chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE.; HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 16-AUG-2022, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA SYRINGE (DEVICE)) 0.5 milliliter, lot number U012004 had been verified to be a valid number; expiration date was reported as 13-JUL-2023 and upon internal validation established as 15-OCT-2022, for prophylaxis (vaccination scheme, frequency, route of administration, anatomical site of injection were not reported). The administered dose of the vaccine was stored at a temperature of 34.5 degrees Fahrenheit (F), during a time frame of1 hour and y minutes, as recorded by a data logger. There was a previous temperature excursion reported as: 13 hours and 52 minutes. There was no adverse effect reported.   This is one of several reports received from the same reporter. ; Sender's Comments:  009507513-2210USA005917 009507513-2210USA005936 009507513-2210USA005916:
swollen joints, mainly ankles, knees, elbows, and wrists; sore joints, mainly ankles, knees, elbows, and wrists; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swollen joints, mainly ankles, knees, elbows, and wrists), ARTHRALGIA (sore joints, mainly ankles, knees, elbows, and wrists), CHILLS (chills) and PYREXIA (fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced JOINT SWELLING (swollen joints, mainly ankles, knees, elbows, and wrists), ARTHRALGIA (sore joints, mainly ankles, knees, elbows, and wrists), CHILLS (chills) and PYREXIA (fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (swollen joints, mainly ankles, knees, elbows, and wrists) and ARTHRALGIA (sore joints, mainly ankles, knees, elbows, and wrists) had not resolved and CHILLS (chills) and PYREXIA (fever) was resolving.            No concomitant medications reported by investigator   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow-up information received on 01-jun-2021 contains second dose has no side effects and maladies was unrelated to the dose 1.
This spontaneous report as received from a Practice Manager refers to a patient of unknown age and gender. On 19-FEB-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J000492, exp. date: 19-FEB-2014) 0.65 ml, subcutaneously that expired. No adverse effects were reported. Additional information has been requested.
Headache; Body ache; Joint pain; This is a spontaneous report from a contactable consumer (patient).  A 31-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, on 22Dec2020 at 11:00 AM at single dose for COVID-19 immunisation. Age at vaccination was 31-years-old. Medical history and concomitant medications were reported as none. On 22Dec2020, the patient developed headache, body ache, and joint pain. The patient reported the body ache has gotten worse, headache is still the same. The patient was treated with Advil. Outcome of all events was not recovered. Information on lot/batch number has been requested.
20mins after taking the shot, I could feel my throat start to swell up. I could still breathe, but I could barely swallow water.. I went to an Urgent Care. They provided me diphenhydramine (oral - I refused a shot since i had just taken a shot that went bad).  After 30mins I could finally drink some water. At this point, I started to have numbness/loss of feeling in my left arm (wrist to shoulder), left side of my neck and face, the left side of my torso, and part way down m left leg. Nothing was done by Urgent Care (they claimed this was simply anxiety). My blood pressure was then taken and was  152/100. That is not normal for me (I do have some spats with pre-hypertension, but nothing beyond 135/80-85). The urgent care once again said this was due to anxiety. Since I could breathe I left. I then contacted my Primary Care. I told them I would wait until they had an appointment. That if anything go worse, I would go to the ER. I have a BP device so I could keep tabs on my BP .I saw, FNP (Cary Healthcare Associates) on 9/7/2021. She found that my blood pressure had finally gone down into a good range. She couldn't see anything really closed up in the upper half of my throat. She's not able to explain the numbness beyond the reports of people stating they've had brief paralysis of the face after the Pfizer/Moderna shot.
Developed pain at injection site, which progressed to weakness in upper arm and shoulder and decreased range of motion. Exam is consistent with rotator cuff pathology - that did not exist before vaccine administration.
