chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer, 61 year old female who on 05-OCt-2007 was vaccinated with a 0.5 mL dose of PNEUMOVAX 23 (Lot # unknown). Concomitant therapies included LIPITOR, TOPROL XL TABLETS, furosemide, PREVACID, aspirin and influenza virus vaccine (unspecified). On 05-OCT-2007 the patient experienced swollen arm and pain at injection site about three hours later. The patient went to ER but was not admitted to the hospital. The patient also had severe diarrhea and weakness. The patient's status was reported as recovering. There was no product quality complaint. Additional information has been requested.
she found out that she was one month pregnant; No additional AE reported.; This spontaneous prospective pregnancy report was received from a patient's husband and refers to a 35-year-old female pregnant patient. She had no pertinent medical history, concomitant therapies or drug reactions and allergies. The patient became pregnant with LMP of an unknown date in 2021.  On 19-JUN-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (exact dose, injection site, route of administration, lot # and expiration date were not reported) for prophylaxis.   On an unknown date in June 2021, after the vaccination, the patient found out that she was one month pregnant (vaccine exposure during pregnancy). The pregnancy outcome was outcome pending. No additional adverse events were reported.
PEN MISFIRE/SOLUTION PRESENT IN SKIN; WATER BLISTER ON SKIN; SKIN ITCHY ON CHEST SHOULDERS AND LEGS; recurring injection site blood/injection site blood in belly; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (WATER BLISTER ON SKIN), PRURITUS (SKIN ITCHY ON CHEST SHOULDERS AND LEGS), INJECTION SITE HAEMORRHAGE (recurring injection site blood/injection site blood in belly) and DEVICE ISSUE (PEN MISFIRE/SOLUTION PRESENT IN SKIN) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049121a) for COVID-19 vaccination.        The patient's past medical history included Cholesterol, Heart attack in 2018 and Bypass surgery in 2019. Previously administered products included for COVID-19 vaccination: JANSSEN COVID-19 VACCINE (Dose 1, intramuscular, Lot number: 1805022) on 07-Mar-2021, JANSSEN COVID-19 vaccine (Dose 2, intramuscular and Lot number: 1855194) on 04-Nov-2021; for Drug use for unknown indication: PEPTO BISMOL. Past adverse reactions to the above products included Hives with PEPTO BISMOL; and No adverse event with JANSSEN COVID-19 VACCINE and JANSSEN COVID-19 vaccine. Concurrent medical conditions included Psoriasis, Insomnia, Vitamin D3 deficiency, Vitamin B12 deficiency, Heart disease, unspecified since December 2018, Alcoholic (FOUR DRINKS A NIGHT RHUM) since 1980 and Non-tobacco user. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Heart disorder, CURCUMA LONGA RHIZOME (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]) for Inflammation and Supplementation therapy, ZOLPIDEM TARTRATE (AMBIEN) for Insomnia, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) for Vitamin B12 deficiency, VITAMIN D3 for Vitamin D3 deficiency.   In 2020, the patient started (HUMIRA) (Subcutaneous) 40 milligram. On 15-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2020, the patient experienced INJECTION SITE HAEMORRHAGE (recurring injection site blood/injection site blood in belly). On 16-May-2022, the patient experienced BLISTER (WATER BLISTER ON SKIN) and PRURITUS (SKIN ITCHY ON CHEST SHOULDERS AND LEGS). On 02-Sep-2022, the patient experienced DEVICE ISSUE (PEN MISFIRE/SOLUTION PRESENT IN SKIN). On 18-May-2022, PRURITUS (SKIN ITCHY ON CHEST SHOULDERS AND LEGS) had resolved. In 2022, BLISTER (WATER BLISTER ON SKIN) and INJECTION SITE HAEMORRHAGE (recurring injection site blood/injection site blood in belly) had resolved. At the time of the report, DEVICE ISSUE (PEN MISFIRE/SOLUTION PRESENT IN SKIN) outcome was unknown.            On 19 Aug 2022, the patient experienced HUMIRA pen misfire.  Patient had cardio therapy for 6 weeks. Patient also took some unspecified statins for cholesterol.   The reporter's causality for the event(s) of WATER BLISTER ON SKIN, SKIN ITCHY ON CHEST SHOULDERS AND LEGS and RECURRING INJECTION SITE BLOOD/INJECTION SITE BLOOD IN BELLY with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of PEN MISFIRE/SOLUTION PRESENT IN SKIN and HUMIRA PEN MISFIRE was not provided. No treatment drug information was provided.
