chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received on 08-MAY-2017 from a licensed practical nurse regarding a 4 month old infant (gender not provided). Medical history, concurrent conditions and concomitant medications were not reported. On 12-SEP-2016 the patient was administered a dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. Administered dose of vaccine experienced a temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004981: US-009507513-1705USA004982: US-009507513-1705USA004983: US-009507513-1705USA004984: US-009507513-1705USA004985: US-009507513-1705USA004944: US-009507513-1608USA012794: US-009507513-1705USA004953: US-009507513-1705USA004954: US-009507513-1705USA004955: US-009507513-1705USA004956: US-009507513-1705USA004957: US-009507513-1705USA004958: US-009507513-1705USA004959: US-009507513-1705USA004960: US-009507513-1705USA004961: US-009507513-1705USA004962: US-009507513-1705USA004963: US-009507513-1705USA004964: US-009507513-1705USA004966: US-009507513-1705USA004967: US-009507513-1705USA004968: US-009507513-1705USA004973: US-009507513-1705USA004972: US-009507513-1705USA004971: US-009507513-1705USA004970: US-009507513-1705USA004969: US-009507513-1705USA005004: Original case 1608USA012908; US-009507513-1705USA005005: Original case 1608USA012908; US-009507513-1705USA005006: Original case 1608USA012908; US-009507513-1705USA005007: Original case 1608USA012908; US-009507513-1705USA004946: Original case 1608USA012916; US-009507513-1705USA004975: Original case 1608USA012916; US-009507513-1705USA004974: Original case 1608USA012916; US-009507513-1705USA004899: Original case 1608USA012916; US-009507513-1705USA004898: Original case 1608USA012916; US-009507513-1705USA004897: Original case 1608USA012916; US-009507513-1705USA004896: Original case 1608USA012916; US-009507513-1705USA004895: Original case 1608USA012916; US-009507513-1705USA004894: Original case 1608USA012916; US-009507513-1705USA004893: Original case 1608USA012916; US-009507513-1705USA004892: Original case 1608USA012916; US-009507513-1705USA004891: Original case 1608USA012916; US-009507513-1705USA004890: Original case 1608USA012916; US-009507513-1705USA004889: Original case 1608USA012916; US-009507513-1705USA004888: Original case 1608USA012916; US-009507513-1705USA004887: Original case 1608USA012916; US-009507513-1608USA012794: US-00950.
From faxed correspondence received at manufacturer on 11/26/2002, it was reported that a 1-month-old female infant was vaccinated with ACTHIB, Aventis manufacturer, lot #UA666AA, IM in the right thigh, IPOL, Aventis manufacturer, lot #1645-2, IM in the left thigh, TRIPEDIA, Aventis manufacturer, lot #U0582AA, IM in the right thigh and HEPATITIS B VACCINE, Merck manufacturer, lot #0513M, IM in the left thigh at 11:00 a.m. on 11/14/2002. All of the vaccinations given on this date were primary doses, except for the Hepatitis B vaccine, which was the 2nd dose. The pt received a 1st dose of HEPATITIS B VACCINE, Merck manufacturer, lot #0513M, IM in the right thigh on 10/17/2002. The pt experienced redness and puffiness at the injection site and inconsolable at 12:00 p.m. on the same day as vaccination. The pt recovered. Linked to cases: U2002-01114, U2002-01115, U2002-01117 and U2002-01138.
NO ADVERSE reaction known. The medical assistant did not add correct amount of diluent to the vial of  baby/young child covid vaccine prior to injection.  She only added 0.1 ml of diluent and then administered 0.3 ml of the solution.   I spoke to mother of child today.  Child is fine and was fine yesterday.   no fever. acting well.   no adverse signs of symptoms.
Second COVID 19 Moderna injection administered in upper left arm pharmacy. Needle left in for one minute. When I asked the nurse if she was almost finished because my ears popped and I felt like I was going to faint, I was told that she could not because my arm was "small." Injection site also seemed high on arm. Excruciating pain, 8 days later, at all times but worsens at night. Can't move arm. Left arm completely immobile.
Fatigue, nausea, fever (101.6), pain of left arm, general achiness.
Administer expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. HCP administer expired vaccine to patients, after the manufacture date of expiration and wanted an assessments on the case.  Number of doses/vials:168 doses Date the vial was initially stored in the refrigerator was unknown. Date(s) of administration of vaccine 10-Nov-2021 and 11-Nov-2021. The vial did not undergo any temperature excursions.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information. Additional reporter added
I do not think my event has any connection to a vaccine (aside for a sore injection site for less than a day). I began to experience unexplained vomiting starting at work (elementary school with constant KN95 use) on 10/19.  Vomiting became too intense to work, hydrate or eat on 10/24 urgent care. Prescribed anti nausea could not be kept down. Went ER 10/25. Suspicious lump (noticed in mid September) on abdomen was CAT scanned. I was given a terminal diagnosis of stage 4 metastatic cancer 9 inch tumor by stomach, other tumors: wrapped around colon, seeded throughout omentum, right ovary, on liver, spleen and lung differences deemed "suspicious in context." Also, I had a thorough upper and lower abdominal ultrasound the first week of August, for painful frequent gas but there were no masses observed.
