chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 28th December 2020, the patient received Shingles vaccine. On an unknown date, less than 5 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient received vaccine to prevent shingle and got shingles from the vaccine and the patient was still fighting them at the time of reporting. The patient would never take another shingle shot again. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation was not reported.
DEATH; BREAKTHROUGH INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a physician via a company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: hypertension, dyslipidemia, type 2 diabetes, and Chronic renal failure (CKD). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, 1 total administered on unspecified therapy start date for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced breakthrough infection with Covid-19 vaccine ad26.cov2.s(suspected clinical vaccine failure), and died. On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of breakthrough infection and suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: 20210949213-covid-19 vaccine ad26.cov2.s-Suspected Clinical Vaccination Failure. This event(s) is considered not related. The event(s) has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS  20210949213-covid-19 vaccine ad26.cov2.s-Death, breakthrough infection. This event(s) is considered unassessable. The event(s) has an compatible/suggestive 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: UNKNOWN CAUSE OF DEATH
2019: was walking 6 miles a day no issues. 3/13/21: Went rollerskating and no issue. 3/20/21: First Vaccine 4/11/21: 2nd Vaccine  4/17/21 Noticed first cramping of right calf. within minutes of playing basketball.  Assumed just lack of exercise. Contnue to hurt for many months, and finally went to vasular doctor in 10/21.  I could not walk 1/4 mile without stopping to rest for a few minutes. Testing showed significant claudication in both the left and right legs.  Neck and belly arterial tests showed no issues.
Fell at home 10/21/2009. By weekend began paralysis of arms and legs. Had trouble eating and swallowing. 10/24/2009 to ER Hospitalized 2-3 days. Discharged and returned to hospital for two additional visits, nursing home placement for 3 weeks. Returned home mid December 2009 with nurses and hospice care. MD told family he thought she had Guillain Barre but would not put it in writing.
Fatigue; Joint pain; Muscle pain; Chills; Headache; Sore injection site; This is a spontaneous report from a contactable consumer, the patient. A 61-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 25Apr2021 at 16:45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included mirtazapine (MANUFACTURER UNKNOWN), propranolol (MANUFACTURER UNKNOWN) and hydroxyzine hydrochloride (HYDROXIZINE); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received pneumococcal vaccine (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced allergy to vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Apr2021 at 02:00, the patient experienced fatigue, muscle and joint pain, chills, headache and sore injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, muscle and joint pain, chills, headache and sore injection site were resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Lightheadedness, fever, chills, blurry vision, migraine, nausea, generalized weakness, severe pain in left arm
AstraZeneca as First Dose (clinical trial) and Moderna as Second dose; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (AstraZeneca as First Dose (clinical trial) and Moderna as Second dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) 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-Feb-2021, the patient experienced WRONG PRODUCT ADMINISTERED (AstraZeneca as First Dose (clinical trial) and Moderna as Second dose). On 13-Feb-2021, WRONG PRODUCT ADMINISTERED (AstraZeneca as First Dose (clinical trial) and Moderna as Second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received on 13-JUL-2021 and contains no new significant information
COUGH ED to Hosp-Admission Discharged  5/9/2021 - 5/13/2021 (4 days) Hospital  MD Last attending ? Treatment team Pneumonia due to COVID-19 virus Principal problem  Hospital Course:   Please refer to the admission H&P for details of presentation. In summary, patient is a 56 y.o. female with known history of moderate obesity, obstructive sleep apnea requiring CPAP at home, dyslipidemia, hypothyroidism and bronchial asthma was admitted to the hospital service for evaluation of shortness of breath and cough.  Upon admission patient was found to be having Acute hypoxic respiratory failure secondary to COVID-19 pneumonia.  Chest x-ray upon admission showed Patchy bilateral opacities consistent with atypical pneumonia.    Patient completed 5 days course of remdesivir during hospitalization.  Patient was discharged on dexamethasone.Patient received 1 unit of conversant plasma during hospitalization. Patient qualified for 2L of oxygen by nasal cannula at  discharge.  Patient currently feels well and is wanting to go home today.  Patient is advised to follow-up with primary care physician within a span of one to 2 weeks.  Currently patient is being discharged in a medically stable condition after being evaluated by our team.  All the questions and concerns of the patient and family were addressed in detail at the time of discharge.