Pressure/heaviness on top and back of head. Dizziness, light-headed. Dissipated after 45 minutes.  Then developed flu-like symptoms for three days. All symptoms diminished and subsided by 4th day.
Body ache; Messed up taste; Cough; Nausea; Chills; Vomiting; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), TASTE DISORDER (Messed up taste), COUGH (Cough), NAUSEA (Nausea) and CHILLS (Chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter. .  Concomitant products included LEVOTHYROXINE, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), VITAMIN D NOS and CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN (Body ache), TASTE DISORDER (Messed up taste), COUGH (Cough), NAUSEA (Nausea), CHILLS (Chills), VOMITING (Vomiting) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO-BISMOL) ongoing since an unknown date at an unspecified dose and frequency. On 03-Mar-2021, PAIN (Body ache), NAUSEA (Nausea), CHILLS (Chills) and VOMITING (Vomiting) had resolved. At the time of the report, TASTE DISORDER (Messed up taste), COUGH (Cough) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
PT complained of leg pain, chest closing and chest pain. She also had 2  panic attacks and had to be transported to the hospital.
Arm pain for 2 days Inability to move arm for 2 days Chest pain for 1 hour Fever for 2 days Headache for 3 days
Intense and prolonged pain at injection site, with resulting limited range of motion of left upper limb for almost 2 weeks.
NO ADVERSE REACTKION OCCURED!!!!  JUT FREPORTING THAT PATIENT GOT , A BIT, EXPIRED LOT
On 8/12/2005 approximately at noon when child began to start vomiting and vomited some clear fluids, finally some thick fluids and formula, had an episode where his eyes rolled back, and the patient essentially went limp. Very difficult to arouse the child and 911 was called. In ER child febrile (temp 102), and large raised red rash at site of vaccine noted.
Suspected vaccination failure; Was diagnosed with shingles; Experienced back pain; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included myelofibrosis and polycythemia vera.   In February 2020, the patient received the 2nd dose of Shingrix (intramuscular). In November 2019, the patient received the 1st dose of Shingrix. On 25th January 2021, between 10 and 12 months after receiving Shingrix and between 1 and 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and back pain. On an unknown date, the outcome of the vaccination failure was not recovered/not resolved and the outcome of the shingles and back pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and back pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: After receiving 2 doses of Shingrix, the patient experienced back pain and was diagnosed with shingles. Formulation of Shingrix was not known. The reporter did not consent to follow up. This case was considered as suspected vaccination failure, since the laboratory confirmation was not provided.
Approximately 1 hour after receiving first dose of the COVID 19 Vaccine the member began feeling shaky and itchy around neck and chest area and then spread to arms and hands.  Member was given 50 mg oral benadryl. Member had elevated BP upon arrival, 181/118.  Member was then given 60 mg oral prednisone and started on an IV of .9%sodium chloride, 1000ml. Member began feeling better and symptoms subsided.  She was sent home with benadryl and prednisone and informed that if symptoms return to return to the hospital.
Entire body broke out in hives, causing my skin to become very red and inflamed. Then full skin peeling. Was given fluids and creams to help with inflammation. Given a biopsy on right arm and leg to make sure it was not Stephen Johnson?s Syndrome And left with with psoriasis like scales after skin all over body peeled off.
Swelling, redness - entire upper arm lymph node swelling, fever, pain diagnosed by MD - cellulitis.
This spontaneous report was received from a nurse refers to a 4 months old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 28-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # N009948, expiry date: 12-OCT-2018) orally 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 from 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-009507513-1709USA007014: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA000054.
N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia
Information unavailable.  Patient died at home.  Covid 19 listed as a cause of death on death certificate.
Fatigue, cough, body aches, stuffy/runny nose, fever. Symptoms ran from Tuesday to Sunday.  Prescribed Tamiflu on Thursday and started taking it on Thurday @ 4:00 pm. She started feeling a little better by Saturday and had no more fever by Saturday.  Today Wednesday she still has a little chest/cough congestion.
I am having severe pain in my hands, arms, upper legs and knees, and in my back. I am becoming stiff to the point I can?t hardly walk and I?m to the point with my hands I can?t even open the door. I went to the er the gave me muscle relaxers but it don?t touch pain. I have moments where I?m shortness of breath and my chest feels heavy but haven?t been coughing much. It?s more feels like my muscles are stiffing up and the pain gets unbearable.
This spontaneous report as received from a physician refers to a male patient of unknown age. The patient was vaccinated with GARDASIL in August 2012, "in the past 8 days". Lot#, route and specified date were not reported. It was reported that the patient experienced syncope and vomiting with in 5 minutes of receiving GARDASIL. The outcome of syncope and vomiting was unknown. The patient sought medical attention for the adverse event occurred in the physician's office. This is one of several reports received from the same source. (1209USA002964, 1209USA003021, 1209USA001616, 1209USA003023, 1209USA003024). Additional information has been requested.
