chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blood Pressure did not decrease significantly post medication; Blood Pressure increased to 224; Pain (Grade 8 out of 10) under breast line, chest and across the back shoulder blades; Intestine blockage; Constipation Continued (Initiated 3 days prior to Vaccination); A spontaneous report was received from a consumer concerning a 91-year-old, female patient who developed Pain (Grade 8 out of 10) under breast line, chest and across the back shoulder blades, Constipation Continued (Initiated 3 days prior to Vaccination), Blood Pressure increased to 224, Blood Pressure Did not decrease significantly post medication, Intestine blockage, and Reduced Pain (Grade 4 out of 10 now) post Bowel Movement.    The patient's medical history included constipation. Concomitant product use was not provided by the reporter.     On 28JAN2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:031L20A) intramuscularly in the upper arm for prophylaxis of COVID-19 infection.    On 28JAN2021 patient received the first dose of Moderna COVID-19 vaccine. For three days prior to vaccination patient was constipated and did not have a Bowel Movement at all. After the vaccination patient had pain (Grade 8 out of 10) under breast line, chest and across the back-shoulder blades. The evening of 28JAN2021 she visited the Emergency Room because of the pain. ER nurse reported patient Blood Pressure went up to 224 and was very high. Patient was treated with BP medication, but BP did not change significantly. This led to patient being admitted to the hospital at for overnight for observations. All tests were negative. She was diagnosed as "Intestines were blocked". She was released on 29JAN2021. She had a BM 6 days later on 03FEB2021. The pain is better (Grade 4 out of 10 now).   The outcome of the events was unknown; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested. Company assessed the events to be unlikely related to company product.
Case had allergic rx x 2 days with itching, redness & hives all over her body & declined to take 2nd dose.  7/20 test + COVID s/s start 7/19
Temperature; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 56 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (ongoing), notes: Thyroid; "Anxiety" (ongoing); "Cholesterol" (ongoing); "Asthma" (ongoing). Concomitant medication(s) included: SYNTHROID oral taken for thyroid disorder, start date: 2015 (ongoing); SERTRALINE oral taken for anxiety, start date: 2013 (ongoing); ATORVASTATIN oral taken for blood cholesterol, start date: 2021 (ongoing); PROAIR [SALBUTAMOL SULFATE] taken for asthma (ongoing); TRELEGY taken for asthma, start date: 2021 (ongoing). Vaccination history included: BNT162b2 (Dose 1, Anatomical site of injection: upper arm, Route of administration: intramuscular, Batch/Lot number: Pfizer EN6207), administration date: 31Mar2021, for Covid-19 immunization; BNT162b2 (Dose 2, Anatomical site of injection: upper arm, Route of administration: intramuscular, Batch/Lot number: Pfizer EW0158), administration date: 14Apr2021, for Covid-19 immunization, reaction(s): "Dose 1: 31Mar2021/ Dose 2: 14Apr2021". The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Temperature"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "body aches".
This is a spontaneous report obtained from a contactable nurse. This nurse reported similar events for two patients. This is the first of two reports. A 76-year-old male patient received, on 28Sep2016, at 11:00, PREVNAR 13, Lot, M35761, Expiration date: 30May2017) 0.5 ml, single, in the left deltoid, for immunization (prevention of Pneumonia). Relevant medical history included type 2 diabetes mellitus (ongoing), hyperlipidemia (ongoing), and hypertension (ongoing). Concomitant medications included influenza vaccine injection on 26Sep2016, for immunization; oral amlodipine 5 mg once a day, for hypertension (ongoing); atorvastatin 10 mg once a day at night, for hyperlipidemia (ongoing); oral tadalafil (CIALIS) 20 mg, as needed, for erectile dysfunction (ongoing); oral glimepiride, one tablet daily for type 2 diabetes mellitus (ongoing); losartan potassium, 100 mg once a day, for hypertension (ongoing); oral metformin, 1000 mg one tablet twice daily, for type 2 diabetes mellitus (ongoing) and oral cinnamomum verum (CINNAMON) 500 mg twice a day, for type 2 diabetes mellitus (ongoing). On an unspecified date, in 2016, after administration of pneumococcal 13-val conj vac (dipht crm197 protein), the patient experienced cellulitis. He was seen in a urgent care and was on antibiotics (unspecified) for 10 days. The patient recovered completely on an unspecified date, in 2016. There was a reasonable possibility the event was related to pneumococcal 13-val conj vac (dipht crm197 protein). Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, the following relevant information is not available: onset date of the event. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This case was reported by a healthcare professional (nurse) and described the occurrence of fatigue in a 18-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent vaccination included MENVEO (non-gsk); Novartis; unknown; unknown given on 31 May 2013. On 31 May 2013 the subject received 2nd dose of ENGERIX B (10 mcg, unknown route, right arm). On 18 July 2013, the subject received 3rd dose of ENGERIX B (unknown details) and experienced drug dose administration interval too short. On 31 May 2013, the same date as vaccination with 2nd dose of ENGERIX B, the subject experienced widespread rash. The subject was evaluated by the doctor's office for the rash. The nurse noted that "the rash had no itch or swelling to it." On 19 July 2013, one day after vaccination with the 3rd dose of ENGERIX B, the subject experienced fatigue, puffy eyes, dizziness. Per the nurse, the subject has not required medical attention for the fatigue, puffy eyes and dizziness at the time of reporting. At the time of reporting the outcome of the events of rash were resolved. The nurse reported that the rash "resolved approximately 7 days post immunization" in June 2013. At the time of reporting the outcome of the events of fatigue, puffy eyes, and dizziness were unspecified. The healthcare professional considered the event of rash was possibly related to vaccination with ENGERIX B. The nurse did not comment on the relationship of the other events. The lot number was reported as AHBVC88AA; however, based on a safety lot number review received 11 September 2013, the lot number was updated to AHBVC188AA.
