chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The time interval between second dose and third dose exceeded 25-35 days timeline) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045C21A, 008B21A and 011A21A) for COVID-19 vaccination. The patient's past medical history included Knee replacement on 26-Jan-2022. Concurrent medical conditions included Gluten sensitivity, Lactose intolerance, Drug allergy (Several Antibiotics.), Hodgkin's lymphoma, Immunocompromised, Blood pressure high (Diagnosed in 2016-2017) and Cancer. Concomitant products included HYDROCHLOROTHIAZIDE, ASPIRIN [ACETYLSALICYLIC ACID], FISH OIL, MULTIVITAMINS [VITAMINS NOS], MAGNESIUM OXIDE, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]), PYRIDOXINE HYDROCHLORIDE (VITAMIN B-6), COLECALCIFEROL (VITAMIN D 3), IMMUNOGLOBULIN HUMAN NORMAL (GAMUNEX) and SELENIUM for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The time interval between second dose and third dose exceeded 25-35 days timeline). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The time interval between second dose and third dose exceeded 25-35 days timeline) outcome was unknown. It was reported that the patient did not experience any COVID or was tested positive. Consumer received 3rd full dose because of cancer and immunocompromise. No treatment medication was provided. This case was linked to MOD-2022-590654 (Patient Link).
About 7 hours post-immunization, child was getting out of a warm bath when her legs collapsed and she slide face down into the water. Mother immediately scooped her up and noted her to have a blue-grey appearance and that she was limp in parents arms.  EMS called and child returning to baseline on their arrival, MOC estimated event lasted about 8 minutes.
This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of improperly stored VARIVAX (Merck) subcutaneous (dose, lot number were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recvd vax 17SEP92 & 19SEP92 started c/o stuttering, slurred speech & inability to verbalize (difficulty speaking); 21SEP92 went to ER because of events; exam in the ER was nl; 22SEP92 seen by neurologist & underwent a CT Scan & an EEG;
Excursion vaccine was administered to patient; Patients have been administered from vaccines that experienced a T excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Excursion vaccine was administered to patient) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion). On 23-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Excursion vaccine was administered to patient). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Excursion vaccine was administered to patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The reporter informed that an excursion occurred about a month ago, at the time the reporter didn't ask for a stability report but now has been asked to send the stability report, The reporter also mentioned that the excursion duration was 7 hours instead 5.  Maximum or minimum temperatures reached was 64 degrees Fahrenheit. Excursion duration was approximately 7 hours. The vaccine was stored in refrigerator at the time of the excursion. There were no changes in visual inspection. Pertinent details: At the time they were unpunctured. Vaccine was administered on 23-Mar-2022 and vials were returned to the refrigerator. Tran date was 23-Mar-2022.The patient did not experience any adverse events post injection.  No treatment medication was reported.   This case was linked to MOD-2022-545986 (Patient Link).
pt recvd vax & exp inject site redness, tenderness, a blister, exudated plaque of 8 cm (rt), & scarring;
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received SHINGRIX. Concomitant products included Atorvastatin. On 1st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd May 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm, axillary pain and headache. On 5th May 2018, the patient experienced skin discoloration. On 7th May 2018, the outcome of the pain in arm, axillary pain, skin discoloration and headache were recovering/resolving. It was unknown if the reporter considered the pain in arm, axillary pain, skin discoloration and headache to be related to SHINGRIX. Additional information was reported as follows: Concomitant medication included eye medicine. The patient reported that, after vaccination with SHINGRIX the patient's arm was sore to touch and she had a bad headache. The patient felt as if she had rash in her armpit but there was nothing there. On Saturday the patient's skin was red, black, blue and tender under her arm. By Monday the symptoms were better and almost gone.
Patient sat in mother's lap while administering vaccine in Left Deltoid. Patient squirmed immediately prior to insertion of needle, causing the needle to scrape left upper arm, leaving an approximate 1 inch vertical abrasion. Site was cleaned and bandaged by staff. Staff instructed mother to monitor the site when child returned home from school, clean it and apply a topical "bacitracin" as necessary. Staff also notified patient's School Nurse (as patient at clinic for vaccination before the school day) to be aware of the situation and to monitor the site, clean and redress as necessary throughout the school day.
Warm, red, swollen at injection site the following day after administration. BENADRYL prescription given.
