chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a female in her 30's with asthma who in December 2007 "sometime this week," was vaccinated with pneumococcal 23 v Polysaccharide vaccine (lot # unknown). Subsequently, on an unspecified date the patient experienced irritation at the injection site, redness and swelling. No further information was provided. Additional information has been requested. This is one of two reports from the same source.
10 patients administered vaccine past the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  Date the vial was initially stored in the refrigerator: 26-Oct-2021 The pharmacist administered some vaccinations on 05-nov-2021 morning from a Moderna COVID-19 vial that had been punctured on 04-Nov-2021 at 9:40 am and was now past the 12 hour beyond use date. 10 patients received vaccine from this vial.
Chronic Myelogenous Leukemia.We do not have information on dates of the administration of Lymerix. My husband had 2 doses while he was employed. This would have been between the years 1985 and 1991.  12/30/2008 MR received from oncologist from 8/12/08 to 12/22/08 with DX:  Chronic Myelogenous Leukemia-chronic phase. Pt initially presented with 3 month hx of decreased exercise tolerance with SOB and dyspnea on exertion. Noted to have neutrophilia and thrombocytosis. DX with CML 2' to bone marrow bx results. Started on Gleevac. Continued to have fatigue with tx.
feel like every joint is twisting; Fatigue; Chills; cramps in my stomach; I cannot repeat, it just hurt my head even more; my head is so heavy; I cannot repeat, it just hurt my head even more; my head is so heavy; I can't speak right, just not feeling well; I had the booster yesterday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 08Dec2021 (Lot number: FH8027) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021, outcome "unknown", described as "I had the booster yesterday"; ARTHROPATHY (non-serious), outcome "unknown", described as "feel like every joint is twisting"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; CHILLS (non-serious), outcome "unknown", described as "Chills"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "cramps in my stomach"; HEADACHE (non-serious), HEAD DISCOMFORT (non-serious), outcome "unknown" and all described as "I cannot repeat, it just hurt my head even more; my head is so heavy"; MALAISE (non-serious), outcome "unknown", described as "I can't speak right, just not feeling well".  Additional Information: Consumer stated, "Look if I have to report this I am calling to through 'rc' I will feel tomorrow better and call you back. I'm having like post the vaccine (voice not clear) like not feeling well and I cannot repeat, it just hurt my head even more. I had the booster yesterday before noon I should say. I feel a little bit fatigue and 'feel better' in the evening but it was tolerable. But during the night time I started feel chills, shivers and cramps in my stomach and I feel like every joint is twisting and my head is so heavy. I don't think I do have a fever. But I can't even get up from the bed. Paraphrased the concern, Consumer stated, I had them over night, I didn't had them right away. I want to know is there anything that I can do to feel better. Is there any ideal for, I don't know for care of me, 'to gather' anything I can take just to feel better. Right now I'm not feeling well. I'm almost falling, I can't get up."  No follow-up attempts are possible. No further information is expected.
Pt received Johnson & Johnson vaccine on 6/12 @11:03 at the Vaccination Site. Patient started walking to observation area, reported feeling dizzy, lost consciousness, was assisted to the ground by staff at 11:05. When awakened, patient reported right elbow pain, headache, and was found to have a small amount of bleeding from his right ear. No preceding chest pain/palpitations/dyspnea, seizure activity, nor focal weakness. He was transported to the ED via EMS for further evaluation. In the ED patient reported previous history of syncopal episode with preceding dizziness several years ago but did not seek further evaluation. No nausea/vomiting. Evaluation revealed decreased hearing, drainage from ear, and right elbow tenderness. CT of head demonstrated right temporo-parietal bone fracture extending to skull base with blood within right mastoid air cells. Elbow x-ray showed no obvious fracture with right elbow contusion diagnosed. Trauma and neurosurgery further evaluated patient and recommended non-operative management of right temporal skull fracture extending into the auditory canal with no evidence of intracranial bleed nor depression. Hospital consulted and prescribed Ciprodex drops for 1 week with follow-up audiogram in 6 weeks. Patient to follow-up in trauma clinic or with PCP in 2-3 weeks. If hearing still muffled at follow-up, ENT will be consulted. Patient was discharge later in the evening on 6/12/2021.
A nurse reported a pt received vaccines on 10/4/00. The next day the child developed soreness at injection site.
Second dose not administered in allowed time; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose not administered in allowed time) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not administered in allowed time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose not administered in allowed time) outcome was unknown.        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.   It was reported that the patient did not experience any side effects after he received the first dose of vaccine. However, the patient had poor health status prior to vaccination with the first dose and was in hospital for unrelated" reasons during vaccination process, as described by the pharmacist. As a result, the patient missed her second dose appointment.  Concomitant medication and treatment drug were not reported.  Company Comment: This report refers to a case of product dose omission issue for the second dose of mRNA-1273 with no associated AEs reported after the first dose. There is no supportive information to assess the case as serious at this point.   This case was linked to MOD-2021-111911, MOD-2021-111912, MOD-2021-111913 (Patient Link).; Sender's Comments: This report refers to a case of product dose omission issue for the second dose of mRNA-1273 with no associated AEs reported after the first dose. There is no supportive information to assess the case as serious at this point.
In the evening of 11/18 after receiving the Prevnar13 vaccine, patient developed fever, chills and hallucinations. Woke up the next morning on 11/19 with terrible all over body pain. Patient called our office on 11/20 pain was only in her lower legs, pain improved when walking and taking ibuprofen 600mg three times to four times daily as directed by Dr. Patient called again on 11/22 to report her pain in her lower legs had improved but it was still present. At this time the patient requested we list the Prevnar13 vaccine as an allergy in her chart and wanted this reported as an adverse event. Dr. agreed.
Mass to right thigh t days following vaccine administration. Working diagnosis: sterile abscess started. Motrin, Keflex, warm pads.
fever, cough, runny nose, congestion, poor appetite, vomiting, headache, fatigue and chills.
PERIPHERAL NEUROPATHY 4/6/2022 ATHEROSCLEROSIS OF AORTA ACUTE PULMONARY EMBOLISM 5/28/2022 ATHEROSCLEROSIS OF AORTA HYPOTENSION 5/28/2022 ATHEROSCLEROSIS OF AORTA PERIPHERAL NEUROPATHY 4/6/2022 UTI (URINARY TRACT INFECTION) ACUTE PULMONARY EMBOLISM 5/28/2022 UTI (URINARY TRACT INFECTION) HYPOTENSION 5/28/2022 UTI (URINARY TRACT INFECTION) PERIPHERAL NEUROPATHY 4/6/2022 GROIN ABSCESS ACUTE PULMONARY EMBOLISM 5/28/2022 GROIN ABSCESS HYPOTENSION 5/28/2022 GROIN ABSCESS PERIPHERAL NEUROPATHY 4/6/2022 LARYNGEAL LESION ACUTE PULMONARY EMBOLISM 5/28/2022 LARYNGEAL LESION HYPOTENSION 5/28/2022 LARYNGEAL LESION PERIPHERAL NEUROPATHY 4/6/2022 GI HEMORRHAGE ACUTE PULMONARY EMBOLISM 5/28/2022 GI HEMORRHAGE HYPOTENSION 5/28/2022 GI HEMORRHAGE PERIPHERAL NEUROPATHY 4/6/2022 MELENA ACUTE PULMONARY EMBOLISM 5/28/2022 MELENA HYPOTENSION 5/28/2022 MELENA PERIPHERAL NEUROPATHY 4/6/2022 HYPOTENSION ACUTE PULMONARY EMBOLISM 5/28/2022 HYPOTENSION HYPOTENSION 5/28/2022 HYPOTENSION PERIPHERAL NEUROPATHY 4/6/2022 URINARY RETENTION ACUTE PULMONARY EMBOLISM 5/28/2022 URINARY RETENTION HYPOTENSION 5/28/2022 URINARY RETENTION PERIPHERAL NEUROPATHY 4/6/2022 ACUTE POSTHEMORRHAGIC ANEMIA ACUTE PULMONARY EMBOLISM 5/28/2022 ACUTE POSTHEMORRHAGIC ANEMIA HYPOTENSION 5/28/2022 ACUTE POSTHEMORRHAGIC ANEMIA
Rash & Tachycardia Narrative: TOOK OTC BENADRYL FOR ITCHING. NO OTHER MEDICEAL INTERVENTION NOTED.
patient was seen for large reaction on right thigh at the injection site measuring 15X15 mm area of erythema and warm to the touch. diagnosed with cellulitis and placed on abx.
Severe back pain on the same side as given Covid shot.  Sent me to the ER. Cankers in mouth on same side as given Covid shot
PATIENT REPORTED A RAISED ROUGH RASH WITH SWELLING AND HEAT THAT WENT FROM SHOULDER TO ELBOW. LASTED APPROXIMATELY 5 DAYS BUT HAS NOW RESOLVED. PATIENT TOOK BENADRYL AT THE TIME OF REACTION.
Cervical vertebra 7-vesicular rash, A-Zoster, Rx Acyclovir
After vaccine in the waiting area, my blood sugar went up to 250 and that was after drinking water only since the night before and no food. I stayed about 1/2 hour, no one could say if this happens,  About 12:30 or 1pm I wanted to sleep and slept 4 hours.  The next dayi experience sensitivity to light sound headache nausea dizzy and ringing in the ears. I had to take off work at 12:30 and every since then I have had a headache after trying to work only a few hours. I couldn't keep my head set on, cant talk or train because the headaches are too bad. My doctor prescribed Imitrex.  The Imitrex didn't even tough the headache, it just made me tired.
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent condition, concomitant drug and drug reactions/allergies were not reported. On 20-MAY-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route was not reported) lot # r024023, expiration date of 22-AUG-2019 for prophylaxis (product storage error). Other suspect therapies included sterile diluent (strength, dose, route of administration, lot/batch# and expiry date were not reported). No adverse effects were reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter.
Vaccines 12/22. Fever 104 degrees 12/23. Febrile seizure - ER, no tx.
Narrative: approx 5 minutes after vaccine administration, pt reported feeling tingling in arms and sensation of cold, "like a cool breeze". Symptoms lasted approx 1 minute then resolved. He denied other symptoms. Provided pt with water, monitored VS. Observed for additional 15 minutes. Pt reported all symptoms had resolved and he wished to return home.
C/O headache, dizziness and feeling like she couldn't walk. Mother gave her Tylenol. Went to ED but left after one hour without any treatment or being seen by a provider since mother refused to wait. Child indicated she was feeling better at that time. Mother thought some of the discomfort lasted 2 days.
I have been having facial swelling, mouth and face. Welts on torso butt and arms since a week after last vaccine 1/26.
mom called in am on 3/25 stating child developed fever, vomiting  (x 1), and diarrhea in the am.  no previous reaction to vaccine.  widespread community GI illness based on recent medical visits and parent calls.  patient is not in childcare.   home treatment for symptoms given with advice to call for appt if worsening symptoms.
Pt reports he felt lightheadedness, sweating, and flushing after receiving vaccine. Denies LOC. No previous reactions to vaccinations in the past. Pt had gatorade in hand at time of arrival to med obs #1. Pt able to stand and ambulate to stretcher from w/c independently without difficulty. Orthostatic VS obtained per MD request. No s/s of distress noted. VS at 1055: BP 131/74, HR 60, RR 17, O2 sat 96% on RA. VS at 1105: BP 130/73, HR 60, RR 16, O2 sat 99% on RA. VS at 1107: BP 142/68, HR 63, RR 16, O2 sat 98% on RA. VS at 1108: BP 149/78, HR 63, RR 17, O2 sat 98% on RA. Pt escorted to exit via w/c with staff.
Client received the 1st dose of the COVID vaccine (Moderna Lot #026C21A and expiration date 06/27/2021) at 1517. Client returned for her 2nd dose on 06/30/2021. Client reported that three hours after receiving her first dose she started to "feel body aches and took some aspirin." The client stated that the body aches lasted until the next morning, and when she woke up "half of my body felt numb on the side that I received the vaccine." She also stated that she was having "chest pain and shortness of breath." The client stated that she called EMS and was transported to the emergency room, at hospital, where they completed an MRI and gave her medicine. The client does not recall what medication she received, and she also stated that the doctor told her, "the MRI came back fine, and to follow up with my primary care provider." The client stated, "the medicine helped with the numbness." The client did not follow up with her primary care provider. The client has no known medical conditions, is not taking and medications, and has no known allergies.
Pt had fever but also extreme irritability, inconsolable x 7 1/2 hrs and seemed to be in pain esp both legs even with light touch. He was admitted for obs and D/C'd after 1 day fully recovered. Pt came into the office yesterday for 6 month well visit and received ROTA/PENTACEL/PVC has been very fussy since with fever and leg swelling to both legs; slept x 3 hrs after shots and then fussy throughout the day but inconsolable since 9PM last night; still drinking and wetting; no diarrhea; emesis sm amt x 1; TYLENOL helps with fever - TMAX 102 but not with fussiness; no rash. He presented with fever. It is described as acute. The symptom is sudden in onset. The symptom started 7 hours ago. The temperature is 102 degrees (maximum temperature). The frequency of episodes is daily. Episodes occur upon awakening. Important triggers include no known associated factors. The symptom is alleviated by TYLENOL. Pertinent findings include fatigue, denies abdominal pain, denies constipation, denies cough, denies nausea, denies vertigo and denies vomiting.
