chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mom called on 10/18/00 and said that 2 nights prior, pt awoke crying and was wide awake and then for 1-2 minutes, started not responding to mom's voice. He then became king of limp and in a couple of minutes, he was awake, alert and active. His HR and RR were fine per mom. She is unsure of his coloring. Sibling developed 3rd degree heart block requiring pacemaker after receiving MMR. On exam on 10/19, he had temperature of 102F and pink macular rash. On 10/20, he was very active, comfortable with a low-grade temperature, mild rash and conjunctivitis.
Shoulder pain; shoulder stiffness; burning; painful when I lie on it. Ice pack relieves symptoms for short while.
@ about 9 oclock pt started screaming & crying & was inconsolable; pt had been given APAP but fever was 104; p/an hr pt was taken to ER & given shot to counteract the vax;
Unauthorized Age Group - 17 yo  given 1st dose Moderna on 4/15/21 . Arrive at  Clinic for 2nd dose. Unauthorized age group discovered upon check-in . 2nd dose given 5/13/21 with parental/patient consent and proper counseling to complete series (off-label usage).
Employee called Health Services on 10/29 stating after receiving her Moderna booster on 10/27 she had numbness in her arm followed by dizziness and stiffness in her neck. She was asked if she notified the staff at the vaccine clinic and she said no because she didn't think it would be that bad. Later after getting to her office she stated her symptoms worsened. As of today 10/29 the numbness in her arm is improving, but she can not move her arm back, has headache, some dizziness, and still has stiffness in her neck. At this time she is unable to come to the office or another provider due to transportation issues. She was advised to contact dr. after hours or to make an appt with  express care. She states she will make an appt with the express care and was emailed the link to start the process. She was also advised to call Health Services next week to make an appt with a provider if her symptoms persist.
Patient experienced vasovagal syncope approximately 5 minutes after receiving her first COVID vaccine at approximately 3:00PM. Patient received vaccine and waited for sister to get hers. She ambulated back to waiting area to sit for 15 minutes post vaccine. Within minutes of sitting down patient experienced vasovagal syncope.  Father initially denied EMS as patient did hit fall from chair but passerby was able to catch her. Waited approximately 10 minutes, patient vomited and was sweaty. Did not take blood pressure yet as waiting for patient to recover. EMS did arrive as pharmacy staff called proactively at the beginning of the event. They recommended that patient report to ER for further evaluation to ensure no residual issues from vaccine or syncopal event.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 22-JUL-2015, the patient was vaccinated with improperly stored M-M-R II,lot # J016232 and 19-DEC-2015 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
inadvertently administered just the liquid DTaP-IPV component of the Pentacel vaccine, and not the lyophilized Hib component  with no AE; Initial information received on 20-Sep-2021 regarding an unsolicited valid  non-serious case received from a pharmacist.   This case involves an unknown age and unknown gender patient who experienced inadvertently administered just the liquid dtap-ipv component of the pentacel vaccine, and not the lyophilized hib component while receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient medical history, medical treatment(s), vaccination(s) , concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to product preparation issue [Latency: on the same day].  It was reported "The caller reported a patient only received the Dtap portion of Pentacel. The caller wanted to know what to do now for the patient. pharmacist stated that a patient early last week was inadvertently administered just the liquid DTaP-IPV component of the Pentacel vaccine, and not the lyophilized Hib component. Pharmacist asked it is a valid dose for DTap-IPV and also whether the left-over lyophilized Hib component could be administered and if so, how should it be reconstituted, or should they use a separate commercially available Hib-only vaccine. Pharmacist asked whether the dose of Hib in Pentacel was the same as the Hib dose in ActHib. Pharmacist stated that a patient early last week (the week beginning Monday, 13 Sep 2021) was inadvertently administered just the liquid DTaP-IPV component of the Pentacel vaccine, and not the lyophilized Hib component"  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the 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 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.  There will be no information available on the batch number for this case.
This spontaneous report was received from a registered nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. Since 14-DEC-2015, the patients were vaccinated with an improperly stored doses of GARDASIL 9 (dose and route were not reported, lot # L020015, expiration date 16-AUG-2017). There was no adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
bruise at injection site; Bleeding at injection site; sore arm; This is a spontaneous report received from contactable reporter (Consumer or other non HCP).  A 10-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Nov2021 (Lot number: FK5127) at the age of 10 years as DOSE 1 (TRIS), SINGLE for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE HAEMORRHAGE (non-serious) with onset 05Nov2021 15:00, outcome "recovered" (Nov2021), described as "Bleeding at injection site"; PAIN IN EXTREMITY (non-serious) with onset 05Nov2021, outcome "recovered" (Nov2021), described as "sore arm"; VACCINATION SITE BRUISING (non-serious) with onset 06Nov2021, outcome "recovered" (07Nov2021), described as "bruise at injection site". Therapeutic measures were not taken as a result of vaccination site haemorrhage, pain in extremity, vaccination site bruising. No follow-up attempts are possible. No further information is expected.
