chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in sinus; pain in jaw; pain in her face; top and back of head; Pain neck; sore in both arms, head and face; severe pain in her arms; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non healthcare professional via Medical Information (Reference number- 00436627) and transmitted to Sanofi on 22-Oct-2020.  This case involves a female patient (age not reported) who had pain in sinus (sinus pain), pain in jaw, pain in her face (facial pain), pain in top and back of head (headache), pain neck (neck pain), sore in both arms , head and face (ulcer) and severe pain in her arms (pain in extremity), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PARACETAMOL (TYLENOL).  On an unknown date (past year on a Saturday afternoon), the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (on Sunday at 4 am), the patient developed a non-serious pain in sinus (sinus pain), pain in jaw, pain in her face (facial pain), pain in top and back of head (headache), pain neck (neck pain), sore in both arms , head and face (ulcer) and severe pain in her arms (pain in extremity), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The reporter would like to know if there had been adverse events (AE's) associated with patients taking the Fluzone High Dose vaccine who had underlying conditions such as myalgia's or rheumatological disorders. The reporter also wanted to know if there is a difference between last season Fluzone HD and these seasons. She would like to know how the vaccine works and if it caused inflammation or increased inflammation if a patient had an autoimmune condition. She wanted to know more information about the coronavirus disease of 2019 (COVID-19) vaccines.  The patient took the flu shot the year before that it didn't bother her. She took Tylenol and it took 4 hours to subside but then for the next month off and on she experienced face pain. It was unknown if she had any underlying conditions or not. She went to a lot of doctors, but they could not really diagnosis these disorders. She took Prednisone and all her pain went away and had no inflammation markers.  The details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for all the events.  There will be no information available on batch number for this case.
Development of diabetic ketoacidosis and type I diabetes mellitus.  Nurse follow up on 07/29/04 states: "No new information."
Incorrect medication administered error. Patient had been signed up for the Moderna bivalent vaccine but was given the monovalent dose again. Parents reported no reaction to the vaccine.
Complained of numbness in left check and "heavy tongue". Denies reaction to first Pfizer vaccine. Denies flushing, shortness of breath, swelling or itching. No difficulty in swallowing or speaking. Ruled out signs or symptoms of a stroke. Provided Benadryl at 10:30 am. By 10:40 am noted improvement of above. At 10:59 am, improved. No concerns. Drove home by self.
24 hours after receiving the vaccine I began experiencing adverse side effects that have continued to last (Tuesday-Friday). I've experienced constant migraines, nausea, fatigue, diarrhea since Monday, all of which have caused difficulty with eating and sleeping.
PASSED OUT IN THE OBSERVATION AREA ,DIZZY, SWEATY, PALE. BP72/48 LAYDOWN ,LEGS ELAVATED WITH MEDICS FOR 30 MINUTES. 9:50 AM FEELING BETTER ATE SOME FOOD AND DRINK WATER.. WENT HOME AND BP 116/72
I am the epidemiologist reporting on behalf of 75 year-old female patient.  Patient received two doses of the Moderna vaccine, according to immunization records. The first dose was on 4/23/21 and the second was on 5/17/2021.  The patient was found dead at home on 5/19/2021 (2 days post second dose). The death certificate lists ?cardiopulmonary arrest? as the immediate cause of death secondary to ?CHF, Interstitial Lung Disease, OSA, AFIB (FEW weeks) and RHEUMATOID ARTHRITIS, HTN, DIABETES (MANY years).? No additional information is available.
1st dose 10jan2023, 2nd 17Jan2023; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 33-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3A745, expiry date 12th March 2024) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX).   On 17th January 2023, the patient received the 2nd dose of Boostrix. On 17th January 2023, unknown after receiving Boostrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 19-Jan-2023 Reporter's comment: The health center manager called to inquired how to proceed or what to look for  or any harm to the patient. The reporter mentioned the first dose of Boostrix was administered in the facility but in a different department and the second dose was administered in the facility but in their department. Did not consent to follow-up. Additional supportive information: The patient received the second dose of Boostrix, which led to extra dose administered.
Information has been received from a licensed practical nurse concerning a 10 year old white female who on 16-AUG-1996 was vaccinated SC in the left thigh with a dose of Varivax (lot # 617265/0566D0. On 16-MAY-2006, at 1:00 p.m., the patient started with spots on the neck area and then had them on the back, face, and chest. She also had a few on the arms and legs. The experience required a doctor visit. On an unspecified date, the patient recovered. Additional information is not expected.
1/8, 11:40am - parent returned to health department; states infant difficult to arouse, sleeyp, only sipping at bottle.  Had fever (100.1F rectal),  1/7, around 2 pm gave <0.4 cc infant tylenol, then again between 6 & 7 pm gave same amount of tylenol & again 1/8 am around 8:30.  Advised to take infant to ER (no PMD) and stop tylenol.  1/9, mother stopped tylenol, no ER visit; infant "fine" to her - drinking formula & without fever.  Mother did not follow up with a physician; infant alert, easily arousable, feeding well, without fever.
