chrisvoncsefalvay/vaers-outcomes huggingface dataset:
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; 190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant products were not provided. Treatment medication were not reported. Unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Per pt a few hours after vaccine noted that his entire tongue felt "like when you burn it on something hot." It has persisted since then, no worsening, no other symptoms. Just wanted to get it checked out and documented.
o Mild headache, nausea 8 hrs post vac, which resolved next day  o Itchy systemically, urination urgency 10 hrs post vac, both resolved by next day o Slight wheezing 32 hrs post vac, which resolved within few hrs
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Type 2 diabetes mellitus, Hypercholesterolemia, Vitamin D deficiency, Gastropathy and Drug allergy (HYDROCODONE ALLERGY). Concomitant products included METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET) from 22-Feb-2022 to an unknown date for Diabetes mellitus, AMLODIPINE from 19-Oct-2021 to an unknown date and LISINOPRIL from 19-Oct-2021 to an unknown date for Hypertension, CALCIUM, ERGOCALCIFEROL (CALCIUM/VITAMIN D [CALCIUM;ERGOCALCIFEROL]) from 14-Dec-2020 to an unknown date for Vitamin D deficiency.    On 17-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) to be not related.    No treatment information was provided.
Broke out in a rash on my neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 10Feb2022 (Lot number: FL3198) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 12Feb2022, outcome "unknown", described as "Broke out in a rash on my neck".  Additional information:Consumer stated, "On her neck. She want to know if the vaccine was not kept cold enough (Further clarification unknown) could that cause a reaction? Phone Out 1:43PM, 1st attempt by phone to consumer to obtain mailing information. Phone answered by consumer who provided mailing address and stated she has been experiencing 'other things'.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant refers to a 14 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-JAN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II lot # L031601, expiration date: 18-FEB-2018 (exact dose, therapy type, anatomical location and route of administration were not provided). This is one of several reports received from the same reporter. This is one of two reports concerning the same patient. Additional information has been requested.
They were very cold; They felt foggy and not themselves at all; They were very very tired, and slept for a day and a half.; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (They were very cold), FEELING ABNORMAL (They felt foggy and not themselves at all), FATIGUE (They were very very tired, and slept for a day and a half.) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced FEELING COLD (They were very cold), FEELING ABNORMAL (They felt foggy and not themselves at all), FATIGUE (They were very very tired, and slept for a day and a half.) and PYREXIA (Fever). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. In February 2021, FEELING COLD (They were very cold), FEELING ABNORMAL (They felt foggy and not themselves at all), FATIGUE (They were very very tired, and slept for a day and a half.) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product used was high blood pressure medication NOS and heart condition medication NOS.   This case was linked to MOD-2021-113925 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow-up information from the patient updated the outcome for all events to recovered. The patient reported they are doing fine and recovered from all the events, which only lasted for eight hours.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The patient was prescribed PNEUMOVAX 23 (dose, route and lot number were not reported) but received an unspecified product manufactured by Glaxo Smith Kline (lot number H45098, exp. date was not available) (dose, route and indication were not reported). No adverse event was reported. Additional information has been requested.
Large 5 inch round red hot and hard spot on arm, 102.9 fever severe headache and body aches, fatigue.
This spontaneous consumer report (initial receipt 15-Jan-2015) concerns a 63 year old female patient. The patient had medical history of an allergy to mercury. On 02-Jan-2015, the patient received intramuscular AFLURIA (batch number 'T511708') at 0.5 ml annually. This was the first time the patient received the flu shot. The patient did not receive seasonal influenza vaccine or monovalent 2009 H1N1 vaccine in the past. On 02-Jan-2015, after the injection, the patient experienced redness, swelling, bruising and a hot to touch bump, where the shot was administered. The patient described the bruise as 4 inches in length and 2 inches wide. Later, her arm could not move or rotate and she felt tingling in her hands - both of which caused her difficulties in getting dressed. Two days later, she felt pressure and burning when trying to urinate. Approximately three days later, she had a temperature of 103 degrees Fahrenheit fever. She also experienced a severe headache and nausea and could not eat or drink. This caused her to be dehydrated and she also passed a kidney stone recently. She saw the physician for kidney stone. The patient received treatment with acetaminophen for fever and headaches from the 02-Jan-2015 until 07-Jan-2015 which did not alleviate her symptoms. The patient also received treatment for kidney stones. The outcome was reported as not yet recovered (recovering but not fully recovered), except for the event of arm could not move or rotate and hand tingling which resolved on 07-Jan-2015. Reporter comments: The reporter causality/relatedness was assessed as related. The patient required consultation with a doctor but no admission to hospital to hospital emergency department.
