chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a health care professional and described the occurrence of decreases therapeutic response in a 32-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). There were no concurrent medications. The subject had received two historical HEPATITIS vaccinations on 25 March 1997 and 13 May 1997 prior to coming to the reporter's clinic. On 8 September 2008, 16 October 2008 and 12 February 2009 the subject received 1st dose, 2nd dose and 3rd of ENGERIX B (20 mcg/mL, left deltoid, left deltoid and right deltoid, respectively). On 10 October 2008, a titer was drawn which was negative at 7.8. On 12 February 2009, the subject experienced drug dose administration interval too short. On 10 March 2009, 26 days after vaccination which the third dose of ENGERIX B, the subject experienced decreased therapeutic response. On 10 March 2009, HEPATITIS B surface antibody was low at 8.9 mIU/mL. A product complaint was associated with this report. Reporter states that 5 out of 6 subjects who received dose one from the same lot, dose 2 from the same lot, and dose 3 from the same lot experienced this adverse event. The subjects received the doses on a 0, 1, and 4 month schedule. The reporter did not believe there were any physical problems with the vaccines, but ws questioning the quality and content of the vaccines. This reporter felt strongly that that there was something potentially wrong with one of these vaccine lots because sc many subjects did not become seroprotected. This is something she has not seen and she gives these vaccinations on a routine basis. Reporter believes a quality assurance problem caused the adverse event. Please see A0778211A, A0778216A, A0778217A, and A0778218A. Follow-up information was received on 14 May 2009 from Quality Assurance. Per the Quality Assurance. Per the Quality Statement: ENGERIX vaccine lot numbers AHBVB703AA, AHBVB584AA and AHBVB670AA met the requirements of Quality Assurance's specifications and the batches were suitable for vaccination purposes.
Infanrix administered to 36 year old patient; Patient got infanrix instead of boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 36-year-old male patient who received DTPa (Infanrix) for prophylaxis.   On 20-APR-2023, the patient received Infanrix. On 20-APR-2023, an unknown time after receiving Infanrix, the patient experienced adult use of a child product (Verbatim: Infanrix administered to 36 year old patient) and wrong vaccine administered (Verbatim: Patient got infanrix instead of boostrix). The outcome of the adult use of a child product and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-APR-2023 The Health care professional reported that a 36 years old male patient received an Infanrix instead of a boostrix dose. The reporter gave consent to follow up. A 36 years old patient received Infanrix against the recommended age group which led to adult use of a child product. The patient intended to receive boostrix however received Infanrix instead of boostrix, which led to wrong vaccine administered.
Two days after receiving (3RD) vaccine  developed tinnitus, both ears. Then developed rapid heart beat. Don't  know when it started. Never had these symptoms prior to the vaccines. Have a physical  every year. Had heart stress test approximately 3 years ago. No problems
0925 patient in general observation, ambulated to nurse stating she felt funny. Color pale, ambulated to private observation area. States she feels nauseated. Sat in chair and given emesis bag.  HR 157; O2 99%: BP 138/72. HR ausculated and rate confirmed. State she has no history of tachycardia or rapid heart beat. Denies "feeling" heart race. Denies itching, shortness of breath or difficulty swallowing. States she took her lisinopril and anxiety meds this morning. States she ate breakfast and performed her self catherization.  0940 Offered EMS transport/evaluation. Patient declined.  0942  patient states nausea resolved, BP 140/82; HR 136: O2 99% remains on rooms air.  0945 Auscultated Heart Rate at 140, strong/regular. Bilateral breath sounds clear to ausculation. Patient sitting in chair at rest. Color remains pink. Denies chest pain.  0948 Mother called patient's physician and reported to physician. PCP to return call to patient 0952 Patient to restroom, mom accompanied.  0955 Upon return from restroom, HR 160; O2 99% r/a, Denies feeling clammy, or having chest pain. denies hx of sinus tachycardia. Re-offered EMS eval due to elevated HR. Patient agreed to EMS eval.  0957 EMS activated 1013 Patient sitting in chair wringing hands. states she has excessive sweat glands and normally is very diaphoretic, states she feels dry at the moment. HR 144; O2 99% 1015 EMS and FD arrived.  1017 BP 103/61; HR 138; O2 99% and per EKG in ST per EMS monitors 1019 EMS recommended transport. Patient agreed.  1020 Transported via stretcher to ambulance to  Hospital ED.
