chrisvoncsefalvay/vaers-outcomes huggingface dataset:
discomfort on the site of the injection especially at night; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (discomfort on the site of the injection especially at night) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A121A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE DISCOMFORT (discomfort on the site of the injection especially at night). At the time of the report, VACCINATION SITE DISCOMFORT (discomfort on the site of the injection especially at night) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment drugs were reported.
16 month old was given 2 doses of Hib, given Acthib when he already got a dose of Pentacel with no reported adverse event; Initial information was received on 16-May-2022 regarding an unsolicited valid non-serious case received from a health care professional via call center.   This case involves a 16 months old male patient who experienced 16 month old was given 2 doses of hib, given acthib when he already got a dose of pentacel with no reported adverse event while receiving vaccine HIB (PRP/T) vaccine [ACT-HIB].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included prevnar and pentacel for Prophylactic vaccination.  On 16-May-2022, the patient received 0.5 ml of suspect HIB (PRP/T) vaccine (lot UJ521AA and expiry- 22-JUL-2023 ) (strength and formulation: unknown) via intramuscular route in the left upper thigh for immunization.  On 16-MAY-2022 the patient developed a non-serious 16 month old was given 2 doses of hib, given acthib when he already got a dose of pentacel with no reported adverse event (extra dose administered) (latency same day) following the administration of HIB (PRP/T) vaccine.  Action taken:  not applicable.  At time of reporting, the outcome was Unknown for the event 16 month old was given 2 doses of hib, given acthib when he already got a dose of pentacel with no reported adverse event.  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 the guidelines. 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.
Patient had Moderna vaccine, her second, on 2/16. About two days later developed flank pain. Went to urgent care about 5 days later and had negative urinalysis. Reassured, sent home. Next month noted to have new onset hypertension. Had HTN work-up with renal arterial ultrasound (negative), aldo/renin (abnormal), followed by CT abdomen/pelvis showing renal infarct. In retrospect this was likely the etiology of the flank pain at the urgent care visit. Seen by vascular surgery, cardiology, hematology. Unclear if related to vaccine or not. Imaging suspicious for fibromuscular dysplasia (vascular surgeon does not agree ) vs vasculitis. No HIT antibodies were done. Platelets were normal at time of HTN evaluation - a month after symptoms started.
Pt recvd vax 21MAY93 & 31DEC93 febrile, had febrile sz; MD visit-dx OM; rx'd Amoxicillin; 4 days later still febrile & lethargic; hospitalized; CSF culture revealed H. influenzae type B; had 2 focal sz;
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, and drug reactions or allergies provided. On 03-MAY-2017, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB injection (lot # M034189, expiry date 23-MAY-2019, dose, route and site of administration were not reported). The vaccine was stored over 32 but under 35 degrees Fahrenheit for 552 hours. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported. No product quality complain was involved. Additional information has been requested.
Resident received second dose of C0VID -19  ON 2/2/21 complaint of headache ON 2/3/21.
Woke up the morning after my second vaccine with swollen lymph nodes on the right side of my neck and near my right collar bone.   Right arm is also very sore, slightly swollen.
Patient received a higher dose than intended due to dilution error.  The patient has a sore arm and had a fever. Mom feels her son is getting better and is not concerned.
