chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This literature market report was received from an author. Abstract: Studies assessing the economic burden of a mumps outbreak in a highly vaccinated population are limited. A mumps investigation was conducted in an affected village with a highly vaccinated population. To understand the epidemiology, standardized mumps case definition and active surveillance were used to identify mumps cases. In addition, an economic assessment of a combined outbreak investigation and third dose MMR vaccine intervention was performed; estimated by retrospectively evaluating public health response-related activities including use of a third dose of MMR vaccine. From 24-SEP-2009 through 15-JUN-2010, 790 mumps cases were reported-64% were male and highest attack rate was among 11-17 year age group (99.1 cases per 1000 individuals). Of the 658 cases with known vaccination history, 83.6% had documentation of 2 doses of mumps containing vaccine. No deaths were reported. The 2 major exposure settings were schools (71.8%) and households (22.5%). Mumps cases were classified according to the 2008 mumps definition of the Council of State and Territorial Epidemiologists (CSTE). A clinical case was defined as an illness with acute onset of the parotitis, lasting at least 2 days, and without other apparent cause. Clinically compatible illness was defined as that which may present as aseptic meningitis, encephalitis, hearing loss, orchitis, oophoritis, parotitis, or other salivary gland swelling, mastitis or pancreatitis. Laboratory confirmation included isolation of mumps virus from clinical specimen, or detection of mumps nucleic acid, or detection of mumps IgM antibody, or demonstrated of a 4-fold increase in mumps IgG antibody titer. Mumps cases were then classified epidemiologically. A probable case was defined as that which meets the clinical case definition without confirmation and was epidemiologically linked to a clinically compatible case. A confirmed case was defined as a case that met the clinical case definition or had clinically compatible illness, and was either laboratory confirmed or was epidemiologically linked to a confirmed case. This report refers to a patient of unknown age and gender who had 2 documented dose of measles, mumps, and rubella virus vaccine, live (manufacturer unknown) (dose, route and lot # were not reported). On an unknown date the patient developed meningitis. The outcome of meningitis is unknown. The reporter considered meningitis to be related to Measles, Mumps, and Rubella Virus Vaccine, Live (manufacturer unknown). Upon internal view, meningitis was considered to be medically significant. This is one of the several reports with literature linked. Additional information has been requested.
Site: Pain at Injection Site-Mild, Additional Details: Patient was sitting in chair and fainted approx 5 mins after vaccination. His mother got my attention after he picked himself off the floor. Pt reported blacking out and falling on the carpet. He had a small bruise with a little bleeding (from carpet burn). His mother gave him water and I got him some paper towels to wipe off the small amount of blood on forehead.  I asked pt if history of fainting and he said yes.  He said he didn't mention it because the more it is discussed, the worse it is.
This spontaneous report as received from a licensed practical nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with 0.5 ml doses of VARIVAX (Merck) (lot # not reported) subcutaneously that were improperly stored between November 2014 and January 2015. No adverse effects were reported. Additional information is not expected. There is no permission to contact the physician.
Pt's daughter called on 10/22/ regards to her mother's vaccinations. She stated that her mother's left arm is 3 x normal size. It is very swollen and painful. She also has high fever. I recommended to apply some ice and given her MOTRIN or TYLENOL, and see PCP. But, she was very upset and stated that she is the nurse, and this is not normal reaction to the vaccine. She wanted Rph name who gave vaccination.
Vaccine administered at 2PM. Patient developed acute mental status change around 9PM. Patient admitted to Medical Center and worked up for possible meningitis. CSF has been clean thus far in treatment, patient's mental status moderately improved on 9/15.