Almost Immediate tingling from Left elbow down to pinky and ring fingers. Same sensation of being hit on the funny bone. The tingling was at higher intensity for about 10 days before dying down to a 3/10 pain level. In the meantime there was also minimal swelling in the elbow, outside area. I can name 5 nights where I was awoken from an increase in tingling levels and had to take advil to bring it down. Its more uncomfortable than painful. After 4 weeks I got a massage to try to move things around. Tingling died down but soreness is still present almost 6 weeks later.  Background - 12 years ago I dislocated that left elbow and tore the UCL. I never got surgery on it. On occasion it is sore or swells due to 100% humidity levels in the air or excessive weight training. It has never tingled though since the initial injury which is more cause for concern than anything. My second shot was given in my right arm. As of today, the tingling is a 1/10 in pain, just enough to be present but the soreness in elbow is there. The best description I can give this feeling is exhaustion. I feel as though I've been lifting weights with it, but I haven't.
Same bruising on bridge of nose; Random bruises on arms; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0172; Expiration Date: 31Aug2021), via an unspecified route of administration in left arm on 27Apr2021 (at the age of 40-year) as dose 2, single for COVID-19 immunization. Medical history included ongoing factor v leiden mutation which she was diagnosed at 25 years old and takes Baby Aspirin and had no issues for years. The patients concomitant medications were none. The historical vaccines include bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0150; Expiration Date: 31Jul2021), via an unspecified route of administration in left arm on 06Apr2021 as dose 1, single for COVID-19 immunization. On an unspecified date in May2021 the patient randomly started to experience bruising that started in the left arm. It was in the forearm where an IV would typically be put in the vein. There were 3 or 4 bruises there. It started in her right arm and they are all about the same size, ranging from the size of a Nickel to the size of a quarter. They were all similar in colour. On 18May2021 she woke up and had one on the inner side of the left side and bridge of her nose. This was highly unusual. It was the same appearance, was the same size and same discoloration. The patient felt it was odd and felt like when you hit your arm and have random bruising. There were too many random bruises and she does not usually really bruise easily.  The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer (registered nurse). This case is linked to 2018SA250129 (Same reporter). This case involves a 62 years old male patient who experienced fuzzy, felt funny, strange and received FLUBLOK subcutaneous instead of intramuscular, while she received vaccine FLUBLOK QIV. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Sep-2018, the patient received 0.5 mL dose of suspect FLUBLOK QIV lot number was unknown, frequency once, via subcutaneous route in the left arm. On 04-Sep-2018, same day post vaccination patient developed a non-serious fuzzy, felt funny and strange. It was also the case of actual medication error due to inappropriate route of vaccination (received FLUBLOK subcutaneous instead of intramuscular). Relevant tests were not reported. Final diagnosis was fuzzy, felt funny and strange. It was not reported if the patient received a corrective treatment. The outcome of the events were unknown. 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 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. List of documents held by sender: none.
Information has been received from a physician concerning a 17 year old female who on 30-JUL-2007 was vaccinated with her first dose of 0.5 ml GARDASIL IM in the right deltoid. On 02-AUG-2007 the patient experienced area of redness and tenderness near her right clavicle. Subsequently, the patient recovered on 09-SEP-2007. Additional information has been requested.
HYPOVOLEMIC SHOCK 5/30/2022 CARDIOGENIC SHOCK  HYPOVOLEMIC SHOCK 5/30/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED  HYPOVOLEMIC SHOCK 5/30/2022 CHF, STAGE D
Ache: Bones, Ache: joints, Ache: joints and muscle, acid reflux, anal fissure, appetite: loss, mood: anxiety, arthritis, balance: "dizziness, cold and flu-like symptoms, concentration loss, concentration difficulty.
I scheduled the Bivalent Booster with Pharmacy. I brought my vaccine and booster cards. The pharmacist gave  me the booster and when I got home I looked further at the booster information and discovered I have now had two Bivalent Boosters. The pharmacist had the first Bivalent Booster on the card I gave him today. From what the card said I did not know if I had already had the Bivalent Booster. I contacted the CDC information via telephone and they gave me a link to this form.
