chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; Temp 99.7; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Fatigue) and PYREXIA (Temp 99.7) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergy to Augmentin.), Hypothyroidism and Borderline diabetes. Concomitant products included THYROID (ARMOUR THYROID), IBUPROFEN (ADVIL [IBUPROFEN]), CETIRIZINE HYDROCHLORIDE (WAL ZYR), CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), ZINC, IODINE (IOD [IODINE]) and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced FATIGUE (Fatigue) and PYREXIA (Temp 99.7). On 20-Jan-2021, FATIGUE (Fatigue) and PYREXIA (Temp 99.7) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2020-001271 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: This follow-up will be processed at the same time as the initial. Duration for the symptoms was reported as only lasting one day after dose #2.
Information has been received through the Merck Pregnancy Registry via a physician concerning a 19 year old female with a history of tobacco abuse and cannabis abuse who on 20-Feb-2008 was vaccinated with the first dose of GARDASIL 0.5ml, IM, (lot #, not reported). Concomitant therapy included prenatal vitamins (manufacturer unknown). On 21-Apr-2008 the patient was given the second dose of GARDASIL 0.5ml, IM to the left deltoid, (lot # 659655/14860). After the patient received her second dose, she later reported her pregnancy. Unspecified medical attention was sought and routine prenatal tests (data and names unspecified) were performed with results not reported. Therapy has been discontinued as of 07-May-2008. Patients last menstrual cycle was reported on 20-Feb-2008, her due date was calculated to be 26-Nov-2008. No adverse events were reported. No product quality complaint was involved. Follow-up information has been received from a physician concerning a female patient with nicotine dependence, THC use during pregnancy and a history of abnormal Papanicolaou smear and no previous pregnancies. It was reported that on 4-Apr-2008, on 22-Jul-2008 and on 10-Sep-2008 routine screening test were performed, all of them within normal results. On 26-Nov-2008, 39+ 0 weeks from the last menstrual period, the patient delivered a normal healthy female baby weighing 5 pounds 5 ounces. The baby's length was 19 inches, her APGAR score 9/9 and her head circumference was 11 1/2 inches. It was reported that during the pregnancy the patient developed a meticillin resistant staphylococcus aureus (MRSA) abscess which was treated with Clindamycin (Unspecified) 150mg, QID during 7 days. Also the patient was taking calcium + vitamin D (unspecified) , 500/200 mg, BID for the treatment of poor calcium mass, fish oil (unspecified) , 500 mg daily for nutrition and metoclopramide (unspecified), 5mg, QID/ PRN for the treatment of nausea. It was also reported that on an unspecified date the patient had gonorrhea infection.
Ambulated without assistance.  ambulated to husband where she collapsed and became unresponsive - RRT initiated and patient transported to Emergence room
Initially had deltoid pain and swelling for 1 day, improved, then 2 days after vaccine started with swelling and pain over medial elbow. Today still has some swelling in deltoid in addition to pain/swelling in medial elbow. Symptoms also consistent with medial epicondylitis, uncertain if vaccine is contributing.
This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. The patient was vaccinated with her first dose of GARDASIL, 0.5 ml, intramuscular (lot number not reported) in September 2011. No other co-suspects were reported. No concomitant medications were reported. On 24-OCT-2012, that day, the patient might receive her second dose of GARDASIL, 0.5 ml, intramuscular (lot number not reported). No adverse effect reported. Additional information has been requested.
It seems like it took a long time to complete administering the vaccine. I felt almost faint than I heard/felt a "pop".  The next day the soreness from the arm migrated to the back/top of the left shoulder, then up the left side of the neck then up to the ear.  The pain/soreness then come over to the front of the should down under the clavicle bone.  The pain/soreness is still present today with mild headaches.
pt recvd vax 26OCT95 lt arm;pt devel pain,about a 20cm erythema,rash & itchy;poss allerg rxn
No adverse reaction known. Vaccination given outside of recommendations as patient had another vaccine 3 days before this vaccine.
Information has been received from a female consumer with a history of severe painful shingles outbreaks who in October 2007, was vaccinated with zoster vaccine live (Oka/Merck). The patient believes the vaccination treated her shingles outbreaks and the pain associated with the outbreaks. At the time of the report the patient's status was unknown. There was no product quality complaint involved. No further information is available. This is in follow-up to report(s) previously submitted on 6/24/2008.  Follow-up information was received from the consumer.  The patient recently developed two painful lesion on her left shoulder.  No other symptoms were noted.  The patient's two painful lesion on her left shoulder persisted.  The patient did not seek any medical attention.  Follow-up information from a registered nurse indicated that they had no record of an adverse reaction for this patient.  Additional information is not expected.
Two small bald patches were noticed on this day.  They developed into many large bald patches, and now is almost completely bald.  She is currently taking topical steroids. She also complains of joint pain.  She is currently being treated by a Dermatologist and Rheumatologist.
