chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mother stated patient began running fever (102.9) and became fussy throughout the weekend, crying alot. Gave Tylenol and Motrin, liquids and cool bath. Advised mother to have patient seen by PMD today.
Information has been received from a physician concerning a 16 year old female patient who on 25-JUL-1995 was vaccinated with a first dose of MMR II.  On 17-FEB-1998, the patient was vaccinated with a second dose of MMR II (routes, sites and lot numbers were not reported).  On 28-NOV-2009 the patient experienced mumps.  Date of diagnosis reported as 12-NOV-2009.  On 12-NOV-2009, the patient was afebrile.  Parotitis count was 106.  Laboratory tests on 12-NOV-2009 showed serum immunoglobulin M test - negative, serum immunoglobulin G test - 5.71 and serum amylase - 361.  The patient had right parotitis.  At the time of the report, the patient's status was unknown.  Follow up information has been received from the physician who indicated that the 16 year old (also reported as 14 year old) female patient on 28-DEC-2009 experienced mumps.  Date of diagnosis reported as 29-DEC-2009.  The patient was afebrile and presented swelling of the left side of her neck.  The patient developed left parotitis.  Laboratory tests on 29-DEC-2009 showed serum immunoglobulin M test - 0.43, serum immunoglobulin G test - 7.45 and serum amylase - 57.  No further information is available.
Information has been received from an administrator referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L048854 with expiration date 31-AUG-2017, lot # L035510 with expiration date 13-MAY-2017, lot # L027070 with expiration date 30-APR-2017, oral; dose unknown). The lot # L048854 of the vaccine was exposed to temperature excursion of 46.58 Fahrenheit degree (F) for 26 hours and 30 minutes. The lot # L035510 and L027070 were exposed to 50.45 F for 32 hours 45 minutes. Data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Initial literature report received on 01 Nov 2010: This patient with a medical history of heart failure participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with Influenza virus vaccine 2007/2008 (manufacturer unknown, batch number: unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction assay of the nasal swabs or a 4-fold or greater rise in the antibody titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza. This patient who had a history of heart failure had an antibody titer value of 10, 20, 20, and 160 after 0 weeks, 4 weeks, 10 weeks and 20 weeks of vaccination respectively. The patient had 4-fold increase in titer value and tested positive for seroconversion of A/H3N2 strain. Therefore this patient was considered as an LCI case of Influenza A/H3N2. The outcome was not reported.
redness; swollen arm; rash; a little nauseous; A spontaneous report was received from a consumer concerning a 86-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nausea,injection site erythema,injection site swelling and injection site rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Immediately after the first dose patient felt nauseous.On 20 Feb 2021,patient felt the events injection site erythema,injection site swelling and injection site rash.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events nausea,injection site erythema,injection site swelling and injection site rash was unknown.
administrated a third dose of Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number abxb39ac, expiry date 3rd July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (received 2nd dose on 12th October 2021) and Bexsero (received 1st dose on 3rd August 2021).   On 14th January 2022, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 14th January 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the patient was inadvertedly administrated a third dose of Bexsero, which led to extra dose administered. No further events were reported. The reporter consented to follow up.
BROKE OUT INTO HIVES 72 HOURS AFTER VACCINE 2 INJECTION
This case was reported by a healthcare professional to a sales representative and described the occurrence of injection site hemorrhage in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. On an unspecified date on or before 24 April 2006, the subject received a dose of Pediarix (dose number and lot number not reported). Less than one day after vaccination with Pediarix, on an unspecified date on or before 24 April 2006, the subject experienced injection site bleeding. The healthcare professional reported that, "the TIP-LOK syringes made the patient bleed more because they had to push harder to give the injection". The outcome of the event was not reported. Follow-up will not be available.
On 4/6/23 at approximately 1314 the nurse alarm was called. At approximately 1315 nurses arrive to lobby to find 34-year-old pregnant female, laying on chairs with legs elevated accompanied by her son. Per pt she had received 3 vaccines (Fluarix, Tdap, and Hep B) approximately 2 hours earlier on an empty stomach and left the clinic; two hours later, she walks back to Clinic for son's appointment. Pt. reported feeling dizzy and having blurry vision. Pt. was alert to name, time, location, and situation and reported feeling better after resting. Pt reported this was her second pregnancy and she was 7 months. Pt. denied any abdominal pain, underlying medical conditions and allergies. Pt.'s first set of vial signs were O2 99%, HR 90 bpm, and BP 115/70 mmHg. At approximately 1329 911 was called. Second set of vitals were O2 97%, HR 89 bpm, and BP 110/70 mmHg; pt reported feeling better. EMS arrived at 1338 and assumed care. Client refused transportation to the hospital and remained in lobby with son against medical advice.
