chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a child was administered Rotarix intramuscularly instead of orally; This case was reported by a pharmacist via call center representative and described the occurrence of wrong route of administration in a infant patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 27th April 2021, the patient received Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 27th April 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong route of administration. On an unknown date, the outcome of the wrong route of administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at the vaccination was not reported. The patient received Rotarix intramuscularly, which led to wrong route of vaccine administration. No additional details at this time. The reporter consented to follow up.
This spontaneous report was received from a physician via company representatives and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 23-MAR-2015, the patient was vaccinated orally with a dose of 2 ml of ROTATEQ 10 unit dose tube, lot # K000487, expiration date 27-SEP2-2015. This vaccine was improperly stored exposed to three temperature excursions, one for a sum of 144 hours with a lowest temperature recorded as 31 degrees F (-0.555555556); other for a sum of 24 hours with a lowest temperature recorded as 33 degrees F (0.555555556 degrees C); and another for a sum of 216 hours with a lowest temperature recorded as 34 degrees F (1.111111111 degrees C). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator(R)". No adverse effects were reported. There was no product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Extreme pain in left shoulder, stiffness in shoulder, and numbness in the arm (left arm) that the vaccination was given.
Patient's whole body was extremely itchy. This feeling started 20 minutes after the Pfizer vaccine was administered. Other than whole body itching, she did not have any shortness of breath or swelling. This sensation has happened to her before when she had morphine. EMS told her to take a non-sedating anti-histamine to help with the itching when she got home. All vitals were stable.
This spontaneous report was received from a 78 years old female consumer reporting on herself who on 11-OCT-2012, was vaccinated subcutaneously with a dose ZOSTAVAX (dose and lot number not reported). No other co-suspects were reported. Concomitant medications included estradiol, citalopram and lovastatin (manufacturer unknown). The consumer reported that on 13-OCT-2012, she developed a rash on her left arm and swelling developed at the injection point where ZOSTAVAX was administered. On 14-OCT-2012, the consumer developed a rash on her face. No treatment was given for the experience. At the time of the report, the patient's outcome was unknown. The patient did not seek medical attention. The relatedness for patient developed a rash on her left arm, rash on her face and patient developed swelling at the injection point was unknown for ZOSTAVAX. Additional information has been requested.
Information has been received from an OB nurse concerning a baby whose 23 year old mother, with no medical history or preexisting allergies, was vaccinated IM on 22-SEP-2010 with a 0.5 ml first dose of GARDASIL, (Lot no. not reported). Her LMP was on 08-SEP-2010. No concomitant therapies were mentioned. Nurse reported that an ultrasound performed on the mother's mid-trimester showed a choroid plexus cyst. The nurse stated that "everything was normal at the follow-up ultrasound". On 24-JUN-2010, the mother delivered a baby in good health. Nurse reported that there were no congenital anomalies. Nurse confirmed that baby and the mother were in good health at her post-partum visit. The mother's experience has been captured in WAES 0911USA02673. Upon internal review choroid plexus cyst was considered to be a congenital anomaly. Additional information has been requested.
Client received vaccines on 1/30/2019 at approx 08:50 am. Client's mom called on 1/31/2019 around 2:15 pm reporting client started with fever on 1/30/2019 and that he has been cold. She reports that today he vomited.
Menveo is a two-part vaccine. It has a powder in one vile that is to be reconstituted with a specific liquid from another vile. It was discovered by our vaccine coordinator that there was half of a dose left unused on three separate occasions. This was discovered in the late fall/early winter 2022. This means that there are three patients of our practice who received incomplete Menveo vaccines and we have not yet identified them. Presumably, the powder was reconstituted in a separate diluent.  We had IT run a report of all patients in a certain window of time who received Menveo at our practice. We compared it with our handwritten logs that clinical staff use to track all vaccines.  Unfortunately, the best we could do was to rule down the list to 8 potential patients. I did submit a separate report about one of these patients a few months ago as that was the first patient potentially identified   We have done lots of reeducation with clinical staff since this time. We have also implemented a protocol that all pediatric vaccines must be double checked by a second clinical staff person before being administered. Our vaccine coordinator is also taking a manual inventory weekly to ensure that should a mistake be made, we are aware of it closer to the date or error. We have also discussed with the medical director that for state supplied vaccines we are going to phase out the use of Menveo (two vial dose) and go back to using a (single vial dose.)  The course of action is to place a call to each of the 7 patients who got Menveo in the suspected time frame and explain that while we are not sure they are under vaccinated, it cannot hurt anything to repeat the Menveo vaccine. That would ensure they are fully vaccinated.  Our medical director and the CDC has advised that a repeat dose is appropriate and should be offered to anyone affected. PCPs have been alerted and agree with the plan for office manager to reach out to patients/guardians
This case was reported by a pharmacist and described the occurrence of swelling injection site in an adult subject of unspecified gender who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of FLUARIX QUADRIVALENT (unknown route and injection site). On an unspecified date, 2 days after vaccination with FLUARIX QUADRIVALENT, the subject experienced swelling injection site, injection site warmth and injection site hives. At the time of reporting, the events were improved. The pharmacist considered the events were probably related to vaccination with FLUARIX QUADRIVALENT. This case is one of the 5 cases reported by the same reporter for the same vaccine.
