chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mother states she noticed a red scattered rash on most of body starting on Monday 3/10/03.  Pt saw Dr. on 3/11/03.  Pt received an injection and was instructed to take Benadryl at home. Infant still has a fading red scattered rash on most of body.
pt rcvd vax; pt took APAP; pt exp fever & difficulty breathing; mom took pt to ER & had an injection; pt had pneumonia & cardiac arrest;
h/a w/nausea for 1wk;rash on legs for 1wk
This spontaneous case reported by a consumer, describes the occurrence of rash (developed, 2 different types of rashes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced rash (developed, 2 different types of rashes). At the time of the report, rash (developed, 2 different types of rashes) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information provided.
I experienced sore arm, fever, burning sensation on my skin, red rash on my left leg, and extreme fatigue.
Initial and follow up information has been received from a nurse practitioner concerning a 25 year old female customer service representative. On 9/18/06, the pt was vaccinated in the right deltoid with the first dose of 0.5ml of HPV vaccine (lot 653937/0637F). There were no other illnesses noted at the time of vaccination. The nurse practitioner reported that the pt was severely obese and when she received the HPV vaccine, the medication dribbled down her arm. It was report that upon removal of the needle, blood tinged fluid flowed from the injection site. The nurse practitioner was unable to estimate the amount but assumed the pt received less than the full dose. The plan was to re inject the pt with a full dose. At the time of this report, the outcome of the events were unk. Additional information has been requested.
Narrative: Patient was administered the COVID-19 vaccine during his inpatient stay in the program. Early the next morning he complained of soreness and an itchy rash on his arm, and later that afternoon he developed facial swelling that the observing physician diagnosed as edema of the parotid gland. The patient received 50 mg of diphenhydramine intramuscularly and fully recovered.
Injection site swelling, redness, warm, lymph nodes in arm swelled up, canker sore on lip.  2nd shot, same issues - lymph nodes in armpit swelled up, injection site swollen, canker sore on lip bigger more painful than first dose.  3rd/booster shot, worse, injection site swollen for a week, lymph nodes in armpit and neck swollen, sinuses swollen, canker sores under tongue and in throat.  Valacyclovir prescribed after first shot, it seemed reduced the affects
This spontaneous report was received from a physician referring to a 10 week old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 30-SEP-2015 at 09:42 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Received Td injection 8/11/06 developed fever, swelling to emergency room treated with antibiotics.  Treated 5/15/06.
This spontaneous report was received from the registered medical office manager referring to an unknown number of patients of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On unspecified dates in 2015, reported "since 24-JUN-2015", the patients were vaccinated with improperly stored doses of ROTATEQ oral (lot # K016261, expiration date: 23-JUN-2016; L008034, expiration date: 05-AUG-2016). Concomitant medications were not reported. No adverse effects reported. There was not a product quality involved. This is one of the several reports from the same source. Additional information has been requested.
I felt fine immediately after the injection, but then about 3 minutes after the injection, I was "hit" by a very intense reaction:  metallic taste in mouth, nauseous, burning heat throughout my back, sweating, very hot, very anxious/scared.  This quieted down after about 10  minutes, but then I got "hit" again, a few minutes after that.  This time with burning heat in my chest and then burning heat traveling down my left arm, sweating, very hot, very anxious/scared.  I was under observation for 45minutes before they let me drive home (just 4 miles away).  Once I got home, I felt extremely exhausted and foggy headed.  This lasted for about 6 hours, and then it began to lift.  That night, I was woken from sleep suddenly by pain in my arm (at injection site); it was a sort of pain I've never experienced -- it was sharp and moving around.  The following day (today) I'm having lingering fatigue, lingering slight nausea, and a sore arm at injection site.
headaches; Body aches; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), FATIGUE (Tiredness) and HEADACHE (headaches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Apr-2021, the patient experienced PAIN (Body aches) and FATIGUE (Tiredness). On an unknown date, the patient experienced HEADACHE (headaches). At the time of the report, PAIN (Body aches), FATIGUE (Tiredness) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication was provided.    This case was linked to MOD21-090747, US-MODERNATX, INC.-MOD-2021-133325 (E2B Linked Report).; Sender's Comments:  MOD21-090747: US-MODERNATX, INC.-MOD-2021-133325:son case
dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use By Date) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use By Date). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vial was initially stored in the refrigerator on 01-Dec-2021. The vial had not undergone any temperature excursion issues. It was reported that 11 doses from one vial, was punctured on 05-Jan-2022. No concomitant medications were reported. No treatment information was reported.
