chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she tested positive for Covid-19 on 27Dec2021; she tested positive for Covid-19 on 27Dec2021; reports a very high blood pressure incident reaching 190/95; Caller reports losing her voice; This is a spontaneous report received from a contactable reporter(Consumer) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergic to most medications" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Flu shot for Immunization, reaction(s): "Allergies: allergic to flu shot". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "unknown" and all described as "she tested positive for Covid-19 on 27Dec2021"; HYPERTENSION (medically significant) with onset 2021, outcome "unknown", described as "reports a very high blood pressure incident reaching 190/95"; APHONIA (non-serious) with onset 2021, outcome "unknown", described as "Caller reports losing her voice". The event "reports a very high blood pressure incident reaching 190/95" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (2021) 190/95; sars-cov-2 test: (27Dec2021) positive. Therapeutic measures were taken as a result of covid-19, hypertension, aphonia.  The lot number for bnt162b2 was not provided and will be requested during follow up.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; SORENESS; FATIGUE; This spontaneous report received from a patient concerned a 38 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 not reported, batch number: 1805021, and expiry: UNKNOWN) dose was not reported, 1 total administered on 13-MAR-2021 at right deltoid as prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2021, after vaccination patient had a little soreness and some fatigue for first two days. The patient experienced cold and felt run down for past week because patient was exposed to neighbor on 18-Apr-2021 who was tested positive for COVID-19. On 23-APR-2021, patient got tested for COVID-19 and received positive results for same on 24-Apr-2021. It was stated that patient felt run down, fatigue and common cold. The patient also had some chest congestion, but did not have any consistent cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness, and fatigue on 15-MAR-2021, had not recovered from suspected covid 19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint. Sender's Comments: V0:-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
This spontaneous report as received from a 73 years old female patient with no drug allergies/drug reactions. The patient no longer had a thyroid. On 02-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, route and dose were not reported) in the left arm. Concomitant therapies included SYNTHROID. On 03-JUN-2013, the patient experienced weakness, headache, pain throughout her body and her blood count went to "1". The patient sought medical attention, went to a hospital and was treated (treatment details unspecified) in the emergency room and was released. No diagnosis was made. Hospital physicians referred her to hematologist and gynecologist for further evaluation. At the time of the report the patient stated that her symptoms were the same. She went to the gynecologist, no diagnosis was made. She has not contacted her primary physician who prescribed the vaccine yet. She has not gone to the hematologist either. The outcome of weakness, headache, her blood count went to '1' and pain throughout her body was reported as not recovered/not resolved.
Cold; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) and VACCINATION SITE PAIN (Vaccination site pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced NASOPHARYNGITIS (Cold). At the time of the report, NASOPHARYNGITIS (Cold) was resolving and VACCINATION SITE PAIN (Vaccination site pain) had resolved.            No concomitant medications was reported. No treatment medications was reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Information has been received from a pharmacist referring to multiple patients of unknown age and gender. The patient's pertinent medical history and concurrent condition were not reported. On multiple unspecified dates ranging from January 2015 through April 2016, the patients possibly received with improperly stored VARIVAX (dose, route and lot# were not reported), due to a thermometer malfunction in the reporter's freezer. No adverse events were reported. Additional information has been requested.
Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. On unknown dates, an unspecified number of doses of improperly stored (Merck) VARIVAX (lot number K015946, expiration date 23-SEP-2016, dose and route were unknown) were administered to the patients. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This report refers to a 6 months old infant patient. On 25-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Immediate redness and hives to surrounding area then large confluent hive/angioedema like (L) thigh at injection site.
Hives Both Arm and Upper Body - Moderate Swelling Decreased pulse left hand. Moderate Swelling with Erythema - Sent To ER for Evaluation and Doppler to evaluate for Blood Clot
Arm red & swollen, sore muscles x 9 days. Muscle sore on 10/7/11 - all swelling & redness gone.
