chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inappropriate dose of vaccine administered; wrong solution used in drug reconstitution; This case was reported by a pharmacist via patient support programs and described the occurrence of inappropriate dose of vaccine administered in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and wrong solution used in drug reconstitution. On an unknown date, the outcome of the inappropriate dose of vaccine administered and wrong solution used in drug reconstitution were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The pharmacist constituted another solution with the Shingrix vaccine while she administered on the patient, which led to inappropriate dose of vaccine administered and wrong solution used in drug reconstitution. That solution was not a part of the Shingrix vaccine package. No further information was received.
Within minutes of  receiving vaccination, pt stated he  was hot and thirsty, became unrepsonsive to verbal stimuli. Pt proceeded to have tonic-clonic seizure lasting 25 seconds. Pt lowered to the ground by staff, monitored VS. No incontinence, no biting of tongue. pt regained consciousness,  and oriented x3. VSS. pt reported he felt light-headed. When attempted to  place in chair, symptoms returned, and pt was placed back in supine position. EMS arrived, and after VS established, EKG indicated sinus rhythm, placed in chair. Pt stated he did not feel good, and similar symptoms began with eyes rolling back and contractures. Pt taken to hospital.
Noticed this AM a  large (3x3inch) circular rash at site, hard, tender to touch.
Pain, swelling, redness and warmth around injection site began 10/2/10 and increased such that seen at Urgent Care 10/3/10 and then MD office. Emergency room 10/4/10. IV and PO antibiotics, steroids, antihistamines.
pt recv ax & plunger pulled back before inj;lt deltoid area immed began to swell & reached approx 25-30min in diameter & raised 5-7mm;ice was applied & was reduced to about 10mm in diameter;
Just a tiny red mark; This is a spontaneous report from a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms. A contactable consumer (patient) of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation. The medical history and concomitant medications were not reported. The patient did not have pain, swelling or anything. Just a tiny red mark. The outcome of the event was unknown.  No follow-up attempts are possible. Information about batch number cannot be obtained.
This spontaneous report as received from a pharmacist refers to a 62 year old elderly female patient. No information about medical history, concurrent conditions was reported for the patient. On 08-JUN-2015 the patient was vaccinated with one dose of ZOSTAVAX, lot L011529, expiration date 03-JUL-2016. 0.65 ml, subcutaneously. Concomitant therapies included CLARITIN, ZYLET and ESTRACE. On 10-JUN-2015, the patient experience3d 2 inch by 2 inch red, warm, raised, swollen rash around the site of injection. Varicella Zoster Virus Identification Program (VZVIP) package sent to pharmacist and physician assistant. The patient applied ice to the injection site as the treatment for the events reported. The outcome of events was reported as not recovered/not resolved. The patient sought medical attention. No product quality complaint was involved. The causality was not provided by the reporter. Additional information has been requested.
Pt was administered both Janssen and Moderna vaccines. Janssen occurred on 4/2/21 while Moderna was administered on 4/1/21 and 5/5/21.
Shot given at 3pm on Nov. 26th. By 9pm I had headache, fever, chills, extreme fatigue and felt like my hand tendons were going to snap. I could only get out of bed for very brief moments all day the 27th and 28th due to fatigue, chills, muscle/tendon pain.  On the 29th I could do ADLs,  but muscles felt weak. I got a PCR covid test to be on the safe side, it was negative. Nov 30th-Dec 3rd I felt fairly normal during the day, but would completely soak my sheets with sweat at least 6 times each night. This stopped on Dec  4  and I felt fine. On the evening of the 8th, my head started to itch. On morning of the 9th my left flank had several red spots that were itchy and my head, armpits, and groin itched a ton. On the 10th this continued and at 7pm I took Benadryl so I could sleep. That took the edge off, however at 11am on the 11th I started getting huge red areas that would randomly pop up in different parts of my body and my feet, hands, head, armpits and groin were the most itchy yet. These traveling hives (?) continue.  If I scratch or rub an area, it will start to itch, sometimes just passing my hand over an area results in welts and redness and itching. My feet and hands  itch the most, however they are not turning red and I am noticing that  they itch the most with temperature change.  I have never in my life had itchy skin, I do not react to poison oak or have allergies, I have only had a rash once in my life and it was from a hot tub and did not itch.
