chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PAIN ON THE ARM; TIREDNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 16-JUL-2021, the subject experienced pain on the arm. On 16-JUL-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain on the arm, and tiredness on 19-JUL-2021. This report was non-serious.
30 minutes after injection became itchy around the whole body. Injection sight was inflamed, warm to touch, red, and bruised the next morning 9/11/2020. Took 50mg of Benadryl to relieve itchiness. Itchiness was relieved after an hour of taking Benadryl and injection sight redness and other symptoms disappeared after two days.
2 days p/vax site arm began to get red & to swell;by 3rd day was hard & warm to touch;pt devel fever;taken to MD & given ATB;by 4th day sx beginning to subside;
Headache, Myalgia, Diarrhea, "extreme exhaustion, like I can barely stay awake." Narrative:  Employee reports self-treating w/: "I took Aleve, that seems to help w/ the body aches & headaches. Averaging about ii tabs q. 8 hrs. or so but today I haven't taken anything."
Per Patient: "I took the first dose of Vivotif typhoid vaccine today and am having negative side effects (abdominal pain, vomiting, nausea, diarrhea) and am wondering how to proceed with subsequent doses. I took the dose at 8am (on an empty stomach after not eating since the night before), ate some bread and coffee around 10am, started feeling sick around noon, first vomited around 1pm, and am still feeling sick as I write this around 4pm and have not been able to keep down any food or liquids. I have taken Vivotif before in 2016 and 2012 and don't recall having any issue"
Red 3" band around arm, warm, tender to touch at injection site. Nausea, dizziness.
Feeling cold; Oxygen saturation low; Intermittent headache; Feeling unwell; Pain in arm; Cough; Phlegm; Hypoxemia; Chest cold; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOXIA (Hypoxemia) and LOWER RESPIRATORY TRACT INFECTION (Chest cold) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.  The patient's past medical history included Blood pressure high, Urinary tract disorder, Non-smoker and Abstains from alcohol. Concomitant products included AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BENAZEPRIL) for Blood pressure high, TAMSULOSIN for Urinary tract disorder.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg every two weeks. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). In June 2021, the patient experienced MALAISE (Feeling unwell), OXYGEN SATURATION DECREASED (Oxygen saturation low) and HEADACHE (Intermittent headache). In 2021, the patient experienced HYPOXIA (Hypoxemia) (seriousness criterion medically significant), LOWER RESPIRATORY TRACT INFECTION (Chest cold) (seriousness criterion medically significant), COUGH (Cough) and PRODUCTIVE COUGH (Phlegm). On an unknown date, the patient experienced FEELING COLD (Feeling cold). In 2021, HYPOXIA (Hypoxemia), COUGH (Cough) and PRODUCTIVE COUGH (Phlegm) had resolved. At the time of the report, LOWER RESPIRATORY TRACT INFECTION (Chest cold), MALAISE (Feeling unwell), PAIN IN EXTREMITY (Pain in arm), FEELING COLD (Feeling cold), OXYGEN SATURATION DECREASED (Oxygen saturation low) and HEADACHE (Intermittent headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Oxygen saturation: 85 % (Low) 85.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Reporter stated that patient had other concomitant therapy of supplemental oxygen.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
I obtained my third dose (booster vaccine) on October 26, 2021. Approximately 12 hours after the vaccine, I experienced common side effects such as headaches, arm ache, etc. The morning of Wednesday, November 11, 2021, I woke up with a rash on my chest. By early afternoon, a rash and hives had spread to my back, neck, groin, chest, and other areas. I had extreme head itching, too. I went to the student health center. Student health center provided me 50mg of Benadryl as well as Methylprednisolone via intraMUSCULAR injection. Additionally, I was provided a Methylprednisolone taper to begin taking the following day with Benadryl as needed. After 6 days of repeated breakouts, I went to see Dr. After looking at photos and listening to my description, he stated there is a possibility this was caused as a result of an adverse reaction to the vaccine or an underlying virus. I was told to begin taking Allegra (180 mg) every morning and Xyzal (5 mg) every night for the next month to try to stop the hives and rashes. We will then reexamine and address treatment at that time.   Timeline of Hives and Rashes: 11/10/21 AM: Rash on upper chest and head itch 11/10/21 PM: Body covered in rash and hives. Head itches. Went to  Student Health 11/12/21: Head itches, but no hives 11/13/21: Head itch, body itchy in evening, no major hives 11/14/21: Small patch of hives on back, stomach, and hand 11/15/21: Large patches of hives on back and side 11/16/21 @4:30am: Hives on back, itchy head 11/16/21 PM: Hives on various spots of body 11/17/21: Broke out in hives on neck and face after shaving. Was seen by Dr at 1:00pm  Benadryl was taken at various times throughout these dates to alleviate itching and hives. Hives seemed to get worse or also appear after an initial itch or scratch (ie. Dr scratched my arm with a popsicle stick and it broke out in hives).  Photos of my rashes and hives can be provided if they are needed.
