chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a 57 year old female patient via Pfizer reporting on herself. The patient's concurrent conditions included hypertension. Concomitant therapies included GLUCOPHAGE, HYZAAR, LIPITOR and unspecified medication for cholesterol. On 26-OCT-2018, the patient was vaccinated at facility in her left arm with the first dose of PNEUMOVAX 23 intramuscular (strength, lot number and expiration date were not provided) for prophylaxis. On the same date, her arm was hurting throughout the rest of the day, then on 27-OCT-2018, the patient had red spot on arm that looks like a wheel or circle. In regards to the size, the doctor said the area was 3.75 by 3.5 (units not provided). The patient states the spot kept getting bigger and bigger. The patient's doctor gave her medicine to take for 5 days, however she did not know the name of the treatment and could not determine if it improved the spot on her arm. On an unknown date in 2018, the patient experienced itching and was also given BENADRYL as treatment (unsure dosage). At the time of the report, the outcome of rash macular was reported as not recovered. The outcome of pain in extremity and pruritus was not provided. The reporter did not assess the relatedness between the events and PNEUMOVAX 23.
This is a spontaneous report from a contactable consumer reporting for herself.  A 69-year-old female patient received PREVNAR 13, intramuscular, on 11Jan2017, at 0.5 ml single, for immunisation. Medical history included hysterectomy from 1989 and ongoing (performed at the age of 42 years) and blood pressure abnormal. Concomitant medication included losartan (unspecified trade name), oral, from/to an unspecified date, at 50 mg 1x/day, for blood pressure abnormal and estrogens conjugated (PREMARIN) tablet, oral, from 1989 and ongoing, at 1x/day (low strength, it was 0.3%), for hysterectomy. The patient experienced burning and itching were so severe that she wanted to rip her skin off on 15Jan2017 with outcome of not recovered, stinging on 15Jan2017 with outcome of not recovered, big red circular area on arm at the site of the shot on 17Jan2017 with outcome of unknown and vitamin B12 level elevated on 26Jan2017 with outcome of unknown. On 26Jan2017 the patient underwent lab tests and procedures which included: differential white blood cell count: normal; full blood count: normal; metabolic function test: normal; thyroid function test: normal; vitamin B12: elevated. The reporter described the events as episodes of severe sudden onset of burning, stinging and itch but no rash at different part of patients body, for 15-20 minutes every time, basically daily. The day before happened three times during the day that the itching and burning were so severe that she wanted to rip skin off. She went to her doctor and performed some blood test. Therapeutic measures were taken as a result of burning and itching were so severe that she wanted to rip her skin off and stinging and included treatment with Tricalm as needed and Benadryl as needed before bed.
Fainting; Remained unconscious for a few seconds; Sweating; Minor tightness in the chest; Blurred vision; This is a spontaneous report was received from a contactable consumer (patient). A 44-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8734), via an unspecified route on 08Apr2021 at 13:15 as 1st dose, single in the left arm for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included Betamethasone Dipropionate Cream USP 0.05%. The patient had known allergies with Keflex (cephalexin). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 (5 minutes after vaccination), the patient experienced sweating, minor tightness in the chest and blurred vision followed by fainting and remained unconscious for a few seconds. After regaining consciousness, continued sweating for maybe 10 minutes. The patient visited emergency room. The patient did not receive any treatment for the events. On an unspecified date in APR-2021, the patient had recovered from the events.
Patient was administered 1 mL of HPV instead of 0.5 mL left arm. No treatment. Hep B 1 mL was also administered in the same arm by different medical assistant.
intermittent vaginal bleeding lasting approximately 3-4 days.  First occurrence happened approximately 3-4 weeks after 2nd vaccination and lasted 3 days.  Second occurrence began 04/19/21 and is persistent.
Skin rash on arm around injection location started one day after vaccination and was mild, more red and bumpy 10 days later.
Flushing face, apprehension, SOB, lightheaded, dizziness, 104 pulse & pounding, heavy chest BP 160/90 all subsided in 20 mins; Tingling lower lip & feet, cold hands, much improved x/very tired & sore throat BP 124/80; By 14FEB91 feels fine.
