chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 25-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Developed diffuse rash and fever to 102 less than three days after MMR and Varicella vaccines were given.  Both rash and fever were consistent with common MMR reaction, but experienced mother of four was quite frightened and needed office visit for reassurance.  Time of onset was shorter than typically reported.
Low grade fever began about 21 hours after shot. Very achy all over about 24 hours after shot. 36 hours after shit the lymph nodes under my left arm began to swell and hurt. Over the course of the next 2-3 days after that, the nodes continued to swell and hurt down my arm past the elbow. A week after the shot it was all resolved
a patient received 2.5mL of IPOL; Initial information was received on 04-May-2021 regarding an unsolicited non-valid non-serious case from other health professional (Inquiry number: 00587508).  It was reported that a 13-year-old patient received 2.5ml of IPV (VERO) [IPOL] (lot number: R1F97 and expiry date: 03-Oct-2021) (suspension for injection) via an unknown route at an unknown administration site of prophylactic vaccination (overdose).  It was a case of actual medication error due to vaccine overdose.  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
It caused me five hours of low blood sugars and severe fatigue could not stay awake family kept waking me to eat protein to help sugars   Then for 1 week after I had a flare up of my joint pain all over whole body ( usually it?s 1 x a month a day or two with my illnesses this was all at once   And my temp was 95.8 for three days I was always cold
On 3/1/21 the injection site became bright red (2" W x 3 1/2" L)and very slightly swollen.  No change on 3/2/21.  Morning of 3/3/21, redness appears to be starting to fade.
Patient is a 66 y.o. female presents with increasing shortness of breath and fatigue the last few days.  The patient presented to the ER just a few days after being discharged from Hospital.  The patient was treated as an inpatient at Hospital little under a week ago for a COPD exacerbation.  She showed dramatic improvement during this time, but over the last few days has started showing increasing signs of shortness of breath and severe fatigue.  She has no known coronavirus (COVID-19) contact, but states that anything is possible.  Her rapid coronavirus (COVID-19) test in the ER was negative.  However, her chest CT seem to suggest a severe viral pneumonia.  Because of this, the patient is going to be admitted to the hospital as she has failed outpatient therapy and is significantly hypoxic.
I woke up in the morning with swollen jaw and eye on left side of face. Went to the ER.  they looked at it and said it was Bell's Palsey. They gave me prescriptions. I filled the Prednisone and took one pill a day for 7 days. Also ordered Acyclovir but I didn't  finish it because too many  side effects hitting me from pills. I am out of Prednisone and my face is still swollen. Bell's Palsey still here and active- 10 days later.
Adolescent became lightheaded then fainted several minutes after receiving immunizations. LOC approx 1 min. and color pale. Remained nauseous and lightheaded 10 mins. Walked on own to parking lot accompanied by mother and nurse. Mother called 2 days later and stated adolescent fine after arriving home.
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-FEB-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 56 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius), second lasting for 24 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.56 degrees Celsius), third lasting for 24 hours, with the highest recorded temperature of 48 degrees Fahrenheit (8.89 degrees Celsius), fourth lasting for 120 hours, with the lowest recorded temperature of 29 degrees Fahrenheit (-1.67 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 30-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) during pregnancy. Concurrent medications included Prenatal vitamins. On 12 October 2009 the subject received unspecified dose of BOOSTRIX (unknown), and experienced vaccine exposure during pregnancy. Her last menstrual period was on an unspecified date and estimated date of delivery was not provided. It was uncertain if the subject may have been pregnant or became pregnant shortly after vaccination. The outcome of the pregnancy was unknown. Follow-up information was received on 04 January 2010 via a pregnancy initial notification form. It was reported that the pregnant patient was 30 years of age at the time of event with an estimated due date of 24 June 2010. The date of last menstrual period was not reported as the patient had been receiving oral birth control (Ortho Tri-Cyclen). BOOSTRIX was given on 12 October 2009 during the patient's 1st trimester. Concurrent medications included prenatal vitamins, XANAX and Augmentin. The subject experienced a spontaneous miscarriage at 7 weeks, 3 days gestation. No further details were provided.