Pt given 12mo shots on 3/9/09.  Had seizure on 3/19/09.  Febrile after seizure noted.  Continued to be febrile X 2d.  Fever broke, developed full body rash consistent with Roseola.
Information has been received from a physician concerning an approximately 14 year old female who was vaccinated with Gardasil.  Subsequently, the patient developed a headache and pain at injection site that radiated to the back of her shoulder and to the back of her neck.  Subsequently, the patient recovered from the headache and the pain at injection site that radiated to the back of her shoulder and to the back of her neck.  Additional information has been requested.
Perosn Receives Covid 19 Booster vaccine of Pfizer at Facility vaccine event on 03/25/2022, starts to have side effects 03/26/2022 the next morning of Fever (100.6), headache, chills, and body aches. Taken Tylenol to help alleviate pain and assist with fever. Will Continue to monitor for the next 48 hours.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: Patient reported severe dizziness and nausea about 5 minutes after receiving the Pfizer vaccine. She ended up vomiting  few times. Patient was  given water and crackers. She did not end up feeling better even after resting for 15 minutes. The family called 911 and Emergency  services took her to the hospital
Patient experienced headache, confusion, anger and anxiousness. By the end of the evening she was shaky and crying. The next morning 9/5/13 she felt better but still had a headache and confusion.
On 02/23/21, 67 yo F presented to clinic for dose #2 of COVID-19 vaccine (Moderna). On 01/26/21, after receiving dose #1, pt experienced an allergic reaction. For second dose, pt pre-medicated with diphenhydramine. At 1537, pt was administered 0.5 mL in left deltoid (lot #024M20A). Within 10 minutes of injection, pt developed cough, chest tightness and itching. Pt was administered epinephrine 0.3 mg IM, albuterol 2.5 mg via nebulization, methylprednisolone 125 mg IV and diphenhydramine 50 mg IV. Due to pt's previous reaction, pt was transported to ED for additional monitoring. EMS administered famotidine 20 mg IV. On arrival to ED, pt was placed in observation. Due to persistent coughing and sensation of throat closing, pt was given second doses of epinephrine 0.3 mg IM , albuterol nebulization and diphenhydramine 25 mg PO. Pt was then held in observation x 4 hours with return to baseline. and no symptom recurrence. Pt discharged with instructions to return to ER for any symptom recurrence.
Started breaking out with a rash and bumps the day after all aver most of my body lasted about a week  itching badly
Mother states pt had immunizations on 4/17/06 about 14:00 PM. States pt ran low temperature on 4/18/06. States she gave him Advil (children's Tylenol) on 4/18/06. States he did not have anymore fever until 4/23/06. States has had fever off and on since 4/23/06. Voices no other complaints. Referred mother to child's pediatrician for evaluation of fever.
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed vaccine and advised lot 007B21A maintained activity necessary to protect against covid 19 on date vaccine was administered. Also patient did not call in to complain of adverse event.  This was administration error without adverse event.
Burning sensation on ulnar side of left hand, severe pain in both wrists and hands with swelling, severe pain with limited range of motion in both shoulders.
Thursday morning: dizzy and weak. Late evening, 9 pm nausea and vomited. Friday: am nasea, dizzy. Saturday: weak, temperature 99.5, evening felt like had sniffles and eyes stinging. Sunday: light sniffles. 98.4 at noon.
