chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; Fatigue; Muscle pain; body aches; Fatigue; nausea; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), the second episode of FATIGUE (Fatigue), MYALGIA (Muscle pain), PAIN (body aches) and the first episode of FATIGUE (Fatigue) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced the first episode of FATIGUE (Fatigue), NAUSEA (nausea) and MYALGIA (Myalgia). On 21-Apr-2021, the patient experienced NAUSEA (Nausea), the second episode of FATIGUE (Fatigue), MYALGIA (Muscle pain) and PAIN (body aches). On 31-Mar-2021, NAUSEA (nausea) and MYALGIA (Myalgia) had resolved. At the time of the report, NAUSEA (Nausea), the last episode of FATIGUE (Fatigue), MYALGIA (Muscle pain) and PAIN (body aches) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided by the reporter. No concomitant medication was provided by the reporter. No lab data was provided by the reporter.   This case was linked to MOD-2021-090364, MOD-2021-090364 (Patient Link).
Rash around injection site. Bruise at injection site. Rash appeared 5 day after admin below site and spread up to site. As the rash spread more prominent (red color) on surrounding area.(Flu and PREVNAR LA0
Three days post vaccination has C5-6 radicular pain syndrome (pain in R shoulder muscles). He has past history on c5-6 radiculitis first in 1994 and again in 1998. 14 days post vaccination pt is worse. Current problem.
excruciating low back pain; difficulty walking; significant fatigue; lot of sleeping; This is a spontaneous report received from contactable reporter (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Oct2021 at 14:00 as dose 3 (booster), single (Lot number: 30155BA) at the age of 53 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "total knee replacement", start date: 2012, stop date: 2012. No known allergies. Concomitant medication(s) included: WELLBUTRIN; VITAMIN E [TOCOPHEROL]; ZINC; CHLORTHALIDONE and multi vitamin. There was no other vaccine in four weeks. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Lot number: ER8737, Administrator route: Intramuscular, Administrator time: 04:45 PM, Vaccine location: Left arm), administration date: 02Apr2021, when the patient was 52-year-old, for Covid-19 immunization, reaction(s): "muscle aches especially in my low back"; BNT162b2 (DOSE 1, SINGLE, Lot number: EN6204, Administrator route: Intramuscular, Administrator time: 04:45 PM, Vaccine location: Left arm), administration date: 12Mar2021, when the patient was 52-year-old, for Covid-19 immunization. The following information was reported: BACK PAIN (medically significant) with onset 10Oct2021 at 01:00, outcome "recovered", described as "excruciating low back pain"; GAIT DISTURBANCE (medically significant) with onset 10Oct2021 at 01:00, outcome "recovered", described as "difficulty walking"; SOMNOLENCE (medically significant) with onset 10Oct2021 at 01:00, outcome "recovered", described as "lot of sleeping"; FATIGUE (medically significant) with onset 10Oct2021 at 01:00, outcome "recovered", described as "significant fatigue". The events " excruciating low back pain", "difficulty walking", "significant fatigue" and "lot of sleeping" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of back pain, gait disturbance, fatigue, somnolence. Treatment was Muscle relaxer. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to all the reported events cannot be completely excluded based on temporal association and known drug safety profile The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Adverse effect of other vaccines and biological substances, initial encounter on 2022-03-25.
Info has been received from a physician concerning a 6 year old male who on 10/29/99, was vaccinated with a dose of varicella virus vaccine live. On 4/22/05, the pt developed breakthrough varicella with 3 lesions after being exposed to another previously vaccinated classmate that contracted chickenpox. Unspecified medical attention was sought. A product quality complaint was not involved. No further info is available. The physician who also reported that one female child and approximately 6 other children developed breakthrough varicella after vaccination with varicella virus vaccine live.
Chest flush with bilateral arm flush EMS evaluated. Stayed 10 minutes longer and flush started to resolve.  Went home.
