chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe pain in abdomen; Severe body/muscle pain; Severe body/muscle pain; Fever 102; Vomiting; Diarrhea; Facial swelling; Severe headache; This is a spontaneous report from a contactable other healthcare professional, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 21Sep2021 at 12:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included common variable immunodeficiency, non-converter of vaccines, COVID-19 and allergy to penicillin (PCN). Prior to the vaccination, the patient was diagnosed with COVID-19. Prior the vaccination, the patient had been tested for COVID-19. On 13Sep2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received influenza vaccine (FLU) for immunisation on an unknown date and experienced allergy. The patient previously also received midazolam hydrochloride (VERSED), pethidine hydrochloride (DEMEROL) and clarithromycin (BIAXIN); all for unknown indication and experienced drug allergy.  On 22Sep2021 at 14:30, the patient experienced severe pain in abdomen, severe body pain/ muscle pain, fever 102 (unspecified units), vomiting/diarrhea, facial swelling and severe headache. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events severe pain in abdomen, severe body pain/muscle pain, fever 102 (unspecified units), vomiting/diarrhea, facial swelling and severe headache was not resolved at the time of this report.
Coughing lot; Pain on vaccination arm; Feels cold; Pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing lot), PAIN IN EXTREMITY (Pain on vaccination arm), FEELING COLD (Feels cold), PAIN (Pain) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced COUGH (Coughing lot), PAIN IN EXTREMITY (Pain on vaccination arm), FEELING COLD (Feels cold), PAIN (Pain) and CHILLS (Chills). At the time of the report, COUGH (Coughing lot), PAIN IN EXTREMITY (Pain on vaccination arm), FEELING COLD (Feels cold), PAIN (Pain) and CHILLS (Chills) outcome was unknown.            No relevant concomitant medications were provided.  No treatment information was provided.
17 month old male, previously healthy with an unremarkable medical history with no prior adverse reactions to vaccines, presented to us initially with suspected Hypotonic-Hyporesponsive episode s/p DTaP.  24 hours after DTaP #4 and IPV #3 was administered, the patient developed "weak, wobbly legs", with "difficulty walking", with a "wide-spaced gait".  Other musculoskeletal symptoms included difficulty eating ("gagging on food").  Behavioral symptoms included "clinginess, fussiness, low energy".  A facial rash also developed at the same time (red, individual mac-pap rash, non-pruritic on the cheeks and some on the neck; total of about 20-40).  4 days later, the patient developed a temperature of 100.1-100.2F, in addition to a cough, and rhinorrhea.  5 days after the vaccine, his gait and behavior started to improve, with full recovery by day 6.
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: 15 minutes post administration patient reported numbness /tingling @ left wrist and left hand (outside edge of hand along little pinky finger side).
3/11/21 orthostatic hypotension, Fall and N-Stemi dx at a hospital -3/12 transferred to another hospital - 3/16 discharged to Swing bed at another hospital   HPI: History of Present Illness:  Patient is an 89-year-old Caucasian male with a medical history significant for atrial fibrillation on anticoagulation due to prior GI bleed, HTN, HLD, T2 dm, BPH who initially presented to outside facility following a fall.  Fall was mechanical in nature and occurred whenever he slipped on water while walking with his cane out the front door.  Primary point of impact was on his left leg in hip as well as possible head trauma.  Preceding this event, patient denies any presyncope, syncope, chest pain, shortness of air, palpitations.  An extensive workup was performed outside facility including CT scan of the left hip without contrast, CT scan of the head without contrast, lumbar x-ray, CT scan of the left knee without contrast all of which showed no acute fracture or abnormality.  EKG showed normal sinus rhythm heart rate of 75 with incomplete RBBB.  Labs are included below.  Vital signs normal.  Patient was getting ready to be discharged from facility and whenever they sat him up, he had an episode where he stared ahead and got diaphoretic as well as dizzy.  Patient has recollection of this incident.  Outside ER decided to get troponin at that time and came back elevated at 0.163.  Patient continues to deny any chest pain.  Denies other associated symptoms including fever, fatigue, chills, shortness of air, palpitations, abdominal pain, nausea, vomiting, diarrhea.   CBC:  WBC 9.2, HGB 13.4, HCT 39.3, PLT 223 BMP:  Na 141, K 3.7, Cl 104, HC03 31, BUN 22, CRT 0.94, GLU 124.  PT 10.5, PTT 24.7, PLT 1.07.   Due to lack of Cardiology coverage at outside facility, patient transfer was requested for further troponin trending and possible cardiology evaluation should be deemed warranted.  hpi 3/16 The patient is a 89 y.o. male with a past medical history notable for atrial fibrillation, CAD, diabetes, BPH, hyperlipidemia. The patient presents for evaluation of worsening issues of weakness status post recent hospitalization were patient was fainted and was found to have orthostasis. Patient had a cardiac workup which was negative for any significant cardiac disease. Patient's plan is to hopefully get stronger return home to more independent living. Patient was seen today in his room. Patient notes that he has done very well with therapy after his fall. Patient is hoping to get stronger. Patient has no issues with any bowel or bladder function. Patient denies any shortness of breath. Patient has had good intake. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed.
