chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccinations given 7/2/08 @ 11:00am. TC from mother 7/3/08 stating  that patient had become fussy and whiney @ 5:00am 7/3/08.  She then suddenly developed a temp of 106 and that her legs and arms began twithching.  Mother gave the infant Tylenol and took her to the ER.  The ER assessed and monitored and then sent home when the temp was back to 98.  Mother states that patient is just really tired now.
headache quickly after seizure later in day (has chronic seizure disorder) Fever to 101.6F on 7/2/19
On 2/3/2021, 15 days after injection that was given on 1/19/2021, reported arm swollen red and hot to touch. 3 x3/1/2 inch whelped area. Pain to left arm, left shoulder, numbness and tingling to thumb palm and index and middle finger.  Assessed by physician - diagnosed with Cellulitis of arm.  Cephalexin 500 mg 4 times a day and Motrin 600mg as needed ordered.
81y.o. male past medical history of HLD, HTN presenting with constipation and rectal bleeding. Patient stated that he was constipated for the last 5 days and had tried OTC fiber that did not work well for him then he tried 2 fleet enemas together at the same time and felt sudden pain in his bottom but could not get his stool out. He reports that sometimes he tries to manually disimpact at times and it helps. This has been a chronic problem for him and he does admit to unhealthy diet including potato chips. In the ER, initial chemistry panel was unremarkable however CBC showed leukocytosis and low RBC count and H&H at 12.7/37.7 with normal MCV. Platelets are slightly decreased at 141. Patient was found to be COVID-positive. CT abdomen/pelvis with IV contrast showed inflammatory changes of the rectum likely proctitis. No immediate plans for inpatient endoscopic intervention, we do recommend following up outpatient for discussing possible flex sigmoidoscopy vs colonoscopy for further evaluation of his abnormal CT findings.
On Saturday04/03/21 the lymph node on the right low jaw was painful & swollen. On Sunday 04/04/21 my eyebrows, around my mouth, my chin & under my neck were excessively itching. To the point I felt like I had two chins. On Monday 04/05/21 my body began feeling itchy and during the evening I began seeing scanty rashes. By Tuesday 04/06/21 it was unbearable.  I could not sit still. Different areas would feel funny like a burning sensation, then wherever I feel the burning rashes would break out with severe itching. My body itched beyond relief. I sought medical treatment at Urgent Care Facility. I was given predisone40 mg daily & Benadryl for 5 days. Only today 04/09/21 I finally got relief. My breast & abdomen still very  tender, I took Photos of my rashed arm.
I had the usual  flu like symptoms that evening past the 2nd injection, but there was also unusual aches and erratic shooting pains in my limbs. I was pretty much over this by the end of the next day. However, I began breaking out in a raised itchy/stingy/raw or burning type rash on the exact sites that the leaflet shows where you would normally have shingles rashes. It is not severe, but nevertheless unusual and continues to be bothersome. Wondering if I don't have a case of the shingles??
Heavy arm tingling in right side of neck. Experienced after last shot not as bad. EMS evaluated. Stayed until 2:30 then home
Mother called this am, stating child had a temp 102 and was "lethargic", not as acting his usual self. He has no redness or warmth at injection sites. Told mom T. 102 was probably not unusual-treat with Motrin or Tylenol. If child is truly lethargic take child to Dr.
Moderna COVID-19 Vaccine EUA 1 hour after injection, vomiting ensued and persisted through the evening. Low-grade fever (treated with Tylenol).  Also experiencing weakness and fatigue.
Mother noticed some swelling around the injection site where he was complaining of pain as well.  The next day, he developed a fever Tmax 102F.
persistent chills and body aches for 3 days; Severe heat rash down the entire left side of  neck.; Lymph node swelling under bicep and in arm pit; Redness around injection site; Itchiness on upper back.; persistent chills and body aches for 3 days; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 19Apr2021 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Concomitant medications included sumatriptan (IMITREX), verapamil (MANUFACTURER UNKNOWN) and lactobacillus nos (CULTURELLE); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 25Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021, the patient experienced persistent chills and body aches for 3 days, redness around injection site with lymph node swelling under bicep and in arm pit along with a severe heat rash down the entire left side of neck and she also had itchiness on upper back. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events persistent chills and body aches for 3 days was resolved on 23Apr2021. The clinical outcome of the events redness around injection site with lymph node swelling under bicep and in arm pit along with a severe heat rash down the entire left side of neck and itchiness on upper back was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
No adverse event; Patient received Dose 1 on 23-Feb-2021 and Dose 2 on 14-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Dose 1 on 23-Feb-2021 and Dose 2 on 14-Feb-2022) and NO ADVERSE EVENT (No adverse event) in an 80-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 069H21A and 001A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Feb-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Dose 1 on 23-Feb-2021 and Dose 2 on 14-Feb-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Dose 1 on 23-Feb-2021 and Dose 2 on 14-Feb-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Dose 1 on 23-Feb-2021 and Dose 2 on 14-Feb-2022).    No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2023-704339 (Patient Link).
