chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CN#3 palsy; left eye ptosis; double vision; This spontaneous case was reported by a physician and describes the occurrence of IIIRD NERVE PARALYSIS (CN#3 palsy) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced IIIRD NERVE PARALYSIS (CN#3 palsy) (seriousness criteria disability and medically significant), EYELID PTOSIS (left eye ptosis) and DIPLOPIA (double vision). At the time of the report, IIIRD NERVE PARALYSIS (CN#3 palsy), EYELID PTOSIS (left eye ptosis) and DIPLOPIA (double vision) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The reporter is the brother of the patient and reported that there were no adverse events after the first dose of the vaccine. On an unspecified date, an ophthalmologist was consulted who confirmed the diagnosis of cranial nerve 3 palsy.  Treatment information was not provided.  Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Administered Janssen COVID-19 vaccine to a 17 year old but the minimum age is 18 years old.
Left arm pain  and decreased ROM onset same day as vaccination 12/28 and improved over the next few days. 12/30 patient with improved symptoms and 1/4 patient reported all symptoms resolved. 01/06, patient reports reccurance left arm pain, advised to come to company care for evaluation. Treatments and outcomes ongoing at this time.
mouth ulcers - painful mucosal ulcers  diffusely the margin near lips (b/l upper mouth and R lower mouth), does not include the lips, vermillion border, or skin beyond the lips. additional lesion on tongue. No ulcer in the throat.
A report was received from a health care professional on 12/5/03 concerning a 32 year old female vaccinee who inadvertently received Fluvirin ID instead of a TB skin test and experienced minor redness at the injection site on the same day. The vaccinee had already received influenza vaccine on approximately 11/25/03. On 12/5/03, the vaccinee inadvertently received Fluvirin ID instead of a TB skin test and experienced minor redness at the injection site on the same day. The health care professional mixed up the Fluvirin and TB PPD vials accidentally. The vaccinee had already received influenza vaccine on approximately 11/25/03. There was insufficient information to determine the reporter's causality assessment. Update 2/10/04: A follow up report was received from a health care professional indicating that the vaccinee had experienced non adverse events at the time of reporting. No follow up pending, all information received.
Varivax administered post temperature excursion; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapy was not provided.  On 20-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml once, lot# S032355, expiration date 14-OCT-2021 (route of administration was not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT). The vaccine underwent a temperature excursion from 9 Celsius degrees to 8 Celsius degrees (-2.8 Celsius degrees) for 5 hours and 2 minutes. No previous temperature excursion was reported. Digital data logger was used.
Patient called after 1 month of receiving her flu vaccine and still has soreness and tenderness upon putting pressure on L arm and also raising L arm to shoulder height; also has slight burning sensation.
Arm swollen, +induration, unable to move freely. Denies fever, skin breakdown.  Used Tylenol, Motrin with minimal relief
Not unexpectedly, I felt a little sick overnight and all day the next day; I have a rash all across my torso, front and back, similar to the rash I got after my Shingrix (shingles) shot in June; I have a rash all across my torso, front and back, similar to the rash I got after my Shingrix (shingles) shot in June; My throat and armpit are a little sore, too; My throat and armpit are a little sore, too; temp. 100 degrees; achy; tired; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Oct2021 (Lot number: FE3590) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: known allergies: Yes. Concomitant medication(s) included: INFLUENZA, start date: 30Sep2021, stop date: 30Sep2021; LEVOTHYROXINE. Vaccination history included: Bnt162b2 (dose 2, single, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 17Mar2021, for Covid-19 immunization; Bnt162b2 (dose 1, single, Batch/Lot No: EN6202, Location of injection: Arm Left), administration date: 26Feb2021, for covid-19 immunization. The following information was reported: ILLNESS (non-serious) with onset 28Oct2021, outcome "not recovered", described as "Not unexpectedly, I felt a little sick overnight and all day the next day"; PYREXIA (non-serious) with onset 27Oct2021, outcome "not recovered", described as "temp. 100 degrees"; PAIN (non-serious) with onset 27Oct2021, outcome "not recovered", described as "achy"; FATIGUE (non-serious) with onset 27Oct2021, outcome "not recovered", described as "tired"; RASH (non-serious), HERPES ZOSTER (non-serious) all with onset 28Oct2021, outcome "not recovered" and all described as "I have a rash all across my torso, front and back, similar to the rash I got after my Shingrix (shingles) shot in June"; OROPHARYNGEAL PAIN (non-serious), AXILLARY PAIN (non-serious) all with onset 28Oct2021, outcome "not recovered" and all described as "My throat and armpit are a little sore, too". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of illness, pyrexia, pain, fatigue, rash, herpes zoster, oropharyngeal pain, axillary pain.  Additional information: Not unexpectedly, I felt a little sick overnight and all day the next day: temp. 100 degrees, achy, tired. I have a rash all across my torso, front and back, similar to the rash I got after my Shingrix (shingles) shot in Jun. My throat and armpit are a little sore, too. Reporter stated that I did NOT get a rash after Pfizer on 1 (Feb) or on 2 (Mar). I only previously got it after shingles shot on 1 (Jun). I did NOT get a rash after my flu shot, either (30Sep- just 4 weeks ago). Now, after Pfizer 3, it has reappeared. No if covid prior vaccination. No if covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a female who was vaccinated with the first dose of Gardasil. One week later, the patient developed a yeast infection and she sought unspecified medical attention. Subsequently she recovered from the yeast infection. On an unspecified date, the patient was vaccinated with the second dose of Gardasil and developed a yeast infection one week later. She sought unspecified medical attention and subsequently recovered. On an unspecified date, the patient was vaccinated with the third dose of Gardasil. With the third dose, the physician gave the patient unspecified medication along with the dose and no yeast infection occurred. Additional information has been requested.
LARGE AREA OF REDNESS AND ITCHING AROUND INJECTIONS SITE.  ONE FLUID FILLED LARGE BLISTER IN THE CENTER OF THE REDNESS.
The patient received  a Fluzone HD vaccine instead of a Fluarix (under 65yr).  No adverse reaction occurred.  She received the wrong dose flu shot.
Patient came into the pharmacy asking for a vaccine, he didn't speak language. To understand, I asked about what vaccine he was wanting, he then said the vaccine card, and I asked if it was for Covid, and he said yes.  There was also a translator in the pharmacy getting a vaccine, who was fluent in multiple languages. The translator asked the patient if he wanted the first dose of his covid vaccine and they spoke in language and said yes. The translator asked him what vaccine he wanted and when he said covid the patient said yes. So, I put the information in the computer that this was his first covid vaccine. The patient then filled out a VAR form for the covid vaccine and returned it to me.  I then filled the syringe with the covid vaccine, then called him back to give the vaccine. I, the patient and the translator went back to the vaccine area to then explain this is the covid vaccine dose 1, and what side effects he might have.  The patient then said yes, and I proceeded to give the vaccine. I verified with the patient his name, and what vaccine I was giving. Before the vaccine I gave him his receipt, and a VIS form about the vaccine. He then walked away. About 5 minutes later he comes back to the counter and the translator is still in the pharmacy and tells me he got the wrong vaccine. He said he had wanted the MMR vaccine and that he got 3 doses of the covid vaccine, all of this with the help of the translator. He showed us a copy of his vaccine card on his phone which showed his last dose was in 1/28/2022. He apologized and said it was fine he just wanted to get the other vaccine which I didn't have in stock. I apologized for the situation, and the translator told me the patient told him he wanted the covid vaccine.  The translator and I talked about how he translated everything he said and everything I said to each other word for word.
This spontaneous report as received from a Medical Assistant refers to an 18 year old patient of unknown gender. On 30-AUG-2007, the patient was vaccinated with a pediatric dose of VAQTA (Lot #/exp. date, dose and route of administration were not provided) and then on 12-MAY-2016, the patient was vaccinated with an adult dose of VAQTA (Lot# L004745; exp. date: 28-APR-2017) (dose and route of administration not provided). No adverse effects were reported and no PQC was involved. Additional information has been requested.