Patient received vaccination at 10am on 8/14/18. At approximately 7pm, patient started experiencing chills, nausea, flushing, and dizziness. She also describes feeling of her skin crawling, she felt weak and feverish. Around 9pm, she went to bed, and awoke at 11pm and was shivering and felt nausea. She went back to bed, and awoke again at 1am on 8/15. At this time, she vomited and then was able to go back to bed. As of 12pm on 8/15, patient still unable to tolerate food and feeling unwell, but symptoms seem to be improving.
The patient did not have any reactions. I administered the 1st dose of the Pfizer on 8/2/21. I will not administer the 2nd dose as directed by the IRIS representative. The patient receive the Janssen vaccine in May 2021. The patient was wanting MRNA coverage due to the outbreak of the Delta variant.  I believe this was a very logical step for the patient to protect himself. I informed my staff that only one pfizer dose is to be given to Janssen patients if this arises again.
Heart palpitations lasting a few seconds occurred while relaxing sitting up before bed, after awakening in the middle of the night while in bed, and in the morning after awakening while in bed. Headache lasting approximately 2 hours after the vaccine.
This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer. This consumer reported similar events for herself and a friend. This is 2nd of 2 reports. A female patient of an unspecified age and race received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date (3 or 4 years ago) for immunisation. The patient medical history and concomitant medications were not reported. The patient just got pneumonia recently on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016449610 Same reporter/vaccine/event, different patient.
Burning pain below site of injection. Red and puffy below site of injection; seen at ER and given an oral liquid steroid to treat
Severe nausea I started at 11:30 pm.  Vomiting continued roughly every 30 minutes until 5:30 am the following day.  I also had fever (highest was 103) and chills.  I am a hypertrophic obstructive cardiomyopathy patient.  Hydration  is critical for me as well as  taking heart and blood pressure medicine timely.  My resting heart rate had  continually climbed  during the night and by 5:30 am it was running 120 and I was starting to feel dizzy and lightheaded (a symptom of my heart condition..  At this point I was taken to the emergency room for treatment. I was diagnosed with enteritis ,  given IV fluids and IV anti nausea medication.  I was prescribed 10 days of Metronidazole and Ciprofloxin orally and released.
5APR91 pt fainted @ work about 3 1/4hrs p/Typhoid #1 inject, hit head...blacked out for a short time... c/o chilling for about 2hrs...temp not taken...very pale colors, puffy red face; MD felt rxn to shot; No difficulties breathing;
Patient presented to the ED on 9/12/21 with report of fevers, chills, malaise, and nausea for 1 week PTA. Patient was found to be COVID positive in the ED on 9/12 (despite being fully vaccinated for COVID), but his chest X-ray was negative for pneumonia.  His foley bag had cloudy urine suspicious for infection, so antibiotics were started.  Patient's urine culture later grew out Klebsiella pneumoniae. Patient has now been hospitalized for 3 days, and he has not been hypoxic since admission. Therefore, patient's febrile illness is believed to be a combination of COVID and CAUTI. Patient is not currently on any treatment for COVID since he is not hypoxic.
SARS-CoV+SARS-CoV-2 Ag Resp Ql IA.rapid performed on 7/26/21 at 11:15. Test came back detected. Case investigation interview with patient has not been conducted as of the time of this note.
COMIRNATY was administered before 19 days of primary dose.; Fever; Extreme sweatiness; Ringing in ears; Headache; Chills; Stomach cramps; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the arm left on 05Apr2021 at 14:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to plants (tress), grass allergy, pollen allergy, dust allergy and mite allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Concomitant medications included fexofenadine hydrochloride, pseudoephedrine hydrochloride (ALLEGRA-D 12 HOUR) and fexofenadine hydrochloride (ALLEGRA 12 HOUR) for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm left on 22Mar2021 at 15:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient previously took azithromycin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication. On 05Apr2021, the patient experienced fever (48 hours), extreme sweatiness (30 minutes), ringing in ears (30 minutes), headache, chills and stomach cramps. The events did not result in doctor or other healthcare professional office/clinic visit, 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 fever, extreme sweatiness, ringing in ears, headache, chills and stomach cramps was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
raoid heartbeat; blood pressure went up; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (raoid heartbeat) and BLOOD PRESSURE INCREASED (blood pressure went up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced HEART RATE INCREASED (raoid heartbeat) and BLOOD PRESSURE INCREASED (blood pressure went up). At the time of the report, HEART RATE INCREASED (raoid heartbeat) and BLOOD PRESSURE INCREASED (blood pressure went up) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Patient developed facial, appendage & trunkal hives withing4-5 hours. She subsequently developed nausea, chills, HA, lethargy.
off-label use as per local labelling due to four doses given instead of five with no reported adverse event; Initial information received on 03-May-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (patient).  This case involves an unknown age male patient for whom four doses given instead of five with no reported adverse event while receiving vaccine Rabies (HDC) vaccine [Imovax Rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received four doses instead of five doses of suspect Rabies (HDC) vaccine Powder and solvent for suspension for injection with unknown strength, batch number & expiry date via unknown route in unknown administration site for post exposure immunization (Immunisation) (off label use) (unknown latency). Information on the batch number was requested.  This situation is reported as an off-label use as per local labelling due to four doses given instead of five.  Action taken: not applicable.  At time of reporting, the outcome was Unknown.