onset fever, malaise, aches, h/a's 11JAN PM & cont w/elevated fever to max of 104 by 13JAN PM w/flushing assoc;
Chronic pain in arms mostly at night while trying to sleep, very sore around the area where there is a knot from the shot. Impossible to sleep on my sides/shoulder constant pain. I as being a man, didn't go to doctor right away, try to take the pain thinking it will go away. I've been using Lidocaine patches 5% my doctor gave me a strip for Physical Therapy for evaluation and treatment Plus MRI Right/Left shoulder. The knot is on the (Lower) part of my Right shoulder. I've been using a Tens Unit as well Tramadol 50mg tablets. I don't know if you know what it's like to pray to get a full night of sleep. The pain is so severe I can't get a full night rest. I can't sleep on my back because I have a breathing problem due to my heart condition. I wake up between 2:30 an 3AM can't go back to sleep because my mind start to wondering, during the day I have (headache) I take sleeping pill to try to get a good night sleep it is hard on my body I need to sleep more but the pain in my shoulders is so devastating.
One hour after receiving vaccines, she started crying hard, screaming, and her body would be stiff every 2 minutes. This lasted 2 hours mom gave TYLENOL. No fever.
Recieved injection about 2:30 pm , at about 4:30 pm noticed soreness in Left upper arm.  At about 6:30pm the soreness increased to a pain and tenderness in lymph nodes under the arm.   Pain level on 0 to 10 scale estimated to be an "8".  Tylenol and ice packs applied but no pain relief.  Ice caused an increase of pain at the site.  This morning, 2/26/21 Pain level is at a 10, pain at rest or with any movement.    Recommend that she contact clinic for evaluation.
Narrative: 72 yo male reported feeling dizzy during the 15 minutes observation period post vaccination. Pt received Pfizer Covid19 vaccine on 1/21/2021. Per patient, patient dizziness/lightheadness lasted less than one minute. Prior to vaccination, patient denied any prior severe reaction to this vaccine or its components or a severe allergic reaction such as anaphylaxis to any vaccine or any injectable therapy.
When he was preparing Abrysvo vaccine about an hour ago, he inverted the plastic piece connected to the syringe. However, it got separated off from the syringe; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 09Nov2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group, Program ID.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), outcome "unknown", described as "When he was preparing Abrysvo vaccine about an hour ago, he inverted the plastic piece connected to the syringe. However, it got separated off from the syringe". Additional information: The pharmacist reported that when he was preparing Abrysvo vaccine, he inverted the plastic piece connected to the syringe. However, it got separated off from the syringe. So, he was asking if he could be refunded for this. The plastic piece connected to the syringe separated off and then he was not able to use the product anymore, so the vaccine spilled. He was asked if he tried to administer the same product, but he said that he used another vial, so no patient was involved. The vial little piece of plastic that attached to the vial, that you screw the thing into, popped off. It is a single dose.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.
I had all listed most-common side effects (fever, body aches, chills, fever, fatigue). The main, additional side effect I want to report is lymph-node shooting pains under my right armpit and throughout my right arm and forearm that occurred on 2/11 and 2/12 (one and two days after). Three days after the shot, I noticed slight lymph node shooting pain on my right jaw, under ear.   I?ll be getting the second shot...it beats COVID-19 by at least a mile!
Patient had redness, inflammation, and pain in arm after injection. Patient received injection on March 4th. She reported to her MD on March 7th where she received blood work, MD says it appears to be an allergic reaction.
This spontaneous report was received from a medical assistant and refers to 3 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of GARDASIL 9 (lot # M024261, expiration date 05-FEB-2019) (dose and route of administration were not reported) for prophylaxis. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 35 degrees Fahrenheit for 24 hours. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
After 10-12 hours elevated temp to 102.5 degrees, excessive crying & irritability, generalized redness in legs not localized or measurable.
Patient did not receive second Moderna shot within 35 days of the first shot; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive second Moderna shot within 35 days of the first shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not receive second Moderna shot within 35 days of the first shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive second Moderna shot within 35 days of the first shot) had resolved.        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 product use was not provided by the reporter.  Treatment information was not provided.
Morbilliform drug eruption only. No fever, lymphadenopathy, or mucosal involvement present.