I have had numbness and tingling in my left arm every morning; my arm is just going to sleep but it happens every morning; I have had numbness and tingling in my left arm every morning; my arm is just going to sleep but it happens every morning; I have heart palpitations sometimes; I am starting to have difficulty in walking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 01Nov2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 62 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer, ), for COVID-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious), outcome "not recovered" and all described as "I have had numbness and tingling in my left arm every morning; my arm is just going to sleep but it happens every morning"; PALPITATIONS (non-serious), outcome "unknown", described as "I have heart palpitations sometimes"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "I am starting to have difficulty in walking". Therapeutic measures were not taken as a result of hypoaesthesia, paraesthesia, palpitations, gait disturbance.  Additional Information: The patient stated that she was wondering if having a side effect from the Pfizer vaccine booster or whatever she had the first and second shot last year. The patient  had the booster but there was things going on usually she was extremely healthy but lately had numbness and tingling in left arm every morning and also had heart palpitations. The patient stated,  thinking it's possible that was a side effect that she was having. The patient  do have a doctor appointment on 25Oct to talk to doctor about the numbness and tingling in left arm which she  told him once before and he saw that it was that arm was just going to sleep but it happens every morning and the patient concerned about it. Well, it's actually happening now so the numbness and tingling in arm are concern of  patient and then had heart palpitations sometimes. The patient started to have difficulty in walking. Now, that's another reason patient going to doctor on 25Oct. The patient hope it was not anything but maybe it could be that hips going out on me she don't know, it could be knee. The patient don't know but  having difficulty in walking lately. So, that was the concern of patient but you know she may not have nothing to do with anything other than the normal aging process but we can just, the patient just thought she  should report it just in case.
I can't even think anymore; I'm having such a bad day; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program (005570). The reporter is the patient.  A patient of unspecified age and gender) received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: THINKING ABNORMAL (non-serious), outcome "unknown", described as "I can't even think anymore"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I'm having such a bad day". The action taken for pneumococcal 20-val conjugate vaccine (diphtheria crm197 protein) was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pityriasis Rosea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2022 16:45 (Lot number: FK9896) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "PCOS" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (dose number=2, product=COVID 19, brand=Pfizer, lot number=FF2589, administration date=05Oct2021 , administration time=12:00 PM, vaccine location=Left arm), administration date: 05Oct2021, when the patient was 26 years old, for COVID-19 immunization; Bnt162b2 (dose number=1, product=COVID 19, brand=Pfizer, lot number=FF2588, administration date=17Sep2021, administration time=12:00 PM, vaccine location=Left arm), administration date: 17Sep2021, when the patient was 26 years old, for COVID-19 immunization. It was reported that patient was not suffered with Covid 19 prior to vaccination. Patient was not tested Covid positive post vaccination.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 25Feb2022 16:45, outcome "unknown", described as "Dose number=3; administration date=25Feb2022/ dose number=2; administration date=05Oct2021"; PITYRIASIS ROSEA (non-serious) with onset 06Mar2022 12:00, outcome "not recovered", described as "Pityriasis Rosea". The event "pityriasis rosea" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pityriasis rosea.  No follow-up attempts are possible. No further information is expected.
Patient was experiencing sore throat/throat swelling and numbness of tongue reported approximately 50 minutes after administration of covid-19 vaccination. Patient was given benadryl, 50mg, and watched for an additional 20 minutes.  Benadryl was effective at reducing numbness in tongue and throat swelling. Patient was instructed to continue benadryl if needed for symptoms and to take an anti-inflammatory such as ibuprofen or naproxen.
Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown. Not Provided          On an unknown date, the patient experienced Injection site pain from COVID-19 Vaccination. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Info has been received from a registered nurse concerning a 72-year-old female who on 11/05/2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #642750/0210M). On approx 11/05/2002 the pt experienced local redness, induration and pain at the injection site. It was reported that she still had symptoms as of 11/07/2002, but they are improved. On 11/07/2002, "the site is now itchy". Unspecified medical attention was sought. Additional info has been requested.
Patient experienced adverse event after her 2nd COVID vaccine. Shortly after receiving her second Pfizer vaccine, she was at checkout desk and experienced a syncopal episode falling to the ground and striking her head. 911 was called due to head strike. She had approximately 10 seconds of loss of consciousness. When she awoke she was alert and oriented x 3. Initial VS: BP 78/40, HR 50. Although patient had reported to Vaccinator today that she did not have history of adverse reactions to vaccines. She then reported an episode of syncope after HPV vaccine at age 15.  Patietn did not have syncope after1st Pfizer vaccine 3 weeks ago.  Patient reported not have anything to eat or drink prior to her second vaccine in contrast to first. Repeat BP 104/79, HR 77. 911 called due to head strike  but no visible bruising or bleeding. Patient transported to  via ambulance.  Upon follow up call 24 hours later, patient reports that she was assessed in  ED for head injury. With no concerning symptoms, no CT scan was performed. She was discharged home from ED with instructions to call with any concerning symptoms. Upon f/u call she reported feeling well. She was  advised to alert any  vaccinator of history of syncope after vaccinations.
