chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives; This case was reported by a consumer via call center representative and described the occurrence of hives in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2019, the patient received the 1st dose of Shingrix. On 13th June 2019, 1 days after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination with dose of Shingrix, experienced hives that still had not clear up. The patient wanted to know how many people have called in to report side effects. The patient stated that, did not want clinical trial information from the PI. No addiational information was provided concerning this event. This case has been linked with case US2019AMR175765, reported by same reporter. The patient did not consent to follow up. The event outcome was reported as recovering which is discrepant so considered as not recovered as per narrative.
Initial information received on 25-Jan-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case involves male patient (age not reported) who experienced heart attack, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On unknown date of September 2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UI812AA) Exp. Date, dose, route and administration site not reported. On unknown date, the patient developed heart attack (myocardial infarction), following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized due to the event. Details of lab data not provided. Final diagnosis was heart attack. It was not reported if the patient received any corrective treatment. The event outcome was not reported. List of documents held by sender: none.; Sender's Comments: This case concerns an elderly patient who presented with myocardial infarction after vaccination with FLUZONE HIGH DOSE. The time to onset is unknown. Moreover, patient's medical condition at the time of vaccination, concomitant medications and lab tests ruling out alternate etiologies were not reported. Based upon the reported information and considering the advanced age of the patient, the role of the vaccine is unlikely.
Pneumococcal vaccine was given at patient's PCP office in LUE that resulted in cellulitis and pain. Cephalexin 500 mg BID x 10 days prescribed at time of visit for cellulitis. Cellulitis resolved.
Pt recvd HIBTITER/OPV & approx 1 hr later returned w/generalized hives; Given Adrenalin, DPH & steroids w/immediate partial clearing;
dry throat; Pressure on my head; muscle pain; tiredness; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 19Feb2021 at 16:00 (at the age of 26-years-old) (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history (also reported medical history as no) and concomitant medications were not reported. The patient was not pregnant at the time of the events. The patient has no known allergies.  The patient did not receive other vaccine in four weeks. The patient did not have COVID prior to vaccination and had not been tested for COVID post-vaccination. On an unspecified date, the patient experienced pressure on her head, muscle pain, tiredness, and dry throat. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient returned today with grandparents stating that she is having a reaction to the flu vaccine. The right arm Deltoid area was red, warm to touch, and tender to touch area was 5 &1/2 cm x 6 cm in size.
administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time). At the time of the report, PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information reported.
Information has beenr eceived from a physician concerning a 67 year old white female with allergies to sulfa and celecoxib (CELEBREX), who has coronary artery disease, asthma and hyperlipidemia and a history of a myocardial infarction, a rash while on therapy with glucosamine and a dysrhythmia while on therapy with chlorpheniramine tannate, phenylephrine tannate, pyrilamine tannate (RYNTANA) who on 10/11/2001 at 09:00 was vaccinated with pneumococcal vaccine 23 polyvalet (lot #636158/1456K). Concomitant therapy, that same day, included influenza virus vaccine. On 10/12/01, the patient developed erythema, induration and increased warmth to the injection site. The patient sought medical attention in her physician's office. Subsequently, the patient recovered. Additional information is not expected.
BLOOD PRESSURE STARTED INCREASING; MUSCLE ACHES IN SHOULDERS, NECK AND LEGS; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with cefalexin, and codeine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, Laboratory data included: Blood pressure (NR: not provided) 146/87 mmHg. On 01-APR-2021, the subject experienced muscle aches in shoulders, neck and legs. On 15-APR-2021, the subject experienced blood pressure started increasing. On 30-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 165/96 mmHg. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 120/80 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle aches in shoulders, neck and legs on 22-APR-2021, and had not recovered from blood pressure started increasing. This report was non-serious.
Hep B given L deltoid at approx 9:30A-drove to work-noticed L hand seemed swollen and purplish in color and L arm felt tingly. Ret' d to health dept at 12:15. L arm still feels tingling and cole- hand sl. swollen and darker color than R hand - had been keeping hand hanging at site. L hand elevated to chest level and normal color after 10 min. No swelling or redness at injection site. No systemic symptoms.
Received Pfizer vaccines on 3/5, 3/26, 11/9/21. Tested positive for COVID by PCR on 12/13/21. Admitted Hospital on 12/13/21 with COVID 19 pneumonia.
Patient reported her arm hurt "even when he gave it to me on Monday".  She did not have the red/ hot-to-the touch place until this morning.  She noticed the place on her arm after taking a shower.  I called her regular physician, made an appointment for her to be seen today at 2:15PM. She and I stepped next door to the urgent care to see the NP, who looked at the place and reported a localized reaction/possible cellulitis.  She prescribed Keflex bc of patient's history of pancreatitis and her arm being so sore. NP believes it is just a localized reaction but does not want to take a chance that it develops into anything further.
