chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of lip swelling in a adult female patient who received ENGERIX B adult (batch number B39CM, expiry date 3rd February 2020). Previously administered products included DTP vaccine with an associated reaction of lip swelling (refer case US2017GSK190455). On 1st December 2017, the patient received ENGERIX B adult (intramuscular) 1 ml. In December 2017, 6 hrs after receiving ENGERIX B adult, the patient experienced lip swelling (serious criteria life threatening), anxiety (serious criteria life threatening) and chest tightness (serious criteria life threatening). The patient was treated with prednisone and BENADRYL. In December 2017, the outcome of the lip swelling, anxiety and chest tightness were recovered/resolved. It was unknown if the reporter considered the lip swelling, anxiety and chest tightness to be related to ENGERIX B adult. Additional details were provided as follows: The patient received DTP vaccination as a child and had similar reactions, specifics unknown by reporter. The patient required urgent care visit for the events. The reporter stated that the reactions were attributed to the pertussis portion of the vaccine. The brand name was unknown for the DTP vaccine.
Complained of awaking on 1-28-21 at 5:45 AM  with dizziness, body aches all day, nausea and vomiting. Symptoms resolved on 1-29-21.
Swelling in axilla area of left arm approximately 12 hours after receiving COVID-19 booster (Phizer Lot#FM0698 Exp:05/31/2022). Minor pain is felt when palpated and when left arm is extended overhead. Area of swelling is approximately 10cm x 15cm. Depth of swelling is approximately 1.5-2cm. Booster was administered in the deltoid area of the left arm.
Child in severe pain and unabe to walk on the leg in which vaccine was administered within 3 hours, accompanied by swelling and fever. White blood cell count of 27,000.
pt recv vax & had t102 R w/uncontrollable crying spells- & redness & swelling of the lt leg as of that date;pt seen in office that afternoon;temp controlled w/APAP;
PT RECEIVED PEDIATRIC MODERNA BOOSTER ON 09/08/2022 AS OPPOSED TO NEW MODERNA BIVALENT. CALLED AND LVM. THIS IS A VACCINE ADMINISTRATION ERROR. NOT AN ADVERSE EVENT REPORTING
Jaw locked in the open position, tongue stuck out stiff, couldn't close mouth or move tongue for hours at a time, not even to eat, drink-head jerking, constipation, fever, fussy, runny nose, loss appetite, snoring.
Patient stated had reaction which included rash, swelling, and pain in the arm the following day.
Suddenly crying for no reason followed by uncontrolled laughing. Slurred words and unusual speech. Symptoms lasted for about 24 hours.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PROQUAD lot # M048201, subcutaneous for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD. {Additional information has been requested. Additional information is not expected}. Sender's Comments: US-009507513-1706USA009372.
A 12 year old received a pediatric dose instead of an adult one. Parent was informed, event was recorded in our records. No medical reaction occurred.
This patient had giant hives all over entire body, beginning 1 hour after taking vaccine and lasting for 3 days. Her temp 99.8. In the ER she was given Benadryl IM and sent home to take oral Benadryl.
Chest pain only, worse with inspiration, no shortness of breath or urti symptoms. Improved with Motrin
joint pain; Chills; Fever; Tiredness; horrible nightmare when I fall asleep; I really feel awful; felling terrible; 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 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; NIGHTMARE (non-serious), outcome "unknown", described as "horrible nightmare when I fall asleep"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I really feel awful"; MALAISE (non-serious), outcome "unknown", described as "felling terrible".  Additional Information: Consumer stated, I just have a question. I don't need to be reporting, I just have a question about booster that I got. I received the Pfizer Booster (Name not clarified, hence captured as Unspecified booster) yesterday around 11 and I was fine and then I got the horrible joint pain that I got with the first two shots (Further clarification unknown, hence suspect captured conservatively as unspecified shots; Manufacture not clarified, hence tab left unchecked) now I have like joint pain and chills and may be a fever but I don't know but you know tiredness and having horrible nightmare when I fall asleep. So, my question is how long is this last because its not severe enough to go hospital but I really feel awful. By then hopefully the side effect will go away by Monday, wouldn't you think. They don't last forever when you get the shot. They should have somebody there all weekend because they want you to call and you are felling terrible you cant go the the hospital. So, they want people to get the vaccine, they should tell us if you getting this shot on weekend we are close. I am not blaming you but its ridiculous they want these people to get these vaccine, oh I am am sorry we cant talk to you now because we are not working that's just awful. You also give me the number I will wait till Monday .LOT#: Consumer stated, I don't know it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200835540 Same patient, same product, different dose.