02/21/2021 Patient was found on the floor of his room at 0800am hitting the right temple resulting in a  laceration of the area. Patient complaining of Right arm pain within the location of vaccination site.  02/21/2021 1215 pm Patient fell forward out of his wheelchair hitting his right temple resulting in  bruising and hematoma arm.   02/23/2021 1300 patient with increased agitation, combativeness, and change in mental status.  Patient sent to emergency room for evaluation to rule out intercranial bleeding.   Patient has fallen 3 times since the vaccine striking his head twice and now with changes in mentation.
soreness at injection sight; sniffles; felt like a fever; aches and pains at joints; fatigue for 12 hours.
4.5 mo male infant in study had hematochezia reported to study PI on 11/30/2010 by study report card submission. Mother had not called during AE. Patient had some reported blood in stool, 2 - 4 episodes per day, from 10/23/10 - 10/27/10. Mother had changed patient's formula prior to this. The Primary doctor changed the patient to Prosoybee formula -10/22/10-, a soy based formula, and the blood in the stools stopped by 10/27/10. This appeared to be unrelated to vaccine dose #2 administration from 10/1/10. This AE resolved completely by 10/27/10 and did not recur. This AE appeared to be related to the formula change. This serves and first and final report.
Pt is a female on birth control (Nexplanon, left arm) and has not had her menstrual cycle since 9/2019. After receiving the COVID vaccine, pt experienced severe cramps and began her menstrual cycle with heavy flow. This is a manageable adverse reaction, but important to consider when administering COVID vaccines to female pts and how they might interfere with fertility, menstruation, and hormones.
Patient given vaccines on Friday 4/10/15, called and returned to clinic 4/13/15. Patient had local reaction, large "hive" at site. Mother stated that reaction occurred with previous vaccines, advised icing. Patient's reaction improving as of 4/13/15.
Covid Arm. 2? firm red itchy rash at injection site with well defined margins appeared upon awakening.
started high temp 102.8 27FEB97;high temp up to 104.2, cont until 30JAN97;temp mainly 103 range;rash devel 30JAN97 all over body most of rash had faded by 3FEB97;started on face progressed to trunk than arms & legs;dec appetite;APAP for fev
Initial and follow up information has been received from a vaccine coordinator concerning a  female (age not reported) who on an unspecified date was vaccinated with 0.5 mL of Gardasil (yeast). Subsequently, the patient experienced pain at the injection site. It was reported that the vaccine hurt the patient more when injected into the arm rather than the upper thigh, hip area. It was reported that the "pain was so great that the patient said they would not finish the series". The patient sought unspecified medical attention. The shot was from a pre-filled safety syringe. The vaccine coordinator thinks "the pain may have something to do with the technique because the shots given from the single dose vials have not experienced as much pain". It was further reported that "she was unsure if the extreme pain was caused by the vaccine, injection site or the technique used with the safety syringes." At the time of this report, the outcome of the events were unknown. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 12/14/2006.  Initial and follow up information has been received from a vaccine coordinator concerning a 26 year old female who on 08-SEP-2006 was vaccinated in the left deltoid with the second 0.5 mL dose of GARDASIL (Lot # 654540/0800F).  On 08-SEP-2006, the injection site area filled up with fluid with tennis ball size swelling per the patient.  It was reported that the duration was "a couple hours".  It was previously reported that the patient had developed pain at the injection site.  It was reported that the vaccine hurt the patient more when injected into the arm rather than the upper thigh, hip area.  It was reported that the "pain was so great that the patient said they would not finish the series".  The shot was from a pre-filled safety syringe.  The vaccine coordinator thinks "the pain may have something to do with the technique because the shots given from the single dose vials have not experienced as much pain".  It was further reported that "she was unsure if the extreme pain was caused by the vaccine, injection site or the technique used with the safety syringes".  The patient stated that this "was not a big deal but preferred the injection in her leg".  At the time of this report, the outcome of the events were unknown.  Additional information has been requested.
No additional AE/PQC reported; improperly stored; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided.  On 03-DEC-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # T015598, expiration date 02-NOV-2021, (exact dose, injection site and route of administration were not reported) for prophylaxis.  Administered dose of vaccine experienced the temperature excursion of 20.5 degrees Fahrenheit for 1 hour and 54 minutes. The digital data logger was involved in recording the temperature excursion details. Administered dose of vaccine experienced the previous temperature excursion of 6 to 14 (12.3) degrees Fahrenheit for 23 hours. There was no additional adverse events reported.
