chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A Medical Assistant administered the Moderna Covid Vaccine (Lot #003C21A, Expiration Date 10-17-2021) after the 12 hours that was supposed to be administered. The vial was always at the refrigerator, but it was used after the recommended time. The Moderna Covid Vaccine vial was originally at a temperature of -3.2 degrees Fahrenheit. On 8-5-2021 the vial was placed on the refrigerator at a temperature approximately of 41.0 degrees Fahrenheit, and the vial was at that temperature for 24 hrs, when the vaccine was administered. The vial was opened on 8-5-2021 at 9:20 am, and by protocol, the open vial was not supposed to be used after 3:20 pm of the same day. On 8-6-2021, the same vial was used by the Medical Assistant, to vaccinate the patients She thought that the vial was already prepared for the day and the expiration time was 3:20 pm, but she didn't notice that the vial was from the day before (8-5-2021). The vaccination protocol was followed, the patient was observed after vaccination, and the patient didn?t have an adverse reaction. This incident was reported to upper medical staff members one of whom recommended to call the patient that received the vaccine to inform the incident. The patient also will be called for three days to evaluate her health condition. Staff member called and reported the event with a Case #MOD21127564. Recommendations will be presented the next 7 days.  The MA called the patient to explain the situation about the use of the vaccine after the time recommended. She communicated with the patient on 8-6-2021, patient understood the explanation and will wait for her call the next three days to evaluate any health complaint. The patient was called today, and she informed that she feels well, only pain in her arm.
Pt presented to the ED for right leg weakness, recent CVA with residual weakness, leg went completely flaccid but now back to baseline.  Tested in the ED and found to be COVID + but asymptomatic.  Pt admitted for TIA workup and remained asymptomatic for COVID. Discharged 1/27/22. Previously vaccinated and boosted with Moderna 1/28/21, 3/1/21, 12/31/21.
A mild cough; Low fever; Tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (A mild cough), SARS-COV-2 TEST POSITIVE (Tested positive for Covid) and PYREXIA (Low fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for Covid). On an unknown date, the patient experienced COUGH (A mild cough) and PYREXIA (Low fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (A mild cough), SARS-COV-2 TEST POSITIVE (Tested positive for Covid) and PYREXIA (Low fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Anaphylaxis-like symptoms; A spontaneous report was received from a physician concerning a 45-year-old,  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis-like symptoms.  The patient's medical history included hypertension. The patient had no history of allergies or prior vaccine reactions. No concomitant medications were reported.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient experienced anaphylaxis-like symptoms that included, anaphylaxis, angioedema, shortness of breath, itching, swelling of eyes, and sleepiness. The patient was treated with epinephrine injections and taken to the emergency department.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, anaphylaxis-like symptoms, was unknown.; Reporter's Comments: This case concerns a 45-year-old patient with medical history of hypertension, who experienced a serious, unexpected event of Anaphylactoid reaction. The event occurred the day  the patient received the first dose of mRNA-1273 (Lot number: 041L20A), at an unspecified time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Body aches, fatigue, poor balance All resolved within 40 hours. Injection site pain - resolved within 72 hours
This spontaneous report was received from a medical assistant and refers to a unspecified patients of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions and allergies and concomitant therapies was reported. On an unknown dates, multiple doses of improperly stored ROTATEQ lot # M041184 with expiration date 31-MAY-2018 were administered to multiple unspecified patients for prophylaxis. Improperly stored vaccines underwent following temperature excursion: 9 Celsius degrees to 25 Celsius degrees (8.5 Celsius degrees) for 12 hours. Data logger was involved. No adverse event was reported.; Sender's Comments:  US-009507513-1708USA000956: US-009507513-1708USA005614: US-009507513-1708USA005615: US-009507513-1708USA005616:
IMZ with PNEUMOVAX 23 11:30am 5/19/12. 5/21/12 10:30am pt shows 4x6" rash at inj site. Pt advised BENADRYL/Ice/IBU & call if worsens.
INJECTION SITE PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 22-JUN-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain. This report was non-serious.