Patient has Parkinsons. After receiving vaccine dose 1 has had severe flare of symptoms, weakness, no longer able to care for himself at home. He is also having widespread myalgia/arthralgia necessitating hospital admission and rehab placement
COVID Vaccine Breakthrough CAse  Moderna Dose 1 2/11/21 (024M20A) Moderna Dose 2 3/14/21 (002B21A) Moderna Dose 3 11/11/21 (065F21A) COVID Positive 12/10/21  12/10/21: History is obtained from patient as well as by personal review of records. Mr. is 94-year-old gentleman with known history of stage IV clear cell carcinoma of right kidney with bilateral lung metastasis, left-sided pleural effusion and bony metastasis.  He also has urothelial cancer in-situ of urinary bladder.  Patient developed diarrhea on axitinib and dose was reduced. Followed up with his oncologist on 11/29/2021 who noticed worsening left-sided pleural effusion. Patient reports worsening generalized weakness of 3 days duration.  Has noticed worsening cough.  Mostly nonproductive.  He tested positive for  SARS-CoV-2.  Urinalysis also showed pyuria. He has received antibiotics in emergency department. Patient denied focal motor weakness.  No focal sensory loss.  Denied double vision or other visual problems.  No difficulty with swallowing.  No difficulty with speech.  He previously underwent thoracentesis on 7/5/2021  12/15/21: Patient is being discharged home with his family and services for nursing, PT, and OT.  He has been enrolled in the safe at home program and the nurses will follow-up with him after discharge.  He should continue Levaquin 750 mg p.o. q.48h x2 more doses and dexamethasone 6 mg p.o. daily x5 days.  He should continue to self-quarantine x5 days.  He should follow-up with his primary care provider in 1-2 weeks.  He should follow-up with oncology as scheduled.  He has been provided patient education for COVID self-care, UTI, generalized weakness, Levaquin, and dexamethasone.  I have answered all of his questions and addressed all of his concerns.  The patient is being discharged in improved and will condition.
phone call on 30DEC91 stating that rt arm had been very sore w/some numbness since inject was given; also having problems w/stiff, tight & sore neck; apparently has had hx of neck problems for many yrs; 13JAN92 rt arm has lump;
After 1st shot (Feb 11) - 5 days after, I started vomitting and running a fever for 2 days, my stomach was upset until the second shot After 2nd shot (March 4) - 2 days post shot, I started excessive itching - after 11 days, and trying various antihistamines - the bruising and rashing from itching covered my entire body.  I started jaundice on March  17, this continued to worsen and is still present.
Excessively heavy menstrual cycle within a couple days of second dose, off normal menstrual cycle as well as the following (normal time) 3 cycles.  My menstrual cycle has been tapering off as I just turned 50. Now I'm having heavier flow and more intense cramping  than any other time  in my life.
Fine right after shot. At 4:15 am the following morning (16 hours later after second Pfizer) I awake with swelling of the soft palate and uvula.  By 7:30, swelling had advances and was beginning to involve the back of my throat.  By the time I was seen at the Walk=in ER clinic, the swelling  started to abate and eventually resolved on its own, without any intervention.  I also used my nebulizer with albuterol and cromolyn meds.  Finally resolved by noon on April 23, 2021.
Red, raised swelling rash on arm underneath (not at injection site). Shots were given spaced appropriately, however, in the same arm due to patient preference to avoid arm with artificial shoulder.
Information has been received from a medical assistant concerning multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history and concurrent conditions were not informed. On unknown dates, the patients were administered improperly stored doses of GARDASIL 9 lot # M020103, expiration date 15-FEB-2018, (dosages and therapy routes were not provided). Concomitant therapies were not informed. No adverse effects were reported. Temperature: 48.2F. Time frame: 61.75 hours. There was a call because of a data logger. There was not a previous temperature excursion. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.