PT states chest pain starting 20-30 minutes ago with chest tightness and shortness of breathe radiating through the back (got J/J vaccine 1430). PT states pain has since gotten better (taken broken tailbone medication- oxycodone 5mg at 1900/2000).
Monitor blood sugar, it gave me reading of 166, checked it again and it said 196, checked it back to back it said 202 and third time it said 187; Monitor blood sugar, it gave me reading of 166, checked it again and it said 196, checked it back to back it said 202 and third time it said 187; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date 27Mar2021 09:00 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 immunisation. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 28Mar2021, outcome "unknown" and all described as "Monitor blood sugar, it gave me reading of 166, checked it again and it said 196, checked it back to back it said 202 and third time it said 187". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:  The only one thing that the patient did noticed, was, the patient was diabetic but do not take any medication for this, mostly keep it under control with diet. Monitor blood sugar every morning, it was 107 which is okay for me. And then when the patient ate some food at 3-o-clock, normally do not check it twice a day but have eaten something not nothing sweet but a lot of chips. So at 3-o-clock the patient just ate that food. So, like 7, the patient decided to check it again because the patient was getting hungry, reading of 166 which was okay, that did not concern so much, it is just 4 hours and it will most probably come down soon to in a way to 108 to 90. But this is what the patient did not understand after that 166 the patient waited another hours and checked it again and it said 196, so that kind of warned the patient, not experience that but it was for the patient, there was a time at evening that the patient checked it back to back and the second time, it said 202. And checked it third time, checked machine to make sure the reading was right and the third time it said 187 and the patient was like I had not eaten anything for like 5 hours when I checked at 8-o-clock. So now have you had any report of this vaccine raising people the blood sugar level?"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt received Tdap, GARDASIL and meningococcal vaccines in our office on 11/11/14 at 10:00 AM. He did not eat before visit. After leaving our office, he vomited and felt dizzy in the parking lot. We brought him into the office and took vital signs. Temperature 98.2, oxygen 96, pulse 84, BP 100/60. He sat in the office for 10 minutes then left.
Extreme chills; fitful, restless sleep; body aches, headache, hot-cold sweats, shaking from cold. No swelling no redness at injection site.
This spontaneous report was received from an office manager and refers to a 16-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 09-MAY-2017, the patient was vaccinated with PROQUAD (lot # M037652, expiration date: 28-FEB-2018, dose and route of administration were not reported) reconstituted with a sterile diluent (manufacturer unknown). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Approximately 10 minutes after receiving 2nd Covid 19 vaccine, patient reported not feeling well.  She was assisted to a cot where she was able to lie down.  VS taken: Pulse-101, O2 sat 99% bon 2L/min of Oxygen, BP 135/87. At 12:30 she was anxious and began to c/o tightening of the throat and 0.3mg of epinephrine was administered IM into the right leg via auto injector by RN per protocol.  EMS was at the POD site and monitored until she was transported to the emergency department by ambulance.
Client complained of being light headed and tightness in his chest.  Client reports history of panic attacks which resulted in similar symptoms.  Gave a bottle of water to drink.  Lightheadness and tightness in chest subsided quickly.  Clients BP at 11:15 164/84.  Has history of borderline hypertension.