Dizziness, Hot flash. Laid supine for 30 minutes, while repeatedly checking blood pressure.
Vaccine administered from the syringe that was withdrawn the day before; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered from the syringe that was withdrawn the day before) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered from the syringe that was withdrawn the day before). On 25-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered from the syringe that was withdrawn the day before) 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 concomitant medication was reported.
Round reddish, raise, itchy warm Left arm Left anterior arm  Benadryl prefilled liquid 4x for 2 days.
Rash to face, arms and legs. ITCHY. Dizziness, Syncopal episode
anterior cervical fusion; Headache; tested positive for COVID-19; tested positive for COVID-19; muscle aches; Loss of taste; Loss of smell; Nausea; sore arm; Tiredness; This is a spontaneous report from a contactable nurse (patient).  A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot  EJ1686, intramuscular in right deltoid on 03Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included ongoing essential tremor started in her 50's.  The patient's concomitant medications were not reported.  The patient did not receive other vaccine within four weeks.  On 03Jan2021 the patient experienced sore arm and tiredness.  On 07Jan2021 the patient experienced anterior cervical fusion and was hospitalized from 07Jan2021 to 09Jan2021. On 08Jan2021 the patient experienced nausea. On 09Jan2021 the patient experienced muscle aches, loss of taste and loss of smell. On unknown date the patient experienced headache. The patient was tested positive to COVID-19 on 11Jan2021. The patient did not visit Physician Office or Emergency Room. Laboratory data included COVID-19 Rapid Test positive on 11Jan2021. The outcome of the events tested positive for COVID-19, and anterior cervical fusion was unknown. The outcome of the events sore arm, tiredness, nausea, muscle aches, headache was resolving. The outcome of the events loss of taste, loss of smell was not resolved.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 03Jan2021, and COVID-19 test positive on 11Jan2021.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use.  This 69-year-old female had medical history of ongoing essential tremor started in her 50's.  The reported anterior cervical fusion was most likely due to concurrent disease, and unlikely causally related to the vaccine of BNT162B2.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient developed erythema of deltoid, then the next day had swelling of the whole arm down to his hand, right arm. Visited ER on 10/07/11 and 10/09/11 pm and was admitted for iv antibiotic/steroids.
After severe coughing problems not solved by zpac antibiotics, routine blood test taken when follow up on cough and noticed very high creatinine level. Took blood test again 2 days later and level was even higher. went to emergency room for sonogram of kidneys and every thing was okay. went to nephrologist next day - more blood work. number continued to go higher. went on low does of steroids. two weeks later, number was very high and checked into hospital for kidney biopsy. determined it might be an allergic reaction to pantoprazole. stopped taking that along with some other medications, put on high doses of steroids on hospital. continued with oral steroids after release from hospital. weaned off steroids over 2 months but creatinine level started to go higher again. back on steroids for another 2 months got the numbers to an acceptable level but not back to normal. now on maintenance drugs to keep inflamation of kidneys down. Creatinine slowly is creeping back up again - now at 2.32 - taking imuran once a day.
Immunization reaction - erythematous blanching rash started on left side of chest -patient was given MMRV and DTaP-IPV and flu shot.  Within about 15 min she started to develop a faint red rash around her left side of neck and chest that seemed to be spreading and was on her left arm.  No pain.  No vomiting. No trouble breathing. Was well appearing at baseline behavior and energy.   -benadryl 12.5 mg given in office, patient observed for about 5 min was very well appearing, mom was taking her home, discussed signs to watch out for and to call office with any changes -can give 12.5 mg of diphenhydramine every 6 hours for the next 24 hours if needed.
Lip swelling in first hour that lasted for weeks. Severe digestive problems that did not exist before the vaccine. Severe constipation for first ten days. Constant abdominal pain, constant flatulence, constipation lasting for several months. Bouts of severe blood never seen before. Incomplete recovery after 4.5 months.
