chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter, concerning a patient of unknown age and gender. Information about pertinent medical history, concurrent conditions, concomitant medications and drug allergies or reactions was not provided.   On 07-DEC-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA(M-M-R II), lot number T033814, with expiration date reported and validated as 05-OCT-2022 (strength, exact dose, vaccination schedule, route of administration, anatomical site of injection were not reported) for prophylaxis that underwent a temperature excursion. No additional adverse effect reported.   The vaccine underwent a temperature above 9 degrees Celsius (12.4 degrees Celsius), for a timeframe of 0 hours 53 minutes and 0 seconds, above 9 degrees Celsius (9.6 degrees Celsius) for 0 hours and 34 minutes and 0 seconds, above 9 degrees Celsius (9.5 degrees Celsius) for 0 hours 23 minutes and 0 seconds, above 9 degrees Celsius (8.5 degrees Celsius) for 0 hours 9 minutes and 0 seconds. No previous temperature excursion (product storage error).; Sender's Comments:  US-009507513-2112USA006870: US-009507513-2112USA007442: US-009507513-2112USA007443: US-009507513-2112USA007429: US-009507513-2112USA007428: US-009507513-2112USA007430: US-009507513-2112USA007431: US-009507513-2112USA007432: US-009507513-2112USA007433: US-009507513-2112USA007434: US-009507513-2112USA007435: US-009507513-2112USA007440: US-009507513-2112USA007441: US-009507513-2112USA007444: US-009507513-2112USA007445: US-009507513-2112USA007446: US-009507513-2112USA007447: US-009507513-2112USA007427: US-009507513-2112USA007426: US-009507513-2112USA007425: US-009507513-2112USA007436:
1:25 am 4-25-21  Temperature 97.5 (0.2 degrees lower than normal on the testing equipment) Right front lower gut pain.  (not usual for me) both elbows in pain shot in  arm  in  pain dry mouth heat in arm, in  and around area of shot urine darker yellow and more profuse than expected 98/73 blood oxygen some stomach nausea.  Nausea is not usual for me.  3:14 am 4-25-21 98.1 temp (my usual temp is 97.5-ish  3"35 am 4-25-21 Temperature 98.4, nearly one degree higher than usual.  Feeling feverish. Heat in throat.  Possibly starting on a sore throat. Extreme nausea. Actually vomited.  (It was all water or water-ish).  Vomiting for me is highly unusual.  Through-out all 3 of these times, I was severely impacted by extreme fatigue; inability to think, move or do things.  11:53 am 4-24-21 Temp 99.5 (this is two degrees higher than my normal temp taken by the same equipment. Extreme fatigue, sore ears, mild head ache (back of the head on both sides. Another bout of chills.  16:38 pm 4-25-21 99.9.  My head doesn't feel hot, but my cheeks do.   I don't feel nauseated. I do feel like I want to sleep, so I'm going to. I've successfully sat up to type into this report, which is more than I could do this morning.  So, when I wake up, I'll take note of how I feel then.
This spontaneous report as received from a nurse refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 21-AUG-2014 the patient was vaccinated with extra dose of (Oka/Merck) VARIVAX (dose/frequency: 0.5 ml, Therapy route: subcutaneous) after receiving a dose of PROQUAD. No adverse effects were reported. No product quality complaint (PQC) was reported for (Oka/Merck) VARIVAX. Additional information has been requested.
Redness at immunization site on Left vastus, warm to touch, child fussier on evening on immunizations.  Mom demonstrates to nurse today at appointment approximate size of redness 4 x 4 cm.  Today at clinic when mom reports redness at immunization site, size of redness is 7 x8.5 cm, red, very warm to touch, solid and firm to touch area under entire measured area, child fusses when it is touched.
Swelling. hives after 3-4 days of receiving vaccine. But she did not have any fever or pain. Just swelling, a hive at left arm, and itchiness.
Pt had a irregular "bruise-like" discoloration about 2-3 inches above the elbow but not where the vaccine was administered. Patient said she did not have any adverse reaction to any vaccine before. Patient did not have any ill effects from the vaccination (no fever, no pain at site of "bruising"). When asked if patient has any blood clotting disorders, she answered "no" and also responded with a negative if she bumped into anything recently.
