chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: en6198), in right arm, on 01Apr2021 as dose 2, single (Lot number: en6199), in right arm, on 12Nov2021 as dose 3 (booster), single (Lot number: fh8027), in left arm and on 05May2022 as dose 4 (booster), single (Lot number: fm9992) at the age of 65 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Paxlovid treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Reportedly the patient received anti-viral COVID 19 treatment with Paxlovid from 27Sep2022 to 01Oct2022 for treatment of COVID-19.
PATIENT HAD ALREADY COMPLETED THIS SERIES, HAD VACCINE OUT OF STATE, AND I WAS UNAWARE. PATIENT HAD NO ADVERSE REACTIONS.
swollen lymph nodes; pain under left armpit (arm of injection); swollen; difficult to move my arm; This is a spontaneous report from a contactable consumer. This 53-year-old non-pregnant female consumer reported for herself that she received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 08Mar2021 at 17:00 (at 53-year-old), as dose number unknown, single for COVID-19 immunization. No other vaccine was received in four weeks. Other medications in two weeks were reported as none. It was reported that Covid prior vaccination and covid tested post vaccination was reported as no. Patient had no allergies and no medical history. On an unknown date patient had swollen lymph nodes and pain under left armpit (arm of injection), it was very swollen and uncomfortable and difficult to move arm. The event outcome was unknown.  No follow-up attempts were possible; information about batch/ lot number could not be obtained.
Within 3 minutes of receiving Influenza injection, pt's left arm became reddened and edematous from elbow to shoulder, then spreading across chest and up to face. Pt then began wheezing respirations. Pt left facility within 5 minutes to go to MD's office where she received one epinephrine injection.
No adverse event; administered an expired dose of the Moderna COVID-19 monovalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired dose of the Moderna COVID-19 monovalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Jan-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Feb-2023, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired dose of the Moderna COVID-19 monovalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered an expired dose of the Moderna COVID-19 monovalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered an expired dose of the Moderna COVID-19 monovalent vaccine).    No concomitant medications were reported.  Vial size was 5.5 mL  The vial was initially stored in the refrigerator 30-Jan-2023.  The vial did not undergo any temperature excursions.  No treatment medications were reported.
Area of warmth and redness measuring 12 x 17 cm. anterior left thigh surrounding shot site.
Redness, hot, swollen, nodule, painful radiating 4 inches from injection site. Pt treated with pain medication, steroid, and antihistamine.
pt recv vax OCT93 & NOV93 was found to be 1mo pregnant;@ an unspecified time pt exp a sore muscle;
02/17/03- received smallpox (repeat #3) and anthrax #2 "About three weeks after"- c/o cp while doing PT- was evaluated at the ER- advised that cp was non-cardiac "Early March 2003"- got deployed to Iraq "3rd wk of March"- had recurrent episodes of cp with sob- pt. ignored sxs- continued to have sxs for the following 3 mos 6/8/03- medical attention sought- abnormal EKG 6/12/03- evac'd - exercise stress test positive with both cp and EKG changes 6/17/03- pt subsequently flown for a cardiac catherization 6/20/03- pLAD stent placement in LAD No cp, sob, and other associated sxs since above procedure. Has multiple cardiac risk factors Strong FH of cardiac problems  A copy of the patient clinical summary sent to VAERS via FedEx on 11/21/03
Patient states received MODERNA vaccine 1/14/2021. 1/16/2021 developed severe muscle pain and fatigue starting in bilateral calves moving superiorly to the neck. Edema of BUE. Loss of strength in BUE. Pain in Bilateral  groin.  All progressively worsening . Sought medical evaluation on 1/19/2021. Labs drawn. Given NSAIDS and Cyclobenzaprine for muscle pain and tightness. Encouraged hydration. Revisit on 1/22/2021. Sx improvement, not resolutions. Muscle weakness present. Quick to fatigue, example writing name of form, extreme muscle fatigue and hand edema developed. Repeated labs.
