chrisvoncsefalvay/vaers-outcomes huggingface dataset:
powder reconstituted with other diluent; powder reconstituted with other diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA582A, expiry date 30th August 2022) for prophylaxis.   On 31st August 2021, the patient received Menveo. On 31st August 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional information was provided as follows: The nurse reported that the powder was reconstituted with other diluent not the one that comes with the Menveo vaccine, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Shortly after the vaccine I started experiencing widespread pain throughout my body.  My fingers, hands and wrists became extremely painful and difficult to move.  I felt as if my body was going "haywire".   I still have occasional throbbing pain at the injection site.  I reported my symptoms to my doctor.  I was sent to a Rheumatologist who did a series of blood tests which came back positive for drug-induced lupus and extremely high inflammation markers.  I did not and do not take any medication that causes drug-induced lupus.  I do not have the usual signs/symptoms of lupus except that my hair started falling out and continues to fall out since contracting Covid from a family member in July 2022.
Information has been received from a 62 year old female consumer with no known allergies, cholesterol and hypertension who on 25-FEB-2008 was vaccinated with 0.65ml of zoster vaccine live (Oka/Merck). Concomitant therapy included atorvastatin calcium (LIPITOR) and bisoprolol fumarate/HCTZ (ZIAC). On the same day that she was administered zoster vaccine live (Oka/Merck), 25-FEB-2008 the patient developed shingles. On 01-MAR-2008 patient reported she started taking famciclovir (FAMVIR) and experienced a headache. Unspecified medical attention was sought. There were no lab studies performed. The patient's outcome was not reported. There was no product quality complaint involved. Additional information has been requested.
Pharmacy grad intern reconstituted the pediatric Pfizer vial instead of the adult Pfizer with 1.8ml saline and administered 0.3 ml to patient. Patient may have received a too-diluted dose that may not illicit an appropriate immune response
Information has been received from a physician concerning a 92 year old male with chronic arterial disease, hypertension, high cholesterol and asthma who on 16-MAR-2007 was vaccinated with a single dose of Zostavax. On approximately 12-JAN-2008 the patient experienced had trouble breathing, so the patient had complete blood count test done, but the results were in the normal limits. On 26-JAN-2008 the patient was still having trouble breathing, so he had gone to the ER and there they had done another CBC test and the patient was diagnosed with acute leukemia. The patient was admitted through the ER and the patient was still in the hospital. Unspecified medical attention was sought. A product quality complaint was not involved. The reporter considered patient's experience as immediately life-threatening and disabling. Additional information has been requested.
I have a fever that is 100; body aches; Headache; This is a spontaneous report from a contactable consumer (patient). A patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history included covid before very, very, very, very, very bad. The concomitant was not reported. The patient work in a hospital and got her shot (Covid Vaccine) on 23Dec2020, and she have all the reactions to it in Dec2020. Patient have had Covid before very, very, very, very, very bad, it seems like she was starting all over it again. She don't feel like she was going to die or anything, she already went through all of that but patient have a fever that is 100, the body aches, the headaches the whole thing, they all starting now which patient assumed this is just temporary because she don't want to have through with this thing again. A lot of people do not get it that is with patient it's like patient was the one who has everything. So, patient was calling and letting company know that she was having the side effects to it, patient don't think she would but here she was with it.The outcome of the events was unknown.  Information about Lot/batch no has been requested.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 07Jun2022 at 15:00 as dose 4 (booster), single (Lot number: FM0173) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing); "juvenile asthma" (unspecified if ongoing), notes: juvenile asthma; "Known allergies: Iodine contrast" (unspecified if ongoing), notes: Known allergies: Iodine contrast. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.
C/O rash over upper and lower limbs and face noted 24 hours after receiving flu shot on the left arm. denies fever, SOB, facial swelling or hoarseness. Parents deny past vaccine reaction. He was evaluated in the ER (MC) on 10/6/23 for temp of 104.3 and diagnosed with a viral syndrome. fever laster until 10/09/23. He was afebrile when he received te flu shot on 10/11/23. benadryl was given this morning for the rash that has improved per mom.