Paralysis in both arms, lasted several per neurologist, pt had developed days an odd strain of Guillain Barre. 10/19/2009 records from neuro consult dated 9/23/2009. Patient presents 2 weeks post vaccine with sx of numbness, weakness , pain and poor grip strength in hands. PE notes minimally + Tinel's sign rt and lt wrists, diminished sensation of distal 3 first fingers. Tx: none at this time, Impression: post vaccine reaction, polymyalgias with borderline diabetic neuropathy.  10/26/2009 ED records for date 9/19/2009. Patient presented with c/o's weakness upper extremities, myalgias. PE did note LUE weakness. Tx none noted Dc DX Diffuse extremity weakness
Wrong vaccine given. Monitored patient for additional time, no sxs reported at that time.
No other details provided; She took the product while pregnant; This spontaneous, prospective pregnancy report was received from a consumer and refers to herself, a 28-year-old, female patient. She had no pertinent medical history, no concomitant medications, drug reactions or allergies.   On 09-DEC-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, first dose of two scheduled doses (exact dose, strength, exact route of administration, anatomical location, lot # and expiration date were unknown) for lack of antibodies. The patient stated, that she took the vaccine after getting pregnant and at the administration time she did not know that she was pregnant (exposure during pregnancy). The patient wanted to know, if the vaccination would affect her pregnancy, although she did not search medical attention. The last menstrual period (LMP) was on approximately unknown date in 2020. The estimated delivery date (EDD) or gestational period were not provided. The pregnancy outcome was pending (unknown fetal outcome). The therapy was reported as discontinued on 13-JAN-2021, as the patient took only one of the two scheduled injections. No adverse event was reported.
About 20 hours after the shot, I was exhausted, and had a headache.  I could not function or think clearly.  My head really hurt.  Temp 97.3   By  the next morning, the headache had lifted but the fatigue remained for another day.  That day,  I made several significant errors when copying email addresses and forwarding email info to group members.  Fast forward to March 6.  Very tired and hard to focus.  Felt worse on March 7 but kept pushing myself. March 8, I couldn't function and sat in a chair a lot of the day.  My head hurt and I noticed a red hard and hot area over the injection site.  My temperature was elevated to 98.8 which for me is 1.5 to 2 degrees elevation. Then it all made sense.  Today, March 9, I'm feeling better, but very tentative about how much to do.  At least well enough to fill out this form.  I can think clearly and I am able to function.
Information has been received from a nurse concerning a 19 year old female who on 08-JUN2007 was vaccinated Intramuscularly with a first dose of Gardasil. On 9-JUN-2007, the patient called the office to report that her lymph nodes was swollen on her neck. The patient read the information that mentions swollen lymph nodes as one of the side effects of the vaccine but called the doctor's office to confirm. The patient did not see the doctor but was advised to call back if the symptoms worsened and no laboratory diagnostic studies were performed. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/14/2007. Initial and follow up information has been received from a nurse concerning a 19 year old female with an allergy to codeine, who on 07-JUN-2007 (previously reported as 08-JUN-2007) in the morning was vaccinated intramuscularly in the left arm with a first dose of GARDASIL (Lot# 653978/0955F). On 08-JUN-2007, the day after vaccination, (previously reported as 09-JUN-2007), the patient called the office to report that her lymph node was swollen on her neck. The patient read the information that mentions swollen lymph nodes as one of the side effects of the vaccine but called the doctor's office to confirm. The patient did not see the doctor but was advised to call back if the symptoms worsened and no laboratory diagnostic studies were performed. At the time of the report, the patient's outcome was unknown (also reported as recovered). No product quality complaint was involved. Additional information is not expected.
Pt rec'd varicella vaccine in the left arm on 6/29 and pt states that  Thursday morning 6/30 that she noticed that it was sore, itching and getting swollen. Pt states that for 2 days it became progressively worse and warm to touch.
devel 4cm x 3cm erythema & possible abscess @ site given;treated w/oral Keflex & heat to area;
Extreme itchiness all over body accompanied by hives.  Began approximately 1 week after the booster. No new changes to diet, detergent, no exposure to new pets, or other potential irritants. Itching began on breasts, then armpits, then neck, then back, now moved to legs.  After second dose, arm that I received injection on had a 4cm hive 1 week after injection.
Then next day, I had serve headache and eye pain.  I also had nausea.  I had blurry vision and colors.  I went to the ER.  They diagnosed me with acute angle glaucoma in both eyes. They gave my eye  drops.
