chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Autoimmune disease date of onset after the second vaccine and became extremely severe following booster shot in October 2021.
developing itching on arm, belly, ear following moderna #2.  given 50mg diphenhydramine with improvement, vitals with normal HR/RR, unable to obtain pulse ox.  patient monitored additional 15 minutes and sent home
she complained of not being able to feel her right arm and her feet were numb, she claimed that the vaccine acerbated her  Raynaud's Symptoms along with anxiety
Peripheral neuropathy of both lower extremities initially presenting as pain but then followed later by numbness and paresthesia's. The pain started a week after first shot and got worse after the second shot. Also later developed a left lower extremity deep venous thrombosis. Patient is now on chronic Eliquis and Gabapentin.
This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a adult patient who received SHINGRIX. On an unknown date, the patient received SHIGNRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site rash, injection site erythema, erythromacular rash, fever and chills. On an unknown date, the outcome of the injection site rash, injection site erythema, erythromacular rash, fever and chills were unknown. It was unknown if the reporter considered the injection site rash, injection site erythema, erythromacular rash, fever and chills to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a receptionist. The age at vaccination was not reported. The health care professional reported that the patient experienced a red rash at the injection site, described as red spots. The health care professional declined to provide any additional information. This is 1 of the 4 cases reported by the same reporter.
Developed redness of the face and forearms.  No swelling.  Symptoms resolved after 30 minutes.
Increasing inject site redness, swelling, warmth. Entire left tricep / bicep area involved. Erythema spreading over last 24 hrs. Had entire series in past without prob's. This was booster dose. Treated by MD for cellulitis > 12 cm. Area induration (21 x 28 cm)
Pt was given DTaP and should have had Tdap - no adverse events, vaccine admin error only.
A non-serious, spontaneous report of red skin all over, fever, fatigue and runny nose was received from a sales representative concerning a two year old female patient, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing committment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 03-Oct-2008. On 04-Oct-2008 the child had symptoms of a fever of 104.7 F, fatigue, red skin all over and was seen by a local health provider. On 06-Oct-2008 the child was evaluated again and the fever had declined to 100.7 F, red skin had resolved and the only other symptom was a runny nose. No further information was provided.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with VARIVAX (Merck) (lot # reported as H006530, exp date 09-MAR-2014) on an unknown date. On an unknown date the patient experienced swelling of the tongue and dizziness. The patient sought for medical attention via unspecified contact. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Patient came into pharmacy and complained of his arm/injection site still being sore after the second dose. Arm is sore in the muscle and is a dull, achy pain. Patient showed me where it was sore and it was in the ideal spot for IM injection. Patient reports self massage and using ice. Pain is not severe but is bothersome. He was planning on getting with the doctor regarding this but had not had a visit yet.
This spontaneous report was received from a nurse and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot# M004116 with expiration date: 12-OCT-2017, lot# M013636 with expiration date: 15-FEB-2018 (dose and route of administration were not reported). The temperature excursion ranged between 32 and 36 degrees Fahrenheit and lasted 72 hours. There was no previous temperature excursion. Digital data logger was not used. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA005129: US-009507513-1703USA000842: US-009507513-1703USA005126: US-009507513-1703USA005127:
I listed my 2nd COVID vaccine(2//4/21). Both were given at D & H Drugstore. (1/7/21, then 2/4/21).  Itchy hives began around 3/29. Minor..not extensive, but would come and go. Then became constantly present. Seen by dermatologist. April 7, with my son who was having more extensive s/s following his 1st dose of moderna (will document separately). Started cetirizine bid, then by April 16, increased to cetirizine q 6 hours b/c of continued flares with no improvement. Hives became much worse April 24-all over the body, started prednisone taper April 28: 60mg x 3 days, 50 mg x 4 days, 40 mg x 3 d, 30 mg x 3 d, 20 mg x 3 d, 10 mg x 3 d. The first 3 days of prednisone taper, hives were the worst they've been, so uncomfortable, considered ER visit, but did not go to ED. No lip swelling or anaphylaxis of any kind.  Now, Day 12 of taper, they are much improved. Still on cetirizine q 6 hrs. S/s most present in the morning on awaking now, but minor compared to 1 week ago.  Follow up with Dermatology on 5/17/21.
Child received Tdap/Varicella in Left deltoid area on 1-25-07; redness, pain, rash developed over next 2 days; evaluated in our office 2 times; reaction to vaccines, resolved over next few days.
Information has been received from a registered nurse concerning a 20 week old black male patient with one, 3 year old sibling that had been adequately immunized with Haemophilus B conjugate vaccine and did not require any prophylaxis medication. On 9/11/02 the patient was vaccinated with a first dose of Haemophilus B conjugate vaccine (lot number 643453/0645M). The patient was suppose to receive the second dose on or about November 11th, however, he became ill between 11/11/02 to 11/22/02 and was hospitalized on 11/27/02 for haemophilus influenza meningitis. On 11/27/02, a cerebral fluid culture was positive for haemophilus influenza. It was reported that the patient was currently hospitalized with haemophilus influenza and had survived. The nurse was contacted through a telephone conference and is not directly caring for the patient but he reported that to his knowledge the patient had recovered and was discharged from the hospital. The nurse will notify us if he discovers any other follow up information. No further information has been requested.
