chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure/Took second dose, got the virus; Passed out; Got the virus; Aches; Fever; Chills; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant), shingles, pain, fever and chills. On an unknown date, the outcome of the vaccination failure, passed out, shingles, pain, fever and chills were unknown.   It was unknown if the reporter considered the vaccination failure, passed out, shingles, pain, fever and chills to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient took 2nd dose and passed out. On an unknown date, the patient had experienced aches, fever, chills to got that virus. The patient stated that just not him/her but he/she sure went through a lot. This case was considered as suspected vaccination failure as details regarding time to onset and  laboratory test confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
chronic autoimmune urticaria restarted.  had not had hives since about 2017.  usually lasts several years before subsiding.  have had them since 1975
Moderna COVID-19 Vaccine EUA. I started feeling body aches and fever chills around 11am the day after I received my first dose. I had to leave work early due to the symptoms.
Seven days after vaccination, pt reports small vesicles appearing on the left arm and forearm and left lateral hip. They are itchy and tender. Pt hospitalized to remove him from areas.
felt a little woozy; This is a spontaneous report received from a contactable consumer (patient). This male consumer reported in response to consumer letter sent to consumer via telephonic follow-up activity.A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN9581), via an unspecified route of administration on 15Mar2021 as single for CVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9266) on 18Feb2021 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced felt a little woozy on an unspecified date in Mar2021. Investigations Not Provided. Caller stated that he read it takes 2-4 weeks for the vaccine to be effective. Patient wanted to ask if that was a side effect even though it's 2 weeks later. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Started like red ant bites, spread all over my body, severe itching, chills and fever. Over the counter ointments to no avail, skin on hands peels and splits. About 10 days before seeing a doctor, rx to no avail. Biospy 10/26/2010 drug related. Referred to dermatologist 11/05/2010.
I had swelling/redness/pain/warm to touch at injection site. The warmth traveled up to the L side of my face, so L side of my face was warm and R was not. That warmth lasted for several hours / resolved by Sat 1/16. No other symptoms. Redness did not spread. The pain went away come Saturday 1/16 and the site started to itch. Redness subsided over the next couple of days. Reported to my PCP
Tingling in her right and left arm/leg; Tingling in upper lip; This spontaneous case from the  was received on 23-Oct-2020 from other non-health professional (consumer) via The Agency (reference number: SEQW20-04144) and concerned a 64-year-old, female patient.   The patient's past medical history included respiratory problem. The patient's concurrent conditions included migraines. The patient's concomitant medications included sumatriptan and Benadryl (diphenhydramine hydrochloride), both used for unreported indication.  On 20-Oct-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, anatomical location: left upper arm and route of administration: intramuscular) for influenza prophylaxis. The batch number was not reported.   On the same day, 10 to 15 minutes after receiving Afluria Quadrivalent, the patient started to feel tingling in upper lip. Later, the patient experienced tingling in her right and left arm/leg.  On an unspecified date in Oct-2020, the patient called doctor and was advised to wait and contact again if she felt worse.   At the time of initial report on 23-Oct-2020, the patient had not recovered from the events. The patient was still feeling tingling in her right and left arm/leg. The symptom was coming and going, and it was not improving.   The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  Company comment: The events of 'tingling of extremity' and 'tingling lips' are considered as related to Afluria Quadrivalent.; Sender's Comments: The events of 'tingling of extremity' and 'tingling lips' are considered as related to Afluria Quadrivalent.
Narrative: 89yo male patient with a history of carcinoma bladder. Past medical hx: Sick sinus syndrome (SCT 36083008) Long-term current use of anticoagulant (SCT 711150003) Carcinoma of bladder (SCT 255108000) Carcinoma of prostate (SCT 254900004) Cardiac pacemaker in situ (SCT 441509002Gastroesophageal reflux disease (SCT 235595009) Pt died on 12/19/21 with no info in chart regarding pt's death. Pt had received covid vaccines on 2/2/21 & 3/2/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No Treatment medications were reported.
headache; sore muscles throughout my body; alternating sense of hot/cold; general fatigue; strong soreness at the injection site (left arm); feeling chills; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm left on 16Feb2021 09:00 (Batch/Lot Number: EN 5318) (at the age of 39-years-old) as single dose for covid-19 immunisation. Medical history included none. The patient had no known allergies. Concomitant medication included desvenlafaxine succinate (PRISTIQ) 50 mg ER taken for an unspecified indication, from an unknown start date (two weeks prior to vaccination). The patient previously received BNT162B2 (Batch/Lot Number: EN 5318) dose 1 via an unspecified route of administration in left arm on 26Jan2021 at 12:00 for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On the day when patient received second dose on 16Feb2021 at 21:00, he felt strong soreness at the injection site (left arm) and began feeling chills by the time he went to bed (12 hours after receiving the vaccine), but no other symptoms. On the following day (17Feb2021) when he woke up, he experienced a multitude of symptoms, including headache, sore muscles throughout my body, alternating sense of hot/cold, and general fatigue. These symptoms continued most of the day but began to subside by that evening. No treatment was given for the events. The outcome of the events was recovered on 18Feb2021.
