chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A spontaneous report has been received from consumer via the regulatory authority. The report concerns a male patient of unknown ethnic origin (age 10 years, height 135 cm). No medical history was reported. No concomitant products were reported. The patient received FLUENZ TETRA, via nasal route, for influenza immunisation on 04-Oct-2018. On 05-Oct-2018, the patient experienced fever, crying, allergic rash, headache and tired all the time. At the time of reporting, the fever, crying, allergic rash, headache and tired all the time were ongoing. The events fever, crying, allergic rash, headache and tired all the time to be serious with seriousness criteria important medical event. Sender's Comments: Pyrexia, crying and dermatitis allergic are not listed in the company core data sheet of Live attenuated influenza vaccine (Q/LAIV). The events occurred 1 day after the administration of drug. Rash is expected with Q/LAIV. However, due to limited information on details of events (treatment given, outcome), medical history, concurrent diseases, concomitant medications, etiological and diagnostic work up (complete blood count, allergy test), it is not possible to make a conclusive assessment of the causal relationship of events with suspect drug.
Swelling and heat about 3" x 3" right deltoid area. Pt came to clinic to have PPD skin test read; dad pointed out swollen, hot area on pt arm.
Patient experienced heart racing and felt the color from her face go pale. Patient was brought to EMS area. Vital signs monitored. Adverse feelings resolved within 15-20 minutes
no adverse event; temperature excursion total time: 25 mins, 3 excursions on dates: 9/9/22 for 8 mins, 9/16/22 for 5 mins, 1/3/23 for 12 mins; This spontaneous report was received from an office manager and refers to a 11-year-old male patient. No information on patient medical history, current conditions and concomitant medications was provided.  On 04-OCT-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dosage form, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites and routes of administration were not provided) administered for prophylaxis (product storage error and no adverse event).  Temperature excursion total time was 25 minutes. There were 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day. Patient was vaccinated in private doctor's office/hospital.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:original source: 2304USA002221
Pt had a rash on the abdominal area next to the navel area after administering ZOSTAVAX on 9/3/09. Pt reported rash on 9/15/09.
This spontaneous report was received from a nurse and refers to 4 unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L035637, expiration date 09-JUN-2017, exact doses were not reported, orally). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 49.8 degrees Fahrenheit for 30 minutes before administration to the patients. No previous temperature excursion was reported. No adverse symptoms were reported. This is one of the several reports received from the same source. Additional information has been requested.
Administration error - mixed vaccine product Patient received Janssen vaccine in March 2021. Patient also recieved 1 dose of Pfizer 7/30/21. This was not caught at time of service. Voicemail was left with patient with notice of 2nd Pfizer appointment cancelation due to CDC guidelines.
General achiness all over and soreness in her arm after receiving the vaccine; General achiness all over and soreness in her arm after receiving the vaccine; This spontaneous case was received on 08-Feb-2021 from other non-health professional via Med Communications (reference number: SEQW21-00439) and concerned a female patient of unspecified age. At the time of initial reporting the patient was in her 70s.  The patient's medical history and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified, dose, route of administration, indication and anatomical location: not reported). The batch number was not reported.  On an unspecified date, unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced general achiness all over and soreness in her arm after receiving the vaccine.  The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  The case is linked to the case 202101374 (the same patient).  Company comment: A female patient of unspecified age was administered influenza virus vaccine polyvalent. On an unspecified date, unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced general achiness all over and soreness in her arm. Causal role of the suspect vaccine is unassessable for both events, due to lack of information regarding temporal relationship.; Sender's Comments: A female patient of unspecified age was administered influenza virus vaccine polyvalent. On an unspecified date, unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced general achiness all over and soreness in her arm. Causal role of the suspect vaccine is unassessable for both events, due to lack of information regarding temporal relationship.
arm rash with redness and itching  - 8 days after injection which lasted 5 days
gets flu and bronchitis; gets flu and bronchitis; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 07-Dec-2020.  This case involves a female patient of who gets the flu (influenza) and bronchitis (bronchitis), while she received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient stated that she gets the flu (influenza) and bronchitis (bronchitis) unknown latency after the shot.  It was not reported if the patient received a corrective treatment.  Outcome of both the events were unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Developed 2 Lipoma  on my neck, 12 centimeters big. Saw fill in doctor at primary cares office. Was referred to an ENT and Oncology where I had an Ultrasound. Ultrasound didn't show cancer. ENT diagnosed me with benign Lipoma's. Waiting to see Oncology again next month.
