chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Crohn's disease aggravated; Vaccination site pain; Vaccination site rash; caused sore arm at injection site; fever; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4287516-00.  A 18 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 30Apr2021 (Batch/Lot number: unknown) at the age of 18 years as dose 2, single and intramuscular, administration date 09Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CROHN'S DISEASE (medically significant), outcome "not recovered", described as "Crohn's disease aggravated"; VACCINATION SITE PAIN (non-serious) with onset 09Apr2021, outcome "recovered" (Apr2021), described as "Vaccination site pain"; VACCINATION SITE RASH (non-serious) with onset 09Apr2021, outcome "recovered" (Apr2021), described as "Vaccination site rash"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "fever"; PAIN IN EXTREMITY (non-serious) with onset 09Apr2021, outcome "recovered" (Apr2021), described as "caused sore arm at injection site". The action taken for adalimumab was unknown.  Causality for the  Drug : Pfizer BioNTech covid-19  vaccine(tozinameran)(tozinameran),unknown for the events Crohn's disease aggravated, vaccination site rash,  vaccination site pain, fever was reported as probable and not reported for the event caused sore arm at injection site.  Causality for the Drug : HUMIRA(Solution for injection in pre-filled  pen)(ADALIMUMAB), ,unknown for the events Crohn's disease aggravated, vaccination site rash,  vaccination site pain, fever was reported as no reasonable possibility and not reported for the event caused sore arm at injection site.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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
Diarrhea, blood in stool, grabbing at groin area (patient is nonverbal).  Increased ulcerative colitis meds, had stool tested and the result was severe inflammation of the intestines. Patient is on steroid currently for this condition.
swollen throat; headache; felt tired; This case was reported by a consumer and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th December 2020, the patient received Shingrix. On 27th December 2020, 1 days after receiving Shingrix, the patient experienced headache and fatigue. On 28th December 2020, the patient experienced throat swelling. On an unknown date, the outcome of the headache, fatigue and throat swelling were not recovered/not resolved.   It was unknown if the reporter considered the headache, fatigue and throat swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported but selected as an adult as per vaccine indication. The reporter stated that, the symptoms were on left side. The patient was looking for more advice.
Patient experienced high blood pressure over 160/90 several hours after vaccine. Patient still has high blood pressure 3 weeks after vaccine. They never had high blood pressure prior to vaccine. Patient also began having recurring migraines the next day after vaccine. Also had heartburn start shortly after, along with sinus drainage.
Patient describes a transient "burning" at injection site. She reports a redness and burning the day after injection (11/13/12). Went to provider (NP) in January for redness/swelling at injection site. Prescribed KEFLEX which resolved the redness. Pt still reports burning 4/11 (no redness or knots at site).
Fever, chills, significant pain at injection site arising several hours after administration and lasting for 3-4 days.
fever; tired; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer (in right side). Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on an unknown date, refer case US2019076856).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced fever and tiredness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever and tiredness were unknown.   It was unknown if the reporter considered the fever and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient's husband. The reporter couldn't recall which arm she received the vaccine in, however, the patient had a history of breast cancer in her right side, so he believed she received the Shingrix in the left arm. It was reported that, with the second shot the patient had a worse fever around 101 degrees F.  The patient felt fine the first day and the next day her symptoms hit. With the second dose, her fever was higher than the first dose. The reporter did not consent to follow-up.      Lab Comments: On an unknown date, the body temperature was recorded as 101 degree F.
Local hive-like reaction at injection site.  Itching at site.  Coughing.  BENADRYL given, 25mg PO.
Left arm and hand swelling; shingles; kidney pain; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 09Mar2021 11:00 (batch/lot number: EN6206) as 2nd dose, single for covid-19 immunisation. Medical history included breast cancer and Lyme's disease. The patient was not pregnant. Concomitant medication included trastuzumab (HERCEPTIN). The patient received first dose of bnt162b2 on 16Feb2021, 01:00 for covid-19 immunisation. On 09Mar2021 17:00, the patient experienced left arm and hand swelling, shingles and kidney pain. The events were considered serious due to disability. The patient received treatment for the events. The patient underwent lab tests and procedures which included ultrasound with unknown results on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of events was not recovered.
Vesicular lesions together w/crusted over and new papular and some urticaria-like lesions all over trunk, few on neck, and all over leg X 6 days now.
2 day fever, itching, swelling of the injection site, injection site induration, some dizziness when arrived home.
