chrisvoncsefalvay/vaers-outcomes huggingface dataset:
died of pancreatic cancer; This spontaneous case was reported by a consumer and describes the occurrence of PANCREATIC CARCINOMA (died of pancreatic cancer) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PANCREATIC CARCINOMA (died of pancreatic cancer) (seriousness criteria death and medically significant). The reported cause of death was Pancreatic cancer. It is unknown if an autopsy was performed.            Reporter stated that the patient was fine beforehand and used to run marathons.  No relevant concomitant medications were reported. No treatment information was provided.  Company Comment: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected event of Pancreatic Cancer. The event occurred approximately 6 months after receiving an unknown dose number of mRNA-1273 Vaccine and had a fatal outcome, with death occurring around the same time. The reported cause of death was Pancreatic cancer. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected event of Pancreatic Cancer. The event occurred approximately 6 months after receiving an unknown dose number of mRNA-1273 Vaccine and had a fatal outcome, with death occurring around the same time. The reported cause of death was Pancreatic cancer. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Reported Cause(s) of Death: pancreatic cancer
Patient received 38 Imovax vaccines in the past three months/ No AE; Initial and follow up information was received on 20-Feb-2020 and on 21-Feb-2020 regarding an unsolicited valid non-serious case from a other health care professional.  This case involves a 42 years old male patient who from Nov-2019, received 38 doses of vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] (lot number not reported via unknown route in unknown administration site for an unknown indication in past three months (extra dose administered)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing delusion (patient was delusional and during his states he believes that he has contracted rabies).  The reporter stated that the patient had not been bitten but was cleaning in an area with bats and thinks he has rabies and in the last three months has had a total of 38 rabies injections from different facilities he has checked into in the new area.   It was of actual medication error case due to extra dose administered.  Relevant laboratory test results included: Blood test - In Sep- 2019 and in Oct-2019:  [Unknown] (had blood draws to show that patient didn't have rabies).  At the time of reporting, no adverse event was reported.  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.  Information on the batch number was requested.  After the internal review on 04-Mar-2020, the case 2020SA047837 was identified to be a duplicate of the 2020SA051321. Hence the case 2020SA051321 qualified for deletion and all information has merged in retained case 2020SA047837.
Pt complained of burning during vax administration and immediately after complained of unusual feeling and cramping of muscle (deltoid) 3 minutes post vax pt developed dime sized welt with vague respiratory complaints. Pt also complained of lightheadedness. Pt treated with Benadryl 25mg PO 10 minutes post vax and ice pack to area. Repeated Benadryl 25mg 40 minutes later.  Welt increased in size to 10 cm.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Nov-2021 at 2:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products were not provided. On 03-Nov-2021, Excursion time was 11 AM, temperature was 35, total doses given for the day was 117, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021. 6 vials were sent to clinic. Vaccine BUD date was 05-Nov-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Information has been received from a registered nurse concerning a 12 year old female with an unknown vaccination history who was vaccianted with a dose of varicella virus vaccine live. In the wintertime, somewhere between December 2004 and March 2005, the patient contracted chickenpox. It was reported that the patient was hospitalized and discharged. The patient's present status was unknown. There was no product quality complaint involved. Follow up information from the registered nurse indicated that the patients records could not be located. The registered nurse stated that, one person has told her the patient was vaccinated in the past and one person said she was not. Additional information is not expected.
Delayed Injection Site Reaction, red large rash on left arm around the injection site about 8 days after the first injection. No other side effects.
This spontaneous report was received from a nurse practitioner refers to a 17 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-SEP-2016, the patient was inadvertently vaccinated with an adult dose of RECOMBIVAX HB (lot # L048209, expiry date 31-MAY-2018), instead of the intended pediatric dose. Nurse practitioner reported that, on an unknown date in September 2016, the patient did experience "localized swelling at the injection site". The outcome of the events was unknown. Causality assessment was not provided. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
pain at injection site; arm is heavy and it is painful to lift; arm is heavy and it is painful to lift; This is a spontaneous report from a non-contactable consumer (patient) via medical information team. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via unspecified route of administration on 27Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in Mar2021 patient stated that he had a little pain at injection site for 2 days. Now his arm was heavy, and it was painful to lift. The outcome of the events was unknown.  No follow-up is required. No further information expected.