I started work at job around 6:00 pm. I started doing some heavy physical activity, then I started not feeling well with a pounding headache and anxiety mixed with wanting to vomit. My left arm was very sore more than the first time. I spoke to my manager and he excused me for the evening around 7:00 pm, then I went straight to Hospital Emergency Department via public transportation.  The intake nurses provided a calming story that other nurses, staff, and doctors were experiencing the same symptoms.  I was seen by MD and PA-C. The medications prescribed were acetaminophen and ondansetron.  If I needed more medication, the doctor and physician assistant recommended Tylenol or Motrin until the soreness and headache goes away.
Severe acid indigestion uncontrollable by prescription Omeprazole 20 mg QD.  Begining 10/24 at 5:25 pm. Switch to Omeprazole 20 mg BID with supplemental Calcium carbonate AR starting  10/25. Symptoms continuous regardless of diet and medication.
Started to get extreme headaches, pain behind her eye. Pain in her hips, neck and back she felt stiff all over and significant inflammation. She lost feeling in her right leg and became very tired. She slept for 24 hours straight. She is having a lot of vaginal pain but she is not menstruating, also fever and chills and unable to perform normal duties. She stated she she feels miserable all over. She is having bone pains her upper legs hurt, her knee, face and teeth feels swollen.
This spontaneous report was received from a 70 year old female consumer referring herself. The patient had no medical history, concurrent conditions or drug reactions/allergies reported. On an unknown date in 2015 reported as "towards the end of the summer in 2015", the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (Lot #, expiration date, strength, dose and frequency were not reported). No concomitant therapies were reported. On approximately 25-OCT-2016, the patient developed shingles, furthermore she developed a rash on her face, eyes and ears. The patient also had a lot of eye irritation since an unspecified date. On an unknown date, the patient visited her physical, who treated her with cephalexin and other unspecified medications, which helped her to clear up her single symptoms (recovering), but she was still experienced some pain and irritation around her eyes(not recovered). No laboratories or diagnostics studies were performed. No Product Quality Complaint (PQC) was involved. The causality between the events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Patient received first dose of Moderna vaccine 1/27/21 and presented to urgent care 2/8/21 with complaint of sores on inside of lower lip.  Patient reported that sores started on 2/5/21 and seem to be growing in size.  Patient did not recall any injury and sees dentist regularly for annual cleaning.  Patient also does not smoke or chew tobacco.   Patient was referred to his dentist who was able to get patient in and felt that lesions and ulcerations were not infectious or cancerous.  The NP ordered lab work and recommend patient follow up with PCP.  Labs came back two hours later and showed patient had a platelet count of 1 (THOUS/uL).  Patient was sent to ER at Hospital 1 and was transferred to Hospital 2 for a hematology work-up.  Patient is currently admitted and receiving IVIG and steroids
Headache since last night; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache since last night) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced HEADACHE (Headache since last night). At the time of the report, HEADACHE (Headache since last night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
Patient presented after recently receiving the first dose of Moderna vaccine with dizziness, blurred vision, and hearing disturbances with associated nausea and vomiting. Patient's labs in the ER revealed significantly elevated free T4 and was started on hydrocortisone and methimazole therapy.
Moderna Covid 19 EAU.  Patient presented with right arm soreness and a "goose egg" on top of shoulder measuring 3" x 4".  Nontender and no redness, soft to palpation.  Good pulses in arm.  Patient states he saw a provider at healthcare facility and she said to just monitor site.  Patient is going to massage area and report if any soreness or redness occurs.  Patient to call on 4/19/21 to let me know if problem is resolved
She experienced very bad headache; Nauseated; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (She experienced very bad headache), NAUSEA (Nauseated) and MYALGIA (Muscle ache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced HEADACHE (She experienced very bad headache), NAUSEA (Nauseated) and MYALGIA (Muscle ache). At the time of the report, HEADACHE (She experienced very bad headache), NAUSEA (Nauseated) and MYALGIA (Muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
experience a slight tenderness around site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (experience a slight tenderness around site of the injection) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included AMLODIPINE for Blood pressure, VITAMINS NOS for an unknown indication. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (experience a slight tenderness around site of the injection). At the time of the report, VACCINATION SITE PAIN (experience a slight tenderness around site of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided.   This case was linked to MOD-2021-280653 (Patient Link).