Information has been received from an LPN concerning a 12 month old female who on 9/20/00 was vaccinated with the 1st dose of MMRII, a 1st dose of varicella virus vaccine and a 3rd dose of Hep-B. On 9/20/00, the same day of the vaccinations, the child experienced urticaria with rash and hives. The pt's experiences were intermittent for 5 weeks. The child was initially treated with Benadryl for a week. Benadryl was discontinued. On 10/23/00, the child was seen and prescribed Atarax. The reporter noted that the rash was not a vesicular rash. The reporter noted that another pt had an adverse experience following vaccination with MMRII and Hep-B (WAES 00110453). In follow-up information received from the nurse, it was reported that the pt's rash resolved for 2 weeks after hydroxyzine therapy and then "came back". The pt's father restarted hydroxyzine, "but only used (it) for a few days." As of 12/21/0, the pt's father reported the pt had experienced "hives off and on" and believed it was "food allergies". The reporter stated that the pt recovered; however, at the time of the report the pt still "had a few spots." No additional information is expected.
Roughly 2 weeks after the vaccine a rash appeared on my face. It looks like small, red, pinprick dots that begin below my cheekbones and down to my jawline. The rash gains and loses intensity throughout the day. It is sometimes hot, but does not itch. This has happened roughly 2 weeks after each vaccine in the series so far.
Moderna COVID?19 Vaccine  8 Days after the shot, I developed a red, itchy bump near the injection site. It was about as big as a quarter. The bump has gone down in size as the days progress, however the red rash remains and grows in size daily. It is a circular rash near the injection site, and I have also developed several additional red, splotchy rashes on my bicep.
Decrease appetite-12/23,12/24, 12/25,,12/26,12/27 Increase Joint pain-same as above  General muscle aches-same as above  Numbness bilateral arms w/ tingling in fingers-12/24, 12/25, 12/26 Fever w/ chills - 12/25 Headache w/ nausea on and off 12/23, 12/25, 12/27 Dizziness and weakness 12/23, 12/27 Tiredness and feeling unwell 12/25, 12/26, 12/27 Chest tightness 12/27 I didn?t take any other OTC medicine, just tried to Go through
Localized arm swelling at the site, the morning after administration. no fever or other systemic symptoms. No pain at the ejection site.
Janssen COVID-19 Vaccine EUA Started 5 hours after injection and lasted total of 36 hours. Had fever of 102 degrees in the first 8 hours of the event, and a fever of 100 for remainder of the event. Had chills and uncontrollable shakes. Lips turned blue at the start of the event. Had a headache for almost the full time of the event. Had brain fog during the last 12 hours of the event. Had flu-like aches and pains for the duration of the event.
Chills; fatigue; This is a spontaneous report from a contactable consumer (reported for himself). A 73-years-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6200) administered in left arm via an unknown route of administration, on 19Feb2021 at 10:15  am as SINGLE DOSE for covid-19 immunization. Medical history included hypertension, chronic obstructive pulmonary disease. The patient previously received first dose of bnt162b2 (Lot number: EL3249) administered in left arm on 29Jan2021at 09:00 am. The patient's concomitant medications were not reported. On 19Feb2021 at 14:00, the patient experienced chills and fatigue. The patient did not received treatment for the events. In Feb2021, the patient recovered from the events. Prior to vaccination the patient was not tested for covid-19. There were no known allergies.