Patient a minor inadvertently vaccinated with Moderna on 3/23/21. The mother put in the wrong birthdate in the system of date instead of date. Multiple ID's in the computer. Pt. presented today with correct ID and for second dose of Moderna to complete the series. RN verified ID, FDA explained, all questions answered, Off label consent form signed by mother. Doctor notified. Site Manager and other personnel informed of the situation.
Patient presented with AKI in the setting of DKA from outside healthcare facility.  Patient's spouse stated patient had received the Moderna series and one booster, unable to provide vaccination facility nor dates received.  This is the entirety of information available to me.
I received my vaccine on the 3rd and on 7th I was at work, I'm an ER nurse I developed a sore throat and cough so I asked to be COVID test tested, I was negative. I continued to get worse with minimal excursion my RHR was 130 and would go into the 150s with minimal excusserion, I was tachycardia, I was short of breath and cough continued. My husband drove me to My ER, I felt like something was very wrong I had numbness in face and extremities and at that point they called a stroke alert I lost  the ability to use my right and foot and progressed to my left side and my entire body. They did extensive imaging. They did blood blood work and my d dimer came back elevated at 3.54. Because of elevated D'Dimer they were concerned I had a pulmonary embolism or a DVT. They brought infectious disease doctor in to run more test. They have been treating me with steroids and muscle relaxants, pain medication. They believe in a possible flare up of my FMF.
Woke up with a fever of 100, chills, body aches, and a headache. Everything felt better by 9am except the headache lasted until 4pm and I was fatigued until 3pm.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site pain, tenderness, wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and vaccination error. On an unknown date, the outcome of the injection site pain, tenderness, wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and vaccination error were unknown. It was unknown if the reporter considered the injection site pain and tenderness to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that dose of SHINGRIX was inadvertently reconstituted using sterile saline, which led to wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and vaccination error. The patient experienced pain during administration of the vaccine. At the time of reporting, tenderness which remained ongoing. Vaccine was administered by patient's primary care physician and not by the reporting pharmacy. The health care professional had limited information. The health care professional was unsure of the exact site of administration but stated it might have been the patient's right arm.
pt recv vax 14AUG97 & 5SEP97 devel scratchy throat, perioral numbness, itching in mouth;exam on 8SEp97 reveals 7-8 discrete brown areas & 2-3 red areas on buccal membranes of mouth;
ARMED SITE INFLAMED, ITCHY, HARD & SIZE OF A GOLF BALL, STILL EXISTS SIZE OF A NICKEL 2 WEEKS LATER HARD, & ITCHY.
I was extremely cold. Very nauseated. Very awful headache. It lasted from April 9. 9:45 pm. Through April 11.  About exactly 9:45 pm.
Arm sore 1/6-1/7. It went away. 1/13 when I woke up my arm was very sore with a lump and very warm to touch. Felt like it was burning. 1/14 Still have some pain but it has gotten better I took 3 Advil for pain. Arm is still warm to touch. Feels slightly itchy as well.
All of these occurred the 1st day after vaccination:  1) Soreness at injection site 2) Increased resting pulse rate (90 instead of 60) 3) Muscle aches and feeling weak 4) Slightly elevated temperature 5) Slight headache 6) Slightly reduced blood pressure 7) Clogged nose and some coughing
Morning of 5/19/18 (day after administration) patient had very sore arm, thought it was from exercising but it was 10x worse than that. Night of 5/19/18 patient developed chills and was very cold. She woke up morning after that and felt fine, just still had a sore arm. Still felt fine and had sore arm 5/21/18.
having covid and being in the hospital; having covid and being in the hospital; This is a spontaneous report from a contactable nurse and a contactable consumer (patient). A 64-year-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation and tofacitinib citrate (Xeljanz XR, Prolonged-release tablet, Batch/Lot number and Expiration date was not reported), via oral route from Aug2017, at a dose of 11 mg, daily for rheumatoid arthritis. The patient medical history included ongoing rheumatoid arthritis. Concomitant medications included atorvastatin calcium, duloxetine hydrochloride (HCl), gabapentin, levothyroxine, lisinopril, metformin HCl, methotrexate and omeprazole (all taken for an unspecified indication, start and stop date were not reported). On Sep2021, patient had COVID-19 and was hospitalized for 5 days for COVID-19 on an unspecified date of 2021. The action taken for tofacitinib citrate was permanently withdrawn on an unspecified date Sep2021 due to COVID-19 and being in the hospital. The outcome of the events was unknown.  The lot number for the vaccine, BNT162b2 was not provided and will be requested during follow up
Complain of heart racing. Patient was examined and vital signs were within normal limits. Within minutes the patient felt normal and was ok to go home. She does report history of anxiety and feeling anxious before receiving the vaccine.