Case number PHEH2014US017501 is an initial spontaneous report received from a medical assistant on 27 AUG 2014. This report refers to an 83 year old female patient. Her medical history and concomitant medications were not reported. It was reported that unopened FLUVIRIN MDV's reached 50.7F for 4 hours. Reported as one tie excursion. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 1410801) at a dose 0f 0.5 ml intramuscularly on 25 AUG 2014 from the MDV after the excursion. No adverse event was reported. No further information was provided.
Left leg turned red upon administration of DTap and IPV x 2-3 mins. Good circulation and pulse. Monitor and apply cool compress.
vaccines have been administered after excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines have been administered after excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No information on medical history 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 EXPIRED PRODUCT ADMINISTERED (vaccines have been administered after excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccines have been administered after excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No information on medical history was reported. No information on concomitant medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received on 29-07-2021.Includes No new information Added.
Pt reports hx of "fainting" after receiving injections or lab draws. Client received injection of J&J then client's color appear very pale and became diaphoretic,  Client  had near-syncope episode, moved client to floor and raised feet into chair. Skin diaphoretic and remains  pale. Vs checked WNL, Awake and mild anxiety noted, clam emotional support given. Lungs clear, no facial swelling or difficulty breathing noted. Over 15-20 minutes color improved, skin warm and moist but no diaphoresis present. vs remain stable, reported feeling better speech clear. Assisted client to sitting position, po fluids given tolerated well, snack provided vs stable continues to deny any issues, allergic reaction noted.  After lapse of 45 minutes total, vs stable, pt up walking around and sent home.  Dr. (medical director) notified of incident.
This is a copy of the letter that was sent to the local health department  March 6, 2021 Good Afternoon,      Yesterday, thankfully I received my second Moderna vaccine. I am notifying you of what happened in hopes that you will be able to increase my understanding of what took place and  the implications in regard to the efficacy of the vaccine I received. While getting the vaccine some of the content was dripping at my elbow. I caught the drip and then told the person giving me the shot that it was running down my arm. She said, ?it?s on your arm,? then wiped my arm with a piece of gauze. I did not see it, only felt it so I do not know how much ran down my arm rather than going in my arm. While sitting in the waiting area I realized how different that experience was from my first dose. The shot in general felt different (more like a stamp). I asked to speak with someone there with medical knowledge of what happed with my vaccine. I was connected with a woman (I don?t know her name or role at the site) who asked me questions then went to talk with the person who gave the shot. When she came back she told me something to the effect that this had happened a few times before and that it was a problem with the injector from the supplier having a separation allowing some of the vaccine to leak. She also said (this is where she lost me) there is a small amount of the vaccine at the end that is not really needed and that may have been the part that leaked out. She said that I should be covered by that part of the vaccine that I did receive and that she would have to fill out a report on what happened. When I returned home of course I wanted to read about faulty injectors and leaking vaccine during the trial studies and the conclusions drawn. I was not able to find anything so I contacted my primary care physician to tell her what had happened and to see what she knew. She also could not find any information on Moderna vaccines leaking in her resources and encouraged me to contact you.   My questions:  What percentage of the vaccine dose is actually not needed to achieve the desired coverage?  How does that equate to how much leaked during my shot? Do you or Moderna have a way of checking with a blood test to see if I have received an accurate or adequate vaccine dosage? Where can I get a copy of the report that was written?  Thank you in advance for your help.   Date:03/05/2021 Time: 10:43 Chair #7
Subsequently post vax, the pt experienced a fever of 103-104. She also experienced exhaustion.
Received 1st Gardasil shot in office around 11AM Later that day broke out with hives all over her torso and arms. Mom called Dr - Dose of Benadryl was administered. Hives faded no other reaction reported. Spoke with mom on 6/18/07 child was fine.
Patient received the second dose at wrong interval ( 12 days ) from when the first vaccine was administered instead of 28 days interval.
