chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 1 month after after my 2nd booster shot (Dose 4), I contracted COVID and had the following symptoms: Sore throat, Fatigue, Sinus congestion, Runny nose, Fever. I took Tylenol for treatment and called my doctor for consultation and was prescribed with Paxlovid. As of today 05/11/2022 I am feeling much better now - there's still a bit of congestion in my head but my energy level has been back to normal.
Patient stated after one week of receiving the new Moderna bivalent booster she experienced having itchy, rash all over her body and it continues to spread. She still has it after 2 weeks. Benadryl is not helping.
ER visit for pelvic pain. Admitted to hospital for HSV (herpes simplex virus) anogenital infection. Treated and discharged. ED visits and hospital admission within 6 weeks of receiving the COVID vaccine.
It started with a pain in my right shoulder as the day the went on the pain moved down my right arm and eventually moved to my thumb and index finger, then a little rash appeared that hurt but did not itch, when I went to urgent care I was diagnosed with Shingles.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 03-Aug-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        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. The date of refrigeration of vaccine was reported as 7-May-2021.
About 24 hours after the vaccine moderate soreness/pain in the area of the injection on the left upper arm. It disappeared 48 later without treatment. Also, 48 hours after the vaccine, a slight pain in the right ear/upper right mandible, especially when chewing,  presented itself. it disappeared without treatment three days later, about five days after the vaccination.
Patient came few days after she got a Fluzone High dose vaccine and said that She has itchiness on her face and she thinks it is because of vaccine. We are in touch with patient to see how is she doing.
Unknown symptom onset; symptoms were fever, chills, myalgia, rhinorrhea, sore throat, headache, fatigue, and cough. Intubated at some point during hospitalization.  Person extubated while in hospice care and died on 2/24/2022.
seizure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: SEIZURE (medically significant) with onset 23Oct2022, outcome "unknown". Clinical course: A patient called in and said she got a primary series of Pfizer covid-19 vaccine and got a Pfizer covid-19 vaccine booster, and she heard on the news that they will start charging on the booster. The caller asked when they would start charging for the booster. The caller also mentioned that she had a seizure last night.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
A non-serious spontaneous report of we gave expired H1N1 to several patients was received from a registered nurse/ health professional concerning a four-year-old female out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. The original expiry date was 12-Feb-2010 which was changed. On 20-Jan-2010, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Moderna vaccine booster was administered on 11/5/2021 with an expiration date of 10/11/2021. Inquiry has been submitted to Moderna requesting validation of vaccine potency.  A response from Moderna is expected to be received between 8-10 business days.  Expiration date is currently not printed on the vaccine vial or carton and vaccine expiration date listed is 12/31/2069.  To find the expiration date, "look up expiration date" tool is to be used from Vial Expiration Date Lookup | Moderna COVID-19 Vaccine. Patient contacted on 12/4/2021 and no adverse effects reported.
Tdap expired 5/2/09 and was administered on 5/6/09.
She came in 2 days after the immunization with a large rash, dark red, irregular shaped around 4 cm x 4 1/2 cm, with a lighter flat rash around the smaller rash 6 1/2 cm x 7 1/2 cm. It itches and only hurts when something bumps it or she lays on it. She "noticed" rash morning after immunization. Her normal temp is 97.4 but 10/23/13 in evening it was around 99. She feels well otherwise. Rash was bigger per pt 10/24 than it was 10/23 PM. Dr office drew line around rash, around periphery at 2:00 PM 10/24. Pt came to show us at 4:00 PM. Rash has started receding.
pt recv vax & devel whooping type productive cough w/o fever;no further details known as of the date of this report
seizure type of reaction; high fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 as dose 3 (booster), single (Lot number: GJ2524) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation as dose number unknown, single. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: FF8839), administration date: 12Nov2021, when the patient was 79-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6200), administration date: 23Feb2021, when the patient was 79-year-old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 05Nov2022 at 23:00, outcome "recovered", described as "high fever"; SEIZURE (medically significant) with onset 05Nov2022 at 23:00, outcome "recovered", described as "seizure type of reaction". Therapeutic measures were not taken as a result of seizure, pyrexia. Clinical courses is as follows: The patient received other vaccine flu  in 4 weeks. The patient experienced covid prior vaccination. Covid wasn't test post vaccination.
lightheaded & faint;went to ER was not hospitalized;middle chest & stomach, felt like having a heart attack
Pt fainted (vagal response) after receiving the 3rd shot. She had a drop in BP 55/35 and paramedics were called. Pt refused transport but followed up w/MD.