Woke up at 3:00 AM Friday 5/24 having chest pain near my heart and issues breathing. I sat up on the corner of my bed feeling dizzy. Every time I would take anything more than a light breath, I would get a tight pain on the left side of my chest, which specifically felt like I had blockage in my heart. As I sat on the corner of my bed I tried to control my breathing and started to rub the area as I was taking breaths. The sharp pain in my chest while taking normal / deep breaths lasted for a few minutes and I feared I was having a heart attack. After going away initially that night, I felt the sensation  in a less intense fashion again later on Friday night and once more got a slight tight feeling in my chest while breathing on Saturday. During the initial episode on Friday night, I also got a deafened noise in my ears as if they had to pop as if I was gaining altitude in a plane or something. I got up off my bed to go to the bathroom and sat to urinate in case I was going to faint. The deafened noise went away after about a minute or so and turned into a static / fizzy noise for another minute or two while I was in the bathroom.  (The static fizz sounds got louder as I put my chin to my chest for some reason.) I was also sweating profusely throughout this entire process.
No adverse effects reported; Nurse states patient inadvertently received a first dose of ROTA TEQ that was expired.; This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions, allergies, and concomitant therapies were not reported.     On 23-JUL-2019, the patient inadvertently received an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength was not reported; lot # R002060 with expiration date 05-JUN-2019) for prophylaxis. No adverse effects reported.   Lot number and expiration date were reported in the source document. But, when entering the lot number in the system automatically auto-populated the correct expiration date, which sometimes may differs from the expiration date reported by the source.
Information has been received from a consumer concerning her 9 year old granddaughter with no pertinent medical history or drug allergies/reaction who was vaccinated with the first dose and booster dose of VARIVAX (Oka/Merck) on unspecified dates. There was no concomitant medication. On 07-APR-2008 the patient had bumps on the bottom of her left foot appear. On 08-APR-2008 the size of the bumps on the bottom of both feet were the size of a half a dollar and itchy. She also has little bumps (some of them are "pimple like") appeared on the belly and back that are itchy. The patient had blood work done at the physician's office on 09-APR-2008 and the results came back on 10-APR-2008 which stated "it is clear". The physician said "it is not chickenpox-, strep or staph." As of 10-APR-2008, the event persisted. The grandmother considered the event to be disabling as the patient can't walk because of the blisters of the bottom of the feet. The consumer also reported on her grandson (cousin of the patient mentioned above) and the cousin's father who had a similar problem (refer to WAES number 0805USA04691 and 0805USA04930. No further information is available.
1ml dose of Moderna Vaccine was given.; A spontaneous report  was received from a pharmacist concerning patients who received Moderna's COVID-19 Vaccine and received a 1 mL dose.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an undisclosed date, prior to the onset of the event, the patient received their planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  The patient received 1 mL of the Moderna COVID-19 Vaccine when the nurse did not pay attention that the dose should have been 0.5 mL. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, patient received a 1 mL dose, was resolved.; Reporter's Comments: This case concerns a patient of unknown age and gender who received 1mL of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 instead of 0.5 mL dose. There were no reported adverse events in this case of accidental overdose.
Upon checking out status post sitting in the observation area for about 15 minutes, the patient reported dizziness when asked about their current health state. Declined to continue sitting in monitoring or to drink fluids.  Declined feeling faint.