Moderna COVID-19 Vaccine EUA Chills, fatigue, restlessness, fever up to 100.9 beginning at ~5pm -11pm, relieved by tylenol, ~400am headache relieved by tylenol
Within minutes of injection: numbness, weakness, tightness of left wrist. Mostly resolved. Within hours of injection: chest tightness/heaviness. Mostly resolved. Morning post-injection: TMJ or tightness/pain in jaw. Persistent still.
Amenorrhea from November 15 to April 19. No spotting, only tender breasts, fatigue, and menstrual-like discomfort in lower abdominal region throughout the 23 week period, mimicking symptoms of oncoming menstruation for 6 months.
This case was reported by a consumer and described the occurrence of pinkeye in a 12-year-old male patient who received DTaP vaccine. Previously administered products included DTaP, DTaP, DTaP, DTaP and DTaP with an associated reaction of prophylaxis (DTA). Concurrent medical conditions included slow speech development. (He was okay but he was not trying to talk at 18 months of age) and attention deficit/hyperactivity disorder. On 20th January 2015, the patient received the 5th dose of DTaP vaccine. On 20th January 2015, an unknown time after receiving DTaP vaccine, the patient experienced wrong vaccine administered. On 21st January 2015, the patient experienced pinkeye. On an unknown date, the outcome of the pinkeye was not recovered/not resolved and the outcome of the wrong vaccine administered was unknown. It was unknown if the reporter considered the pinkeye to be related to DTaP vaccine. Additional information: The patient is the caller's son. He received DTaP vaccinations on 3/8/2004, 5/11/2004, 7/2004, 1/22/2008 and a DTaP/HIB on 04/27/2005. He was supposed to get a TDAP vaccination on 2/20/15, but was given another DTaP by mistake. The hospital told her over the phone that the last DTaP was a GSK product.
COUGH; CHILLS ON AND OFF; HEADACHE; HIGHEST FEVER 102.4 ON AND OFF; ARM SORE FOR A WHILE; BODY ACHE ON AND OFF; GOOSE EGG ON ARM; STAYED IN BED OR ON THE COUCH FOR TWO DAYS; ELEVATED HEART RATE FOR ABOUT 4 HOURS; ANXIETY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On SEP-2021, the patient experienced body ache on and off. On SEP-2021, the patient experienced goose egg on arm. On SEP-2021, the patient experienced stayed in bed or on the couch for two days. On SEP-2021, the patient experienced elevated heart rate for about 4hours. On SEP-2021, the patient experienced anxiety. On SEP-2021, the patient experienced arm sore for a while. Laboratory data included: Heart rate (NR: not provided) Elevated. On 20-SEP-2021, the patient experienced cough. On 20-SEP-2021, the patient experienced chills on and off. On 20-SEP-2021, the patient experienced headache. On 20-SEP-2021, the patient experienced highest fever 102.4 on and off. Laboratory data included: Body temperature (NR: not provided) 102.4 (unit not provided). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from goose egg on arm, stayed in bed or on the couch for two days, elevated heart rate for about 4hours, and arm sore for a while on SEP-2021, and highest fever 102.4 on and off on 22-SEP-2021, and the outcome of chills on and off, cough, headache, body ache on and off and anxiety was not reported. This report was non-serious.
