chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; Date the vial was initially stored in the refrigerator 23-DEC-2022,some pediatric 6m-5y recived the dose after the BUD; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 23-DEC-2022,some pediatric 6m-5y recived the dose after the BUD) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 23-DEC-2022,some pediatric 6m-5y recived the dose after the BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 23-DEC-2022,some pediatric 6m-5y recived the dose after the BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 23-DEC-2022,some pediatric 6m-5y recived the dose after the BUD).    It was unknown patient had receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.    Date the vial was initially stored in the refrigerator on 23-DEC-2022.The vial did not undergo any temperature excursions. No treatment information was reported.   This case contains information for Patient no-03 out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:Master case
soreness of arm and back and he was super sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness of arm and back and he was super sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and unknown) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (soreness of arm and back and he was super sore). At the time of the report, MYALGIA (soreness of arm and back and he was super sore) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
Itchy L upper arm-became red, inflammed-swollen from shoulder to elbow. Tight painful about 32 hrs post injection.
Patient reports itching at throat area, redness to chest, no hives, no flushing.  Patient took 25mg  Benadryl, patient has history of allergies after getting flu vaccine. Cleared by EMS
Patient reports that he recently got the booster shot on 10/27/2021.  Patient stated was feeling fine and then three days later had severe event of vertigo, dizziness, and a sense of feeling like he was going to pass out.  He reports since the day of the event, 10/30/2021, he reports a persistent dizziness and instability along with a sense of wooziness that will not go away.  The patient has been to ENT and no vestibular deficit was identified but was not given a formal Videonystagmogrpahy test.  Patient is coming into physical therapy from a referral from his MD for dizziness for vestibular therapy.
inflammation in the vaccinated shoulder (looks like an infected mosquito bite). Redness, itching
From initial information received on 27/May/2005 from a physician regarding an adverse event occurring in the USA, it was reported that an 18 month old male pt received his fourth dose of Tripedia vaccine, lot number U1349AA, and his fourth dose of IPOL vaccine, lot number Y0240, administered on 26/May/2005. 12 hours later, the pt developed an "opisthotonic reaction" characterized by rigid arms and lack of head control. Additionally, the pt's jaw was somewhat clenched and he was "crying throughout". The physician stated the episode lasted approximately one hour and was then followed by periods of it coming and going for 2.5 hours until it resolved. The pt was hospitalized for these events and recovered an unspecified amount of time later. Additional information was also received on 27/May/2005 from another physician who reported that the pt also developed an increased temperature, facial grimace and "archiness" 12 hours post-immunization. The reported stated that events are now resolved.
Aorta aneurysm/ Chest pain/ Feels chest muscle being pulled; Could walk around feel pain; This spontaneous case was reported by a consumer and describes the occurrence of AORTIC ANEURYSM (Aorta aneurysm/ Chest pain/ Feels chest muscle being pulled) and PAIN (Could walk around feel pain) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 013L20A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced AORTIC ANEURYSM (Aorta aneurysm/ Chest pain/ Feels chest muscle being pulled) and PAIN (Could walk around feel pain). At the time of the report, AORTIC ANEURYSM (Aorta aneurysm/ Chest pain/ Feels chest muscle being pulled) and PAIN (Could walk around feel pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Electrocardiogram: normal (normal) Normal. In 2021, Magnetic resonance imaging: abnormal (abnormal) Aorta aneurysm was detected. In 2021, Pulmonary function test: normal (normal) Lungs were normal too.         No relevant concomitant medications were reported. No treatment information was provided.  Patient had chest pain. Patient visited physician and series of test have been conducted such MRI, aorta aneurysm was detected. EKG was normal and lungs were normal too. Patient walk around feel pain sometimes in chest like chest muscles being pulled away. Patient was doing physician follow-up in Feb-2022.
expected to feel under the weather; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EJ1685) at the age of 47 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (ongoing), notes: For years; "Depression" (ongoing), notes: For years; "Positive ANA", start date: 2019 (ongoing); "Hypertension" (ongoing), notes: For years. Concomitant medication(s) included: ASPIRIN 81 oral; CYANOCOBALAMIN oral; CALCIUM CARBONATE AND VITAMIN D3 oral. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "expected to feel under the weather".
On 5-4-21 experienced SOB and left sided chest pain.  Went to ER and diagnosed with massive bilateral pulmonary embolism.  Emergency Thombectomy immediately.
Patient is 6 years old and was supposed to receive 0.25ml dose, but was given the 0.5ml dose of the Bivalent Moderna vaccine on accident.
CHIEF COMPLAINT:   Pt presents tonight with lethargy,decreased appetit and on reccomendation of pcp. Pt tested + for covid on the 28th of january   HISTORY OF PRESENT ILLNESS:     Presents with: _cough, covid  Duration: _cosbtant  Onset: _acute  Course: _same  Location Pain Onset: _lungs  Location Pain at Present: _same  saRadiation: _denies  Pain Quality: _out of breath
This spontaneous report was received from a 74 year old female patient referring to herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The patient did not have any drug allergies. In May 2008, the patient was vaccinated with a dose of ZOSTAVAX (route of administration, lot number and expiration date were not provided). On 21-AUG-2016 the patient was diagnosed with shingles. She contacted her physician and he provided treatment with VALTREX. No laboratory diagnostic studies were performed. At the time of the report, the patient was not recovered from shingles. There was not product quality complaint involved. The causal relationship between shingles and ZOSTAVAX was unknown by the reporter. Additional information has been requested.
