chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a health professional concerning a 6 year old, male patient. Concomitant medications and medical history were not reported. On 10-OCT-2012, the patient received FLUMIST. The health professional reported that they have inadvertently gotten FLUMIST in a patient's eye may have been given. The patient was examined next morning and his eye looked fine. At the time of the reporting the outcome of the events of inadvertently got FLUMIST into the patient's eye and partial dose may have been given was unknown.  The event of inadvertently got FLUMIST into patient's eye was considered to be non-serious by the reporter. The event of partial dose may have been given was identified by company physician from the source document and it was added as non serious event. Corrected report 06-DEC-2012 the coding of inadvertently got FLUMIST into patient eye was changed from wrong route of administration dispensed to drug administration error. Corrected report 10-APR-2014 full narrative, initials added, route corrected to ophthalmic.
Patient was being administered the second dose series of the Shingrix vaccine within the 2-6 month window for the second dose. During administration, the syringe assembly failed between the syringe needle and the rest of the assembly and approximately half of the vaccine was administered into the patient and the other half was sprayed onto the patient's arm. We called the manufacturer GSK to ask about possible readministration. Per Pilar at GSK, it is recommended to revaccinate if less than 0.4mL of the vaccine was administered to the patient. We notified the patient's primary care physician regarding revaccination and agreed with the plan for revaccination. We called the patient and scheduled a revaccination on October 12, 2021.
blood pressure skyrocketed, it was 175/110/Very high blood pressure; almost falling down; Severe fatigue; Dizzy/dizziness; Bad headache/severe headache; Neck pain; This is a spontaneous report from a contactable nurse (reporting for herself).  An adult female patient (over the age for 60) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in an unspecified deltoid on 28Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced dizzy/dizziness, bad headache/severe headache, neck pain on 28Dec2020 and almost falling down, blood pressure skyrocketed (175/110)/very high blood pressure and severe fatigue on 29Dec2020 10:00.  Clinical details were reported as follows: After the vaccine the patient was there waiting for 20 minutes and when she got in her car, after about an hour after the patient was really dizzy and was driving and was going to get in the next lane and thank God did not get in an accident. The patient parked and called her family to come pick her up. She had a bad headache, neck pain and dizziness that lasted for an hour. Finally, they came in and took me home.  The patient slept for 7 hours. 9 hours after, the headache, neck pain, and dizziness were gone. The next day at 10:00 at work the patient almost fell down and one of the coworkers held her. The patients blood pressure skyrocketed, it was 175/110 and the patient was very dizzy again had severe fatigue.  Her blood pressure was high for about 2 hours and slowly came down, but the fatigue lasted for almost a week and it slowly got better. The patient underwent lab tests and procedures which included blood pressure measurement: 175/110   on 29Dec2020 skyrocketed/very high.  The outcome of the events was recovered on an unspecified date.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the event blood pressure increased cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
1 week later serotonin symptoms appeared; tremors; Blurry vision; Uncoordinated; Confused; headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SEROTONIN SYNDROME (1 week later serotonin symptoms appeared) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was provided by the reporter). Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL (OCELLA) for Birth control, DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ), QUETIAPINE FUMARATE (SEROQUEL), FLUVOXAMINE MALEATE (LUVOX CR) and METHYLPHENIDATE HYDROCHLORIDE (RITALIN) for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced SEROTONIN SYNDROME (1 week later serotonin symptoms appeared) (seriousness criterion medically significant), TREMOR (tremors), VISION BLURRED (Blurry vision), COORDINATION ABNORMAL (Uncoordinated), CONFUSIONAL STATE (Confused) and HEADACHE (headache). At the time of the report, SEROTONIN SYNDROME (1 week later serotonin symptoms appeared), TREMOR (tremors), VISION BLURRED (Blurry vision), COORDINATION ABNORMAL (Uncoordinated), CONFUSIONAL STATE (Confused) and HEADACHE (headache) was resolving.        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.; 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.
72 hours post injection of Tdap, developed warm, raised, firm area approx 5 cm in diameter.
Reactivation of VHS after being vaccinated with Fluad Quad; This spontaneous case from the  was received on 23-Oct-2020 from other non-health professional via The Agency (reference number: SEQW20-04156) and concerned a female patient of unreported age.   The patient's historical condition included Herpes simplex and reactivations of virus herpes simplex (VHS) as reaction of depressed immune system. The patient's concomitant medications were not reported.   On 19-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose, route of administration and anatomical location: not reported) for flu prevention. The batch number was not reported.   On 21-Oct-2020, two days after receiving Fluad Quadrivalent, the patient had reactivation of virus herpes simplex (VHS). No treatment measures were used.   At the time of initial reporting on 23-Oct-2020, the patient had not recovered from event.  The reporter assessed the event as not related to Fluad Quadrivalent. The patient did not want to report this as an adverse event, as she had already had VHS reactivations, and this was a normal reaction when her immune system was depressed.   The reporter assessed the case as non-serious.  Case updated on 14-Dec-2020: Correction made to information received on 23-Oct-2020: Company comment amended.  Company comment: Herpes simplex reactivation was associated with the use of the suspect product, Fluad Quadrivalent. The event emerged after 2 days post vaccination. Chronology seems plausible however, due to biological implausibility and medical history of already acquired herpes viral infection and its pathophysiological characteristics, causality is assessed as not related to vaccine.; Sender's Comments: Herpes simplex reactivation was associated with the use of the suspect product, Fluad Quadrivalent. The event emerged after 2 days post vaccination. Chronology seems plausible however, due to biological implausibility and medical history of already acquired herpes viral infection and its pathophysiological characteristics, causality is assessed as not related to vaccine.
Rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Rash around the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) 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 03-Mar-2021, the patient experienced INJECTION SITE RASH (Rash around the injection site). At the time of the report, INJECTION SITE RASH (Rash around the injection site) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
dizziness; soreness at the site of injection in his left (nondominant) arm.; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and VACCINATION SITE PAIN (soreness at the site of injection in his left (nondominant) arm.) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DIZZINESS (dizziness) and VACCINATION SITE PAIN (soreness at the site of injection in his left (nondominant) arm.). At the time of the report, DIZZINESS (dizziness) and VACCINATION SITE PAIN (soreness at the site of injection in his left (nondominant) arm.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use included unspecified diabetes medication daily. No treatment information was provided.
Patient showed up at pharmacy with a swollen area of her arm, not the injection site but on the underside of her arm lower near her elbow on 9/20/2017.  She was advised to go the the ER and she did.
patient woke up around 3am and his feet hurt, couldn't walk on them, compared it to having a broken ankle
Donor donated plasma 879 mL then given a tetanus shot. Donor then went pale, sweaty, blurred vision, dizziness, faint feeling, had donor lay down, monitored gave orange juice and water and monitored. Donor quickly recovered <15 min. went home on 7-3-08
Onset Monday 2/19 with papulovesicles on trunk-progressive worsening over the next 72 hours.  Today (2/22) has approximately 250 lesions -various stages of eruption- varicella lesions.
Approximately 6-7 hours after my 2nd Pfizer COVID-19 booster, I had moderate chills, body aches, muscle weakness and extreme fatigue that lasted about 12 hours. I did not experience any GI side effects other than a loss of appetite.
Presented to ER on 12/22/21. Positive for COVID on 12/20/21. on Thursday he began to develop achy pains and feeling sleepy.  When his symptoms did not improve he decided to call his primary care doctor on Monday.  Patient thought he had a urinary tract infection.  He was tested for COVID and was positive.  He states since that time he has been monitoring his O2 saturations.  On his pulse ox at home his O2 saturations are dropping below 90%.  Patient arrived into the emergency room at 88% on room air.  He was requiring 5 L nasal cannula to maintain his O2 saturations greater than 92%.  He states that he has had decreased appetite, a nonproductive cough.  He reports that he took his a.m. medications. Placed on dexamethasone, ceftriaxone, azithromycin and remdesivir. On 1/4/21, patient continued to be hypertensive overnight and required increased pressor therapy.  He also had a small right-sided pneumothorax that was treated with a right-sided chest tube yesterday with resolution of the pneumothorax.He continued to be hemodynamically unstable from the COVID sepsis/septic shock also possible PE with elevated lactate.  His kidney function worsened and he needed CVVH overnight.  In the morning of 1/4/21 he had cardiac arrest with ROSC after 3 cycles of ACLS. Passed away on 1/4/21
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDDVAXHIB lot # L009649, expiration date 29-NOV-2017 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Fever   Headache muscle aches   Joint pain.  Metal taste in mouth. Pain in arm.   Fatigue.
Post vaccination, recipient "blacked out" and fell onto floor. Regained consciousness after about 2-3 seconds. Recipient awake, alert, and conversant. Skin diaphoretic, and cool/clammy. Reported he had bitten his tongue. Tongue slightly bleeding. Denied hitting his head. Observation TL (physician) on site and attended to recipient. Assisted him to a supine position with legs elevated. Allowed to lay for a wheelchair and escorted to observation area. VS monitored and stable. Tongue had stopped bleeding. Ambulating with steady gait. Released at 0930 in no acute distress and without incident.
sore throat following shot. by evening shaking, chills, temp 102.5, fever still next am. Started on TAMIFLU 10/1/09
Neck pain; fatigue; Tiredness; Throar pain; hard to swallo; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NECK PAIN (Neck pain), FATIGUE (fatigue), FATIGUE (Tiredness) and OROPHARYNGEAL PAIN (Throar pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LOSARTAN, PRAVASTATIN, FUROSEMIDE, GLIPIZIDE, PIOGLITAZONE, METOPROLOL, POTASSIUM, ACETYLSALICYLIC ACID (ASPIRIN 81) and VITAMIN D3 for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced HEADACHE (headache), OROPHARYNGEAL PAIN (Throar pain) and ODYNOPHAGIA (hard to swallo). On 24-Feb-2021, the patient experienced NECK PAIN (Neck pain), FATIGUE (fatigue) and FATIGUE (Tiredness). At the time of the report, HEADACHE (headache), NECK PAIN (Neck pain), FATIGUE (fatigue), FATIGUE (Tiredness), OROPHARYNGEAL PAIN (Throar pain) and ODYNOPHAGIA (hard to swallo) 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.   Treatment details included Tylenol.