This is a spontaneous report from a contactable physician received via a sales representative. A patient of unspecified age, race and gender received TRUMENBA, via an unspecified route of administration at single dose and HPV9, via an unspecified route of administration, both on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced high fever (40.5 Celsius) for 2 hours on an unspecified date with outcome of unknown.
t103, nl TM mobility;papular red eruption-neck, arms, legs, proximally-scattered, discrete
I got the chills, then hot flashes all night long. Also, by early morning hours a migraine with nausea developed. All-over muscle aches by morning.
Tinnitus has been escalating in severity.  Just wanted to be included in the data that I do believe the vaccine has exacerbated what was an occasional low level issue to high scale. (Note: i also experienced diabetic type symptoms TEMPORARILY but the tinnitus did not disappear and has been increasing.)
Completed the course of unrefrigerated Vivotif; Spontaneous report received on 24FEB2020.  A healthcare professional reported that a consumer who "completed the course of unrefrigerated Vivotif" (PT: Product storage error). The consumer was receiving Vivotif for immunisation. It was reported that the consumer failed to refrigerate the Vivotif after purchasing it and completed the course of unrefrigerated Vivotif. Action taken with Vivotif with respect to reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer completed the course of unrefrigerated Vivotif (Product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer completed the course of unrefrigerated Vivotif (Product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.
A few hours after patient received vaccine, she felt like a "ball was in her throat" & her lips started to swell/tingle. She phoned her provider who instructed her to go to urgent care. They didn't give her any meds so she went to ER & was given antihistamine & prednisone
Extreme anxiety, heart racing,  both feet were throbbing, shortness of breath, blood pressure rocketed 190/112, dry eyes, two finger shaking, weakness, tiredness, fatigue and moody.
Patient presented to the ED and was subsequently hospitalized for chest pain, elevated troponin, S/P aortic aneurysm repair within 6 weeks of receiving COVID vaccination.
Patient reported raised and red localized reaction on the evening on 8/27/14. Patient took some Benadryl and kept ice packs on the location. Patient went to the doctor and received an antibiotic (Keflex 500mg TID x 10d) for possible cellulitis.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Red welt at the injection site), VACCINATION SITE ERYTHEMA (A red spot at the injection site) and VACCINATION SITE SWELLING (Bump at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (Red welt at the injection site). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (A red spot at the injection site) and VACCINATION SITE SWELLING (Bump at the injection site). At the time of the report, VACCINATION SITE URTICARIA (Red welt at the injection site), VACCINATION SITE ERYTHEMA (A red spot at the injection site) and VACCINATION SITE SWELLING (Bump at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
Bothersome headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bothersome headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced HEADACHE (Bothersome headache). At the time of the report, HEADACHE (Bothersome headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment or concomitant products reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information was 21-May-2021 contains information regarding the outcome of the event headache.
When patient got up to urinate during night following vaccine admin, he reported being light-headed and unable to walk in straight line.  He went back to sleep and in at 7-8 am the following morning still had same symptoms.  The reaction felt different from his usual menier's symptoms (tinnitus, dizziness, vertigo) .   Patient called the pharmacy and was advised to hydrate, remain sitting as much as possible, to change positions slowly and to walk assisted or while holding onto something.     Later the patient reported that symptoms resolved completely later that same afternoon or evening, unsure of time.
Pain upon injection in shoulder and upper arm. Pain continued for several weeks then went to see physician and had cortisone injection in shoulder plus physical therapy.
About 30 minutes after the injection she noticed numbness and tingling on her face, her left arm swelled and was achy, red and warm. She took 2 Benedryl immediately and the numbness and tingling resolved. She had difficulty sleeping and heart racing that night. The next day her fever spiked to 102.9 and she had chills for which she took Tylenol. The fever improved but she had fatigue and redness and itching around the injection site that persisted.
abdominal pain; received the Shingrix Vaccine while having active Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of abdominal pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On an unknown date, the patient received Shingrix (intramuscular) .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced abdominal pain and drug use for unapproved indication. On an unknown date, the outcome of the abdominal pain and drug use for unapproved indication were unknown.   It was unknown if the reporter considered the abdominal pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and started to have abdominal pain. The patient received the Shingrix vaccine while having active shingles, which led to drug use for unapproved indication. No further information available. The reporter consented to follow up.
Temp 97.8, no allergies. Vaccines given 15 min post administration of vaccine a rash was noted on pts abd., chest and neck. Pt. given BENADRYL 12.5 mg/5mL is liquid. Pt given 3 mL for rash, no swelling, no breathing difficulties noted. Pt was sent home.
vaccine administered to unauthorized age of 17 yrs; He thought he was receiving the Pfizer vaccine; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to unauthorized age of 17 yrs) and PRODUCT SUBSTITUTION ISSUE (He thought he was receiving the Pfizer vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to unauthorized age of 17 yrs) and PRODUCT SUBSTITUTION ISSUE (He thought he was receiving the Pfizer vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to unauthorized age of 17 yrs) and PRODUCT SUBSTITUTION ISSUE (He thought he was receiving the Pfizer vaccine) had resolved.        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.   Reporter wanted information about next steps to take. She was guided with information, if the dose is administered at the age of 16 to 17, patient can administer the second dose. Hence, patient being 17 years old can get his second dose 28 days later.   Concomitant medications were not reported.
