chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Numbness on left side(whole left side/in arm and extended into lips; Tingling on left side(whole left side/in arm and extended into lips; Dull pain in chest; Hand ache; wrist ache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness on left side(whole left side/in arm and extended into lips), PARAESTHESIA (Tingling on left side(whole left side/in arm and extended into lips), CHEST PAIN (Dull pain in chest), PAIN IN EXTREMITY (Hand ache) and ARTHRALGIA (wrist ache) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 031LZ0A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness on left side(whole left side/in arm and extended into lips), PARAESTHESIA (Tingling on left side(whole left side/in arm and extended into lips), CHEST PAIN (Dull pain in chest), PAIN IN EXTREMITY (Hand ache) and ARTHRALGIA (wrist ache). At the time of the report, HYPOAESTHESIA (Numbness on left side(whole left side/in arm and extended into lips), PARAESTHESIA (Tingling on left side(whole left side/in arm and extended into lips), CHEST PAIN (Dull pain in chest), PAIN IN EXTREMITY (Hand ache) and ARTHRALGIA (wrist ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: normal (normal) Normal.         Concomitant medication was not provided.  Treatment information was not provided.
spontaneous urticaria all over body, angioedema of the face, eyelids, lips. dermatographia. symptoms began 10 days after Moderna booster (1/11/22).   Began PO prednisone 60mg x 7 days, 40mg x 7 days, 20 mg x 7 days. currently tapering.
Information has been received from a physician concerning a 17 year old female who on 19-JUN-2007 was vaccinated with the first dose of Gardasil (Lot # 655618/0186U) and immediately fainted. It was reported that the patient "came back on her own" 15 seconds later. Concomitant therapy included hepatitis A virus vaccine (unspecified). The patient sought unspecified medical attention. It was also reported that the patient was menstruating at the time. Additional information has been requested.
Pt received Pfizer x2.  Pt tested COVID + on 10/3/21 and admitted to hospital for COVID on 10/5/2021. Pt receiving remdesivir and dexamethasone.
Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 18-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 28 years 10 months.  No concomitant medication information was provided. On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process. Patient got Moderna with vaccine Ndc code 80777-0273-99. Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines. No treatment medication were provided.
On 5/4/99, the pt experienced a generalized pruritic, maculopapular rash involving the face, neck, trunk, and forearms. A visit to a physician was required. The symptoms resolved on 5/18/99 after the use of antihistamines.
This spontaneous report was received from a registered nurse and refers to a 13 month old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 18-JAN-2017. On 06-MAR-2017, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # M038860 with expiration date of 13-MAR-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 49 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA013888.
Woke up with fever that lasted 36 hours, body chills, body aches that lasted 48 hours. Nausea and vomiting happened 72 hours after injection. Have had migraines starting 72 hours after injection. Left arm was and still is red/hot to the touch and feels like a knot. The day after I couldn't lay on my left arm and it stung/throbbed with pain. Has gotten a little better but it is still very sore and hot to the touch.
One hour after 2nd dose of COVID, patient's left eyelid became swollen and reddened. Went to provider and eye doctor over next 8 days. States having some blurry and double vision a few days after vaccine.
She got her vaccine, had no signs or symptoms of anything until 2 weeks after the vaccine.  At that time she developed a right hemisphere headache, rated on a scale of 1/10, it was about a 4 all the time.  It lasted for 5 weeks with her treating it with Excedrin and Tylenol and there 24 hours a day.  After that she went to a Dr, referred to her who diagnosed her with giant cell temporal arteritis immediately who admitted her to the hospital during COVID.  She started her on Dexamethasone 60 mg immediately.  They did a brain scan.  They did not do a temporal biopsy because she had been on steroids so long it would not make any difference.  After the steroids were started for 3 days she has not had another headache.  She then sent her to a rheumatologist who could not find anything.  When she first went to the hospital her SED rate was 70, and her C-reactive was 200.  They also did a chest x-ray at which time they showed an aortic arch aneurysm, which also goes along with temporal arteritis.  She has never been diagnosed for that before, and has been tested before, routine x-rays and has had routine cardiology check ups and never been diagnosed with anything like that before.    She is still under her treatment and she has her on a steroid taper.  She is down to 5 mg of Prednisone a day, she was on 60 for 3 months, and then she brought her down to 40 for 2 months every day.  She has now developed diabetes, hypertension like 200/110.  She is in the ER every time she turns around and keeps monitoring her BP.  She has arrhythmias, and is taking the Prednisone as her doctor told her she would go blind and/or have a stroke.       From what she has read from doctors that there has been very few reported cases of GCA and COVID, she wanted to let us know this information.
became lightheaded; inject site @ rt arm itchy, swollen, hot to touch, red; seen @ ER: tx Atarax
Left flank and back pain thats increasing in severity. It is now interfering with acts of daily living such as driving, bending down etc
Shingles outbreak on right thigh and knee exactly 2 weeks after Covid shot.  Sought medical attention on July 7th, 2021.  Taking valacyclovir (VALTREX) 3 times daily for 7 days starting on July 7th, 2021.
