chrisvoncsefalvay/vaers-outcomes huggingface dataset:
terrible stiff neck; This spontaneous case was reported by a health care professional and describes the occurrence of MUSCULOSKELETAL STIFFNESS (terrible stiff neck) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included MULTIVITAMIN [VITAMINS NOS], VITAMIN B COMPLEX (B COMPLEX (B50)) and VITAMIN D NOS for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (terrible stiff neck). At the time of the report, MUSCULOSKELETAL STIFFNESS (terrible stiff neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included 3 tablets ibuprofen and 2 tablets of acetaminophen.
Localized reaction, red, warm to touch, raised area 2 1/2 X 2 inches RT.
Within an hour extremely exhausted, lethargic, slept from Thursday to Monday, no recollection of those days, horrible cough & shortness of breath started on Monday and continues. multiple ER visits, 9 day hospital stay in June related to coughing & shortness of breath.  Referred to pulmonologist, various tests and procedures continue, allergy testing was negative, referred to interventional Pulmonolgy, 2 broncosopies, biopsies?. Treatments and doctor visits continue 8 months after receiving the vaccine.
swollen eye lids, purple, shut almost, tremors,screaming all of a sudden in sleep for no apparent reason to point of shaking, had massive hematoma from little bit below knee to top of thigh, swollen 2x bigger than rt leg;
Fever, chills,body aches, headaches , pain soreness injection site  Took Tylenol, theraflu
medical assistant inadvertently administered a dose of menquadfi, when they were supposed to receive the mmr vaccine with no reported adverse event; Initial information received on 15-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 20-years-old female patient who was inadvertently administered with a dose of meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi], when they were supposed to receive the measles vaccine, mumps vaccine, rubella vaccine [MMR] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Sep-2023, the patient inadvertently received 0.5 mL dose of suspect meningococcal A-C-Y-W135 (T conj) vaccine, Solution for injection (frequency: once) (batch number: U78278AA; expiry date: 30-Sep-2025) via unknown route in unknown administration site when they were supposed to receive the measles vaccine, mumps vaccine, rubella vaccine vaccine (formulation batch number and expiry unknown) for immunization with no reported adverse event (wrong product administered).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
7hr post vax chills, temp, body shivering out of control, minor sore throat, severe h/a, generalized body aches & pains;
Vomiting, chills, increased heart rate, fever, muscle pain, anxiety, loss of sleep, loss of appetite, teeth/jaw clenching.
It has accelerative of my body degenerative. It flare up my arthritis and my thumb had a grove in it now. It has caused me to get tendonitis all over my body. It caused me to go back into menopaused. It has caused my skin to thinning, wear it tears layers of skin just from a little pump. My skin looks like a 100 year old person now. It has really messed with my thermo-balance. It hurts to seat, stand, to walk and sleep. I have hot flashes so bad. I am always tired as well. I also have night sweats really bad. I been to several specialist. I had x-rays, MRI, and blood work. It shows that my vitamin D is gone completely. I been sent to physical therapy due to the tears in my muscle and bone just from the pump. It shows that my joint are degenerative at a rapid rate. My blood pressure has been evaluated as well. I have also had weight gain since the shot. I also keep getting SOB but they said that my heart is fine.
Inflammation/redness/swelling on shoulder, lasting 4 days. Got progressively worse before getting better. Pain through chest, as well as heart/lung area. Severe/intense coughing/choking/throat tightening. Runny nose.
Pt states at bedtime on 11-25-09 noticed rash (neck and back). She called our pharmacy on 11-27-09 to report. Rec see MD. I called her 11-28-09 states rash Left side of face and on chest - states has HA and rash itching. Rec see MD today because she did not go 11-27. 11-30-09 called to check on pt - still has not seen MD but to go this PM. Has been taking BENADRYL. Pt told me on 11-28-09 had had a rash past seasonal flu vaccination in Sept-2009 but at the time had started on PRESTIQ and her MD thought it was from the PRESTIQ. Rec. see MD. 12-1-09 Telephone call - states did go to MD yest - and was told that he did not know if it was a reaction to vaccine but could possibly be. MD rec to continue to take OTC BENADRYL. Pt states she feels better today. Dr's office was faxed yesterday with report of possible reaction to H1N1 vaccine Lot # and Expiration.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Apr2023 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2023) Positive; (05Jun2023) Negative; (07Jun2023) Negative; (08Jun2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
"My 15yr old daughter had her covid vaccine (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE ("My 15yr old daughter had her covid vaccine (1st dose)) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE ("My 15yr old daughter had her covid vaccine (1st dose)). On 05-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE ("My 15yr old daughter had her covid vaccine (1st dose)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not reported.   Treatment information was not reported.   This case was linked to MOD-2021-211659 (Patient Link).