Information regarding Prevnar was received from a healthcare professional regarding a 3 month old male patient who received a first dose on 13 Jul 2006, along with a first dose of Ipol. On 14 Jul 2006 the patient developed a fever, increased white blood cell count of (23,000( and possible injection site cellulitis. Medical history reported as none. Indication for Prevnar was immunization. Product was administered on 13 Jul 2006. Dose regimen was 0.5 ml 1 time per day (intramuscular). Concomitant medications were not reported. On 13 Jul 2006, the patient received a dose of Prevnar along with a dose of Ipol. On 14 Jul 2006, the patient developed a fever (pyrexia) of 103 degrees Fahrenheit at home, was given Tylenol by the patient's mother, and taken to the physician's office for evaluation. At the doctor's visit, a white blood cell count was obtained which was noted as "spiked" at 23,000 c/mm (white blood cell count increased). The fever was noted to be 101 degrees Fahrenheit. The patient was sent to the emergency room and a complete blood count, blood culture, urine culture and chest x-ray were performed. Results were reported as normal. Patient was not admitted. On an unspecified date in Jul 2006, the physician noted the patient possibly had an injection site cellulitis (injection site cellulitis). Treatment included Augumentin. As of 28 Jul 2006, the patient had recovered from all events and was scheduled for a follow-up office visit. A repeat white blood cell count is planned.
Information has been received, for the Pregnancy Registry for GARDASIL, from a 24 year old female with a history of gestational diabetes who on 04-JAN-2008 was vaccinated with her first dose of GARDASIL.  There was no concomitant medication.  The patient reported that after receiving GARDASIL, she found out that she was 5 weeks pregnant.  Her LMP was approximately 15-Dec-2007.  A pregnancy test was performed.  The patient did not seek medical attention.  Follow-up information was received on 01-FEB-2008 via phone call from a person of a doctor's office indicating that they did not have any record of the patient ever receiving GARDASIL or any indication that she was pregnant.  The patient was last seen in their office in November 2007.  Follow-up information was received from a person of a doctor's office indicating that the Hispanic patient had 2 previous pregnancies and 2 pre-term deliveries.  No birth defects occurred in previous pregnancies.  The patient had pre-eclampsia and gestational diabetes in previous pregnancies.  On 26-FEB-2008 an ultrasound was performed and the results were with normal limits.  The patient was also placed on prenatal vitamins.  Follow-up information was received on 03-NOV-2008 which confirmed that the patient had a past medical history of gestational diabetes.  The patient developed insulin dependent diabetes during this pregnancy.  She was treated with insulin human NOVOLIN (from 110JUL-2008 till EDC), 24 units, twice a day and insulin aspart NOVOLOG (from 11-JUL-2008 till EDC), 20/16 units, 20, every morning and 16, after supper.  Other medication used during this pregnancy included prenatal vitamin (initialized on 20-MAY-2008), 1 mg, daily.  On 02-SEP-2008, 37.3 weeks from her LMP, the patient delivered a normal male baby, weighing 7 pounds, 8 ounces.  The baby's length was 19.5, head circumference was 13.5 and apgar score was 7/10.  There were no congenital anomalies.  There were no other complications or abnormalities.  The patient had no complication during labor/delivery.  There were no infections or illness during pregnancy.  Additional information is not expected.
This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 08-AUG-2016, the patient was vaccinated with improperly stored VARIVAX (dose: 0.5 ml, lot # M003441, expiry date: 19-JAN-2018) via subcutaneous route. Nurse reported that the vaccine was exposed at 28.2 degree Fahrenheit for 1 hour 15 minutes. No adverse effects were reported. Additional information has been requested.