Still very weak; Tired; Sweating; Hurting; Chest oppression; Fainted; Difficulty breathing; Fast Heartbeat; Arm Pain; Couldn't sleep; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainted) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Unspecified). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced HEART RATE INCREASED (Fast Heartbeat), PAIN IN EXTREMITY (Arm Pain) and INSOMNIA (Couldn't sleep). On 08-Apr-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), DYSPNOEA (Difficulty breathing), HYPERHIDROSIS (Sweating), PAIN (Hurting), CHEST DISCOMFORT (Chest oppression) and FATIGUE (Tired). On an unknown date, the patient experienced ASTHENIA (Still very weak). On 08-Apr-2021, SYNCOPE (Fainted) had resolved. At the time of the report, DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Fast Heartbeat), PAIN IN EXTREMITY (Arm Pain), HYPERHIDROSIS (Sweating), PAIN (Hurting), CHEST DISCOMFORT (Chest oppression) and FATIGUE (Tired) had resolved and INSOMNIA (Couldn't sleep) and ASTHENIA (Still very weak) had not resolved. Not Provided          The patient went to UC, where the doctors made an electrocardiogram (EKG), bloodwork (within normal limits), and said she should consult the vaccine providers. She is still very weak, and cannot sleep correctly. Treatment medications included Tylenol (acetaminophen) and Advil (ibuprofen).  This case concerns a 53-year-old female with a serious unexpected event of syncope and nonserious unexpected chest discomfort, heart rate increased, dyspnea, asthenia, hyperhidrosis, pain, pain in extremity, insomnia, and expected fatigue. Event onset 2 days after second dose mRNA-1273. Syncopal event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-073382 (Patient Link).; Sender's Comments: This case concerns a 53-year-old female with a serious unexpected event of syncope and nonserious unexpected chest discomfort, heart rate increased, dyspnea, asthenia, hyperhidrosis, pain, pain in extremity, insomnia, and expected fatigue. Event onset 2 days after second dose mRNA-1273. Syncopal event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I have both knees replaced several years ago. 24 hrs. after I received the flu vaccine both of my knees seized up. Took 3 days to get back to normal. Extreme pain.
Immediate shock like pain to left shoulder upper arm with redness and swelling pain radiated to entire arm. Days (2) tenderness and decrease mobility to (L) arm. Ice initially followed by TYLENOL, Physical therapy started with no effect.
Immediately after receiving Shingrix the patient's arm began to swell and turn red at the injection site.  The patient reported feeling nauseous, lightheaded, and weak; as if the room were spinning.  Daughter took him to the Emergency Department, where he was further observed.  He was later discharged.
Administered tetanus-diphtheria vaccine on 8/23/02 to left deltoid per usual protocol.  States she woke 8/24/02 with hard, warm, painful area at site of injection; area became increasingly more painful and warm.  Presented to me 8/26/02.  Indurated area was approx. 4x4 cm, warm to touch, painful with light palpation,with erythematous border.  Full ROM. No systemic effects.
About 2 hours after vaccine administration patient developed nausea, vomiting, headache, chills, fever, body aches, and sore arm.
Caller stated her menstrual come normally every 28th days. Since she has been vaccinated her menstrual has not been normal.
Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient weight was reported as 193.4. No concomitant medications were reported. It was reported that the vial had not undergone any temperature excursions. No adverse reactions were reported. No treatment medications were reported.
Lower extremity venous thrombosis; Initial information received on 22-Feb-2023 by health care professional regarding an unsolicited valid serious case issued from a literature article:  This case is linked to cases 2023SA063143, 2023SA063144, 2023SA063145, 2023SA063147, 2023SA063137 and 2023SA063148 (CLUSTERS).  This case involves a 62 years old male patient (table 1) who experienced lower extremity venous thrombosis while receiving vaccines pfizer biontech COVID-19 (coronavirus 2019) vaccine and influenza vaccine (quadrivalent).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect pfizer biontech COVID-19 vaccine not produced by Sanofi Pasteur (lot number not reported) via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect high-dose influenza vaccine (quadrivalent) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a serious lower extremity venous thrombosis (venous thrombosis limb) (latency: 26 days). The patient was hospitalized for this event for 3 days.  Action taken with quadrivalent influenza vaccine (influenza vaccine (quadrivalent)) and tozinameran (pfizer biontech COVID-19 vaccine) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Lower extremity venous thrombosis).  At time of reporting, the outcome was Unknown for the event lower extremity venous thrombosis. Reporter's causality: Related; Sender's Comments: Sanofi company comment dated 27-FEB-2023: This case involves a 62 years old male patient (table 1) who experienced lower extremity venous thrombosis while receiving vaccine INFLUENZA VACCINE (QUADRIVALENT). Based on information received the causal role of VACCINE cannot be excluded due to compatible temporal relationship of ADR to the VACCINE. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of vaccine cannot be assessed.
