chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had shooting nerve pain down arm upon administration. Had normal soreness in arm following the vaccination for the next day. However, the nerve pain which is located 3 inches down and 1 inch to the left of the injection site was still bothersome with a pain that ran down from ring finger up to neck. She thought it possibly got aggravated from carrying her son on the 27th and called the 28th of October with questions. I called her doctor and doctor will be returning a call to her and me on October 29th with advise beyond rest and Advil, which patient was already doing.
Patient son states that his mother loss her hearing on 8/21/2020 . States that he took his mother to ER because she could not hear. Stated that doctor did a CAT scan and had no answer for sudden hearing loss. Patient had no fever, redness or soreness at injection site. States she has had good hearing until 8/21/2020. MD gave patient some antibiotic if she had a possible ear infection. Son reports his mother still can not hear
At 1543, patient reported slight dizziness and general weakness to EMT. Patient given water and offered anti-gravity chair. Patient drank water and denied anti-gravity chair. At 1544, Paramedic assessed patient vitals: blood pressure 110/70 mmHg, pulse 66 beats/minute, and 93% SpO2. Patient reported history of fainting with prior vaccinations and a heart murmur. At 1600,  Paramedic assessed patient vitals: 115/70 mmHg, pulse 73 beats/minute, and 93% SpO2. At 1610, Paramedic reassessed patient vitals: 115/70 mmHg, pulse 66 beats/minute, and SpO2 92%. Patient reported she wanted to leave. Patient reported feeling less dizzy and weak. Lead nurse educated patient on signs/symptoms of when to seek emergency care, to sign u on website and to follow up with primary care provider. At 1613, patient left facility with steady gait and unlabored respirations, accompanied by husband and Paramedic.
This spontaneous report from a contactable other healthcare professional (HCP) and from contactable physician. A 18-year-old male patient of an unspecified ethnicity received the first single dose of TRUMENBA, (lot M13065, expiration date Apr 2017) intramuscular in the right upper arm on 06Jan2016 at 5pm. Medical history included ongoing attention deficit/hyperactivity disorder (ADHD) since 29Dec2011 and ongoing Tourette's disorder since 2010. Concomitant medication included ongoing FOCALIN since 22Feb2014 at 10 mg twice a day (at 9 am and at 9 pm) oral for ADHD. The patient experienced redness and swelling at the vaccination site on an unspecified date in 2016. Due to the reported events the patient did not receive any emergency room or physician visit. No specific date in 2016. Due to the reported events the patient did not receive any emergency room or physician visit. No specific tests and/or treatment was required. The reporter considered there was a causal relationship between TRUMENBA and the reported events. Outcome of events was unknown at the time of this report.
w/in 24 hrs of 1st dose of Engerix-B devel an allergic type reaction; arthritis; joint swelling, feet, hands, knees, t100-101 & fatigue;
That afternoon I noticed my arm becoming more and more sore. The next day, late morning I started feeling achy and tired like I was getting sick. Over the weekend I noticed the feeling of nausea starting...By Monday I felt like I had the flu. I hurt all over, very tired and weak feeling, nausea, diarrhea, headache and my arm was sore from my shoulder all the way down almost to my elbow. It hurt to move or touch it, however it never turned red or got hot. This lasted until the next Friday, one week and one day after the shots. The teatnus shot in the other arm never got sore or bothered me in any way. The literature regarding SHINGRIX states 2-3 days, but I had every symptom for a full week.
Patient started to experience stroke like symptoms at 2pm after receiving his second dose of the Moderna Vaccine. He was rushed to the emergency room a 6pm. Diagnosed with stroke at 8pm. As of 4/27 patient is still at the Medical Center. He will be transferring to a Rehabilitation Center on 4/27/21 for stroke Rehabilitation.
12 year old patient administered dose of Flublok, no AE; Initial information received on 21-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 year old patient who received 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], (Product administered to patient of inappropriate age).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   No other vaccines administered to the patient.  On 21-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number uj497aa and expiry date: not reported) via an intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of actual medication error due to product administered to patient of inappropriate age (latency on same day).  At the time of report 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 holder's 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.
