chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This report describes the occurrence of an inject site reaction in a 27 y.o. female who received Hep B vaccine recombinant (Engerix-B). This report was received from the subject who is a pharmacist and has been medically confirmed. The subject's medical history included environmental allergies and allergy to thimerosal (1999). She denied any tobacco use and indicated that she is a social drinker (approximately one drink/month). The subject experienced a "similar type of reaction" (red, pimply rash with some hives) with the tuberculin (TB) skin test a few yrs ago and approximately 36 hrs after receiving her first injection of Hep B vaccine series with Recombivax adult dose (May 02). Concurrent medications included ethinyl estradiol/norgestrel (Lo-Ovral) and acetaminophen (Tylenol). Reportedly, the subject noted that Recombivax adult and the TB skin test, both contained thimerosal. Therefore, for her second injection of Hep B vaccine, she opted to receive Engerix-B pediatric, which she thought did not contain thimerosal. On 6/13/02, the subject received her second injection of Hep B vaccine recombinant (Engerix-B pediatric) in the right arm. Reportedly, for this 2nd injection, 2 doses of Engerix-B pediatric were drawn up in one syringe and was given as one adult strength injection. On the same day, post immunization, the subject developed an inject site reaction characterized by a red, pimply rash with some hives. It was not indicated if treatment was given for the events. The symptoms were reported to have resolved as of 6/16/02. The reporter considered the events to be related to the 2nd injection of Engerix-B pediatric, since she realized after the injection that Engerix-B may have trace amounts of thimerosal. Additionally, the subject realized that she is planning to receive her third dose of the series with the Recombivax pediatric, which she believes, does not contain thimerosal.
Information has been received from a physician concerning a female (age not reported) who was vaccinated with a dose of GARDASIL vaccine (lot not reported) and who developed redness and neuralgia in her arm after vaccination. The patient's status was not reported. Additional information has been requested. In follow-up, the physician reported there was no reaction. Additional information is not expected.
Extreme brain fog; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 32-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 04May2021 (age at vaccination was 32 years and non-pregnant at the time of vaccination) (Batch/Lot Number: EW0179) as dose 1, single for COVID-19 immunization. Medical history included high blood pressure. Concomitant medications included norethindrone (norethisterone) (NORETHINDRONE (NORETHISTERONE)) and hydrochlorothiazide, triamterene (TRIAMTERENE AND HYDROCHLOROTHIAZIDE). The patient was allergic to penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. After receiving the vaccine, the patient experienced two weeks of extreme brain fog and fatigue on an unspecified date in May2021. The events resulted to Doctor or other healthcare professional office/clinic visit and considered as medically significant. Prednisone was given as treatment for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
mild body aches; fatigue; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (mild body aches), FATIGUE (fatigue) and HEADACHE (mild headache) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 014MZ0A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced MYALGIA (mild body aches), FATIGUE (fatigue) and HEADACHE (mild headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MYALGIA (mild body aches), FATIGUE (fatigue) and HEADACHE (mild headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. The action taken with the drug was not applicable.   This case was linked to MODERNATX, INC.-MOD-2021-077752 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-077752:
the patient had a cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (the patient had a cold) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031-A2419) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included GLUCOSAMINE & CHONDORITIN for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced NASOPHARYNGITIS (the patient had a cold). On 03-May-2021, NASOPHARYNGITIS (the patient had a cold) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included high blood pressure medications, high cholesterol medications and medications to treat PSA levels of prostate and fish oil.  No treatment details were reported.     This case was linked to MOD-2021-122966, MOD-2021-122966 (Patient Link).
The next morning when I woke up I had pains in my hands and wrist. I couldn't use my hands and it wouldn't go away even when I took TYLENOL and ibuprofen. I went to the ER after a week because the pain was so bad. They gave me TYLENOL 3. I went to my PCM on January 26th. He took x-rays of my hands and wrists. X-rays came back and said I have arthritis. My doctor prescribed me medication.