AFTERNOON POST VACCINATION PT EXPERIENCED LIGHTHEADEDNESS AND FATIGUE AND DIARRHEA, SYMPTOMS PROGRESSED AT NIGHT TO COLD SWEATS, FEVER. NEXT DAY PT FELT MORE DIZZY AND LIGHTHEADED, SEVERELY FATIGUED, DIFFICULTY BREATHING, SWOLLEN LYMPH NODES, BODY ACHES, PAIN AT SITE OF INJECTION. SWOLLEN TONSILS AND DIARRHEA. SYMPTOMS WORSENED THROUGHOUT THE DAY UNTIL PRESENTING TO THE ER, VITALS WERE ABNORMAL INCLUDING FEVER OF 101.8, TACHYCARDIA, RESPIRATION RATE OF 22 PER MINUTED, BP ELEVATED.  PT WAS TREATED WITH MOTRIN/TYLENOL, IV FLUIDS WITH NO IMPROVEMENT OF SYMPTOMS POST DISCHARGE FROM THE ER. DAY 2 POST VAX STILL EXPERIENCING THE SAME SYMPTOMS AND PT STARTED DEVELOPING ULCERS IN THE MOUTH. PT SEEN IN ER SECOND TIME FOR SAME SMYPTOMS NOT IMPROVING, WAS GIVEN IV FLUIDS,  TYLENOL, MOTRIN, THROAT LOZENGES AND NUMBING MOUTH WASH. ULCERS HAD TO BE CAUTERIZED THE WEEK FOLLOWING THE INJECTION. OVERALL SYMPTOMS LASTED APPROX. 2 WEEKS
pt recv vax 20JUN95 & 11MAR97 pt exp a mild case of varicella;another pt was reported as well (WAES 97031260);
I had facial tingling which included the mouth and jaw, and my vision was blurred. I was also a little lightheaded which subsided but did not go away completely. The next day I was better, but I had soreness around the injection site. I also had diarrhea.
Numbness on left-side of body. I can still move body parts, and still seem to have full strength (checked in office by primary care doctor), but loss of most sensation on skin on left-side. Doctor not sure of cause. Chiropractor suspects result of Pfizer vaccine because 2 other patients had similar reaction. Feeling slowly coming back.
This spontaneous report has been received from a pharmacist regarding a 69-year-old female patient. Concurrent conditions included asthma and hypertension. The patient's concomitant therapies and drug reaction/allergies were unknown. On 14-FEB-2017, the patient was vaccinated with PNEUMOVAX23 intramuscularly on the left arm deltoid (lot # M004318 with expiration date 12-OCT-2017) (dose was not reported) for pneumococcal prevention. On the same date, after the vaccination, the patient reported increased redness (Erythema) and warmth (Feeling hot) that extended from the left shoulder to the left elbow and swelling in lymph nodes under the left arm (Lymphadenopathy). The patient did not receive any treatment for the events and no diagnostic laboratories were performed. At the time of this report, the patient had not recovered from the events. There was no product quality complaint (PQC) involved. It was also reported that on 16-FEB-2017, the patient had a surgery on her gums. The causality assessment between erythema, feeling hot, and lymphadenopathy with PNEUMOVAX23 was not reported. Additional information has been requested.
Fatigue and chills since the day after vaccination.  Tight chest and shortness of breath by on and off since 4/9, about 3x/week. Ringing and echo in ears started occurring 4/18 or so, about 2x/ day
-10 hours post injection, developed malaise and low grade fever that lasted 24 hours.   -About 45 hours post vaccination, noticed a rash that covered my neck, site of injection, torso and extended to the top of my thighs.  there was no pruritus involved and no fever or other symptoms.  75% of the rash was gone within 24 hours and 100% gone 48 hours after it was noticed.
This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 46-year-old female patient who received FLUARIX QUADRIVALENT (batch number 7FF3N, expiry date 30th June 2017. This case was associated with a product complaint. Concomitant products included FAMVIR. On 11th October 2016, the patient received FLUARIX QUADRIVALENT (intramuscular) 0.5 ml. On 12th October 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced site swelling, injection site warmth and injection site erythema. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site erythema and pharmaceutical product complaint were unknown. The reporter considered the injection site swelling, injection site warmth and injection site erythema to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT on right deltoid and experienced swelling, redness, and warm to touch feeling at injection site. The patient required the emergency room visit. Filing related QA since health care professional felt as though events could be due to a specific lot. This case has been linked with case US2016150970 as reported by same reporter.