Pt received vaccine at 11:45 and was sitting in observation for 8 minutes when he stated he felt like he was getting really warm.  Pt was put in wheelchair and taken to a room to lay down.  Vital signs BP 139/88, P 68, R 20 SP02 98%.  Pt face was flush. No signs of SOB or any other symptoms.  After 10 minutes patient  stated the "hot feeling" was going away.  We monitored him for additional 30 minutes and patient was able to sit up without any difficulties or changes in the way he felt.  Patient was released to his command with no limitations.
SWEATING; THROAT FEELS ACIDY FROM THROWING UP; DIARRHEA; VOMITING/THROWING UP; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 24-SEP-2021, the patient experienced sweating. On 24-SEP-2021, the patient experienced throat feels acidy from throwing up. On 24-SEP-2021, the patient experienced diarrhea. On 24-SEP-2021, the patient experienced vomiting/throwing up. The action taken with covid-19 vaccine was not applicable. The outcome of the diarrhea, vomiting/throwing up, sweating and throat feels acidy from throwing up was not reported. This report was non-serious.
She reports feeling severe shooting pain from the injection site down into the fingertips during vaccine administration.  Symptoms did not resolve promptly.  They did last for a while.  She reports that she was unable to sleep night.  Then she is had severe pain in the deltoid area.  She is unable to lift arm.  She does not report feeling weakness.  T
8 syringes found with 0.1-0.25 cc of Moderna vaccine left; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (8 syringes found with small amounts of vaccine left in them) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) UNK dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (8 syringes found with small amounts of vaccine left in them). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (8 syringes found with small amounts of vaccine left in them) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Swollen ly nodes in left arm; Pain at site of injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 10:15 (Lot number: EL3247) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: RITALIN. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 12Mar2021 14:00, outcome "recovering", described as "Pain at site of injection"; LYMPHADENOPATHY (non-serious) with onset 13Mar2021 10:00, outcome "recovering", described as "Swollen ly nodes in left arm". Therapeutic measures were not taken as a result of vaccination site pain, lymphadenopathy.  Additional information: The patient received the vaccine on Friday. She became aware of the first AE (pain in injection site) -4 hours after vaccination and of the second AE (swollen lymph nodes) when she woke up the following morning. The patient did not have any other vaccine in four weeks. The patient did not have covid prior vaccination. The patient was not tested for covid post vaccination. The patient did not have any known allergies.  No follow-up attempts are possible. No further information is expected.
reported "flu like" symptoms for 1 day after receiving shot; This non-serious case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a 68-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced influenza-like symptoms (Verbatim: reported "flu like" symptoms for 1 day after receiving shot). The outcome of the influenza-like symptoms was resolved (duration 1 day).   It was unknown if the reporter considered the influenza-like symptoms to be related to Arexvy.     It was unknown if the company considered the influenza-like symptoms to be related to Arexvy.   Additional Information: GSK Receipt Date: 07-NOV-2023 The pharmacist reported that the patient took Arevxy. The patient experience flu like symptoms for first day after receiving shot.   The reporter did not agree to follow up from GlaxoSmithKline.
Pt vaccinated with DTP/OPV child was playing when she fell into deep sleep 10min after immunization. Difficult to arouse would quickly fall back into deep sleep. HR, BP, RR normal.
Extreme pain in left arm. Unable to raise arm. Pain still persists to this day 01/07/2016. I have seem primary Dr and am scheduled to see specialist on 01/15/2016. Pharmacist remarked that he thought he hit my bone when I told him of my pain.
Petechial rash (mild) developed approx. 2 wks after 2nd Covid vaccine.