Headache, Myalgia, Heartburn at 6P so severe wnet to ER. Got headache and tired afterwards. Narrative: Employee reports ER gave patient Zofran, Pepcid, Toradol. States ER doctor told her it was side effect from vaccine. No follow-up recommended. Completely recovered.
Signs and symptoms consistent with transverse myelitis/first episode of demyelinating disease. Symptoms began on 6/6/21 with circumferential numbness and tingling of lower abdomen/vulva/perineum/perianal area and over the next couple of days progressed distally down both lower extremities. By 6/10/21 she also had numbness and tingling of her right upper extremity and over the next 2-3 days she developed numbness and tingling of her left upper extremity and some "clumsiness" (banging into things, dropping things.) After MRIs were done (see below) she was treated with 5 days of IV steroids and had significant improvement in her symptoms.
Severe lower abdominal pain with vomiting very early morning of 11/21/21. Continuing but relatively diminished abdominal pain over the next few days. Transvaginal ultrasound on morning of 11/24/21 diagnosed two ~2-cm cysts in left ovary. Pain continued to subside throughout the remainder of the week. No prior history of ovarian cyst diagnoses.  Similar abdominal pain morning of 1/7/22, with pain diminishing over the course of the day. Dull low back pain continued through the next 2 days.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 27-AUG-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, (dose and frequency were not provided), lot # K019370, expiration date 16-JUL-2016. No concomitant medication was reported. At the time of this report, no adverse effects were reported. This is one of the several reports received from the same source, Additional information has been requested.
Patient developed a mild (R) facial palsy, 1 day after receiving the influenza vaccine.
PERICARDITIS; This is a spontaneous report from a contactable pharmacist (patient himself). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 13Jan2021 at 13:00 (Batch/Lot Number: EL3248) (at the age of 45-years-old) as unknown, single dose for COVID-19 immunisation. Medical history included blood pressure. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported. On 13Feb2021 at 09:00, patient experienced pericarditis. The event resulted emergency room/department or urgent care. Patient was given Naproxen 500mg twice a day as treatment. Outcome of event was recovering. Since the vaccination, patient has not been tested for COVID-19.; Sender's Comments: Based on the information currently available, a causal association between the reported event pericarditis and BNT162B2 cannot be fully excluded. Case will be reassessed when additional information is 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 RAs, Ethics Committees, and investigators, as appropriate.
March 19th Friday afternoon started a fever between 99-102 degrees with headache lasted two days.
Received vaccine 3/21/14. On 3/30/14 developed fever, then on 3/31/14, develope dmild rash on torso. Rash and fever worsened 4/1/14.
Patient c/o HA, fever, chills, body aches, sore arm the day after the vaccine.  Symptoms lasted 24 hours.  Patient had COVID-19 in August on 2020.
NKDA. Meds PNV 7wks G 1 after with nausea, dizziness, passing out; turned pale diaphoresis. No LOC NO vomit
Complex Febrile Seizure lasting 12 minutes. Admission to the hospital, EEG that came back normal.
Where she got the shot is very red; Where she got the shot is very / tender; This case was reported by a consumer and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2020, the patient received Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site tenderness. On an unknown date, the outcome of the injection site erythema and injection site tenderness were unknown.   It was unknown if the reporter considered the injection site erythema and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter said that a senior auntie got her shot about 4 days ago from the day of reporting, the spot where she got the shot was very red and tender.