Woke up achey all over, arms sore within site of injection. Fever and achey on and off for 2 weeks after, fever up to 100.4 degree.
2/9/22 11 y/o male who had COVID-19 in December, presented to the ER with 8 days of fever, pleuritic chest pain, headache, and malaise. Also 3 to 4 days of periorbital and lip swelling with a macular rash that resolved. Hypotensive 76/43, tachycardia at 126. MIS-C vs Kawasaki. Admitted to ICU. Resp: remained stable on RA. ID: He was given IVIG x1 on 2/10 and started on Methylprednisolone 1mg/kg BID. Blood & urine cultures were negative.  2/9 CXR - small left effusion, EKG w/right bundle branch block. Echo-good contractility, mitral valve insufficiency consistent w/myocarditis.  2/11 Inflammatory markers downtrending, transfer to floor. CV: BP's were stable and he did not require any pressors. He was started on Aspirin 81mg daily and Lovenox. Evidence of mild myocarditis with tachycardia and mildly elevated troponin, which downtrended prior to transfer to regular floor. Repeat Chest Xray on 2/11 showed small left basilar pleural effusion unchanged from previous examination. It also showed subsegmental consolidation left base, suspicious pneumonia, and WBC also increased to 26.52, patient was started on Ampicillin. Ampicillin later changed to PO Amoxicillin as PO tolerance improved and clinical impression improved. Methylprednisolone was also changed to PO Prednisone. Blood and urine cultures showed no growth after 5 and 2 days, respectively.   2/14 Repeat Echo showed trivial-to-small pericardial effusion located posteriorly behind the heart, with excellent biventricular function. Patient remained afebrile while on floor. Inflammatory markers and LFTs continued to downtrend. Electrolyte abnormalities resolved. Discharged 2/15/2022.
has a chronic L lower leg inherited peripheral neuropathy, after injection 2 days later had a marked increase in pain and the pain also involves the entire L leg and hip. Treated with OTC analgesics, use of a cane, increased gabapentin dose. Pain today on 4/12 is improving
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative through social media concerned two patients of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient's received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry date: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported. On an unspecified date, the patient's experienced suspected clinical vaccination failure, and suspected covid-19 infection. Reporter stated that "know this 1st hand, three of us covid-19 positive, sick for 10 plus days, despite pfizer, moderna and jnj news vaccines."  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000212249. This case, from the same reporter is linked to 20220130649.  Version created to amend previously reported information on 17-JAN-2022. Upon review following information was amended: Case was processed as valid.; Sender's Comments: V1: Version created to make case valid. This information does not alter the previous causality assessment. 20220130852-covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
the patient had experienced an anaphylactic reaction; Initial information received on 28-Sep-2021 regarding an unsolicited valid serious case from a physician and consumer/ non healthcare professional (under reference 00788843).  This case involves a 40 years old male patient who had experienced an anaphylactic reaction (anaphylactic reaction), after receiving QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date in September 2015, the patient received 0.5 mL dose of suspect FLUZONE QUADRIVALENT (Total, lot number and expiration date were not reported) via intramuscular route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had experienced an anaphylactic reaction (anaphylactic reaction, serious) (unknown latency) following the administration of vaccine. This event was assessed as medically significant.  The patient was fine now but wanted to know product components so he could assess whether COVID vaccine was okay for him to receive.  Patient needed to got a COVID-19 (coronavirus disease 2019) vaccine, so the MD (Doctor of Medicine) was checking the ingredients of several flu vaccines that were available at the time, to be sure there was no overlap with the ingredients in the COVID-19 vaccine the patient would be receiving.  Caller requested product composition standard be emailed.  No laboratory data were reported.  It was not reported if the patient received a corrective treatment.  The patient recovered from the reported event on an unknown date.  Information on the batch number was requested; Sender's Comments: This case concerns a 40 years old male patient who had anaphylactic reaction, after vaccination with FLUZONE QUADRIVALENT. The time to onset is unknown. Moreover, the patient's medical condition at the time of vaccination and other relevant laboratory data were not reported. Based upon the reported information, the role of a vaccine cannot be assessed.