student missed a dose by one day, no AE; Initial information received on 31-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 year old male patient who has missed his dose by one day, while he received second dose of RABIES (HDC) VACCINE [IMOVAX RABIES] (lot R1C854M, Exp. Date 14-May-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  Medical history, past medical treatment, vaccination and family history were not provided.  It was an actual medication error case due to inappropriate schedule of product administration.   It was reported that the consumer missed their dose by one day even though she had emailed a reminder. States the consumer came in today for the second dose in the series and the series was being given prophylactically for travel.  At the time of reporting, no adverse reaction 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 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.
Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 12-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicines were reported. No treatment information reported.   The vaccine was received on 3/9/2021 and a thawed expiration on 4/8/2021. The vaccine was administered on 4/12/2021, 4 days past the date of expiration
10/8C/O indigestion in evening, woke up  next day, 10/9, with same symptoms.  Hives all over body, swollen. Passed out in shower, in & out of consciousness.  911 called, given Epi pen shot - no result, given 2nd Epi pen shot - transferred to Hospital.  Hospitalized from 10/9-10/13, received IV steroids and Benadryl and Nebulizer treatments.  Experienced 2 more anaphylactic reactions while in the hospital, 2 more Epi pens administered.
Information has been received from a Registered Nurse (R.N.) concerning a female patient between 14 and 16 year old who was vaccinated with a second dose of Gardasil. The reporter mentioned that patient's mother called in to report she was experiencing flu like symptoms. She received the dose of Gardasil 2 weeks earl. It was unknown if patient sought medical attention, the outcome was unknown. Additional information has been requested.
Patient is under 18 years old (17). Moderna vaccine is only FDA indicated in patients 18 years old and older.
Temperature 103.2 degrees rectally on 03/09/2006.  Febrile seizure.
I developed severe, debilitating vertigo (extreme dizziness and nausea ), that lasted from 5:00 PM on Sunday 3/28/21 until 5:00 AM Monday 3/29/21 . My PCP suggested that I go to the hospital ER  that morning (3/29) where I spent about three hours. I was diagnosed with benign vertigo and was found to have a low potassium level. I experienced similar, but milder symptoms for about two weeks thereafter. The mild (but unpleasant)  symptoms continue to reoccur perhaps once/week.   I experienced similar but much milder symptoms following my second Moderna shot on 3/10/21.
Patient received vaccines on 12/27/2006. On 12/29/2006, patient reportedly experienced a simple febrile seizure at home with fever 105.2 rectal documented. Patient defervesced with acetaminophen and ibuprofen. No subsequent seizures were reported on follow-up visit on 1/8/2007 at which time patient was seen for cough/otitis media. 01/25/07-records received and reviewed for DOS 12/29/06- DC DX: Febrile illness, upper respiratory infection, Viral Syndrome HX: Seen at office with temperature of 105 and had seizure, lasted 30 seconds. Acted normal afterwards. Runny nose and slight cough. IN ER temperature 100.  PE: WNL, positive for rhinorrhea. Impression:uncomplicated febrile seizure, source for the fever is upper respiratory type symptoms.
Patient passed out shortly after FLUZONE ID administration. (Approximately) 5 minutes after admin. Patient had stood to pay for administration, fell backwards losing consciousness for a few seconds then became more aware as paramedics arrived. Patient was taken to hospital by ambulance.
ZOSTAVAX given 9-27-07, SQ. Left side of nose developed lesion, left face puffy, left lower lip lesion: 10-11-07. Saw me (primary physician) 10-15-07. Lesions consistent with herpes zoster or herpes simplex of left face. Treated with FAMVIR 500 mg tid x 7 days.