had a headache; tired; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (had a headache) and FATIGUE (tired) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Lymphoma in 2020. Concurrent medical conditions included Immunocompromised.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced HEADACHE (had a headache) and FATIGUE (tired). At the time of the report, HEADACHE (had a headache) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient's oncologist said she was "clinically cured " regarding the lymphoma. Did not mention any product or treatment that was involved in her possible lymphoma treatment. Patient had received the COVID-19 vaccine earlier today. It was Moderna's new COVID 19 vaccine.  Treatment drug was not reported.   Reporter did not allow further contact
UTI; Whole face swelled down to her throat; Cheek bones sore; Hard time chewing; Couldn't eat; Mouth sore; Bright red; Itching; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (UTI), SWELLING FACE (Whole face swelled down to her throat), FACIAL PAIN (Cheek bones sore), MASTICATION DISORDER (Hard time chewing) and EATING DISORDER (Couldn't eat) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced URINARY TRACT INFECTION (UTI), SWELLING FACE (Whole face swelled down to her throat), FACIAL PAIN (Cheek bones sore), MASTICATION DISORDER (Hard time chewing), EATING DISORDER (Couldn't eat), ORAL PAIN (Mouth sore), ERYTHEMA (Bright red) and PRURITUS (Itching). At the time of the report, URINARY TRACT INFECTION (UTI), SWELLING FACE (Whole face swelled down to her throat), FACIAL PAIN (Cheek bones sore), MASTICATION DISORDER (Hard time chewing), EATING DISORDER (Couldn't eat), ORAL PAIN (Mouth sore), ERYTHEMA (Bright red) and PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  Treatment medication included antihistamine.
Child reported headache and not feeling well.  Flushed, felt feverish-temp taken 103 orally. Temp improved down to 99 with Motrin, spiked off and on up to 102 orally for the following 3 days.  Consulted with physician instucted to use antipyretic and other fever reducing measures and seek attention if symptoms worsened or did not respond to medication.
This spontaneous report was received from a nurse practitioner regarding unspecified number of patients whose demographics were unknown. The medical history of patients and their concurrent conditions were not reported. On an unknown date in 2015 (also reported as unspecified dates starting on or after 06-NOV-2015) unspecified number patients were vaccinated with unspecified number of improperly stored doses of PROQUAD (Merck) (lot/batch # L040412, expiry date 13-APR-2017) dose, route unknown. Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the two reports reported by the same reporter. Additional information has been requested.
Tingling in her lips and mouth; numbness; headaches; Chills; achy; Feeling miserable; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling miserable), PARAESTHESIA ORAL (Tingling in her lips and mouth), PAIN (achy), HYPOAESTHESIA (numbness) and HEADACHE (headaches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced FEELING ABNORMAL (Feeling miserable) and CHILLS (Chills). 26-Feb-2021, the patient experienced PAIN (achy) and HEADACHE (headaches). On 01-Mar-2021, the patient experienced PARAESTHESIA ORAL (Tingling in her lips and mouth) and HYPOAESTHESIA (numbness). On 27-Feb-2021, PAIN (achy), HEADACHE (headaches) and CHILLS (Chills) had resolved. On 28-Feb-2021, FEELING ABNORMAL (Feeling miserable) had resolved. On 03-Mar-2021, PARAESTHESIA ORAL (Tingling in her lips and mouth) and HYPOAESTHESIA (numbness) had resolved.            No concomitant medications were provided by the reporter.   Treatment information was not provided.  The action taken with mRNA with the events was considered as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up information received on 15-JULY-2021 and contains significant information. Email address added. New events and outcome added.
Two adverse events: 1) I have paroxysmal atrial fibrillation. I go into AFib for more than a few seconds perhaps only one or twice a year. I went into AFib several hours after this (the second) SHINGRIX vaccination. I did not after the first. I have never had zoster.) 2) By 1 1/2 days post vaccination (starting this morning), I had a tender erythematous rash at the vaccination site and extending several centimeters away. One red lesion, not multiple. Very well defined (sharp) border with normal skin. Warm to touch. Only very slightly raised. No vesicles. Underlying arm muscle is sore, but only to an expectable degree (not overly).
I am just wondering, I had sore arm; I was scared to get the shot but I went to had it; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0178), dose 1 via an unspecified route of administration on 16Jun2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. In Jun2021, the patient experienced "I am just wondering, I had sore arm; I was scared to get the shot but I went to had it". The patient received the second dose of bnt162b2 on 07Jul2021 for COVID-19 immunization. She was scared to get the shot but she went to had it and got it anyways because of "fear of Mom" (not clarified). The outcome of the event was unknown.