Felt tightness and pressure on her throat, called EMS and treated with 25 mg of Benedryl immediately at 10:15 during her post observation. Happened 10 minutes after receiving the vaccination
concussion syndrome; dizzy; head fuzzy, vertigo; nauseous with a sore neck; nauseous with a sore neck; head fuzzy, vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Feb2021 (Lot number: Unknown) at the age of 64 years as dose 2, single and administered in arm left, administration date 31Jan2021 13:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CONCUSSION (non-serious) with onset 01Feb2021, outcome "recovered" (2021), described as "concussion syndrome"; DIZZINESS (non-serious) with onset 01Feb2021, outcome "recovered" (2021), described as "dizzy"; VERTIGO (non-serious), FEELING ABNORMAL (non-serious) all with onset 01Feb2021, outcome "recovered" (2021) and all described as "head fuzzy, vertigo"; NAUSEA (non-serious), NECK PAIN (non-serious) all with onset 01Feb2021, outcome "recovered" (2021) and all described as "nauseous with a sore neck". The events "concussion syndrome", "dizzy", "head fuzzy, vertigo", "nauseous with a sore neck", "nauseous with a sore neck" and "head fuzzy, vertigo" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of concussion, dizziness, vertigo, nausea, neck pain, feeling abnormal.  Additional information: After the first vaccine, Patient came down with reported event and all got worse after the second vaccine, has been like this now for the past few weeks. Patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Other medications the patient received within 2 weeks of vaccination: No. Prior to vaccination, the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Allergies to medications, food, or other products: none. Seriousness was reported as: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Medical assistant reported that an unspecified number of patients might have received an unspecified number of doses of MMR II (lot #, dose, frequency, route and indication not reported) that were exposed to temperatures outside of the prescribing information which were not supported. No adverse events were reported. This follow-up was received from the certified medical assistant, who confirmed that MMR II was exposed to temperatures outside of range multiple times for a total time of 7 hours, with a highest temperature of 53F. She did not have any patient specific information. Additional information has been requested.
Patient was shaking for about 30 seconds and appeared to lose consciousness for about 30 seconds.
I noted onset of chronic, mild nausea 15Jan21 to present.  Eating or drinking usually quells it.  Bilateral ramped up to the point &  noted that I am talk louder than usual and am asking 'What did you say?' frequently with hearing aids.  Having to discriminate against tinnitus causes mental fatigue.  Marked increase and violence of head tremor (as noted with influenza vaccine) making sleep difficult where head will not stop shaking.
Pain in my arm; Dizzy; Anxiety; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 53 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "Pain in my arm"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; ANXIETY (non-serious), outcome "unknown", described as "Anxiety". Therapeutic measures were taken as a result of pain in extremity.  Additional information: The patient's arm is better now, it's just a little sore. The patient took ibuprofen 800 (unit unspecified) and drank water and took one.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A report has been received from a Study Investigator concerning a 17 year old, female subject, Height: 4.1 inches; Weight: 94.0 Pounds, enrolled in a study. The patient's medical and concurrent history was not provided at the time of reporting. FLUMIST (intranasal) started on 28-Sep-2013 for influenza. The patient experienced undesired pregnancy which started on 06-Sep-2013. The outcome of the event of undesired pregnancy is unknown. Action taken with FLUMIST was unknown at the time of reporting. The outcome of the pregnancy was reported to be an elective abortion on 24-Oct-2013. The investigator assessed the event of pregnancy to be non-serious.
Shortly after the vaccine I developed severe body pains in my legs, joints and back area.  I had abdominal pain, chills, a massive headache. And my left hand swole which lasted about 5 days. I was 12 weeks gestation at the time of the vaccine and the EDD is 9/18/2021.
3 or 4 days after shot he started getting a cough which caused chest pains, he started getting a tingling feeling in his right leg, heart rate went up and oxygen level dropped
I thought I was having a sinus infection. I had congestion in my head and chest. I took a Covid test the day before new years and it was negative. On new years, a friend of mine said some friends tested positive for Covid. Then, the Tuesday after new years I got tested again and it was positive. They also did a chest x-ray to see if I had pneumonia, but I did not.  I am getting better but I still have some congestion.