Vaccine was given.  Patient stayed in the clinic after vaccine until her time was up.  She felt fine at that time and left.  Approximately 15 minutes after she left she began having coughing, dizziness and rash.  Her husband took her to her PCP where she was treated for an anaphylactic reaction to the vaccine.
Post vaccination patient complaint of dizziness VS checked  B/P 180/90  P-82 R-20, Recheck VS after few mins B/P-160-89 P-78 R-19, patient said she felt better did not want any further care. Advised to go to ER for eval, and refused. Release form signed. Left with a friend with no further complains.
Face flushing, face eruptions to the left side of the face.  Lasted 7 days, 10 days prior to diminishing.  Face and feet bright red in color Face flushing with warmth day after vaccine, face break out with crusting same time frame.
Local reaction at injection site characterized by erythema, warmth, tender to touch, pain, and swelling.
Information has been received from a Certified Medical Assistant concerning a 25 year old female with a history of oedema, cellulitis and an allergic reaction to Augmentin who on 13-SEP-2006, at 15:00, was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 650350/0970R). Concomitant therapy included Robitussin and Zithromax. The patient had a negative antibody for mumps. At the time of report the patient was "normal" other than low titer. Unspecified medical attention was sought. Patient was advised "to do another MMR." There was no product quality complaint.
HEADACHE, LITTLE COUGH, ARM SWOLLEN, ITCHING, FELT THROAT CLOSING. WENT TO HOSPITAL. THERE, MD ADMINISTRATED EPI PEN SHOT, BENADRYL, ROFERCERIN, AND ZOFRAN.
Patient received 2nd set of shots (Pediarix, HIB, Prevnar)-the following day had febrile seizure with temp 39.2 deg. EEG/MRI/LP normal.   05/24/2007 MR received for a 2 night admission (1/7-9/2007) for c/o an episode of  body stiffness and shaking of the 4 extremities and  rolling back of the eyes. Infant had had a cough x 4 days and a temp of 102.6 was  noted in the ER. PE: (+) for Nasal congestion and systolic innocent murmur.  Discharge DX:  Febrile seizure.
Information has been received from a physician and a registered nurse concerning an 8 year old male who on 27-JUN-2007 was vaccinated subcutaneously with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 657412/0594U) in the right quadricep. On 30-JUN-2007, the patient experienced a local injection site reaction that was hard, swollen, red and feverish to touch. During a phone call on that day, the parent reported redness approximately the size of a silver dollar to the thigh. There was no high fever, behavioral changes or allergic response noted. "After receiving the chart note, it appears that the patient only had a mild localized reaction which was considered a normal problem associated with the vaccine." The physician counseled the parent to apply hydrocortisone cream or Benadryl to the site to treat the reaction and call back if symptoms worsen. "There were no further phone calls or visits regarding the reaction, so it can be assumed that the redness resolved on its own." Subsequently, the patient recovered from injection site reaction that was hard, swollen, red and feverish to touch. No product quality complaint was involved. Additional information has been requested.
pancreatic cancer; This spontaneous report was received from the patient's wife concerning to her 76 year old husband, who had no known allergies. The patient's concurrent conditions included heartburn. The patient's concomitant therapies included NEXIUM (esomeprazole sodium) (started 20 years ago).     On 09-OCT-2002,  when the patient was 59 year old, he may had received a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23)  (confirmed by paper work from the site where the vaccine was obtained) (dose, route, lot# and expiration date were not provided) as vaccine for pneumonia. it was a Merck vaccine. On the same date, the patient also received an unspecified influenza virus vaccine inactivated (unspecified) (reported as "flu shot") as well.  Afterwards, on an unspecified date, the patient experienced pancreatic cancer.              At the time of the report, the outcome of the event was unknown.  The causal relationship between pancreatic cancer and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was unknown.  Upon internal review, pancreatic cancer was determined to be medically significant.
High fever 102 degrees, extreme fatigue, headache, severe joint and muscle aches.
