chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare student referring to a patient of unknown age and gender. Pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date in November 2014, reported as "one year ago", the patient was vaccinated with ZOSTAVAX, (dose, lot # and expiration date were not provided). Concomitant medication was not reported. On an unknown date, in 2015, reported as "recently", the patient developed unspecified cancer and received unspecified chemotherapy. At the time of reporting, the outcome of cancer was unknown. The reporter did not assess the relatedness between cancer and ZOSTAVAX. Upon internal review, the event of unspecified cancer was considered serious as other important medical event. Additional information has been requested.
Pt recvd 2 doses of Hep B vax on 10MAY91 & 10JUN91 & felt lightheaded & on 21JUN91 devel herpes-zoster;
1st shot on 8/5/2021, immediate elevated heart rate lasted 8 hours. Also,. 2 hours later rash on chest. 2nd shot on 8/26/2021, Immediate elevated heart rate, anxiety. These episodes have continued to last, which today is 9/9/2021. Few days after 2nd shot, chills, headache, with increased anxiety and episodes of normal heart rate of 70 and will immediately jump to 130, light headedness. This has happened since the 2nd injection of the heart rate increase 16 times. The anxiety has not let up. Went to physician on 9/7/2021 and he had no answers and told me that he has never heard of issues.
My first injection caused severe dizziness; ultimately unable to speak; unable to function; ultimately unable to remember; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Sep2021 16:30 (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Two extensive spinal fusion surgeries" (unspecified if ongoing), notes: Other medical history: Two extensive spinal fusion surgeries; "Severe sensitivies to dairy" (unspecified if ongoing), notes: Known allergies: Severe sensitivies to dairy, sugars, and carbohydrates.; "Known allergies: sugars and carbohydrates" (unspecified if ongoing), notes: Known allergies: Severe sensitivies to dairy, sugars, and carbohydrates. Concomitant medication(s) included: BUDESONIDE; AZELASTINE; TRAMADOL. The following information was reported: DIZZINESS (non-serious) with onset 21Sep2021 20:30, outcome "recovered with sequelae", described as "My first injection caused severe dizziness"; APHASIA (non-serious) with onset 21Sep2021 20:30, outcome "recovered with sequelae", described as "ultimately unable to speak"; IMPAIRED WORK ABILITY (non-serious) with onset 21Sep2021 20:30, outcome "recovered with sequelae", described as "unable to function"; MEMORY IMPAIRMENT (non-serious) with onset 21Sep2021 20:30, outcome "recovered with sequelae", described as "ultimately unable to remember". The events "my first injection caused severe dizziness", "ultimately unable to speak", "unable to function" and "ultimately unable to remember" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of dizziness, aphasia, impaired work ability, memory impairment.  Additional information: Onset latency for the events was 4 hours from vaccination. AE treatment: Benadryl (no effect), Lorazepam. Patient did not had covid prior vaccination. Patient was not tested positive for covid post vaccination. Other vaccine in four weeks: No   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
01/06/2021 02/03/2021 DX COVID 01/10/2022
Rash has developed around the injection site 8 days after initial injection. Rash is 2 inches wide and a little over 3 inches long. Very mild soreness can still be felt, almost no itching. Doesn't seem serious.
Information has been received from a nurse concerning a 23 year old female who on 17-MAY-2010 was vaccinated with the first dose of GARDASIL 0.5ml intramuscular administration (exp date unspecified), on 04-FEB-2011 was vaccinated with the second dose (lot#665607/1333Y) (exp 25-JUN-2012), and on 01-APR-2011 was vaccinated with the third dose (lot#665607/1333Y) (exp 25-JUN-2012). Following injection (number of injection unspecified) the patient experienced soreness around the injection site. There was no lab diagnostics studies performed. The patient received unspecified medical attention. At the time of the report, the patent's status was unknown. Additional information has been requested.
Widespread hives all over body, palms, scalp. Benadryl and Zantac taken at home, briefly relieved hives and itching but hives returned in the evening around 8 Pm. Second dose of Benadryl and zantac taken with little relief. Went to urgent care the next day around 9 AM and received IM solumedrol and RX for Medrol dosepak. Hives still present for two more days but not as severe. I am required to get the flu shot for work and have for the last several years. This is the first year I've had a reaction to it.
