chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Issue from a flu shot that caused him to be paralyzed; Issue from a flu shot that caused him to be paralyzed; This spontaneous case was retrieved on 13-Jan-2021 via Novartis (reference number: NVSC2021US006533), reported by other non-health professional (consumer) and concerned an 84-year-old, male patient.   The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, indication and anatomical location: not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced an issue which caused him to be paralyzed.   The outcome of events was not reported.  The reporter assessed events as related to influenza virus vaccine polyvalent, as it was reported that the patient was dealing with issue from flu shot that caused him to be paralyzed.   The event of paralyzed was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: An 84-year-old patient was administered influenza virus vaccine polyvalent. On an unspecified date, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced an issue which caused him to be paralyzed. Causality is unassessable for unevaluable event and paralysis, due to lack of information regarding events, temporal relationship with the suspect vaccine and diagnostic findings.; Reporter's Comments: The patient was dealing with issue from flu shot that caused him to be paralyzed.; Sender's Comments: An 84-year-old patient was administered influenza virus vaccine polyvalent. On an unspecified date, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced an issue which caused him to be paralyzed. Causality is unassessable for unevaluable event and paralysis, due to lack of information regarding events, temporal relationship with the suspect vaccine and diagnostic findings.
No adverse event; Moderna Covid 19 Bivalent vaccine that was first punctured on 09Feb2022 was accidentally administered on 10Feb2022 more than 12 hours after first puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine that was first punctured on 09Feb2022 was accidentally administered on 10Feb2022 more than 12 hours after first puncture) and NO ADVERSE EVENT (No adverse event) in a 50-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine that was first punctured on 09Feb2022 was accidentally administered on 10Feb2022 more than 12 hours after first puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine that was first punctured on 09Feb2022 was accidentally administered on 10Feb2022 more than 12 hours after first puncture) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine that was first punctured on 09Feb2022 was accidentally administered on 10Feb2022 more than 12 hours after first puncture).    Concomitant product information was not provided by the reporter.   It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment information was not provided.
The next day(Friday) after my first Pfizer covid vaccination,  in the evening around 7pm I started experiencing trouble breathing and pain in my  right leg.  I was also very tired.  At first I thought it was a reaction to the medication.  By Saturday, it was so bad I could not work more than few steps without feeling and breathing  like I had ran a marathon.  Monday I made an appointment with my doctor for the following Wednesday March 31.  I also went for a Covid test Monday at a drive through.  That test was negative.  By Wednesday, it was so hard to walk into my doctor appoint. I was exteremely fatigued and out of breath.  My legs no longer hurt though. My doctor took one look and sent me to the hospital for several tests.  The tests determinted I had several small Pulminary embolisms (in my legs) including a saddle embolism which is very danger and a couple of larger clots in my right leg.  I was admitted to the hospital and put on high doses of blood thinners. I have to take eloquis for an undeterminted amount of time and wear compression socks for the next two years.   My doctor also told me not to get the 2nd Pfizer Covid vaccination.   She and I both think that possibly the combination of my birth control and the vaccination caused the blood clots.
Same day 02/07/02021 about 6:35PM, I started feeling hot, nausea, dizzy, my heart was beating really fast. I felt like I was going to pass out. My blood pressure was so high. I called the nurses from the office. They had me monitor for 2 hours before I was able to leave. I had to call my doctor and went to the doctor he gave me blood pressure medication. The paramedics said I had a panic attack. I took blood thinners.
Dizziness, Headache, Myalgia, RespDepression, Palpitations, arm soreness and discoloration, chills Narrative
She got the Pfizer vaccine and told me it's kicking her butt; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that she got the Pfizer vaccine and told it's kicking her butt on an unspecified date. The clinical outcome of the event was unknown.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Chills, Spasm, Aches  Do not know connection but with prescription chough medicine resulted in a over night hospital stay
EE, a FT CT technician, reports to OIM with a CC of "lower extremities numbness and tingling." EE reports that symptoms started after he had his flu shot on Sunday the 4th of October. On Wednesday the 7th of October, he "woke up with numbness and tingling sensation in his calves." As the day progressed, the numbness and tingling moved to his thigh and pelvic area. On 10-08-2015,  the numbness and tingling was "more intense," and the sensation had moved up to his abdomen. On the 10-09-2015, the symptoms had intensified so much so that he could not lay down or sleep. On the 10-10-2015, he reports that he felt "pressure in his belly and spine," that was unbearable, and felt like "the two had collapsed on each other." He presented to the ED that same day. Per eemr notes, he did receive extensive testing all of which was negative. Last note by neurologist indicates a differential diagnosis of Guillain Barre vs transverse myelitis. He was discharged on Monday, 10-12-2015. He reports that the symptoms continued Monday night and he felt as though his right leg was going to callapse. He called the neurologist, who advised him to come back to the ER. However, patient decided not to at the time and his symptoms resolved. He reports that the symptoms continue to occur, but are not as intense as they were over the weekend. He continues to have numbness and tingling constantly, but numbness and tingling is more intense certain times of the day and can last for 2-3 hours. Her takes tramadol to help with the "pain," but he is not sure if the tramadol helps or the symptoms subside over time. He does have a f/u with the neurologist on 10-19-2015. Formally diagnosed with "paresthesias or lower extremities."