First few days - nausea , upset stomach, headache, and arm soreness. Injection site is hot to the touch.   March 5th - noticed itching and burning in arm. Injection site is still hot to touch. Noticed roughly 3 or 4 hives on left arm. Muscle soreness. Arm became swollen and red near injection site could not move it. This lasted roughly 3 days.
The pt developed fever seizure with temp of 103.6 deg. F., eyes rolled back in head, non-responsive, frothy drooling, and moaning.
This spontaneous report was received from a registered nurse refers to an unspecified child patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 05-OCT-2016, the patient was vaccinated with an expired dose of VARIVAX (lot # unknown with expiry date 23-SEP-2016) (dosing details and anatomical location not known). The reporter was not aware of an adverse experience. No Product Quality Complaint (PQC) was filed. Additional information has been requested.
Patient reported she started experiencing an allergic reaction 30 minutes after receiving the vaccine. She started to feel swelling in her tongue and the swelling moved down to her throat. She took Benadryl that evening and the next morning. After the next morning, her symptoms resolved.
Second dose given 7 days after 1st dose.  Offender has denied any complications.
May 11, 2021 I had very severe heartburn worse then I have ever had before. May 12th I went to hospital; appendicitis. A month later I saw something on my hand and had to go into doctor and have tests done. I also had to have a root canal which I haven't had to have done in years.
Information has been received from a registered pharmacist via a company representative, referring to a 75 year old female patient. On 09-JUL-2016 the patient was vaccinated with ZOSTAVAX. On approximately 12-JUL-2016, three to four days following the administration of vaccine, the patient experienced itching and a swollen area (size of an egg) that was localized at the injection site. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart was raising), PAIN IN EXTREMITY (Sore arm), ASTHENIA (feeling weak), DIZZINESS (Dizzy) and MYALGIA (Body ache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PALPITATIONS (Heart was raising), PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizzy), MYALGIA (Body ache), HEADACHE (she woke up in the middle of the night with pounding headache) and NAUSEA (Nauseous). On an unknown date, the patient experienced ASTHENIA (feeling weak). On 01-Apr-2021, PALPITATIONS (Heart was raising), PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizzy), MYALGIA (Body ache), HEADACHE (she woke up in the middle of the night with pounding headache) and NAUSEA (Nauseous) had resolved. At the time of the report, ASTHENIA (feeling weak) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant  medication was reported. No treatment medication was reported. This case was linked to MOD-2021-101719 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up received on 22-JUN-2021 and an event felt weak was added.
Breakthrough case admission after 2 vaccines Pfizer 8/19/21 Lot# FC3183;  Pfizer 10/7/21 Lot# FF8841
pt came in requesting for tetanus shot through pre appointment booking. techincian, administered covid-19 moderna bivalent instead.  pt also received the boostrix shot as well for the correct shot she requested  Pt did not experience any adverse events.
Patient reported adverse reaction to Hep B vaccine.   After receiving Hep B vaccine and leaving the health department, patient was brought back to the health department by his supervisor at work stating he thought he was allergic to the vaccine. Reports 45 minutes after receiving vaccine he started to feel dizzy, lightheaded, and nauseous. Initial VS were: B/P 102-62 HR 79 Pulse Ox 98% ORA. Injection site to Left Deltoid free of redness and swelling. No rash noted. Patient reports throat is dry, gave patient water and crackers. Patient began to feel better after water and crackers. Patient reports he has been on Phenteremine x 1 month and had not eaten since 530am today. I then called Dr. for further guidance. Dr. instructed to recheck VS and if normal patient may leave clinic. Patient to seek medical treatment via nearest ER or PCP if needed. VS upon discharge: B/P 112/80 HR 74 Pulse Ox: 98% ORA. Provided patient with Dr. instructions. Patient was able to ambulate out of the clinic without assistance.
Two days after receiving the second Moderna Covid vaccine, pink spots showed up on my abdomen.  After a few hours, they were a brighter red, looked like chicken pox blisters, were filled with fluid, and itch.  I was seen by a dermatologist on day 3 and was prescribed some anti-itch cream and told this could last for 2 weeks.  This is day 4 and they remain the same.
Injection site redness, pain, warmth that continued to increase in size for 3 days.  About 12 cm in diameter.  Improved within 24 hours of starting Keflex p.o.