Patient stated that the vaccine she received a week ago she was just starting to have a reaction to. She has a little swelling, inflammation, redness, warmth and itching around the injection site. She said that this started just yesterday (~6 days after the vaccine and was getting worse). Told her she could try to ice it, take benadryl and something for the pain and if it continued to get worse to let her doctor know.
Sore arm, low grade temp for 24 hours, headache, body ache, nausea.
whike sleeping I could hear my heartbeating fast . Could hear it  from my right ears as well. the T zone of my face was puffy,  Right nose, rirht throat was clugged and kind of dry. At about 2am I woke up when  i couldnt take it anymore. I called the    vaccination provider. also called /left a message on the toll number found on the fact sheet that was given to me .  Hope to vist the dr. in the morning.
Pt given covid vaccine at 11:30.  1140:  Pt co dizziness.  BP 182/81, Pulse 72.  O2 sat 100%.  Given water to drink.  Pt to stay in room longer for monitoring,  Pt  Rechecked at 1158.  BP 187/81.  Dizziness resolved.  Now co "blurred vision".  Which is new.  Pt taken to ED via w/c.  Pt texted son that she was being transported to ED.
husband also fell 16 days after the vaccination and she believes that is when the second stroke occurred; can't drive anymore; first stroke occurred sometime within a 2-week period after receiving the Moderna vaccination; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (husband also fell 16 days after the vaccination and she believes that is when the second stroke occurred) and CEREBROVASCULAR ACCIDENT (first stroke occurred sometime within a 2-week period after receiving the Moderna vaccination) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement and Carpal tunnel syndrome. Concurrent medical conditions included Overweight and High cholesterol.    On 10-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced CEREBROVASCULAR ACCIDENT (first stroke occurred sometime within a 2-week period after receiving the Moderna vaccination) (seriousness criterion medically significant). On 26-Jun-2021, the patient experienced FALL (husband also fell 16 days after the vaccination and she believes that is when the second stroke occurred) (seriousness criterion hospitalization). On an unknown date, the patient experienced IMPAIRED DRIVING ABILITY (can't drive anymore). The patient was hospitalized for 2 days due to FALL. The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) ongoing since an unknown date at a dose of 325 milligram once a day and ATORVASTATIN CALCIUM (LIPITOR) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, FALL (husband also fell 16 days after the vaccination and she believes that is when the second stroke occurred), CEREBROVASCULAR ACCIDENT (first stroke occurred sometime within a 2-week period after receiving the Moderna vaccination) and IMPAIRED DRIVING ABILITY (can't drive anymore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The patient's medical history of Hypercholesterolemia and being overweight are possible confounding factors.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The patient's medical history of Hypercholesterolemia and being overweight are possible confounding factors.
I received the ZOSTAVAX vaccine at the office on November 14, 2012. At first a slight swelling of the left arm (site of injection area) was noted a gradually warmth was felt over a 6-12 hr period. A few days (just before a scheduled appointment with my primary physician I noticed I seemed a little saddened not so obviously so, but I felt "down". At the doctor's office while awaiting his entrance I shook my head at the nurse's question of how I felt that I did not feel "well". Dr's entrance was enough to make me completely silent, looking downward and tearing up very profusely - there was no reason for this behavior and he sat close to me and asked what was the problem - he had never in 17 years ever experienced this person - nor had I ever behaved so unusually. I was finally able to utter that I didn't feel well that I was sad over what I didn't know. He advised me to go home lie down and breathe deeply and whole forcibly and to return the next day. At home I began reading over the information sheet that was supplied me at the health clinic as I was vaccinated and realized that I had had a reaction to the vaccination. When I saw Dr and related what I believed had happened he questioned me further and we both agreed that I do seem very sensitive to many medications - ie penicillin, vancomycin, DEMEROL and a host of others. The extra rest and deep breathing and explosive exhalation did aide me but intuitively the understanding of possible reaction to the vaccine seemed the correct answer. I have been diagnosed with atrial fibrillation and have had thyroid cancer with complete recovery but naturally am hypothyroid and require medication for that loss. I believe this "note" will have answered questions # 7, 18, 19 and 21. A year before November 2012 I had a very light case of the shingles which did not produce the "usual" painful after effects that I understand is very common and usual and can last for years. I have no other recollections of the adverse reaction of a "melt down" as I had with the vaccination and have not had any repeat performance since. I don't feel any further after affects and believe this was just one of those strange occurrences. Dr did not have to prescribe any medication at the time of the occurrence and we are both content to know it was just one of those occurrences - no need to test or prescribe further. If there is further need for information just keep me informed.