Pt recvd 2nd dose Hep B vax & subsequently exp a flu-like illness;
This is a spontaneous report from a contactable consumer (the patient). A 72 year-old female consumer received PREVNAR 13 on 17Sep2015, at single dose. Medical history included triple bypass on 16 June (unspecified year), heart problem, rock filled vessels, angioplasty and cholesterol. Concomitant drugs included carvedilol (manufacturer unknown) on 16Jun2015 and ongoing at 6.25 mg for unknown indication and LIPITOR on 16Jun2015 and ongoing at 80 mg for cholesterol. On 20Sep2015 the heart symptoms returned. After three months of continuing improvement and feeling good in cardiac therapy, the patient experienced chest discomfort 3 days after having vaccination, on unknown date in Sep2015. No admission in hospital was required for the events. The patient underwent an angioplasty on 05Oct2015. A test showed that three grafts have failed after triple bypass on unknown date. This had less than a one percent chance on an otherwise healthy individual. The patient felt that there appeared to be a body rejection triggered by this vaccination. After angioplasty they determined that all the grafts failed and she was searching for any clue that they could possibly had of why they failed as she was facing another open heart surgery and they did not want it to fail again. Lab data included CAT scan and MRI on an unspecified date in 2015 with unknown result. The patient was dealing with two heart surgeons and a cardiologist but they did not know what to do other than repeat surgery. The patient was not recovered from heart symptoms while the outcome of the other events was unknown. Follow-up (10Nov2015): New information reported from a contactable consumer includes: details of concomitant drugs, new events (chest discomfort and test showed that three grafts have failed after triple bypass), onset of the event (heart symptoms), clinical course, outcome.
Information has been received from a consumer concerning his girl friend's approximately 9 year old daughter who on 4/26/96 was vaccination SC in the left arm with a first dose of varicella virus vaccine live (lot # 617355/0567D). There was no illness at the time of vaccination. Subsequently the patient developed chicken pox, described as a very mild case with 15-20 lesions. The child did not develop a fever. She was treated with Aveno baths and calamine (+) camphor (+) lidocaine hydrochloride. No additional patient details were provided. Unspecified medical attention was sought. There was no product quality complaint. Follow up information received from a registered nurse indicated that the patient developed a pruritic rash on her legs, head, back, and belly for 6 days. The patient was diagnosed with attenuated varicella 8 years post vaccination. The reporter indicated that the was no adverse event. Additional follow up information indicated the adverse event onset was 3/29/04. It was noted that the patient recovered on 4/5/04. No further information is expected.
On 5-13-2022, I noticed fatigue, muscle aches all over, feelings of fever but did not check temp, sweating and right arm soreness to the point that I was having problems lifting it. I stayed in bed for 3 days. On day 4,  i noticed swelling to my ankles and hands but I started feeling a little better and was able to get out of the bed and move to a different room. This was almost an identical reaction to dose 3. Two months after vaccination, I still noticed edema to my ankles and hands along with weight gain and this was unusual for me so I made an appointment for 7-13-2022, and I went to my primary care doctor's office and seen the physicians assistant. She ordered quite a few labwork tests. She stated everything was normal except my TSH thyroid panel which showed clinical hypothyroidism. She wants me to return in September to re-evaluate thyroid blood levels. I do still have edema in my ankles and hands and some fatigue as well.
On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced COVID-19 (Officially diagnosed with COVID-19). At the time of the report, COVID-19 (Officially diagnosed with COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Patient says she had body aches, not at injection site or that arm. Runny nose, nausea, headache. Treated as a cold otc with Zicam, vitamin C, meclizine. Still occcuring as of 9 28 13, but symptoms are better.
Chest wall pain left side severe rib pain immediately after vaccination with fever for 3 days.
Patient had recent episode of herpes zoster with a left sided V1-3 dermatomal distribution (hospitalized 4/1-2) which had been improving (nearly resolved) on oral valacyclovir (4/1-17) and prednisone (4/2-6). She received 2nd dose of Moderna COVID vaccine on 4/13, then on 4/15 developed decreased sensation and taste on the left side of her face and on 4/16 awoke with left sided facial weakness and headache. She re-presented to the hospital on 4/17.  LP performed 4/17 with CSF 9 TNC (95% lymph, 4%monos, 1% other), 4 RBC, protein 38 and glucose 51 (tube 1) and 11 TNC (88% lymph, 4% monos, 4% atypical, 4% other), 4 RBC (tube 4). CSF gram stain and culture negative for PMN or organisms. CSF VZV PCR, HSV PCR not detected.  MRI showed supratentorial white matter changes and right petrous apex changes (latter felt to be incidental finding). Patient was treated with IV acyclovir for 14 days (4/17-5/1) and IV methylprednisolone 1g IV Q24H for 5 days (4/18-22).