Information has been received from a Doctor of microbiology and a licensed practical nurse (LPN) concerning a 45 year old female with end stage renal disease (ESRD), lupus, a history of renal transplant that was failing so patient was being considered for another one; who on an unspecified date, may have been vaccinated or exposed to someone who was vaccinated with a dose of VARIVAX (Merck) (manufacturer unknown) (lot number, dose and route not reported). The LPN reported that after much investigation it could not be determined if the patient had ever received a VARIVAX (Merck) (manufacturer unknown) or if she was exposed to chicken pox, and stated that the office would not have authorized or administered a live vaccine to a immunosuppressed patient. The Doctor of Microbiology reported that on 10-FEB-2012, the patient was admitted to the hospital with a diagnosis of cholecystitis. On 11-FEB-2012 a cholecystectomy was performed. On 15-FEB-2012, rash and skin lesions appeared. On an unspecified date, strain identification for samples was found to be varicella zoster virus (VZV) positive in the lab. The patient experienced respiratory failure on 19-FEB-2012 and died at 11:28 hours. The doctor of microbiology reported that there was "disseminated varicella" at time of death. The cause of death was respiratory failure secondary to herpes zoster viremia. It was unknown if an autopsy was performed (death certificate showed No for autopsy). Additional information has been requested.
Information has been received from a 62 year old female registered nurse with no known drug allergy and hypercholesterolaemia who on 13-JAN-2009 vaccinated a patient with a dose of ZOSTAVAX (lot #: 663199/1557X). Concomitant therapy included FLAGYL, ezetimibe (+) simvastatin (MSD), estrogens, conjugated (+) PEMPRO and calcium. On 20-JAN-2009, a week after the vaccination, the nurse developed shingles. She developed about 12 lesions under her left breast and upper left back next to her spinal column. She was experiencing some pruritis. She was being treated with VALTREX and ibuprofen. At the time of this report, the nurse was not recovered from shingles. The nurse sought unspecified medical attention. Additional information has been requested.
fine rash to rt & lt trunk of body;itching noticed later the day vax given lotion & cocoa butter applied to relieve itching;required no MD visit or hosp;
Pt started to get tingling to left side of face about 15-20 minutes after injection. 30 minutes after injection started to have left facial muscle weakness, tightness, afd fatigue, no issues swallowing. Facial movements not equal c/w bells palsy.
This is a spontaneous report from a contactable pharmacist. A 68-year-old female patient of an unspecified ethnicity received first dose of PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced redness at site injection and beneath arm on an unspecified date after first dose. The outcome of events was unknown. The reporter enquired should patient not receive a second dose, or should she be administered BENADRYL or a steroid before her 2nd dose.
Vaccine expired 9-28-2021. Administered on 9-29-2021.
Adverse effects:  severe whole-body arthralgia (especially ankles, hips, back, wrists, hands), severe pain at injection site restricting movement of left arm, chills, bilateral peri-orbital headache, multiple episodes of diarrhea that was bright green in color, diminished cognitive function, unsteady gait, tiredness  All adverse events started approximately 12 hours after vaccination and continued for 18 hours post-vaccination. Only treatment was rest and acetaminophen.  I lost a day of work (day after vaccination).  Today (48 hours post-vaccination), I feel about 80% better.  My arm is still very sore, I am still experiencing tiredness and headache.
5 minutes after vaccine patient reported feeling dizzy and light headed. Patient assisted to a wheel chair and vital signs were taken. BP 140/90, pulse ox 100%, HR 66. Patients reports that she did not take her BP medication this morning. Patient was given water and asked to sit for 30 minutes. Vitals taken and BP 140/80 and HR 69. Patient reported feeling better and no longer feeling light headed. She walked herself out of clinic.
A few hours after the injection I had a significant amount of arm pain, the injection site was raised and very hot to the touch. After about 3 days it went away. On day 7 or 8 I woke up to sharp pain, burning and itching on my left arm again. The redness was back and it was covering a majority of my bicep area and hot to the touch. These symptoms persisted for an additional 6 days.
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th March 2019, the patient received the 1st dose of Shingrix. In August 2019, between 5 and 6 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that, in August 2019, the patient experienced shingles after vaccination with dose of Shingrix. The pharmacist stated that, the acute stage of shingles resolved. The reporter consented to follow up.
Severe uterine cramping over the 3-4 weeks after receiving second dose of Pfizer vaccine
This spontaneous report was received from a registered nurse, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patient was inadvertently vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU) with lot # M030139 and expiration date on 18-AUG-2017 (dose and anatomical location were not provided) in combination with the sterile diluent (manufacturer unknown) with lot # L001533 and expiration date on 24-OCT-2017 (strength and dose were not reported), for prophylaxis; instead of the intended dose of M-M-R II. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
One week after the shot, woke with upper arm pain, very swollen wheal, warm to the touch with red skin
Face flushed bright red.  Bright red for 24 hours.  Today, Thursday, 10/6/2016 still red but not as much.
SYNCOPE. Patient treated by paramedics on site; refused transport to hospital for further observation.
Right upper arm where vaccine was given, patient had 9x10 cm area of erythema, warm and firm to touch the next day. No signs of systemic reaction, no fever, no pain. Patient was given diphenhydramine liquid orally and triamcinolone to apply to affected area.