Headache, Rash, Light sensitivity r/t headache without history of migraine Narrative:
COVID-19 PNEUMONIA; This spontaneous report received from a consumer (patient's wife) from a traditional media article via a company representative, concerned a male patient of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number and expiry were unknown) dose was not reported, 1 total, administered on 06-MAR-2021 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 01-APR-2021, the patient felt sick, had a stuffy and sore throat, cough, fatigue and then he started to run a fever. On the same day, the patient was tested positive for coronavirus disease (COVID-19) and also developed pneumonia (COVID-19 pneumonia). On an unknown date, the patient was hospitalized and was fighting for his life. At the time of report, the patient's condition was critical and was on medications (unspecified) for his condition. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19 pneumonia. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000178844.; Sender's Comments: V0; 20210516810-covid-19 vaccine ad26.cov2.s-COVID-19 pneumonia. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This non-serious spontaneous case, initially received from a pharmacist on 19-Sep-2018, concerns a female patient of an unspecified age. On an unspecified date, the patient was administered INN flu vaccine seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). On an unspecified date, after vaccination, the patient experienced swelling in the arm. At the time of this report, the outcome of the event was not reported. Non-significant follow-up report received from pharmacist on 08-Oct-2018: The pharmacist stated that the patient was not a regular patient. The patient only told that, the year before she had arm swelling after the vaccination. No new information was received.
Narrative: Patient is a 58 yo vaccinated male with IDDM2 poorly controlled with hyperglycemia. He developed dizziness and vertigo as well as intermittent headache on 8/16, which coincided with when he got his Shingles vaccine. He has had intermittent nausea and vomiting since and was seen in our ED 8/16 and 8/26. CT head was negative on both occasions and symptoms improved with hydration and antiemetics. He presented today to the ED with continued symptoms after arriving on campus for scheduled Endocrine appointment. MRI was done in ED which showed small non-acute cerebellar lacunar infarct. Neurology are consulted and plan for further inpatient workup. He was incidentally found to be COVID-19 positive. He has no rhinorrhea, nasal congestion, DIB, cough, fevers, anosmia, or aguesia, etc.
almost fainted; low blood pressure; sore arm; shaking (chills); A spontaneous report was received from a forty-nine-years old female consumer, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced low blood pressure, almost fainted, sore arm and shaking (chills).  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received the first of the two planned doses of mRNA-1273 on 25-Jan-2021 (Batch# 041L20A) intramuscularly for prophylaxis of COVID-19 infection. Approximately 12 hours later , she experienced low blood pressure, almost fainted, had sore arm and had  shaking (chills).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported  The outcome of the events was reported; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events 12 hours after vaccination, a causal relationship cannot be excluded. Further information has been requested
Body aches, left arm pain/tenderness, redness and swelling at the injection site.
Presented with cough and congestion.  Reports fully vaccinated.  Treated with oxygen, steroids, antibodies, vitc and zinc.  D/c home with O2
Dec 19 -  One swollen lymph node to left neck  Dec 25 - generalized rash/hives  Dec 26 - urgent care for increased generalized rash/hives  Jan 8 - received 2nd dose  Jan 22 - 2 additional lymph node swollen left supraclavicular
Patient vaccinated with Moderna x2 (last in 03/21) admitted to hospital after fall with COVID detected test and subsequent respiratory decline and ultimate death.  Provider discharge note below:    "78 YO male w/ history of CAD, vfib with AICD presented with weakness and after ground level fall. He was found to be COVID positive with imaging noting unstable acute L2 fracture.   During his hospitalization stay, Neurosurgery was consulted who initially planned on surgical intervention due to the unstable nature of his L2 fracture. He received aggressive IV hydration due to suspected rhabdomyolysis. Plan for surgical intervention was then postponed due to acute onset of worsening hypoxia in setting of covid 19 pneumonia. Decadron, Vancomycin and Zosyn were started for COVID 19 pneumonia with possible superimposed bacterial pneumonia respectively. Remdesivir was declined by patient. Rapid response was later called due to concern for hypertensive emergency, encephalopathy and worsening hypoxia. CT imaging later in the day revealed acute pulmonary embolism. Heparin drip started. His hospitalization was further complicated by development of atrial fibrillation with rapid ventricular rate likely due to worsening COVID 19 pneumonia infection. Cardiology was consulted who then started Cardizem drip.    Despite multiple efforts of care escalation, patient continues to decline. ICU was consulted who deemed patient's prognosis very poor. They have spoken with patient's family (son and wife) who changed patient's code status to DNR/DNI from Full code. After patient's wife visited him and witnessed his critical condition and noted to be removing BIPAP mask, she decided to transition him to comfort care. Comfort care placed. Patient passed subsequently. "