A non-serious spontaneous report of inadvertent administration of expired H1N1 LAIV was received from a registered nurse/health professional concerning a nine-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
"Today I received my Moderna booster. I was given a full dose by mistake; not imunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE ("Today I received my Moderna booster. I was given a full dose by mistake) and OFF LABEL USE (not imunocompromised) in a 73-year-old patient of an unknown 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE ("Today I received my Moderna booster. I was given a full dose by mistake) and OFF LABEL USE (not imunocompromised). On 26-Oct-2021, ACCIDENTAL OVERDOSE ("Today I received my Moderna booster. I was given a full dose by mistake) and OFF LABEL USE (not imunocompromised) had resolved.            No concomitant medication listed.   No treatment information provided.
After getting vaccine my child fell asleep and I drove around to let him sleep for about 1 hour when I got home I noticed my child had a red raised rash on the lateral side of his left face mostly around the eye. It then seemed to get worse we then called his doctors office and poison control after another hour the rash resolved.
Stomatitis, raw mouth, pain eating and drinking worse yesterday and today ( day 3 and day 4 )
I had kidney cancer. I had surgery. It was an incidental finding on a CT scan. I had a left total nephrectomy on April 06,2022. It was successful. I have a follow up visit scheduled for 6 months. I am feeling a lot better than during the surgery but I felt fine before it.
4 weeks after vaccine and second vaccine break through period bleeding 10 days after.  Narrative:
Had swelling and redness to right arm. Exmained by provider, patient has possible cellulitis to right arm, started on Keflex and Motrin.
Patient had the recommended two vaccine injections properly temporal spacing. A month later he was found to have rather severe hypertension, which he never had before the vaccine. When I saw him (a few days ago) he was on at least one blood pressure drug, and his BP on arrival in office was 195/100.  None of his health care providers asked him about vaccination. I did, and was surprised to find the problem started just one month later. No symptoms other than marked hypertension. He states he had been quite healthy until this.
Second dose 65 days apart from the first vaccination; Tested positive for COVID-19, had very mild symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19, had very mild symptoms) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 65 days apart from the first vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID-19, had very mild symptoms) (seriousness criterion medically significant). On 07-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 65 days apart from the first vaccination) (seriousness criterion medically significant). On 03-May-2021, COVID-19 (Tested positive for COVID-19, had very mild symptoms) had resolved. On 07-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 65 days apart from the first vaccination) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, SARS-CoV-1 test: positive (Positive) Positive. On 03-May-2021, SARS-CoV-1 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment of these events were not reported.; Sender's Comments: The causality for the events is "Not Applicable"
Pt developed itching throat, nasal congestion, nausea with wretching within 3m after receiving vaccine.  She had experienced this previously after eating specific foods.   Pt would have brief relief of wretching, but after continued to persist, EMS activated.  Given 50mg IV benadryl and 4 mg Zofran with good relief.  Pt transferred to and observed in ER and given addition 4mg IV Zofran as well as IV pepcid 20mg and IV solumedrol 125mg .  Also given 2 sprays each side fluticasone.   Observed and discharged to home that evening at approx 1900.
Radial Neuropathy in left arm. Sensory and Motor involvement. Lower arm and hand muscles are not working. Numb area on thumb side of left hand.
3/13 - woke up at 3:00 am with  Fever at times up to 101.1 Chills/shivering Muscle pain Nausea Fatigue, but couldn't sleep Massive migraine.  Was told not to take tylenol and my random migraine medicine has tylenol in it so didn't want to take it. Took daily migraine meds at 6:30 am - but didn't even touch it   Spent the day with the screaming migraine.  Finally called family doctor around 3:00 pm and he said to go ahead and take the butalb/acetamin/caffeine.  This did get rid of the migraine for a while, but it did come back later in the evening and I had to take another. I was able to sleep that night.