Swelling, red area on left upper arm, hot to touch - No pain, No fever - Redness and swelling 11.5cm x 11.5cm
pt had stuffy nose & dull eyes in AM of 20AUG poor appetite; felt warm 7PM on 20AUG92; fever up to 103.9 1130PM given APAP;
Achiness; Loss of appetite; Cough with bitter taste; Cough with bitter taste; Flu like symptoms; Ache in fingers; Ache above eyeballs; Sweating; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achiness), DECREASED APPETITE (Loss of appetite), COUGH (Cough with bitter taste), DYSGEUSIA (Cough with bitter taste) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN (Achiness), DECREASED APPETITE (Loss of appetite), COUGH (Cough with bitter taste), DYSGEUSIA (Cough with bitter taste), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Ache in fingers), EYE PAIN (Ache above eyeballs), HYPERHIDROSIS (Sweating), NAUSEA (Nausea) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Achiness), DECREASED APPETITE (Loss of appetite), COUGH (Cough with bitter taste), DYSGEUSIA (Cough with bitter taste), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Ache in fingers), EYE PAIN (Ache above eyeballs), HYPERHIDROSIS (Sweating), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Left lymph node in armpit swollen and painful. Left deltoid swollen, hard, seriously bad itchiness.
Dizziness-First experienced PM after received seasonal flu shot about 10 AM 9/26/09-Dizziness has increased since then-ER visit in PM 9/28/09.  9/29/09 2:30 PM Pt reports resolved.
Pain started as left sided rib pain. Felt like a sore muscle for 2 days but no known injury. Professed to stabbing left sided chest pain then pain also in left collar bone. Called primary for visit. Had been taking Motrin for 48 hours. Ekg in office normal, sent for labs and CRP-98. Sent to cardiology who heard a run on exam, ekg again normal with echo asp normal. Now on colchicine for 3 months as treatment for pericarditis. Cardiologist asked maybe questions about recent illness but no illness aside from slight runny nose z 2 day 5 months prior.
Nausea, vomiting x 10 for approx 30 min. Diarrhea followed vomiting throughout morning x 4. Remainder of day slight nausea, and tired. Soup in evening. 12-17-09 - stomach cramps.
patient was educated about the risk of receiving Moderna COVID 19 vaccination. Patient had no symptoms of COVID19 and was afebrile at time of visit.  Patient desires to continue with vaccination.  Vaccine was administered at 11:08 CST.  Patient remained in clinic for 15 minutes after injection, voiced no problems. Patient called within 24 hours  complaining of Chills, Nausea, Severe headache, muscle aches and pain in right arm.  Advised patient to follow up with PMD, encouraged patient to enroll in V-SAFE
This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JUN-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccination error: Pfizer was not mixed with NaCl before administering booster dose of 0.3mL for patient. After communication with patient on day of vaccination and the day after, patient stated he did not have any symptoms/adverse events.
Information has been received from a physician assistant concerning a 72-year-old male with a history of colon carcinoma 1994, who on 14-MAY-1999 was vaccinated with first dose of PNEUMOVAX 23. On 14-MAY-1999, within 3-4 hour post vaccination, the patient experience chills, headache and swelling in arm which went from the injection site to wrist. It was noted that the arm was swollen, red, and tender in the forearm area. The patient was seen by a physician on 17-MAY-1999, who upon physical examination, diagnosed him with "looked like cellulitis of the arm". Therapy with unspecified antibiotics was initiated for treatment of symptoms. It was reported that the patient dose no have any history of prior vaccination with PNEUMOVAX 23. Additional information has been requested.
Pain; Chills; Blurred vision; Double vision; I could see my vitreous humour; Fluid in my eyes; This spontaneous case was reported by a physician and describes the occurrence of VISION BLURRED (Blurred vision), DIPLOPIA (Double vision), VITREOUS DISORDER (I could see my vitreous humour), LACRIMATION INCREASED (Fluid in my eyes) and PAIN (Pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D NOS for an unknown indication.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VISION BLURRED (Blurred vision), DIPLOPIA (Double vision), VITREOUS DISORDER (I could see my vitreous humour) and LACRIMATION INCREASED (Fluid in my eyes). On 22-Jan-2021, the patient experienced PAIN (Pain) and CHILLS (Chills). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 21-Jan-2021, VISION BLURRED (Blurred vision), DIPLOPIA (Double vision), VITREOUS DISORDER (I could see my vitreous humour) and LACRIMATION INCREASED (Fluid in my eyes) had resolved. On 22-Jan-2021, CHILLS (Chills) had resolved. At the time of the report, PAIN (Pain) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B212A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). On 17-Apr-2021, VACCINATION SITE PAIN (Sore left injection site arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Within a couple minutes of the vaccination, patient said she felt like she was going to pass out. The pharmacist took her to a chair to sit down. Within a few seconds, the patient collapsed out of the chair, fell in the floor. She was out for about 15-20 seconds then came around. 911 was called immediately when patient collapsed from the chair. Patient was taken to the hospital for evaluation.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed generalized chickenpox with about 250 lesions. Pt was treated with acyclovir.
Moderna COVID-19 Vaccine EUA Itching, soreness, swelling, slight redness, warm to touch, all at injection site. Reaction occurred 9 days after injection.
Hep B and Hib ordered. 2 doses of Hep B given.