Splotchy red patch would come on face after itching then go away for a few days, then again; Itching from neck upwards; Splotchy red patch would come on face after itching then go away for a few days, then again; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Splotchy red patch would come on face after itching then go away for a few days, then again), PRURITUS (Itching from neck upwards), CHILLS (Chills), HEADACHE (Headache) and RASH (Splotchy red patch would come on face after itching then go away for a few days, then again) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 003C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced CHILLS (Chills) and HEADACHE (Headache). On 03-Jun-2021, the patient experienced ERYTHEMA (Splotchy red patch would come on face after itching then go away for a few days, then again), PRURITUS (Itching from neck upwards) and RASH (Splotchy red patch would come on face after itching then go away for a few days, then again). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 28-May-2021, CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, ERYTHEMA (Splotchy red patch would come on face after itching then go away for a few days, then again), PRURITUS (Itching from neck upwards) and RASH (Splotchy red patch would come on face after itching then go away for a few days, then again) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Patient has been taking Topical Retinoid for Acne as concomitant medication.  Action taken with mRNA-1273 in response to the event was reported as not applicable.
Chills, low temp of 97.3, body ache, headache, localized pain in arm, swelling, large welts on arm between shoulder and elbow (right arm); I took ibuprofen and after the welts appeared , took Benadryl.  Was in bed for two days. I had a pneumonia and shigellas vaccine-do not have the lot or specific name of vaccine. Left message at physician office for a call back
Information has been received from a nurse concerning a 14 year old female patient with a medical history of fainting and no known drug reaction/allergies, who on 18-AUG-2008, was vaccinated with the first dose GARDASIL, 0.5ml, intramuscularly, and on 07-NOV-2008 was vaccinated with the second dose of GARDASIL vaccine (Lot # 660557/0072X), 0.5ml, intramuscularly.  Concomitant therapy included ORTHO TRI-CYCLEN.  The nurse reported that on 07-NOV-2008, the patient received the second of GARDASIL, and fainted twice while laying in the supine position.  Additionally, the patient became nauseous and vomited once.  The nurse reported that the patient was observed in the office and then discharged home.   The patient recovered from the symptoms on the same day of the vaccination.  The nurse reported that the patient did not experience any difficulties with the first dose of the GARDASIL.  Additional information has been requested.
Hives/itching all over body. Chest and jaw tightness. Decrease blood pressure. Tx Benadryl, Epinephrine and steroidal injection then oral steroids.
According to the information I have gathered, she became dizzy, nauseated, vomiting later in the day.  This continued for nearly two weeks.  She then presented to an emergency room and was diagnosed with a cerebellar stroke that likely started on the same day as her vaccine per that physicians report.
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. There were 55,989 in the exposed cohort and 55,989 in the unexposed cohort. The date of the surveillance of the exposed group was Oct 2011 to July 2012. The date of the surveillance of the unexposed group was Oct 2010 to July 2011. 1 Patients in the exposed cohort experienced pulmonary insufficiency, while 2 of the unexposed cohort experienced pulmonary insufficiency. Of the 1 patients in the exposed group age: age group 19-24 Female. Of the 2 unexposed patients 2 were in the age group 19-24. Sex: 2 males.
patient's husband came to pharmacy on 5/29/21 looking for an OTC relief product due to patient having a puffy bottom lip the morning after getting the second moderna vaccine.  It went away and then came back night of 5/28/21. She was currently taking benadryl by mouth.  She also has itchy hives only on the small of her lower back.  I recommended benadryl cream and hydrocortisone OTC for her itchy hives on the back and to seek medical attention if worsening or any difficulty breathing.
24 hours after receiving H1N1 vaccine, c/o fever, sore throat, general body aches, intermittent cough. Symptoms worsened on 12-28-09. Antibiotic therapy was started...Amoxicillin 500 mg TID x 10 days. 12-29-09 Follow up at clinic.
This non-serious spontaneous case, initially received from pharmacist on 24-Oct-2018, concerns a 46-year-old, adult male patient. On 24-Oct-2018, the patient (under age of 65 years) was administered FLUAD (TIV) [batch number: 250798, expiry date: 31-May-2019, dose, route of administration and anatomical location: not reported] (explicitly coded as inappropriate age at vaccine administration). At the time of this report, no adverse event was reported. Non-significant follow-up received from the pharmacist on 21-Nov-2018: The pharmacist states that, the patient didn't report any additional information since the original report. Hence no changes were made in the narrative.
Injection administered on 9/30/05 and pt come in for f/u visit on 10/3/05 stating on Sat 10/1/05 pt had fever, vomiting, diarrhea, redness and tenderness at left deltoid region where tetanus was administered.