1101 patient arrives to observation after feeling lightheaded immediately following injection.   Patient, BP 134/95 HR 98 100% oxygen sat room air.  Patient given crackers and water.  patient monitored for about 15 min before reporting that he felt better.  patient reported that his symptoms have resolved, that he was fine and was ready to go at this time.  patient was escorted to west entrance via wheelchair where he left facility on his own accord at 11:20
During  the evening the inner aspect of the patient's upper arm became painful, red, swollen, and hot to the touch.  This was not in the area of the injections, which had been given in the deltoid.   A few days later (unable to determine when), she developed a "bruised looking  area in the same spot, brownish in color."   She took Tylenol and Benadryl the first two days.  Patient states that it was five days until her arm looked "normal" again.
2/13 arm soreness started. Constant arm pain until 2/19. Pain worsened from 2/19 through 2/20/04. Presented to doctor on 2/20 who prescribed muscle relaxants, antiinflammatories and acetaminophen.
extended heavy bleeding during menstrual cycle fatigue fever stomach bloating ascites anemia dangerously low hemoglobin count  Blood Transfusion 05/25/31 Paracentesis 05/26/21
Pt experienced local itching at injection site within 12 hours with a duration of 7 days. Pt reports worsening of osteoarthritis following vax.
administered act-Hib with a different diluent with no reported adverse event; Initial information received on 19-Oct-2023 regarding an unsolicited valid  non-serious case received via nurse.  This case involves a 4-year-old female patient who was administered HIB (PRP/T) vaccine [ACT-HIB] with a different diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (strength, lot number, expiry date: unknown) not reported via unknown route in unknown administration site for prophylactic vaccination (immunization) and administered act-hib with a different diluent with no reported adverse event (product preparation error) (latency: same day).  Reportedly, Nurse called to report that they administered act-Hib with a different diluent. They did not use the diluent provided on the act-Hib. She said that she has read on a reliable database that dose should be repeated as soon as possible using the diluent provided in act-hib. She wanted to confirm if the data she has read is true and that if they need to report it.  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 and Regulatory Authority 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.
Started at 7pm on 9/19. Felt sore arm, during night. Pt felt hot and cold, weak.
Raised bumps and inflamed and sore at sight of injection. Also spreading to above the shot location.
patients received a refrozen dose of vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received a refrozen dose of vaccine) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 23C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received a refrozen dose of vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received a refrozen dose of vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided.; Sender's Comments: This is a case of Expired Product Administered concerning an elderly patient of unknown gender with no relevant medical history, who experienced no other associated adverse events. The events occurred on an unknown date after receiving the third dose number of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge is unknown since no information on other doses were disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
This spontaneous report as received from a registered nurse refers to a 6 year old patient. The nurse reported that the patient received a dose of 0.5 ml expired (Merck) VARIVAX (lot # 668253/0926Z; Expire date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. No further information is available.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about patient's concomitant medications, concurrent conditions and medical history as not reported. On 01-FEB-2016 the patient was vaccinated with a dose of (Merck) VARIVAX (dose and route not reported, lot number L032394 with expiration date 26-AUG-2017) that had been improperly stored (temperature ranges: 5.5F to 11.8F and time frame: 11 hours and 30 minutes). It was reported that there was a previous temperature excursion: 11.5 F for 14 hours. No adverse effects were reported. This is one of three reports received from the same reporter (other linked case # 1603USA010044 and 1603USA010236). Additional information is not expected because there was no consent to contact the physician for follow up.
Left hand swollen; Left hand pain; Arm sensitive; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left hand swollen), PAIN IN EXTREMITY (Left hand pain) and SENSITIVE SKIN (Arm sensitive) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Prophylactic vaccination: Janssen COVID-19 vaccine (Suspension for injection, Intramuscular, Dose not reported, Batch-unknown, Expiry-unknown.) on 09-Mar-2021, Janssen COVID-19 vaccine (Suspension for injection, Intramuscular, Dose not reported, Batch-unknown, Expiry-unknown) in 2021, Janssen COVID-19 vaccine (Suspension for injection, Intramuscular, Dose not reported, Batch-unknown and Expiry-unknown) in 2021; for Rheumatoid arthritis: HUMIRA (Sub-cutaneous, Batch-not reported and Dose- not reported). Past adverse reactions to the above products included Bruising of arm with Janssen COVID-19 vaccine; Memory loss with Janssen COVID-19 vaccine; and No adverse event with HUMIRA and Janssen COVID-19 vaccine. Concurrent medical conditions included Rheumatoid arthritis.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Left hand swollen), PAIN IN EXTREMITY (Left hand pain) and SENSITIVE SKIN (Arm sensitive). At the time of the report, PERIPHERAL SWELLING (Left hand swollen), PAIN IN EXTREMITY (Left hand pain) and SENSITIVE SKIN (Arm sensitive) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.  The causal relationship between Janssen COVID-19 vaccine and all events were reported as possible. The action taken with Janssen COVID-19 vaccine for all events was Not applicable and HUMIRA(Adalimumab) was unknown.