I woke up almost 12 hours from the time I received the booster shot. I had extreme pain in my right abdomen/groin as well as the right lower side of my back. Pain so bad that it reminded me of child birth labor. I could not get comfortable standing, walking, lying down. I took 2 ibuprofen and it did do anything. Finally at 7:30-8am it settled down so I could sleep. I woke up again at 10:30 with the horrible pain again. It last another hour or so and then stopped. I have had kidney stones before. So possibility it was that and just a coincidence. However, I have never felt that bad from a kidney stone before. It has now been 36 hours since it stopped and I have not seen a passed stone in the toilet. I only called my Drs office but never went in as the pain stopped. Too much longer and they told me to just go to the ER.
Patient reported to the pharmacy the following morning complaining of the following symptoms: knee pain, insomnia, chills, and increased heart rate. Counseled the patient on potential reactions and how the chills may be due to a low grade fever, insomnia/HR due to anxiety about potential side effects. Patient asked about the ability to get paid time off while recuperating from the vaccination, he was referred to the HR department. Patient reports that he called Vsafe and VAERS. He was going to talk to personnel at the end of the conversation at the pharmacy.
I have hives all over my body from head to toe. I used Benadryl to reduce the hives, but it did not work. I am now taking methylprednisolone. So far it has not helped.
This spontaneous report as received from a Pharmacist refers to approximately 75 year old female patient. The patient's current conditions included with diabetes, drug reactions to codeine and drug reactions to penicillin (unknown reactions). No pertinent medical history reported. On 27-APR-2014 the patient was vaccinated with ZOSTAVAX dose 1 (single dose), subcutaneous, lot# J014568 expire date 18-FEB-2015. Concomitant therapies included insulin. On 29-APR-2014, after administration of the ZOSTAVAX the patient developed redness, warmth and itching at the injection site. The patient came to the pharmacy on 08-MAY-2014. The pharmacist noted a 2.5 by 1.5 inch area of redness at the injection site. The patient sought medical attention (came to pharmacy). No treatment was given for an adverse event. No lab diagnostics studies performed at the time of the report. The patient's significant disability or incapacity was reported as no. There was no hospitalization and the adverse event was not life threatening. PQC was not involved at the time of the report. The outcome of warmth, itching at the injection site and redness at the injection site/2.5 by 1.5 inch area of redness at the injection site was reported as recovering/resolving. Additional information has been requested.
Patient received IM vaccination. Was observed for a period of 15 minutes with no symptoms and was released. Had no symptoms but started developing numbness and tingle sensation in left arm.  Patient felt cold sensation in left arm.  Patient is being monitored for signs and symptoms in observation room. Will council patient on reporting to primary care physician. Will continue to monitor patient until resolution of numbness. Currently, patient does not feel any coldness in left arm anymore and is starting to feel normal.
Has not received the second dose > 3 months after the First dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Has not received the second dose > 3 months after the First dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Has not received the second dose > 3 months after the First dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Has not received the second dose > 3 months after the First dose) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. No concomitant drug information was reported. No treatment information was reported.
Sore throat on the right side of throat, still persisting. Gargled with salt water, took Zicam but it is persisting.  I am making a doctors appointment.  Has also had a couple a episodes of dizziness.
Pt was diagnosed with aseptic meningitis approx 3days after vaccination with anthrax #6.
flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) 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 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 INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was reported. The patient got the flu shot after Moderna and then had flu like symptoms, sneezes, coughs, she was having a hard.
Patient received covid vaccine on 2/6/21 at 8:36am. She stated on 2/7/21 @ 5:30pm She felt pain on the same hand she received the vaccine and also stated the pain was localized and its radiating  to other part of the shoulder patient took 2 tabs (650mg) of Tylenol PO
Mom called office stating that pt had imms and a flu vacc. at 9 AM and now had hives on his head, cheeks, and face, and some swelling was developing near Rt eye. Mom states breathing was easy and not in any distress. Mom ? flu vacc reaction. Mom instr. to give BENADRYL.
So far, four days late in starting cycle. This is highly unusual, in fact it has never happened. Definitely a side effect of the vaccine. Migraine headache on day one after the vaccine also.
Past lot that had also been expired administered to patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired administered to patients) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired administered to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired administered to patients).    NDCID number was reported.  Patient age was reported as 64 years 10 months.  Concomitant product use was not provided by the reporter.  It was reported that also another lot of vaccines lot number 065F21A was also expired and administered to patient and lot number O70H21A was administered to patient between 08-Apr-2022 and 15-Dec-2022.  Treatment information was not provided.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-JUL-2017, the patient was vaccinated with an improperly PROQUAD at a dose of 0.5 (units not specified), lot # N013865 with expiry date 31-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208: