chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a Health Professional concerning a 16 year old, male subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The patient reported the following EXPIRED FLUMIST ADMINISTERED which started on 20-Jan-2014. The outcome of the event of EXPIRED FLUMIST ADMINISTERED is unknown. The report was considered to be non-serious by the reporter.
got the shingles shot and still got the shingles/ mine didn't get as bad with the shingles shot/ suspected vaccination failure; got the shingles/ mine didn't get as bad; tingling nerve pain on my left shoulder blade /I still have nerve pain from the shingles.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient got the shingles shot and still got the shingles. The patient stated that nine months later he/she still had nerve pain from it. The patient stated that his/her did not get as bad with the shingles shot as it would have without it. The physician said that the patient had tingling nerve pain on my left shoulder blade from the shingles till the time of reporting. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
both forearms broke out in hives; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 30Mar2021 at 13:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included losartan (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and ascorbic acid (VITAMIN C). The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021 at 20:00, approximately seven hours after the injection, the patient's forearms broke out in hives which were still present a full day later. The right arm was far worse than the left. Later, the patient also noticed them on the lower sides of his abdomen. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the event both forearms broke out in hives. The clinical outcome of the event forearms broke out in hives was not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
Pt reports waking up on Thurs morning after receiving vaccine on Tues evening with a numbness and weakness in right arm.. Came her today after contacting PCP but not seeing them last week.
THREE DEATHS; This spontaneous report received from a consumer via a company representative via social media concerned 3 multiple patients. The patient's weight, height, and medical histories were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified dates, the 3 multiple patients experienced deaths. As per the reporter, "Well, investigations happened and so far, three deaths in total have been confirmed, connected to the J and J vaccine. On an unspecified dates, the 3 multiple patients died from unknown cause of death. It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20210925983-CDOVID-19 VACCINE AD26.COV2.S-Three deaths. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Patient reported arm swelling, soreness and redness that spread down the arm. Affected area about 2in. wide and 4-5 in. long. Symptoms seem to slightly improve when ice is placed on affected area.
Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a 10 year old female with no medical history or drug allergies who on 03-FEB-2009 was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL (lot# 661530/0575X) and then discovered that she was pregnant. No adverse effects were reported. The patient sought medical attention by visiting the physician's office. There was no concomitant medication. On 16-MAR-2009 pregnancy test showed positive (LMP: 17-FEB-2009, EDD =24-NOV-2009). Follow-up information has been received from a nurse practitioner. It was reported the patient had not returned to the office for follow up. The patient had an abortion performed on 17-APR-2009. When the office contacted the patient to arrange for the second dose of GARDASIL, the patient told the nurse practitioner, "I will not be getting anymore of those shots. I have been through enough with the abortion". Follow-up information has been received from the nurse practitioner. It was reported that the patient was 20-year-old not 10-year-old as previously reported. The patient had recovered from the abortion on an unspecified date. The patient had the abortion for a number of reasons including that "she was not married and was exposed to the GARDASIL. Upon internal review, "abortion" was determined to be an other important medical event. Additional information has been requested.
DID NOT COMPLETE VIVOTIF COURSE ONE WEEK PRIOR TO TRAVEL TO AFRICA; THREW UP; This spontaneous case report was received from a pharmacist (PVX2019-613) on 11-Mar-2019. It described a 25-year-old female consumer who threw up following the intake of Vivotif capsule for travelling. The consumer also "did not complete Vivotif course one week prior to travel to country".  It was reported that the consumer took the first dose of Vivotif on 08-Mar-2019 and within 15 minutes, she threw up the capsule. She had a planned travel to country on 15-Mar-2019.  The action taken with Vivotif with respect to the event threw up was unknown while with respect to the event "did not complete Vivotif course one week prior to travel to country" was not applicable.  The clinical outcome of the event threw up was resolved while outcome of the event "did not complete Vivotif course one week prior to travel to country" was unknown.  Company's Comment: In this case, it was reported that a 25-year-old female consumer who threw up following the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, vomiting is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. The causality of the event "did not complete Vivotif course one week prior to travel to country" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, it was reported that a 25-year-old female consumer who threw up following the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, threw up (PT: Nausea) is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. The causality of the event "did not complete Vivotif course one week prior to travel to country" was considered as not applicable.
