chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax & devel red rash over extremities; hands became swollen & itchy; t99.9; rash appeared to be maculopapular in origin; rash dec & ranged in size from a few millimeters to 0.75cm; poss viral, poss due to vax;
Headache, extreme muscle tenderness and weakness, dehydration, exhaustion, rapid heart rate, brain fog, anxiety and menstrual disruption.
The patient experienced diffuse redness, swelling and erythema of the right arm after vaccination.
Patient experienced tingling down right lateral arm immediately following vaccination, symptoms had already started to resolve by 20 minutes, reassuring physical exam, no medications given
On January I woke up at 3:00AM thinking I needed to go the restroom. I sleep in a recliner and when I tried to get up I couldn't find the remote for the chair. I felt like I was having a super-low blood sugar event because things weren't connecting in my brain. I realized I was "jerking" in my upper and lower body. I finally found the remote on the floor and realized the colors on the floor and everywhere else that the colors were wrong. I tried to walk to the bathroom and my legs were jerking bad. I did not have to go to the restroom. I almost made it back to the chair and one jerk of my leg caused my knees to give out and I was able to get myself up after falling. I got up and returned to my chair. I called 911 and it took several tries on the phone to hit the right buttons because my hands were jerking so much. I was able to tell the operator what was going on, but it was it was difficult because my thinking and my speaking was disturbed. The EMTs arrived. By the time I got back into the ambulance my color perception was correct. They were unable to get an IV into my vein because I was jerking so much. I went to the emergency department. I noticed while I was there, I was choosing the wrong words when I tried to speak. I dosed off while waiting and jerking dissipated but returned when I woke and sat up. I was released because my symptoms were gone, and my labs were normal. My other symptoms were easily distracted, and my thinking was slower than normal. I was having difficulty completing a sentence because a new thought would come in or I would lose that thought. This has gotten better. I have.
This case was reported by a healthcare professional and described the occurrence of lost consciousness in a 13-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). There were no concurrent medications. On 4 October 2008 at 10:45 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. Immediately after vaccination with FLULAVAL. the subject experienced lost consciousness. Ammonia was used on the subject and she did come around. The subject was only out for about 30 seconds. Paramedics were called and they came out to check on the subject. The subjects mother took her to the emergency room, but she was released. This case was assessed as medically serious by GSK. The healthcare professional considered the event was unrelated to vaccination with FLULAVAL. This was also considered to be a case of medication error as FLULAVAL is not indicated for use in children.
Patient is having severe nausea, and arm is swollen. Patient had a pneumonia vaccination in the same arm on the same day.
excursion lasted for 19 hrs and the thermometer showed the lowest cold reading as negative 2.2 C (with no reported adverse event); vaccine was deemed not suitable as of today and they just realized that the same vaccine had been administered (with no reported adverse event); Initial information received on 15-Sep-2023 regarding an unsolicited valid  non-serious case received from other health professional.  This case involves a 6-month-old female patient and is reported vaccine HIB (PRP/T) vaccine [ACT-HIB] who experienced excursion lasted for 19 hours and the thermometer showed the lowest cold reading as negative 2.2 c was deemed not suitable as of today and they just realized that the same vaccine had been administered (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (YEAST), pertussis vaccine acellular 3-component, polio vaccine inact 3V (VERO), tetanus vaccine toxoid (Pediarix); and pneumococcal vaccine conj 7V (CRM197) (Prevnar) for Prophylactic vaccination (immunization).  On 06-Sep-2023, the patient received a dose 0.5 ml of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection lot UJ834AA expiry date: 23-Feb-2024 via intramuscular route in the thigh not specified for Immunization and excursion lasted for 19 hrs and the thermometer showed the lowest cold reading as negative 2.2 c (with no reported adverse event) (product storage error).   On 06-SEP-2023 vaccine was deemed not suitable as of today and they just realized that the same vaccine had been administered (with no reported adverse event) (poor quality product administered) on the same day following the administration of HIB (PRP/T) Vaccine.  Reported that they had a temperature excursion for ACTHIB on 30Aug2023. They had a hurricane coming and they didn't have an extra fridge to transfer the vaccine into, so someone packed the vaccines in the refrigerator with ice packs, however the ice packs were placed right beside the thermometer, so the reading went below zero, although none of the vaccines were actually frozen. The excursion lasted for 19 hrs and the thermometer showed the lowest cold reading as negative 2.2 C.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events.  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.