Day 1. 3/10/2021- In the evening my left arm was sore and achy. Day 2. 3/11/2021- In the morning, chills, headache, sweats. Early afternoon in the car I had trouble breathing, cold sweats, chills, coughing trying to breathe. My husband went immediately to the pharmacy to purchase Benadryl and opened the capsules and poured in my mouth along with water as my body became completely limp. At home my husband helped me get to bed and gave me 2 rapid release Tylenol tablets. Day 3. 3/12/2021- In the morning, I felt better until I had a cup of coffee and the chills, sweats, nausea, vomiting and blood pressure started escalating 135/98.  I had no previous concerns with blood pressure before the vaccine. I had difficulty speaking (stuttering, confusion and brain fog. I was still so so tired. Day 4, 3/13/2020 - Unable to remain awake after having  a sip of water. Blood pressure 150/101 and ate 3 nuggets and body became limp again and unable to walk and husband carried me to bed. (Difficulty speaking and repeating words over and over-confusion). Day 5, 3/14/2020- In the morning, I felt better and my husband gave me a blood pressure pill (Triamterene/Hctz) . I slept most of the day and had no water, no food. I  was  extremely exhausted and ate in the evening. I had chills, sweats, headache and my body became limp again and husband carried me to bed. Day 6. 3/15/2020- In the morning called Dr. for tele-visit and gave her details of what was happening. I had no food or water and  still felt tired. I went to office for lab work around 4:30. I was walking,  but extremely exhausted and speech difficulty. Day 7. 3/16/2021 -. In the morning blood pressure was 139/96 - took another blood pressure tablet and had a smoothie and felt much better only chills, no headache. Blood test were normal,  and I ate dinner and then chills, sweats, headache and husband helped me walk to bed. After about 30 minutes, legs were movable, but upper body was numb for an additional 30 minutes and then everything seemed fine. I got up and walk around  and went back to bed later in the evening. Day 8. 3/17/2021-First day no meds at all, no BP meds, no Tylenol and I was feeling so much better.  I ate throughout the day with few symptoms except stuttering and repeating words when speaking. Day 9.  3/18/2021- I spoke with Dr. for appointment on the 19th. I felt stronger and ate breakfast, Lunch and dinner and was feeling normal except for occasional stuttering in speech. Day 10  3/19/2021 - No food in the morning, I visited Dr. at 8:35 for examination and she sent me for ct-scan. Blood pressure was back to normal 122/82 with no meds. I felt fine and later today received normal results from CT-scan. I am hopeful that in the coming days, my speech will completely back to normal.
The patient experienced itching after the first dose of the COVID-19 vaccine. Pre-medicated with diphenhydramine prior to the 2nd dose of the OVID-19 vaccine. 9 minutes after the vaccination, the patient felt itchy, flushed and received oral dexamethasone. [atient was sent out with oral dexamethasone home.
Injection site reaction - delayed at day 7 - itching, redness, swelling and hot
Breakthrough case admission after 2 vaccines  Moderna 4/20/21 lot# 007C21A;  Moderna 5/18/21 lot# 033B21A
Kudos on your vaccine error report. Appreciate it. I'm not sure if monitoring errors are within the scope of your article, but wanted to share none-the-less. I don't have specifics to provide, but just want to mention a trend that we have seen related to HPV vaccines. We have had instances (due to demands on speedy room turn over) in our physician offices where patients are asked to sit in the waiting room for 15 minutes following their injection. They are handed a timer and directions are provided to the waiting room, but they faint en route. We have instructed staff to escort the patient to the waiting room chair, arm in arm. Patients may feel that we are over cautious, but we have seen patients exhibit no problem with the first 2 injections, but somehow faint with the 3rd.
Covid test and their rapid test came back positive; Covid test and their rapid test came back positive; This is a spontaneous report from a contactable Pharmacist reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 10Feb2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that a patient who got their 1st dose on 10Feb2021 and went to go and get a Covid test and their rapid test came back positive. They were wanting to know if the patient could get their 2nd dose on 05Mar2021. It was suggested to the patient that to wait times, since caller tested positive after the 1st dose. Outcome of the events were unknown.  Information about the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 vaccine in this patient cannot be completely excluded.
pt recv vax 7AUG98 & 11AUG98 rash, fever, & itching x 3 days;20AUg98 rash is back;MD said it looked like hives;mostly on trunk but als on limbs & face/neck;medication started 24AUG98;
Patient received moderna vaccine on 3/18/21 and 4/15/21. Presnted to Er on 7/19/22. COVID positive on 7/04/22. presents to the ER with complaints of worsening weakness over the past few weeks.  Patient states he has developed a cough with brownish sputum production.  He denies any dysuria but has been somewhat short of breath as well lately.  No skin lesions or rashes noted.  He denies any fevers or chills at home.  He denies any vomiting or diarrhea either or abdominal pain.  Workup in the ER including a CT of the chest was unremarkable for any infectious process.  His vital signs were stable however his WBC count was 32,000 with a neutrophilic predominance.  No infectious etiology can not be determined other than COVID.  UA is normal. Lacitc and procal normal. Patient will be admitted for further workup of his leukocytosis. REceived ceftriaxone. Discharged on 7/21/22
Within 2 hours, the pt was inconsolable, screaming, afebrile. No local reaction at injection site. Screaming persists now 2 months later but more sporatic.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: She reported to me that after the engerix-b she did not feel well. She expressed she felt a little dizzy/nauseaous, as well as some visual disturbances. She was exhibiting symptoms of syncope. I followed up with checking her blood pressure, it was a little low, but not concerning. She nodded off a few times, but she was awake and responsive when speaking to her. EMTs came to be sure she was okay, and she was evaluated and okay. She left feeling okay, and she denied hospital visit.
This child had Left thigh erythema, and swelling surrounding the site of injection. Started the evening after receiving vaccination and worsening over the next 2 days. Admitted for cellulitis, and treated with IV antibiotics, then discharged on PO antibiotics to complete 10 day course.
Patient reports experiencing severe arm pain for 2 days of which he could not lift his arm. Patient denies signs or symptoms of shortness of breath, or rash or hives.
The next day after the vaccination at 3:00 PM, I felt bone pain, tiredness, with a fever and that lasted all afternoon until Sunday. On the same Sunday at 12 noon I started with a stomach ache (similar to some contractions) I went to the bathroom 4 times solid and then on the 5th excretion I saw blood and I thought it was menstruation, from then on I had 11 bloody stools; I was in a lot of pain. He had no appetite. Monday morning to the hospital (at 7AM) and I explained everything to them and they did several tests, they gave me medicine for the pain and the discomfort went away, and they discharged me. I was 8 days with treatment.
This study case was received from the investigator on 27 August 2012. A male subject (date of birth not reported) with no reported past medical history had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 23 September 2009 an elevated Troponin, central laboratory level of 0.12 ng/ml. The subject had a rapid Troponin I level on 23 September 2009 that was within normal limits (negative). No ECG was performed. No other reported visits, no chest x-ray, no echo and no labs. The subject had no concomitant medications. No further information was available at the time of the report. The subject's outcome was not reported. According to the investigator, the event of elevated Troponin was considered an other important event and was possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
Fever, body aches, headache, chills, nausea, sore arm, swelling and redness at injection site  and rash on left arm.
Within 5 days of receiving my first dose of the Pfizer vaccine, I began experiencing ringing in my ears -- Tinnitus
I had my usual chills with shaking, fatigue to the extent I slept most of 9/14. About 8:30 9/14 when I rinsed after using my Pulmicort, water spurted out of the left side of my mouth. The morning of 9/15 the left side of my mouth was drooping slightly, by the end of the day the entire left side of my face was drooping. About 2:30 on 9/16 I went to ER to be checked out for possible stroke. I had a CT scan and other tests to rule out stroke. The diagnosis was Bell's Palsy. I was given prescriptions for Prednisone, acyclovir, and dextran 70-hypomellose eye drops. I was told to see my doctor on Monday 9/18. I can not close my left eye which tears almost constantly, I can not eat or drink on the left side of my mouth.
Left arm redness; Left arm swelling; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Left arm redness), PERIPHERAL SWELLING (Left arm swelling) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and D07B21A) for COVID-19 vaccination.     Concomitant products included INSULIN DEGLUDEC (TRESIBA), METOPROLOL, ISOSORBIDE MONONITRATE, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE, LOSARTAN and WARFARIN for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2021, the patient experienced ERYTHEMA (Left arm redness), PERIPHERAL SWELLING (Left arm swelling) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Left arm redness), PERIPHERAL SWELLING (Left arm swelling) and HEADACHE (Headache) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.
devel t104 1130PM, vomited throughout noc; had been given APAP; very weak, lethargic, lost control of bladder; while sleeping would cry, thrash around; seen in ER 730AM; mom reports pt limp like noodle;
2 days after vaccination woke with (R) foot numbness abnormal reflexes so taken by ambulance to ER. MRI brain & spine. Released 2/13. 2/14 woke with (L) leg numbness both sides progressed up to mid chest. Admitted 2/14-2/16. HTN.