Presented to ED on 10/28 with worsening symptoms, had been seen at outpt facility on 10/25 and tested positive. Symptoms include shortness of breath, weakness and cough. On 5L O2 Nasal cannula
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician).  An 86-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 04May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteopenia" (unspecified if ongoing); "Mixed hyperlipidemia" (unspecified if ongoing); "CAD" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Raynaud disease" (unspecified if ongoing); "STEMI" (unspecified if ongoing); "a fib" (unspecified if ongoing); "HTN" (unspecified if ongoing); "CVA" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Thiazides, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 13Jul2022, outcome "recovered" (29Jul2022), COVID-19 (medically significant) with onset 13Jul2022, outcome "recovered" (29Jul2022) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Symptom onset on 13Jul022. Treated with monoclonal antibody infusion and paxlovid. Recovered. Symptoms recurred 23Jul (day 10 of illness). Home antigen test positive 7/24. Recovered without further therapy (noted 29Jul 5 days after positive test). Patient was treated for COVID-19 with Paxlovid via oral route from 13Jul2022 to 17Jul2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Monovalent vaccines have undergone several temperature excursions and have been administered to patient; No adverse event; Monovalent vaccines have undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Monovalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 22-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Sep-2022 at 10:46 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 dosage form. On 09-Sep-2022 at 10:46 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Monovalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Monovalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent vaccines have undergone several temperature excursions and have been administered to patient) and POOR QUALITY PRODUCT ADMINISTERED (Monovalent vaccines have undergone several temperature excursions and have been administered to patient).    Dose 2 vaccine administered at deltoid region.  Concomitant medication list was not provided. It was reported that refrigeration excursions identified, vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022.state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department was made aware of the situation. No adverse reactions reported to their knowledge for any of these patients. Storage condition at the time of the excursion was refrigerated. Individual vials or unbroken cartons were 2 unbroken cartons 20 vials. Vial was moved from freezer to refrigerator on 07-Sep-2022. Vials were not visualized. It was unknown if patient had ever been diagnosed or tested positive for COVID-19.  Treatment information was not provided.
no adverse event; Medical assistant reported a temperature excursion which was administered to the patient; This spontaneous report was received from a medical assistant concerning, a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.     On 03-APR-2021 the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), 1 dosage form (lot number T024831 which was verified to be a valid lot number, expiration date reported and upon internal validation established as 18-NOV-2022), as prophylaxis (frequency, route of administration, anatomical location and vaccination scheme were not reported) (product storage error). The administered vaccine experienced a temperature excursion above 9 degree Celsius (°C) (9.3C) during a time frame of 0 hours 46 minutes and 0 seconds, as recorded by data logger. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T024831; expirationdate: 18-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA001382: US-009507513-2104USA001375: US-009507513-2104USA001385: US-009507513-2104USA001384: US-009507513-2104USA001386:
Syncope, Flushing/sweating.  BP 116/77 HR 90 O2 Sat 95%.  Patient stable and released from vaccination site
COVID-19 Rebound after taking Paxlovid as characterized by positive viral 05Jun2022; COVID-19 Rebound after taking Paxlovid as characterized by positive viral 05Jun2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 15Feb2021 at 10:00 as dose 1, single (Lot number: EL9266), in left arm, on 06Mar2021 at 10:00 as dose 2, single (Lot number: EN6199), in left arm and on 01Oct2021 at 08:00 as dose 3 (booster), single (Lot number: 30145BA) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02May2022 at 09:00 as dose 4 (booster), single (Lot number: 056M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: Jan2018; TRIAMTERENE/HCTZ, start date: Jan2009; MYRBETRIQ, start date: Jun2014. The following information was reported: VACCINATION FAILURE (medically significant) with onset 05Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 05Jun2022, outcome "not recovered" and all described as "COVID-19 Rebound after taking Paxlovid as characterized by positive viral 05Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (29May2022) Negative, notes: after testing negative on 01Jun2022 and completing Paxlovid on 29May2022; (01Jun2022) Negative, notes: after testing negative on 01Jun2022; (05Jun2022) Positive, notes: COVID-19 Rebound after taking Paxlovid as characterized by positive viral 05Jun2022. Therapeutic measures were taken as a result of covid-19.  Clinical course: Paxlovid, received from 24May2022 to 29May2022, lot number:GA1519, as COVID-19 treatment. No known allergies were reported.