About 3 hours after vaccine severe arm pain in left arm which I expected was normal shortly after and still today intermittent vision(focus)  issues and twitching of right eye with some slight right eye pain
6SEP91 T101.2 in PM; 7SEP91 T103 in AM, dec to 98.6 p/Tempra; cry/screamed from FRI PM to SUN afternoon; saw MD on 7SEP91;
Abnormal menstrual cycle with extremely heavy bleeding/Multiple menstrual cycles were within 2-3 week of each other; Abnormal menstrual cycle with extremely heavy bleeding/Multiple menstrual cycles were within 2-3 week of each other; Patient received Dose 1 and Dose 2 on 20Jan2021.; This is a spontaneous report from a non-contactable consumer (patient herself). A non-pregnant 39-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in left arm on 20Jan2021 (Batch/Lot Number: E13247) as DOSE 1, SINGLE; and then dose 2 via an unspecified route of administration, administered in left arm on 20Jan2021 (Batch/Lot Number: EM9809) as DOSE 2, SINGLE, for COVID-19 immunization, age at time of vaccination: 39 years. Relevant medical history includes high blood pressure from an unspecified date and almond and penicillin allergy. The patient was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination.  The patient previously received erythromycin on unspecified dates and experienced known allergies. On 02Apr2021, the patient experienced abnormal menstrual cycle with extremely heavy bleeding. Required multiple doctors visits. Multiple menstrual cycles were within 2-3 week of each other, ultimately resolving by itself.  Also, very high blood pressure onset at the same time requiring ongoing medication. The adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. Since the vaccination, the patient has been tested for COVID-19, COVID test post vaccination is Nasal Swab PCR on 12Mar2021 with negative result. The patient recovered from the events abnormal menstrual cycle with extremely heavy bleeding/Multiple menstrual cycles were within 2-3 week of each other on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
The vaccine reached Beyond and was store in refrigerator till the date of administration.stability on 19Jun2021; 1 Dose administered after vaccine reached beyond use date (BUD); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 Dose administered after vaccine reached beyond use date (BUD)) and PRODUCT STORAGE ERROR (The vaccine reached Beyond and was store in refrigerator till the date of administration.stability on 19Jun2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 Dose administered after vaccine reached beyond use date (BUD)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine reached Beyond and was store in refrigerator till the date of administration.stability on 19Jun2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 Dose administered after vaccine reached beyond use date (BUD)) and PRODUCT STORAGE ERROR (The vaccine reached Beyond and was store in refrigerator till the date of administration.stability on 19Jun2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.   It was reported the off label stability date was 19-JUN-2021.  No treatment medication reported.
the patient disclosed that she was pregnant only after the dose was given; No additional adverse effects were reported in the patient; Information has been received from a nurse practitioner referring to a 25 years old female patient. The patient's concomitant medications included valacyclovir hydrochloride, sumatriptan, fluoxetine hydrochloride (PROZAC) and oxcarbazepine (TRILEPTAL). Drug reactions or allergies included morphine. Pertinent medical history was reported as none. Last menstrual period (LMP) was not reported.  On 02-MAR-2020, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (subcutaneous; lot number S015463, expiration date 20-MAY-2021; strength, dose, and frequency unknown) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT) (subcutaneous; strength, dose, frequency, lot number and expiration date unknown). The patient disclosed that she was pregnant only after the dose was given (maternal exposure during pregnancy). The estimated date of delivery (EDD) and gestation period at exposure were not known. The pregnancy outcome was outcome pending. No additional adverse effects were reported in the patient. No product quality complaint (PQC) was reported.
CHILLS, FEVER UP TO 101 DEGREES,  BODY ACHES, NAUSEA, WEAKNESS LASTED FOR 24 HRS THEN WEAKNESS
devel sz activity @ home 4PM on day of vax; brought to hosp arrived w/tonic clonic sz activity 450PM; t102.8 R; transferred to hosp still w/sz activity; given Ativan adm to hosp;
stomach is upset; sore throat; a little tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach is upset), OROPHARYNGEAL PAIN (sore throat), FATIGUE (a little tired) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 939906, 010M20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included Back injury (pain meds were taken). Concomitant products included LOSARTAN POTASSIUM (COZAAR) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach is upset), OROPHARYNGEAL PAIN (sore throat), FATIGUE (a little tired) and HEADACHE (headache). The patient was treated with SIMETHICONE at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (stomach is upset), OROPHARYNGEAL PAIN (sore throat), FATIGUE (a little tired) and HEADACHE (headache) outcome was unknown.            Patient reported he had also taken antacids as well as pain meds when he needs them for back injury
Developed rash at back. Resolved spontaneously at one week post vaccination. Vaccine #2 given 3 weeks later @ 2/7/21. Rash reported when patient came in for Pfizer vaccine #2  (after resolved). Did not report to healthcare system or present to medical care for evaluation.