Patient stated feeling faint,  complaints chest tightness, weakness, slumped in chair, clammy skin warm to touch, was verbal, patient aware of own name and location.
States so he doesn't get Covid again, caller states patient said he feels like he has it again; States so he doesn't get Covid again, caller states patient said he feels like he has it again; cold sweat; Body Aches; fever/99.3 last night/100.2 last night; sore arm/Right Arm Hurting; muscle pain/Muscle and Body Aches; Chills and Shaking; Chills and Shaking; This is a spontaneous report from a contactable consumer (patient's spouse). A 74-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), 1st dose on 01Mar2021 (Lot Number: EN6205) and 2nd dose on 21Mar2021 10:35 (Lot Number: EP7534); both via unspecified routes of administration, administered in right arm, as single doses for COVID-19 immunisation. Medical history included ongoing atrial fibrillation (A-Fib, diagnosed around 5 years ago) and ongoing high blood pressure - had it since he was 30 years old. Concomitant medication included apixaban (ELIQUIS) taken for A-Fib from an unspecified start date (started years ago, probably 5 years ago) and ongoing. No additional vaccines administered on same date of the Pfizer vaccines. The patient received the second dose of the Pfizer covid vaccine on 21Mar2021 and had fever, chills and shaking, sore arm, muscle pain. The patient received 2 Tylenol at 7:40 at the time of report and his temp was 98.6. The reporter stated her husband had the vaccine and he has been having fever, chills, and muscle aches. Clarifies that he had chills with shaking that are gone now, and just cold sweat morning (day of reporting). Muscle and body aches: achy all over. Fever: 99.3 on 21Mar2021 and morning of reporting got it down but got up to 100.2 on 21Mar2021, still having a slight fever at time of report. Right arm hurting: states it started as soon as they were in the parking lot after the vaccine. Treatment was Tylenol. Arm started hurting in parking lot 14:00, body aches and fever at 21:00. Events did not require a visit to emergency room or physician office. When asked for the indication of 2nd dose, the reporter stated "so he doesn't get Covid again, caller states patient said he feels like he has it again." Outcome of events fever, muscle and body aches, right arm hurting was not recovered, events chills and shaking recovered on 22Mar2021, other events was unknown. The events were reported as non-serious.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 16Jun2023 to 21Jun2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient was given 5-11 dose and needed to receive the 12 and up dose.
Fever, chills, weakness, severe pain, swollen arm and under the arm, shortness of breath, nervousness, temporary loss of memory.
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR on 12/25.  No issues with hypoxia during stay - admitted for choledocholithiasis.  Provider d/c note:  "79-year-old male past medical history of dementia, strokes.  He presented for chief complaint of abdominal pain.  Labs are notable for transaminitis.  Patient was diagnosed with choledocholithiasis noted common bile duct dilation.  Patient underwent Plavix washout prior to ERCP.  Required vitamin K for elevated INR.  Underwent sphincterotomy with removal of sludge.  Urinalysis was notable for positive leuk esterase.  Patient was treated for urinary tract infection growing Klebsiella completed treatment 1/6.  Patient had constipation improved following MiraLax and senna.  CT abdomen was obtained and was notable for an incidental finding of a 9 mm left oblique fissure nodule which will require outpatient follow-up."
HEADACHE, NECK PAIN, BACK PAIN WAS SEEN IN THE EMERGENCY DEPT. TWICE, ADMITTED TO THE HOSPITAL ONCE AND SEEN IN THE DOCTOR'S OFFICE WAS GIVEN IBUPROFEN PRN AND CYCLOBENZAPRINE PRN FOR PAIN  REFERRED TO NEUROLOGY AND OPTHALMOLOGY
Flu like Symptoms, Shivering and weak for 24-36 hours. Could not report to work the next day.