My heart rate was elevated; Face was brightly flushed; Anxiety for about 24 hours.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).  A 68-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in right arm on 19Feb2021 01:00 AM (at the age of 68-years-old) as dose 1, single for COVID-19 immunization. Medical history included infant immunization from an unknown date and unknown if ongoing known allergies infant immunization (over 60 years ago and unclear which one). Concomitant medication included multivitamin. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. Facility type vaccine School or Student Health Clinic. After approx 30 minutes of receiving vaccine, my heart rate was elevated and patient face was brightly flushed lasting for several hours. This resulted in overall anxiety for about 24 hours on 19Feb2021 at 14:00. For this reason, she concerned about taking the second dose scheduled at a drive event March 12. No treatment was received for the events. The patient underwent lab tests and procedures which included heart rate: elevated on unknown date. The outcome of the events was reported as recovered on unknown date in 2021.  No follow-up attempts are possible, information about batch/ lot number cannot be obtained.
High fever > 103.6 Double ear infections within 1 week Double pink eye within 1 week  Child has not had sickness like this before and no one in his daycare nor home had any illness at the time
Patient presented to the  hospital from nursing home after EMS was called for possible cardiac arrest , per report EMS states they arrived to find staff doing CPR, however pt had normal VS on their arrival.
Spontaneous miscarriage; Spontaneous miscarriage; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Spontaneous miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (Spontaneous miscarriage) (seriousness criterion medically significant) and EXPOSURE DURING PREGNANCY (Spontaneous miscarriage). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. Spontaneous miscarriage. Gestation period not reported. At the time of the report, ABORTION SPONTANEOUS (Spontaneous miscarriage) and EXPOSURE DURING PREGNANCY (Spontaneous miscarriage) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not provided.  Company Comment: This case concerns a female patient, unknown age, who experienced an event of drug exposure during pregnancy and also experienced an event of spontaneous abortion. Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Sender's Comments: This case concerns a female patient, unknown age, who experienced an event of drug exposure during pregnancy and also experienced an event of spontaneous abortion. Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
This spontaneous report as received from a registered nurse refers to a 61 year old female patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). On an unknown date the patient experienced flu symptoms, upper respiratory infection and rash. The outcome of flu symptoms, upper respiratory infection and rash was unknown. The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Presented with SOB, diarrhea; Covid + in ED; admit 9/17 medical with Covid infection Tx with 9/17 steroids started , 9/18 Rocephin, singulair, zinc started; initially on 3 LPM O2; down to RA by d/c
pregnant patient was administered arexvy; patient was administered arexvy by mistake instead of abryvo; patient was administered arexvy by mistake instead of abryvo; No complications during birth; This non-serious retrospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 45-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant patient was administered arexvy), wrong vaccine administered (Verbatim: patient was administered arexvy by mistake instead of abryvo), inappropriate age at vaccine administration (Verbatim: patient was administered arexvy by mistake instead of abryvo) and live birth (Verbatim: No complications during birth). The outcome of the vaccine exposure during pregnancy, wrong vaccine administered, inappropriate age at vaccine administration and live birth were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Live neonate with no apparent congenital anomaly   Additional Information: GSK Receipt Date: 13-NOV-2023 The pharmacist reported a pregnant 45 year old patient was administered Arexvy by mistake instead of abryvo before the approved 60 years of age ,which led to wrong vaccine administered and inappropriate age at vaccine administration The patient was between 32 and 36 weeks received vaccine which led to vaccine exposure during pregnancy. No complications was reported during birth. No lot number or specific vaccination date reported, only stated event happened about a month ago. The reported consented to follow via email.; Sender's Comments:  US-GSK-US2023157093:Same patient, same product
Daptacel administered to a patient 3 days past the expiration date; Initial information received on 20-May-2019 regarding an unsolicited valid non-serious case received from a non-health care professional (office staff).  This case involves patient with unknown age and gender who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patients past medical history, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  It was an actual medication error due to expired vaccine used.  It was reported that Daptacel administered to a patient 3 days past the expiration date.  It was unknown whether patient experienced any adverse reaction after the injection.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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 on the batch number was requested.