Information has been received from a physician concerning an 18 or 19 year old female who may have received three doses of Recombivax HB (manufacturer unknown) and per laboratory data has no titers.  It was reported that she sought unspecified medical attention.  Current patient status was not reported.  A product quality complaint was not reported.  No further information was available.  Additional information has been requested.
temp 100.9-101.5 took tylenol  last night temp  101.8 down to  99.9 chills  body malaise,  running  nose
pt recvd vax & for 2nd time & exp high fever & lifeless-no motion, no response;
8 minutes after being vaccinated pt had extreme anxiety with heart palpitations. Hx of passing out after shots, vitals - nl. Exam - unremarkable Plan observe and home. Unlikely to be allergic Rx
By accident, the dose is administered to the patient who is under 50, which is not approved by FDA. During screening, pharmacy staff misread the DOB of the patient.
I had "heavy" vaginal bleeding approximately 6 hours after my 1st Moderna vaccine. I was 58 at the time of vaccine and had NOT had any vaginal bleeding for 5 months prior. 2 months after 2nd Moderna vaccine I now have constant moderate pain in both my hands. I consider myself to be in good health up until these vaccines.
Patient complained 9/24/14 to employee health services that she experienced muscle pain and loss of mobility of her arm after receiving the injection. The pain was intense enough that she could not sleep on her left side. She could not raise her arm past 45 degrees shoulder flexion.
Devel tingling, mild vertigo, myalgias, & h/a 15 day post vax; on day of admission devel lt peripheral facial paresis w/difficulty closing lt eye & droop of lt side of mouth; probable GBS:
arm is still itching where needle went in; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 046A21A, and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS. At the time of the report, VACCINATION SITE PRURITUS outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
I noticed a scratchy throat and runny nose on the 2nd. I developed a general feeling of unwell. I had a cough and a fever of 101.0 along with a headache. I completed a home COVID-19 test and it was positive. I called my doctor's office and listed all the symptoms that I had. They called in a prescription for PAXLOVID. By Thursday the fever went away and by the next day I no longer had the cough. I do feel that I have completely recovered.
This spontaneous report was received from a pharmacist via company representative refers to an unknown age female patient. Pharmacist reported patient was administered three to five doses of ZOSTAVAX (lot# unspecified) (route, dose and location unspecified) for shingles prevention since an unspecified date with the last dose of ZOSTAVAX administered on 30-AUG-2012. The patient was diagnosed with three cases of shingles on unspecified dates after an unspecified number of doses of ZOSTAVAX were administered on unspecified date. Pharmacist also reported that patient was prescribed FOSAMAX (lot# unspecified) tablet orally once a week 70mg as reported since an unspecified date. Concomitant therapies included with XANAX, Atenolol, Fluoxetine, SYNTHROID, Prazosin, PRISTIQ, SEROQUEL, SIMVASTATIN TABLETS, USP and Trazodone Hydrochloride. Additional information has been requested.
generalized tingling, hot flashes & lips felt swollen; 20 mins p/vax given DPh;
Myalgia, Arthralgia, Fever, NausearVomiting, chills, fatigue Narrative: f. Date of Vaccination - First dose: 12/17/20 Second dose: 01/07/21 g. Symptoms/Complaints - First dose: very sore arm Second dose: very sore arm, deep fatigue, chills, body aches, nausea, fever to 101.7
Patient developed significant rash, swelling and redness in upper arm where she received shot.  The reaction did not resolve for several days. Patient had no reaction to first 2 doses.
Gums have been bleeding on and off since 24 hours after the second dose. It will bleed for about 10-15 minutes and then stop for a couple of hours and then start again. I wasn't eating or drinking anything when my mouth started bleeding, and I don't have any cuts in my mouths. Also, have a strong metallic taste in my mouth. I had an Urgent Care visit after it was happening for nearly 12 hours and the doctor said she had not heard of this side effect and suggested I report it to see if anyone else has had this happen for advise on what to do.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2016, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as a severe herpetic rash. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
4/8/2021 - light headed, dizzy, vomiting, body aches, fever, headache, vivid dreams (upon waking and throughout day) 4/9/2021 - light headed, vivid dreams 4/10/2021 - light headed and felt like about to pass out (3pm), vivid dreams 4/11/2021 - diarrhea, vivid dreams 4/12/2021 - Skin rash/welts, diarrhea
persistent screaming x 8 hrs first 4-5hrs high pitched; no benefit APAP, slept more than usual x 8 hrs back to nl w/48 hrs; PE 8 hrs p/onset was nl;
developed paralysis in the opposite part of the body; Her hand, fingers and knee all became swollen; Her hand, fingers and knee all became swollen; This is a spontaneous report from a contactable consumer via Pfizer Sponsored program Pfizer First Connect.  A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. The patient took the first dose of the vaccine on an unknown date for COVID-19 immunization. In Feb2021, about 12 hours after getting the vaccine, the patient developed paralysis in the opposite part of the body where she didn't get the vaccine. Her hand, fingers and knee all became swollen. She had the symptoms on her right and was given the vaccine in her left. The final outcome of the events was unknown.Information on lot/batch number has been requested.