This spontaneous report as received from a physician refers to a 20 years old female patient with allergy to sulfa and minocin. The patient was vaccinated with the first dose of GARDASIL (route, dose and lot # were unknown) on 31-DEC-2007, the second on 06-MAR-2008 and the third on 05-JUN-2008. No other co-suspects were reported. Concomitant medications included: hormonal contraceptives (unspecified) (Birth control pills). The patient completed GARDASIL series, recently had Pap test done and result came back positive. The test result read: "HPV high risk positive, HPV type 6, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68". PAP test was done on 08-OCT-2012. No treatment was given for adverse event. The outcome of the event was unknown. The patient sought medical attention via visiting office. Additional information is not expected.
PMS; stomach pain; This is a spontaneous report from a Pfizer from a contactable consumer  reported for a female patient. A female patient of unknown age received BNT162B2 (Pfizer BionTech Covid-19 Vaccine, Solution for Injection, Lot number and expiration date: Not reported), via an unspecified route on an unknown date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced PMS or stomach pain since she got the vaccine. wanted to know if there is any documentation of this side effect and what to do. The clinical outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Noticed the day after getting the injection, there was a red splotch on my arm below injection site and to the right.  Slight discomfort and slight itching with it.   Now, a week later, red splotch is twice as large, slightly more discomfort (thought not really painful) and itches a little more.  Have NOT seen anyone about it yet.  Plan on calling the doctor's office tomorrow to see if anything needs to be done.
COULDN'T SIT UP; EXCRUCIATING HEADACHE; NAUSEA; THROWING UP AND JUST COULDN'T STOP/ VOMITING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested No concomitant medications were reported.  On APR-2021, the patient experienced couldn't sit up. On APR-2021, the patient experienced excruciating headache. On APR-2021, the patient experienced nausea. On APR-2021, the patient experienced throwing up and just couldn't stop/ vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't sit up, excruciating headache, nausea, and throwing up and just couldn't stop/ vomiting. This report was non-serious.
Pt is employee, TDAP given on Friday 3/26/2010.  Employee reported Monday 3/29/2010.  RD with redness, swelling, & slight edema silver dollar size.
Hands shaking; fever 100; severe headache; Muscle pain; Joint pain; This is a spontaneous report from a contactable nurse, the patient. A 70-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266) via an unspecified route of administration in the left arm on 23Feb2021 at 09:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, osteoarthritis and hypothyroidism. The patient did not have allergy to any medications, food, or other products. Concomitant medications included lamotrigine (MANUFACTURER UNKNOWN), olmesartan medoxomil (BENICAR) and thyroid (ARMOUR THYROID). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN9581) via an unspecified route of administration in the left arm on 02Feb2021 at 09:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Feb2021 at 21:00, the patient experienced hands shaking, fever 100, severe headache, muscle and joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events hands shaking, fever 100, severe headache, muscle pain and joint pain were recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Became pregnant approx 2nd week of Feb 2004, About 2 weeks after receiving LAIV. On 04/16/04 in the afternoon began spotting. 04/15/04 HCG blood draw done. 04/18/04 HCG blood draw done. Count dropped by 1/2. Emergency D&C done on 04/20/04 for hemmoraging. To return for next Or. visit during week of 04/26/04. This was 5th pregnancy. Has no previous history of miscarriages.
