chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hot flashes; injection site looks inflamed and is warm to touch; injection site looks inflamed and is warm to touch; joint pain; chills; fatigue; headache; redness around and above the injection site; lymph nodes sore and tender; muscle pain; feeling of nausea; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flashes), ARTHRALGIA (joint pain), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOT FLUSH (hot flashes), ARTHRALGIA (joint pain), CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache), VACCINATION SITE ERYTHEMA (redness around and above the injection site), VACCINATION SITE INFLAMMATION (injection site looks inflamed and is warm to touch), VACCINATION SITE WARMTH (injection site looks inflamed and is warm to touch), LYMPHADENOPATHY (lymph nodes sore and tender), MYALGIA (muscle pain) and NAUSEA (feeling of nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HOT FLUSH (hot flashes), ARTHRALGIA (joint pain), CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache), VACCINATION SITE ERYTHEMA (redness around and above the injection site), VACCINATION SITE INFLAMMATION (injection site looks inflamed and is warm to touch), VACCINATION SITE WARMTH (injection site looks inflamed and is warm to touch), LYMPHADENOPATHY (lymph nodes sore and tender), MYALGIA (muscle pain) and NAUSEA (feeling of nausea) 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.
Patient has developed angioedema, polycythemia vera, elevated red blood cell count, hypothyroidism, uncontrollable itching & swelling of feet, hands, face; throat, ears, genitals Feb 2010 to Nov 25, 2010, BENADRYL, ALLEGRA, SYNTHROID.
For three and a half days I had a low grade headache and exhaustion.  I treated the headache with tylenol which did not ease the pain but I cannot take any other meds as I have renal disease and other NSAIDS can affect my kidneys adversely
Approximatly 5 minutes after vaccine administration, patient stated that she felt light headed and thought she may pass out.  Patient  was given water and Gatorade and monitored for 30 minutes.  She requested to lie down.  She did not lose consciousness and after 30 minutes states she was feeling better and went home.  Pharmacist followed up with the patient about 1 hour later by phone and she reported feeling totally fine.
fever to 103, sore throat, malaise, nausea, diarrhea 48hr p/vax;treated in local ER w/Augmentin;
Pt states on 4/4/01 at 8-9 PM, noticed hives on arms. By 4/5/01 AM, pt awoke with hives over entire body. Went to ER and was given cortisone injection. Pt states all joints were swollen. Given po Zyrtec and prednisone. Pt states that on 3/27/01, went to PCP with sore throat and fluid in ears. Given generic amoxicillin and guaifenesin.
Abdominal pain; A spontaneous report was received from a physician on 20MAR2023 regarding a patient (patient 3) of unknown age and gender who experienced "abdominal pain" (Abdominal pain) following the administration of Vivotif capsule (Typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that on an unknown date in 2023, "last month", the patient experienced abdominal pain with no other symptoms due to Vivotif.  The outcome of the reported event was unknown, at the time of this report.  The action taken with Vivotif with respect to the reported event was unknown.  No additional information was reported.  Based on the information available in the document three individual case safety reports 23000101 (patient 1), 23000102 (patient 2) and 23000103 (patient 3) were created and cross-linked into the database.  Company comment: A consumer took Vivotif for immunisation and experienced abdominal pain. Further information regarding the event, medical history and concomitant medications is limited. Considering the case information, the causality of abdominal pain is assessed as possible with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: A consumer took Vivotif for immunisation and experienced abdominal pain. Further information regarding the event, medical history and concomitant medications is limited. Considering the case information, the causality of abdominal pain is assessed as possible with Vivotif. The case is considered non-serious as per medical assessment. 23000101:Linked case (Patient 1) 23000102:Linked case (Patient 2)
Information has been received from a registered nurse concerning a 24 year old female with a penicillin allergy and had no other pertinent medical history reported. On 03 Nov 2006, the patient was vaccinated intramuscularly in the right deltoid with a 0.5 mL of Gardasil vaccine (yeast) (Lot # 653736/0868F). There were no concomitant medications reported. On 29 Nov 2006, the patient was examined by the physician and was complaining of swelling of the right cervical lymph node and low grade fever. The physician ordered a complete blood count (CBC), which was normal. On 30 Nov 2006, the patient was re-examinined and the right cervical lymph node had increased in size and the patient had developed swelling of the right axillary lymph nodes, peri-sternal discomfort and extreme malaise. The physician ordered a throat culture and results were pending. The patient was being referred to her internist for follow up. Unspecified medical attention was sought. At the time of this report, the patient had not recovered from the events. Additional information has been requested.