Patient stated that she believes that the needle hit a nerve and she felt immediate pain upon injection on 12/15/2022.  When I spoke with her on 3/7/2023, she said she was still having nerve pain and could not lift her arm completely.  She stated that she tried a steroid, but was still having issues and  intended to follow up with a neurologist next.
Little nagging cough; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced little nagging cough since he received the Covid-19 vaccine on an unspecified date. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  .
the patient stated that she could barely lift her arm past her shoulder; Her arm just drops down and she couldn't control it; The patient had other vaccine on the same date when the second dose was administered; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 27May2021 10:00 (at the age of 57 years old) as second dose, single dose for COVID-19 immunisation in the pharmacy. Medical history included high blood pressure and depression. The patient has no known allergies. Concomitant medications included venlafaxine, amlodipine, trazodone, and bupropion. The patient previously received first dose of BNT162B2, administered in the left arm, on 06May2021, at 11:00. The patient had other vaccine on the same date when the second dose was administered. No other vaccine was received within four weeks before vaccination. On 27May2021 at 10:00 (also reported as three days after the second dose), the patient stated that she could barely lift her arm past her shoulder. Her arm just drops down and she couldn't control it. The patient had no COVID prior vaccination and was not COVID tested since vaccination. The patient has not recovered from the events.  Information about lot/batch number has been requested.
1st one she had a little headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "1st one she had a little headache".  Additional information: Patient wanted to report that she got 3 Pfizer covid vaccines, the 1st one she had a little headache, the 2nd one it got worse, but the 3rd one was the worst (Lot EN6204). Caller also reported that her nurse at the clinic as well as her brother in law died because of the vaccine. She also mentions that her sister in law first got covid recovered with no problems and got more sick when she got the vaccine and was asking for help because her doctor has tried everything already and that she cannot live like this anymore.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
white blood count has dropped/white blood count was down/WBC were 2.5; Neutrophils were 1.0; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 82-year-old female patient received palbociclib (IBRANCE), at 100 mg; BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (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: Covid-19 vaccine (dose 1; manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (dose 2; manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (dose 3; manufacturer unknown), for Covid-19 immunization. The following information was reported: WHITE BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "white blood count has dropped/white blood count was down/WBC were 2.5"; NEUTROPHIL COUNT DECREASED (non-serious), outcome "unknown", described as "Neutrophils were 1.0". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for palbociclib was unknown.  Additional information: The patient stated that her white blood count has dropped since taking Ibrance and she got her Pfizer booster week ago and she was asking if that could possibly have caused it to drop. Her white blood count has dropped a little. She did get the booster with variant 2 weeks ago and wondered if that could also drop her white count. Her white count was a little low today but, doctor said he was going to retake blood count Friday and it might be back up by then and wondered if it was from taking the Ibrance drug. Patient just reordered the Ibrance and didn't think it would be a problem with taking the Ibrance. Patient was off this week from the Ibrance.  All of a sudden, it came to her mind that she had that booster. She clarified that she does have the exact name of the booster, just that it is the Pfizer booster with variant. She stated this might not have anything to do with the Ibrance. She went to get blood work today and her blood count was a little low, her WBC were 2.5 and her Neutrophils were 1.0, and the normal range is 1.8 to 7.7.  She forgot to mention to her oncologist that she had the booster two weeks ago. She was curious to see if the vaccine could lower her white blood cell counts. She was having her blood retested on Friday. She was wondering if the Pfizer Covid booster could be causing her white blood cell counts to be dropping and not the Ibrance. She has been on Ibrance since May (year unspecified) and its been very successful.  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.
2 days after immunization pt developed an urticarial rash on her right thigh, trunk, and face. She was otherwise well. Overnight, she was fussy and seemed uncomfortable, so parents gave a dose of Zyrtec. The following day the urticaria were resolve.
8/12/13 DTap administered. 8/14/13 Welt 3 inch on injection site; also bumps on left face/cheek. 8/20/13 vesicles started on hands eventually went away; facial lesions L face/cheek stayed on.
Vasovagal syncope and seizure (less than 30 seconds). No treatment needed. Initial BP 115/72; BP after event 94/52, HR 93, Blood sugar 111.
MALAISE; FEW HOURS OF MILD FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced malaise, and few hours of mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from malaise, and few hours of mild fever. This report was non-serious. This case, from the same reporter is linked to 20211210219 and 20211210699.