Red burning rash on palms of hands broke out a month later. Burned really bad, sore to touch. Left hand still has red patches today, like scars. Red patches never scaled or broke open. Were around edges of both hands
On June 18th a blood test showed that my Thyroid Stimulating Hormone was at 11.700 mcIU/mL from 1.3 mclU/ml and my Thyroid Peroxidase Antibody 289.1 U/mL from 47.1 U/mL. I have been under the care of a Endocrinologist for 10 years having testing done once a year to maintain which it had been always under control. I had severe brain fog and slept for 16-20 hours a day for over 6 weeks until medication was increase to 175mcg and moved to Tirosint instead of Synthroid as I was having issues absorbing. Since Thyroid has been under control, I have retained the significant brain fog, heart palpitation, confusion and difficulty with speech; resulting in inability to work. As of 4 weeks ago, my speech is closer to normal though I still search for words at times.  I still have significant brain fog and confusion; heart palpitation has lessened and as of September 7, I began having experiencing Tinnitus  constantly.
my eyes started to have a fair amount of swelling; Some swelling above my cheek bones; Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 10:15 (Lot number: FA7484) at the age of 36 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "hypermobile Ehlers Danlos Syndrome" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: BACLOFEN; TIZANIDINE; MELOXICAM; CANNABIS. Past drug history included: Amoxicillin, reaction(s): "Known allergy: Amoxicillin"; Ceclor, reaction(s): "Known allergy: Ceclor".  The following information was reported: EYE SWELLING (non-serious) with onset 19Aug2021 15:00, outcome "not recovered", described as "my eyes started to have a fair amount of swelling"; SWELLING FACE (non-serious) with onset 19Aug2021 15:00, outcome "not recovered", described as "Some swelling above my cheek bones"; NAUSEA (non-serious) with onset 19Aug2021 15:00, outcome "not recovered", described as "Nausea". Therapeutic measures were not taken as a result of eye swelling, swelling face, nausea.  Additional information: Other medications in two weeks: Baclofen, Tizanidine, Meloxicam, Med Cannabis. If other vaccine in four weeks: No. If Covid prior vaccination: No. If Covid tested post vaccination: No. Adverse event: Normal response for the first 24 hours. At about 36 hours eyes started to have a fair amount of swelling below the brows covering eye lids. Some swelling above cheek bones, nausea.  Follow-up attempts are completed. No further information is expected.
Had 2 severe migraines since the Moderna vaccine dose; Felt tired; Itchy at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (Had 2 severe migraines since the Moderna vaccine dose), FATIGUE (Felt tired) and VACCINATION SITE PRURITUS (Itchy at injection site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced FATIGUE (Felt tired) and VACCINATION SITE PRURITUS (Itchy at injection site). On 24-Mar-2021, the patient experienced MIGRAINE (Had 2 severe migraines since the Moderna vaccine dose). On 25-Mar-2021, MIGRAINE (Had 2 severe migraines since the Moderna vaccine dose) had resolved. At the time of the report, FATIGUE (Felt tired) and VACCINATION SITE PRURITUS (Itchy at injection site) 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.   patient received treatment with Tylenol twice and Maxalt twice for her migraine.   This case was linked to MOD21-063235 (E2B Linked Report).; Sender's Comments:  MOD21-063235:
This spontaneous report was received from a nurse via Pfizer concerning a 66 years old female patient with osteoporosis since 2010. The patient's medical history was not reported. On 20-SEP-2016, the patient was vaccinated in her left deltoid with a dose of an unspecified flu vaccine, other concomitant therapies included SYNTHROID, ZOCOR and PRILOSEC. On 13-OCT-2016 (also reported as 23-OCT-2016), the patient was vaccinated in her right deltoid with a dose of PNEUMOVAX 23 injection, 0.5 ml, intramuscular route (lot number reported as: M02286 (which is an invalid lot number for PNEUMOVAX 23); expiration date 09-OCT-2017). No additional vaccines were administered on this date. On 13-OCT-2016 (reported as a few hours after receiving PENUMOVAX 23), the patient experienced extreme pain in her right arm with no redness, warmth or signs of infection where the vaccine was administered. On 14-OCT-2016, the patient returned to the doctor's office and received a shot of TORADOL for immediate relief as well as 10 mg of prednisone (manufacturer unknown). There were no relevant tests performed to the patient. The patient was told to call the office if the pain did not go away and she had not called so they assume the pain had resolved. However, the patient's status at the time of the report was unknown. The causality between the event and the PNEUMOVAX 23 was not reported. Additional information has been requested.
4 hours post FLUMIST administration, patient developed red, raised urticaria on (L) inner leg. Seen in office 9/7 AM - few small wheals noted on (L) leg. BENADRYL given x2 given. Denied respiratory distress, headache & fever.
Pt C/C of localized redness to L arm. Shot auba w/o extension of redness (2"), PT denied SOB or any other maladies. Gave Pt 25mg BENADRYL SC w/relieve
Suspected vaccination failure; Had a reaction / Internal shingles; Had a reaction / Nerve damage / Nerve injury; This case was reported by a consumer via other manufacturer and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included dupilumab (Dupixent) for product used for unknown indication.   On an unknown date, the patient received Shingrix and Dupixent 300 mg at an unknown frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and nerve damage. The action taken with Dupixent was unknown. On an unknown date, the outcome of the vaccination failure, shingles and nerve damage were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and nerve damage to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient received the dose of Shingrix and dupilumab (Dupixent) and patient experienced nerve damage and internal shingles. No lab data was provided. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Inconsolability, abdominal pain: bloody stools started 02/19/2014, admitted to hospital 02/27/2014 found to have small bowel/small bowel intussusception, twice visualized on ultrasound, self resolved. No lead points or polyps in bowel identified to cause this by diagnostic barium enema. Discharged from hospital in good condition 3/1/2014.
