chrisvoncsefalvay/vaers-outcomes huggingface dataset:
appendicitis; Sunday morning: wake with mild stomach pain; pain increasing consistently/considerable and unbearable pain; Vomiting; Saturday: largely symptom free, though tired and lethargic; Saturday: largely symptom free, though tired and lethargic; moderate headache; Wednesday morning: developed mild to moderate fever and chills; Wednesday morning: developed mild to moderate fever and chills; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 17:45 at the age of 41-years-old (Batch/Lot Number: FIL30161) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included Surgery for pinned broken thumb. surgical repair of achilles tendon.  The patient previously took erythromycin and experienced known allergies: Erythromycin (Nausea). The patient received first dose of BNT162B2 administered in Arm Left on 03Apr2021 04:00 PM at the age of 41-years-old (Batch/Lot Number: ER8737) for covid-19 immunisation. The patient did not take other vaccine in four weeks. Other medications in two weeks included only post-surgery pain meds after vaccine. The patient did not get covid prior vaccination. On Tuesday evening 27Apr2021, Pfizer second dose administered. On Wednesday morning 28Apr2021 10:30 AM: developed mild to moderate fever and chills. On Thursday 29Apr2021: mild to moderate fever and chills continue, new symptoms include a moderate headache. On Friday 30Apr2021: fever and chills begin to subside, headache remained. On Saturday 01May2021: largely symptom free, though tired and lethargic. On Sunday morning 02May2021: wake with mild stomach pain. On Sunday noon 02May2021: pain increasing consistently. On Sunday early afternoon 02May2021: considerable and unbearable pain. Vomiting. The patient was transport to Urgent Care. Urgent Care recommended Emergency Room. On Sunday early evening 02May2021: admitted to ER, administered pain medication. Vomiting ensues. CT Scan administered and showed positive for appendicitis. On Sunday Evening 02May2021: transported to surgical center, prepped for surgery. On Sunday Night 02May2021: emergency surgery performed, appendectomy. Overnight hospital stay was required. On Monday morning 03May2021: discharged from hospital. The adverse events appendicitis, stomach pain, pain and Vomiting resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment received included Pain medications and Surgery (appendectomy). The patient underwent lab tests and procedures which included computerised tomogram: positive for appendicitis on 02May2021, CT Scan administered and shows positive for appendicitis, Nasal Swab: negative on 02May2021.  The outcome of the events was resolving. The case was reported as serious due to Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage.
Information has been received from a physician assistant, for the Pregnancy Registry for GARDASIL, concerning a 24 year old black healthy female with a history of 6 pregnancies and 3 live births and a history of spontaneous abortion and stillbirth at 17 weeks for fetal anomalies who on 28-AUG-2008 was vaccinated with her first dose of GARASIL (Lot number 659964/1978U). There was no concomitant medication. The patient was pregnant. She had a menstrual period in Jun 2008 and then had vaginal bleeding on 28-AUG-2008 which was assumed to be a menstrual period. The patient sought medical attention and had been seen in the emergency room. The pregnancy test was performed there and the result was positive. On 04-SEP-2008, an ultrasound was performed for vaginal bleeding and the result showed as live intrauterine pregnancy at 6 weeks 3 days. The date of last menstrual period was unknown and the estimated delivery date was 26-APR-2009. Additional information has been requested.
On 09/21/2022, I had a runny nose, high fever, achy bones, wheezing, difficulty breathing, and I was miserable. I ended up losing my voice for almost a month. I took an at home COVID-19 test that night and it was positive. I waited a day or two to call my doctor and see if it would pass, but it did not. I called my doctor. He prescribed azithromycin for 5 days, but it didn't seem to help at all. He then prescribed a high dose of prednisone. The prednisone helped my coughing, wheezing, and lungs. However, it left a terrible taste in my mouth and made me sick. I took it for around 10 days before I stopped. My symptoms did improve. After the third or fourth week of having COVID-19 symptoms, I went back to the doctor who gave me a shot of something to help open up my lungs. I don't recall the name of the medication, however.