Pt. given DTaP shot 10/18/12. Mother noticed redness/swelling at injection site. Mother took pt. to ER 10/19/12. ER advised if not better within 2 day to take pt. to Dr. Pt. seen at clinic 10/21/12 at 12:40 PM. Left arm still slightly red, but better per Mom. Pt. given prescription to take daily and advised to f/up with provider if not improved or resolved over next few days.
Double  Vision. Unable to focus far away . Blurry up close. Urgent care. Primary Dr. 2 eye drs  primary care three times . Out of work vision issue is on going
Information has been received from a physician concerning a male who was vaccinated with a 1st dose of Hepatitis B vaccine recombinant. Several hours later, the patient experienced respiratory infection, and swelling at the injection site, and a fever of 39 degrees C. The patient was taken to the ER. No injection site symptoms were noted at the ER. The patient's blood pressure was normal. The patient experienced "some respiratory problems that were indicative of a respiratory infection". A diagnosis or respiratory infection was made. The physician did not believe the symptoms were related to Hepatitis B vaccine recombinant. No further information is available.
After shot 5 repetitive headaches of increasing strength and duration. First noted symptoms after Anthrax shot 3 on 29 Mar 2007, and follow-up shot 4 on 29 Aug 2007. 1-1/2 years after shot 5, symptoms occurred less frequently, and decreased in duration and strength.
ENCEPHALITIS; BLOOD PRESSURE SKYROCKETED; ANXIETY; TACHYCARDIA; This spontaneous report received from a consumer concerned a 46 year old female. 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, batch number and expiry were not reported) dose was not reported, administered 1 in total on SEP-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 5 decade old. No concomitant medications were reported. On an unspecified date in 2021, the patient started experiencing weird symptoms shortly after vaccination. There was no exact timeline available as to when the symptoms have started but consumer reported within the first month. Patient was having anxiety, tachycardia, extreme fatigue, paresthesia, tingling, and patient was continuing to have health issues. Patient had encephalitis at one point and was hallucinating. Patient's blood pressure had skyrocketed. Patient was still experiencing these symptoms. Patient went to an urgent care, but not aware if she was admitted or not. Laboratory data (dates unspecified) included: Blood pressure High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from anxiety, tachycardia, encephalitis, and blood pressure skyrocketed. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221111557- Encephalitis. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age, ethnicity, and gender received PREVNAR 13 via an unspecified route of administration in the left arm on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient reported  getting the pneumonia shot on late Monday night at a pharmacy and the next day, on an unspecified date, experienced joint pain in hips and in lower spine and in the left hand where the shot was given, was very tender. It had gotten worse and it was not going away and the patient was wondering how long  the reaction was going to be. The patient stated that they gave the shot and did not give anything else. The patient clarified that the injection was in the left arm but it was the hand that got very sore. The outcome of the events was unknown.  Follow-up information on lot number, batch numbers, and expiration date has been requested.
Low blood pressure; Low heart rate; Lightheaded, dizzy; Felt she was going to pass out; Anxiety; Felt maybe the vaccine was going to her head; Blood pressure was high after the vaccine,Top number for blood pressure was 144; Looked pale; Nervous; Tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Low blood pressure), HEART RATE DECREASED (Low heart rate), DIZZINESS (Lightheaded, dizzy), PRESYNCOPE (Felt she was going to pass out) and ANXIETY (Anxiety) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced HYPOTENSION (Low blood pressure), HEART RATE DECREASED (Low heart rate), DIZZINESS (Lightheaded, dizzy), PRESYNCOPE (Felt she was going to pass out), ANXIETY (Anxiety), FEELING ABNORMAL (Felt maybe the vaccine was going to her head), HYPERTENSION (Blood pressure was high after the vaccine,Top number for blood pressure was 144), PALLOR (Looked pale), NERVOUSNESS (Nervous) and FATIGUE (Tired). At the time of the report, HYPOTENSION (Low blood pressure), HEART RATE DECREASED (Low heart rate), DIZZINESS (Lightheaded, dizzy), PRESYNCOPE (Felt she was going to pass out), ANXIETY (Anxiety), FEELING ABNORMAL (Felt maybe the vaccine was going to her head), HYPERTENSION (Blood pressure was high after the vaccine,Top number for blood pressure was 144), PALLOR (Looked pale), NERVOUSNESS (Nervous) and FATIGUE (Tired) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Blood pressure measurement: 144 (High) Top number for blood pressure was 144.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment details were provided. treatment to the events not provided.  The patient also stated that her blood pressure was high after the vaccine and the top number for blood pressure was 144 and stated that something was "50" but was not sure for which vital sign.