I started having flu likes symptoms, I had a headache, a fever of 101, I started throwing up. As I got better I developed pain in my left chest and upper left abdomen, extreme fatigue, muscle pain, soreness. It got worse after a day or two. It has been the same for the past week and a half. When I started throwing up and having the chest pain I went to the doctor they said it could be myocarditis because of the vaccine. They prescribed ibuprofen and another medication. I took that for a week but the symptoms will not go away. Yesterday I went to the ER and they did tests and an x-ray but they did not find anything out of the ordinary. They prescribed Tylenol for the pain.
On August 15th the back of my throat was swollen.  The swelling moved from the back of my jaw into the jawline.  It then moved into my smile line in my cheeks.  I was prescribed prednisone.  My doctor and he said that it is not uncommon for this to happen in areas where I receive filler injections.  This type of swelling had never happened before.  The swelling is still there but it is a lot better.  The swelling isn?t freaky, but it is definitely volume added to my face.
Pfizer vaccine was administered to patient as dose number 2 in series.  Should have been a Moderna dose.  No adverse symptoms reported.
This spontaneous report as received from a nurse refers to a 1 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 11-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
This spontaneous report as received from a nurse refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unspecified date in May 2016, the patient was vaccinated with an improperly stored does of VARIVAX injection (lot # L037560 with expiry date: 29-SEP-2017) and a dose of M-M-R II injection (lot # L027431 with expiry date: 22-JUL-2017; strength, dose, route and site of administration were unspecified for both). The administrated vaccine underwent the temperature excursion at 50 degrees Fahrenheit for 3.5 hours. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Had cancer for 8 years after vaccine there is no sign of cancer; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Had cancer for 8 years after vaccine there is no sign of cancer) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Colon cancer (for 8 years).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Had cancer for 8 years after vaccine there is no sign of cancer). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Had cancer for 8 years after vaccine there is no sign of cancer) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
Receive Flu vacc .5cc inj. on 12/3/10; injection site red, itchy, swollen x 3d, non-tender, local splotchy, non-raised, (L) upper arm; physician prescribed DIPROLENE AF to apply locally BID and p.o BENADRYL 3 tsps q. 6 hours when she saw the pt. today.
Haha I had shot and still got shingles/Suspected Vaccination Failure; Haha I had shot and still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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 details were reported as follows: The age at vaccination was not reported. The patient had shot and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Body-wide aches 24+ hours after vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 16:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN. Vaccination history included: COVID-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 Immunization; COVID-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; COVID-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 09Sep2022 at 16:00, outcome "recovering", described as "Body-wide aches 24+ hours after vaccination". Therapeutic measures were not taken as a result of pain.  Additional information: The patient did not receive other vaccine in four weeks. The patient did not test for COVID-19 post-vaccination.  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.
patient received her Covid-19 vaccination  (Janssen) on 8/20/21 around 1:30pm and at around 10:30pm began experiencing nausea, vomiting, headache, and fatigue. Vomiting ended on 8/20-8/21 however other symptoms continued until she went to Hospital on 8/22/21.  Hospital prescribed toradol for her headache and ondansetron for the nausea.
Round red and warm to the touch, started off as the size of a half of a dollar then grew larger over time.
red and watery eyes; red and watery eyes; cough; nasal congestion; earache; lack of appetite; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 4-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2022 at 15:30 as dose 1 (maroon cap), single (Lot number: FT9142) at the age of 4 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: COUGH (non-serious) with onset 10Nov2022 at 18:00, outcome "recovering"; EAR PAIN (non-serious) with onset 10Nov2022 at 18:00, outcome "recovering", described as "earache"; DECREASED APPETITE (non-serious) with onset 10Nov2022 at 18:00, outcome "recovering", described as "lack of appetite"; NASAL CONGESTION (non-serious) with onset 10Nov2022 at 18:00, outcome "recovering"; OCULAR HYPERAEMIA (non-serious), LACRIMATION INCREASED (non-serious) all with onset 10Nov2022 at 18:00, outcome "recovering" and all described as "red and watery eyes". The events "red and watery eyes", "cough", "nasal congestion", "earache" and "lack of appetite" required emergency room visit. Therapeutic measures were taken as a result of ocular hyperaemia, lacrimation increased, ear pain. Additional Information: The patient did not receive other vaccines within four weeks prior to COVID vaccine. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Ear infection was treated with Amoxicillin. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, an unspecified number of improperly stored doses of GARDASIL 9 (lot # L038503, expiration date 18-DEC-2017, dose and route were unknown) might had been administered to the patients. No adverse effects were reported. The excursion temperature was 31 F with duration of 16 hours and 30 minutes. The call was due to date logger. There was no previous excursion. This is one of several reports from the same reporter. Additional information has been requested.