This spontaneous report as received from a medical assistant refers to a 14 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 16-JUL-2014 the patient was vaccinated with the first dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # J009243, expiry date: 23-APR-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013, and 1407USA013014 (same reporter link). Additional informatin has been requested.
Four days following administration of Fluarix, Lot Number AFLUA380CA, Expiration 6/30/09, I came down with facial palsy on the same side of the body (right) as the injection.  The palsy started with loss of taste sensation, moving through the mouth and up to the eye, resulting in partial paralysis by the following afternoon (complete paralysis of the mouth).  Current course of treatment is Prednisone and Zovirax in addition to Chinese herbs. 1/14/09 Reviwed ER medical records of 11/13/2008. FINAL DX: Bell's palsy Records reveal patient experienced gradual right sided facial numbness, inability to close right eye, droop right mouth, loss of right nasolabial fold x 1 day.  Tx w/antiviral & steroid meds.
On 06/19/2022 I had a loss of appetite and was very tired, woke up with chills and couldn't get warm.  I woke up around 2 a.m. on 06/20/22 and took a home test and was positive.  On 06/20/2022 I had an appointment for drive thru pcr test that came back positive. I had a virtual appointment on 06/20/2022 and received a prescription for antiviral Molnupiravir started same day. I felt better the next day and was back to normal routine. I started Monday 06/27/2022 feeling like I had a little cold and I am still having a little pressure in my chest like I have a cold.  I have continued to test positive for COVID-19 today.
Pt recv vax on 9/15/98; on same day pt exp urticaria on arms, neck & torso x 2wk; tx=Benadryl
With in 8 hours, starting running a fever and went to bed and took Tylenol before bed. When she awoke she could not move legs and pain severe in hips and knees and every joint in her entire body. And grew large lymph node inflammation the side of a size B out of left arm pit. Working in the hospital and was working at the vaccine client and  the pharmacy was working with the vaccination in drawing the syringes advised to take Tylenol and keep working.
pt recv vax 21AUG96 & 22AUG96 pt became achy & devel a fever of 103, nausea, vomiting & chills;23AUG96 pt exp a h/a;sx resolved 24AUG96;
@ inj site arm became red-yellow-red line devel swelled through to back severe h/a-bed rest required;
Pt was given vaccine that had been drawn up since 2:00 pm the previous day and  was in refrigerator over night
Dizziness,    Weakness,    JoinPain,   Nausea,  Short winded.
11-year-old female patient given the Pfizer vaccine indicated for those 12 years and older.
a patient was adminstered a 2 hours old vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a patient was adminstered a 2 hours old vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (a patient was adminstered a 2 hours old vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a patient was adminstered a 2 hours old vaccine) 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.    Reporter did not allow further contact
Localized area of redness and warmth surrounding injection site within 24 hours after injection (8x6 cm size). Possible cellulitis vs allergic reaction. Was treated with antibiotic for staph infection of left axilla following insect bite the week prior. Vaccine given in left arm. Sent to PCP for further eval and treatment.
"I got my second dose around 1pm on 1/22. At 3am I woke up with chills and fever 100.8. I took Tylenol every 6 hours. The highest my temp got was 101.8 on Saturday around 4pm. At that time I had body aches and headache too. Since then I?m been fatigued with a powerful headache, temps ranging 99.1 to 99.8. Taking Tylenol for the headache."
Patient DOB 10/4/1960 was vaccinated on 3/17/2021 with 1st dose Pfizer, lot ER2613 expiration date 6/30/2021. Patient reports medical condition includes hypertension. Allergies include sulfa and amoxicillin. Patient informed RN that after receiving the 1st dose she experienced "itchy thighs" within 3 hours that resolved 3 days later. Patient denied rash, heat, or redness. Medication includes blood pressure medication. RN notified PHN who texted PHN Supervisor, Manager, and QAS. Per medical team patient is to wait until 28 days post 1st Pfizer dose before receiving Janssen vaccine. Patient changed timing of itching to starting the next day after vaccine. Per medical team, patient is advised to consult with her provider first.