SEVERE SHOULDER PAIN (SHOULDER AT THE  INJECTION SITE HURTING); This spontaneous report received from a patient concerned a 55 year old male. The patient's weight was 165 pounds, and height was 75 inches. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies and was a skinny man. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced severe shoulder pain (shoulder at the injection site hurting). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe shoulder pain (shoulder at the injection site hurting). This report was non-serious.
Reaction on both thighs from Hep A, Daptacel, and Prevnar.  All three sites were red, swollen, and warm to touch. On the left thigh, they measured 2 x 1 1/2cm and 3 1/2 x 1 1/2 cm.  On the right thigh, it measured 3 x 2 1/2 cm. Treated with benadryl and tylenol and ibuprofen.
11JUL95 pt recv vax & screamed for 24 hrs, fever above 100; MD was not used but parents called pediatrician; mom called MD 18JUL & they had documented mom reported rt leg red & swollen, cried for sometime;
immed post vax pt exp redness, itching, swelling, joint pain, went to bed during day (unusual) fever, does not feel well,hoarseness, wheezing, hives, weakness;
Bloody nose , fever , blurred vision , ear ringing , nausea , tiredness. Slept for 20 hours. Periods of extreme headache and feelings of burning behind my eyes and in my ears.
Mother reports fever of 101 and decreased appetite as well as left leg feeling warmer to touch than right leg. Infant was vaccinated at appx 1610 PM on 4/10/17 and held for 15 min following immunizations. No reaction noted.
Patient given vaccine out of recommended age range. Patient reports her arm was sore for 2 days
Headache, fatigue,  achy joint pain, cold, and a bit nauseated.  This started in the middle of the night on the 18th and lasted all the next day, the 19th.  I took one acetaminophen tablet every 6 hours until morning of the 20 when the symptoms went away.
headaches; Chills; nausea and vomiting; nausea and vomiting; arm started to swell; Dry mouth; Weakness; This is a spontaneous report received from a contactable reporter (Consumer).  A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 22Mar2021 09:00 (Lot number: EN6204) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Aneurysm" (ongoing), notes: Diagnosed about a year ago, on right side of brain, 2mm very small; "Lupus" (ongoing), notes: Diagnosed a few years ago. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 22Mar2021, outcome "recovering", described as "headaches"; CHILLS (non-serious) with onset 22Mar2021, outcome "recovering", described as "Chills"; NAUSEA (non-serious), VOMITING (non-serious) all with onset 22Mar2021, outcome "recovering" and all described as "nausea and vomiting"; PERIPHERAL SWELLING (non-serious) with onset 22Mar2021, outcome "recovering", described as "arm started to swell"; DRY MOUTH (non-serious) with onset 22Mar2021, outcome "recovering", described as "Dry mouth"; ASTHENIA (non-serious) with onset 22Mar2021, outcome "recovering", described as "Weakness". The events "headaches", "chills", "nausea and vomiting", "nausea and vomiting", "arm started to swell", "dry mouth" and "weakness" were evaluated at the emergency room visit. Additional Information: The reporter stated that she was told to call about the symptoms her mom was having. The reporter stated her mom got the Pfizer Covid vaccine on Monday, 22Mar2021, and she has had some side effects and the doctor told her to call them in. The patient got the first dose on 22Mar2021 around 9AM. After a few hours later she started having headaches, got chills and extreme nausea, her arm started to swell, had dry mouth and felt weakness. These all occurred on the same day and have improved since then. The patient went to urgent care around 8:30PM on 22Mar2021.  No follow-up attempts are possible. No further information is expected.
HAD THE SERIES OF 3 GARDISIL VACCINES, HAVE BEEN EXPERIENCING PAIN IN FEET, HANDS, THEN OTHER JOINTS, BEEN TO DOCTORS, JUST BEEN TOLD MAY HAVE RHEUMATOID ARTHRITIS!!  AT AGE 28.  THESE SYMPTOMS STARTED AFTER THE VACCINE,BUT HAVE WORSENED OVER LAS 9-12 MONTHS!!  I THNIK IT IS FROM THIS VACCINE!  WHAT CAN WE DO? DON'T WANT MY DAUGHTER TAKING RA MEDS IF SOMETHING ELSE CAN HELP!!  2/2/09 Rheumatology consult received for eval of joint pain dated 12/19/08.  Pt initially c/o sore feet, particularly in MTP joints x 2 yrs. Hand pain x 1 yr.  Recent hand swelling jaw pain, and R shoulder, elbow and wrist pain with morning stiffness x 30 minutes. (+) canker sores and fever blisters. PE (+) for L posterior cervical lymph node, decreased thumb flexion, joint tenderness, synovitis, and swelling. Presntation c/w inflammatory arthritis such as RA.