Febrile seizure along with fever of 101.3. Complex febrile seizure lasting about 15min, child was not able to move head, right side of body or eyes.
Left Shoulder very sore to lay on for about a week. After that I have felt the nerves affected like I did back in 2007 when I had the shingles even after the shingles went away. I still had nerves bothered where I was put on Gabapentin for about 6 months after. That is what I am feeling in my left shoulder only.
Patient was given refrigerated Moderna that was expired beyond it's 'Beyond Use Label' date of 01/27/2022. Vial was placed into fridge on 12/28/2021. Vial was not removed from fridge in time for 'Beyond Use' expiry date and inadvertently administered. Manufacturer's expiry date is March 25, 2022. Provider informed. Moderna informed and stated that 'the vaccine administered on January 28 to February 7, 2022 from lot number 033H21A maintained the activity necessary to protect against the SARS-CoV-2 (Covid-19) virus at time of administration'.  Unable to get ahold of patient to assess for adverse effects.
Father tested positive for covid 19 after receiving 1st dose; Father had no symptoms but he was tested positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Father tested positive for covid 19 after receiving 1st dose) and COVID-19 (Father had no symptoms but he was tested positive) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 28-Feb-2021, the patient experienced COVID-19 (Father tested positive for covid 19 after receiving 1st dose) and COVID-19 (Father had no symptoms but he was tested positive). At the time of the report, COVID-19 (Father tested positive for covid 19 after receiving 1st dose) and COVID-19 (Father had no symptoms but he was tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2021, SARS-CoV-1 test positive: positive (Positive) Tested positive 17 days after receiving 1st dose.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment details were not provided.    This case was linked to MOD-2021-039688, MOD-2021-039511 (Patient Link).
blood clots; Patient received second dose 23 days apart from 1st one; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose 23 days apart from 1st one). On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criterion medically significant). On 28-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose 23 days apart from 1st one) outcome was unknown. At the time of the report, THROMBOSIS (blood clots) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications was not provided.; Sender's Comments: This case concerns a 28-year-old, male patient with no relevant medical history, who experienced the serious adverse event of special interest of Thrombosis. Inappropriate schedule of product administration was considered as an additional event. The events occurred on an unknown date after the second dose of Spikevax. The rechallenge was assessed as not applicable as the AEs occurred after the second dose. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.
Information has been received from a physician concerning a female who in April, 2003 was vaccinated with a dose of varicella virus vaccine live. In October 2003, the patient developed headaches, lethargy and cellulitis and "possibly shingles on the area of her body where the vaccine was given". It was unknown if treatment was provided. Unspecified medical attention was sought. There was no product quality complaint involved. No other information was provided. Additional information has been requested.
Severe shoulder joint pain and mobility limitation.  Suspected SIRVA due to incorrect injection site.
flu like symptoms; falling off a ladder and hitting head; concussion; Head injury; dizzy; occasional fatigue; This case was reported by a consumer via other manufacturer and described the occurrence of influenza-like symptoms in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included palbociclib (Ibrance) for metastatic breast cancer and anastrozole (Arimidex) for metastatic breast cancer.   On an unknown date, the patient received the 1st dose of Shingrix. In April 2017, the patient started Ibrance 125 mg once daily (125 mg daily). In April 2019, the patient started Arimidex 1 mg once daily (1 mg daily). On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms (serious criteria hospitalization), fall, concussion, head injury, dizziness and fatigue. On an unknown date, the outcome of the influenza-like symptoms, fall, concussion, head injury, dizziness and fatigue were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fall, concussion, head injury, dizziness and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix on 27th February. The patient developed flu like symptoms for which he was on rest. The patient fell off a ladder and hit her head, the ladder incident was not related to the ibrance but was patient's stupidity in placing the ladder into the damp soil and the ladder was shifted once weight was too high. The patient experienced concussion but no broken bones and stated no more ladder the patient had to visit emergency room.. There was no side effect from the Ibrance except for occasional fatigue, especially around 14th day of pill cycle. It was unknown if the reporter considered the influenza-like symptoms, fall, concussion, head injury, dizziness and fatigue to be related palbociclib (Ibrance) and anastrozole (Arimidex). For tolerance to 2nd dose of Shingrix, refer case US2019GSK133032. Clarification was raised to confirm vaccination date and event onset dates. However, no reply received hence case processed as per worst case scenario.