Patient received two vaccines on 8/4/2020 by this reporter (nurse). Pt requested vaccines to be administered in same arm. Today 8/5/2020, patient called Dr.'s office to report symptoms of lethargy, malaise, fever, flu like sx, and muscle pain at injection site and pain in armpit. This nurse paged Dr. who agreed to have pt take tylenol or motrin to remedy symptoms. Also, pt was told to monitor the redness at the injection sites to make sure it does not spread. Pt was agreeable with this plan and was given direct contact info should any other concerns arise. Dr. offered appointment tomorrow 8/7/2020 if the patient's symptoms are still persistent and pt is aware of this.
lump in deltoid 1 wk later, lt pain inc warmth; seen by MD; dx sterile abscess;
Hives on hands and face. Gave BENADRYL 12.5/5 6ml PO x one in office. No progression of hives or concerns of distress.
Migraine began 6 days after infection, lasted 2 days. No other symptoms. Resolved.
Increased CK (creatine kinase) level (Discharge Diagnosis) - 12/12/21 Syncope/Near syncope (Discharge Diagnosis) - 12/12/21 Leukocytosis (Discharge Diagnosis) - 12/12/21 Syncope and collapse (Final) - Abnormal levels of other serum enzymes (Final) - Elevated white blood cell count, unspecified (Final) - Abrasion of left elbow, initial encounter (Final) - Exposure to other specified factors, initial encounter (Final) - Activity, exercise machines primarily for cardiorespiratory conditioning (Final) - Unspecified place in unspecified non-institutional (private) residence as the place of occurrence of the external cause (Final) - Abrasion of oral cavity, initial encounter (Final) - Activity, unspecified (Final) - Unspecified place or not applicable (Final) - Unspecified external cause status (Final) - Procedure and treatment not carried out because of patient's decision for other reasons (Final) - Discharge Disposition: Home or Self Care Attending Provider: DO Admitting Provider: DO
Pt broke out w/red whelps & throat started closing up; took to ER was treated w/ATB for throat infect & med to gargle with; ER MD told mom this was not related to vax;
Large red oval rash at injection site, approx. 2 inches by 3 inches.   Started 5 or 6 days after injection.  Accompanied by intense itching which started at the same time.  Injection site was also hot and sore to the touch.  Now at day 11 after injection, arm is still red but only mildly itching.
Patient reports tingling in the tip of her tongue since getting the vaccine (for the past 3 days). She also reported extreme fatigue once she got home (felt fine at the pharmacy during the observation period). She also states she was so fatigued she didn't remember driving home and had to crawl from her front door to her bed and that she was in bed fatigued for 2 days. She has recovered from the fatigue but is still experiencing tingling in the tip of her tongue, which she hasn't experienced before receiving the vaccine.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 24-SEP-2013 the patient was vaccinated with M-M-R II (lot # J002502, expiration date 28-FEB-2015). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for the 15 minutes, 17-SEP-2013 for 35 minutes, on 19-SEP-2013 for 1 hour and 35 minutes, on 20-SEP-2013 for 40 minutes and on 25-SEP-2013 for 45 minutes. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375,  1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
second dose given on day 21 after first dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given on day 21 after first dose) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 24-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given on day 21 after first dose). On 14-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given on day 21 after first dose) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.
pt recv vax 8JUN98 & later the same day pt devel fever of 100 & inj site redness, warm to touch, itching, soreness & tenderness;pt tx for event w/motrin & warm compresses to the site;
shingles; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th October 2019, the patient received Shingrix. On 30th November 2019, 52 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient first noticed symptoms of shingles on 30th November 2019, and  her physician diagnosed her with shingles on 2nd December 2019. The shingles rash appeared on her bra line toward the back. The reporter consented to follow up.
Information has been received from a registered nurse and a female patient who on 24-NOV-2008 was vaccinated with ZOSTER vaccine (Lot # not provided) subcutaneously. On 24-NOV-2008 after the patient received ZOSTER vaccine, she developed a fever of 101F later that evening. The same day the patient contacted the office and was suggested to take ADVIL. On 25-NOV-2008 the patient called the office and complained of nausea, weakness and arthralgia. The patient has been scheduled for an office visit later that day. On 26-NOV-3008 the patient called to report that she experienced a flu like symptoms and her heart were raising?? after she received ZOSTER vaccine. There were no laboratory diagnostic studies performed/ At the time of this report on 25-NOV-2008, the patient"not recovered". Additional information has been requested.
Complaint of tingling tongue. No swelling noted. Initial vitals: T 98.3, BP 122/60, R 16, P 70, O2 97%. Monitored for 30 minutes. Stated the tingling had decreased. Vitals: T 97.4, BP 120/80, R 18, P 72, O2 98%. Left clinic with decreased symptoms.