Narrative: 98yo with bladder cancer died on 11/7/2021/ Pt received oncology care outside of hospital. Last chart note was 3/39/2021.Pt had received covid vaccines on 1/8/21 & 2/5/21. This death is likely not related to the vaccinations due to patient's cancer diagnosis, advanced age, and length of time from vaccine administration.
pt recv vax 10SEP96 & 18SEP96 pt devel chickenpox w/30 to 50 vesicular pruritic lesions & a fever of 102;MD noted there was wild type chickenpox occurring in pt day care ctr & felt probably devel the wild type chickenpox;
They found several blood clots in the lungs; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (They found several blood clots in the lungs) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M200) for COVID-19 vaccination.     Concurrent medical conditions included Deaf (deaf at baseline). Concomitant products included ATORVASTATIN CALCIUM (ATORVASTATIN [ATORVASTATIN CALCIUM]), TIMOLOL, BRIMONIDINE TARTRATE, TIMOLOL MALEATE (COMBIGAN) and IPRATROPIUM BROMIDE (IPRATROPIUM [IPRATROPIUM BROMIDE]) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jun-2021, the patient experienced THROMBOSIS (They found several blood clots in the lungs) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (They found several blood clots in the lungs) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medication- Lisinopril HCTZ 10-12.5mg, vitamins treatment :blood thinner  Company comment: This case concerns a 63-year-old male patient with no relevant medical history, who experienced the unexpected events Thrombosis. The event occurred approximately 3 months after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) with serious outcome. The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 63-year-old male patient with no relevant medical history, who experienced the unexpected events Thrombosis. The event occurred approximately 3 months after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) with serious outcome. The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Hear heart beating in ears. constant beating, hissing, at times ringing. never lets up; Hear heart beating in ears. constant beating, hissing, at times ringing. never lets up; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 66-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP7533, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 25Mar2021 at 11:30 am (age at vaccination was 66 years) as dose 1, single for COVID-19 immunization. The patient did not have any medical history. The patient did not have any known allergies or allergies to medications, food, or other products. Concomitant medications the patient received in two weeks included levothyroxine sodium (SYNTHROID), acetylsalicylic acid (BABY ASPIRIN) and Zanax all taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Mar2021 at 04:00 am, the patient heard heart beating in ears. Constant beating, hissing, at times ringing. Never lets up. It was so unbearable. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Headache, Arthralgia, Fever,  fatigue, injection arm pain, no appetite
The red area is pretty large, sort of oval, with a redder rim around the outside; m It got extremely red around the vaccine site with a circle around it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (The red area is pretty large, sort of oval, with a redder rim around the outside) and ERYTHEMA (m It got extremely red around the vaccine site with a circle around it) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE BRUISING (The red area is pretty large, sort of oval, with a redder rim around the outside) and ERYTHEMA (m It got extremely red around the vaccine site with a circle around it). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of half a benadryl and CORTISONE at a dose of 1 dosage form. On 02-Feb-2021, VACCINATION SITE BRUISING (The red area is pretty large, sort of oval, with a redder rim around the outside) and ERYTHEMA (m It got extremely red around the vaccine site with a circle around it) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This case was reported by a pharmacist and described the occurrence of raised area injection site in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The pharmacist reported that, "50 percent of the patients," experienced a raised area at the injection site, however, a specific number of subjects was not provided. On an unspecified date in 2005, on or before 09 November 2005, the subject received a dose of Fluarix (lot AFLUA148BA). Information regarding previous immunization with influenza virus vaccine was not provided. At an unspecified time following vaccination with Fluarix, on or before 09 November 2005, the subject experienced a red, raised area at the injection site. The subject was taken to the emergency room. The outcome of the injection site reaction was not provided. The pharmacist considered the injection site reaction to probably be related to vaccination with Fluarix.
Initially nickle sized redness at injection site, continue to progress to baseball sized redness. Rash on face, back and chest. Pt advised to use Benadryl and to alert pcp. Pt selected to use Allegra otc to help with symptoms, to avoid drowsiness.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient reported that he felt bad at the end of his 15 minutes seated observation time. He reported that he felt light-headed/dizzy, had some nausea, had red dots in visual field, and he appeared pale. Patient was encouraged to stay seated. He consented to transitioning to lying down on a couch and hydrating with a water bottle. BP was within normal limits. He did not faint. After ~15 minutes of lying down he felt recovered and normal. Patient was able to walk out fine with his friend.
Injection site, it's feeling numb; Her neck, ear, and side of her head on the left side is also feeling numb; She feels funny; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HYPOAESTHESIA (Injection site, it's feeling numb), HYPOAESTHESIA (Her neck, ear, and side of her head on the left side is also feeling numb) and FEELING ABNORMAL (She feels funny) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-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 an unknown date, the patient experienced VACCINATION SITE HYPOAESTHESIA (Injection site, it's feeling numb), HYPOAESTHESIA (Her neck, ear, and side of her head on the left side is also feeling numb) and FEELING ABNORMAL (She feels funny). At the time of the report, VACCINATION SITE HYPOAESTHESIA (Injection site, it's feeling numb), HYPOAESTHESIA (Her neck, ear, and side of her head on the left side is also feeling numb) and FEELING ABNORMAL (She feels funny) outcome was unknown. Not Provided           Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.