This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (parent's patient) reported that a 14-month-old male patient of unknown race received PREVNAR 13, at single dose, varicella vaccine,  MMR, FLUZONE and VAQTA all on unknown date for immunization. Five days later (over the weekend), on unknown date the patient developed an allergic reaction to peanut butter. The outcome of the event was unknown.
3/5/ 21 Received J & J at facility.  3/7/21 Client had troubles walking and went to Urgent Care.  then he went home.  He did not have good control (wife described that his legs did not have strength but was able to walk.  Symptoms started getting better later that day.  3/15 He got up and he said he was not feeling to good.  Chest hurt and shoulder hurt.  Wife took him to the ER at Hospital.  He was transported to Hospital.  3/16/21 Hospital did a Heart catherization.  He had a complete blockage in the widow maker and 2 stents were put in.   He had 2 blood clots in the Widow Maker.  3/18/21 He was discharged from the hospital.  He is doing ok but he has no energy.
Nausea, dizziness and numbness from neck to waist area. Patient provided liquids and snacks initially. After approximately 15 minutes of observation, he was transferred to the emergency room for further observation and care.
3-10-04- had possible reaction 10-12 hrs after 2nd dose of Rabies vaccine- abdominal cramps, dizziness, muscles soreness, seen by MD. About 8 days later experienced rust colored urine. Had various tests done and blood drawn. Saw a neurologist infectious disease specialist. Had limited peripheral vision- saw and opthamologist. Is currently on steroids. Signs slowly resolving still under doctor care.
Day after vaccination, arm pain upon waking up. Gradually the area around my left eye (eye lid/brow area) got itchy, noticed that my neck on the left side was itchy too. Symptoms worsened as the day went on and by evening had a slight fever, additional swelling around the left eye and neck and the area near my right eye started to get itchy. Took 1 Benadryl at 7:30PM and went to bed. Woke up at midnight with slight swelling near my right eye, took another Benadryl and went to sleep. Woke up at 5:00AM, left eye 90%+ swollen shut, right eye 50% swollen shut, left side of neck very itchy, swollen, and bumpy.
Severe headache behind left ear, hot sweats, fever, nausea and fatigue for two days. The headaches have still occurred everyday at varies times.  It is a sharp pain that interrupts my thought process and I have to stop what I am doing until it passes.
Ball in the left plantar arch; Pain in the plantar arch; This spontaneous case was reported by a consumer and describes the occurrence of PLANTAR FASCIITIS (Pain in the plantar arch) and PLANTAR FASCIAL FIBROMATOSIS (Ball in the left plantar arch) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included INSULIN for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PLANTAR FASCIITIS (Pain in the plantar arch). On an unknown date, the patient experienced PLANTAR FASCIAL FIBROMATOSIS (Ball in the left plantar arch). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, PLANTAR FASCIITIS (Pain in the plantar arch) and PLANTAR FASCIAL FIBROMATOSIS (Ball in the left plantar arch) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, X-ray: normal (normal) No abnormalities.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-101847 (Patient Link).
provider ordered a MMR vaccine to pt. but Varicella was given. No adverse events reported and pt. received his MMR as ordered by PCP.
Unable to walk, lower back pain, constipation, September to present. Unstable blood pressure, fever, fatigue.
Onset of feeling of weakness and mild discomfort in left arm within a few days of vaccination. This feeling progressed over the course of the next couple months, and then plateaued. He progressively noticed difficulty in performing tasks with left arm, especially those requiring flexion or abduction of the shoulder. Examination for this problem occurred on 12/07/2018. At that time, there is visual evidence of atrophy of left anterior deltoid muscle, with moderate severe weakness of abduction and forward flexion. No distal weakness noted. The patient has been referred to Neurology for further testing and treatment.