a patient was administered a dose of improperly stored PROQUAD; No adverse effect reported; This spontaneous report was received from a medical assistant referring  to a patient of unknown age and gender. No information was provided regarding the patient's medical history, current conditions, concomitant medications, drug reactions and allergies.  On 21-AUG-2019, the patient was administered a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) with lot number S003863 and expiration date on 08-AUG-2020 (dose, dose number, route of administration and anatomical injection site were not reported) for prophylaxis.     It was reported that on an unknown date, the vaccine was exposed to a temperature excursion between -14 Celsius (C) degrees and -10 C degrees (-14.4 C degrees) for 18 minutes. There were no previous temperature excursions. The call was placed because of a Digital Data logger report, since it was on calibration. No adverse effects were reported.
That morning, I woke up with a red circle on right thigh was extremely itchy and hot and it was a little bit raised - on the 7th at 09:00 am. By 7 pm that night, it had more than doubled in size - three times that size by the evening. From 2 inches to 6 inches in diameter. It was very hot and it was raised. Out from a red circle was a white line - a white circle - , as well, at the seventh inch mark. It had started right at the place of injection. I went through Blue cross/Blue Shield and ordered a Telemed visit - with a doctor  - January 22, 2021- He looked at it and ordered Augmentin antibiotic. I picked that up by 09:00 pm and took my first dose and in the morning, everything stopped growing and by my second dose of the antibiotic it started to retreat. Dr called it a Staph Infection.  The symptoms resolved 10 days later after I got on the antibiotic.
achy and sore left arm( injection site); Temperature was 99.0, and 2 hours later was reported to be 100.0; sore arm; mild body aches; feeling lethargic; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administration date 22Nov2021 16:00 (Batch/Lot number: unknown) as dose number unknown, single dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LETHARGY (non-serious) with onset 23Nov2021, outcome "recovered" (2021), described as "feeling lethargic"; VACCINATION SITE PAIN (non-serious) with onset 23Nov2021 09:30, outcome "recovered" (2021), described as "achy and sore left arm( injection site)"; BODY TEMPERATURE INCREASED (non-serious) with onset 23Nov2021 09:30, outcome "recovered" (2021), described as "Temperature was 99.0, and 2 hours later was reported to be 100.0"; PAIN IN EXTREMITY (non-serious) with onset 23Nov2021 09:30, outcome "recovered" (2021), described as "sore arm"; PAIN (non-serious) with onset 23Nov2021 09:30, outcome "recovered" (2021), described as "mild body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lethargy, vaccination site pain, body temperature increased, pain in extremity, pain. Additional information: Approximately 15 hours post vaccination , reported feeling lethargic, achy and sore left arm( injection site)Temperature was 99.0, and 2 hours later was reported to be 100.0. He took Acetaminophen for symptoms which all resolved without recurrence. Additional information: In the Follow up:(25Nov2021),it was reported that the patient took Acetaminophen only.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case number PHEH2012US016200 is an initial spontaneous report received from a pharmacist on 15 Aug 2012. This case refers to a patient of unspecified age and gender (patient details not available at the time of this report). The pharmacist stated that they found an extra vial of MenCYW-135 liquid conjugate vaccine component of MENVEO in the box. Therefore they believed that a patient may have received only the MenA lyophilized conjugate vaccine component of MENVEO (batch number: unknown, intramuscularly) reconstituted with a sterile diluent and did not receive the MenCYW-135 liquid conjugate component of MENVEO. No adverse event was reported. No other information was available.
