chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received vaccine after being more than 30 days stored in the fridge; No adverse event; 40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge).    No concomitant medications were reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vaccine was stored in the fridge on 30-Jun-2021, Best Used Date reported as 30-Jul-2021. Doses were administered between 02-Aug-2021 and 20-Sep-2021. Patient did not report any side effects. Treatment information was not provided. This case included information for patient 15 out of 31 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master Case
AE to the Moderna Booster; experienced tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (AE to the Moderna Booster) and TACHYCARDIA (experienced tachycardia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 032L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TACHYCARDIA (experienced tachycardia). On an unknown date, the patient experienced VACCINATION COMPLICATION (AE to the Moderna Booster). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. On 30-Oct-2021, TACHYCARDIA (experienced tachycardia) had resolved. At the time of the report, VACCINATION COMPLICATION (AE to the Moderna Booster) outcome was unknown.            No concomitant medications were provided.  Patient had reported that the tachycardia came on at 2 PM on 30 Oct 2021 and lasted until 7 PM in the evening. She stated she went to a clinic for evaluation but should have went to the emergency room.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: The recent follow-up contains significant information due to additional event and patient gender updated. Reporter were also updated.
Patient experienced dizziness and fainted. He was checked by EMT and recovered. Had not experienced (syncope) before. Patient is ok.
A report was received on 1/2/02 concerning a 77 year old male patient who experienced COPD exacerbation on 3/22/99 after receiving Fluvirin vaccine on 10/29/98. The event was considered serious (OMIC).
Developed red itchy raised welts on feet, face beginning a few hours after vaccine. Still occurring intermittently now 3 days later, possibly related to vaccination.
After 5th vaccine administered pt became pale, denied need to lay down. Pt remained sitting on exam table with back leaning against wall while nurse updated paperwork in room. Pt becomes diaphoretic, pale, dizzy. Assisted to lying on exam table, cool cloth provided to forehead, BP 104/68. Pt remained lying for about 30 min, assisted to sitting for additional 15 min. Recovered, skin pink, warm, dry. Denies dizziness, left clinic.
He got the shot in (18) of September got bad reaction, he couldn't control his body, he fell down 3 times then they take him to Emergency 2 time and now he is inpatient he was in (ICU).
The patient awoke the next day after the vaccines were given and had developed a swollen upper lip. She did not have any pruritis, airway compromise, difficulty with speech or swallowing, rash, hives, fever, or other symptoms. The swelling resolved within 48 hours.
April 22, about 7 pm, vision was way off, blurry and even lost to the far left in my left eye. Woke up on the 23rd confused, I had a maintenance coming to the house and when they called, I had no idea who they were....thank the Lord they called 911. EMT's came and took me to the hospital where I stayed for 5-days. Diagnosis: Hypertension; Embolic stroke
tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloating; shakes; blurred vision and couldn't focus on my cell phone; tachycardia/heart rate went up; dizziness/ felt dizzy; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: ER9231), via an unspecified route of administration in the right arm on 06Jan2021 at 10:00 AM at a single dose as COVID-19 vaccine. Medical history included anaemia and anaphylactic reaction to shellfish. The patient was not pregnant at the time of vaccination, did not receive any other vaccine within 4 weeks prior to the COVID vaccine, and had no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. There were no concomitant medications. On 06Jan2021, within 2 hours (at 12:00 PM), the patient experienced blurred vision, within 4 hours tachycardia and dizziness, within 8 hours headache, chills, body aches, and extreme fatigue, and within 12 hours, tightness in her chest, SOB, extreme fatigue, and body aches. As treatment, the patient received ibuprofen. The patient stated that she had a pretty severe reaction. She also informed her employer but nobody helped. They observed her 15 mins. post-vaccination. She was fine within 15 minutes. It was also reported that within 2 hours, she had blurry vision, tachycardia, and felt dizzy. In the middle of the day, she felt chills, shivers, dizziness, bloating, and headache. The patient also stated that she experienced shakes and taking a shower hurt, also, chest was tight all day. It was further reported that when she was sent back home from work, she started having a severe body ache, fatigue, chills, and shivers. She experienced tightness in her chest , shortness of breath, and she could barely get out of bed. This lasted all day. She still had the blurred vision and couldn't focus on her cell phone. She felt a little bit better today but was still not 100%. She contacted her MD who advised her to report this to Pfizer. The patient wanted to know if it was safe to receive the second dose of COVID-19 vaccine. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Outcome of the event 'Vision blurred' was not recovered, for the event 'Tremor' was unknown, while for the rest of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (received expired vaccine) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 006B21A) for COVID-19 immunization. No medical history reported. In 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 8, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 8, 2021, patient administered expired product (received expired vaccine). At the time of the report, administered expired product (received expired vaccine) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
18 days after receiving the H1N1 nasal mist, client developed jerking in her mid-section. After 1 week, jerking developed in shoulders, arms, hands, and feet, continuously. Has no control over jerking, mid-section stops jerking only when in a deep sleep. When she picks up a crayon, she drops it. Went to ER 2x's and Dr on 12-04-09 and 12-21-09. Want to send her to a neurologist in OKC 1 wk ago had muscle pain used tylenol muscle med for relief. Appetite ok.