Arm, neck and shoulder felt very tight and hard as a rock. Had chills and body aches.
Information has been received from a RN concerning a pt who on 02Jun95 was vaccinated with a dose of varicella virus vaccine live (lot 608579/0407B). Subsequently, on 23Dec01, the pt developed chickenpox. The pt was seen in the office. The reporter also indicated that 30 other pts were vaccinated with varicella virus vaccine live and developed chickenpox (WAES0409USA00600, WAES0409USA01045, WAES0409USA01046, WAES0409USA01047, WAES0409USA01048, WAES0409USA01049, WAES0409USA01050, WAES0409USA01051, WAES0409USA01052, WAES0409USA01053, WAES0409USA01054, WAES0409USA01055, WAES0409USA01056, WAES0409USA01057, WAES0409USA01058, WAES0409USA01059, WAES0409USA01060, WAES0409USA01061, WAES0409USA01062, WAES0409USA01063, WAES0409USA01064, WAES0409USA01065, WAES0409USA01067, WAES0409USA01068, WAES0409USA01069, WAES0409USA01070, WAES0409USA01071, WAES0409USA01072, WAES0409USA01073, WAES0409USA01074). No further information is expected.
Rash on arms, legs, and back of neck. Itchy and burning sensation on said rash. Progressively getting stronger.
Pain all over the body; Neck pain; Joint pain/elbows it really hurt; Muscles pain; Bone pain; she barely stayed up due to the pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 01-NOV-2023, the patient received Arexvy (right arm). In NOV-2023, less than a day after receiving Arexvy, the patient experienced general body pain (Verbatim: Pain all over the body), neck pain (Verbatim: Neck pain), joint pain (Verbatim: Joint pain/elbows it really hurt), muscle pain (Verbatim: Muscles pain), bone pain (Verbatim: Bone pain) and weakness (Verbatim: she barely stayed up due to the pain). The outcome of the general body pain, neck pain, joint pain, muscle pain, bone pain and weakness were resolving.   It was unknown if the reporter considered the general body pain, neck pain, joint pain, muscle pain, bone pain and weakness to be related to Arexvy.     It was unknown if the company considered the general body pain, neck pain, joint pain, muscle pain, bone pain and weakness to be related to Arexvy.   Additional Information: GSK Receipt Date: 02-NOV-2023 The reporter was the patient who stated that she received Arexvy yesterday in her right arm and she developed pain all over the body, specially neck, muscles, joints, bones and she barely stayed up due to the pain. The patient stated if she touch her elbows it really hurted. According to the reporter she was feeling a little bit better on the day of reporting. The reporter consented to follow up.
PATIENT (PT) CALLED PHARMACY 2-21-21 AT APPX 11:15AM AND SPOKE TO ME,RPH. PT DESCRIBED REACTION TO MODERNA COVID-19 VACCINE RECEVIED ON 2-8-21. PT STATES THAT THE REACTION STARTED SEVERAL DAYS AFTER THE VACCINE. SHE BELIEVES AROUND 2-14-21. PT DESCRIBES REACTION AS PAIN AND ITCHING AT AND AROUND INJECTION SITE. SHE DESCRIBES THAT THERE ARE RED MARKS/SPOTS BELOW INJECTION SITE DOWN TO ELBOW ON BOTH THE INSIDE AND OUTSIDE OF HER LEFT ARM. THE INJECTION ARM WAS BRIGHT PINK FROM BELOW INJECTION SITE TO TWO INCHES ABOVE LEFT ELBOW ON INSIDE AND OUTSIDE OF LEFT ARM. PATIENT STATES THAT INJECTION ARM WAS 'PUFFY' OR SWOLLEN. PT MEASRUED CIRCUMFERENCE OF BOTH HER LEFT AND RIGHT ARM AND FOUND THAT HER LEFT ARM WAS 1&1/2 INCHES BIGGER IN CIRCUMFERENCE THAN HER RIGHT ARM. PT STATES THAT SHE TOOK BENADRYL YESTERDAY AND THAT PROVIDED SOME RELIEF TO THE SYMPTOMS. I ADVISED PATIENT TO CONTINUE TAKING THE BENADRYL AND TO CONTACT HER DOCTOR ASAP TO GET HELP FROM DR. SHE SAID SHE WOULD CONTACT HER PRIMARY CARE MD, TOMORROW. I ADVISED PATIENT THAT SHE MAY WANT TO GO TO AN URGENT CARE TODAY IF SYMPOTOMS WORSEN OR ARE NOT IMPROVING. PT SAID SHE WILL CONT DR MONDAY MORNING FIRST THING.