red injection site; swollen injection site; hard injection site; warm injection site 101.6ºF; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red injection site), VACCINATION SITE SWELLING (swollen injection site), VACCINATION SITE INDURATION (hard injection site) and VACCINATION SITE WARMTH (warm injection site 101.6ºF) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (red injection site), VACCINATION SITE SWELLING (swollen injection site), VACCINATION SITE INDURATION (hard injection site) and VACCINATION SITE WARMTH (warm injection site 101.6ºF). At the time of the report, VACCINATION SITE ERYTHEMA (red injection site), VACCINATION SITE SWELLING (swollen injection site), VACCINATION SITE INDURATION (hard injection site) and VACCINATION SITE WARMTH (warm injection site 101.6ºF) outcome was unknown. Not Provided
Inconsolable crying starting 1.5 hours after the administration of vaccinations on 3/2/04. Inconsolable crying for continuous 4 hours.
Pt fainted immediately after vaccination.  He came to but was nauseated and vomited.  He declined emergency care from ED.  He recovered in about 30 minutes.
Injection site soreness, injection site red, hot and hard lump. Headache, fatigue, tiredness, chills
Pt received vaccines around 11AM. Had febrile seizure around 9 pm. Transported by ambulance to local hospital. Temp 103.3 Had rec'd MOTRIN earlier in evening for leg pain & low grade temp approximately 100.
Five to six minutes after receiving injection, a half dollar sized area appeared. It was swollen (no knot) and the area was red and itching. After an additional 10 minutes, redness had subsided and area did not itch.
On February 18, 2020 the patient received Shingrix in the right deltoid. The patient experienced body aches, chills, nausea and limited mobility for 2 days post-vaccination. Unknown treatment regimen or whether patient sought medical attention for adverse reactions. On February 21, the patient was feeling better though the body aches had not resolved. Pharmacy received a request for further documentation from GSK regarding this ADE.
Started 10 min post vaccine, began to feel chills, nauseous with body aches. Next day, symptoms worse with vomiting. PCP prescribed zofran to use as needed. Denies fever. Symptoms resolved as of 3/21/2021, except for nausea. Follow up with PCP as needed.
mom noticed pt w/blank stare in infant seat 8PM 8MAR95; mom called pt name twice a/pt looked; pt began to fun a fever & became very fuzzy; mom took pt having jerking of body; states cont approx 40 mins; dx URI
Right arm from sholder to elbow is red and hot to the touch.  Patient feels feverish and chills.
Client stated her lips were beginning to tingle shortly after receiving the 2nd covid-19 vaccine. Approximately 5 minutes later client felt the right side of her mouth was feeling swollen. Denied itching of throat, throat tightening or difficulty breathing. Client escorted to urgent care area of clinic for assessment/treatment.  BP 131/91 LA, P 103, RR 16, O2sat 98%. Client given Benadryl 25 mg po and kept in UC for observation. Client felt better and was released by provider 30-45 minutes later.
Acute onset of muscle & joint pain, fever, headache, chills, sweating, weakness & fatigue.  Fever broke at 9:00 PM on 9/27/13. The following day my other symptoms were improved but not resolved.  I felt 100% when I awoke on 9/29/13.
Pt just received PNEUMOVAX booster on 29 Nov 17. Had the Pneumococcal Polysaccharide PPV23 vaccine on Wednesday morning, noted redness and pain at about 0200 the next morning as it woke her from sleep. Called the advice nurse and they triaged her into apt today. Pain bothered her last night. Erythema and edema have greatly reduced since yesterday with application of warm compresses. Tried ibuprofen 400mg 3x yesterday. None today. No pain, drainage or fluctuance noted by patient. Never had before with vaccine. Warm to touch and not bleeding.
