chrisvoncsefalvay/vaers-outcomes huggingface dataset:
experiencing fever; chest pains; difficulty breathing; painful red rash on body; red eyes; This is a spontaneous report from a contactable consumer. A 16-year-old female patient received bnt162b2 (Pfizer COVID Vaccine), dose 2 via an unspecified route of administration on 12Aug2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Historic vaccine was bnt162b2 received via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization. The patient experienced experiencing fever, chest pains, difficulty breathing, painful red rash on body and limbs, red eyes early Monday morning on 16Aug2021. The patient was hospitalized for events from Aug2021. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received the Moderna vaccine on 1/28/21 and 2/25/21, so was fully vaccinated when they tested positive for COVID-19 on 8/20/21.
noticed warm, raised and red mark on injection site; drew borders (5 cm diameter) but medial border has slight 1cm length streak, no increase over last few hours, no fever but very tender to touch
Child was sent home from school due to Left arm pain and itching at flu shot injection site.  Child rec'd flu shot on 10-25-12.  Child is also coughing. Cetirizine 5mg q day x 5-7 days.
Headache fatigue, arm swollen, insomnia Narrative: Call in to notify of headache, insomnia, fatigue
LACK OF APPETITE; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 10-MAY-2021, the subject experienced lack of appetite. On 10-MAY-2021, the subject experienced chills. The action taken with covid-19 vaccine  was not applicable. The outcome of the chills and lack of appetite was not reported. This report was non-serious.
she is feeling dizziness; vertigo; she felt a little unsteady on her feet; soreness at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 12:30 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 11Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: bnt162b2 (Dose: 01, Lot: EL0140, Expiry date: Unknown, Site: Right arm), administration date: 10Jan2021, when the patient was 68-year-old, for COVID-19 Immunization; bnt162b2 (Dose: 02, Lot: EL9265, Expiry: May2021, Site: Right arm), administration date: 29Jan2021, when the patient was 68-year-old, for COVID-19 Immunization; bnt162b2 (Dose: 03, Lot: FE3590, Expiry: 30Nov2021, SIte: Right arm), administration date: 12Oct2021, when the patient was 69-year-old, for COVID-19 Immunization; covid-19 vaccine moderna (Dose: 04), administration date: 23May2022, when the patient was 69-year-old, for COVID-19 Immunization; covid-19 vaccine moderna (Dose: 05), administration date: 26Oct2022, when the patient was 70-year-old, for COVID-19 Immunization; Flu shot (She gets 1 every year. She gets the senior dose after she turned 65. Has gotten vaccinated with flu shots ever since she was 21 year old.), for Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 11Oct2023, outcome "not recovered", described as "soreness at the injection site"; BALANCE DISORDER (non-serious) with onset 12Oct2023, outcome "unknown", described as "she felt a little unsteady on her feet"; DIZZINESS (non-serious) with onset 12Oct2023, outcome "not recovered", described as "she is feeling dizziness"; VERTIGO (non-serious) with onset 12Oct2023, outcome "not recovered". Additional information: If she moves her head rapidly it increases her vertigo symptoms. She has to move slowly. She noticed the dizziness and vertigo 17-18 hours after receiving the immunization (as reported). She woke up early in the morning and noticed that she felt a little unsteady on her feet. She received the vaccine about 1230 yesterday 11Oct2023. Her symptoms are a little worse than from when she first noticed it. She does have some soreness at the injection site that is mild and is typical like other vaccines. Noticed the soreness started within probably 5-6 hours of getting the injection.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Feeling hot; Redness; Rash; muscle ache; Chills; Nausea; Vomiting; persistent cough; persistent tightness in the chest; persistent sinus headache; blowing nose; phlegm; left arm was sore; poor sleep; extreme fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm was sore), POOR QUALITY SLEEP (poor sleep), RHINORRHOEA (blowing nose), PRODUCTIVE COUGH (phlegm) and COUGH (persistent cough) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ROSUVASTATIN, MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (left arm was sore), POOR QUALITY SLEEP (poor sleep), FATIGUE (extreme fatigue) and HEADACHE (headache). On 22-Apr-2021, the patient experienced RHINORRHOEA (blowing nose), PRODUCTIVE COUGH (phlegm), CHEST DISCOMFORT (persistent tightness in the chest) and SINUS HEADACHE (persistent sinus headache). On an unknown date, the patient experienced COUGH (persistent cough), FEELING HOT (Feeling hot), ERYTHEMA (Redness), RASH (Rash), MYALGIA (muscle ache), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, PAIN IN EXTREMITY (left arm was sore), POOR QUALITY SLEEP (poor sleep), RHINORRHOEA (blowing nose), PRODUCTIVE COUGH (phlegm), COUGH (persistent cough), CHEST DISCOMFORT (persistent tightness in the chest), SINUS HEADACHE (persistent sinus headache), FATIGUE (extreme fatigue), HEADACHE (headache) and MYALGIA (muscle ache) outcome was unknown and FEELING HOT (Feeling hot), ERYTHEMA (Redness), RASH (Rash), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information on treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-027155 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: reporter contact information updated. On 12-Aug-2021: non-significant follow up On 12-Aug-2021: Significant follow-up appended. Patient demography updated. Concomitant medication updated Events updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-027155:Case for dose 1
Eyelid swelling that has occurred about 4-5 times. Initial event was the following week after the second dose; bilateral eyelid swelling (one upper lid, other lower lid). Subsequent episodes are unilateral with left side occurring greater than right. Usually resolves in about 5 hours. Most recent episode was the largest it has been and it has persisted beyond 12 hours. No other associated swelling, no eye pain, no itching or irritation.