Body aches and general malaise started about 7 hours after vaccine was given.  Next day rash across chest, both sides of neck, and injection site red, swollen firm/painful to touch. Rash worsened over night into day Two. Rash fully covered front of neck,chest, and below breasts.
varicella-zoster virus infection, abdomen; treatment = valacyclovir 1000 mg q 8 hr x 7 days began on 09/26/2019
The vial was moved from the freezer to refrigerated conditions on 28-DEC-2021; Expired moderna vaccines administered to 5 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccines administered to 5 patients) and PRODUCT STORAGE ERROR (The vial was moved from the freezer to refrigerated conditions on 28-DEC-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccines administered to 5 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was moved from the freezer to refrigerated conditions on 28-DEC-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccines administered to 5 patients) and PRODUCT STORAGE ERROR (The vial was moved from the freezer to refrigerated conditions on 28-DEC-2021) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial did not undergo any temperature excursions.  The vial was moved from the freezer to refrigerated conditions on 28-DEC-2021.  No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2022: Follow up received contains Non significant information, Reporter information was added.
On 1/28/2021, I noted round circle of redness (approximately 7.5 x 5.5 mm in size) on my left deltoid in the area of receiving the second Moderna injection on 1/27/2021. Area was warm to touch and slightly raised with minimal itching. Left Deltoid had been moderately sore 2 hours after injection on 1/27/2021, and significantly sore 12 hours after injection. Additional symptoms noted 12 hours after injection were temp of 100.8, chills, fatigue, and nausea. As of this date 1/29/2021, left deltoid is only slightly sore with the noted round circle of redness as described above.
This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on right arm on 21Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced sore arm on Jan2021. It still fets sore only if she presses on it. The outcome of event was unknown. Information about batch/lot number has been requested.
This spontaneous report as received from a health professional via a company representative refers to 2 patients of unknown age and gender. On an unknown date, also reported as "a while ago for one of the patients", the patients were vaccinated with 2 doses of ZOSTAVAX (dose and route of administration were not reported). The second doses of ZOSTAVAX were administered due to staff error only. No adverse effects were reported. It was reported that both patients were fine. Additional information has been requested.
Information has been received from a registered nurse concerning a 60 year old female (weight 75.4 kg, height 162.5 cm) with ibuprofen (MOTRIN) and Duloxetine HCl (CYMBALTA) intolerance, lipids increased, diabetes mellitus, obesity and hypothyroidism and a history of relapsing-remitting multiple sclerosis, pain in elbow, pain in foot, nausea, chronic back pain, diverticulosis and lipoma who on 25-SEP-207 was vaccinated with a dose of Pneumovax 23 (lot #655290/0959F), IM in the left deltoid. Concomitant therapy included acetaminophen (APAP), cyanocobalamin, interferon deta-la (REBIF), metformin HCl, levothyroxine Na, lisinopril-HCTZ (MSD), omeprazole, red yeast, estradiol (CLIMARA), psyllium husk (METAMUCIL), calcium (unspecified), pyridoxine and vitamin D (unspecified). On 26-SEP-2007, the patient awoke that morning with chills, lightheadness and general body aching. On 02-OCT-2007, the patient was seen by a neurologist who reported that the patient had a clinical relapse of multiple sclerosis. The patient also perceived weakness in her right leg with a heavy sensation, which required her to use a cane for the last 3 to 4 days in order to ambulate with security. The patient was treated with IV steroids for her quit impairment. The outcome of the events was not reported. Chills, lightheadness, general body aching and clinical relapse of multiple sclerosis were considered to be other important medical events. Additional information has been requested.
tummy trouble after wards; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (tummy trouble after wards) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (tummy trouble after wards). At the time of the report, ABDOMINAL DISCOMFORT (tummy trouble after wards) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
no AE; Proquad given to 18 yo; This spontaneous report was received from a nurse and refers to a 18-year-old patient of an unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-JUN-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S021325 has been verified to be a valid lot number, expiration date reported as 05-JAN-2020, but upon internal validation established as 05-JAN-2021) (exact dose and route of administration were not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse events reported.
Passed out, racing heart, nausea, vomiting the rest of the day, some diarrhea.