04/20/2022--tenderness in right breast 04/22/2022--woke up with pain that felt like mastitis in right breast 04/27/2022--felt like bug bite on back, could not see  04/28/2022--developed rash on right breast (in cleavage and on lower side of right breast under armpit). Redness  extended across the breast from the left to right side.  Back pain became more severe.   04/30/2022--pain from rash intensified, especially on right side of breast. Treated rash with hydrocortisone 5/4/2022--received diagnosis of Shingles from Urgent care
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. On 06-Dec-2021, placed Lot 012H21B vials in refrigerator. Between 06-Jan-2022 and 11-Jan-2022, there were a total of 69 administered doses of Lot 012H21B. Of these, 68 doses were boosters and 1 dose was a first dose. No treatment medications were reported.
Pt called complaining of arm still being tender & sore at injection site after 2 wks.
I receive the injection at 7:30 in the morning. At 10:30 in the evening I awoke to having severe Rigors . Shaking uncontrollably. I then became very nauseous. I walked to my bathroom but then felt very dizzy so I had ole my husband up and got myself to the floor . I then passed out and lost consciousness. My husband almost called 911 as he said I was convulsing and he thought I was having a seizure. When I came to I started vomiting .  Today I have a headache , body aches , body chills and exhaustion .
About one minute after vaccines completed, patient was pale and c/o nausea. Bucket given. RN got H2o. Patient unable to swallow and H2O just dribbled down face. Patient awake and responsive but stated he couldn't see. RN got MD. Patient placed on bed. BP 96/60. O2 > 90%. HR 58. Monitored patient. Mom at bedside also when he came more alert H2O offered again. BP taken several times until baseline which was 114/72 at 1408/
pt had menveo and bexsero on 8/2/23 during her physical, the next morning she noticed right hand/wrist swelling, right improved some, then left hand/wrist started to swell. later that day she had left foot swelling. Family took her to ER and they transferred her to hospital. They observed her over night, symtoms improved and she was released. Since discharge the left side of her face is slightly swollen. no more swelling of the arms and legs. she was treated with motrin/tylenol and was given 1 dose of clindamycin in the ER, but this was not continued.  no cold sx, no fevers. no n/v/d.
Information has been received from a registered nurse concerning a patient at an elementary school of kindergarten to fourth grade, who on 06/03/1996 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  Between 03/01/2004 and 04/05/2004, the patient developed breakthrough varicella.  The patient had more than 50 pox, but was afebrile.  Unspecified medical attention was sought.  A product quality complaint was not involved.  The reporter also mentioned other cases of breakthrough varicella at the same elementary school.  Additional information is not available.
She received the vaccine at 0930 and had itching her lips became numb shortly after starting around 1200. She developed hives around her entire body on her left jaw, face, arms, and rack. Rash resolved within 24 hours with a lot of Benadryl.
I fainted, along with having fever, chills, headaches, nausea and swollen sore arm. I hadn't read of people fainting, so I wanted to let you know. I only fainted once and I was recovered by March 25.
Information has been received from a physician concerning a 65 year old male patient with no drug reaction/allergies, and with rheumatoid arthritis active, chronic hepatitis C at low level, adult-onset of type 2 diabetes mellitus that was diet controlled and hyperlipidaemia, who in July 2009, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not reported). Concomitant therapy also included an antihyperlipidemic medication. The physician reported that on 26-JAN-2011, the patient reported to him with a "classic presentation" of zoster. No lab diagnostics studies were performed. The physician stated that the patient received dexamethasone 4 mg intramuscularly on 26-JAN-2011 and was prescribed VALTREX 1 gram three times a day for 10 days and a MEDROL pack. At the time of the report, the patient's classic presentation of zoster persisted. Additional information has been requested.
No adverse event; A dose of the 18 years of age and older bivalent Moderna COVID-19 vaccine was given to a patient that is 5 years old; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (A dose of the 18 years of age and older bivalent Moderna COVID-19 vaccine was given to a patient that is 5 years old) and NO ADVERSE EVENT (No adverse event) in a 5-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 17-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (A dose of the 18 years of age and older bivalent Moderna COVID-19 vaccine was given to a patient that is 5 years old). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A dose of the 18 years of age and older bivalent Moderna COVID-19 vaccine was given to a patient that is 5 years old) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (A dose of the 18 years of age and older bivalent Moderna COVID-19 vaccine was given to a patient that is 5 years old).    No concomitant product reported by reporter.  Patient received dose 1 of Spikevax on 27-Jun-2022 and dose 2 on 28-Jul-2022 for indication of COVID-19 prophylaxis. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. A dose of the 18 years of age and older bivalent Moderna COVID-19 vaccine was given to a patient that was 5 years old. No symptoms were experienced.  No treatment medication reported by reporter.