Hashimoto Disease; tinnitus; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), 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, Manufacturer Unknown, no side effects in the first 2 doses), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown, no side effects in the first 2 doses), for COVID-19 immunization. The following information was reported: AUTOIMMUNE THYROIDITIS (medically significant), outcome "unknown", described as "Hashimoto Disease"; TINNITUS (non-serious), outcome "unknown", described as "tinnitus". She stated having reported Tinnitus, and then proceeded to report several complaints regarding the available information for the Pfizer COVID-19 Vaccine and then stated that Pfizer and Moderna are not as transparent with the information as (whiteheld). Caller proceeded to state that FDA won't give any side effects unless they are presented above 1% and this can be misleading. She continued by saying that information should be as honest as it is in TV commercials when they are announcing medicines and stated that Pfizer should do the same instead of being a broke record that only states that the vaccine is safe, even with side effects below 1% of occurrence. She then continued to say that Pfizer, Moderna, CDC and FDA can't be trusted. Caller stated that (Name), reported tinnitus being a very common side effect of the COVID-19 Vaccine. Caller then shared some data about 13 thousand people having tinnitus but since the population taking the vaccine is so huge, this fact can go missing. She also shared data about a trial where 800 patients with tinnitus reported a growth in tinnitus causing pain from 1 to 9 in a scale from 1 to 10. Then she stated that tinnitus is so dangerous, that an acquaintance of her (65 years old, male) committed suicide due to the discomfort caused by tinnitus. Caller then stated that she has heard of people having vertigo and misdiagnosis of breast cancer due to the inflammation that the COVID-19 Vaccine causes. She proceeded to complain about how the ingredients on the vaccine are too difficult to understand and that patients should have a right to know what to they are putting in their bodies. She finally stated that she isn't an anti-vaxxer but that the misinformation caused by Pfizer is so big, that she's already heard people believing that the vaccine would kill people in 5 years. In referral to the AE reported, caller stated also having Hashimoto Disease and that the tinnitus was caused after the booster dose of the Pfizer COVID-19 vaccine, but that she had no side effects in the first 2 doses.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine given to pt outside of age recommedations for vaccine.  Pt denies any complications at this time.
her right hand has two big lumps after getting the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Apr2021 (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: VACCINATION SITE MASS (non-serious), outcome "unknown", described as "her right hand has two big lumps after getting the vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash on the left arm approximately 6 in. wide, itching at the site of administration (left arm).
The Pfizer (maroon cap) vaccine was administered to this patient who is 2 years old. However, the nurse used the incorrect volume of diluent to reconstitute the vaccine vial. 1.3ml of sodium chloride was used for reconstitution instead of the required 2.2mL for the maroon cap vaccine. The patient was given the vaccine and monitored during the observational phase. No adverse event was seen.  Contacted Pfizer representative for more information regarding future vaccination schedule. Pfizer representative stated that the patient should just continue the vaccination schedule normally as indicated by the CDC guidelines.
COVID; COVID; off label use; Dose 4 Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Feb2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE], start date: Oct2009. Vaccination history included: Covid-19 vaccine (DOSE 1, 2 and 3 , Manufacturer Unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 21Feb2022 at 12:00, outcome "unknown", described as "Dose 4 Booster"; OFF LABEL USE (medically significant) with onset 21Feb2022 at 12:00, outcome "unknown"; COVID-19 (medically significant) with onset 23Apr2022, outcome "recovering", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: began testing positive again on rapid covid test. Therapeutic measures were not taken as a result of immunisation, covid-19, off label use. Clinical course: On 15Apr2022 to 20Apr2022 (Lot No: fx4466), the patient was treated with Paxlovid for Covid-19. The patient had rebound of Covid symptoms after last dose of Paxlovid. Tested negative after antiviral treatment for 2 days then symptoms came back and began, testing positive again on rapid Covid test. Device timestamp was reported as, 25Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Itching; Tingling sensation; Numbness; Sneezing; cough; feeling hot; flushing; Generalized Rash; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), PARAESTHESIA (Tingling sensation), HYPOAESTHESIA (Numbness), SNEEZING (Sneezing) and COUGH (cough) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching), PARAESTHESIA (Tingling sensation), HYPOAESTHESIA (Numbness), SNEEZING (Sneezing), COUGH (cough), FEELING HOT (feeling hot), FLUSHING (flushing), RASH (Generalized Rash) and CHILLS (Chills). At the time of the report, PRURITUS (Itching), PARAESTHESIA (Tingling sensation), HYPOAESTHESIA (Numbness), SNEEZING (Sneezing), COUGH (cough), FEELING HOT (feeling hot), FLUSHING (flushing), RASH (Generalized Rash) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator  Antihistamines and steroids are the treatment medication reported by reporter.  Patient stated that on 15JUL2021, the events are recovered with residual effects like sneezing, itchy rash throughout the body   This case was linked to MOD-2021-154634 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: follow up received, additional events were added.