Headache, Myalgia, Arthralgia, chills, injection site pain, fatigue, loss of apetite Narrative:  The morning after receiving the vaccine, the patient reported having chills, a headache, back ache, injection site soreness, loss of appetite, and fatigue. She took one dose of ibuprofen 200mg.  Other Relevant History:
Patient was administered 2nd vaccine on 1-8-21 by a nursing student.  During 15 observation period, arm began to feel cold at injection site area. At that point the patient realized the vaccine was given toward the back of upper left arm near the fatty tissue instead of toward the middle of the arm. Approximately 20 min after vaccine administration,  patient became short of breath, dizzy,  light headed, and throat felt a little swollen and almost passed out. A rapid response was called and the patient was seen by Occupational Health. The patient's BP and heart rate were elevated but normalized during observation in Occupational Health. At this time, the patient did not feel they needed to be seen in the emergency department. The patient was discharged home at this time.  12 hours after the shot, the patient began experiencing normal side effects from the vaccine. The nursing student was informed of administration at the incorrect site.
soreness on her left arm; pain the in the injection site; fatigue; headaches; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Mar2021 12:45 (Lot number: 59267-1000-02) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: VENLAFAXINE. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 14Mar2021, outcome "not recovered", described as "pain the in the injection site"; FATIGUE (non-serious) with onset 14Mar2021, outcome "not recovered", described as "fatigue"; HEADACHE (non-serious) with onset 14Mar2021, outcome "not recovered", described as "headaches"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness on her left arm". The events "pain the in the injection site", "fatigue" and "headaches" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of vaccination site pain, fatigue, headache. Additional information: The patient has not had COVID prior to vaccination and has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received the first dose of the vaccine on 07Mar2021. The first week after the vaccine, the patient started to have pain the in the injection site, fatigue, headaches. It was further reported that at first, she felt fine but now she developed soreness on her left arm on an unspecified date which goes on and off, as well as fatigue. She would like to know how long these symptoms will last.   No follow-up attempts are possible. No further information is expected.
Went in to get my second COVID shot and the pharmacy accidentally injected me with a booster shot. They then decided to give me the second COVID shot i the other arm, on top of that. Since then, I have felt horrible (feverish, chills, headache)
Information has been received from a pharmacist concerning a female who on 04-MAY-2009 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck).  On 13-MAY-2009 the patient developed a rash on the left side by her hips that was painful and looked just like her husband's rash when he had the shingles.  At the time of reporting the patient did not recovered.  Follow up information was received concerning the 62 year old female patient who on 04-MAY-2009 (at 5:22 pm) was vaccinated subcutaneously in the right deltoid with a single 0.65 ml dose of ZOSTAVAX (Merck) (lot # 664090/0139Y).  On 10-MAY-2009 the patient developed a rash which was a composed of papular lesions.  The patient also experienced flu like illness a few days before eruption (10-MAY-2009).  It was reported that the patient was not recently exposed to chicken pox or shingles.  "The patient was enrolled in the VARICELLA ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  The sample of the lesion was collected on 13-MAY-2009."  Follow up information received via telephone from the pharmacist on 13-MAY-2009 reported that the patient had an appointment that afternoon with a physician and provided the phone number and fax number of the physician.  Additional information received via telephone from the physician explained that 9 days ago (on 04-MAY-2009) the patient had been vaccinated with a dose of ZOSTAVAX (Merck).  Four days post vaccination the patient developed irritation on her skin which was painful.  The rash was 5 days old and there was a small area at L5 on the left side.  Additional information received from a pharmacy on 14-MAY-2009 reported that the patient was vaccinated subcutaneously in the left deltoid with a dose of ZOSTAVAX (Merck) (lot # 664090/0139Y) (exp. 24-JUL-2010) on 04-MAY-2009 at 5:22 pm.  Additional information has been received from the pharmacist and an associate research scientist.  The pharmacist reported that the patient experienced a rash (description Herpes ZOSTER) and flu like illness before eruption.  The diluent's lot number was 4115X.  The pharmacist reported that the patient had no recent exposure to chickenpox or shingles.  The associate research scientist reported that a sample of the lesion was collected on 13-MAY-2009 from a vesicle/papule and was sent to laboratory on 14-MAY-2009.  The sample was adequate.  The VZV DNA was amplified and the results showed a wild type strain of VZV.  No further information is expected.