Twitching of the face; Syncope; Weakness; A spontaneous report was received from a pharmacy intern, concerning a 23-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced syncope, weakness, and twitching of the face.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020, approximately 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 025J20-2A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient was working and experienced syncope and weakness.   On 06 Jan 2021, the patient reported experience twitching of the face beginning on an undisclosed date and she also continued to experience weakness. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, syncope, was unknown. The events, weakness and twitching of the face, were considered not resolved.; Reporter's Comments: This case concerns a 23-year-old, female, who experienced serious unexpected event of syncope, and non-serious unexpected events of asthenia and muscle twitching. The events of syncope, asthenia occurred 2 days after mRNA-1273 (Lot# 025J20-2A), while the event of muscle twitching occurred on an unspecified date after mRNA-1273 (Lot# 025J20-2A). Treatment details were not provided. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
Digestive discomfort, lack of appetite, tired and feverish (100.7 Farenheit 24 hours after vaccination, 99.4 F 48 hours after vaccination, ), Facial neuralgia  28-40 hours after vaccination.  Fully recovered after 72 hours.  Treated with acetominophen, 2 doses(fever) and ibuprofen, 1 dose (neuralgia)
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (patient received expired Moderna COVID-19 vaccine) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 030B21A) for COVID-19 immunization. No medical history reported. On Sep 24, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 24, 2021, patient administered expired product (patient received expired Moderna COVID-19 vaccine). At the time of the report, administered expired product (patient received expired Moderna COVID-19 vaccine) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. The vial was initially stored in the refrigerator on Sep 24, 2021. It did not undergo any temperature excursions. It was not known which arm the patient received the Moderna COVID-19 vaccine. It was not known if these vaccines were primary series or booster doses. The patient did not report any other adverse events.
Use of Unapproved Diluent; Use of Unapproved Diluent; Use of Unapproved Diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number Amva642a, expiry date 1st November 2022) for prophylaxis.   On 8th June 2022, the patient received Menveo (intramuscular). On 8th June 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 17-Jun-2022 Reporter's comments: The patient received Menveo in left deltoid, which was reconstituted with unapproved diluent. The consent to follow up was given. Additional Supportive Information: The patient received Menveo that was reconstituted with unapproved diluent, which led to wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and inappropriate preparation of medication.
This case was reported by a consumer via call center representative and described the occurrence of glucose increased in a elderly female patient who received SHINGRIX. On 3rd April 2018, the patient received SHINGRIX. On 4th April 2018, 1 days after receiving SHINGRIX, the patient experienced glucose increased, feeling cold and loss of energy. In April 2018, the patient experienced emotional distress. On an unknown date, the outcome of the glucose increased, feeling cold, loss of energy and emotional distress were unknown. It was unknown if the reporter considered the glucose increased, feeling cold, loss of energy and emotional distress to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. On Tuesday the patient received SHINGRIX and by Wednesday the patient's blood sugar had greatly elevated, she was cold and had no energy. The patient was very upset and very rude. The patient gave permission to contact her physician but could never get the name. The reporter said that she had things to do so information was limited. The reporter could contact later with more details.
I began to have chills and a fever of about 102.0 which woke me up in the middle of the night. I then developed Afib which I had had before but was more on a seasonal basis. After a prolonged period I went to the doctor who put me on blood thinners and a cardiogram machine to take home. That did not work so the doctor shocked my rhythm back into alignment which lasted about 7 hours. He then gave me another medication which aligned my heart rate and it has been steady since then.
a female patient at the hospital with appendicitis; This is a spontaneous report from a contactable physician. A 40-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE , batch/lot and expiry unknown), via an unspecified route of administration on 22Feb2021 at a single dose for covid prevention. The patient's medical history was not reported. There were no concomitant medications. The patient received her first dose of Covid vaccine on 03Feb2021 (40 years) for Covid-19 immunisation. 4 days after getting her second dose of the Pfizer COVID Vaccine, patient was in the hospital with appendicitis on 26Feb2021. Patient was hospitalized, and he believes the patient was heading into the operating room (OR) now.  It was confirmed that the patient had no other vaccines on the same day as both her COVID vaccine doses. The causality was reported as "unrelated".  Information on the Lot/batch number has been requested.; Sender's Comments: In agreement with the reporting physician, the company considers that the event appendicitis is unrelated to suspect vaccine BNT162B2. Appendicitis is most likely an intercurrent condition. There is no plausible mechanism implicating BNT162B2 to the reported event based on the drug known safety profile.