He just reported to basic training on 5/23/22 and was given the vaccines on 5/31/22.  Mother is reporting this.  As far as she knows is that he started having some chest pain with vomiting and then the vomiting stopped, the chest pain got worse and worse on activity like running and exercise.  Right after he got the vaccines then they went into actual training.  Then he started having the symptoms and he reported them to the Supervisor who then sent him over to the clinic.  Then they did an EKG and other tests and then he was transported by ambulance to the ER.  Then he was admitted with pericarditis.  After being admitted then he was diagnosed with myo-pericarditis and was there from 6/2/22 to 6/10/22.  Mothers understanding is that he was given steroids, IV fluids, some other medicines such as Colchicine, Solumedrol and 5 treatments with the immunoglobulins.  Eventually they started treating him with immunoglobulins, and then once they did that his troponin's started going down as they were elevated.  Then he was discharged he went back to the base which the cardiologist put him on no strenuous activity for 6 moths.  He continues to have the chest pains.  They are doing a med-board process at this time but he cannot stay in the employment unless he is cleared by the cardiologist, and they are still having him with symptoms and is not going to clear him to stay.  He is due to have a cardiac stress test to determine if he can stay or not.  When he was discharged he was taking a steroid and Ibuprofen but that was discontinued within a couple of weeks.  He has not been treated with anything else for his symptoms.   Mother states that he says that he is very fatigued and depending on what he is doing activity wise he has the chest pains and shortness of breath.   He is being treated at the Facility while on location.
Shoulders, back, and neck began to ache about 9:30pm on 2/5/21.   I went to be about 10:30 pm and woke up at 2:00 am ish with a headache.    I also experienced a muscle cramp in my right calf.   Took 2 Aleve.   Headache (mild), tiredness, muscle aches continued through Saturday.   Woke up on Sunday, 2/7 and feel better.
Swelling and redness at vaccination site that, over the course of 4 days, grew to encompass entire deltoid muscle. Painful to move. Was advised to to go Urgent Care for possible treatment of injection site infection. Presented to Clinic and was told to take Benadryl for treatment of vaccination site reaction.
20FEB91 temp 103 no other sx was given; Pediaprofen @ ER temp down w/in 1 hr;
I had an ear infection last week; This spontaneous case was reported by an other health care professional and describes the occurrence of EAR INFECTION (I had an ear infection last week) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EAR INFECTION (I had an ear infection last week). At the time of the report, EAR INFECTION (I had an ear infection last week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that not known which manufacturer the patient received for her primary Series. Concomitant information was not provided. Treatment information was not provided.
10/02 patient presented to office with left upper arm painful and red. Physical exam left arm over bicep muscle red, warm, swollen. Patient started on AUGMENTIN 500mg two times a day for 10 days. Recommended warm compresses. 10/08 patient seen for follow up. Left arm red, scaly and weeping however showed some improvement from 10/02. Patient to continue taking AUGMENTIN and warm compresses.
Fussy the evening of the shots, woke mom at 7 AM with fists clenched, eyes moving, foaming at mouth x 3-5 minutes, then groggy, no color change: felt warm and sweaty. Mom called doctor on call and came to clinic. Had another seizure on the way home. Sent to  Hospital.
Patient presented to the pharmacy at approximately 7:40 pm on 03/10/2022, requesting a  COVID-19 booster shot. He reports that he completed his original series October 2021 (Astra Zeneca), but did not have his vaccine administration card with him. He completed his vaccine administration record and it was reviewed by the pharmacist.  At approximately 7:55pm, the pharmacist administered the Pfizer COVID-19 (gray cap) 0.3ml dose intramuscularly, in the patient's left arm.  The patient was advised to go sit in the waiting area for 15 minutes to make sure he did not have any reaction before leaving the store (which he did).  About 5 minutes later, the pharmacy technician on duty recognized that patient was losing consciousness.  He had a friend with him, who supported his arm and the pharmacist went quickly to his other side and they were able to keep patient from falling forward or sliding down in his chair.  He regained consciousness in less than a minute. The technician called 911 and an EMT arrived about 10 minutes later. Patient at that time said he felt okay and did not want to go to a hospital. Patient stated that his blood pressure is usually low.  The EMT got her equipment and spent about 15 minutes checking /monitoring patients vital signs. Patient and his friend remained sitting for another 10 minutes after the EMT left, and then they left the store at approximately 8:35pm.
Dizziness, Headache, Myalgia, Arthralgia, Fever, fever chills malaise
This non-serious spontaneous case, initially received on 16-Mar-2018, was reported by a 57-year-old adult male patient. On 25-Feb-2018, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 170105P, expiry date: 31-May-2018). On an unspecified date, after vaccination, the patient developed sore in arm. It was reported that, the patient had pain even after 2 weeks of vaccination. At the time of the report, the patient had not recovered from the event.