About an hour after receiving the vaccine patient's arm became itchy, red, and swollen. Overnight the swelling and pain worsened so the patient went to the pediatrician on 9/10 who diagnosed her with cellulitis. The cellulitis appeared to spread in the evening on 9/10 so the patient with to the ER.
Severe swollen glands and fevers of 102 for 48 hours after the shot. Then woke on 12/14/21 with a mild stutter, aphasia, and migraine that has not abated since.
Expired dose of FLUZONE HD QIV was administered to a patient with no AE; Initial information regarding an unsolicited valid non-serious case was received from a health care professional via a consumer/non-health care professional via Regulatory Authority (RA) (Reference number- 00839623) and transmitted to Sanofi on 02-Nov-2021.  This case involves a 74 year old female patient who was received a expired dose INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccines.   On 02-Nov-2021, the patient received a first 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ537AC, expiry: 30-Jun-2021, formulation: prefilled syringe) via unknown route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  It was reported "Caller states an expired dose of FLUZONE HD QIV was administered to a patient. Caller is looking for information in regards to possible adverse effects as well as if they need to revaccinate. A nurse practitioner (NP) administered a dose of FLUZONE QUADRIVALENT HIGH DOSE today that expired on 30Jun2021. The NP plans to administer a dose of in-date vaccine to the patient as soon as possible."  No other 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 holder's compliance with the requirements set out in the Directive 2001/83/EC. 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.
not getting better, instead getting worse on a daily basis; "can't function at work"; chills; headaches; nausea; something in his stomach; feeling "super sick"; diarrhea 3 times a day; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling "super sick"), DIARRHOEA (diarrhea 3 times a day), ABDOMINAL DISCOMFORT (something in his stomach), CHILLS (chills) and HEADACHE (headaches) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced MALAISE (feeling "super sick"), DIARRHOEA (diarrhea 3 times a day), ABDOMINAL DISCOMFORT (something in his stomach), CHILLS (chills), HEADACHE (headaches) and NAUSEA (nausea). On an unknown date, the patient experienced IMPAIRED WORK ABILITY ("can't function at work") and CONDITION AGGRAVATED (not getting better, instead getting worse on a daily basis). At the time of the report, MALAISE (feeling "super sick"), DIARRHOEA (diarrhea 3 times a day), ABDOMINAL DISCOMFORT (something in his stomach), CHILLS (chills), HEADACHE (headaches), NAUSEA (nausea), IMPAIRED WORK ABILITY ("can't function at work") and CONDITION AGGRAVATED (not getting better, instead getting worse on a daily basis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
Around 3AM noticed his lips were swelling so he went to ER. While in ER he broke out in a red rash all over body. Given "three antibiotics" (actually prednisone 60 mg for 7 days, Pepcid 20 mg for 14 days, and Benadryl 25mg x1. States rash and swelling went down as soon as he received the medications. No further problems after he received treatment. No labs drawn.
pt recvd MMR vax & currently exhibited a lack of response to mumps; no further details were provided;
1 week after vaccine the patient experienced  a 5-6 inch red area extending down  her arm. She reports arm feeling funny, almost numb, she also noticed a rash. I seen the rash today ( 1/25/2021) it is almost resolved.
pt called c/o swelling, redness, pain & warmth @ site of inj;states has been using ice & taking Ibuprofen;went to ER 23AUG96 & tx by MD & given ATB & pain med;
Bumps raised on legs after taking a shower and shaving my legs; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH mRNA COVID-19 VACCINE; Lot number: EL9269) via unspecified route of administration on the left arm as a single dose on 03Mar2021 at 9:45 am for COVID-19 immunisation. Relevant Medical history included Atrial Fibrillation, Atrial Tachycardia and Meniere's Disease. The patient was allergic to the drug Tramadol. Concomitant medications included Eliquis (MANUFACTURER UNKNOWN) 5 milligram, Sotalol HCL (MANUFACTURER UNKNOWN) 80 milligram and Triam/HCTZ 37.5 25 unspecified units for unknown indication on an unknown date and unknown if ongoing. The patient had not taken any vaccines in past four weeks before vaccination. The patient had not infected with COVID-19, prior vaccination. The patient has not tested for COVID-19, post vaccination. On 18Mar2021 at 12pm, after taking the shower and shaving her legs, the patient noticed that her legs had raised bumps and they appeared as full of blood. She informed that she had never encountered this response after shaving her leg. The patient has not received any treatment for the event. Clinical outcome of the event was unknown at the time of reporting.    No follow-up attempts are needed. No further information is expected.