I have a rather large welt on my right arm surrounding the vaccination site - about 3 inches by 8 inches or so.  It looks like a hive.  I only noticed it when it began to itch.  The site is a bit sore and still itches four days after onset.  I have been taking Tylenol for it which seems to help.  Is this really a "rare" reaction so long after receiving the vaccination?  Just curious.
it was so faint; he checked his temperature, it was 100.3; Body aches; aching in hips; Chills; little mild headache; arm started hurting/his arm was so sore; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration in left arm on 19Jan2021 16:00 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were none. The patient on 19Jan2021 at about 4:00PM, got his first dose of vaccine, later clarified as COVID vaccine, and he was very energetic last night, he didn't feel the medicine going in, but today (20Jan2021), the more he was up, the worse he felt, and he checked his temperature, it was 100.3, and his employer said to not come in today, he knew can't get the virus from the vaccine, but this was not a side effect listed on the sheet. He had body aches, his arm, he can't hardly lift it, and last night he was so energetic and felt great, but his arm was so sore throughout the night, it woke him up, and he was aching in hips/aches primarily in his hips, he has hip issues, but was achy in that area. He was also starting to get a little mild headache, it was so faint right now, his symptoms came along the longer he was up, the more he was experiencing things. Primary care doctor's information declined, stated he didn't have one, he moved to another state, and didn't have one yet. Workplace said not to come if temperature was 100.4, but it's so borderline, so they said to stay home. Outcome: he had checked 4 times, and it kept saying 100.3. Overnight, his arm started hurting, but he got up today, and had chills and body aches. His arm was not hurting if he moved his arm, but other than that, he felt like something was there, but didn't ache or anything. The outcome of events faint, chills and headache was unknown, for events temperature was 100.3, body aches, arm hurting, and aching in hips was not recovered.
Adult dose HEP A given instead of pediatric dose - no signs/symptoms - patient was seen in office for recheck 8/13/10 and discussed with parents.
(I don't know what type of Influenza vaccine I was given. Form doesn't say. Manufacturer GSK) My arm continued to hurt, and felt weak. After several weeks, I attended exercise class, which works every muscle in the body, includes Zumba, Bands, Balls and weights, hoping this would serve as rehab for my arm. It didn't work. My arm was still weak, I had very little range of motions and severe pain. So, six months after the injection, I went to my doctor, who referred me to Physical Therapy. The pain is a bit less, but not gone. My range of motion has improved 6 to 7% after six sessions of PT. I still have four more sessions, but I am very concerned that my arm is not even close to back to normal.
About 4-5 hours after receiving flu shot, substantial swelling  had formed around injection site (circle with diameter of about 5 inches). Swollen skin was warm and tender to the touch. Center of swollen area was reddish, surrounded by tight white skin, with a reddish border. Itching was minimal. Doctor recommended treatment with Benadryl (standard dosage, per directions on bottle)
Severe swelling of face (especially eyes), rash on chest and back, skin felt hot.
Nurse administered entire vial of Moderna Bivalent Vaccine (2.5 mL) to recipient instead of the recommended 0.5ml dose. No symptoms reported at the time of making report.
Both arms sore; Back pain; Ringing in ears; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 27Apr2021 at 09:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, high blood pressure and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL XR), losartan potassium (LOSARTIN) and tamsulosin (MANUFACTURER UNKNOWN) all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 30Mar2021 at 09:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 15:00, the patient experienced both arms sore, back pain, ringing in ears and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events both arms sore, back pain, ringing in ears and tiredness were not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
12 hrs after receiving the vaccine, I was going to sleep and my heart started beating very rapidly on and off for about 10-20 minutes and my chest felt like it was all congested on and off for the same 10-20 minutes.  Other than being a little sore, no more issues until 1 week later......my left arm started getting sore and it swelled up, turned red, got very itchy and was extremely hot to the touch.  Ice pack did not help much.  Swelling started going down 6 days later.  Apparently it's being called "Covid arm?" I also had an odd shaped, non-itchy splotch just behind my armpit.  It showed up out of the blue the day after my arm swelled up, but went away on it's own after a few days.
Medical Assistant administered an influenza vaccine but noticed leakage from the syringe and the needle. More than half was not administered. NP reviewed CDC guidelines and recommended the MA readminister the vaccine during the visit.