Report a side effect; 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 VACCINATION COMPLICATION (Report a side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 VACCINATION COMPLICATION (Report a side effect). At the time of the report, VACCINATION COMPLICATION (Report a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Arm started getting sored and that lasted for 24 hours; A week later the arm pit started to feel sore, going down to the inside of the elbow; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm started getting sored and that lasted for 24 hours) and AXILLARY PAIN (A week later the arm pit started to feel sore, going down to the inside of the elbow) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMINS NOS for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm started getting sored and that lasted for 24 hours). In March 2021, the patient experienced AXILLARY PAIN (A week later the arm pit started to feel sore, going down to the inside of the elbow). On 06-Mar-2021, PAIN IN EXTREMITY (Arm started getting sored and that lasted for 24 hours) had resolved. At the time of the report, AXILLARY PAIN (A week later the arm pit started to feel sore, going down to the inside of the elbow) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included cholesterol medications. No treatment information was provided.
During a blood test patient went pale and had a seizure. First had them 2 or 3 a day or more than 3 times per week during period of 8/29 to 10/11. Went to ER for testing on 9/11. Started taking Topamax on 10/18. Doctor described them as migraine induced seizures. 1/3/08-records received-clinic visit 11/20/07-seen in follow up of seizures, headache and dizziness without seizure risk factors. Bradycardia. First episode was approximately 4 years ago and next was approximately 18 months ago. Starting on 8/29/07-began having frequent spells and LOC, shaking of left leg and upper extremity. All other seizures are staring lasting 1-2 minutes with LOC. Fatigued. confused afterwards. Previously had daily headache now less frequent. 1/15/2010 She still has seizures 1 to 3 a month. She is on Topamax 25mg in am and 50 mg at night. This has helped control them to 1 upt to 3 a month.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 27-AUG-2015 the patient was vaccinated with an improperly stored dose of VAQTA (SDV, 10-pack; lot # J005010, expiration date: 23-OCT-2015; dose, frequency and route unspecified). No adverse effects were reported. The storage criteria was refrigerator (R). Celsius conversion of the lowest recorded temperature was 0 (Fahrenheit degree/Celsius). The total cumulative excursion time was 48 hours with the lowest recorded temperature 33 (Fahrenheit degree/Celsius) and they type of excursion (R/F) was R. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a consumer concerning his 12 year old daughter with no pertinent medical history and no known allergies who on 15-JUL-2009 was vaccinated with the first dose of GARDASIL(lot number not reported). Secondary suspect drug included MMR II (MSD). Concomitant therapy included meningococcal vaccine (unspecified) and diphtheria toxoid (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VACCIN DTP). On 19-JUL-2009 the patient started experiencing difficulty breathing. Unspecified medical attention was sought. The patient's physician prescribed her prednisone 40 mg (manufacturer unspecified) and the patient had been taking it for 4 days. At the time of the report, the patient was not recovered. Follow-up information has been received from a physician concerning the 12 year old female patient with reactive airway disease usually triggered by respiratory infection who on 15-JUL-2009 at 4:05 PM was vaccinated IM in the left deltoid with the first dose of GARDASIL (lot number 622404/0312Y). Secondary suspect vaccination on the same day at 4:05 PM included a second SQ dose of MMR II (lot number 664363/0554Y) in the right arm. Concomitant vaccinations on the same day at 4:05 PM included a first IM dose of MENACTRA (lot number U2918AA) in the right deltoid and a first IM dose of DTAP (UF471AA) (Sanofi Pasteur) in the left deltoid. There was no illness at the time of vaccination and no adverse event following prior vaccination. On 21-AUG-2009 the patient saw the physician for a 3 day history of cough with a 4 days history of afebrile upper respiratory infection (URI). It was noted by the patient that the shortness of breath (SOB) worsened with physical exertion (PE). The patient's mother started albuterol metered dose inhaler (MDI) 2 days before the office visit. The patient had a physical exam and an arterial blood oxygen saturation test performed with a result of 99%. A respiratory rate measurement was also performed with a result of 16 (unit not provided). The patient stated that she had a decreased voluntary air exchange. The patient was placed on XOPENEX (versus Albuterol) and prednisone for 5 days. On 23-JUL-2009, the patient saw the physician for subjective SOB. The patient vital signs and physical examination were within normal limits. On 25-JUL-2009, the patient recovered. Additional information is not expected.
Patient began experiencing nausea, emesis, and headache after second dose of Moderna COVID-19 vaccination on 8/28/21. Patient also reports neck stiffness, fever, and malaise. In ED, patient is febrile to 103.2F with pulse 104 and BP 100/55. The patient is being evaluated for suspected meningitis. Patient will receive lumbar puncture to further evaluate. Patient has received fluid bolus, acetaminophen, ceftriaxone, and vancomycin. The patient will be admitted to the hospital.
Patient complained of stomach pain, nausea and laid down on the floor.  Vitals signs was taken and stable.  Patient stated that she thought that she had worked herself up over taking  the shot.  She recovered quickly and was watched an additional 30 minutes and went home with her husband by private vehicle.