Extreme pain when moving my arm at and above shoulder's high and when moving arm past the chest plane towards the back of my body.  I had taken Naproxen (440mg) every 12 hrs. for several days but it doesn't seem to help. This started about a month or so after the first dose of the vaccine and it felt like a minor discomfort but it gotten worse over time to the point of not being able to use my arm normally; for instance, I cannot lay on that side when in bed.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-SEP-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K010215, expiry date: 05-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Pt. had redness and enduration to Left arm at varicella injection site measuring 5 X 4.5 inches.  Recommended Benadryl for symptoms, or if worsens to see MD.
Vaccine dose # 2 given on 12/13/22 as vaccine dose #1 was given  on 12/06/22. Mother and child remained in clinic for 45 minutes without adverse reaction.  Pediatrician notified. Nursing Director notified. Mother instructed to contact nurse/doctor if adverse effects reviewed are present.
Shingles on left side of face. It's a mild case, but pain and extreme sensitivity to touch, numbness in some areas, fluid-filled blisters that break open and crust over, itching.
She said her left arm was sore after her first COVID-19 Vaccine dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 (Lot number: EN6198) at the age of 72 years as 1st dose, single for covid-19 immunisation. Relevant medical history included: "Oral lichen planus" (ongoing), notes: Verbatim: Oral lichen planus, 10-15 years ago.; "Rheumatoid arthritis" (ongoing), notes: Verbatim: Rheumatoid arthritis; "Spinal leak" (ongoing), notes: Verbatim: Spinal Leak, 1-1/2 year ago; "Gluten" (unspecified if ongoing), notes: triggered her rheumatoid arthritis; "fractured her L4 vertebrae", start date: 2020 (unspecified if ongoing), notes: in last summer 2020; "Sciatica", start date: Feb2020 (unspecified if ongoing), notes: pinched sciatic nerve since Feb2020; "Bone density issue" (unspecified if ongoing). Concomitant medication(s) included: EXTRA STRENGTH TYLENOL PM; ADVIL [IBUPROFEN]; GABAPENTIN  (3 capsules in the morning, 2 capsules 5 hours later, 3 capsules after another 5 hours, and 3 capsules before bedtime). Vaccination history included: Flu vaccine, reaction(s): "mouth sores". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 02Mar2021, outcome "recovered" (Mar2021), described as "She said her left arm was sore after her first COVID-19 Vaccine dose".  Additional information: she had a flu vaccine about 15 years ago, and the day after the flu vaccine, she got mouth sores, and the mouth sores got worse. She said her local doctors didn't know how to treat her mouth sores, so she went to the (Privacy). She said the (Privacy) doctors told her she had Oral Lichen Planus, and the Oral Lichen Planus was caused by the flu vaccine she had received. She stated she did not have any information (NDC, Lot, & Expiration Date) for the flu vaccine she received back then. She stated she has not had a flu vaccine since that time. Reported she had medication she takes every day, and she continued to take the medication to help her symptoms. She said she took Extra Strength Tylenol, Advil, and Gabapentin.   No follow-up attempts are possible. No further information is expected.
Fever 101.2; Headache; Nausea; Pain in left arm; Chills; This is a spontaneous report received from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration in the left arm on 17Mar2021(at the age of 68 years old) at 09:00 as a single dose for COVID-19 immunisation. Medical history included Migraines, sjogrens and allergy to metals (nickel and gold). The patient also previously had first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration in the left arm on 26Feb2021 at 09:00 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19 and was not tested positive for COVID- 19, post vaccination. Concomitant medications included Lexapro (MANUFACTURER UNKNOWN), Wellbutrin (MANUFACTURER UNKNOWN), Sumatriptan (MANUFACTURER UNKNOWN), Ambien (MANUFACTURER UNKNOWN), Ativan (MANUFACTURER UNKNOWN) and Tizanidine (MANUFACTURER UNKNOWN) within 2 weeks of vaccination and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 06:00, the patient experienced fever, headache, nausea, pain in left arm and chills. The patients fever 101.2 decreased after taking Excedrin for Migraines and sumatriptan. The clinical outcome of the events headache, nausea, pain in left arm, fever and chills was recovering at the time of reporting. No therapeutic measures were reported for the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.