Got COVID Moderna vaccine at 8:35 AM. 10 minutes post vaccine felt like tongue was itching, 4/10. 12 minutes felt like throat was tight. Given 25mg of benadryl oral, 18 minutes (8:53 AM) felt like throat was itching. Given IM epi 1mg L hip. HR at 68. Felt like symptoms stopped worsening. Given 25mg of benadryl IM. She is breast feeding, discussed risks of antihistamines drying breast milk, but needed to stop reaction,  encouraged good hydration and pumping for the next several days). Tightness resolved, itching improving. Vitals stable. 9:20, itching resolved.  Dad here to drive her home and stay with her. He is a retired nurse so she feels good in his care. Discussed emergent care if needed. Discussed that since she had COVID and 1 vaccine, will need to pre-treat with antihistamines before 2nd vaccine, and may want to hold on receiving 2nd vaccine for now. The patient had the following order(s) completed today: Adrenalin epinephrine inject Per .1 MG. Obtained on 07/07/2021, Dose 1 mg via Intramuscular on Left buttock and Diphenhydramine hcl Benadryl (50 Per Unit). Obtained on 07/07/2021, Dose 25 mg via Intramuscular on Right buttock.
PT MENTIONED REDNESS AND SWELLING ALONG WITH A "HOT TO THE TOUCH" FEELING AT INJECTION SITE OF UPPER RIGHT DELTOID.
Patient tested positive for COVID-19 by PCR on 4/2/21, >2 wks after fully vaccinated w/ Pfizer vaccine.  Was asymptomatic and only tested due to upcoming procedures at our medical facility.  Patient had a previous positive COVID by PCR test on 8/22/20.
Mom called office after leaving office. Child was given vaccines around 12:30pm. When giving child a bottle around 2pm mom noticed that child was beginning to develop hives.  By the time he finished the bottle he as broken out from head to toe. Mom noted that child was very itchy and agitated. Mom laid child down for a nap and made sure he was in a cool room without clothes on. Mom has been observing child and has noted child has not had any trouble breathing at this time. Mom called office and sent pictures to the office for review. Child has eczema and already had a mild rash. Mom was given okay to use liquid Benadryl at  dose per provider of 2 ml every 6 hours prn. Mom to keep a close eye on child and if swelling spreads, especially to face/mouth, or any trouble breathing develops mom was instructed to take child to the ER.
got sick as a dog; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 26-Nov-2020.  This case involves a 66-years-old patient who reported that the patient got sick as a dog (sickness), while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient stated that the patient got sick after the patient got the shot.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.  The reporter assessed the causal relationship with suspect vaccine as related.
pt got dizzy & fainted w/in first 3 mins of receiving vax; struck head (occipital area) on the counter top then forehead on the floor; came to quickly but for a split second rolled eyes back in head; some jerking motions;
This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients over 14 years of age received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date of the administration of GARDASIL 9 for this patient (gender not specified) was reported to be 1) 09-AUG-2016. [Date as reported.] No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
BROKE OUT IN HIVES ALL OVER HIS BODY AND HAD TO GO  TO THE EMERGENCY ROOM
This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, concomitant medications or medical history were reported. On 12-MAR-2019, the patient was inadvertently vaccinated with VARIVAX lot # R024022 with expiration date on 22-AUG-2020 and PROQUAD recombinant Human Albumin (rHA) with lot number R013575 with expiration date on 10-NOV-2019 (dose and route of administration was not reported) MERCK STERILE DILUENT. However, no adverse effects were reported.
Within 30 seconds of getting the shot, I passed out. EMTS immediately administered first aid to me, and had me wait quite a while before letting me leave. They insisted that just because I passed out,please come back for 2nd dose April 5 at 7:30am.