A rash on the injection site approx. 2x3" wide appeared today.  It feels warm to the touch but does not bother me much at this point.
A spontaneous report was received from a healthcare professional concerning a 46 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced migraine.   The patient's medical history was not provided. The patient denied any history of previous adverse reactions to vaccines.  No relevant concomitant medications were reported.   On 12 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch number: 025L20A) via unknown route in right deltoid muscle for prophylaxis of COVID-19 infection. Follow up response to treatment was good, the patient was discharged and was stable to go home and to be followed up with primary care physician.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event migraine was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Phone call from school secretary on 2/17/11 patient c/o (L) arm being sore. On back of (L) arm has red, hard lump about size of a quarter, itchy.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Weakness-Mild, Additional Details: pt experienced fatigue diziness minor tingling of the tounge and minor tightness of chest. paramedics were called to the store however after examantion paitent decided he was fine and decided to leave
He was septic; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 28Jan2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was septic. It was reported that his other vaccination was closely 21 days after that's okay, so they took him to primary care physician. He will be perused in rehab and they were supposed to do on 04Mar2021. They were asking if his second shot is going to be good. His primary care said it to Johnson and Johnson, but it was not supposed to mix them. Outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Brachial neuritis in left shoulder, improving with therapy and time, still ongoing residuals.
Patient came in the store the following day showing her arm which was erythematous and warm to touch. The patient wanted to confirm this was an ADR to the vaccine since she had previously been immunized in the past with no issues. The area was large covering 3 to 4 inches in diameter and 2-3 inches in length. She stated that it did itch and took a BENADRYL that seemed to help. The patient also voiced concern about getting the vaccine the following year.
Received the Shingrix 50MCG/0.5ML SUSR on 12/23/19. Experience severe headache for 2 weeks - acetaminophen or ibuprofen would not relieve symptom of headache. Also experienced nausea for 3.5 weeks.
Dosage administered was incorrectly given. Was given 0.5mL instead of 0.25mL.
Parent states "woke from nap with hoarse cry, whimper, pale color, very limp and no response to voice". Respirations and heart rate accelerated. Event lasted 5 minutes. Called Pediatrician and was instructed to report to ER. Given dose of Rocephin at ER. Pediatrician feels related to DTAP.
Pt felt very run down the day after vaccination, said she could barely lift her limbs. She has redness at the injection site, but the evening after vaccination, she developed a fluid filled knot at the base of her neck above her shoulder. She states that it's sore to the touch, but does not bother her otherwise.
cardiac arrhythmia tachycardia 220 BPM, an operation to install An implantable cardioverter-defibrillator (ICD)
09/16/2021 AM  Awoke to find the hematoma  Conjunctivitis - broken blood vessels and given eye drops - Ciprofloxacin 10mg two drops every two hours for first two days, then two drops for times a day for five days. Observation for objects and cleaning of the eye and she could not see anything. Hematoma of the eye.
Alien Arm Syndrome; feel off when it happens; I feel Dizzy/Light headedness; she felt tired; Blood Pressure went up really high/ blood pressure increased to >200/102 mmHg/ BP increases; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (Blood Pressure went up really high/ blood pressure increased to >200/102 mmHg/ BP increases), ALIEN LIMB SYNDROME (Alien Arm Syndrome), FEELING ABNORMAL (feel off when it happens), DIZZINESS (I feel Dizzy/Light headedness) and FATIGUE (she felt tired) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERTENSION (Blood Pressure went up really high/ blood pressure increased to >200/102 mmHg/ BP increases). On an unknown date, the patient experienced ALIEN LIMB SYNDROME (Alien Arm Syndrome), FEELING ABNORMAL (feel off when it happens), DIZZINESS (I feel Dizzy/Light headedness) and FATIGUE (she felt tired). At the time of the report, HYPERTENSION (Blood Pressure went up really high/ blood pressure increased to >200/102 mmHg/ BP increases) and DIZZINESS (I feel Dizzy/Light headedness) had not resolved and ALIEN LIMB SYNDROME (Alien Arm Syndrome), FEELING ABNORMAL (feel off when it happens) and FATIGUE (she felt tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2022, Blood pressure measurement: increased to >200/102 mmHg.. On 15-Mar-2022, Electrocardiogram: Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient reported that she received 3 doses of Moderna COVID-19 vaccine. After the first 2 vaccines she felt tired and she did not have any symptoms. After the 3rd shot her Blood Pressure went up really high and after that she started having symptoms every month right before her period. She went to the doctor and was diagnosed with Alien Arm Syndrome but that was not exactly what was happening. That was the closest diagnosis they could come up with. She stated, her symptoms restarted every month right before the period, Blood pressure increased, felt dizzy, light Headed, and felt off when it happened.  No treatment information was provided.
Since getting the vaccine my sense of smell of very off. Everything has a rancid smell to it including non food items such as hand soap.
Ringing in my ears which has not gotten better, I also have experienced some minor chest pains, and I have experienced joint pains.