migraine; muscle weakness; Brain fog; headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Right on 25Feb2021 13:00 (at the age of 65 years old) (Batch/Lot Number: EN6198) as single dose for COVID-19 immunisation. Medical history included ongoing inflammatory bowel disease (IBD), ongoing anxiety. Concomitant medication(s) included metoprolol taken for skipping heart beats from an unspecified start date and ongoing; bupropion taken for anxiety from an unspecified start date and ongoing; estrogens esterified, methyltestosterone (ESTRATEST) taken for Hormones from an unspecified start date and ongoing; progesterone (PROGESTERONE) taken for Hormones from an unspecified start date and ongoing; butalbital, caffeine, paracetamol (BUTALBITAL APAP CAFFEINE) taken for headaches from an unspecified start date and ongoing. The patient previously received first dose of vaccine, Intramuscular in the right arm on 01Feb2021, 09:00 AM (Batch/Lot number: EN5318) and experienced Muscle weakness, Nausea, Brain fog. On 25Feb2021 13:00 PM, the patient experienced Muscle weakness, Brain fog, Headache. It was reported that after the second shot, the patient had immediate brain fog and slightly headache. On the second day (26Feb2021), the patient had Migraine which lasted 3 day. The patient received treatment for Migraine with Midrin. Still recovering from muscle weakness and headache. The patient underwent Covid-19 test on 11Jun2020, 19Aug2020 and 29Oct2020 and the result was negative. Outcome of the event migraine was recovered and other events was recovering.
Lump and redness at site, like a whitehead or zit. Pt was given an antibiotic BACTRIM.
pt stated the evening after getting the vaccine she was laying down and she started feeling moisture in the vaginal area.  She had ringing in the back of her head.  The next day she developed a yeast infection.  It also made her breathing worse.  Pt states her the yeast in her body was increased and her tinnitus condition and her breathing became much worse.  It also caused fluid to build up in her ears.  She still has the ringing in her head and her breathing has not improved.
100F fever; muscle aches; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8730) via an unspecified route of administration in the left arm on 28Mar2021 at 11:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205) via an unspecified route of administration in the left arm on 07Mar2021 at 11:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient reported no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Mar2021 at 06:00, 18 hours after vaccination, the patient experienced 100-degree Fahrenheit fever, muscle aches and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatments were not taken as the result of adverse events. The clinical outcome of the events pyrexia, myalgia and fatigue were recovering.   No follow-up attempts are needed. No further information is expected.
TOOK ONLY THREE DOSES; A spontaneous case report was received from a nurse on 28-Feb-2019 for two consumers.  Based on the information obtained from the nurse, two individual case safety reports PVX201903-000162 (PVX2019-551; younger female) and PVX201903-000163 (PVX2019-552, elder female) were created and cross-linked in the database.  This case report describes a female consumer who "took only three doses". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took only three doses of Vivotif and forgot to take the fourth dose.  The action taken with Vivotif with respect to event "took only three doses" was not applicable.  The clinical outcome of the event "took only three doses" was unknown.  Company's Comment: The causality of the event "took only three doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took only three doses" was considered as not applicable. US-PaxVax Berna GmbH-PVX201903-000162:
Patient vaccinated for and then tested positive for COVID-19 on 9/1/21.
~24hr after receiving the vaccine, I woke up the next day to have mild-moderate paresthesias/numbness in my left hand (3rd/4th/5th digits  and partways proximal into the midhand) also between the upper left scapula and the spine.   While I have had the upper back numbness in the past when my neck goes into spasm, I have not had left hand paresthesias/numbness before.     My hand continues to be numb/tingly.  There is some increased tenderness in the palmar/ulnar aspect of my forearm.  My neck continues to be in spasm.  I took flexeril and aleve on 12/24-12/26 to mild relief but symptoms return again when not taking the meds.  It's been a week.
Fever started getting as high as 100.9 degrees; Sinus-like headache; Aches and pains; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (Sinus-like headache), MYALGIA (Aches and pains), CHILLS (Chills) and PYREXIA (Fever started getting as high as 100.9 degrees) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced SINUS HEADACHE (Sinus-like headache), MYALGIA (Aches and pains) and CHILLS (Chills). On 10-Jan-2021, the patient experienced PYREXIA (Fever started getting as high as 100.9 degrees). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SINUS HEADACHE (Sinus-like headache) had not resolved and MYALGIA (Aches and pains), CHILLS (Chills) and PYREXIA (Fever started getting as high as 100.9 degrees) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.; Sender'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.
Injection site redness; Injection site swollen; Injection site extremely itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PRURITUS (Injection site extremely itchy) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012620A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PRURITUS (Injection site extremely itchy). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PRURITUS (Injection site extremely itchy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.