Severe bodyaches headache fever of 102.4 chills and two days after receiving the injection broke out in hives
Strong headache; Muscle pain; Dizzing; arm pain; chills; join pain; nausea; tiredness; rash; itching; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm left on 17Apr2021 at 14:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and known allergies were reported as n/a. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included fish oil (OMEGA 3), ascorbic acid (VITAMIN C) and zinc (MANUFACTURER UNKNOWN),all for unknown indications from unknown dates and unknown if ongoing. On 18Apr2021 at 01:00, the patient experienced chills, nausea, strong headache, muscle pain, dizzing, arm pain, join pain, tiredness, rash and itching. On 20Apr2021, the patient underwent SARS-CoV-2 nasal swab test and the result was unknown. The adverse events did not result in doctor or other health care professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events chills, nausea, strong headache, muscle pain, dizzing, arm pain, join pain, tiredness, rash and itching were resolving at the time of this report.    No follow-up attempts are needed. No further information is expected.
patient complaining of arm soreness after receiving the flu vaccination on 11/07/2007. Patient made pharmacy aware on 6/9/08.
He experienced headache; He experienced shakiness; He experienced dizziness; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (He experienced shakiness), DIZZINESS (He experienced dizziness) and HEADACHE (He experienced headache) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced TREMOR (He experienced shakiness) and DIZZINESS (He experienced dizziness). On 06-Apr-2021, the patient experienced HEADACHE (He experienced headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TREMOR (He experienced shakiness), DIZZINESS (He experienced dizziness) and HEADACHE (He experienced headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medications were provided.
Redness, swollen, nodule, tender to touch left thigh injection site of Dtap vaccination on 7/15/09 back in office for reevaluation on 7/17/09 and treatment as follows: reaction to DTAP likely, discussed monitor for fever, pus. motrin/ tylenol if tender, can use ice and mild compression for comfort. call if problems or difficulty. Dad aware and agrees.
Extreme tiredness, Confusion, Delusions.   This was on-set after 2nd vaccination.
16 year old patient was mistakenly given the Moderna COVID 19 vaccine booster; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient was mistakenly given the Moderna COVID 19 vaccine booster) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer COVID 19 vaccine and Pfizer COVID 19 vaccine. Past adverse reactions to the above products included No adverse event with Pfizer COVID 19 vaccine and Pfizer COVID 19 vaccine.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient was mistakenly given the Moderna COVID 19 vaccine booster). On 30-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient was mistakenly given the Moderna COVID 19 vaccine booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient who received Pfizer COVID 19 vaccine as primary doses was mistakenly given the Moderna COVID 19 vaccine booster.  No concomitant medication were reported.  No treatment information was reported.
Information has been received from a physician concerning a 19 year old male who on 20-OCT-1993 and 14-OCT-1994 was vaccinated with the first and second doses of MMR II (LOT# not reported). On 28-NOV-2009 the patient experienced mumps. On 30-NOV-2009, the patient diagnosed with mumps. The patient was afebrile and also experienced "pain and swelling under right". The blood work was done on 30-NOV-2009 and the result was not reported. The patient's outcome was unknown, this case was non-serious. Follow-up information was received which reported that the patient on 29-NOV-2009 experienced onset of symptoms. On 30-NOV-2009, the patient was diagnosed with mumps. The patient was fever of 101 F. On 30-NOV-2009, blood work was done and revealed that IgM was 0.28 and IgG was 5.9. The patient's outcome was unknown. The AE onset date and blood work results have been updated. No further information is available.
1 wk symptoms 2 wk recovery complete physical breakdown felt as if hit by a truck" weak, chills, pain back + ribs; chills; nausea; loss of appetite; chest congestion. all cold symptoms. Slept for 3 days; should have been hospitalized.