He is currently admitted at  Hospital and started feeling a sore throat last Saturday. He then began feeling progressively worse throughout the next few days and was admitted to  Hospital on Tuesday 07/06. PUI has congestive heart failure, COPD, Stints put in, high BP, and is a diabetic. He was given a breathing device today to monitor his o2, but was moved out of ICU. He reports that he rarely leaves his house due to water blisters on his legs, but he comes to the wound clinic once a week. He is medically disabled and does not work
causing vertigo, very dizzy, nauseous, severe headache, feel extremely shaky , eyes hurt, directly after getting shot tasting a metal taste and still taste metal today
box was left out and was not refrigerated, duration: 5 days with no reported adverse event; the product administered to a patient with no reported adverse event; Initial information received on 14-Nov-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 14 years old unknown gender patient who was administered the vaccine Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent] whose box was left out and was not refrigerated, duration: 5 days with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Nov-2023, the patient received a dose of 0.5 ml suspect Influenza Quadrival A-B Vaccine (lot U8200AA and expiry date: 30-Jun-2024) (strength, formulation, expiry date unknown)via unknown route in unknown administration site for prophylactic vaccination(Immunization) (poor quality product administered) (Latency: same day).  On an unknown date the box was left out and was not refrigerated, duration: 5 days with no reported adverse event (product storage error) (unknown latency) following the administration of Influenza Quadrival A-B Vaccine.  It was reported that the box was left out and was not refrigerated. No one knew in the facility, it was delivered. Max/low temperature reached: Unknown since it was in the box. Duration: 5 days Human error- Yes If negative advice, was the product administered to a patient? Yes Does extended stability data cover the excursion- No  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 the 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.
Expired Vaccine Used; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use not provided.  Treatment information not provided.
Soreness and small red/bruised spot on arm even after 10 days of shot.
Child started with high fever, 48 C, post vaccination and died on 11/12/2007.  12/11/2007 Reviewed autopsy report which states COD as acute bronchopneumonia complicated by acute gastroenteritis.  Blood c/s neg.
Raynaud's Phenomenon; Nervous condition, paresthesia - information has been received from a company representative concerning a patient who was vaccinated with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live .  On 17 Jan 2001 the reporter states that the doctor was to see a consult patient who on an unspecified day developed nervous ticks, pareathesia and Raynaud's phenomanon type problem in fingers and toes.  It was noted that the onset of the patient's symptoms was claimed to be after vaccination.   additional information has been requested.
Feeling of something caught in throat and persistant cough. Sent to emergency room for observation. Pre medicated with Xyzal for 2 days.
16 hours from onset, thought ''I'' was improving, ''I'' then lost sense of taste; Shaky; Dizziness; 13 hours following onset of 2nd vaccine, started experiencing fever; Muscle ache; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 19Apr2021 at 14:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient medical history reported was not applicable (n/a). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 29Mar2021 at 14:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient previously received amoxicillin (MANUFACTURER UNKNOWN), for unknown indication from an unknown date and experienced drug allergy. On 20Apr2021 at 03:30, 13 hours following onset of 2nd vaccine, the patient experienced, fever, muscle ache, head ache, shaky, fatigue and dizziness. 16 hours from onset, (20Apr2021 at 03:30) thought she was improving, she then lost sense of taste, but not sense of smell. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of events fever, muscle ache, head ache, shaky, fatigue, dizziness and lost sense of taste was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
No adverse event; Monovalent doses administered after the BUD to patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients.).    No concomitant medications were reported. Total 77 Monovalent doses were administered after the BUD to patients 12 and up.37 doses from Lot 059H21,26 doses from Lot 065K21A, and 12 doses from Lot 058A22-2A. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment information was provided.
Narrative:  Patient expired related to subdural hematoma following a fall at home approximately 2 weeks after receiving COVID vaccine
1wk p/vax area from elbow to shoulder reddened & swelled intense itching followed in 1-2 days w/small white eruptions;pt was seen by MD noted 4"x 4" raised area w/red pinpoint dots, induration & soreness of arm & back;
6 hours of feeling bad, nausea, eyes tearing, coughing, chill, sweats, no fever
Individual reported to employer that one week post vaccination expereinced and was diagnosed with Bell's Palsy;  primary care physician indicated that he felt is was related to the influenza vaccination
every time she took it she stayed whole night where she can''t walk; would fall to the floor; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster) , single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, single), for Covid-19 immunization; Bnt162b2 (2nd dose, single), for Covid-19 immunization. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "every time she took it she stayed whole night where she can''t walk"; FALL (non-serious), outcome "unknown", described as "would fall to the floor".  Additional Information: Consumer said, she took three times the Pfizer COVID-19 vaccine, and called today because every time she took it she stayed whole night where she can't walk and would fall to the floor, she can't walk for 7-8 hours, she can't walk three times, so she wants to know if this is a problem from her or the vaccine. Report related to a study or programme.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (03Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.