4/3/09 @ 9am- phone call from parent. Parent reports child right upper arm is red, swollen, & hot to the touch. Symptoms began on 4/01/09 and is worse today. Has been giving tylenol for fever & pain. Also has been applying a warm press to area. Began warm press & tylenol today. Continue current therapy/tx. If no improvement see PMD>
8 days after injection, developed large red rash with itching and swelling. No redness overlying injection site but directly below site. Also developed similar rash to opposite arm after second injection 12 hours after injection. Again, no redness overlying at injection site but was directly below the injected area. + large red rash with itching and swelling.
Heart palpitations, fluttering,  larger oxygen variations when sleeping.  Palpitations everyday multiple times a day, especially when exercising, for first month, slowed down to every other day, currently every 3-4 days.
1st dose 08Sep2021, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th September 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's Comments: The registered pharmacist (RPH) reported two patient had not yet received their second doses of Shingrix (second dose not yet given). The health care professional (HCP) unable to provide additional adverse event details at this time. The  HCP gave consent for safety team follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case is linked with US2023032799, reported by same reporter.; Sender's Comments:  US-GSK-US2023032799:Same reporter
small bump on the right side of her neck where the neck meets the shoulder/ puffiness on right side of neck; bruising under the right armpit; This case was reported by a consumer via call center representative and described the occurrence of neck swelling in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2021, the patient received the 1st dose of Shingrix (intramuscular). In January 2021, an unknown time after receiving Shingrix, the patient experienced neck swelling and contusion. On an unknown date, the outcome of the neck swelling was recovered/resolved and the outcome of the contusion was not recovered/not resolved.   It was unknown if the reporter considered the neck swelling and contusion to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself.  The patient experienced a small bump on the right side of her neck where the neck meets the shoulder, puffiness on the right side of the neck, bruising under the right armpit.  The patient said she would continue to monitor the symptoms.  The reporter did not consent to follow-up and did not give permission to contact the healthcare professional.
Patient C/O Pain at site, redness, swelling, mild fever, headache, nausea, vomiting, body aches.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. ON 25-AUG-2014 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J005849, expiration date 17-AUG-2014)(dose, route, unspecified). No symptoms reported. Additional information has been requested.
Myalgia, fever like chills, inability to work. 2 hrs to discomfort after smallpox vax.
Swelling of the face, fast heartbeat, dizziness weakness tiredness terrible headache muscle pain chills sweated at night swollen site injection nauseated feeling unwell diarrhea arm pain extreme feeling very very weak .
L arm upper 4.5 cm X 2 cm erythema slight tenderness, warm to touch + blanches. No induration. 10 days after vaccination.
R outerlateral thigh with 3 x 2.5cm area of erythema and induration. Area painful to touch. No noted streaking. Fussy.
Cellulitis, 24 hours, post vax. Pt went to local ER and was treated with Ancef, Rocephin and Augmentin. Temperature 102F. Cellulitis has responded to treatment.
Eyes rolled back, shaking, fainted for 5 seconds, regained consciousness, and was confused on what happened
This spontaneous report was received from a nurse and refers to a multiple unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On unknown dates, the patients were vaccinated with a improperly stored M-M-R II, (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. The vaccines were exposed to temperatures between 46 Fahrenheit and 77 Fahrenheit during 1 hour. There was no previous temperature excursion reported and data logger was filed. No adverse effects were reported. This is one of two reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA009049.
