselled on need for additional Covid-19 vaccine.
vaccine spilled out from opposite of needle onto the arm; needle became disconnected from syringe from deltoid muscle of left arm; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (vaccine spilled out from opposite of needle onto the arm) and DEVICE CONNECTION ISSUE (needle became disconnected from syringe from deltoid muscle of left arm) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (vaccine spilled out from opposite of needle onto the arm) and DEVICE CONNECTION ISSUE (needle became disconnected from syringe from deltoid muscle of left arm). At the time of the report, UNDERDOSE (vaccine spilled out from opposite of needle onto the arm) and DEVICE CONNECTION ISSUE (needle became disconnected from syringe from deltoid muscle of left arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant or treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow- up information received reporter confirmed no adverse event.
Flu like symptoms/pretty bad flu like sysmptoms; feel achy/aches all over my body; severe chills; fever; insomnia; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 52-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th August 2020, the patient received the 1st dose of Shingrix. On 24th August 2020, 6 hrs after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain, chills, fever and insomnia. On an unknown date, the outcome of the influenza-like symptoms, chills, fever and insomnia were recovering/resolving and the outcome of the general body pain was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, general body pain, chills, fever and insomnia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and in the evening of the infusion day the patient experienced flu like symptoms and feel achy all day and felt a bit better. After approximately 6 hours after infusion, the patient suffered severe chills, aches all over body and the patient believed a fever. The patient also experienced insomnia. The patient wanted to know would the efficacy of Shingrix go down in 4 years.
Acute right flank and back pain. No n/v. Unable to lay, walk, stand without severe pain. No fever.
reports a migraine; left arm injection site pain; This case was reported by a consumer via call center representative and described the occurrence of migraine in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 13th September 2020) and Engerix B (2nd dose received on 10th February 2021).   On 4th April 2021, the patient received the 1st dose of Shingrix. On 4th April 2021, 1 hr after receiving Shingrix, the patient experienced migraine and injection site pain. On 5th April 2021, the outcome of the migraine and injection site pain were recovered/resolved.   It was unknown if the reporter considered the migraine and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported, however it could be 56 or 57 years. The patient received 1st dose of Shingrix in left arm. The patient experienced migraine and left arm injection site pain which started an hour after the vaccination. The patient wished to remain anonymous.  The reporter did not share lot number or expiration date of Shingles vaccine and did not share where she received vaccines or who was her health care professional.  The reporter did not consent for follow up with her health care professional and did not provide email to offer Shingrix PI to be emailed to her. The reporter accepted MI telephone number to share with her health care professional. This case had been linked with US2021085458, reported by the same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021085458:Same reporter
I felt fever coming on and a slight headache. I was actually out of town. I did a rapid test and it was negative. I drove back home and was okay. I stopped at the county site and got my PCR. I was positive for COVID. Body aches and fever about 100.4. It lasted three days.
The patient received the first dose of the Moderna Covid-19 vaccine.  The patient was administered the vaccine in the immunization booth.  The PQCF was reviewed by the administering pharmacist and the patient marked no for all questions including Question 5 concerning seizure disorders.  The patient remained in the immunization booth due to the immobility of the patient.  The immobility of the patient was not related to the following event.  The patient's mother within 5 minutes of the vaccine being administered called that the patient was having a seizure.  Code White was called to the pharmacy to support the pharmacy staff in the needs of the patient.  The patient was monitored and associates were stationed near the patient as she remained seated during and after the seizure.  The patient was monitored closely.  The patient's mother stated after the seizure that the patient has seizures regularly and was "due for one" meaning a seizure.  The patient was continuously monitored for 20-25 minutes at which point she attempted to walk under the supervision of the pharmacy manager.  The patient was able to walk under her own power and it was determined at this point she was able to leave the pharmacy area.  Follow up with the patient will occur later in the evening and the next day to ensure the patient is doing well.
Shortly after being vaccinated, patient reported feeling very hot and pain and spasms in his legs and lower back where he said he was unable to move. This continued for about 10 minutes, while emergency medical services were contacted. His temperature was checked and was around 94 degrees F, and his blood pressure was in normal range. By the time EMS arrived, patient reported feeling much better. He was evaluated and at the end he was able to stand up and walk.