Mom called office on 3/5/2019 at 5 pm to state that the child has been having fevers all day and was lethargic, she hasn't given any TYLENOL/MOTRIN at all due to not wanting to interfere with immune response, mom was advised to give 3.75 mls of TYLENOL and if child has no improved within 1 hour child needed to be evaluated in the ER or urgent care setting. Mom called back on 3/25/2019 in the AM to advised that child had a reaction to vaccines and described the symptoms of fevers x 1 week, not wanting to crawl, crying when not being held and limp in nature, child wasn't evaluated at time of noted symptoms. Mom states that symptoms lasted approx 1 week then resolved and child is currently acting normal.
Rotateq vaccine dose #1 given at age 17 weeks. As per manufacturer dose #1 not to be given after 12 weeks of age.
Rebound case of COVID.  Symptoms and positive tests ended on day 7.  New symptoms and positive tests began on day 12.; Rebound case of COVID.  Symptoms and positive tests ended on day 7.  New symptoms and positive tests began on day 12.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Lisinopril for high blood pressure, notes: high blood pressure treated with Lisinopril. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Jun2022, outcome "not recovered" and all described as "Rebound case of COVID.  Symptoms and positive tests ended on day 7.  New symptoms and positive tests began on day 12.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (13Jun2022) Positive, notes: Rebound case of COVID. Symptoms and positive tests ended on day 7. New symptoms and positive tests began on day 12; (Jun2022) Positive, notes: Rebound case of COVID. Symptoms and positive tests ended on day 7. New symptoms and positive tests began on day 12. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Booster; Significant lower body discomfort to the point; Significant impact on ability to sleep; localized leg pain; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 05Oct2021 at 15:30 as a single dose for COVID-19 immunisation. Medical history included blood pressure high and abnormal blood cholesterol (borderline). The patient did not have known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration both as a single dose for COVID-19 immunisation. On 06Oct2021 the patient experienced significant lower body discomfort to the point that had a significant impact on his ability to sleep. On the same day, the patient felt localized leg pain just the entire lower body. On 07Oct2021, the patient underwent a SARS-CoV-2 test (Abbott) and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included treatment with ibuprofen (MANUFACTURER UNKNOWN) 900mg every 8-12 hours from an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events significant lower body discomfort, significant impact on ability to sleep and localized leg pain just the entire lower body were recovering at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Droopy face bells palsy; An ear ache; A spontaneous report was received from a consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events droopy face bells palsy/facial paralysis and an ear ache/ear pain.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 16 Jan 2021, approximately 22 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 097k701A) for prophylaxis of COVID-19 infection.  On 08 Feb 2021, the patient had an ear ache, and on 09 Feb 2021 the patient had droopy face bells palsy. At the time of this report she still had Bell's palsy and was being treated by her doctor with prednisone and an anti viral. She was scheduled to receive her second shot on 13 Feb 2021. The event droopy face bells palsy was considered as medically significant. Treatment for the event included prednisone and an anti viral.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event droopy face bells palsy was considered as not recovered. The outcome of the event an ear ache was unknown.; Reporter'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.
This spontaneous report as received from a nurse refers to unspecified number of patient of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot #M002268, expiration date 20-SEP-2017 (dose and route of administration were not reported). There was no adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
flu like sx 14 days p/vax; body aches & t101 lasting 3-4 days; mild bronchitis given ATB;
24 hours post vaccination, the patient developed hives.  Patient was seen by her PCP for evaluation.  Prescribed oral prednisone and OTC antihistamines.
On 14May2021 had tingling in right forearm, then throughout the days it travelled/ on 22May2021, bumps appeared on her right hand and arm/ a test and results on 25May2021 was shingles; This is a spontaneous report from a contactable consumer (patient).  A 35-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 08May2021 13:30 (at the age of 35 years old) (Lot Number: EW0162) as first dose, single dose for COVID-19 immunisation. Medical history included type 2 diabetes from an unknown date and unknown if ongoing. The patient did not have COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included glipizide, metformin, insulin glargine (BASAGLAR) and Vitamins; all taken for unspecified indication, start and stop date were not reported. Six days after 1st dose (14May2021), patient had tingling in right forearm, then throughout the days it travelled. In the morning of 22May2021, bumps appeared on her right hand and arm. On 24May2021, doctor did a test and results on 25May2021 was shingles. Tingling was random but happened throughout body on both sides. Patient was given antiviral meds (valacyclovir). The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did got tested for COVID post vaccination. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
10.5 x 7 cm area lat. proximal (R) upper arm sl. erythematous sl. swollen - not painful not causing LOM.