Kinrix and IPV given at same time.  No adverse reactions seen at this time.  Will continue to monitor for reaction. 08/01/2022
Noticed large lump on back for neck (right) 6/16/03 P.M., Noticed large purple spot in injection area 6/17/03 A.M. (thought it was just bruised). Started breaking out in spots 6/18/03 A.M. There was no real itching or pain just a prickly sensation and no fever. I went to clinic as instructed by my physician 6/18/03 P.M. No treatment given, instructed that it was Measles and told to quarantine myself and see primary physician if condition worsens. Also I was told to contact my newborn physician to find out what actions to take for my child. I telephoned physician and was told it was not the measles just a reaction, that it would look like measles but it would pass. The next day I noticed more spots and on the following day, I noticed they were growing in size to the point that they were connecting. These spots looked like bullseye targets, there was a spot in center and it had 2-3 rings circling around it, They were extremely red and raised from the skin. I then went to the Emergency Room 6/20/03 P.M. where it was diagnosed as Serum Sickness. I was given two injections of Antihistamine, and was then sent home with prescriptions for Hydroxyzine and Methylprednisolone.
Skin pealing at injection site Tingling felling in fingers and lip/chin area Sporadic pain in right knee Pain in neck and back area  All symptoms appeared in both original shot j+j (9/20/2021) and j+j Booster shot 3/1/2022
Patient said that his arm (left arm) was hurting really bad and he had to go to the emergency room and they told him to take ADVIL (ibuprofen) and TYLENOL and ice. The left arm was where he got his PNEUMOVAX 23.
Patient was admitted to the hospital for hypoxia due to COVID-19 pneumonia on 9/14/21.
Redness, swelling, pain at injection site. About 8cm in diameter, hardness of tissue underneath; applied steroid creme on area today for the first time. Experiencing random localized soreness in left arm, fingers,
This spontaneous report was received from a registered nurse via medical assistant and refers to a 13-month-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, past drugs and drug allergies were not reported. On 14-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (lot # M034387; expiry date: 19-JUL-2018) (dosing details were not provided) for prophylaxis. Temperature excursion details of the vaccine were not provided. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1709USA008861: US-009507513-1710USA013424: US-009507513-1710USA013470: US-009507513-1710USA013465: US-009507513-1710USA013440: US-009507513-1710USA013468: US-009507513-1710USA013442: US-009507513-1710USA013445: US-009507513-1710USA013460: US-009507513-1710USA013463: US-009507513-1710USA013464: US-009507513-1710USA013438: US-009507513-1710USA013439: US-009507513-1710USA013450: US-009507513-1710USA013430: US-009507513-1710USA013469: US-009507513-1710USA013467: US-009507513-1710USA013435: US-009507513-1710USA013434: US-009507513-1710USA013432: US-009507513-1710USA013428: US-009507513-1710USA013437: US-009507513-1710USA013441: US-009507513-1710USA013443: US-009507513-1710USA013444: US-009507513-1710USA013446: US-009507513-1710USA013447: US-009507513-1710USA013448: US-009507513-1710USA013436: US-009507513-1710USA013449: US-009507513-1710USA013451: US-009507513-1710USA013452: US-009507513-1710USA013454: US-009507513-1710USA013455: US-009507513-1710USA013456: US-009507513-1710USA013457: US-009507513-1710USA013458: US-009507513-1710USA013459: US-009507513-1710USA013461: US-009507513-1710USA013462: US-009507513-1710USA013466: US-009507513-1710USA013427: US-009507513-1710USA013471: US-009507513-1710USA013472: US-009507513-1710USA013473: US-009507513-1710USA013474: US-009507513-1710USA013475: US-009507513-1710USA013476: US-009507513-1710USA013425: US-009507513-1710USA013433: US-009507513-1710USA013423: US-009507513-1710USA013040: US-009507513-1710USA013426: US-009507513-1710USA013429: US-009507513-1710USA013431: US-009507513-1709USA008666: Original Case: 1709USA008666: US-009507513-1710USA014650: Original Case: 1710USA014649: US-009507513-1710USA014651:Original Case : 1710USA014649: US-009507513-1710USA014649: Original Case: 1710USA014649.
peripheral nerve issues/permanent small fiber neuropathy; nerve tingling; muscle twitches; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) as dose 2, single 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.  The following information was reported:  The patient stated that he/she acquired significant peripheral nerve issues approximately 2 weeks after receiving the second Pfizer COVID vaccination shot. After many months of testing and analysis of symptoms, the patient's neurologist has determined that he/she has permanent small fiber neuropathy that will result in experiencing constant nerve tingling and muscle twitches for the rest of his/her life. All events were not recovered and all events were evaluated at the physician office visit.   The lot number for BNT162b2 was not provided and will be requested during follow up.