Developed rash on left outer thigh at site of injections (PCV-13 and Varicella).  Patient irritable, no fever, eating well, sleeping well.  Rash doubled in size by 9/05/13 at time of presentation to the ER.  No medication/treatment given in time prior to arrival.
Pt had hives on arms, legs and back. None on face, chest.  Parent gave BENADRYL 2 tsp. dose and hives cleared.
This spontaneous report was received from a Medical assistance referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions/ allergies, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB  lot # reported as M023895 expiration date 15-SEP-2017 (dose  and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 46.6 degrees Fahrenheit  for 45 minutes. Data logger was involved. There were no previous excursions reported. There was no product quality complaint involved. Additional information has been requested.
swelling in her throat; swelling in her face; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (swelling in her throat) and SWELLING FACE (swelling in her face) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PHARYNGEAL SWELLING (swelling in her throat) and SWELLING FACE (swelling in her face). At the time of the report, PHARYNGEAL SWELLING (swelling in her throat) and SWELLING FACE (swelling in her face) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's treatment included unspecified steroids.   Reporter did not allow further contact
started having tinnitis 5 hours after the vaccine. its been continuous since then for the past 4 weeks
Complaint of severe right shoulder pain that occurred almost immediately after vaccination. Shot up and down her arm. States any type of movement makes the pain worse. Denies numbness or tingling.   Reported to ED for evaluation the following day.  Prescribed: Oxycodone/APAP 5/325 prn pain; Prednisone 10mg- 6day; Robaxin 750 PRN pain;
March 22 and March 23, 2021 belly pain, nausea, vomiting of digested blood (emesis appeared as coffee grounds), not able to keep ingested food down. Stool appeared normal as solid brown without red, black or tarryness. March 24 nausea/vomiting resolved but remaining anorexic. March 27 urine now appears darker (possibly due to dehydration). Patient remains anorexic so not eating well, minimal drinking, urine remains darkish. April 2 urine now with frank blood.  Blood not rectal as patient has colostomy and not vaginal as patient Hx of hysterectomy. April 2-4 frank red blood. April 4 now urine burgundy. April 6 urine now cola-colored. Seen by physician. No UTI.
Pt back in clinic day after IZ with rash over body; most prominent around MMR injection site. Fever of 101.4F. Medical impression: mild vaccine associated rash and fever. Called and spoke with grandmother on 9/20/00 AM and she reports child is afebrile and eating and acting fine but still with rash over body.
Patient called 4-5 days post vaccine to complain of rash on shaft of penis this developed into blistery lesions which bleed, dried up and resolved by 4/16/12.
I had on 18 May2021 congestion and drainage, fluid pressing and went to urgent care on 20May2021 for pain in the left ear, they said I had an ear infection. 20th and 30th of May went to ER again. Referral to ENT on 2 Jun2021. Diagnosed with Meniere's disease. End of Jun2021, Another test where they spin your car VNG. Changed diet and on medication and less salt. Vertigo in May2021 can be very severe and limited ability to drive and hearing loss and intense feeling of left ear.
Left facial numbness; arm  soreness; A spontaneous report was received from a health care professional concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm soreness/pain in extremity and left facial numbness/ hypoaesthesia.   The patient's medical history was not provided. Concomitant medications was not reported.  On 08-JAN-2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly at unknown location for prophylaxis of COVID-19 infection.   On 08 Jan 2021, after receiving the mRNA-1273, the patient felt arm soreness.  on 10 Jan 2021, patient felt left facial numbness.   Treatment for the events were unknown.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the  events pain in extremity and hypoaesthesia was unknown.; 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.
Patient received vaccine purchased by employer on 7/14/2011 administered by Board of Health. Vaccine MMR. Patient states he was "immune" by blood titer and still had to receive shot. Developed subsequent delayed hypersensitivity reaction. Ended up in hospital.
Severe abdominal pain. Liver was not getting enough blood. Heart enlarged and caused severe mitral and tricuspid valve regurgitation. Heart required pacemaker. Admitted to hospital on 3/10 and discharged 3/13. Readmitted on 3/20 with congestive heart failure adjusted pacemaker and discharged 3/16.
joint pain three weeks after first dose; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain three weeks after first dose) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ETANERCEPT (ENBREL) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced ARTHRALGIA (joint pain three weeks after first dose). At the time of the report, ARTHRALGIA (joint pain three weeks after first dose) outcome was unknown.        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 treatment drugs were provided.