In the middle of the night, I woke up a few times coughing and not being able to breathe. I got up that morning and used a home COVID-19 test and it came back positive, my husband thought that I needed to test again. I waited two hours; this test came back positive quick. I called my doctor's office, spoke with my doctor's PA discussed my symptoms was prescribed the Paxlovid. Took the first dose that night, the next day I felt like I wasn't sick at all. By day five I felt good came out of quarantine wore my mask and until day ten. I feel great.
Expired Vaccine was administered, Patient was contacted and informed of situation. Staff offered a medical appointment to return to receive 2nd dose of the primary series but the patient decided to go to a pharmacy for this dose.
Approx 30m. after injection pt felt as if she might faint, was then noted by mother to be unresponsive, shaking. Started to cry, rapid respirations
Patient received his first Pfizer dose 21 days prior in his left arm.  The lymph nodes in his throat were still visibly swollen and palpable. He spoke with a nurse prior to coming who advised him to get second dose. RN assessed patient for any additional symptoms that he may have been experiencing and informed him that he should follow up with his primary doctor.
Apparently when I administered the the injection (1) the syringe was empty - we did not notice it and he did not receive the medicine, in the first puncture.  I needed to inject him with a second syringe to receive his Moderna Booster vaccine. The daughter said that the next day, Sunday, he presented the usual side effects of the Covid-19 vaccines: Fever, arm pain, tiredness.
Fever, fatigue, pain in both arms, red swelling hives in left upper arm, chills.
PAINLESS BUMPS INSIDE THE MOUTH ALONG THE UPPER AND LOWER LIPS; PAINLESS BLISTERS INSIDE THE MOUTH ALONG THE UPPER AND LOWER LIPS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: neck injury, neck fusion surgery, sinus issue, and shortness of breath. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 13-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced painless bumps inside the mouth along the upper and lower lips, and painless blisters inside the mouth along the upper and lower lips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painless bumps inside the mouth along the upper and lower lips, and painless blisters inside the mouth along the upper and lower lips. This report was non-serious.
rash first started on the chest and back (right side). went to Dr. on 11/1/22 and was diagnosed with shingles, being treated with valacyclovir 500 mg - 3 times a day
vaginal bleeding; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer reported for a female patient(Daughter). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Feb2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter reported that, Daughter (Patient) received covid vaccine on Thursday that morning and daughter was experiencing vaginal bleeding, but that did not look like blood from menstral cycle wanted to know if that was a normal reaction from receiving covid vaccine. The outcome of the event was unknown.  Information on the lot batch number has been requested.  Follow-up attempts are completed. No further information is expected.
On 2nd day after vaccine my face was swollen around my eyes and cheeks. Eyes hurt and were red. NO itching or redness on face.  Next I began to have pain and tenderness behind my right ear with sharp shooting pains along jaw line and behind R. ear. Loss of sense of smell and taste (has returned but not normal yet).  Extreme fatigue, aching joints.  Several weeks later I awoke to find my right eye red and swollen. I have been unable to wear contact lens and my eyes have not returned to normal.  Ophthalmologist believes some type of inflammatory response or maybe I had COVID 19 virus.
I have been experiencing diarrhea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (I have been experiencing diarrhea) 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 DIARRHOEA (I have been experiencing diarrhea). At the time of the report, DIARRHOEA (I have been experiencing diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information  was provided. No treatment medication information was provided.
the patient had intended to administer Pentacel, since Quadracel is not approved for patients under 4 years of age with no AE; Initial information regarding an unsolicited valid non-serious case was received from a Other Health Care Professional via Regulatory Authority (Reference number- 00382011) and transmitted to Sanofi on 04-Dec -2020 via call-center.  This case involves a 2-years-old female patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] on an unknown date (lot number: C5763AA and expiry date was unknown) via intramuscular route in the right thigh (3rd) dose in the series, when they had intended to administer Pentacel, since Quadracel was not approved for patients under 4 years of age  (Product administered to patient of inappropriate age) for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and and family history were not provided. Concomitant medication included HEPATITIS A VACCINE.   It was an actual medication error case due to vaccine administered to patient of inappropriate age (latency: unknown).  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.
Headache; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified and Muscular dystrophy.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills). On 11-Mar-2021, HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided Treatment medication included antibiotics