I had extreme indigestion the day after the shot. I was unable to eat anything  almost the entire day  except water. I had nonstop belching. I also had this after my 1st shot.
admitted to the neurological ICU with R MCA territory infarct and was found to have COVID pneumonia
Approximately 3 minutes after vaccines were given, patient said she needed to throw up. Patient's skin was pale. I got the patient a cloth for her head, a garbage can and asked her mom to hold her. Patient was alert, responsive and oriented with no wheezing. Paged nurses to immunization room to assist in evaluation patient. After calling for assistance, patient's lips were gray. Patient vomited mostly water. RN reported no edema in throat. BP 82/48, Pulse 96, Respirations 24, Pulse Ox 99 @ approximately 11:00 a.m. Mom reported that patient had a reaction (reports she got chickenpox from vaccine) when she was young, no other reaction reported. Patient's mom stated the doctor told her just to wait and get immunizations in a couple of years. Protocol reviewed by RN, Nurse Manager and 911 was called and arrived approximately 11:10 a.m. and patient was taken to hospital.
Pt came to ER on 3/2/2021 with complaints of leg pain after the second COVID shot that were not getting better.
Pt recv vax on 2/24/99; on 2/26/99 pt exp "spells" of arching back, turning head to left rooting of mouth, deviation of tongue upward x 1-2 min
Hepatitis A vaccine and FluMist given 10/3/08.  On the morning of 10/9/08, school teacher reported trembling and inability to balance.  Parents noted irritability, trembling, inability to balance, and unbalanced gait.  Diagnosis was acute cerebellar ataxia. 10/24/08 Reviewed PCP medical records of 10/9- FINAL DX: acute cerebellar ataxia Records reveal patient experienced trembling, unbalanced, irritable, uncoordinated, bumping into walls on 10/9.  RTC 10/10 w/vomiting x 1 & decreased appetite.  Observed to have wide based gait & unsteady w/tremor of both hands & head.  Phone consult w/neuro & decided on observation.  Admitted to hospital 10/13-15.  11/11/08 Reviewed hospital medical records of 10/13-10/15/2008. FINAL DX: acute cerebellar ataxia Records reveal patient experienced ataxia & shakiness x 5 days. Neuro consult done.  Improved some in hospital & d/c to home w/outpatient PT/OT.
Pt voiced had scratchy throat, felt like passing out in early evning, at one am woke up didn't feel well like passing out again, went to ER, was admitted, doctors said it was due to shot but was cleared of all problems, my cardiac was fine, has some type of medical hx of BP lowing and like going to pass out, but said she could go ahead and continue with next schedule HBV. Instructed patient to return to clinic with doctors note/rx with medical clearance to receive HBV.
Redness and pain in injection site. Fever and muscle aches and pain lasting 3 days. Fatigue.
One of five pt with pain upon injection, and injection site erythema and/or pain and/or swelling following immunization.
I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 4/29/2023 WEAKNESS I82.409 ACUTE DVT, UNSPECIFIED VEIN 4/14/2023 WEAKNESS I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 4/29/2023 WEAKNESS I82.409 ACUTE DVT, UNSPECIFIED VEIN 4/14/2023 WEAKNESS I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 4/29/2023 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN I82.409 ACUTE DVT, UNSPECIFIED VEIN 4/14/2023 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 4/29/2023 MALAISE AND FATIGUE I82.409 ACUTE DVT, UNSPECIFIED VEIN 4/14/2023 MALAISE AND FATIGUE I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 4/29/2023 MALAISE AND FATIGUE I82.409 ACUTE DVT, UNSPECIFIED VEIN 4/14/2023 MALAISE AND FATIGUE
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions could have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 19-Sep-2022 at 10:39 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 19-Sep-2022 at 10:39 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions could have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions could have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.       The vial(s) moved from freezer to refrigerator on 7-SEP-2022. Reportedly, the nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. It was reported that no adverse reactions were reported to their knowledge for any patients. It was unknown  if patient had ever been diagnosed with/ tested positive for COVID-19. Treatment medication was not provided by the reporter.