Patient received 2 vaccinations from intern while being supervised by pharmacist. Two vaccinations were given around 5:15pm (will complete two VAERS): Moderna pediatric (6mo-11yr) and Flucelvax (LOT#944495). The order of the vaccinations are unknown. A moment later, pharmacist ran over and told the other pharmacist to call 911 at 5:17 pm. The fire department/paramedics who were on the phone with pharmacist told her to ensure patient lay on her left side and not be given food or water, and be monitored the entire time. which was done. Patient was conscious, had no shortness of breath, was responsive to all questions, no pain, but crying. Paramedics took her blood pressure and it was within normal range. Her dad was with her and pharmacist monitored her the entire time. Paramedics from the fire department came within 5 - 7 minutes. The paramedics offered to take her to the hospital but the patient's dad declined. Patient was able to walk away from the incident, thanked the pharmacist, and appeared to be fine.
Dizzy; Fogginess; Blood pressure spikes; Anxious; Did not have much of an appetite; Real stick to her stomach and threw up; Nauseous; Pain in left kidney area; Bleeding after shot; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), FEELING ABNORMAL (Fogginess), BLOOD PRESSURE INCREASED (Blood pressure spikes), VACCINATION SITE HAEMORRHAGE (Bleeding after shot) and ANXIETY (Anxious) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE, CLONIDINE, ONDANSETRON and TOCOPHERYL ACETATE (VITAMINE E) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding after shot). On 10-Feb-2021, the patient experienced RENAL PAIN (Pain in left kidney area). On an unknown date, the patient experienced DIZZINESS (Dizzy), FEELING ABNORMAL (Fogginess), BLOOD PRESSURE INCREASED (Blood pressure spikes), ANXIETY (Anxious), DECREASED APPETITE (Did not have much of an appetite), VOMITING (Real stick to her stomach and threw up) and NAUSEA (Nauseous). The patient was treated with ONDANSETRON at an unspecified dose and frequency. On 03-Feb-2021, VACCINATION SITE HAEMORRHAGE (Bleeding after shot) outcome was unknown. At the time of the report, DIZZINESS (Dizzy), FEELING ABNORMAL (Fogginess), BLOOD PRESSURE INCREASED (Blood pressure spikes), ANXIETY (Anxious), DECREASED APPETITE (Did not have much of an appetite), RENAL PAIN (Pain in left kidney area), VOMITING (Real stick to her stomach and threw up) and NAUSEA (Nauseous) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Left arm, swelling, redness, calor x 3 days.Pt given keflex for cellulitis.
Patient developed itchy rash right A/C space and distal. She reported she has had this reaction before to vaccines and brought Benadryl with her. Resolved after 15 minutes
chills; upset stomach; fever; severe headache; nausea; This case was reported by a consumer via call center representative and described the occurrence of chills in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included gastric infection (for 24 hours).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 11 hrs after receiving Shingrix, the patient experienced chills, upset stomach, fever, headache and nausea. On an unknown date, the outcome of the chills, upset stomach, fever, headache and nausea were recovered/resolved.   It was unknown if the reporter considered the chills, upset stomach, fever, headache and nausea to be related to Shingrix.  Additional information received were as follows: The patient asked regarding the side effects of fever, chills and upset stomach typically how soon after the shot do they appear and how long do they last. At around 6:00 pm, the patient received Shingrix. At around 5:00 am, on next day of vaccination, the patient experience fever, chills, severe headache and nausea, which lasted about 23 hours with the headache and nausea ceasing about the same time. The patient was not sure whether this was due to the vaccine or a 24 hour stomach bug.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, an unspecified number of patients were vaccinated with VAQTA (route, does, lot # and expiration date were not reported). It was reported that VAQTA was improperly stored and the temperature excursion was found to be unsupported with in-house stability data. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.