sore arm; This is a spontaneous report from a contactable consumer. This 66-year-old female consumer (patient) reported that COVID-19 Vaccine is a Pfizer product, COVID-19 Vaccine manufacturer Unspecified, Start: Unspecified Stop: Unspecified), Unknown number of COVID-19 Vaccine and Expiry Date of COVID-19 Vaccine: Unknown (the)Reaction(s)/Event(s) as reported by primary source Dates for I was feeling a bit light headed and dizzy: (From: Unspecified To: Unspecified),Dates for I was on the bathroom floor in the pool of blood; I got myself up, I passed out again: (From: Unspecified To: Unspecified), Dates for I am badly bruised: (From: Unspecified To: Unspecified)Dates for My eyes rolled back to my head: (From: Unspecified To: Unspecified),Dates for Sore arm: (From: Unspecified To: Unspecified),Dates for Very very low grade fever: (From: Unspecified To: Unspecified), Dates for Tired: (From: Unspecified To: Unspecified) Dates for I hit my head: (From: Unspecified To: Unspecified), Dates for I am not able to open, not able to eat because in the fall I hit my jaw so badly: (From: Unspecified To: Unspecified).  Additionall information; The patient stated, "The patient  just want to report, I am going to report it to you or the CDC because the place that I got the booster does not seem really that concerned, the patient had a terrible side effect to the Pfizer Booster vaccine that I think should be made aware of, I don't know if other people have reported some of the effects." The patient have stated Pfizer COVID 19 Vaccine it was the COVID 19 Pfizer booster, The patient had the first two shots and this is my booster." Treatment: The patient Stated, "Well Few days after I just took some Advil because I am not able to open, not able to eat because in the fall I hit my jaw so badly, so the only thing I have been taking is some Advil, I took absolutely before my vaccine and took nothing for two or three days after my vaccine." Other Vaccine (Prior to 4 weeks of COVID Vaccine): The patient stated, "No Nothing"    No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101465729 Same patient and drug, different events separated in time;US-PFIZER INC-202101465992 Same patient and drug, different events separated in time
3-4 doses administered past published expiry; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3-4 doses administered past published expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3-4 doses administered past published expiry). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (3-4 doses administered past published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Treatment medication was not provided by the reporter.  A nurse accidentally administered 3-4 doses of  expired Moderna COVID-19 vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: Non significant information received
Temp of 100.8 night after vaccination, rash at site of vaccination two days later, and hives across entire body 6 days after vaccine.  I took Benadryl for the hives.
1 Day after immunizations, patient took BS in AM - routine BS - 294 fasting prior to admin. of test 7 AM 10/11/06.
Patient reports that after receiving second dose he started having cold-like symptoms, sweating, hot flashes, difficulty breathing and heart racing/fluttering.  I recommended he contact his cardiologist regarding the heart palpitations and irregular heartbeat.
L upper arm red swollen size of adult palm, warm to touch, no oral temp. Mother instructed to continue Tylenol or Motrin with Benadryl & Cold compresses
2 months after my second vaccine I started to develop a series of large and painful styes in each eye. My right eye had a total of 6 and my left had 2 over the course of about a month. I saw both an eye doctor and a naturopath. I was treated with oral antibiotics, eye cleansing spray, natural remedy called CytoQuel to calm cytokines, a $575 "Tear Care" treatment to try and unclog the eye glands and countless warm compresses. At this point, my last stye started on 8/8/21 and I do not know if it is the last. I cannot wear makeup on my eyes, still need to hot compress 2x daily, stay on the CytoQuel indefinitely and my right lower eyelid is still red and inflamed no matter what we do. My eye pressures were also almost double what they were in March, the month before my first shot. In addition, JUST IN MY SMALL CIRCLE, I have found 7 other people experiencing the same thing- 6 women and 1 man, all in their 40's-50's, one will not need eye surgery to remove a stye that progressed, even with medical care, to a chillazean.
Fever, chills, headache, nausea  (days 2-3), sore arm (days 1-4), swollen and painful axillary lymph nodes (left) still ongoing (stared day 3- now on day 5.)
no adverse effects reported; patient received an improperly stored dose of PEDVAX.; This spontaneous report was received from a medical assistant, and refers to a 2 month old female patient. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.      On 03-OCT-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # R036177 with an expiration date in 08-OCT-2021), for prophylaxis (strength, dose and frequency were not provided), that underwent a temperature excursion of 46.5 degrees Fahrenheit during a time frame of 5 minutes. Digital data logger was involved, however no previous temperature excursion was reported. No adverse effects were reported.        This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA006584: US-009507513-1910USA006415: US-009507513-1910USA006562: US-009507513-1910USA006576: US-009507513-1910USA006268:
can't get a side effect from no longer taking a flu shot; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non- healthcare professional (hcp).  This case involves adult patient (unknown age, gender) who can't get a side effect from no longer taking a flu shot while receiving vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency: unknown) (lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination. Information on the batch number was requested.  On an unknown date the patient developed a non-serious event "can't get a side effect from no longer taking a flu shot (unevaluable event)" (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, "this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. I can't get a side effect from no longer taking a flu shot. It is unknown if the patient experienced any additional symptoms/events".   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (can't get a side effect from no longer taking a flu shot).  At time of reporting, the outcome was Unknown for the event can't get a side effect from no longer taking a flu shot.
Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 70-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 Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 18-Jun-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) had resolved. after second dose          Concomitant medication and treatment information were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up information received on 21-May-2021 contain no new information