Fever of 100 to 103 persistent since evening of vaccine. Because Mom's described "lethargy" not relieved by antipyretics went to ER next morning. ER dx OM, Rx'd Abx. Fevers gone by 9/15/07. Small lump at shot site 9-25-07.
Severe swelling of the right side of face, especially in the area around the jaw and ear (TMJ area). The swelling started to go down the jaw to the throat area.  I was unable to move my mouth without pain and discomfort from the swelling.
Patient noticed rash 30 hrs after vaccine and the next day it got worse so the day after that-3/20-patient went to MD to get it checked. Rash went from elbow up towards back of shoulder. It was itchy, red, swollen and hot to touch. MD gave cefadroxil. Pt started cefadroxil 3/20 at 6pm. Rash was getting better by 3/21 12pm.
Flublok Quadrivalent at age 16 and 17 years of age with no AE; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2019SA304586, 2019SA304587, 2019SA304588, 2019SA304589, 2019SA304580, 2019SA304591 and 2019SA304592.  This case involves a 16 years old patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA1938, expiry date: 30-Jun-2020) unknown route, indication and dosing details in Oct-2019 (not confirmed if 1st, 2nd or 3rd Oct-2019)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to product administered to patient of inappropriate age. It was reported that patient received Flublok Quadrivalent at age 16 and 17 years of age.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
7/13/20 GI bleed -> hospitalized for intussusception reduced with enema
PATIENT REPORTED SMALL RED RAISED RASH THE "SIZE OF HER LITTLE FINGER AT THE SITE OF INJECTION".
nausea & vomiting, diarrhea, t102, was seen @ hosp ER tx for dehydration
Patient lost consciousness immediately after injection. Patient regained consciousness, very pale-stated very tired, stomach upset. Seemed as if short of breath. He described felt as if bug bite on his throat and cough. Called 911. Patient was checked out and released with father. Patient stated he started to feel better after 911 was called. He states he didn't eat much that day.
4 expired doses were administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 expired doses were administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 expired doses were administered). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (4 expired doses were administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that  4 patients received an expired vaccine. It was reported that vials were transported in a cold container and remained cold the entire time while being transported.   This case was linked to MOD-2021-387476, MOD-2021-387484 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Number of patients and gender confirmed and additional information received. On 15-Nov-2021: No new information.
Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist via phone. This case is linked to case 2018SA331498. This case involves an elderly female patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (Batch number: UJ04AB, expiration date: 20-Jun-2019, site of administration: right deltoid and route was not reported) on an unknown date instead of Pneumonia vaccine. The patient had also received a prior FLUZONE HIGH DOSE (Batch number, expiration date, site of administration and route was not reported) at her HCP's office in Sep-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered and extra dose administered. FLUZONE HD vaccine was administered today to a husband and wife for the second time this season instead of the Pneumonia vaccine. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Swollen lymph node in left armpit; This is a spontaneous report from a contactable other health care professional (patient herself). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 15Sep2021 at 16:00 (at the age of 59-years-old) (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Medical history included sensitive to most medications. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 17Sep2021, at 13:00, the patient experienced swollen lymph node in left armpit. No treatment was received for the event. The outcome of the event was not resolved.   No follow-up attempts are possible. No further information is expected.
Patient with bronchospasm started 24 hours after vaccination, not improving with with steroids. Bagonits and Advair. Still persistent.
Patient was given incorrect COVID vaccine age range. Received the 12 years and up, when patient should of received the 5 years to 11 years COVID vaccine. Spoke to mom of patient and she stated that there had been no symptoms or reactions.
fever, aches, and a headache; fever, aches, and a headache; fever, aches, and a headache; patient feels woozy; head tingles; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever, aches, and a headache), PAIN (fever, aches, and a headache), HEADACHE (fever, aches, and a headache), DIZZINESS (patient feels woozy) and PARAESTHESIA (head tingles) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever, aches, and a headache), PAIN (fever, aches, and a headache), HEADACHE (fever, aches, and a headache), DIZZINESS (patient feels woozy) and PARAESTHESIA (head tingles). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever, aches, and a headache), PAIN (fever, aches, and a headache), HEADACHE (fever, aches, and a headache), DIZZINESS (patient feels woozy) and PARAESTHESIA (head tingles) outcome was unknown.
Swelling, redness, itchy in a 5 x 10 cm oral area at site of vaccination.
Sharp pains in shoulder at side of injection since March18 , radiating to upper and lower arm. and left hand multiple times a day.
Exacerbation of pre-existing tinnitus:  One hour after receiving the vaccine my tinnitus became very pronounced.  Constant high level volume and consistent tone.  This not the typical presentation of my tinnitus.  It lasted without interruption from 6:15 on April 1 to 12:30 PM on April 2.    It has since returned to a more typical presentation but I don't know if it will prolong my recovery from tinnitus or contribute to it being a permanent chronic condition.