Patient given 2.5mL of Moderna instead of the 0.25mL dose. Patient was still in waiting area when the overdose was discovered. Patient monitored for at least 30 minutes, and warned of possible side-effects due to the overdose. Our clinical teams were called in for advice. Told to monitor for 48 hours and will follow-up the patient daily.
The first two weeks after the immunoglobulin shot and rabies vaccines began I experienced nausea and diarrhea causing me to be sick in middle of nights. I was not sleeping well at night and was weak and exhausted. Barely able to function. I spent half of each day sleeping. For the duration of the shots I experienced: Pressure in Temples, around skull and eyes. My vision was worse. I was dizzy when I would bend over and try to stand up. I was depressed. I felt out of reality but not experience brain confusion. It took 3 months to regain my ability to focus on my work. I found the CDC phone line quite rude when I tried reporting my symptoms.
First 3 days arm was hot, red and hot.  This went away and on 1/29/2021 arm began to get red, hot, hard, and extremely itchy.  Pain throughout the arm with a swollen red rash several inches large
Red itchy patches slightly showing up wrist; Red itchy patches on her arm ,chest and back/The patches are slightly raised, some are the size of a dime, some are bigger, and some are smaller.; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULO-PAPULAR (Red itchy patches on her arm ,chest and back/The patches are slightly raised, some are the size of a dime, some are bigger, and some are smaller.) and RASH PRURITIC (Red itchy patches slightly showing up wrist) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 003A21A and 030420A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH MACULO-PAPULAR (Red itchy patches on her arm ,chest and back/The patches are slightly raised, some are the size of a dime, some are bigger, and some are smaller.). On 29-Oct-2021, the patient experienced RASH PRURITIC (Red itchy patches slightly showing up wrist). At the time of the report, RASH MACULO-PAPULAR (Red itchy patches on her arm ,chest and back/The patches are slightly raised, some are the size of a dime, some are bigger, and some are smaller.) and RASH PRURITIC (Red itchy patches slightly showing up wrist) had not resolved.            No concomitant medication reported. No treatment information was provided It was reported that she had been using some cream she had from her dermatologist to stop the itching; it provided temporary relief, but they are starting to itch again. She had not reached to her doctor.
Pt recvd vax & exp achiness in extremities, weakness in extremities, occasional sharp pains in extremities, body aches, muscles cramps, muscle aches, generalized sharp pains, felt weak & difficulty w/writing;
Body Aches, Fever, Headache, Hives,  after second dose of Moderna Covid-19 vaccine
Upper arm (deltoid, primarily) is red and itches.  Does not appear to be swollen at this time.  Ring of darker red on distal part of skin covering deltoid, in a horseshoe shape (open end  points superiorly).  Not as red at injection site.  Not taking anything for it.
Patient states that she developed chills and high fever (105) one day after receiving vaccine. States she was unable to lift arm up and arm where vaccine was received was red and swollen. Patient states that fever lasted for 5 days. Patient states that she self medicated with ADVIL for 5 days until fever broke. States that she engaged in bed rest and had plenty fluids to aid in recovery. Patient has fully recovered. Does not currently have fever and is able to move arm without pain.
patient said that 2 days after the vaccine he had nerve pain down the same arm that the vaccine was administered in. Per the patient, he went to see a doctor who sent him to physical therapy and the doctor said it was due to the vaccine.
pt recvd vax in AM-pt put down for a nap in PM awakened 2 hrs later screaming-cried cont for 2 days; consolable 10 mins @ a time, fever 101, leg red & swollen
Sinuses stuffed up; Sleepy/sleeping more around 12hr; Kind of weak; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of SINUS CONGESTION (Sinuses stuffed up), SOMNOLENCE (Sleepy/sleeping more around 12hr), ASTHENIA (Kind of weak) and FATIGUE (Exhausted) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced SINUS CONGESTION (Sinuses stuffed up), SOMNOLENCE (Sleepy/sleeping more around 12hr), ASTHENIA (Kind of weak) and FATIGUE (Exhausted). At the time of the report, SINUS CONGESTION (Sinuses stuffed up) was resolving and SOMNOLENCE (Sleepy/sleeping more around 12hr), ASTHENIA (Kind of weak) and FATIGUE (Exhausted) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Patient may have been given an additional dose of the original Pfizer COVID shot, Lot FP7138 instead of the bivalent booster, Lot GH9702