Initial report received from a health care professional on 09 February 2011. A 2-year-old male child received (dose 3) on 03 January 2011 an injection (route and site not reported) of DAPTACEL, lot number C3577AA and an injection (route and site not reported) of Hepatitis A vaccine, Merck lot number not reported. The patient had a history of reactive airway disease. He had no known allergies, no other vaccinations within 4 weeks of the DAPTACEL and no illness at the time of vaccination. The patient takes no medications but has had homeopathic substances. He had two previous doses of DAPTACEL. On 07 February 2011, the patient developed swelling of the eyes, elevated cholesterol, protein in the urine, weight gain of 7 pounds and nephrotic syndrome. The patient required a doctor visit. The outcome was reported as unknown. Documents held by sender: None.
They have her double dose of Heb B and polio. The next day when she woke up she had a 101.8 fever and it lasted for 3 days and her injections were red! She didn?t eat or sleep good for 3 day also.
Swelling at the neck, over left clavicle . Painful to touch. Lymphoid seem to be enlarged
the patient took the Pfizer dose of  pediatrics instead of the toddler dose  but the mother gave the incorrect date of birth of the patient. The patient's actual age was 4 at the time of the vaccine administration of their first Pfizer dose. The patient was notified that the wrong dose was given to them, but they were aware that they gave the incorrect date of birth of the child.   This was discovered  on 7/7/22 when the father returned for the child's second dose.
10:05 am Pt received vaccine and was seated in observation area. Pt alert, interacting with staff and other pts. 10:15am Pt appears asleep, rouses with touch and when spoken to. Observation area nurse notified, provided pt with bottle of water and helped her take a drink. Nurse then notified pharmacist who came to pt's side. Pt given 25 mg benadryl caplet. Able to swallow it, needed assistance for holding water bottle. Pt breathing regular, pulse regular and easily palpable. 10:25 Pt increasingly lethargic. Nurse and pharmacist with pt. Lips and tongue slowly swelling, responsiveness decreasing. Pharmacist called 911. 10:30am Pt's daughter administered epipen 30mg, L outer thigh. Swelling of lips and tongue quickly resolving. Pt lethargy increasing. Increasingly slow to open eyes and respond to questions. Pulse and breathing continue regular. EMS arrived on scene approx 10:35-10:40. BP 80/60, NSR, pulses palpable, pupils reactive, able to answer questions but slow to respond and weak voice. Pt transferred to Medical Center. In ER pt given IV solumedrol, IV fluids, CXR, EKG. Awake and oriented, arms shaking, weak, requires assistance to stand, intermittently drowsy. Admitted for observation. 3/3/21 pt preparing for discharge, BP extremely high. Pt given metoprolol, BP increased, tachycardia increased, pt very drowsy. Continued to monitor, given Lisinopril, bp decreasing. Pt feeling much stronger, alert, interacting with staff and daughter. Discharged home.
After a few hours the injection site was very red, swollen and sore. I went to bed and when I awoke I was nauseous, throwing up (dry heaves and bile...no food. I could not stop throwing up and felt dehydrated). My temperature was over 99. I was listless, dizzy and had a hard time sitting up. I went to the ER where they administered a saline drip along with hydrocortisone and an anti nausea med. The latter did not work so they administered a second anti nausea drug which worked marginally. I went to the ER at 9:00 AM and now at 4:30, my temperature is 101.7.
FLU LIKE SYMPTOMS; CHILLS; SHIVERING; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced flu like symptoms. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced shivering. On 21-MAR-2021, the subject experienced nausea. On 21-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, chills, shivering, nausea, and headache on 22-MAR-2021. This report was non-serious.