facial swelling, facial drooping, complaints of left ear pain Emergency department visit diagnosed with Bell's palsy treated with valtrex prednisone
This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On an unknown date in 2017, the patients were vaccinated with incorrectly stored doses of RECOMBIVAX HB injection (lot# M013639, expiry date 15-SEP-2017; exact dose and route of administration were not reported). There were no concomitant therapies reported. The administered doses of the vaccine were exposed to the following temperatures on the following dates: on 01-FEB-2017: 33.746 degrees Fahrenheit (F) for 23 minutes; on 03-FEB-2017: 47.336 F for 6 minutes; on 06-FEB-2017: 34.988 F for 18 minutes; on 07-FEB-2017: 34.772 F for 17 minutes; on 08-FEB-2017: 6.692 F for 1 minute and 34.592 F for 90 minutes; on 09-FEB-2017: 33.89 F for 290 minutes; on 10-FEB-2017: 32.918 F for 298 minutes; on 11-FEB-2017:33.71 F for 317 minutes; on 12-FEB-2017:34.538 F for 302 minutes; on 13-FEB-2017:34.214 F for 255 minutes; on 14-FEB-2017: 34.322 F for 333 minutes; on 15-FEB-2017: 31.108 F for 464 minutes; on 16-FEB-2017: 31.874 F for 284 minutes; on 17-FEB-2017: 31.28 F for 585 minutes; on 18-FEB-2017: 31.316 F for 512 minutes; on 19-FEB-2017: 31.55 F for 517 minutes; on 20-FEB-2017: 30.866 F for 3 minutes and 31.136 F for 566 minutes; on 21-FEB-2017: 31.406 F for 245 minutes and 48.02 F for 47 minutes; on 22-FEB-2017: -4.108 F for 1 minute; on 24-FEB-2017: 34.322 F for 180 minutes; on 25-FEB-2017: 34.106 F for 240 minutes; on 26-FEB-2017: 34.214 F for 263 minutes; on 27-FEB-2017: 34.322 F for 230 minutes; and on 28-FEB-2017: 34.394 F for 289 minutes. A digital data logger was involved. The reporter stated that there were also previous excursions on unspecified dates (details not provided). No adverse experience were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA008835.
Bad chills; Fever; Bad headache; Every joint aches; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Bad chills), PYREXIA (Fever), HEADACHE (Bad headache) and ARTHRALGIA (Every joint aches) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced CHILLS (Bad chills), PYREXIA (Fever), HEADACHE (Bad headache) and ARTHRALGIA (Every joint aches). At the time of the report, CHILLS (Bad chills), PYREXIA (Fever), HEADACHE (Bad headache) and ARTHRALGIA (Every joint aches) outcome was unknown.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. On 11-FEB-2018, the patient was vaccinated with PNEUMOVAX 23, (lot # N013541, Exp date: 23-JAN-2019), dose 1, 1 DF, intramuscularly for vaccination. On the same day, the patient experienced generalized local reaction that went away in a day and a half after receiving the vaccine. The outcome of event was reported as unknown (also reported as not recovered). No other information was available. Sought to medical attention was yes. No product quality compliant (PQC) was found. Lab diagnostics/Studies performed were reported as none. The reporter did not report the causal relation of event with respect to PNEUMOVAX 23. Pharmacist requested that a lot check needed to be performed. This case is cross linked with 1802USA007344 (same reporter).
Narrative: Veteran called seeking advice. She had the J&J a little over 2 weeks ago. Three days she began having headaches, aching in bilateral calf area and abdominal discomfort. She has hx. of PE she states its from tamoxifen. Denies chest pain, sob, calf swelling, warmth or redness. I strongly urged ER now for  immediate evaluation in ER, she agreed. referred veteran to closest er for evaluation of symptoms and to rule any blood clots.
Significant changes in my menstrual cycle . I got my period on the 7th of August & a few days into my ovulation cycle , I started to spot brown blood along with some red as well . This went on for about a week to the point where there was so much coming out of me that I had to where tampons . There were no other period side effects other than the bleeding at this time . I normally have a really heavy period and after the week of having a light and brown period, it seems that I started a normal period again! My period is now( 09/21/21) is heavy like it normally is and is the normal color . I also have other symptoms such as bloating , acne , and cramps with this period .