Began fatigue and arm soreness Tuesday, the night of vaccination. During the night he was uncomfortable with generalized body aches and pains, chills/shivering. Fever 101, rising to 103. Began taking acetaminophen and ibuprofen regularly for fever and severe body aches/pain. Temp remained 103 all Wednesday. Fatigue all Wed; shortness of breath in the evening. Put on his CPAP and went to bed. Thursday AM, woke with a bad rash on the front of his neck, across chest, underarms and belly. The rash is painful. Denies itching. His temp was down to 100. Fatigue persists. He called his PCP and reported this to the nurse and has not received a call back from the doctor. He reports no problems with the first two Pfizer Covid shots.
slight temperature; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight temperature) and CHILLS (chills) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013MZ0A and 014M20A) 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 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (slight temperature) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PYREXIA (slight temperature) and CHILLS (chills) outcome was unknown.            patient was taking blood pressure medications and cholesterol medications.   This case was linked to MOD-2021-056157 (Patient Link).
Patient came in for her first COVID-19 vaccine but she was very nervous and anxious about the vaccine. Her sister was with her so she gave her some water and calm her down. Approx after 15 min, patient said that she is ready to get vaccine so one of my tech gave her vaccine and right after that patient was feeling that her left arm is numbing and she was feeling very warm.  Patient was able to walk and talk but looked very anxious. She waited for 20 min in the waiting area and mean while pharmacist took her blood pressure and it was elevated (151/127). Upon sister's request, we call emergency and paramedics came and took her vitals. Patient was very anxious so they took her to the hospital
pt recv vax 17MAR99 & parents reported 29MAR99 pt had broken out w/blisters all over body;
Pt vax /w MMR & on 9NOV90 developed Hepatitis.
Flu like sxs - severe body aches, back pain, headaches, Temp increased 101.6 x 48 hours.
pt presented with covid and altered mental status, pt had poor prognosis and brother made him comfort measures, pt deceased.
Allergic reaction, flushing of skin on face, confusion and swelling of face. Then extremely heavy menstruation afterwards, 18-20 days out of every month. Extremely heavy bleeding.
full body very itchy rash/ sore throat/hard to breathe/fatigue/stuffy nose/ congestion / nausea/ vomiting
Pt had a 4" X 5" large, swollen, purple discoloration to left thigh at DTAP  and MMR injection sites, given 3 days ago on 7/25/2000.
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot number FD0809. The local Public Health District, per guidance from Centers for Disease Control and Prevention (CDC), and Pfizer have determined that the dose of vaccine that you received is valid.
this is 1 of 6 pt from this site to have an unspecified adverse exp p/vax;pt was treated w/ATb;
Pt. states after receiving Phizer 2nd dose 03/25/2021, suffering joint pain inflammation, tiredness.
pt recvd vax JAN93 & inadvertently recvd another dose 6JUL94 by 7JUL pt devel an inj site rxn consisting of swelling & pain w/a low grade fever of 99.8;
patient reports redness, swelling and hot at area of injection site, possible cellulitis/infection
Moderna COVID-19 Vaccine  Adverse events: fever, chills, body aches, fatigue, headache, pain at injection site, stomach pain Treatment: rest, ibuprofen, water
patient was given the Pentacel vaccine without mixing the powder so the patient only was given the liquid portion, No AE; Initial information received on 24-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2020SA165285 (same reporter).  This case involves a seven month old male patient who received a 0.5 ml third dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot Diluent: U6615AA, Powder: UJ196AB, expiry date: 02-Mar-2021) once via an intramuscular route in the left thigh for prophylactic vaccination on 16-Jun-2020, without mixing the powder so the patient only was given the liquid portion.  The patient's past medical treatment(s), vaccination(s), and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE, ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique.  At the time of report, 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 holders compliance with the requirements set out in Directive and Module VI of the 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.