dose administered after vial had been punctured >12 hours; Max temp was 71.2 degrees F, min temp 65.4 degrees F. Lot number 031H21A. Vial was moved from freezer to fridge on 11/17/21.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after vial had been punctured >12 hours) and PRODUCT STORAGE ERROR (Max temp was 71.2 degrees F, min temp 65.4 degrees F. Lot number 031H21A. Vial was moved from freezer to fridge on 11/17/21.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after vial had been punctured >12 hours) and PRODUCT STORAGE ERROR (Max temp was 71.2 degrees F, min temp 65.4 degrees F. Lot number 031H21A. Vial was moved from freezer to fridge on 11/17/21.). In November 2021, EXPIRED PRODUCT ADMINISTERED (dose administered after vial had been punctured >12 hours) and PRODUCT STORAGE ERROR (Max temp was 71.2 degrees F, min temp 65.4 degrees F. Lot number 031H21A. Vial was moved from freezer to fridge on 11/17/21.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported.   No treatment drug were reported.    Vial was at room temperature from 3 pm the previous day until 9:30 am the next day. The vial was punctured at 3 pm the previous day. Max temp was 71.2 degrees F, min temp 65.4 degrees F. Vial was moved from freezer to fridge on 17-Nov-21.
SX began as severe chills at 10 hours following the second shot. Severe chills progressed to a 103.5 degree Fahrenheit fever for several hours. Patient maintained hydration and remained in bed under multiple blankets due to severe chills. As SX progressed to a sweating fever, patient discarded blankets. Fever broke around 0630 the following morning, and remained slightly elevated for the remainder of the following day at around 100 degrees Fahrenheit. Patient took ibuprofen on the second day of symptoms to help manage the fever. Additionally, patient experienced ?waves coursing through the body, in one direction then the next. This continued to alternate throughout the night.?
Pfizer-BioNTech COVID-19 Vaccine EUA 4/23 - in the evening swelling and soreness around the point of injection on the left arm 4/24 - Woke up feeling a sharp pain on the left collar bone. the swelling and soreness continued on my left arm. the pain on the collar bone continue throughout the day and moved to the upper part of my left shoulder. 4/25 - the pain continued on the left  collar bone and upper part of my left shoulder. the swelling and aching on the left arm dimmed down close to none existent. 4/26 - woke up feeling an ache in my left eye, there was no redness but the my eye would get watery. the pain on the left collar bone and upper part of my shoulder has decreased but I can still feel some aching in those areas. the swelling in the left arm and aching has completely gone away.
Lethargy, muscle pain about 24 hours after injection - took ibuprofen and used a heating pad Swollen lymph nodes about 48 hours after injection; collar bone on side of injection is hot to touch, tender, and swollen - took ibuprofen and used an ice pack
A few minutes after administration, the patient started getting itchy on the left hand.  I gave her 10 ml of liquid Benadryl as well as an ice pack.  Minutes later, the symptoms went away and she was fine.  We continued to monitor and she had no complaints.  She then went home and I did a follow-up phone call to check on her and she reports no symptoms.
Parosmia, everything smells like rotten meat. Anything savory (salty, rich) tastes of the same rotten or putrid smell. Sugary tastes remain unaffected but taste has greatly diminished. Phantosmia, or smelling things that aren?t present, is also present. The smells are always of a foul odor and are transient throughout the day. Began occurring roughly 24 hours after vaccine, remain ongoing.
vertigo; This is a spontaneous report received from a Pfizer-sponsored program via medical information team. A contactable pharmacist reported that a 32-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 22Jan2021 (at the age of 32-year-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient received his first dose of the Pfizer covid vaccine and experienced vertigo in 2021. He waited to have that clear up and now coming back to the pharmacy for his second dose. He wanted to know guidance on the second dose sine its been close to 90 days. He wanted to know if she could administer the 2nd dose or start over from the 1st dose. The event assessed as non-serious. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Began as bad arm pain despite taking 600mg of ibuprofen after the injection. At 0500, woke up with chills, body aches, and dizziness.