7mar86 pt found asystole by babysitter & EMT ,no resp effort,cyanosis,dilated fixed pupils,resp effort & cool skin/T;failed to respond to CPR;autopsy including brain microscopy revealed only pulmonary congestion; death due to SIDS;
Patients haven't completed the 2 dose series; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in an unspecified number of patient's who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Patients haven't completed the 2 dose series).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-SEP-2022 The reporter reported that the physician was interested in the efficacy data with just one dose of Shingrix vaccine. The reporter stated that the patients had not completed the 2 doses of series. Till the time of reporting, the patients did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
4 days after both vaccines, became extremely depressed for approximately 2 wks after each vaccine.  Just wanted to report definitely effected efficacy of my meds for Bipolar type 2
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Patient developed rashes on both arms the night after flu shot. Patient also had fever and chills. Patient went to Urgent Care on 1/15/13 and got a prescription for prednisone to treat the reaction.
Information has been received from a physician, via a company representative, regarding a set of triplets (age not specified), who on an unknown date was vaccinated with a dose of Gardasil (lot # not reported). Subsequently "one of the triplets" (a female) experienced some form of "paralysis." No further details were provided. The outcome of the events was not specified. Upon internal review, "some form of paralysis" was considered to be serious as an other important medical event. No further information is available.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 5/14/2021 and 6/04/2021. Presented to an ED  on 11/2/21 with right hand numbness and tingling and transient slurred speech.  Admitted and diagnosed with left parietal lobe infarct per MRI and received TPA.  In the early am of 11/6 he decompensated and requiring intubation. Taken to cath lab where an Impella CP was placed in the right femoral site. Required extreme high doses of inotropes and pressors with fever spikes.  Diagnosed with COVID- PCR + on 11/5/2021. Transferred to another Medical Center for ECMO. Patient noted to have lactic acidosis up to 20 on 11/5/2021, AKI with oliguria requiring CRRT, transaminitis with AST and ALT > 7000, and development of compartment syndrome requiring fasciotomies of RLE.  Patient required continued support of ECMO.  Code status was changed to DNAR-AND and he expired 11/10 am.
patient received Pfizer vaccine #1 on 3/25/2021, the 2nd one on 4/15/2021. she got abdominal pain starting on/around 4/15, then on 4/18 she went to the ER with severe pain, Nausea, vomiting, and had surgery for appendicitis. Unsure if the two are related but seems a bit too coincidental. so reporting as possible adverse reaction. she is now post laparoscopic appendectomy, pain is tolerable with pain medication. I was not with patient when she got her shots or when she went to the ER. did a virtual visit on 4/21/2021 as a follow up.
The same day I rec'd vaccine the following occurred  redness, swelling, tenderness @ deltoid area, febrile 101F, nausea, vomiting. All occurred within 8 hrs also severe headache  5pm. Then developed skin lesion on side of face near nose, which had trouble healing. Continued low grade fever and generalized malaise for 2 wks. Reported incident to private physician. My R deltoid remained swollen, tender for week.
This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Dec2021 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine nRVV ad26 (JANSSEN COVID-19 VACCINE), on 08Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing), notes: Other medical history: obesity; "depression" (unspecified if ongoing), notes: Other medical history: depression. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was not pregnant, No other medications in two weeks. No other medications in two weeks. If treatment AE, no. No known allergies. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
cellulitis, right arm, at site of injection.  tx with Keflex.  Pt has not yet f/u, so outcome unk.