This spontaneous report was received from a Medical assistant concerning to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a improperly stored lot of VARIVAX (incorrect product storage), but the reporter was not sure which of the lots the unspecified patient received: Lot# L044526, the expiration date: 09-NOV-2017, Lot# M047662, the expiration date: 02-DEC-2018, Lot# reported as N001528, the expiration date: 13-JAN-2019, Lot# M044349, the expiration date: 04-NOV-2018 or Lot# M038856, the expiration date: 14-SEP-2018 (dose was not reported) for prophylaxis. No adverse effect reported. The call was made due to a data logger with a temperature in the range of 6°F to 14°F during 30 minutes. There was no previous temperature excursion provided. Additional information has been requested.
lymph node pain; lymph node swelling; heart was beating loud; heart was beating strongly; low fever; body aches; headaches; weak; tired; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date, refer case US2019AMR176800).   On 18th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a day after receiving Shingrix, the patient experienced fever, general body pain, headache, weakness, tiredness, heart sounds abnormal and heart pounding. On 19th September 2019, the patient experienced lymph node pain and enlargement of lymph nodes. On an unknown date, the outcome of the fever, general body pain and headache were recovered/resolved and the outcome of the weakness, tiredness, lymph node pain and enlargement of lymph nodes were not recovered/not resolved and the outcome of the heart sounds abnormal and heart pounding were unknown.   It was unknown if the reporter considered the fever, general body pain, headache, weakness, tiredness, lymph node pain, enlargement of lymph nodes, heart sounds abnormal and heart pounding to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. The patient had the second dose of Shingrix on Wednesday.  She experienced low fever, general body aches, headache. She was pretty much recovered from those symptoms but she was still feeling weak and tired.  The first night, less than a day after she had the shot, she also noticed that her heart was beating strongly or loud. On day before reporting, 1 days after receiving Shingrix she started having pain in the lymph node under the arm, which she also experienced with the first shot of Shingrix.  However, she was also having swelling in the area under the arms. It was under one arm which was exactly the arm where she received the injection. The reporter consented to follow up. This case had been linked to the case US2019AMR176800, reported for same patient. In the XML document outcome of events weakness, tiredness, lymph node pain and enlargement of lymph was reported as recovering, but in system it's mentioned as not recovered, so kept as reported in system.
Muscle pain, Joint pain in fingers/wrist/elbow, fatigue, low grade fever, diarrhea, pain in injection site, headache
pt recv vax 12noon & returned to daycare;put down for nap 350Pm;checked on baby 415PM & not breathing resuscitated in local ER, transferred to another hosp;cont profoundly hypotensive w/severe metabolic acidosis & expired @ 0647 11NOV97;
Escalating pain in arm by 4 hours. Increased until it was VERY bad (and I have always had a high pain threshold). Moving the arm in any way was excruciating.  After movement, I'd have to wait about 5 minutes for the pain to drop to merely very painful. After another couple of hours got chills and shivering, which lasted about three hours. The pain in my arm, without movement, was my entire world. I thought about getting up to take an oxycodone left from previous eye surgery, but concluded that the pain from moving my arm during getting and taking the tablet would be too much, given how high the "background" pain was. I was having trouble thinking straight and actually selected a point in symptoms at which I would call 911, because I was afraid that if it kept escalating I would be unable to do so. After about 6 am, everything began improving, and pain gradually dropped to merely uncomfortable when moving my arm. This was by far the worst prolonged pain and discomfort I've ever experienced. I would happily choose shingles over this experience, and I know how bad shingles can be.
Within 2 hrs, arm swelled and ached. Next day arm very swollen, hot and blood red, very painful. Third day same and visited my Dr. He told me I had a severe allergic reaction and recommended my never it again. It took 5 days for it all to disappeared and allow me to sleep pain free.
On 1/25/22, Patient contacted Nurse to report numbness and tingling to her L arm and right leg that started the day after receiving the listed 5 vaccinations. Nurse referred her to clinic. On 1/31/22 she had her first clinic visit where she was instructed to use ice 2-3 times per day, 15 min. at a time, home stretches, and follow up in 2 weeks. Regular duty.  Second clinic visit on 2/7/22 added prednisone to the treatment regime with follow up in 10 days. Third clinic visit on 2/15/22 added Gabipentin and Physical Therapy
Patient returned to clinic and reported that left arm injection site is extremely sore after Tdap administration. Patient returned the next day and was seen by NP, patient stated that left arm is very painful, left upper arm deltoid area examination revealed no swelling or redness but patient stated that it is painful to touch and that ROM is restricted. Patient advised to follow-up with PCP. VAERS completed.
Her physician called to report that her flu shot resulted in the inability to move her entire arm, but the condition is improving.  Her arm was very sore and tender and the doctor thought maybe the injection had been given too high on her arm.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 06Oct2021 at 12:15 as dose 4 (booster), single (Lot number: 8841) at the age of 72 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: rebound positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient did not receive any other medication in 2weeks. The patient received treatment for COVID 19 with Brand: Paxlovid 150(X2)-100mg Pk(eua). Treatment start date: 23Jul2022, Treatment stop date: 28Jul2022.
patient was accidentally given the wrong vaccine he was supose to be second dose merderna but was given 2nd dose pfizer instead. no reactions were noted was repoted to site leader patent was monitored blood pressure every 10 minutes  for one hour 911 was called patient refused to go.