Information has been receivd from a registered nurse concerning a patient of unknown age and gender. On 16-MAR-2007 the patient was vaccinated with a first dose of unspecified Hepatitis B vaccine (manufacturer unknown) (dose, lot #, expiration date and route not reported). On 30-APR-2007 the patient was vaccinated with a second dose of COMVAX (lot # and expiration date not reported) 0.5 ml, intramuscular. On 31-JUL-2007 the patient received third dose of COMVAX (lot # and expiration date not reported) 0.5 ml, intramuscular. The patient received doses of Hepatitis B on a shorter than recommended schedule. No adverse effect was reported. It was unknown if the patient sought medical attention. Additional information has been requested.
This spontaneous report was received from a Licensed Practical Nurse referring to a 1 year old patient of unknown gender. The patient's concurrent conditions and medical history were not provided. On 22-FEB-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) lot # L032757, expiration date: 24-FEB-2017 (route, dose and anatomical location were not reported), which was improperly stored. Concomitant therapies were not provided. No adverse events were reported. No product quality issue was involved. Additional information has been requested.
chills, nausea, swelling and redness at injection sight, itching, pain and tenderness in arm. MODERNA COVID-19  VACCINE
After flu shot was administered, patient waited with me for 10 minutes in treatment said he felt warm but otherwise ok. He got up and went back to work. Patient had never previously received flu shot. I walked with him down the hall and he said he was having trouble breathing. We went back to the treatment room. He said his throat started to "feel funny". Per protocol, I administered .5ml of epinephrine IM into his left leg. Also called the house supervisor who came down with our CNO and the hospital Nurse Practitioner. 25mg of po Benadryl given after patient stated he was having an easier time breathing. VSS. patient waited with me (vaccine administrator) until his wife came to pick him up an hour later.
After my first Covid vaccine I experienced mild light sensitivity for a couple of days.  A few days after the second, I experienced extreme light sensitivity in my right eye.  The opthamologist  diagnosed uveitis and I was treated with steroid and dilation drops for 3 weeks.  Everything resolved and I have had no further problems. The doctor said this was more usual following an infection, but as I had not been ill, it seemed likely to be a sequela of the covid vaccination.
This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient's husband (age unknown) was vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. On an unknown date, reported as 48 hours later (after her husband's vaccination), the patient developed shingles. There was no product quality complaint involved. The outcome of the event was not reported. The relatedness between ZOSTAVAX and the event was not provided. Additional information has been requested.
Janssen 3/26/21 Patient presented to the ED from skilled nursing facility for altered mental status, electrolyte imbalance and hypothermia with a temp of 91.  White cell count is 7.65, hemoglobin is 7.8, platelet count is 457,000, MCV is 80.1.  Sodium is 141, potassium is 3.0, creatinine is 0.88.  Troponin is 37.  ProBNP is 1110.  Liver function panel is normal.  Lactic acid is 1.3.  SARS COVID-2 virus is detected.  Chest x-ray showed interstitial pulmonary edema.  Electrocardiogram showed sinus rhythm at a rate of 67 beats per minute.  Left bundle-branch block, otherwise negative.  Admit for septic shock.  Patient's status continued to decline and her family opted for hospice treatment.  She was discharged to hospice on 2/1/2022.
Pt recv vax on 7/30/98; on 8/1 pt exp fibromyalgia, fatigue, sweet/metallic taste in mouth,rash&burning rt side face,stomach cramps,pain in shoulderblades,skin irritated, cough, breathing problems, chills/sweats,burning sinus&eyes cont....
BLOOD CLOT; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, frequency one total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced blood clot after receiving vaccine and died from blood clot on an unspecified date. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211009196-COVID-19 VACCINE AD26.COV2.S-Blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BLOOD CLOT
Immunocompromised patient, fully vaccinated with Moderna (2 doses) with breakthrough COVID infection. Patient states she initially tested positive for COVID on 11/16/21. We do not have record of this positive, but presented to our facility on 11/27/21 with worsening symptoms and had a positive lab on 11/27/21.
It started with random itching, my scalp, my back, my neck so I wasn't sure if my skin was dry and it was patches all over my body. this past weekend at night I had a tremendous itching all over my body. Ever since then I notice that if I don't take Benadryl or Zyrtec I start itching right away, It doe gets worse at the evening and at night it keeps me up. There is nothing that I can do to get rid of it. within the next couple of days I notice that I have a deep scratch and I have lines, I've never been sensitive with my skin. I have an appointment on 03/09/2022 with Dr. which he is an allergist. I have met someone that has experience the same exact symptom after our booster, the pictures are identical.