Pt recvd Hep B vax approx JAN92 & approx 1 wk p/vax devel a serum sickness-type reaction w/arthritis, fever & an elevated sed rate;
Experienced initial pain with injection of medicine that resolved shortly after;woke two days later with +8-9/10 pain LT deltoid at injection site; intermittent pain radiation to posterior aspect of LT forearm;at no time was there any swelling and/or discoloration;denies any tingling and/ or numbness;decreased ROM and strength of LT arm and cannot raise LT arm above her waist without assistance of other arm; minimal improvement over last three weeks; has done no self treatment e.g. NSAIDS or cold or heat application;feels fatigued and "run down"; pt was referred to her private MD for further evaluation
On the evening of 3/31/2023, I developed a sore throat. During that night, I began coughing. On the morning of 4/1/2023, I woke up with body aches, coughing, a feeling of feverishness but no fever, and a sore throat that extended into both ears. I took a home antigen test on 4/1/2023 and got a negative result. When I took another on 4/3/2023, I got a positive result. I emailed my doctor's office and told them of the test results and the symptoms I was having. I decided not to take an antiviral, because I didn't want to experience the same side effects I had when I took PAXLOVID during my first COVID-19 infection. This time, I just treated my symptoms with ROBITUSSIN DM for the cough and TYLENOL for the sore throat and earaches. The ROBITUSSIN helped me expel some of the mucus. I also slept sitting up during this time, because I was more comfortable coughing while sitting up than I was lying down. The TYLENOL helped a little with the sore throat and earaches. My symptoms were pretty much gone after ten days. I took another home antigen test on 4/11/2023 and got a negative result. I had lingering fatigue that lasted for maybe two or three weeks after I had tested negative.
multiple pt recv vax & devel flu;the reporter indicated pt had been vaccinated w/on of the recalled lot but was unable to identify a specific lot#;
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 59-year-old female patient received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: EW0150) at the age of 58 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "thyroid condition", start date: 2016 (ongoing), notes: States she does have a thyroid condition. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Fever"; RASH (non-serious) with onset Apr2021, outcome "recovered" (Apr2021); PAIN (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Severe pain/would say joint pain but the pain was everywhere and not just the joints"; SWELLING (non-serious) with onset Apr2021, outcome "recovered" (Apr2021); LYMPHADENOPATHY (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Swollen lymph nodes". Therapeutic measures were not taken as a result of lymphadenopathy, pain, rash, swelling, pyrexia.
Patient was given vaccine on 1/25/2021, he was observed for 30 minutes, and did well. The patient then called 1/29/2021, and spoke with the receptionist. He stated he had a rash on thigh prior to the vaccine that seems to have worsened after getting the vaccine. I attempted to called the patient back 1/29/2021 at 1:17 pm, and again at 4:00pm he did not answer so I left a message. He returned my call 2/1/2021 and states he now has a blister like rash on his back, chest, arms, and thighs that is itchy. I advised the patient I would be reporting this to VARES, however if he develops any shortness of breath, trouble swallowing, or severe hives  to go to the ER. He is not a patient of this clinic and stated he called his PCP who referred him back to us.
Pediatric office didn't discuss vaccine options and gave the Novavax but patient previously received only the two dose primary series for Pfizer.  Patient reports a hard little bump at the injection site (similar to TB testing bump) and is surrounded by a large red rash about 12 hours following administration. Patient reports having trouble moving arm due to pain she is in. The little hard bump at the injection site is the most concerning as this is not a typical adverse reaction. Patient also has other side effects like headache, uncontrolled fever, general malaise, and muscle aches. Patient is concerned the office should not have given Novavax as the first booster when she received Pfizer for her primary series.
At 0730 CNA went into resident room for repositioning and at that time no seizure activity was noted. At approximately 0800 nurse went into resident room to disconnect her feed and noted that resident was seizing.  It was noted that resident bilateral arms and legs were shaking. Resident face was twitching and resident had bilateral REM. At 0805 EMS was called for transport to ER.   At 0825 resident left with EMS and was still seizing. Received report from ER nurse that resident Dilantin level was within normal limits, that no infection present, and labs were within normal limit. They were unable to determine the reason that resident was seizing and it was encouraged to report it as an adverse reaction to the vaccine. ER nurse reports that resident didn't stop seizing until 0930.
wife tested positive for Covid-19 "about a month ago"; wife tested positive for Covid-19 "about a month ago"; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 79-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 78 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Jan2021 as dose 1, single (Lot number: 039K20A), on 09Feb2021 as dose 2, single (Lot number: 028L20A), on 24Aug2021 as dose 3 (booster), single (Lot number: 014C21A) and on 04Apr2022 as dose 4 (booster), single (Lot number: 065K21A) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Allergic reaction to bee sting" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient didn't receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (2023) and all described as "wife tested positive for Covid-19 "about a month ago"". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive.