When beginning to take my second vaccine, I told the nurse(?) about having bad symptoms that lasted about two weeks.  She said I must have had Covid.  I told her that I had no congestion or cough during that time.  Fever,nausea and joint pain and muscle aches.  She said I must have had a bug.  She gave me the second shot.  By that evening I was extremely nauseated and again sever joint pain and muscle aches..  And have been that way since that shot.  Except the nausea it passed in about three or four days.  My ability to work has suffered.
On 10-14-16 seen in our office with a history of fever and rash onset last week which was 6 days after receiving Varicella.
After taking the vaccine on March 19,2021 that same day he had a fever of 105.  8 days after the vaccine was inserted in his arm in March 27, 2021 he got a seziure and was rushed to the hospital.  Today April 5 2021 he got another sezuire and was taken to the hospital.
Redness/warmth in arm where vaccine was given. To ER-was advised to take BENADRYL and was given a steroid by ER. No signs of respiratory distress.
This spontaneous report was received from a pharmacist refers to a 40 year old patient. Patient medical history and current condition was not reported. On an unknown date the 40 year old patient was vaccinated with GARDASIL series (dose and unspecified) (Inappropriate schedule of drug administration). Product quality complaint was not reported. No adverse effect reported. The outcome of the event was unknown. Additional information has been requested.
Mom noticed extreme swelling with warmness on child's left upper arm and took him (child) to ER at hospital around midnight (early on 8/16/11). Child was Dx'd "bacterial infection, cellulitis due to vaccination, not allergic reaction" and was prescribed Keflex, tid for 10 days with Benadryl, prn. On 8/16/11 11:00am, grand mother and the child came to the public health center where he had vaccinated and reported of the incident.  At the time, child was afebrile, left arm was swelling but not "extreme" with mild warmness. The child was alert, not complaining of pain and left clinic ambulatory with grand mother. At 4pm, mom was notified by the phone that VAERS would be made by nurse (me) and she accepted the action. No further complaints were heard from mom.
3 days after receiving the Pfizer SARS-CoV-2 vaccine, pt developed Bell's Palsy on the left side of his face. This has not remitted despite standard treatment (prednisone and valacyclovir).
Unconsolable crying, beginning 11am on 04/10/2002 for six hrs or more with fever of 100.4 deg. F. Ecchymosis on right upper thigh at injection site. pain on leg movement or touch. On 04/11/2002 fussiness subsiding; less swelling of leg. Improving and feeding well.
Pt was seen at hospital for a febrile seizure. She was unresponsive for a few minutes. Pt was admitted for observation and discharged within 36 hours.
I had the shot and still got them/Suspected Vaccination Failure; I had the shot and still got them; This case was reported by a consumer via interactive digital media and described the occurrence of 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 28-Feb-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had the shingles shot and still got shingles. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Pain; Mobility issues; Administered in shoulder joint; Extensive swelling of vaccinated limb; This case was reported by a consumer and described the occurrence of extensive swelling of vaccinated limb in a 58-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 17th October 2022, the patient received the 1st dose of Shingles vaccine. On 17th October 2022, less than a day after receiving Shingles vaccine, the patient experienced extensive swelling of vaccinated limb and vaccine administered at inappropriate site. On an unknown date, the patient experienced pain and mobility decreased. On an unknown date, the outcome of the extensive swelling of vaccinated limb, pain and mobility decreased were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, pain and mobility decreased to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 24-DEC-2022 Reporter's Comment: The case was reported by the patient. The pharmacist administered the vaccine in her shoulder joint instead of her muscle in the arm.  The patient was still experiencing pain and mobility issues.  The pain radiated still during certain movements.  The reporter requested to send information on any long term or short term effects of this poorly administered experience (entering the shoulder joint and not the muscle).  The patient was trying to manage her recovery expectations. Extensive swelling of vaccinated limb were the symptoms and was treated. The reporter consent to contact was not given. The reporter had permission to contact the patient. Additional Supportive Information: The pharmacist administered the vaccine in her shoulder joint instead of her muscle in the arm, which led to vaccine administered at inappropriate site. Note: Clarification was send for Adhesive capsulitis as its unclear its event or else.