Within 12 hrs of receiving Pediarix, Prevnar, and flu vaccine temp to 103 and papular rash on shoulder, chest, back. Received Motrin.
I had the first dose of the Pfizer vaccine last night (6 p.m.).  Within 15 minutes my left hand and left arm started to itch. I saw the medical folks on location but since there were no hives or anaphylaxis,  I was told "it must be eczema" (which I do not have.  The itching continued to get worse and spread to under my eyelids, inside my ears, and "under" the surface of my skin - mostly on my face, skull, neck, behind my knees.  I called the advice nurse at 7:30 but there was still no hives, visible rash, or breathing issues.  I started taking 10 ml of Benadryl every four hours but the itching was awful and the Benadryl only "took the edge off" and the itching persists enough I could not sleep last night (3/28). There is still no visible rash or breathing issues but the itch is awful.  I reached out to my primary care Dr and I was instructed to  take Zyrtec in addition to the Benadryl.  It helps but makes it slightly tolerable, it does not stop the itching.  As of right now (7:36 p.m. the day after the shot), I am still experiencing itch...but it is less than it was this time last night (however, I am taking both Zyrtec and Benadryl).
Fevers the day prior, followed by pruritic morbilliform rash on trunk and back spread to face and extremities the following day. Treating with ibuprofen and diphenhydramine.
sore throat, headache, body aches, chills, "real cold" all night, chest pain that hurt all night and went into friday and saturday
Pt's mother states her daughter can not hold her cell phone to ear for very long, her arm goes numb. Father states there's a knot at vaccine site.
Extreme fatigue lasting 4 days, foggy brain (inability to make decisions, concentrate)
This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was recovered/resolved. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The patient was a friend of the reporter. The age at vaccination was not reported. The patient had bad side effects. The caller reported 3 friends all had bad side effects. This was 1 of 4 cases, reported by the same reporter.
No further AE details; HCP called to report an expired dose of VARIVAX was administered to Multiple patients.; Improper storage of product in use; This spontaneous report was received from a pharmacist and refers to a 15-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-JUN-2023, the patient was vaccinated with expired dose varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Expired product administered). On 02-MAR-2023, the vaccines underwent temperature excursion for 9 minutes in 70 Farenheit (F) (Product storage error). No additional adverse events were reported.  This lot number #W0252273 is verified to be not valid for varicella virus vaccine live (oka/merck).
Diagnosed positive of Covid19; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed positive of Covid19) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Seasonal allergy.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced COVID-19 (Diagnosed positive of Covid19). At the time of the report, COVID-19 (Diagnosed positive of Covid19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications are taken. No treatment information was provided.
Sudden onset of shaking, HA, vomiting, nausea, & LOC. hypotension & bradycardia persisted for 3 hrs. Tx w/IV fluids & Tylenol.
Developed symptoms consistent with Bells Palsy 2 days after receiving his second Anthrax vaccination.  Also Developed no specific musculo-skeletal pain which developed approximately 5-6 days after his second anthrax vaccination.
about 2 -3 weeks after my second moderna covid shot, I had excessive hair loss that is not new to me . nothing else changed in my situation to contribute to hair loss, all my lab work was normal . the shot was the only difference
Began not feeling well about 8 hours after my shot. That night I developed a fever (under 100 degrees) and chills. Had some heart palpitations. Next day I still had a slight fever, general malaise, soreness from shot in arm, a few occurances of heart palpitations, sore back. On third day, no fever, but still felt under the weather, with a sore arm plus some hardness in the injection area. Had some palpitations that evening. By the 4th day, felt better in general, but began feeling a very slight numbness on lips and surrounding facial area. Arm still sore with hardness. Better on 5th day. Day 8 & 9 had pains in lower shins. Day 9 I noticed tiny small bumps on upper front and back shoulders and upper arms. They were not hive like and some were itchy. Took some Benadryl that night which didn't reallly help. Days 10-12 - still have tiny bumps some slightly pink, mostly skin tone, spreading to neck area. Saw my internist on 2/25/21 Day 14 to ask if symptoms related to vaccine shot. He didn't think the rash was related because it didn't start away after shot. The continuing ever so slight numbness in lips and surrounding area may be just from anxiety, he said. 3/1/21 - still have occasional slight numbness off and on of lips with "grainy" rash still present.