Fever 101 for 6hrs; headache; chills; body aches; nausea; This is a spontaneous report from a contactable Other-health care professional (patient herself) of 55 years old female received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; Lot number: unknown) via intramuscular route of administration in the left arm on 12Feb2021 at 12:00PM and first dose on unspecified date via unknown route of administration both as a single dose for COVID-19 immunization. Patient medical history was not reported. Concomitant medications included escitalopram oxalate. The patient had no known allergies. The patient had COVID prior to vaccination. The patient was not tested for COVID-19 post vaccination. On an unknown date, the patient developed fever of 100 degree centigrade. On 12Feb2021 at 10.00 PM, the patient developed fever 101 for 6hrs and experienced headache, chills, body aches and nausea. The patient underwent lab tests and procedures which included body temperature: 100 centigrade an unknown date and body temperature: 101 centigrade on 12Feb2021 fever 101 for 6 hours. The clinical outcome for the events were considered as recovered.
mom states pt started w/fever that afternoon on 14MAR91 & was given APAP; fever 105 was taken to ER & kept overnight in ER until fever dec; was told DTP reaction not to give DTP again;
zoster related vision loss; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 09-FEB-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for zoster related vision loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event zoster related vision loss was not recovered. The causality assessment was considered as related by the lawyer.  Upon internal review, zoster related vision loss was determined to be medically significant.
Patient was inadvertently given Tdap, MCV4 and HPV9 meant for her 11 year old sibling. Mom was immediately notified of the error. Child did not report any symptoms immediately after. Mom was instructed to call immediately if she noticed anything unusual.
patient passed away; This case was reported by a consumer via patient support programs and described the occurrence of unknown cause of death in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On 26th July 2020, less than 9 months after receiving Shingrix, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 26th July 2020. The reported cause of death was unknown cause of death.   The reporter considered the unknown cause of death to be unrelated to Shingrix.  Additional details were provided as follows: The reporter stated that, after vaccination with Shingrix 1st dose on December 2019, the patient passed away on 26th July 2020. The reporter stated that, cause of death was undisclosed. There was no product complaint. The reporter consented to follow up; Reported Cause(s) of Death: Death NOS
I was okay for the first two weeks I went to the ER on 05-30-2021 due to cough, slight headaches, pain in my back. I came to find out the pain I was experiencing was "walking pneumonia".  At the ER x-rays of the chest, CT scan of the chest with contrast , UA were performed.  I was given albuterol inhaler and z-pack and Oxycodone for pain.  I still have bit of pain to my back and slight headaches that come and go.
next morning woke with fevers, body aches, chills, nausea and headaches.  today diagnosed with new onset atrial fibrillation and LLL pneumonia.
arm was a little sore at the injection site/injection site soreness; has muscle pain in her groin and states it has nothing to do with the vaccine; she moved her leg wrong yesterday after the vaccine; This is a spontaneous report from from a sponsored program. A contactable female consumer (patient) of an unspecified age received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 06Feb2021 14:30, single dose for COVID-19 immunization. The patient medical history was not reported.  Concomitant medication included acetylsalicylic acid (ASPIRIN). Patient states she takes supplements everyday at the same time and she took 81 mg of aspirin. Caller would like to know if taking 81 mg if aspirin would affect the efficacy of the vaccine. On 06Feb2021, patient's arm was a little sore at the injection site. Patient states she had muscle pain in her groin and states it has nothing to do with the vaccine. She moved her leg wrong yesterday after the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Approximately 30 minutes after shot I felt numbness of of lips, tongue, jaw and left hand. Lasted approximately 29 minutes. That evening I started experience cramping of right calf followed by charlie horses. It has been ongoing for the last 23 hours. I also experienced chills, joint soreness, fatigue and mild headache. I have not seen a physician as of yet. If it continues into tomorrow I will call PCP Dr.