Initial report received on 30 November 2007 from a health care professional. A 35-year-old female patient had received an intramuscular injection of ADACEL, lot number C2842AA, on 24 October 2007. Site of administration was not provided. The patient's last menstrual period was 20 October 2007. It was determined that the patient was pregnant. The estimated date of delivery was uncertain at the time of this report. Current medications included Nasonex. Per the reporter, the patient did not experience any adverse event. Follow-up information was received from the health professional on 16 June 2008. In addition to ADACEL, the patient also received an intramuscular injection of FLUZONE (lot number U2437AA) on 24 October 2007. The reporter did not consider the patient to be pregnant at the time of vaccination, as the date of last menstrual was 20 October 2007 and the patient received the vaccines on 24 October 2007. No additional information was provided. Follow-up information received on 25 July 2008 from the original reporter who is a health care professional. The ADACEL and FLUZONE SV 2007-2008 administered to the patient on 24 October 2007 were the first, and fifth doses the patient had received of these vaccines respectively. The patient's estimated date of delivery was on July 28, 2008; however the patient experienced a spontaneous abortion (also reported as miscarriage) approximately two months post-vaccination of one single fetus beginning in December 2007 that was confirmed on 02 January 2008. The patient was less than 20 weeks gestation. The reason for the spontaneous abortion was not known, but the patient's Beta HCG's levels had been decreasing in value that indicated a "miscarriage." The patient had not received any prior treatments for infertility, and had not experienced any illnesses during the pregnancy. No prenatal testing had been completed. At the time of this report, it was "unknown" if the patient had recovered. After review of this new information, this case was upgraded to serious.
tested Covid-19 Positive; tested Covid-19 Positive; This is a spontaneous report from a Pfizer-sponsored program received from a contactable Pharmacist. A male patient of an unspecified age received first dose of BNT162B2 (BNT162B2), via an unspecified route of administration on 22Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested covid-19 positive on an unspecified date and reported as medically significant. It was reported that the patient got the first dose of the vaccine last 22Mar2021 and he was tested Covid-19 Positive before he can take his second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and COVID-19 the suspect drug BNT162B2 .
Pain at injection site, complete loss of appetite, nausea/vomiting, weakness, and proctitis. Rushed to emergency on 3/19/2021. Discharged from hospital on 3/21/2021. Passed away on 4/22/2021
I was given the shot at my doctor's office by his nurse. Initially, my arm was just sore then the following day, my arm was sore and swollen with a red bump. The next few days, I also had a low fever, body chills and had problems moving my arm. Around the fourth day, my red bump had turned into a large welt from one side of my arm to the other side. This is when, I went to an online clinic and reported and sent a picture to the provider. A couple of days later the redness went away however, I still have a welt scar on my left arm.
Vaccine was PPSV, 23 - valent. Large red rash that grew from quarter size to palm of hand size with hard knot and noticeable heat under injection site over 4 - 5 days.  Hard knot at injection sites still present on 07/29/15.  Fever of ~ 101 F on 7/21, 7/22 and 7/23. Fatigue, general aches in body finally gone 07/25/2015.
This spontaneous report as received from a consumer, as part of a marketing research program conducted by Evolution Marketing Research, refers to her daughter's friend of unknown gender and age. On an unknown date, the patient was vaccinated with the second dose of GARDASIL (dose and lot# not reported). It was reported that the patient "stayed puffy for a couple months" after 2nd shot and finished off the series. This is one of several reports received from the same source. Additional information is not expected.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 20-JUL-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M000996, expiry date 07-JAN-2018, dose, strength, vaccination site, route unspecified). The vaccine was exposed to a temperature of 6.5 Fahrenheit (F) for 80 hours. Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
He also had a fever with the 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date 05Feb2021 (Lot number: EL3302) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (ongoing), notes: Diagnosed about 15 years ago; "Blood pressure high" (unspecified if ongoing); "Heartburn" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for hypertension (ongoing); PRILOSEC taken for dyspepsia (ongoing). Vaccination history included: Bnt162b2 (1st dose, Lot: EL1283, NDC: Unknown, Expiry Date:14Oct2021), administration date: 19Jan2021, when the patient was 51 years old, for COVID-19 Immunization.  The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "He also had a fever with the 2nd dose".  No follow-up attempts are possible. No further information is expected.
flu; Initial information was received on 19-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age of male patient who experienced flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength,lot number not reported) via unknown route in unknown administration site for prophylactic vaccination(immunization).  On an unknown date the patient developed a non-serious event of flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Headache FATIGUE Narrative: FATIGUE AND HA LASTED 1.5 DAYS WITH ONSET MORNING AFTER VACCINE