Has fever, generalized body aches and chills. Reports that they do not have a thermometer so have not been able to take a temperature. Some localized redness at site of vaccine without swelling or significant pain. "She has not been able to get out of bed".
She received vaccine at 1140 am.  At 1200pm, she c/o dizziness upon standing and intermittent chest pain.  She stated that she had not eaten today.  Crackers and water given.  Chest pain worsened.  Dr  evaluated pt.  911 called.  EKG done;no acute changes noted.  She was taken to the ER by fire department.
Patient missed second dose on 01MAY2021; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed second dose on 01MAY2021) 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 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed second dose on 01MAY2021). On 14-Jun-2021, PRODUCT DOSE OMISSION ISSUE (Patient missed second dose on 01MAY2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not reported.
Body Aches, Headache, upset stomach, weakness, loss of appetite,  shortness of breath.
Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 12 years old female patient who received vaccine MENACTRA and reported that MENACTRA on 3/8/2019 that had expired on 3/5/2019/no AE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included BOOSTRIX. On 08-Mar-2019, the patient received a dose of suspect 0.5 ml MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U5841AA and expiry date: 05-Mar-2019) (dose in series, route and site of administration was not reported). It was a case of actual medication error due to expired vaccine used. It was not reported if any adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Information has been received from a licensed practical nurse, for GARDASIL, a Pregnancy Registry product, concerning a 26 year old female patient with drug hypersensitivity/allergy to aspirin and no pertinent medical history, who on 23-NOV-2011 was vaccinated with a first dose of GARDASIL 0.5 ml, IM (lot number 1397AA, exp 09-APR-2013). On 24-JAN-2012 the patient received the second dose of GARDASIL (dose, route and lot number unspecified). There was no concomitant medication included. The nurse stated that at the time of the report the patient was 10 weeks pregnant. The patient's last menstrual period was 19-DEC-2011 and estimated delivery date would be 24-SEP-2012. At the time of the report the patient's outcome was unknown. No treatment was given for an AE. Laboratory diagnostic studies were performed - urine pregnancy test. Follow-up information has been received from health care professional via Pregnancy Questionnaire, for GARDASIL, a Pregnancy Registry product, concerning a 26 year old female patient with panic, anxiety and bipolar, no previous pregnancies, no spontaneous abortions, no deliveries who on 23-NOV-2011 was vaccinated with a first dose of GARDASIL (dose and route not reported) (lot number 668261/1397AA). On 24-JAN-2012 the patient received the second dose of GARDASIL (dose and route not reported) (lot number 1437AA was not valid for GARDASIL and appeared to be 10 weeks pregnant (LMP: 19-DEC-2011, EDD: 25-SEP-2012). Other medications used this pregnancy included: KLONOPIN (1 mg, PRN, indication - anxiety, stopped 07-FEB-2012), SEROQUEL (150 mg, HS, indication - bipolar, stopped 07-FEB-2012) and CELEXA (40 mg, every day, indication - bipolar, stopped 07-FEB-2012). It has been reported that on an unknown date the patient underwent elective termination. At the time of the report the patient's outcome was unknown. On 07-FEB-2012 laboratory diagnostic ultrasound prenatal test was performed - single and IUP (intrauterine pregnancy. Upon internal review elective termination was considered to be an other important medical event. Additional information has been requested.
Arthritic pain constant and worsening through spring and summer 2021. On September 29 contacted primary care doctor with low grade fever, head and neck pain. Diagnosed as Giant Cell Arteritis per biopsy on October 11, 2021.   Treated initially with Prednisone. Currently being treated with Actemra.   Will follow up with Dr. .
no adverse event; patient received an extra dose of both MMRII and VARIVAX; This spontaneous report was received from a medical assistant and refers to a 4-year-old female patient.  The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On an unspecified date in February 2022, the patient received the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, lot number, expiration date, anatomical location, and route of administration were not provided); and a second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, lot #, expiry date, anatomical location, and route of administration were not provided) per de recommended schedule, both given as prophylaxis.  On 16-SEP-2022, the patient was inadvertently vaccinated with a third dose (extra dose administered) of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #U032852, expiration date: 20-OCT-2023 (strength, anatomical location, and route of administration were not provided); and with an extra dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) 0.5 milliliter, lot #U014655, expiration date: 07-MAY-2023 (strength, anatomical location, and route of administration were not provided) both given as prophylaxis. The reporter stated that at the time of the report, the patient had no symptoms or adverse events of receiving those vaccines.