developed refractory seizures on 04Feb2021 after receiving covid-19 vaccine dose #2; This is a spontaneous report from a contactable physician. A 65-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), intramuscular on 30Jan2021 at a single dose for COVID-19 immunization. Medical history included diabetes, breast cancer, rheumatoid arthritis and known allergies with penicillin. Concomitant medications included metformin (METFORMIN), hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ), letrozole (FEMARA). The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), intramuscular in Jan2021 at the age of 65 years old for COVID-19 immunization. It was unknown if the patient had other vaccines in four weeks. The patient developed refractory seizures on 04Feb2021, after receiving the second dose of BNT162B2 on approximately 30Jan2021. The patient was hospitalized for 5 days, in the ICU and received anti-seizure meds among others. The patient had no COVID prior vaccination and it was unknown if tested post-vaccination. The event resolved on an unspecified date in 2021.   Information on the batch/lot number has been requested.
erythema 2-3cm & tenderness 4-5cm over lt deltoid 36 hrs p/vax; low grade temp, myalgia 36 hrs p/vax;
One of my coworkers gave a Moderna vaccine to someone under the age of 18; A spontaneous report  was received from a healthcare professional concerning a 17-year-old patient, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, one of the reporter's coworkers gave a Moderna vaccine to someone who was under the age of 18. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, "one of my coworkers gave a Moderna vaccine to someone who is under the age of 18", was considered resolved on an unknown date.; Reporter's Comments: This case concerns a 17 year old patient who received their first of two planned doses of mRNA-1273 (lot number: unknown) for prophylaxis of COVID-19 infection. There were no reported adverse events after the vaccine was administered in the case of product administered to patient of inappropriate age.
Sore arm, felt warm. Tingling of middle of tip of tongue for approximately 29 hours. No swelling or discoloration or any  signs of allergic reaction
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 31-AUG-2015, the patient was vaccinated with expired doses of MMR II (lot # J010601, subcutaneous, 0.25 ml). The nurse also reported that as the vaccine was being administered, patient pulled away and received less than full dose. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Mild vestibular issues (the spins when turning my head) Began about 2 days after vaccination (7/29 vax date), still occurring (as of 8/14)
pt recvd vax 3FEB94 & 16FEB94 exp arthritic joints & hands; 23FEB94 exp stiff neck & h/a;
Dizziness, inability to think clearly ("brain fog"), swollen and somewhat sore throat, pain at injection site
Redness in the upper arm (deltoid region), sore. It is hot. The redness is spreading superior from the site of injection. On 6-6-18, customer reports that ringing in ears, feeling fogginess, extreme fatigue and week; staggered when walking.
Information has been received from a physician's assistant concerning a 59 year old female with no drug reactions or allergies and a history of breast cancer who on 2-JAN-2008 was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX. There was no concomitant medication. On approximately 22-JAN-2009, about a week ago, the patient experienced mild pain at the T3 dermatome. The patient did not have a rash. Comprehensive metabolic panel was performed (result not reported). At the time of this report, the patient was not recovered. The patient was seen for medical attention. Additional information has been requested.
VACCINE GIVEN >24 HOURS AFTER MDV PUNCTURED  PT SCHEDULED TO RE-VACCINATE