DTaP injection given on 4/5/22. Redness and pain to injection site noted in AM on 4/6/22. Redness gradually dissipated, encircling injection site for several days until no longer noted by 4/12/22. Injection site was mildly swollen during this time and pain to touch also persisted. By 4/12/22, a faint bruise was noted at the site and a small lump was palpable under the skin. Lump is approximately pea or blueberry-sized. At this time, 5/10/22, the lump - or nodule - is still palpable, has not decreased in size, and is still painful to touch. No bruising, redness, or edema noted at injection site.
Headache in the back of head with level 9 pain for initial reaction, bodyache with painlevel 6 persisted 36 hours.
Mosquito type rash to bilateral upper and lower extremities, severe migrane and vomiting, patient presented to ER for follow up
Within 5-10 minutes of given GARDASIL vaccine patient developed urticaria and angioedema of face, cheeks, ears. Patient also complained of throat tightness and sense of difficulty breathing. Erythema also developed of face and progressively spread with swelling to neck and chest. Epi 0.2cc given subcut. with notable improvement.
Reports signs of severe pain, redness, swelling, irritation and discomfort. Had called primary care physician for further care.
2 weeks after administration of vaccine, client complained of left arm tingling and fingers and toes numb  She saw er M.D. and no treatment nor diagnosis made
The patient's wife called the pharmacy stating that the patient cannot lift his arm. The wife believes that the injection got to the shoulder and told us that the pharmacist inserted the needle in and out first and then re-injected the same site. The patient is going to see a Dr. shortly to treat his arm.
Developed Shingles after the 1st dose; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 9235B, expiry date 29th November 2021) for prophylaxis.   On 2nd October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient developed shingles. The reported lot number (L9235B) for Shingrix did not exist and was updated to 9235B, according to sales datasheet. The reporter consented to follow up.
PATIEN COMPLAINED OF DIZZYNESS AND SLIGHT NAUSEA. PATIENT TOOK HER OWN PRESCRIBED ZOFRAN.
One day following vaccination, patient had pain in left middle finger which radiated up hand to wrist. The following day (two days after vaccination), patient had worse pain and new onset swelling of the left middle finger and hand. Patient reported a pain of 8 out of 10, but stated he could handle the pain. I recommended  the patient to call their PCP for treatment.  I also stressed the importance of doing so.
Initial unsolicited report was received on 08 February 2015 from a consumer, who is also the patient. A female patient (date of birth not reported) with a history of asthma had received on an unspecified date a QIV influenza vaccine (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later, developed the flu. No further information was provided at the time of the report. Outcome was unknown. Documents held by sender: none.
I was feeling lethargic, had a slight fever, had a headache, shortness of breath. I tested for two days that came back negative, I had been exposed to my husband who was positive. On day three of my symptoms I tested positive, I called my PCP who scheduled me a virtual visit with a PA. I cancelled that appointment as I was able to get in for the monoclonal infusion therapy. I started feeling better the next day.
pt recvd vax & a few hrs later exp pain & redness @ inject site; 1 day later exp swelling & warmth @ the inject site; sx persisted for approx 2 wks;
Information has been received from a physician in a hospital laboratory concerning a 15 month old patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient experienced breakthrough varicella followed by an infection. The reporter indicated that the patient had eczema. It was also noted that the patient was not a normal host. Patient history was not definitely known at the time of the report. The patient had breakthrough varicella and a secondary staphylococcus and streptococcal infection and may have been hospitalized. The reporter was checking to see if a potential VZV PCR specimen could be obtained. Additional information has been requested.
only received one dose of the moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (only received one dose of the moderna vaccine) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (only received one dose of the moderna vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (only received one dose of the moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
started feeling dizzy and faint after about 5 minutes, became clammy and pale and started sweating, was hot and thirsty, I gave him cool wet papertowels, and ice pack a few sips of water and had him sit in imz booth while I talked to him and watched him. He felt better and had his ride pick him.