Within 24 hours of receiving 2nd Booster of Moderna, the injection site (left arm) swelled up.  It was red, hot and swollen for at least 3 weeks.  Very slowly, over time, I noticed generalized pain in my left arm and restricted range of motion in my left arm.  On Aug 1st, I had a medical physical with my physician and I described my problems with my arm that had appeared since I received my 2nd booster.  She said it sounded like my shoulder and prescribed PT.  From Aug-Sept 2022, I received 16 sessions of PT and did my required exercises daily.  Instead of improving, my ROM and pain increased from Level 1 to Level 4-5.  They discharged me due to limits of my PT sessions and they recommended Acupuncture.  In Oct, I started Acupuncture to try to improve my condition.  It has been slow going and I have increased nerve pain throughout my upper left arm.  This impacts on my ability to dress without pain, put on my seatbelt, reach for objects on the side and high up, lift heavy objects, etc....  It is very debilitating, and I'm upset that it impacts on my quality of life.  Moreover, I just turned 65 and retired and Medicare doesn't cover Acupuncture so I'm paying for it out of pocket.  I don't know if Acupuncture will work or not and if not, what is my next step?  Its frustrating because I'm pro Covid vaccination and I had 3 Pfizer shots and no issues at all.  I feel that this condition is totally under reported and that is why I'm reporting it myself.  I have heard other people have had shoulder issues too since getting the vaccination.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: EW0153), in left arm, on 30Apr2021 as dose 2, single (Lot number: ER8736), in left arm, on 03Nov2021 at 12:45 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 28Feb2022 at 16:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "Hypothyreosis" (unspecified if ongoing), notes: Hypothyreosis; "Vit B12 deficiency" (unspecified if ongoing); "Known allergies: Hazelnut allergy" (unspecified if ongoing), notes: Known allergies: Hazelnut allergy; "Known allergies: Apple" (unspecified if ongoing), notes: Known allergies: Apple; "Known allergies: Pear intolerance" (unspecified if ongoing), notes: Known allergies: Pear intolerance; "Known allergies: Pollen allergy" (unspecified if ongoing), notes: Known allergies: Pollen allergy; "Known allergies: Cat hair" (unspecified if ongoing), notes: Known allergies: Cat hair; "Known allergies: Dust mites" (unspecified if ongoing), notes: Known allergies: Dust mites; "Known allergies: Adhesives/bandaids" (unspecified if ongoing), notes: Known allergies: Adhesives/bandaids. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) Negative; (12Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Seriousness criteria-Results in death was reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no. Other medication in 2 weeks was reported as yes. Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was reported as yes. Did you/the patient previously receive a COVID-19 Vaccine was reported as yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 22Sep2022, outcome "recovering", described as "Body aches"; COUGH (non-serious) with onset 22Sep2022, outcome "recovering"; PYREXIA (non-serious) with onset 22Sep2022, outcome "recovering", described as "Fever"; HEADACHE (non-serious) with onset 22Sep2022, outcome "recovering". Therapeutic measures were taken as a result of pyrexia, pain, headache, cough. Additional Information: It was reported that the case was Non-Serious. Anti viral details: product COVID-19 Treatment. Case narrative: She took the booster on 22Sep2022, she has been experiencing fever, body aches, headache and a cough. Adverse events start date was 22Sep2022 12:00 AM. Outcome of the events was Recovering. AE treatment Took Advil as advised by pharmacy. No known allergies. other medical history was None. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Received the PNEUMOVAX 23 vaccine and the next day experience hives and bruise at the injection site.; Received the PNEUMOVAX 23 vaccine and the next day experience hives and bruise at the injection site.; This spontaneous report has been received from a company representative referring a female patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration, anatomical site of application, lot number and expiration date were not provided).  On an unknown date, husband and wife both received the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the next day experience hives (vaccination site urticaria) and bruise (vaccination site bruising) at the injection site. At time of reporting, the issues where improving (recovering).   The causal relationship between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA002871:
Scratchy and itchy throat before leaving store, sore throat, runny nose, head ache, fever continuing on 10/21/2016. Fever broke 10/22/2016, other symptoms diminished.
This case was reported by a pharmacist and described the occurrence of injection site tingling in an adult patient who received hepatitis B vaccine recombinant (Engerix B). The pharmacist reported that three patient experienced injection site tingling following the administration of Engerix B, however, patient identifiers were not provided. On 2/10/2005, the patient received the 2nd dose of Engerix B (lot ENG5588AH incorrect lot). The site of injection of Engerix B was not reported. At an unspecified time following the second administration of Engerix B, on 02/10/2005, the patient experienced an injection site reaction characterized as tingling. The outcome of the injection site reaction was not reported. The reporting pharmacist considered the injection site reaction to probably be related to vaccination with Engerix B.