Within 5 minutes after vaccination, patient's nurse stated that the patient was losing consciousness and color in her face.  Rescue was called immediately.  Patient was vomiting and felt nauseas while waiting for rescue but regained consciousness.  Rescue arrived within 15 minutes and checked vitals.  Patient stated that she wanted to go home and didn't want to go to hospital for further evaluation.
HCP called to state that the patient was given PROQUAD after a TE event.; no additional AE/PQC.; This spontaneous report has been received from a nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, (PROQUAD) subcutaneous injection (dose, vaccination scheme, anatomical location, frequency, lot number and expiration date were not provided) for prophylaxis, after a temperature excursion (product storage error).   No additional adverse events were provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA006989: US-009507513-2303USA006931: US-009507513-2303USA007002: US-009507513-2303USA006933: US-009507513-2303USA007031: US-009507513-2303USA006940: US-009507513-2303USA006990: US-009507513-2303USA007041:
This spontaneous report as received from a registered nurse refers to a 4 month old female patient. On 30-APR-2013, the patient was administered expired oral ROTATEQ (lot # 0923AA; expiry date: 25-APR-2013) 2ml oral for prophylaxis. No adverse effects were reported. The outcome of the event was unknown. This is one of three reports from the same reporter. Additional information has been requested.
This spontaneous case reported by a consumer, describes the occurrence of dysphonia (voice changed and it sounded husky and cracked), dyspnea (shortness of breath), influenza-like illness (flu-like symptoms), hyperhidrosis (sweaty) and dizziness (dizzy/lightheaded) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Mar 16, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 16, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 16, 2021, patient had dyspnea (shortness of breath) and dizziness (dizzy/lightheaded). On Apr 17, 2021, patient experienced dysphonia (voice changed and it sounded husky and cracked), influenza-like illness (flu-like symptoms), hyperhidrosis (sweaty) and fatigue (tired). The patient treated with Tylenol (paracetamol), at an unspecified dose and frequency. At the time of the report, dysphonia (voice changed and it sounded husky and cracked), dyspnea (shortness of breath), influenza-like illness (flu-like symptoms), hyperhidrosis (sweaty), dizziness (dizzy/lightheaded) and fatigue (tired) outcome: unknown. The reporter did not provide any causality assessments or concomitant product use. Action taken with mRNA-1273 in response to events: not applicable. This case linked to MOD-2021-080388 (patient link).
STAFF C/O FEELING TINGLING IN HER TONGUE, A LUMP IN HER THROAT, AND A RACING HEART. CLINICIAN EXAMINED AND ORDERED BENADRYL 50MG IM.  THE SITUATION WAS RESOLVED AFTER THE IM MEDICATION.
Numbness in throat and arm, bp 137/87,    100% oxygen     heart rate 72.
No adverse event; 2nd Dose Administration date on 14Apr2021 and 1st Booster dose Administration date on 31Jul2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Dose Administration date on 14Apr2021 and 1st Booster dose Administration date on 31Jul2021) and NO ADVERSE EVENT (No adverse event) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0588H21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to allopathic drugs (Ciclosporin), Allergy to antibiotic (ciprofloxacin) and Drug tolerance (Tolerance to Enzyme Inhibitors).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jul-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Dose Administration date on 14Apr2021 and 1st Booster dose Administration date on 31Jul2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Dose Administration date on 14Apr2021 and 1st Booster dose Administration date on 31Jul2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Dose Administration date on 14Apr2021 and 1st Booster dose Administration date on 31Jul2021).    Patient was taking concomitant medication, HCP did not specify what type of medications was used by patient. Patient height was mentioned as 6 foot. The patient never tested positive for Covid. No treatment drug details was reported.   This case was linked to MOD-2022-635175 (Patient Link).