Localized inflammatory response of the arm vaccine administered in (left arm). Left upper arm swollen, erythematous, painful and hot to the touch. Reaction began 1-2 hours after vaccine given. Treatment = warm/cold packs.
Vasovagal syncope response shortly after waking in the morning, only passed out for less than 30 seconds, required suturing for chin laceration
Patient had soreness and redness the first few days. Then by Friday, she has SOB, chest pain, extreme tiredness. Still doesn't have energy.
headachy; arm soreness; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) from a Pfizer-sponsored program.   A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration (at the age of 69-years), administered in arm on 23Feb2021 09:00 as dose 1, single for COVID-19 immunization and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP7534), via an unspecified route of administration (at the age of 69-years), administered in arm on 19Mar2021 09:15  as dose 2, single for COVID-19 immunization. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date , the patient experienced headachy and arm soreness. Not sure why I received this but only side effect was headachy and arm soreness. The treatment was not received for the event. Caller concerned and was calling and indicating that she got her 1st dose of the vaccine last 23Feb2021, and scheduled on 19Mar2021, for the second dose (more than 21 days). She wanted to know as well since she got dental surgery and took antibiotics in between of 1st dose and 2nd dose she wants to know if that will make the 2nd dose less effective. The clinical outcome of the events was reported as recovered on an unspecified date in 2021.  Follow-up (30Jun2021): Follow-up attempts completed. No further information expected.  Follow-up(12Jul2021): The initial case was missing the following minimum criteria: [No adverse effect]. Upon receipt of follow-up information on 12Jul2021 this case now contains all required information to be considered valid included first and second dose date of vaccination, events, treatment with outcome.   Information on the lot/batch number has been requested.
An unprovoked, generalized tonic-clonic (convulsions, stiffness in neck and body, eyes rolling back in the head, unresponsive, interrupted and inefficient breathing) seizure lasting less than 2 minutes occurred around 9:00 PM CT.  A postictal period of unconsciousness for approximately 20 minutes, then an irritable state of confusion for approximately an hour followed.  Pt was taken to a local Clinic where an EEG and EKG were performed and showed no significant findings. A follow-up visit was scheduled and pt. was released. Pt has continued to have multiple unprovoked seizures and is now on medication to control them. A sedated MRI was also performed in October of 2022 with no significant findings.
COVID Breakthrough Case with fever, body aches, chills, the back of my tongue and throat were white. This lasted for five days. On dec27, I was diagnosed with COVID.
diaphoretic, thready pulse, hypotensive & passed out w/in 60 sec of vax;
severe nausea that began one hour post-shot and gradually worsened over next 18 hours. Painful stomach cramps developed two hours post-shot. Gave myself pepto-bismol to alleviate discomfort but it did not help. Diarrhea began at 4 hours post-shot. Vomiting began at 6 hour post-shot. Vomited multiple times. Suffered severe stomach cramps throughout the night and into the next morning. Vomiting subsided after approximately 2:00am
Approximately 30 large and small red, itchy spots located over entire body except groin area no difficulty breathing, no temp, and no irritability noted per parent. Child found this way at 08:30 a.m. on 07/14/2006. Skilled nurse Instructed parent to seek medical attention thru family physician or the emergency room.
Itchy red rash under both arms, April3-5. Itchy red rash on throat, April 6 tocurrent.; Itchy red rash under both arms, April3-5. Itchy red rash on throat, April 6 tocurrent.; slight headache; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730), via an unspecified route of administration in the left arm on 26Mar2021 at 15:00 (at the age of 58-year-old), as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Concomitant medications included valacyclovir 1gm (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN). 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 vaccination. On 31Mar2021 and on 01Apr2021, the patient experienced slight headache. On 03Apr2021, the patient experienced itchy red rash under both arms and itchy red rash on throat. Therapeutic measures were not taken as a result of the events. The adverse event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event slight headache, itchy red rash under both arms and itchy red rash on throat was not recovered.   No follow-up attempts are needed. No further information is expected.
On 1/25 (day after vaccination in left thigh) patient developed an area of redness in the location of the vaccination. Patient was seen in clinic on 1/28 for evaluation of rash. Area of redness 5x5 cm, somewhat firm to touch. No fevers at that time, otherwise well-appearing. Diagnosed with a localized exaggerated reaction to vaccine and advised to return if fever develops or if rash continues to worsen.