Felt fine day of injection.  Next morning upon waking I was extremely fatigued.  I had no appetite nor did I want any liquids.  My joints hurt, no energy to even walk.  I was on the couch all day resting.  I have never experienced this type of fatigued before.  I had a bright, hot, itchy rash on my arm below injection site.    Today, March 30th  the rash is very faint but the itching is still there.  That evening, day after vaccine,  I started to get my energy and appetite back.  Other than faint, itchy sensation on arm, I am back to normal.
Mom called 3/12/04 to inform doctor and I that at 12:00pm on 3/10/04 two hours after recieving his immunizations patient was extremely pale.  He is now doing great and is no longer pale.  Informed mom it could have been IPV, Hib, or PCV7.  Informed mom that we could give each of these three immunizations separately in hopes of ruling out which if any of the three coused the paleness.  Will document in chart.
Patient has sore arm and shoulder and it has lasted for several weeks.  Is using  tylenol and cool packs .
Headaches (severe), joint aches, back pain, memory loss, loss of concentration, constant fatigue, sleep disorder. The 60 day follow up received on 8/21/03 states severe daily chronic headahces, joint aches, memory loss, low back pain. I was age 40 at the time of vaccination. I am now age 41. Born 3/3/62.
high fever (103F) despite Tylenol. low O2 (92%), raised resting heart rate, fatigue and chest discomfort
Within 2 days pain in both legs was excruciating and to this date 7/21/2022 I have trouble walking without pain and can not stand for more than a few minutes.  Have been basically bedridden ever since and have to walk with a cane.  Will not ever subject my body to further destruction by these covid injections.  Only took it to be able to be around grandchildren and cannot even do that now.
Hospitalized 2/18/22-2/26/22 Altered mental status, agitation, fever, weakness, sepsis, UTI, acute encephalopathy, acute renal failure, hypokalemia, tachypnea,
Had the 2nd booster of Pfizer on 2/18/2022 and then that night went to a prescheduled cervical mri.. I had an mri in January no issues. The entire time the mri was being done it wasnt the nioise like usual but severe very severe shooting pain in my head all over to the point I passed out from the pain. Left there with my husband in severe head pain all night continued days later then starting having severe on a scale of 1-10 it was a 10 severe head pain across the back of my head from ear to ear. Then my pulse rate was dropping every late date from normal of 73 to as low as 49 went to a cardiologist sent by my pcp and he will do a longer holter monitor and an electrocardiogram. I am reacting to everything everywhere my head and nerves are tapping all the time I have not been able to function on my own for months now. I have not slept in a bed since that night up all night insomnia and huge amount of anxiety not normal for me. I did not put all this linked to the shot until recently. I figured the MRI machine was defected contacted that facility wasnt that but when things got worse all through FEB MARCH APRIL and still  as of today I have never ever felt this symptom or pain felt like no one gets it PCP CArdiologist Neurologist because never bought up the possible booster as the root cause. Its scarey not knowing if it will ever go away and b having an autoimmune disease I was one of the first to request the second booster I am sure if I only knew. Where do I go who understands we were looking at moving not being able to be left alone. Any help would be appreciated anyone to turn to
No other AE reported.; Medical Assistant calls and reports an expired MMR II vaccine was inadvertently given to a patient.; This spontaneous report was received from a medical assistant, referring to a 12-months-old male patient. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 28-DEC-2020, the patient received an expired dose (expired product administered) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), as prophylaxis (formulation, strength, dose, vaccination scheme, anatomical site of vaccination and route of administration were not provided, lot number reported as R035700, which has been verified to be valid, expiration date reported and validated as 09-DEC-2020). There was no previous temperature excursion reported. No additional adverse event were reported.
Severe Back Spasms and Acute Neuropathy on the right side. Severe Sciatic nerve pain. Symptoms began on 8/18/2021 starting with spasms and cramping in lower back progressing to acute neuropathy on right side.