a few hours after the vaccine my left hip started hurting severely and unrelentingly.  Can barely walk and am using a wheelchair.  Has not improved in the 5 days since then.
Patient 59 y.o. male who presents the ED today from Hospital for further evaluation of aspiration shortness of breath.  Patient has ALS, states that he feels like he is getting worse slowly, is not having difficulty swallowing, states that he wants to focus on his comfort, and go inpatient hospice route.  Patient is currently DNR and has a power-of-attorney currently, who is at bedside with him today.  Patient denies any symptoms of fever, endorses coughing episodes and severe anxiety, but no other symptoms at this time.  Of note,  contact information for provider who cared for the patient at the outside facility not available in our electronic  health record.   On exam, he is ill appearing, cahectic, in mild respiratory distress, on nasal canula, following commands, has good air entry bilaterally with bilateral rhonchi, normal S1S2, soft abdomen, PEG tube in place, has bilateral feet drop and hands contractures and weakness/spasticity.    1- COVID-19 pneumonia in settings of progressive ALS disease: patient was not hypoxic though he is on some oxygen for comfort. No indication for dexamethasone or remdesivir. He was well determined that he would like to pursue comfort care and not undergo any invasive intervention or active treatment of his disease. We will keep im comfortable, morphine PRN, scopolamine patch, Ativan PRN, and Robinul PRN. We will use CPAP at night as may help to make him more comfortable (recommended by pulmonary as outpatient but did not start using it yet)   Presented with shortness of breath in the setting of ALS/MND and concern for aspiration. He was found to have COVID-19 pneumonia but opted for comfort measures. He was provided comfort medications. He passed away prior to transitioning to a nursing facility to pursue hospice care.
Pt recvd vax 10AUG92 & 30 mins following vax pt exp sudden tachycardia, anxiety, tingling, lightheadedness, palpitations, rash w/welts & limp lt arm; devel taste in mouth; chilling, burning, diarrhea, welts;
Patient scheduled an appointment for a COVID booster indicating it had been > 2 months since any prior booster making him eligible for the bivalent booster.  A proper booster was administered without incident.  Upon recording the dose in system, it was discovered he had received the bivalent booster at another pharmacy on September 30, 2022.  At this time, the CDC has not recommended a second booster of the bivalent.    The previous pharmacy had recorded their vaccination on the backside of the COVID card which is not recommended.   Patient has been notified of this extra dose and indicated he has not had any issues with prior COVID vaccinations.
dizyness; 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 DIZZINESS (dizyness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizyness). At the time of the report, DIZZINESS (dizyness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient concomitant medication was not provided. Treatment information was not mentioned   Reporter did not allow further contact
Temperature 103, extreme irritability; acted like he hurt allover, couldn't comfort him.  Reaction lasted 5 days.
Painful tongue; Mouth sores; I was told the sore on my tongue was herpes zoster (shingles); This is a spontaneous report from a contactable physician (Patient himself).     A 70-years-old male patient received first dose of BNT162B2 (BNT162B2, solution for injection, Batch/Lot number: unknown) via an unspecified route of administration, administered in left arm on 08Jan2021 at 12:30 as SINGLE DOSE for COVID-19 immunization. On 29Jan2021, patient received second dose of BNT162B2 (BNT162B2, solution for injection, Batch/Lot number: unknown) via an unspecified route of administration, as SINGLE DOSE for COVID-19 immunization. The medical history and concomitant medications were not reported. Patient developed painful tongue and mouth sores starting 4 days after the first vaccine (08Jan2021) which have persisted over a month. They started to subside but then increased again after the second dose (29Jan2021). Patient had never suffered from any tongue or mouth sores before. Patient told the sore on her tongue was herpes zoster (shingles) and  he took valtrex with gradual improvement. But the other sores in my mouth have not responded. Patient not had COVID prior vaccination and patient not tested for COVID post vaccination. At the time of this report events tongue pain and sore mouth were not recovered and the event shingles was recovering.   Information about batch/lot number has been requested.