Breathing difficulties,  lips and tongue swollen with ulcers, fever blisters and burning
It started itching; Now, she feels as if her bones hurt; She also has swelling in her ankles; It's black in color.; As of now it's peeling at injection site; When she extend her fingers, they hurt at joints/complaining of joint pain; She started with tendered injection site for 4 days after receiving 2nd dose; She noticed some rash on injection site 3 days after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (It started itching), BONE PAIN (Now, she feels as if her bones hurt), JOINT SWELLING (She also has swelling in her ankles), VACCINATION SITE DISCOLOURATION (It's black in color.) and INJECTION SITE EXFOLIATION (As of now it's peeling at injection site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE RASH (She noticed some rash on injection site 3 days after receiving 2nd dose). On 15-Aug-2021, the patient experienced INJECTION SITE PAIN (She started with tendered injection site for 4 days after receiving 2nd dose). On an unknown date, the patient experienced PRURITUS (It started itching), BONE PAIN (Now, she feels as if her bones hurt), JOINT SWELLING (She also has swelling in her ankles), VACCINATION SITE DISCOLOURATION (It's black in color.), INJECTION SITE EXFOLIATION (As of now it's peeling at injection site) and ARTHRALGIA (When she extend her fingers, they hurt at joints/complaining of joint pain). The patient was treated with ALOE VERA for Adverse event, at a dose of Unknown and HAMAMELIS SPP. (WITCH HAZEL [HAMAMELIS SPP.]) for Adverse event, at a dose of Unknown. At the time of the report, PRURITUS (It started itching), BONE PAIN (Now, she feels as if her bones hurt), JOINT SWELLING (She also has swelling in her ankles), VACCINATION SITE DISCOLOURATION (It's black in color.), INJECTION SITE EXFOLIATION (As of now it's peeling at injection site), INJECTION SITE RASH (She noticed some rash on injection site 3 days after receiving 2nd dose), INJECTION SITE PAIN (She started with tendered injection site for 4 days after receiving 2nd dose) and ARTHRALGIA (When she extend her fingers, they hurt at joints/complaining of joint pain) outcome was unknown.            No concomitant medications were reported. Treatment medication includes Pain relievers.   This case was linked to MOD-2021-288025 (Patient Link).
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Concomitant medications, pertinent medical history and drug reactions or allergies were unspecified by the reporter on 21-AUG-2013 the patient was administered a single dose of ZOSTAVAX (lot number, dose, route and site of administration were not reported) as a vaccination. In 2013 (exact date was not reported) the patient developed soreness and tenderness at the injection site. The injections site reactions lasted for 1 week and it was unknown if the treatment was given. The patient sought unknown type of medical attention. On an unknown date in 2013 the patient subsequently recovered from adverse event. The relatedness between therapy with ZOSTAVAX and soreness and tenderness at the injections site was no reported. Additional information has been requested.
1 of 4 pts exp an inj site rxn following vax;lederject syringe w/ 5/8" needle was used;rxn included itching @ site, hardness, swelling & redness;size of rxn not measured, but very noticeable
Sick; Can't turn neck completely, can't turn my neck to the right side; Range of motion in my neck has been lower tremendously, especially right side which is more problematic area with my fibromyalgia; Really bad headache, always had tension headache but never this extreme; Tension headache had become very very extreme; Fever; Couldn't move; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Jun2021 (Batch/Lot number: unknown) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Crohn's disease" (unspecified if ongoing), notes: Consumer stated, "Crohn's disease which is an autoimmune disease."; "PTSD" (unspecified if ongoing), notes: Consumer stated, "PTSD which is a mental disorder."; "PPFE" (unspecified if ongoing), notes: Consumer stated, "PPFE for a mental health."; "Fibromyalgia" (unspecified if ongoing), notes: Patient history: Fibromyalgia , Consumer stated, "Fibromyalgia autoimmune disorder.". The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Sick"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "unknown", described as "Can't turn neck completely, can't turn my neck to the right side; Range of motion in my neck has been lower tremendously, especially right side which is more problematic area with my fibromyalgia"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Really bad headache, always had tension headache but never this extreme; Tension headache had become very very extreme"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; MOVEMENT DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Couldn't move".  Additional information: Patient got the initial dose, the first one and she got so sick to the point where like she was having fevers and she couldn't move. She have fibromyalgia (History) and she have Crohn's disease, so with her Crohn's disease she was urged by her gastroenterologist because she have been on, for a decade on 'Mefenamic' (Not clarified over the call) it's a biological. So, she was told (Voice not clear). So, she got it in May, she still can't turn neck completely, She can't turn neck to the right side, she got like really bad headache since then, she always had tension headache but never this extreme, so her tension headache had become very extreme and she can't turn neck as much her range of motion, especially on her right side where she had more problematic area with her fibromyalgia (Later fibromyalgia was clarified as medical history). So she was used to pick up her kids that she cannot do anymore. She can't turn her head when she used to drive.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Pt presented to MC ECC on 31 AUG with rash which he states appeared on 29 AUG.  Patient has erythematous macules on torso and extremities with itching. He does not have any vesicular lesions.  Presumed to be an adverse reaction to one of the vaccines he received. Patient was treated with Benadryl and topical hydrocortisone.
Pt recv vax in 9/97; in 9/97 pt exp ankle swelling, myalgia, insomnia & fever