received an expired Day 0 Imovax vaccine on 15May2019, the expiration date was 26Feb2019; Initial information received on 16-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 59 years old female patient who received an expired dose of vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patients past medical history and family history were not provided.  Concomitant medications included IMMUNOGLOBULIN HUMAN ANTI-RABIES (RIG) on 15-May-2019.  On 15-May-2019, the patient received a 0.5ml dose post exposure vaccination of suspect RABIES (HDC) VACCINE lot N1B05, expiry date 26-Feb-2019 via intramuscular route in the right deltoid.  It was an actual medication error due to expired vaccine used.  It was reported that patient received an expired Day 0 Imovax vaccine on 15May2019, the expiration date was 26Feb2019.  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.
there was 5 of us and none of us had reactions, only our shoulders was hurting a little but we had not fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for five patients. This is fourth of five reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that, there was 5 of them and none of them had reactions, only their shoulders were hurting a little, but they had not fever. The reporter wanted know that the patient didn't get a reaction that means the shot was not effective and was not working, was that true. The outcome of the event was unknown.  Information on lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021171051 same drug/AE, different patient.;US-PFIZER INC-2021130494 same drug/AE, different patient.;US-PFIZER INC-2021171048 same drug/AE, different patient.;US-PFIZER INC-2021171049 same drug/AE, different patient.
Rash, redness and swelling in the arm (where one of the short was injected). 6 days after shots there is the onset of headaches
ear congestion Bilateral hand swelling, redness BP 132/92 HR 107 P 70 99% RA
Development of bloating and gassiness after she received vaccine; Development of bloating and gassiness after she received vaccine; This is a spontaneous report from a contactable reporter (physician).  A 62-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Mar2021 (Lot number: 001B21A) at the age of 62 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None", notes: Other medical history: none: Known allergies: none. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: 031M20A; Anatomical location: left arm; Route of administration: intramuscular), administration date: 12Feb2021, when the patient was 62 years old, for COVID-19 immunisation. The following information was reported: ABDOMINAL DISTENSION (non-serious) with onset 14Mar2021, outcome "recovered with sequelae" (18Mar2021), described as "Development of bloating and gassiness after she received vaccine", FLATULENCE (non-serious) with onset 14Mar2021, outcome "recovered with sequelae" (18Mar2021), described as "Development of bloating and gassiness after she received vaccine". Therapeutic measures were not taken as a result of abdominal distension and flatulence.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The symptoms continued for 4 days before resolution. She still had occasional symptoms like that (at the time of the report). The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Patient developed a rash at the injection site (5 x 3 cm area of erythema).
Passed out, tremors, eyes rolling in the back of her head Client sent to ER via ambulance.
He began showing dementia like behaviors within 24 hours of receiving 2nd Pfizer vaccine. To be clear, not referring to forgetfullness, referring to full on, can't remember names children or grandchildren, up to and including 'word salad' related symptoms. On a 04/07/2021 follow up he was given 'SLUMS' test and scored 24 of 30, yet struggled to recall appropriate words in the appropriate context.  Ex. degrees for years of age, check for the word 'injection', coinciding with circular coversations, where the same topic is repeated numerous times in a conversation, without recollection...
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In 2016, a healthcare provider at a medical center administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 04-JUN-2018, the patient was treated by a healthcare provider at the Army medical center for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
17 year old received a extra dose of  meningococcal; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA603a, expiry date 11th September 2022) for prophylaxis.   On 11th May 2022, the patient received Menveo. On 11th May 2022, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 13-MAY-2022 Reporters comment: Clinic manager reporting that 17-year-old received an extra dose of Menveo. Adverse event report contained all information provided by healthcare professional at the time of reporting.  The reporter consented for safety team follow up. Additional supportive information: The patient received an extra dose of Menveo, which led to extra dose administered.
Severe migraine headache on morning following vaccine, affecting vision for about 30 minutes, took 2 Tylenol 500mg each, had bad headache for rest of the day.  Left arm pain that radiated into left shoulder and neck area, applied heat.   Was awakened very early 2nd morning with headache, causing me to get up as hurt to lay head on pillow.  Took 2 Tylenol, so far only slight decrease in pain.
onset was immediate after vaccinations. Patient c/o weakness, fever, chest tightness for past 2-3 days Got COVID booster on Friday and had to stay under observation for 2 hours after d/t concern for an allergic reaction Experienced dizziness, neck and chest were red and felt itchy  Did not receive any medications and was eventually allowed to go home Since leaving has felt unwell Today had temperature of 100.5 F Entire body feels weak  Chest tight and getting short of breathe more easily than usual