This is a spontaneous report from a contactable nurse. A 17-year-old female patient received TRUMENBA (Lot Number: T52806, Expire Date: 01Dec2019, intramuscular at 0.5 ml, single in the right deltoid on 24Sep2018 08:30 and MENACTRA (Lot Number: U6016AA, Expiry Date: 09Oct2019, NDC number: 0005-01000-01), intramuscular at 0.5 ml, single in the left deltoid on 24Sep2018, both for immunisation. Medical history none. Concomitant medications were not reported. The patient previously took one dose of MENACTR on 12Jul2012 for immunisation. The patient experienced temperature of 102.1 degrees Fahrenheit on 24Sep2018 10:30 with outcome of unknown, body aches on 24Sep2018 10:30 with outcome of unknown, headache on 24Sep2018 10:30 with outcome of not recovered, dizziness on 25Sep2018 with outcome of not recovered, stiff neck on 24Sep2018 10:30 with outcome of not recovered, vomiting on 24Sep2018 10:30 with outcome of unknown. Reporter seriousness for these events was medically significant. On unknown date stiff neck had worsened with outcome of unknown. The events were described as follows: The nurse had a patient that possibly had an adverse reaction to the TRUMENBA. 2 hours after the injection, the patient had a temperature of 102.1 degrees Fahrenheit, body aches, headaches, stiff neck, and vomiting. These events started within 2 hours of receiving the injection on 24Sep2018. The patient came in the next day to the walk in clinic with these symptoms and was especially concerned about the stiff neck. The patient  also received Menactra on the same day. The patient also experienced dizziness that began one day later, on 25Sep2018. The nurse does not know if the patient still has these symptoms, or if she recovered. She knows that on 26Sep2018 the patient still had a headache, was a little dizzy, and still had some symptoms. The patient came in the next day to the walk in clinic to be seen for the symptoms. At that time, the stiff neck had worsened. The nurse denies other medical conditions and medical tests. She states that the patient was treated with Ondansetron for nausea and vomiting. She was also instructed to take Tylenol or Ibuprofen.; Sender's Comments: Based on the information currently available, a contributory role of TRUMENBA towards the occurrence of "fever, body aches, headache,  dizziness, stiff neck and vomit" cannot be fully excluded considering the close time association. 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.
ONSET HIGH FEVERS (103-104)  ARM REDNESS SWELLING AND TENDERNESS, CHILLING.
Pericarditis and subsequent myopericarditis. Intense chest pain that worsened upon lying down and a low grade fever.
Baby woke up from nap crying and screaming. This is not usual behavior for the baby. He was unusually upset and fussy for the rest of the day. He had a fever of 101.3 and we gave his children's Tylenol. He didn't have much of an appetite that evening either.
Hives on right arm and cheeks shortly after vaccination. After 1/2 hr. they disappeared, no respiratory symptoms.
About 6 hours after the Pfizer COVID vaccine she developed rash and some tongue swelling. Went away with benadryl.
Doses administered after 30-day use by date; Doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) and PRODUCT STORAGE ERROR (Doses administered after 30-day use by date) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) and PRODUCT STORAGE ERROR (Doses administered after 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Number of doses/vials - 23 doses.  Date the vial was initially stored in the refrigerator - 17 Dec 2021. BUD date reported as 16 Jan 2022.  Vial did not undergo any temperature excursions.  Treatment medication was not provided by the reporter.
Headaches literally right before she is due to get her next injection series; Inappropriate schedule of vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Headaches literally right before she is due to get her next injection series) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 immunisation.    Concurrent medical conditions included Chronic migraine. Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) for Chronic migraine.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced HEADACHE (Headaches literally right before she is due to get her next injection series). On 09-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, HEADACHE (Headaches literally right before she is due to get her next injection series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was on Botox for chronic migrations for 3 years.. No treatment medications were reported.
Called by patient's sibling that child was fainting, Went into room and child having a generalized tonic clonic seizure with eyes rolled upwards halfway sitting up from bed. Staff called EMS. Turned him on side and stopped seizing. Lasted about total of 30 seconds. Normal pulses. Equal chest rise. Started saying his L upper arm really hurt at site of vaccination. BP 144/88. HR initially 55-77 throughout episode. O2 sats 99-100%. Conversing appropriately, fully alert and oriented. Mom stated this has happened before, last year after application of vaccines. Child hadn't eaten anything today or had anything to drink. Gave him Candy to eat. Kept him resting, EMS arrived and took patient to hospital.
Patient complained of lightheadedness, dizziness, and fatigue the next morning.  That afternoon she experienced Afib.
Pt recvd MMR vax; Subsequently learned that vax had not been refrigerated for @ least 2 days prior to adm;