Dizziness occurred within an hour of receiving Shingles Vaccine and continued several hours after.  Slept sitting up and next day was fine.
Fever of 104* for 24 hours, body aches, chills, sweats, nausea and vomiting, severe arm pain for 3 days. Red, swollen, painful hot to touch near injection site started on 4th day after vaccine and lasted 2 days.
WITHIN ONE MINUTE, PT EXPERIENCED NAUSEA, BURNING IN THE CHEST AND THROAT AND A BAD TASTE IN HER MOUTH.   THE PHARMACIST ON DUTY TEST HER BLOOD PRESSURE AND IT WAS 198-90.  HER SON CAME TO PICK HER UP AND HE CALLED AN AMBULANCE.  THE EMT TOLD HER TAKE IT EASY BUT DID NOT ADVISE GOING TO THE HOSPITAL.  HER BP CONTINUED TO BE HIGH AND HER DOCTOR HAS HER SCHEDULED FOR APPOINTMENTS EVERY 3 DAYS TO KEEP AN EYE ON HER. SHE IS WAITING FOR EKG RESULTS AND HER BP HAS COME DOWN BUT IS NOT BACK TO NORMAL AS OF 4-21-21.
Pt started having signs/symptoms of COVID-19 on 5/1/21 and tested positive on 5/4/21 with both a COVID rapid antigen and a PCR.  S/S include:  muscle aches, fatigue, cough, nausea, vomiting and diarrhea.
pneumovax & flu vax given & immed burning pain-progressing to significant swelling x 3 nl size burning pain severe erythema pain from upper arm; adenopathy pain & streaking w/swelling to elbow-ax out chest wall; still some prob today;
SORE ARM; TIREDNESS; This spontaneous report received from a consumer . The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) 0.5 ml, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced sore arm. On 11-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and tiredness was not reported. The reporter causality and Company causality between JNJ-78436735 and sore arm, tiredness was possible.  This report was non-serious.
Presented 1 pm 9/20/14 with swelling of both eyes, below and above each eye, mild tightness in chest. Moderate swelling of eyes started this AM.
This spontaneous report was received from a licensed vocational nurse and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 18-MAR-2016, the patient was vaccinated with a dose of M-M-R II (lot # L032181, expiration date: 25-AUG-2017, dose and route were not reported), that was improperly stored (temperature and time frame were unknown at the time of reporting). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
No adverse event to report  Adult patient was administered a Pediatric Pfizer (undiluted) 0.3ml dose instead of the adult pfizer
Vulvar aphthous ulcers; Vulvar aphthous ulcers; This is a literature report.  An adolescent patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Bnt162b2 for COVID-19 immunisation, reaction(s): "Without complications", notes: Dose 1, Single.  The following information was reported: VULVAL ULCERATION (medically significant), APHTHOUS ULCER (medically significant), all with latency 2 days after the suspect product(s) administration, outcome "recovered" and all described as "Vulvar aphthous ulcers". The patient underwent the following laboratory tests and procedures: Cytomegalovirus test: Negative; Epstein-Barr virus test: Negative; Physical exam: Was consistent with a diagnosis of vulvar aphthous, notes: ulcers with no exceptional characteristics. There were multiple ulcerations with fibrinous exudate and some with necrotic islands.; Sender's Comments: Based on the information in the case, an association between the reported events ulceration of vulva and aphthous ulcer and the suspect product BNT162B2 cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200042326 Same article/drug/event and different patient;US-PFIZER INC-202201056246 Same article/drug/event and different patient:;
No adverse events now. The patient received the Pfizer child dose in an undiluted form.
PATIENT FAINTED SOON AFTER VACCINE.  PATIENT WAS HOT AND SWEATY AND NAUSEAOUS. PATIENT' S BLOOD PRESSURE DROPPED
pt recv vax 14JUL97 &  & immed p/vax given pt devel red welts of approx the size of a dime around inj site;pt mom stated that the welt disappeared in approx 1hr;