This spontaneous report was received from a 57 year old female patient, who was reporting on herself. Her concurrent conditions included an allergy to PEPTO-BISMOL. However, information regarding her medical history was not reported. On 25-MAY-2016, the patient was vaccinated with a dose of ZOSTAVAX 1 shot, subcutaneously (lot # and expiration date were not reported). Her concomitant therapies included an unspecified diuretic. On 30-MAY-2016, the patient woke up itching, having a burning skin rash which was primarily located on her chest and went up to her lower neck. It was also reported that she had a patch on her arm which she stated as an injection site reaction, but it was mostly raised bumps on her arm. Therefore, the patient took some antihistamines to help her sleep, and put hydrocortisone cream on to alleviate the pain but did not visited her doctor yet, regarding the issue. No laboratory diagnostic studies were performed and no product quality complaint was involved. At the time of reporting the outcome of all above mentioned events was reported as not recovered. Additionally, the relatedness between the events and the suspect therapy was not provided by the reporter. Additional information has been requested.
Initial discomfort in left shoulder (covid vaccination arm) and pain/stiffness on left side of neck.  The following day or two I had minor cold symptoms (stuffy nose, muscle aches, sore throat, etc.).  Now, two weeks post vaccination I still have all symptoms.  The pain in my shoulder is so bad that I've seen a chiropractor and doctor.  I am unable to lay on my left side while sleeping because I still have pain at the injection site.  My "cold" symptoms have persisted throughout this time.
I have a rash on my face; This spontaneous case was reported by a consumer and describes the occurrence of RASH (I have a rash on my face) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (I have a rash on my face). At the time of the report, RASH (I have a rash on my face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 12-JUL-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M000996, expiry date 07-JAN-2018, dose, strength, vaccination site, route unspecified). The vaccine was exposed to a temperature of 6.5 Fahrenheit (F) for 80 hours. Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one several reports received from the same reporter. Additional information has been requested.
pain in arm; Lab test abnormal; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (pain in arm) and LABORATORY TEST ABNORMAL (Lab test abnormal) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    The patient's past medical history included No adverse event.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm) and LABORATORY TEST ABNORMAL (Lab test abnormal). At the time of the report, PAIN IN EXTREMITY (pain in arm) and LABORATORY TEST ABNORMAL (Lab test abnormal) 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.   Concomitant medications were not provided.
hives/rash, tightness in chest, headache, fever, chills, body aches, soreness at injection site
sore arm; terrible chills; night sweats; This is a spontaneous report from a contactable consumer, the patient.  A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 22Jan2021 at 12:15 (at the age of 55 years-old) in the left arm as a single dose for COVID-19 immunisation. Medical history included Behcet's disease and penicillin allergy; from unknown dates and unknown if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19 from an unknown date and unknown if ongoing.   Concomitant medications included adalimumab (HUMIRA), testosterone (MANUFACTURER UNKNOWN), citalopram hydrobromide (CELEXA), dexlansoprazole (DEXILANT), and paracetamol (TYLENOL); all taken for unknown indications from unknown dates and unknown if ongoing.  It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine.  The patient previously took sumatriptan (IMITREX) from an unknown date to an unknown date and experienced allergy.  On 23Jan2021, the patient experienced sore arm, terrible chills, and night sweats. The patient did not receive any treatment for the events. The clinical outcomes sore arm, terrible chills, and night sweats was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Pain at injection site right away that gradually faded, body aches, fatigue and stiffness that started around 7 PM, 99.1 fever taken shortly before 9 PM with NSAIDs on board and just after taking a drink.
w/in 24hr of vax pt devel mental depression, myalgia & neck pain;these sx persisted as of 2SEP97;
pt recv vax 1MAR96 & 8MAR96 pt devel an itchy rash consisting of 20 lesions on stomach, chest, back, legs & foot;
Breakthrough case of COVD-19; I started feeling achy and warm, I had a low grade fever and I had a headache, and I took a home test and it came back a faint positive, but by morning it came back fully positive. I called my Dr. and he described the PAXLOVID for 5 days, and after about 2-3 days. I have been done the medicine and I have not had any rebounds and since taking the medicine I have felt pretty good.