I have been feeling dizzy since the second day after receiving the vaccine.; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 21Mar2021 at 12:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history were reported as sleep apnea, acid reflux and high cholesterol. Concomitant medication was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID vaccine. On 23Mar2021 at 18:00, it was reported as the patient felt dizzy since the second day after the vaccine was received. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The treatment received for the adverse event was reported as no. The clinical outcome of the event dizzy was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
temp 102, body aches, headace. Temp started at 8:00PM broke at 12:00PM very weak the next day, but getting better
stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Jul2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 2021, outcome "unknown", described as "stroke". The patient reported that he received the pfizer second shot for COVID in Jul2021 and was scheduled for a booster shot on 14Jan2022 but he had a stroke just before holiday and he was wondering if it was safe to get booster shot.    The lot number for bnt162b2 was not provided and will be requested during follow up.
1/27 vaccination 1/28 woke up with fever 102.4, nausea, vomiting, body aches and chills.  Covid; positive  Fever lasted thru the 1st of Feb with body aches and chills.  Presently still having body aches, HA. No fever
Consumer tested positive for Covid-19 after getting the first vaccine dose; >42 days of not administered the second vaccine dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Consumer tested positive for Covid-19 after getting the first vaccine dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>42 days of not administered the second vaccine dose.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Consumer tested positive for Covid-19 after getting the first vaccine dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>42 days of not administered the second vaccine dose.). At the time of the report, SARS-COV-2 TEST POSITIVE (Consumer tested positive for Covid-19 after getting the first vaccine dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>42 days of not administered the second vaccine dose.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     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 reported. Pharmacist reported that consumer tested positive after first dose of vaccine and also took antibody treatment. Treatment information include the antibody treatment.
covid vaccine breakthrough case  all Pfizer dose 1 2/18/21  EL9267 dose 2 3/12/21  EN6199 dose 3 10/14/21 FF2590
Clinic manager  has reported the incidence to Director of Pharmacy and Clinics. The infectious disease specialist of  Hospital has been consulted immediately with reference to CDC guidelines on COVID vaccination errors. According to CDC guideline, "if age 16-17 years and moderna vaccine was inadvertently administered as the first dose, may administer Moderna vaccine as the second dose (as off-label use, because Moderna vaccine is not authorized in this age group)". Staff tried to contact patient regarding incidence, however the phone number provided by patient has been discontinued. staff contacted patient insurance company trying to get patient contact information. However the insurance company does not have phone number in profile for the patient nor her guardians. we set reminder in patient profile to notify patient about the incidence when she return for her second dose on 5/13/2021.
After about 10 minutes, sensations of numbness in face and sinuses and throat and soft-pallet of the mouth.
This case was considered medically important. Additional information has been received regarding Prevnar lot number and physician comments. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 2-year old male patient who experienced a febrile convulsion. The patient received the fifth dose on 11-Aug-2005. The patient has a past history of ear infection. The patient received 4 doses of Prevnar vaccine in the past. Indication for Prevnar was immunization. Product was administered on 11-Aug-2005. Dose regimen was 1 dose 1 time per day (intramuscular). concomitant medications were not reported. The patient experienced a febrile convulsion (febrile convulsion) on 01-Jan-2005. The reporter commented that the patient was symptomatic in the emergency room. the outcome was not specified. See related case(s): HQWYE550225JAN07 (non-expedited and HQWYE024230JAN07 (expedited). No additional information was available at the time of this report. OMIC
This spontaneous report was received from a physician concerning an approximately 60 year old female patient with allergies (unspecified), latex allergy, LIDODERM patch allergy, sulfa allergy, VERAMYST allergy, BEXTRA allergy, CELEBREX allergy, Nickel allergy and Formaldehyde allergy. On 19-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as H022153 and 18-MAR-2014 respectively, dose unspecified) subcutaneously. Concomitant therapies included metoprolol, lisinopril, alprazolam, sumatriptan, hydromorphone, BACLOFEN and acetaminophen, VICODIN. On 22-MAR-2013, the patient experienced welt at the injection site. On an unknown date in 2013 (reported as at some point after 22-MAR-2013), the patient experienced rash on her face and scalp. The patient sought medical attention (called and spoken with the physician.). No treatment was given. No lab tests were performed. The patient had not recovered from all the events at the time of reporting. The relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested.
Soreness in arm within a few hours lasting a couple of days, lightheadedness and dizziness the next morning after getting shot the previous afternoon lasting until the early evening (roughly 8-9 hours), nausea the next morning lasting 12 hours, back pain starting overnight and lasting 36 hours
Swelled lymph nodes in left neck and left axilla. Treatment-PCP notified. naproxen for discomfort and warm compresses applied to sites. Nodes still swelled, not as painful on 2/5/2021
Information has been received from a nurse practitioner concerning a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided. On 25-AUG-2017, the patient was vaccinated with ZOSTAVAX 19400 PFU (lot # M026878, expiration date: 27-JUL-2017) (strength, dose, frequency and route were not reported) with sterile diluent for prophylaxis (expired vaccine used). No adverse effect was reported.
Swollen, red, warm to touch, pain, tightness. Symptoms: Myalgia, rash and injection site reaction.
Pt had no adverse event after the vaccine was given.  He sat at the clinic for 20  minutes after vaccination with no adverse events observed.  He walked away from clinic showing no signs of any adverse reaction.