24 hours after vaccine was administered, patient states she had an allergic rxn.  swollen and itchy eyes and hives on face and neck. Patient went to ER and was given Benadryl Injection and Benadryl capsules for home use. After a week symptoms still persisted and patient went back to the ER and was given a 3 day course of Prednisone.  Patient called pharmacy after the course of the Prednisone was finished without a resolution to the symptoms.  Patient called the pharmacy and we recommended patient to see PCP, or go to ER or clinic. Patient agreed and will go to ER or clinic.
Immediately after the shot was administered I felt a flush of warmth and dizziness, then my heart started racing. My pulse went from mid 60's sitting to 121 sustained. within 5 minutes my blood pressure spiked and it was 180's/110's consistently for 45 minutes. When the pulse settled around 95 bpm and the blood pressure was 145/95 they released me to go home.  I was monitored by paramedics.  I called my pcp and monitored for 5 days after as I could not get my BP and pulse to stabilize and was prescribed Bystolic 5mg daily and this has since regulated my pulse and BP.
This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown demographics. The patients' pertinent medical history, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of VARIVAX (dose and route were not reported) lot # L046887 and expiry date: 23-NOV-2017. The vaccine was exposed to a temperature of 23.5 Fahrenheit for a time frame of 63 hours. The call was received because of a data logger. No previous temperature excursions were reported. There was no adverse effects reported. No product quality complaint was involved. Additional information has been requested.
lymph node in the same side that is enlarging like really really big underneath his left armpit/it's getting larger and larger; lymph node in the same side that is enlarging like really really big underneath his left armpit/it's getting larger and larger; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 39 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 06Aug2021 08:15 (Lot number: EW0172) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 07Aug2021, outcome "not recovered" and all described as "lymph node in the same side that is enlarging like really really big underneath his left armpit/it's getting larger and larger". Therapeutic measures were taken as a result of lymphadenopathy, condition aggravated. Additional information- It was reported that Nurse stated, "My husband received a vaccine on 06Aug2021, Friday and he now has a lymph node in the same side that is enlarging like really  big underneath his left armpit and she was assuming the paperwork that could be a potential side effect and also reported that her husband was really healthy. He's in the gym everyday. No pre-existing health conditions and then all of a sudden this pops up right after getting the Vaccine. Patient also administer an anti inflammatory like Ibuprofen. about 45 minutes ago as a treatment.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse concerning a mother whose infant was vaccinated with a dose of Rotavirus. It was reported that the infant sneezed after receiving Rotateq and the infant's mother claimed the droplets of the vaccine became airborne and went into her mouth. Subsequently the mother was taken to the emergency room with a severe sore throat. No product quality complaint was involved. Follow-up information from a medical assistant indicated that they did not have an employee named as indicated and as a result they did not have any information on the adverse experience. It was reported that the event may have been a joke and not adverse event at all. Additional information is not expected.
Patient with altered mental status, unresponsive, temperature of 102, involuntary muscle contractions. Required intubation and remains intubated.
was in menopause.  last period Jan 2019.  period started again on 4/6/2021
Patient called 3/3 and wanted to know if she was contagious because she said her arm where I gave her the shot was red and she had been itching  (2/27 - 3/3) and was worried that she had shingles (2/27). B/C had flu-like symptoms (3/3).
presenting to clinic for arm pain, redness and swelling - Cellulitis of right upper extremity  Ceftriaxone 250 mg IM injection ordered and given to patient   ?rx written and sent for her to start Keflex 500 mg PO QID for seven days, with food   ?Advised on care instructions for cellulitis and strict ER and return precautions
Breakthrough case admission after three vaccines Moderna 4/17/21 Lot# 048B21A;  Moderna 5/15/21 Lot# 048B21A;  Moderna 6/30/22 LOt# 054A22A
Baby started crying about 2:30 AM; would not take bottle. Had a fever, was given Tylenol. Continued to fuss the entire day.
Pruritic rash occurred 8 days after shingles vaccination, treatment Triamcinolone Acetonide 0.1% cream.
Metallic tatse in mouth, headache, weak, tired, mild loss of taste and smell