booster; blood clots in her whole body; clots from her toes to her lungs; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; THROMBOSIS (medically significant), outcome "unknown", described as "blood clots in her whole body"; PULMONARY THROMBOSIS (medically significant), outcome "unknown", described as "clots from her toes to her lungs". The events "blood clots in her whole body" and "clots from her toes to her lungs" were evaluated at the physician office visit. The clinical course was reported as follows: The caller was calling on behalf of her friend (patient) who took the first and second dose and the booster shot as well, and ended up with blood clots through her whole body. Caller said she is wondering, because it was not only her friend, she is wondering why some people get blood clots and die from getting the vaccine, she was talking about a lot of people, she looked it up. She said there is an expiration on the LOT she got this shot, and she wanted to know how is there going to be expiration on what she got. She said her friend got two shots, and then got the booster, and there are people getting blood clots that are dying or in the hospital, and she wanted to know why some who get the vaccine get blood clots and then some who get the booster have blood clots in their whole body. She said she didn't know why they are still administrating these vaccines, why people who are susceptible to getting blood clots, why should they have been getting these vaccines? She said her girl friend had clots from her toes to her lungs, and her doctor said it was from the vaccine. She said Pfizer shouldn't be allowing the vaccines to be given.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from an 81 year old female with diabetes and a history of nervous breakdown, and no drug reactions who on 22-JAN-2009 was vaccinated with one dose of ZOSTER vaccine live (Oka/Merck) in her arm.  Concomitant therapy included 12 unspecified medications.  The patient has had shingles many times over the past 10 years.  On 28-JAN-2009 she broke out with a recurrence of shingles on her back.  No lab diagnostics study was performed.  The patient's pharmacist told her it would take 3 weeks for ZOSTER vaccine live (Oka/Merck) to start protecting her from shingles.  At the time of reporting, the patient's recurrence of shingles persisted.  No further information is available.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain condition of herpes zoster. During 2016, the patient was treated at physician office for a blistering vesicular outbreak and 'decreased" (unspecified) which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Redness and swelling from deltoid down to elbow, progressed to more painful event on the evening of 09/16/20. Took 200mg Ibuprofen, the pain has now gone down and feeling better progressively thus far.
Mild localized reaction with induration 48 hrs after vaccines were given in reaction to ProQuad and Kinrix vaccinations.
Around 18 hours after getting vaccinated. Rashes start to grow. I first discover it at my injected arm and then it spread to my back, another arm. Then, it starts turning red and itching. The rashes slow its growing at around 25 hours after getting the vaccine
Severe chills (2am 20 Apr thru 5am 20 Apr), fever to 103 (3am 20 Apr thru 3pm 20 Apr), mild fever (intermittent, 9pm 20 Apr to present), severe fatigue, diarrhea, dizziness, periodic nausea (all thru current)
Patient was given Moderna Vaccine on 10/4/2021. The self life of the vaccine expired on 10/3/21. The vaccine was expiration date is 10/10/2021.
Red itchy bumps all over my body; starting on lower extremities, and moving to arms and neck.  Large (over quarter size) very swollen lump under skin appeared on right shin- it is firm to touch.   Other details: I did not consume any foods out of my ordinary diet. I did have 1 gin and tonic the night before (first alcohol since getting the vaccine)  I have not been bitten by any bugs to my knowledge, and have not spent any significant time outside.   Benadryl cream on bumps soothsayer for a short time, but itchiness remains. The more I scratch the more they appear.
I had mild temperature; Fatigue; Body ache; Rashes throughout my body; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 09Apr2021 at 12:45 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The patient had known allergies to Ibuprofen (MANUFACTURER UNKNOWN). Concomitant medications included escitalopram oxalate (LEXAPRO) for unknown indication, on unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 11Apr2021, the patient experienced mild temperature, fatigue, body ache for about 36 hours after getting the dose, which was expected and rashes throughout body. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the adverse event. The clinical outcome of the event's mild temperature, fatigue, body ache and rashes throughout body was recovering at the time of this report.      No follow up attempts are needed; information about lot/batch number cannot be obtained.
Pt admitted on 12/19 for septic shock with possible sources being UTI or pneumonia. Pt was COVID and influenza negative on admission. Pt was tested for COVID on 12/31 at discharge due to requiring SNF placement and was found to be COVID positive.
This spontaneous report as received from a physician on an unknown age refers to herself. The patient did not have any pertinent medical history, drug reactions or allergies and did not take any concomitant medication. The physician reported that on 11-NOV-2016, the solution of (Oka/Merck) VARIVAX (lot # and expiry date were not reported) squirted into her eye due to the vial having some pressure irregularity and it has caused her some irritation around her on the same day. There was no treatment given for the event. She did not have any laboratory test performed and did not seek any medical attention. Product quality complaint was reported. The outcome of the event of some irritation around the eye was reported as not recovered. The reporter considered irritation around eye to be related to (Oka/Merck) VARIVAX. Additional information is not expected because there was no consent to contact physician.