Sore arm,  chills ( no shivering), lethargy, rash 2 days later on stomach and back. Resolved 3rd day.
39 y/o referred to VHC by Dr./OCC HEALTH for report of LLR 24 hrs s/p receipt of Tdap placed on 14NOV12, as part of required Annual FFD exam, as firefighter. No other vaccines received on same day or w/in 30 days prior to Tdap. No viral or GI illness endorsed w/in 30 days prior to receipt of Tdap. Per DEERS, last Td was on (06APR05). Employee states that the Tdap really burned on administration (L deltoid). Denied shooting pain to fingers, no tingling, no paresthesias, numbness or weakness of LUE or left hand. He woke up the next morning (15NOV12) with a hard, painful lump, about 3 inches in diameter, at Tdap injection site (L deltoid). No fever, no significant erythema or warmth at the injection site. He had difficulty sleeping x 2 nights (14-15th NOV12) due to pain in LUE- could not sleep on left side. Self-treated with ibuprofen 600-800 mg q6-8h WF (only took x 2 days). The localized induration & pain made it hard to lift 4 lb bunker jackets with his left arm at work. On 16NOV12 he had a f/u appt with Dr. at OCC HEALTH FOR Part II of his Annual FFD Exam and indicated the indurated, painful area on his left deltoid to Dr., who referred pt to VHC for documentation of adverse event following immunization. Note: patient rated localized pain (L) deltoid as "8"/10, impeding him from executing his job safely due to difficulty lifting with left arm. Excused from work x 1 day. Pt also c/o of redness of his eyes- bilat (sclera) since receipt of Tdap; wife noticed redness around 24 hours. No drainage. No irritation / gritty sensation eyes- just red (bilat)- didn't sleep much x 2 nights. Redness seems to be resolving on its own.
Flu-like symptoms for 48 hours started 18 hours after injection Headache, fever, body aches, nausea, cough, low energy
got vaccinated in his left arm/ and developed a rash on both of his wrists 2-3 days ago; This case was reported by a consumer via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported but it could be 73 or 74 years. The patient received Shingrix and experienced a rash on both of his wrists, 2 to 3 days ago of reporting date. The rash that had not resolved. No further information reported. The reporter consented to follow up.
shortness of breath upon activity; palpitations; Swelling of ankles; Getting up many times at night to pee; echocardiogram which revealed diastolic dysfunction; This is a spontaneous report from a contactable consumer (patient). This 72-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6206) on 04Mar2021 at 08:30 via an unspecified route of administration in left arm as DOSE 2, SINGLE for COVID-19 immunization (age at vaccination: 72-years-old). Patient medical history included: high blood pressure, high cholesterol, treated with meds. Obesity untreated. Major depression treated with meds. The patient reported allergies to Cats, mold, dust mites, and formaldehyde. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient took other unspecified medication within two weeks of the vaccination. The patient did not have Covid prior vaccination neither covid tested post vaccination. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6201) on 11Feb2021 at 08:30 via an unspecified route of administration in left arm as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date, after the second shot the patient experienced shortness of breath upon activity, no matter how minimal. She began having palpitations, had swelling of ankles and was getting up many times at night to pee. She went to her PCP who ordered an echocardiogram which revealed diastolic dysfunction. She never had heart trouble, nor these symptoms. The patient did not receive any treatment for the events. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
no additional AE's reported; Office Manager called to report that a patient over 2 years old received an extra dose of ROTATEQ accidently. The patient already received the 3 dose regimen at the appropriate age but received an extra dose on 2/16/23. No reported patient side effec; This spontaneous report was received from an office manager and refers to a 2-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug allergies/ reactions were not reported.  On an 16-FEB-2023, the patient was accidently vaccinated with extra dose of with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) product quantity: 1, 2 milliliter by mouth for prophylaxis (Extra dose administered) (strength, lot #, and expiry date were not provided). The patient already received the 3 dose regimen at the appropriate age. No reported patient side effects. No additional adverse events reported (No adverse event).
Bilateral PE's after Booster 1/15/22.  Acute onset Shortness of breath after Moderna Booster.  Pfizer for the initial two doses of vaccine.