Increased heart palpitations; almost passed out; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. Medical history included allergies. The patient's concomitant medications were not reported. The patient had not been diagnosed with Covid prior to vaccination. She was not pregnant. On 21Jan2021, the patient experienced increased heart palpitations and almost passed out immediately after second shot. No treatment was received for the events. Events resulted to doctor or other healthcare professional office/clinic visit. Outcome of events was not recovered. The patient was not tested for Covid post vaccination.  Information on the batch/ lot number has been requested.
throat closing up on one side tongue swelling/ numb VS take 154/104 HR 122 97% benadryl 50mg IM given right arm patient was able to leave vaccination site walking out with support person
Patient is a 69 y.o. male patient of MD.   Report on admission: Patient is a 69 y.o. male presenting from home with c/o Patient with history of tonsillar carcinoma.  He recently had an EGD along with colonoscopy and PEG tube placement approximately 5 weeks ago by Dr.  here.  Patient has been doing okay getting chemo and radiation however the last 4 days he seems to have gotten worse with increasing weakness along with increasing trouble swallowing and increasing pain of the throat.  The EGD actually showed that the esophagus and the stomach.  To be normal.  This is mostly in the oropharynx cavity.Patient denies any obvious fever or chills  Hospital course as below.  Infectious disease and oncology followed patient during stay.  Patient was not a candidate for Paxil bed at this time.  Patient was treated accordingly with Decadron.  Patient was discharged home in stable condition and will follow-up with established oncologist as instructed.  1.  COVID: -Chest x-ray no acute abnormalities -Patient on room air, no indication for remdesivir -Decadron for symptomatic treatment -Infectious disease consulted, patient not candidate for paxlovid he cannot swallow pills -Lovenox DVT prophylaxis  2.  Pharyngitis, laryngeal edema: -Imaging reviewed by oncology outpatient -Symptomatic treatment with IV Decadron  3.Oropharynx neoplasm: -follows with oncology outpatient, receiving chemoradiation -9/9/22 underwent bx -Tentative plan was for resumption of radiation tomorrow  4.  Chronic dysphagia secondary to above: -Continue PEG feedings  5.  History of daily alcohol use: -pt states sober since CA diagnosis    6. Acute on chronic anemia: -HH monitoring  -10/13 EGD normal -10/13 c-scope with 2 polyps -received blood transfusion   7. Hypokalemia: -replace -monitor labs  8.  Other chronic medical conditions: Chronic anemia, CAD, hypertension
Patient attested to meeting all criteria for vaccine (including age), and staff did not catch that patient was only 14 years of age. Both prime & booster doses were administered without staff noticing this, and it's not until a couple months later with chart review that we identified this event. Unaware of any harm.
I had the Moderna COVID-19 vaccine shot one on March 16, 2021 and shot two April 13, 2021. I am not sure when the headaches started, but I estimated about two weeks, or about April 9, 2021. The headache on April 23, 2021 was bad enough that my wife called our PCP. My PCP asked me a lot of questions and said for me to get a blood draw and an MRI without contrast STAT. The report dated April 23, 2021 was ?a Large 1.5 cm thick right frontoparietal subdural hematoma with transfalcine right to left herniation measuring 1.0 cm. Tiny parafalcine and left frontoparietal subdural hematomas. Given recent vaccination, consider contrast enhanced MRV to rule out venous sinus thrombosis.? I was ordered to go to the ER where I was admitted the same day. A neurosurgery team performed an operation on April 27 to drain the internal bleeding that had occurred (possibly for over a month). As I was about to be released on April 28, 2021, my heart monitor recorded a ventricular tachycardia (vtac); I exhibited 17 beats of vtac where no Potassium and magnesium levels were present. A cardiology team then got involved. An EKG and ultrasound were taken April 29, 2021. Since there were no recurring issues, I was released on April 29, 2021. I do not know if the spontaneous subdural hematoma or the ventricular tachycardia could have been an adverse reaction to the COVID-19 vaccine, but I thought I should report it.
