chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced SINUSITIS (sinus infection). At the time of the report, SINUSITIS (sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs are not provided. No treatment.   Reporter did not allow further contact
moderna COVID-19 Vaccine EUA. Tachycardia sudden onset 4 minutes after injection (6:09am). Arms and legs cold and weak. Generalized weakness. BP 167/78, o2 sats 100%. Tachycardia lasted about 10-15minutes and resolved to HR 88 and BP 138/78.  Still left with overall weakness, malaise, cold feeling. No other symptoms.  Released from the facility at 6:48am.  Drove 2 blocks to my husband's workplace (hospital). Had diarrhea x 2, dull diffuse headache, odd feeling and malaise that persisted. Sudden onset of terrible feeling, the need to get to the ER at 8:36am. Had a bathroom visit to urinate. By the time we got to the ER the intense malaise improved. I sat in the ER lobby not wanting to be admitted to the ER (didn't want to be having a vaccine reaction). I stayed in the ER lobby. Symptoms completely resolved at 9:45am. I stayed there for 30 more minutes to be sure and then drove home with no other symptoms but Left arm soreness. Tachycardia never returned after the first episode. No rash, no itching, no swelling, no dyspnea. Just felt toxic. Then it resolved completely at hour 4.
Two days after Flu shot I came down with a fever. Then I got a severe cough. I had trouble breathing. My doctor had me get cough medicine and Azithromycin 250mg tablets 6 pak. After ten days I still was very sick so my doctor renewed my Azithromycin for another 10 days. This was on 10-21-10. On Nov 8th I went back to the doctor and she ordered a stronger antibiotic and cough medicine. On Nov 8th I started taking Amoxicillin 250mg capsules, this antibiotic did help me a little. It is now Nov 21st and I still have a cough. Since Oct. 2nd I have never been able to sleep all night. I wake up every 1 to 2 hours coughing and I have to get up and get a drink and cough drops. In all my life I have had many flu shots and never got sick. After this I will never get another flu shot.
Fever; Light Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (Light Headache) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and HEADACHE (Light Headache). At the time of the report, PYREXIA (Fever) and HEADACHE (Light Headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), 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.
Bad headache developed on April 8th at 11 AM.  By 2:30,  needed to sleep.  Unconscious for 3 and 1/2 days.   I have no recollection of any of this time.  I?m only listening to what have  told by the medical field and my family.   My husband started calling MEDICAL CENTER Friday morning and A called the helicopter by Friday afternoon at three.   They were ruling out a stroke.  By the time they landed the helicopter they knew it was not a stroke and started doing testing like CAT scans , lumbar punctures.  From what I?ve been told they ran four antibiotics IVs.  I remember waking up Sunday morning and someone was sitting in the chair next to me and all I kept saying was that I was hungry.  The lady started crying and said that I had been unconscious.  She tried to tell me who I was and that I was something called married and that I had children.  She tried to explain what had happened but I wasn?t able to comprehend.  I didn?t know what it meant that I lived on a farm or that I had animals.  Or that we had a vet practice.   I remember medical people asking me who I was and what the date was and if I remember how I got there and all I could do was smile.   It?s like the words just would not come.  And they diagnosed it as an cephalitis over the next couple days.  Where the brain swells up and you have memory loss and I had a high fever.  I had a lot of nausea after they put me on oral anabiotic?s.  I kept hearing from nurse reports that I had almost died.  These were hard things to here.  I?m forever thankful for all the people that have gone before me for doing the drug trials.    I am a energetic lady and I?m slowly getting back to myself.  I feel very thankful for the great care at the medical center.  I appreciate everything that you do every day.   I would not recommend getting vaccinated with this drug.  I am one of the healthiest people that I know. No I can?t believe this is happened to me.  I take good care and eat healthy and have no bad habits. I meditate and pray and have a joy filled life.
A report has been received from a Physician concerning a 15 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 03-Sep-2013. The reporter said that a 15 year old female received FLUMIST on 03-Sep-2013 and then by mistake again on 26-Sep-2013. The outcome of the event of 15 yo patient received two doses of FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
ACHES; CHILLS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced aches, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, and chills. This report was non-serious. This case, from the same reporter is linked to 20210422355.
A few minutes after receiving vaccine patient reported with itchy throat and tingling of neck and face. Previous history of anaphylaxis to bee stings. Gave 50mg Benadryl and bottle of water. Patient did not want Epi-pen until absolutely necessary because she said previously it took her down for 2 days. She had us call husband and sister and asked for EMS to be called. Still declined Epi-pen. EMS took her to (hospital).