2nd Moderna Shot Kicked my ass with cold chills and soreness all over; 2nd Moderna Shot Kicked my ass with cold chills and soreness all over; 2nd Moderna Shot Kicked my ass with cold chills and soreness all over; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (2nd Moderna Shot Kicked my ass with cold chills and soreness all over), FEELING COLD (2nd Moderna Shot Kicked my ass with cold chills and soreness all over) and CHILLS (2nd Moderna Shot Kicked my ass with cold chills and soreness all over) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (2nd Moderna Shot Kicked my ass with cold chills and soreness all over), FEELING COLD (2nd Moderna Shot Kicked my ass with cold chills and soreness all over) and CHILLS (2nd Moderna Shot Kicked my ass with cold chills and soreness all over). At the time of the report, PAIN (2nd Moderna Shot Kicked my ass with cold chills and soreness all over), FEELING COLD (2nd Moderna Shot Kicked my ass with cold chills and soreness all over) and CHILLS (2nd Moderna Shot Kicked my ass with cold chills and soreness all over) outcome was unknown.            Only minor tiredness from the Pfizer booster.  No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous report was received from nurse practitioner referring to patients of unknown age and gender. No pertinent medical history and concurrent conditions reported. On an unknown date the patients received improperly stored VAQTA, exposed to 8.4 degree for 20 minutes, intramuscular (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The case has been linked with the cases 1407USA012136, 1407USA014425, 1407USA014427, 1407USA014428, 1407USA014429, 1407USA014430, 1408USA000005, 1408USA000006, 1408USA000009, 1408USA000012, 1408USA000013, 1408USA000015, 1408USA000838, 1408USA000843, 1408USA000848 and 1408USA000853. Additional information has been requested.
Information has been received from a woman in a physician's office concerning a 25 year old male pt with no known allergies and no past medical history who on 04/27/2001 was vaccinated SC in the arm with a dose of varicella vaccine. Concomitant therapy included Zyban. It was reported that there were no illnesses at the time of vaccination. On 05/17/2001, 21 days post vaccination, the pt experienced a rash with various size vesicles 96-7cm) that were slightly raised and located on the pt's neck and chest. It was reported that no fever occurred. it was noted thatt he lesions did scab over. Unspecified medical attention was sought. On 06/29/2001 the pt received a second dose SC in the arm of varicella vaccine. Additional info has been requested.
Redness, swelling and numbness in left deltoid after getting Anthrax #3 on 10 Jul 2012, immunization clinic.
Vial was initially stored in refrigerator on 25-Oct-2022 and was administered on 01-Dec-2022; No adverse event; dose administered after the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after the 30-day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 25-Oct-2022 and was administered on 01-Dec-2022) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after the 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 25-Oct-2022 and was administered on 01-Dec-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after the 30-day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 25-Oct-2022 and was administered on 01-Dec-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (dose administered after the 30-day use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 25-Oct-2022 and was administered on 01-Dec-2022).    Concomitant drugs were not reported. The injection site for patient was reported as deltoid. It was reported that the bivalent individual vial in carton of size 2.5ml did not underwent any temperature excursion. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-681955, US-MODERNATX, INC.-MOD-2022-681957, US-MODERNATX, INC.-MOD-2022-681955 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681955:same reporter US-MODERNATX, INC.-MOD-2022-681957:same reporter US-MODERNATX, INC.-MOD-2022-681955:
Within an hour, intense burning/itching across my whole body (from toes to fingers) except my face.  Like my skin was on fire.  The burning took 2.5 days to subside - after taking  much Benadryl.  I then slept for the 2.5 days. Caffeine (tea, chocolate) then set off a  burning/itching feeling over the following 28 days after the vaccine but nothing to the extent of the reaction to the vaccination.  In all fairness, I had shingles in 1991 and caffeine has since then produced an itchy feeling/burning to nerve endings.  However, the vaccination reaction was very intense - not just itching but truly the sense of burning/nerves on fire.
Systemic: Allergic: Rash Generalized-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Additional Details: flu-like symptoms within mins of getting 2nd vaccine
sore arm at Vaccination site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 15:45 (Lot number: Ew0158) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sulfa medication" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "sore arm at Vaccination site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any list of other medications within 2 weeks of vaccination. Event onset was about six hours after vaccination as she went to bed and lasted approximately 48 hours. Facility where the most recent COVID-19 vaccine administered is reported as available. Patient did not have covid prior vaccination and no covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Patient received first dose of COVID-19 vaccine on 5/3/21 at 0733, patient was in observation area when she reported to RN that she feels her throat getting itchy and dry. Per RN, patient kept clearing throat and had edema and redness of the eyes. RN called RRT and administered 0.3 mg of Epi-Pen at 0749 in the meantime.
gave double does of VAR. Called mother informed of error. she did not say if child had any side affects as she did not let me finish explaining side effects
Initial unsolicited report received from a consumer on 15 Sep 2016. This case involves a 53-year-old female patient who was vaccinated with FLU VACCINE (manufacturer: unknown, batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were reported as unknown by reporter. On an unknown date, following the vaccination, the patient had allergic reaction. The patient's laboratory data and corrective treatment was not reported. The outcome of event was unknown. List of documents held by sender: none.
Multiple lesions (in crops) under arms, on hips, on back, behind ears, on chest et extremities in various stages, some papules some vesicles some have an umbilicated appearance 1 in hair with crusting.