Patient lost consciousness and required direct aid from RPH. EMS was activated and had to escort the patient. No Epi-Pen or CPR was needed, the patient regained consciousness within 2 minutes.
The patient blacked out on the bathroom floor. He hit his head and has a sore arm, headache, and fever. He feels exhausted.
Minor throat irritation; Body aches; Headache; Left arm ache where she received injection; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Minor throat irritation), MYALGIA (Body aches), HEADACHE (Headache) and VACCINATION SITE PAIN (Left arm ache where she received injection) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM inhalation gas for Pulmonary arterial hypertension.    The patient's past medical history included Back pain and Dizziness (On 27 Jan 2022, the day after initiating IH Tyvaso, the patient had minor lightheadedness) on 27-Jan-2022. Concurrent medical conditions included Pulmonary arterial hypertension (secondary pulmonary arterial hypertension). Concomitant products included APIXABAN (ELIQUIS) and PIRFENIDONE (ESBRIET) for an unknown indication.   On 27-Jan-2022, the patient started TREPROSTINIL SODIUM (Nasal) 18 microgram four times per day. On 02-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (Minor throat irritation), MYALGIA (Body aches), HEADACHE (Headache) and VACCINATION SITE PAIN (Left arm ache where she received injection). At the time of the report, THROAT IRRITATION (Minor throat irritation), MYALGIA (Body aches), HEADACHE (Headache) and VACCINATION SITE PAIN (Left arm ache where she received injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that on an unreported date in 2022, the patient experienced the event of minor throat irritation. On an unreported date in Feb 2022, the patient experienced the events of body aches pain, headache and left arm ache where she received injection.  Treatment medications were not provided by the reporter.
Muscle ache on both arms that lasted for 2-3 weeks Stomache cramp (sharp pain) loss of appetite fatigue
patients received a dose of the vaccine from a vials stored in the refrigerator beyond 30 days.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received a dose of the vaccine from a vials stored in the refrigerator beyond 30 days.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) 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, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received a dose of the vaccine from a vials stored in the refrigerator beyond 30 days.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received a dose of the vaccine from a vials stored in the refrigerator beyond 30 days.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. On 16-Aug-2021, the Vaccine was initially stored in the refrigerator. The vaccines was administered to several patients beyond this date (16-Sep-2021). The vaccines were administered on several dates to several patients. No treatment information was provided
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Swelling and redness in cheeks. Patient described feeling swelling in lips but no swelling was visible. She was given 25mg Benadryl and monitored for approximately an hour with no additional swelling seen and was driven home by a relative.
4FEB 8PM t103, cranky, whining, screaming; 5FEB 8AM t102 less cranky, still whining but active; 5FEB noon t101 ate lunch, has runny nose, cough; 6FEB AM vomited x 3, t99.4 rx APAP
Human Rabies Immune Globulin (HRIG) - Extreme muscle and joint pain for 12-18 hrs after injections.  Extreme diarrhea at 24 hrs post injections.
How long is the redness supposed to last around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (How long is the redness supposed to last around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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, the patient experienced VACCINATION SITE ERYTHEMA (How long is the redness supposed to last around the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (How long is the redness supposed to last around the injection site) outcome was unknown.
got both shots and still got it/Suspected Vaccination Failure; still got it; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter stated that you could still get shingles but not as bad. The patient got both shingles shots and still got shingles.  The reporter stated that doctor said it would have been worse if he/she did not get the shots. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact detail were available.
Missed 2nd dose window; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose window) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose window). On 19-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose window) had resolved.        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 medications were not reported.  No treatment information was specified.
After the injection I had pain in left deltoid, pain is everytime I go to lift my arm up or lift anything.  Pain has gotten worse over the last month and has been constant since the day after injection. Pain almost feels the same as the day after receiving the IM injection.