Mother called 1/30/17 and stated that patient had complaints of tiredness and achy legs. She stated that she had "no energy."
Lack of appetite 8/2/17, vomiting 8/2/17, bloody stools 8/3/17, intussusception dx 8/4/17 and surgery done. This is a 2-month old female with about a day to day and a half history of decreased po intake, not drinking or eating much at all, and having some bloody stool, since about 1 am this morning. She has also been vomiting. She has not had any fever and she has been very fussy. The child has been seen in the emergency room twice and sent back home. She is seen in the clinic at this time and is admitted to hospital for evaluation.
Patient presented to ER on 3/23/08 with c/o L arm pain with surrounding redness to his smallpox vaccination site. He also reported malaise and tender lymph node under the arm. MD diagnosed with Erythema Multiforme and prescribed Benadryl and Keflex. He was given quarters and instructed to follow up at the Medical Clinic. Seen at the Medical Clinic on 3/24/08 Continued c/o red swollen arm. Given ice and Tylenol to treat. Quarters continued for 48 hours.
Patient received vaccine at 5:50pm and within 2 minutes while under the required 15 minute observation, he passed out and fell forward. Patient hit his chin and mouth breaking a tooth and complaining of jaw pain. Emergency services were called and paramedics checked all vitals and stated vitals were normal. Patient refused treatment and to be transported to Hospital.  Patient has been seated and is still  under observation by pharmacist. Patient left with father at 6:28 pm. Patient seems to be stable and pharmacist recommended to be taken to the hospital for further observation. Will be checking in with patient within the next few hours.
Patient felt very clammy, dizzy, sweaty and hot about 10 mins after administration of vaccine. He was instructed to place his head between his legs, placed an ice pack on his head and waited for an additional 15 mins. He felt better in approximately 10 mins and was able to leave the store on his own. He was accompanied by his wife who stated she would drive.
Headache, Myalgia, Fever, CoughWheeze, NauseaVomiting, Fever 99.8 12/25 Sore throat 12/25 Narrative:
Numbness in my right hand middle finger and tingling in the hand, blurred vision, headaches, and joint pain.
This spontaneous report as received from a physician via a company representative refers to a 68 year old male patient. There was no information about patient's concomitant medications and pertinent medical history reported. In approximately March 2014, (reported as "a year and a half ago"), the patient was vaccinated with a dose of ZOSTAVAX dose, route and site of administration, lot # and expiry date were not reported. On an unknown date, the patient was seen in the physicians' office with shingles "around the eye and the ear". On an unknown date, the unspecified treatment was given for the event. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as the physician did not wish to be further contacted.
Missed period for next two months after second dose of Moderna vaccine. Have never missed a period except for two pregnancies. Not pregnant at time of vaccine or in the months afterwards (or since 2016). On birth control which was not even successful at regulating period after the Moderna COVID-19 shot. Period returned July 2021 and has been shortened to 3 days.
Warmth & redness to injection site 5 1/2cm x 4cm.
Had PREVNAR 13 on 11/09/15. Days after immunization noted swelling, redness, pain, itchiness, tightness with moving arm, no heat or ice were effective. Took extra loratadine (20 mg) - no effect. States BP also up/down since then. Reported headache on 11/12 worse than normal. Has had headaches for the last over a year and had work up for that. But today it is worse and even got dizzy when leaned down. Denies fever, chill. Ibuprofen 600 mg TID.
Swollen arm, and neck was swollen and sore on left side. 1 day 1/2 later my left side was sore and I had shallow breathing, like it was heavy and hard to take breaths.
developed redness of left arm at injection site where given meningococcal and HPV vaccines on day of inoculation. next day was swollen and red with itching. no pain. swelling progressed and increased over subsequent two days. had not rec'd either of these vaccines before. rec'd tdap in contralateral arm on same day, but no redness or swelling or discomfort on that side.
Initial unsolicited report received from a physician on 16 January 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VIRUS VACCINES (batch number, expiry date, dose, route and site of administration were not reported) on unspecified date. Patient's medical history and concomitant medications were not reported. On unspecified date, following the vaccination the patient experienced heavy coughing and URI symptoms. Lab data and corrective treatment was not reported. The outcome of the events was not reported. Upon internal review this case was considered as serious due to Important Medical Event: URI symptoms. List of documents held by sender: none. Sender's Comments: This is poorly documented case as patient was vaccinated with influenza vaccine unknown manufacture following which patient had heavy coughing and upper respiratory infection symptoms. Time to onset is unknown additional information regarding patient medical history, concurrent condition, concomitant medication and diagnostic work-up- are lacking to allow adequate medical assessment. Based on the available information role of the vaccine cannot be assessed.
Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
This spontaneous report as received from a licensed practice nurse refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were administered improperly stored (Merck) VARIVAX lot # L013827, expiry date 21-APR-2017, lot # L019126, expiry date 27-MAY-2017, lot # L034367, expiry date 08-SEP-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Temperature excursion was reported as -12C for 9 hours. Product quality complaint was not involved. This is one of two cases received from the same reporter. Additional information has been requested.
Swollen at injection site at the store 8/27/18. Next morning 8/28/18chills, weakness, fever, upset stomach. Next morning 8/29/18 ok afternoon tired and upset stomach. Day 4 water type blisters starting on head and chest/ back. Day 5 more blisters went to urgent care and received a steroid shot, antibiotics. Day 6 more blisters and getting worse. Day 7 went to urgent care then to Emergency room and admitted for 4 full days for treatment.
72 hours after vaccine #1, she  experienced headaches, arm ache, nausea (vomiting x 24 hours only) also had fever to 99 (day#4), fatigue, light-headedness, trouble sleeping, gradually improved.  General fatigue lasted 20-25 days after vaccine #1.  Self care with rest, fluids, over the counter pain meds.
Acute onset of headache, malaise, myalgia and chills 15 minutes after injection. Administered 25 mg Diphenhydramine 25mg deep IM injection, 1L Normal Saline 0.9% IV fluids administered via bolus, monitored vital signs and airway with no complications. Patient responded well to treatment rendered.
lymph nodes under her arms on her neck; feels like a person who has her monthly cycle; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 IMMUNISATION. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymph nodes under her arms on her neck"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feels like a person who has her monthly cycle". The events "lymph nodes under her arms on her neck" and "feels like a person who has her monthly cycle" were evaluated at the physician office visit.  Additional information: A 70 year old women after her 2nd dose of the vaccine she has lymph nodes under her arms on her neck and feels like a person who has her monthly cycle. She wants to know how long this was going to last. She has never had this happen in her life. She did go to her doctor who told her to call us.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
THROMBOSIS IN FEMORAL VEIN; WEIGHT LOSS; COVID-19; This spontaneous report received from a patient via other manufacturer concerned a 76 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: osteoarthritis, and concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (oral, batch number: 1165105 expiry: unknown, form of admin was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the patient had blood clots following the Johnson and Johnson vaccination. The patient was not sure if Rinvoq influenced this too. The patient's left leg and foot were swollen. The clot was in the femoral vein (thrombosis in femoral vein) (dose number in series 1). The patient was hospitalized and placed on blood thinners and was recovered from this. The patient took a blood thinner. The patient had noticed weight loss (dose number in series 1) since starting Rinvoq and was not losing it drastically but had lost overall 30 pounds. The patient was not sure whether the Rinvoq was the reason but felt that the weight loss began with the Rinvoq. The patient remarks that she had energy. The patient had covid three times and the last infection was in JUN or JUL of 2022 (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient recovered from thrombosis in femoral vein, and covid-19 on 2022, and was recovering from weight loss. The patient additionally received Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of admin not reported, intramuscular, batch number: unknown, expiry: unknown) dose, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with Moderna covid-19 vaccine (elasomeran) (dose number in series 2). This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20220860077-covid-19 vaccine ad26.cov2.s - thrombosis in femoral vein. This event(s) is labeled per database and is therefore considered potentially related.
On April 10th, I developed unprovoked pain in my lower left calf. I went to my primary doctor April 12th, who sent me for a doppler scan to rule out DVT. It came back negative. I was told it was likely a calf muscle strain & to rest it. The pain was still active when I received my second vaccine dose on April 18th. On April 19th, I fainted at home, had several seizures, and difficulty breathing. I was sent by ambulance to the emergency room. There I suffered a massive pulmonary embolism, cardiac arrest, and numerous cascading issues affecting my liver, lungs, kidneys. I underwent a thrombectomy and several other procedures. I was told by doctors that less than 10% of people survive what I went through. con't
This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or around 19-DEC-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage, route of administration and anatomical location were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered left sided facial droop with numbness and was diagnosed with Left Bell's Palsy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations and seriousness of his condition. As a result of the zoster vaccine live (ZOSTAVAX), he sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, he suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of Bell's Palsy was considered to be not recovered. The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX). Upon internal review, the event of Bell's Palsy was determined to be disabling and medically significant.