pt recvd vax; screaming x more than 3 hrs; inject site red & warm;
Cannot say an exact date, but early December 2021, I started feeling bad; gradually feeling worse and worse. Dec 20, I had an appointment with my doctor, and told him I was very tired. My blood pressure was up and down. I was hurting all over. He found I had an elevated white blood count. He prescribed an antibiotic and ordered a CT scan, since my stomach was enlarged some. Dec 23, I was taken to ER at a regional hospital and found to have pneumonia. I was very weak and not eating much. I was given an IV of antibiotics and prednisone. Jan 2, was my second trip to ER at a regional hospital now very, very weak, not eating and still elevated white blood count. I was  released with nothing done because they couldn't find an issue. Jan 7, a CT scan was performed. Nothing found they say. I was so sick, I had to be in wheelchair because I couldn't walk. I was shaking very bad. I was so sick I couldn't function. I've lost about 20 to 25 pounds since this started.
patient received 1st dose of Moderna Covid 19 shot around 3pm on 3-15-21 and did not feel well right after. patient sat in the rx waiting room chair and asked for help. RPH went out and patient said he felt very very dizzy and that his whole body tingled. Patient stated this has never happened before. patient was given water and proceeded to shortly lose consciousness. Ambulance was called and they fully checked him out and said all vitals were fine and that patient could leave whenever he felt OK to do so. Patient ended up sticking around in pharmacy waiting area for around 1 hour in total and then left around 4pm, stating he felt much better and was fine to drive home.
Excruciating headache, bloody nose - then headache started to lift - headaches continue since vaccine 2 weeks ago.  Hot flashes / night sweats since vaccine. Extremely heavy period that came early.
Ramsay-Hunt syndrome; shingle in her facial nerve.; A spontaneous report was received from a consumer concerning herself, a 47-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Ramsay-Hunt syndrome (herpes zoster oticus) and shingles in her facial nerve (herpes zoster).  The patient's medical history was not provided. Concomitant medications reported included hydrochlorothiazide telmisartan, pantoprazole, metformin hydrochloride, vitamin D2, fenofibrate and eicosapentaenoic acid ethyl ester.  On 03 Mar 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (batch 012A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 05 Mar 2021, the patient experienced Ramsay-Hunt syndrome. Patient stated that symptoms started in the middle of the night on 04 Mar 2021, but she noticed it on around 0300 on 05 Mar 2021.  According to the patient, it was related to shingles in her facial nerve.    Treatment for the event included valtrex.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, action taken with the drug in response to the events was not applicable.  The outcome of the events, Ramsey-Hunt syndrome and shingles in her facial nerve, were considered not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a physician concerning a male with obsessive-compulsive disorder diagnosed prior to vaccination on 23-JUL-2007 with a first dose of VAQTA vaccine (lot # 652509/0036F). After the vaccination it was reported that the patient's condition became worse for a short time and then returned to normal. The patient was vaccinated with a second dose of VAQTA, (lot #657840/0797U) on 26-JAN-2008. It was reported that after the second dose "the condition became worse again and the patient did not recover". The patient was also vaccinated on 26 JAN 2008 with varicella virus vaccine live ("lot # 1355A"). The patient was seen in the emergency room (ER) on 4-APR-2008 and was sent home after having undergone a physichiatric consultation. At the time of reporting the patient had not yet recovered. There was no product quality complaint. Follow-up information was received from a physician on 13-MAY-2008 providing additional patient demographic details. Also noted, the patient has obsessive compulsive disorder and, according to "mom", the patient's symptoms got much worse after the Hepatitis A vaccine. Additional information has been requested.
Gave pt. MMRV and Meningo vaccine in Left arm had pt. stand up I moved the chair around to give Hep A in Right arm.The pt. started to pass out and fall towards me I caught him and sat him up and he started to seize. Others came over and we started vitals and someone called emergency services at 1403. B/P 90/60 Pulse 91 and O2 100% at 1406. At 1408 Pulse was 61. Fire dept. showed up at 1409   Pt. seemed alert and able to answer questions. At 1414 anbulance showed up and took over patient walked to stretcher and was taken to Hospital.
Pt recvd 1st hep B vax 29JAN91 & exp erythematous papulosquamous plaques rash on entire body below neck.Rash itched in spots.