Local swelling followed by pain and stiffness, initially affecting the right shoulder, then affecting entire torso
Sudden onset of severe abdominal pain with diarrhea and bloody stool/fluid on Wednesday 1/20/21.  Very weak/lightheaded. To ER on evening of 1/21 - CT noted 2 Thrombi in each branch of portal vein and ischemic colitis of descending colon. No risk factors determined.  Only change in life was Covid-19 Moderna vaccine.   Other side effect from vaccine was only a sore are at injection site.  Seen by surgery and hematology.   Rapid Covid test was negative and wife's pcr  Covid test was negative. As of today is feeling significantly improved but not yet taking PO and remains on heparin drip.
On 2/7/2021:  Patient came to ER with symptoms of cough, congestion, weakness, nausea, vomiting, and diarrhea x 2 days. Shortness of breath.  Patient reports she has been experiencing chest pressure and states that pain is worse with deep breathing and movement.  She denies radiation.  No cardiac history.  Reports secondhand smoke exposure but denies history of smoking.  Patient additionally reports nausea and diarrhea.   On 2/4/2021: Patient came to ER with symptoms of right sided numbness face and arm.   On 2/4/2021: bilateral tingling and weakness of his lower extremities.
patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Upon second medical examination of the case during internal review on 23-Oct-2019, a significant correction was performed on 15-Nov-2019 to correct the case as valid from non-valid.  Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 62 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as left) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  Addendum on 23-Oct-2019: a significant correction was performed on 15-Nov-2019 to correct the case as valid from non-valid.
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 7th September 2021, the patient received the 1st dose of Shingrix. On 7th September 2021, 6 hrs after receiving Shingrix, the patient experienced general body pain and influenza-like symptoms. On 8th September 2021 22:00, the outcome of the general body pain and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the general body pain and influenza-like symptoms to be related to Shingrix. The patient self-reported this case. The patient stated that after 1st Shingrix dose given in his right arm and experienced flu like symptoms, body aches and pain on the same day and were resolved by the end of the next day at 10 pm. The reporter could not provide the lot number or expiration date of Shingrix vaccine he was administered. The reporter did not want to provide his address or email when collecting demographics. The reporter consented to be contacted however did not want to provide his physician's demographics. For tolerance of 2nd dose refer case US2021263854, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021263854:same reporter.
Unconsolable crying with high pitched cry for 4-5 hours. Pink hard nodule left leg.
Approximately 15 minutes after receiving the Covid booster vax, patient asked if it was normal that he felt warm. He stood up to leave the clinic after waiting his mandatory 15 minutes. He spoke and ambulated without s/sx of distress or difficulty. There was no diaphoresis, coughing, SOB, or skin color changes noted. Also note, prior to receiving the vaccine, during the screening process, the patient said, "I know this is going to mess me up, I just know it is." When queried further, the patient denied any allergies other than dilaudid.   RN told the patient to remain in the clinic at least 15 more minutes and advised the public health nurse who provided cold packs and suggested he use them on his face and/or neck. Upon further assessment, patient also complained of slight nausea and was belching without emesis present. RN had patient go into a private area to place cold packs and remove his mask; the entire time he was visible to this RN. Next, about 20 minutes after the vaccine was administered,  Staff was consulted and the patient now had red patches where the cold packs had been. He remained alert, oriented, and able to speak clearly but belched frequently. He still complained of feeling "hot" and now mild diaphoresis was noted on his brow. Staff provided patient with something to drink and continued to monitor from approx 3 meters distance.   At about 25 minutes after the vaccine administration, RN asked Staff who was passing by, to check on the patient in the lactation room. The medic alerted Staff as the patient's condition seemed to have deteriorated. They took the patient away from the lactation room - he was able to ambulate without difficulty - for further evaluation and treatment.   He was then evaluated by a physician and given 40 mg prednisone, 50 mg benadryl and 4 mg of Zofran (all oral, no IVs). He improved without epinepherine per Dr. who stated that "given that patient can demonstrate when and how to use epi autoinjector and has another person in his domicile than can help him, the patient was discharged. Patient to take prednisone 40 mg daily for 5 days and use benadryl as needed for itchiness."  Note:  medication was COVID MRNA vaccine Pfizer lot #FJ8757 given in left deltoid