Confusion; Balance was off; Vision was blurred; General sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion), BALANCE DISORDER (Balance was off), VISION BLURRED (Vision was blurred) and PAIN IN EXTREMITY (General sore arm) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALPRAZOLAM (XANAX), OLANZAPINE, OXYCODONE and BUTALBITAL, CAFFEINE, PARACETAMOL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) for an unknown indication.    On 15-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced CONFUSIONAL STATE (Confusion), BALANCE DISORDER (Balance was off), VISION BLURRED (Vision was blurred) and PAIN IN EXTREMITY (General sore arm). At the time of the report, CONFUSIONAL STATE (Confusion), BALANCE DISORDER (Balance was off), VISION BLURRED (Vision was blurred) and PAIN IN EXTREMITY (General sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Hard, firm, tender, red spot former about half an inch to an inch under the intention site. The spot is about two to three inches across by about an inch to an inch and a half. This morning it is no longer firm or swollen, but it's still red and tender. While I put "no"under 20 since this hasn't fully resolved yet, it's definitely getting better. I bet it'll be cleared up completely in another day or two.
CHILD C/O HAVING HARD TIME SWALLOWING AND FEELING CRACKLY IN HER CHEST. ABLE TO EAT LUNCH.  SAT 100%, NO DISTRESS AT TIME RETURNED TO OFFICE.
This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 03Feb2021 as single dose for COVID-19 immunisation. Medical history included sickle cell anemia from an unknown date and unknown if ongoing, Addison's disease from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, diabetes from an unknown date and unknown if ongoing, and pacemaker from an unknown date. The patient's concomitant medications were not reported. The patient called to schedule her second dose of BNT162B2 and reported that she had her first dose on 03Feb2021 and had not returned for her second dose yet. She reported that she became very sick the evening after her first vaccination and had not wanted to get her second dose until now; further reporting she had a number of underlying medical conditions. The clinical outcome of became very sick was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
was sicker than could ever remember; Initial information received on 17-Dec-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non- healthcare professional (hcp).  This case involves a 57-year-old and unknown gender patient who was sicker than could ever remember after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in 2004, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dose: unknown) (lot number and expiry date: not reported) via unknown route in unknown administration site for flu vaccination.  On an unknown date, the patient developed a non-serious event of was sicker than could ever remember (illness) within 2 weeks following the administration of INFLUENZA VACCINE.  It was reported, the patient had to get the flu shot because the patient worked with old people. Missed over 2 weeks of work. Never ever again.  It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (was sicker than could ever remember).  At time of reporting, the outcome was Unknown for the event was sicker than could ever remember.
Patient waited at Pharmacy for 15 minutes then checked out groceries. Went to car & developed severe chest pain, SOB & pain on left side. Went home. Pain lasted until 3AM 12-29-21. after 3 pfizer shots did not cause this
Towards the end of 30min observation period, patient reported headache and lump in her throat. Vital signs initiated at 1812, WNL; was provided water and continued to monitor. Denied any difficulty breathing or respiratory symptoms. Second set of vitals taken at 1819, WNL. Patient stated symptoms still present, "it feels like when you have nasal congestion but in my throat", "the lump in my throat feels like when I had a (anaphylactic) reaction to doxycyline, but not as severe." Patient was offered IM Benadryl, accepted. Medication was administer at 1825. At 1835 patient stated symptoms of headache resolved but lump in throat was still present. At 1840 last set of vitals taken, WNL. Client requested to leave, stated that she felt comfortable to go even though symptoms had not fully resolved. Was educated to contact her primary healthcare provider, if symptoms worsen or any difficultly breathing/chest pain presents, she should seek emergency medical care. Patient verbalized understanding. Left with daughter at 1842.
Pregnant physician that received the vaccine; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant physician that received the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant physician that received the vaccine). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant physician that received the vaccine) had resolved.        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 and treatment information was provided. This is a case of product exposure during pregnancy with no associated AEs for this unknown aged female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this unknown aged female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
After pt received HPV he was sitting on bed and fell backwards and eyes rolled back, head and body jerking and drooling from (R) side of mouth. Episode lasted 10 - 15 seconds. Pt did not respond during that time when pt was finally able to respond he wasn't sure what happened pt was pale and clammy. Dr assessed pt and kept pt in office x 1 hr 10 minutes.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: TRINTELLIX, start date: Oct2018; LOESTRIN FE, start date: Jan2021. Clinical course included other medication details: other medication in 2weeks product: Trintellix, Loestrin FE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.