1hr p/recvd vax mom states pt had non stop crying x 3 hrs or more; also noted swelling of lt leg; denies pt having a high pitch cry or convuls; t102 R & controlled by APAP; mom states following day crying stopped but cont to run temp;
Woken up by extreme headache, body aches, and fatigue. Feeling of extreme weakness throughout the day and pain in the ears. Nausea and vomiting throughout the day.
On 11/10/2000 the patient developed "little blisters" and was treated with cortisone cream. The physician reported that the patient had a rash on the right of the midline of the back to the midline front of the trunk. Therapy with coritsone was discontinued. Subsequently, on 11/16/2000, the patient was diagnosed with mild shingles and was seen by his physician on 11/17/2000. The shingles lasted for 1 week. No further information is expected.
The patient was immunocompromised and received full booster dose.; This spontaneous case was reported by a consumer and describes the occurrence of OVERDOSE (The patient was immunocompromised and received full booster dose.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OVERDOSE (The patient was immunocompromised and received full booster dose.). At the time of the report, OVERDOSE (The patient was immunocompromised and received full booster dose.) outcome was unknown.            Concomitant medications were not reported.  The patient was immunocompromised and got three full shot and went for the booster and received a full shot.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-600670 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-600670:
States noted 11/24/2005 early afternoon sharp pain in left anterior chest, later able to feel in posterior chest.
This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. The medical assistant reported that an unspecified number of doses of GARDASIL 9 (lot# M005714 with expiration date: 03-OCT-2017 and lot# M021407 with expiration date: 30-APR-2018, dose and route of administration were not reported) were administered to the patients on unknown dates following a temperature excursion of 32.9F for 22 hours and 17 minutes. No adverse effects were reported for any patients receiving doses. This is one of three reports received from the same source. Additional information has been requested.
Patient received Monovalent COVID-19 vaccine. Recommendations from CDC updated on 9/2/22 to discontinue Monovalent COVID-19 Boosters and to begin using BIVALENT COVID-19 Boosters.
Feels yucky; Feels like she has the flu; Feels tired and sluggish; Fever; Chills; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the second dose bnt162b2 of (BNT162B2, Solution for injection, Lot number: EL9264), via an unspecified route of administration, in the left arm on 03Feb2021 09:30 (at the age of 70-years-old) as single dose for protection from Covid. Medical history included knee arthroplasty from an unspecified date in Sep2018, blood pressure measurement, thyroid disorder, anticoagulant therapy. Concomitant medications included levothyroxine sodium (SYNTHROID) (MANUFACTURER UNKNOWN); aspirin (ASPIRIN [ACETYLSALICYLIC ACID]) (MANUFACTURER UNKNOWN); losartan (MANUFACTURER UNKNOWN). On 03Feb2021 20:00, the patient experienced fever, chills, feels like she has the flu, feels tired and sluggish. On 04Feb2021 20:00, the patient experienced feels yucky. The patient underwent lab tests which included body temperature: 100.7 degrees and covid-19: she had covid on an unspecified date in Aug2020. The patient did not receive any treatment for the events. The clinical outcome of the fever was unknown, for chills, feels yucky were recovering and for feels like she has the flu, feels tired and sluggish were not recovered. No follow-up attempt are possible.
Vaccine was diluted with 0.8mL, instead of the 1.8mL.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with ROTATEQ lot number K023532, expiration date 21-JUN-2016 (route was not provided). Concomitant therapy information was not provided. On unknown dates, there was incorrect product storage as multiple unspecified patients received improperly stored ROTATEQ. The temperature was 47.98 F and the time frame was 63 hours. No adverse event was reported. At the time of the report, the patients' status was unknown. Additional information has been requested.
After 18, hours I started to have fever, body aches, joint pain and chills. After about another 24 hours, all symptoms except joint pain went away. I am still experiencing sever joint pain all over my body, especially in my hips, and it hurts to walk and do other daily activities.