Nausea, unable to sleep. Nausea is now 24hrs a day. No vomiting.
MISSED THE SECOND DOSE; A spontaneous case report was received from a caregiver on 14-Jun-2019 for four consumers.  Based on the information obtained from the caregiver, four individual case safety reports PVX201906-000497 (PVX2019-1546; mother) and PVX201906-000498 (PVX2019-1547, eldest daughter) PVX201906-000499 (PVX2019-1548; son) and PVX201906-000500 (PVX2019-1549; youngest daughter) were created and cross-linked in the database.  This case describes a 13-year-old adolescent female consumer who "missed the second dose", while being on Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 11-Jun-2019 and missed her second dose, which was due on 13-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed the second dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the second dose" was considered as not applicable. US-PaxVax Berna GmbH-PVX201906-000497:
This spontaneous report was received from a medical assistant referring to a 59 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-MAY-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB with lot # M046373 and expiration date 04-NOV-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning RECOMBIVAX HB with lot # M046373. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009240 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009240 is being deleted from our files and the case is consolidated into case # 1711USA004093 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
Pt initially noticed prolonged soreness at the injection site 2 wks after receiving injection, which then developed into noticing tingling, numbess, pain and muscle spasming of R biceps muscle.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 23-JUL-2015, the patient was vaccinated with an improperly stored single dose of PNEUMOVAX 23 0.5 ml, which had a lot # L003188 (also reported as "l003188" and an expiration date of 06-JUL-2016 (route and anatomical location of administration were not reported). The sum of hours in excursion was 912 hours and the lowest recorded temperature reported was 27 Fahrenheit (F) (-2.777777778 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
On 6/5/04 client developed one red bump on her left hand and then on 6/6 she developed vessicles on her upper left arm and shoulder. no other symptoms
This case was reported by a physician and described a 76 year old female pt who received Engerix-B and subsequently tested positive for hepatitis B surface antigen. On 1/7/04, prior to immunization with Engerix-B, the pt tested negative for hepatitis B surface antibody. On 8/23/04, the pt received the 1st dose of Engerix-B (lot AHBVA077AB). Approximately 4 days later, on 8/27/04, the pt tested positive for hepatitis B surface antigen. The physician considered the event to be related to vaccination with Engerix-B.
Patient was to receive her second dose of the Moderna vaccine. However, the nurses administered a dose of the Pfizer vaccine. The patient did not have a adverse reaction or any signs of a adverse reaction.
Covid tongue (oral thrush) plus ulcers along with sore throat and swollen lymph nodes in neck. Started two to three days after second vaccination. Typical symptoms fatigue, headache occurred between 24-48 hours of getting the second shot.
I got my first COVID19 vaccination on 3/24/2021. Within an hour of the vaccination, I began having numbness in the right hand, which then spread to both hands, both feet, and the left side of my face. The hand numbness included itching, pain, and an inability to grip. I saw various doctors, who ultimately agreed that the vaccine may have triggered a response from something already present in my body. The neuropathy gradually escalated for about 6 weeks, with the worst of it being in mid-May. After that, it gradually improved. It eventually got to the point that it was almost gone, though I still had some numbness in the right hand and left foot. I filed a VAERS report for the symptoms I experienced after the first vaccination, and the e-report number is 402786. I then got my second vaccination on 8/18/2021. Everything was fine for about 24 hours, but then the numbness that was already present in my right hand and right foot began escalating. It also spread some to the left foot, though it wasn't severe. On 8/19/2021 at about midnight, I began having severe diarrhea and nausea, which ended up lasting for about 2 days. On 9/1/2021, I went to the ER Hospital, when I experienced  a second bout of diarrhea and nausea. I had also taken an at-home COVID19 test, which came out positive, and I decided to go to the hospital to obtain monoclonal antibodies to treat it. At the hospital, I underwent both a rapid test and a PCR test for COVID19, both of which came out negative. I was also given an IV to replenish the fluids I had lost with the diarrhea and vomiting and anti-nausea medication. I came home, and the diarrhea and nausea subsided. The mild neuropathy continued. On 9/11/2021, I had a third bout of severe nausea and diarrhea, which lasted for about a day. At present time, I continue to have neuropathy in the right hand and both feet, which is manageable and less severe than it was after the first dose. I also continue to test negative for COVID19.
Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling in chest. No sob.  Early on 1/8/21 in the AM, had 2 runs afib, that responded to metoprolol. She reported the afib to her cardiologists. Called again on 1/19/21 to report continued fevers, fatigue, body aches, nausea, and chills that caused her to call off on 1/17/21. Ordered COVID-19 PCR.