Vertigo symptom; extreme dizziness and nausea constantly for 3 days. Went to the emergency room for fluid and nausea medication.  Continued for 4 more days.  Slowly felt less dizzy.
Late afternoon on February 18 I developed a rash on my upper arms.  The rash is worse on the upper right arm.  Over the course of the evening and night the rash spread over most of my body including wrists, upper and lower legs, ankles and butt.  In addition, my lips are swollen and the taste on my lips is salty. This morning I applied topical Benadryl to the affected areas and took two Benadryl (Allergy) tablets (25 mg).  This seems to relieve the itching which is not severe and my swollen lips may be receding.   I plan to continue with this treatment and hopefully the rash and swollen lips will subside in a day or two.
Pt vaccinated with Engerix-B 24 hrs post 2nd dose felt unwell & drained, then fainted. Taken to hospital. Felt nauseated, neck, groins & axilla were tender. Condition lasted x4 days. See WORM for more details.
cause of reaction is unknow, pt also received Flucelvax Quadrivalent  lot# 308467 at the same time in the same arm, and  Boostrix  lot#3A745 in the other (right) arm.  Patient called the pharmacy on 3/25/22 to report a red swollen arm that was very painful and was difficult to move.  She had been taking 800 mg Ibuprofen for the last 2 days without relief.  The pain began several hours after recieving the vaccinations and persisted through the night, which kept her from sleeping.  She described a red swollen area going from the shoulder almost to the elbow.  She complained about the arm being painful and difficult to move and questioned if the shot had been given "too high".  A discription was given about how the placement of the shots had been determined, about 2 inches down from the top of the shoulder and 1 to 1&1/2 inches horizontal to each other.  By the following Monday,  3/28 she said the arm was feeling "a little better".  She had taken some Keflex for a suspected cellulitus and wasn't sure if it had helped but was going to continue  taking it for a few more days.
The day after vaccination, experienced severe headache, nausea, edema of left upper arm and left axilla.  Area of redness, slightly elevated approximately 2.5 inches x 1/2 - 1/4 inch in width noted in left upper arm below injection site.  States also radiating pain in left shoulder/neck.  Has applied moist heat to area and to arm.  Ibuprofen for discomfort.
rash; itchiness; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced rash and pruritus. On an unknown date, the outcome of the rash and pruritus were unknown.   It was unknown if the reporter considered the rash and pruritus to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The caller was from a pharmacy who had a question about Shingles vaccine. The patient received 1st dose of Shingrix and next day broke out with rash on neck and spots on arms and itchiness, the patient wanted to know if she should get 2nd dose of Shingrix. The reporter asked how effective would it be at 1 dose. The reporter filed adverse event with limited information.
Client lost consciousness following the 3rd vaccine (out of 8 needed) with tonic arm movements, then would become semi-conscious with high pitched screaming/crying. This cycle repeated 8 times. EMS contacted and transports client to Hospital.
Employee c/o fever on 3/1/16, as well as rash and itchy bumps on arm. 3/2/16 she had increased bumps to torso, hips. Sent to medical for work comp evaluation. Determined to be adverse reaction to varicella vaccine.
Both sites have redness, warmth, swelling, and hard knots underneath skin. Pt has been fussy and irritable and not sleeping well since vaccinations. Right side measured 2.5 by 2 inches. Left side measured 1.5 by 1 inch.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 11-JUL-2016, the patient was vaccinated with a dose of improperly stored (wistar ra 27-3) M-M-R II (lot # L026553; strength, dose, route and site of administration were unspecified). This is one of several reports received from the same reporter. Additional information has been requested.
about 1wk p/vax pt devel fever of 103, severe upper rt quad pain;went to ER;blood work/UA done;told had hep c;took reports to specialist the following day;mononucleosis w/inc liver involvement;