21NOV96 thigh swollen-4cm-warm & tender to touch;red around area-vomiting & feverish 22NOV96;
Headache, Myalgia, Fever, CoughWheeze, UrticariaPruritus, Diarrhea, NauseaVomiting, HYPERtension, Syncope, Tachycardia, Sweating, Facial flushing, Sore throat, Fatigue, Loss of taste, Decreased sense of smell Narrative: Was seen and treated in ED. Saw PCP also for treatment
My kids got very ill from the pertussis in the DTP vaccine/ suspected vaccination failure; My patient got very ill from the pertussis; My patient's got very ill; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis.   On an unknown date, the patient received DTP vaccine. On an unknown date, unknown after receiving DTP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), pertussis (serious criteria GSK medically significant) and unwell. On an unknown date, the outcome of the vaccination failure, pertussis and unwell were unknown.   It was unknown if the reporter considered the vaccination failure, pertussis and unwell to be related to DTP vaccine.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The reporter's patients got very ill from the pertussis in the DTP vaccine. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
She got her vaccine, and had the body aches that were all over.  Then she had headaches that started, not as bad as the COVID headache, but was bad. She fell back to sleep and had chills, took her temp and it was 101.  She fell back to sleep and woke back up at 6:00 AM and her temp was 103.3, and took Tylenol and got it down to 102.7.  She then had uncontrollable chills with shivering and her temp stayed at 103.  Then she got it down during the day, and was alternating between 101-103 throughout the day.  That night when she went to sleep around midnight it was 101.  It broke during the night and she then got a cough which lasted all day, and had it yesterday as well, and woke up today with everything was completely gone.   These symptoms were worse than when she had COVID back in February/March.
Booster; I got my three Pfizer shots and my symptoms are very mild/his Covid breakthrough infection; I got my three Pfizer shots and my symptoms are very mild/his Covid breakthrough infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 03Jan2022, outcome "unknown" and all described as "I got my three Pfizer shots and my symptoms are very mild/his Covid breakthrough infection". It was unknown if therapeutic measures were taken as a result of suspected covid-19. Clinical course: It was unknown if patient had COVID prior to vaccination or COVID tested post vaccination. The patient had a breakthrough infection with mild symptoms and he was boosted.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported chest pain earlier in the day.  Patient reported less chest pain time of shot and reported this occurs due to food sensitivities. Clearance received by physician to proceed with shot. During observation period, patient reported dizziness. Patient evaluated. During this time she also reported feeling cod. BP readings as followed: 146/88, 146/91 and then 145/83. O2 and HR remained WNL. PA on site evaluated patient. Patient refused ER reporting "they do not like me there." Orthostatics negative upon leaving. Patient received clearance to return home by PA on site as signs and symptoms were not indicative of reaction to COVID Vaccine.
1622:  Pt reported feeling dizzy and ear ringing immediately after covid vaccine.  She also reported slight SOB which self resolved before she reported dizziness.  Pt was assisted to chair outside procedure room, as procedure room was occupied.  Pt was able to stand and ambulate without feeling feeling like she was going to pass out, she stated she felt like the room was spinning.   1624:  Pt was given juice and water, declined crackers.  Reported no change in dizziness.  BP 119/62 HR 98 SPo2 98%% RA.   1629:  Pt was transferred to gurney. Slow steady gait noted while she held on to my arm. 1635:  Dizziness slightly improved.  No facial swelling noted, no itching reported,  BS clear to auscultation bilaterally.  Noted nystagmus when pt sat up to allow me to listen to her lungs.  Pt reported slight headache.  Pt also reported that dizziness was the same and there was no improvement after all.   1640:  VS repeated.  BP 101/63 HR 71 1642:  I have contacted Dr, incident to provider for covid vaccine clinic, and reported pt's symptoms and VS.  She state to keep patient for futher monitoring and she would discuss with urgent care provider and call back with disposition.   1654:  Dr. returned call.  Per Dr. pt may be discharged home, she will place orders for dramamine and patient to follow up in urgent care or ER should her symptoms get worse.  Read back completed.  Pt's father has also arrived.  Parents given instructions.  Pt and her mother were instructed to keep paperwork (EUA) in a safe place and to refer to it if she developed any sxs of severe allergic reaction such as swelling of the tongue, throat, face, difficulty breathing, SOB, generalized rash, abdominal pain, vomiting, dizziness and / or palpitations. In which case she should seek immediate medical attention. Pt's parents and patient verbalized understanding.   1802:  Per pt's mother she would feel more comfortable taken patient to urgent care now.  Discharge vitals BP 97/55 HR 79 SpO2 98% RA.  No other needs or complaints verbalized. Discharge ambulatory with her parents.