This is a spontaneous report from a contactable pediatrician and nurse via a Pfizer sales representative. A 13-year-old male patient received first dose (three dose series) of TRUMENBA (Lot# J29203, Exp date 01Jun2016), intramuscular in right arm, on 27Apr2015 at approximately 03:15 pm, at 0.5ml single. He left the reporter's office at 3:30 pm feeling fine. The patient was otherwise healthy, no other medical conditions. Concomitant medication included first dose (three dose series) of HPV vaccine (Lot# L004601, Exp date 04Nov2016), intramuscular in the left arm, on 27Apr2015 at approximately 03:15 pm, at unspecified dose and frequency. On 27Apr2015 the patient experienced pain at the injection site, headache, fatigue, nausea, extreme dizziness, right arm feeling sore or painful, pallor and chills. The patient came back to see the doctor on 28Apr2015 at 11:45 am for extreme dizziness and other side effects. At doctor's visit he could barely lift his right arm. The patient was running into corners of the wall when he had the dizziness. Patient stated he felt like blood rushing through him fast (Apr2015). On 29Apr2015 the patient experienced trouble walking: needed to go down stairs on his back, and could not walk down the stairs because of weakness in legs. On an unspecified date the patient experienced fever. The patient was completely checked out and examined at hospital and was diagnosed with convulsion disorder, for which received treatment. He was brought to the emergency room (ER), where full neurological work up was performed. Outcome of events trouble walking, weakness in legs and extreme dizziness was not recovered at the time of this report. Outcome of the other mentioned events was unknown. The reporting physician did not think side effects had anything to do with the HPV vaccine, he thought they were from TRUMENBA. Follow-up (05May2015): new information received from a contactable pediatrician via a Pfizer sales representative includes: event "Convulsion disorder" added, lab data added.
had a stroke; upper respiratory infection; sick; in bed; This serious case was reported by a consumer via interactive digital media and described the occurrence of stroke in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced stroke (Verbatim: had a stroke) (serious criteria death and GSK medically significant), upper respiratory tract infection (Verbatim: upper respiratory infection) (serious criteria death), sickness (Verbatim: sick) (serious criteria death) and bedridden (Verbatim: in bed) (serious criteria death).  The reported cause of death was stroke, upper respiratory tract infection, sickness and bedridden.   It was unknown if the reporter considered the stroke, upper respiratory tract infection, sickness and bedridden to be related to Shingrix.     It was unknown if the company considered the stroke, upper respiratory tract infection, sickness and bedridden to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-OCT-2023 This case was reported by a patient via interactive digital media. It was reported that the patient was sick in bed with upper respiratory infection and side effects from Shingrix vaccine. The reporter stated that the only person he knew had a stroke afterwards and died within two years of complications. The follow-up could not be possible as no contact details were available.; Reported Cause(s) of Death: Stroke; Upper respiratory tract infection; Sickness; Bedridden
Per pt had orange size lump/ swelling/ redness - sore to touch first 24h - used ice - advised use allergy crm & ice for sx
The patient has a history of rheumatoid arthritis. She was brought to the Hospital ED by EMS on 4/22/23 with diarrhea and dizziness. She has had continuous loose stools and vomiting since 4/1/23. She had been evaluated at an outside ED and clinic previously, however returned to the ED due to persistent diarrhea, nausea, cough, fever, and dizziness. She was admitted 4/22/23. On day of admission, she tested positive for COVID by PCR. Notably, she previously tested positive in February 2023; she reports she tested negative following this episode of illness. During admission she did require supplemental oxygen up to 15L O2.  She was treated empirically for possible bacterial pneumonia. On 5/2/23 she was transferred from this Hospital to a different Hospital due to need for bronchoscopy. On 5/4/23, the patient had worsening oxygenation which prompted eventual transfer to the ICU and treatment with BiPAP. She suddenly worsened on 5/7/23 and was intubated. Following this, she developed nonperfusing ventricular arrhythmias - CPR was done, however the patient did not survive and passed away 5/7/23. Discharge diagnoses included COVID infection with pneumonitis and acute hypoxic respiratory failure, among other diagnoses.
Nausea,  vomittin, pain in left arm, fatique, extremely tired, achy muscles,
Past 35 days for the second dose; 17 yrs son received Moderna; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 yrs son received Moderna) and INTENTIONAL PRODUCT USE ISSUE (Past 35 days for the second dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 yrs son received Moderna). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Past 35 days for the second dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 yrs son received Moderna) and INTENTIONAL PRODUCT USE ISSUE (Past 35 days for the second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  No treatment medication was reported.  Patient was not able to receive the second dose due to being under 18 years old. Caller wanted to know what to do because he is past the recommended time.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up received: Reporter slider first and second were added. Suspect action taken updated Not applicable from unknown.