Headache, Myalgia, Arthralgia, Fatigue, Chills Narrative: Took Tylenol for symptoms
small sore throat; little bit of congestion; lot of aches and pains; very tired; her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too; her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, lot number: EL1284, expiry date: 31Apr2021), via an unspecified route of administration on the left arm, on 15Jan2021 09:30, at single dose, for covid-19 immunization. Medical history included heart issues from an unspecified date, cardiac ablation in 2020, total knee replacements on 2001 (approximately 20 years ago) and 2009 (approximately 12 years ago), spinal fusion surgery in 2017 (3 fused disc in her back approximately 4 years ago). Concomitant medication included cortisone which started on 21Jan2021 (as reported, pending clarification) for an unspecified indication. In Jan2021 (reported as "Saturday morning"), the patient experienced small sore throat, a little bit of congestion, a lot of aches and pains, and felt very tired. She was calling because she didn't know if it was possible if she could be having a reaction. She stated she had one other symptom, her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too. Treatment for the events small sore throat, a little bit of congestion, a lot of aches and pains, and felt very tired included Mucinex Night Shift Cold and Flu syrup, Halls Relief lozenges and Advil. The patient reported that her symptoms have stayed about the same. The patient took her temperature on an unspecified date and reported that it was fine. She reported she did not any lab tests done for the events. The outcome of the events was not recovered.
No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 33-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  They accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage. No adverse event was reported for any of the patients.  Treatment medications were not reported.  This case contains information for patient 25 out of 25.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2023: Live Significant follow-up received contains Patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:master case
Headache first symptom, sore right arm, high fever 102 for 24 hours, chills, dizzy , achy all over , very tired. after 24 hours symptoms dissipated. Then just tired and sore arm next day.
Expected:  sore arm at injection site. 2 days. Hives on chest area, from waist to neck.  Slight itching, red splotchy.  Lasted about 3 days.
The proteins in my urine went up to 900 and there supposed to be less than .1.
lymph node swelling in the armpit of the arm that got the shot; exhausted all day; slept all day; heart rate has been elevated all day; This case was reported by a consumer via interactive digital media and described the occurrence of heart rate increased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 7th July 2021, the patient received the 1st dose of Shingles vaccine. On 7th July 2021, less than a day after receiving Shingles vaccine, the patient experienced heart rate increased, exhaustion and sleepiness. On 8th July 2021, the patient experienced axillary lymph nodes enlarged. On an unknown date, the outcome of the heart rate increased, axillary lymph nodes enlarged, exhaustion and sleepiness were unknown.   It was unknown if the reporter considered the heart rate increased, axillary lymph nodes enlarged, exhaustion and sleepiness to be related to Shingles vaccine.  Additional details were provided as follows: The age at the vaccination was not reported. This case was reported by patient herself/himself. The patient had received first Shingles shot a day before reporting date and his/her heart rate had been elevated all day and now lymph node swelling in the armpit of the arm that got the shot and also exhausted, slept all day.
This spontaneous report as received from a physician assistant via company representative, referring to a 13 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were unknown by the reporter. On an unspecified date, the patient was vaccinated with the first dose of GARDASIL 9 for human papillomavirus prevention (HPV) (strength, dose, route, frequency, lot# and expiration date were not reported). On 16-APR-2018, the patient was vaccinated with the second dose of GARDASIL 9 for human papillomavirus prevention (HPV) (strength, dose, route, frequency, lot# and expiration date were not reported). On the same date, around 8:00 PM, the patient complained of headache. On 17-APR-2018, around 2:30 AM, the patient was discovered sleepwalking. The patient did not receive any treatment and was unknown if the diagnostic laboratories were performed. At the time of reporting, the outcome of headache and sleepwalking was unknown. Additionally, the causality assessment between headache and sleepwalking with GARDASIL 9 was not provided.
Soldier received 5th Anthrax immunization on 4/28/2007 and presented with a swollen upper arm with redness, itch pain, mild fever on 4/30/2007. Doctor prescribed Benadryl and Motrin.