3:50 PT C/O EYES BURNING FACE FLUSHED, BP 240/132 HR 112 SKIN MOIST  NO SHORTNESS BREATH , PT ASATES HX HTN BUT HE STOPPED MEDS A YEAR AGO BECAUSE THEY WERE NOT WORKING. 3:55 HR 104  4:00 PM BP 216/142 REFERRED TO ER- AMBULANCE CALLED  4:05 BP 240/132-   TURNED OVER YTO AMBULANCE STAFF =   4:45 AMBULANCE STAFF OBSERV ED PT TIL BP RET'D NORMAL AS PT REFUSED TO GO TO ER
ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 4/24/2023 HX OF STROKE
The vial was initially stored in the refrigerator on 31-May-2023 and administration of vaccine was 17-Jul-2023; No adverse event; Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administration of vaccine was 17-Jul-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 17-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administration of vaccine was 17-Jul-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administration of vaccine was 17-Jul-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administration of vaccine was 17-Jul-2023).    It was unknown if the patient any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Vial was individual vial with multi dose 0.5 ML. It was not reported if the vial undergoes any temperature excursions or not. Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 12 out of 19 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733761:
When I caught COVID-19 I had mild symptoms. In the afternoon I felt tired more so than I normally would. I had a tiny bit of an upset stomach, but I had no vomiting. I just felt queasy. I had a runny nose and a dry throat. I called my doctor, and I was prescribed Paxlovid. I took the 5 day course, and I feel fine.
Dose 1:  mild pain at injection site Dose 2:  moderate pain at injection site; fatigue, chills, muscle aches, low grade fever (100), headache
Vaccine was stored on refrigerator on 21-Sep-2021 and then administered on 22-OCT-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 21-Sep-2021 and then administered on 22-OCT-2021) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 21-Sep-2021 and then administered on 22-OCT-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 21-Sep-2021 and then administered on 22-OCT-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported. On 21-Sep-2021, the vial was placed in the refrigerator. The vial did not have any temperature excursion and the patient had no adverse event. No Treatment medication reported.
Warm to touch; itchiness; mild hardness, pinkish skin color around the injection site that had spread about a size of a palm on the left arm.
he tested COVID-19 positive; he tested COVID-19 positive; fever and chills; fever of 100.5; takes all his energy to walk around or eat or do anything; injection site turned red and sore; injection site turned red and sore; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 15Feb2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL2347), intramuscularly, in the left arm, on 29Jan2021 at 11:00 at single dose for COVID-19 immunisation. Medical history included esophageal cancer from 2020, had major surgery from an unknown date about 4 months ago, and a third of his esophagus was taken out from an unknown date. There were no concomitant medications. No history if immunizations were provided. No other vaccines within 4 weeks prior to vaccination. The patient had the first dose on 29Jan2021 at 11:00 at a site sponsored by the health department, on 12Feb2021, it was reported that patient tested COVID-19 positive. On 31Jan2021, the patient reported that he had chills and a fever of 100.5, a couple times his fever spike up and goes away. He does not want to do anything since it takes all his energy to walk around or eat or do anything. On 29Jan2021, after the injection, the patient reported injection site turned red and got sore. He is asking how long the symptoms last. The events did not require physician's office or emergency room visit. No treatment was given. The outcome of the events injection site turned red and sore was recovered while for the rest of the events was unknown. The patient was asking if he should get the second dose.
8 hours after MMR, pt became very irritable and c/o pain right ear. Mom noted swollen neck and face. Today (apprx 18 hours later). right ear very erythema and swollen, mild LA appreciated.
Return of covid symptoms; Return of covid symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 08Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "acid reflux" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE], start date: 28Apr2022, stop date: 01May2022; TYLENOL, start date: 01Jan2022, stop date: 10May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Return of covid symptoms". Therapeutic measures were taken as a result of covid-19. Clinical information: Patient has received other medication in 2 weeks. It was reported that return of covid symptoms 5 days after completion of Paxlovid despite complete isolation.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Deathly sick; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) on 09-Nov-2020.  This case involves a patient with unknown demographics who experienced deathly sick (Illness), when received vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced deathly sick (Illness), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  It was not reported if the patient received a corrective medication.  At the time of reporting, the outcome was unknown for the reported events.  There will be no information available on batch number for this case.
a pediatric patient received an adult dose of Havrix in error.; a pediatric patient received an adult dose of Havrix in error.; This case was reported by a physician via call center representative and described the occurrence of adult product administered to child in a 11-month-old male patient who received HAV (Havrix 1440 adult) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On an unknown date, the patient received Havrix 1440 adult. On an unknown date, unknown after receiving Havrix 1440 adult, the patient experienced adult product administered to child and accidental overdose. On an unknown date, the outcome of the adult product administered to child and accidental overdose were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that the pediatric patient received an adult dose of Havrix in error, which led to adult product administered to child and accidental overdose. The reporter consented to follow up by mail.