Generalized seizures, afebrile; also with low tone.  Treating with phenobarb; seizure activity has persisted.  May have had seizures prior to vaccines (Mom describes tongue thrusting in retrospect)
Tunnel vision; Dizziness; Nausea; ringing in ears; Flushed face; chest pressure; my blood pressure up; fatigue; headache; fluctuation with blood pressure and heart rate; fluctuation with blood pressure and heart rate; chest pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient also received first dose of BNT162B2 on 22Mar2021 for COVID-19 immunization and experienced fatigue, headache, ear ringing, and flushed face that lasted a couple days; and fluctuation with blood pressure and heart rate and chest pain which resulted to hospital admission. The patient mentioned that with the second dose, the patient had just typical reaction with the first one (such as fatigue, headache, fluctuation with blood pressure and heart rate, and chest pain) on unspecified dates in 2021. The patient also mentioned that immediately like within 20 minutes following second dose on 21Apr2021, the patient had like tunnel vision, dizziness, nausea, ringing in ears, and flush face. The patient further stated, "Well here is my problem, I am having this, it will go away for a day and then it'll come back worst, and today is the worst it's been. I was fine this morning but for 10 hours now, my heart rate is up, it's just in the 90s, I have chest pressure, my blood pressure up. This morning when I got up and I didn't have any symptoms, my pressure was 107 over". Outcome of the events was unknown.   Information on the lot/batch number has been requested.
High blood pressure 150/80; High blood pressure 142/80; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (High blood pressure 142/80) and HYPERTENSION (High blood pressure 150/80) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced HYPERTENSION (High blood pressure 142/80). On 12-Apr-2021, the patient experienced HYPERTENSION (High blood pressure 150/80). At the time of the report, HYPERTENSION (High blood pressure 142/80) and HYPERTENSION (High blood pressure 150/80) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Apr-2021, Blood pressure measurement: 142/80 mmhg High. On 12-Apr-2021, Blood pressure measurement: 150/80 mmhg (High) The patient said his lifestyle stays the same and believes the high blood pressure was caused by the vaccine since his last doctor check up before the vaccination was normal at 120/78..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported by the reporter No treatment medications was  provided by the reporter.
Pain side and chest, fever 101.0 F, shooting leg pain 10/10.
Starting 1 day after the vaccination, and lasting for approximately 3 days, patient experienced:  diarrhea, nausea, headache, dizziness. Arm was red and slightly swollen/red for 4 days. No increased temperature noted during that time.
Patient reported having a sore arm later in the day after receiving vaccine.  Then was having stiff neck and nerve pain whenever he moved his head and swallowing larger amounts of food.  Was advised to take acetaminophen and ice packs to help with symptoms until Monday where his primary care physician could be contacted in order to further treat the symptoms.
arm was sore as hell; felt really tired and drained; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 (Lot number: ER8731) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Stress disorder", start date: 2012 (ongoing), notes: He is being treated for a stress disorder; "Benign prostate enlargement", start date: 2014 (unspecified if ongoing), notes: benign prostate enlargement; "antidepressant" (unspecified if ongoing), notes: In conjunction with counseling and therapy he takes antidepressants. Concomitant medication(s) included: FLUOXETINE taken for antidepressant drug level, start date: 2014 (ongoing); CLONAZEPAM taken for antidepressant drug level, start date: 2014 (ongoing); TAMSULOSIN [TAMSULOSIN HYDROCHLORIDE] taken for benign prostatic hyperplasia, start date: 2014 (ongoing). Past drug history included: Allergy injection for allergy, notes: He had an allergy injection on 06 or 08Apr2021.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Apr2021, outcome "recovered" (25Apr2021), described as "arm was sore as hell"; FATIGUE (non-serious) with onset 23Apr2021, outcome "recovered" (25Apr2021), described as "felt really tired and drained".  Additional information: Additional information: Caller reported no problems but then went on to say his arm was sore as hell and he felt tired and drained. He has an allergy shot coming up on 14May2021 and wanted to know if he should postpone the allergy shot. His arm became sore 4-5 hours after he received the vaccine. It felt like someone had knocked it off or like a truck had hit him in the arm. He became tired 3-4 hours after he received the vaccine. He was being treated for a stress disorder. In conjunction with counselling and therapy he takes antidepressants. There was no History of all previous immunization with the Pfizer vaccine considered as suspect reported. No additional vaccines were administered on same date of the Pfizer suspect. Adverse events were not resulted in emergency room/ physician Office. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The relevant tests were not reported.  No follow-up attempts are possible. No further information is expected.
Mother called office at 5:00 pm.  Patient crying non-stop for 3 hrs. with fever of 100.6.  Office visit at 5:30 pm: Fever of 101, fussy, no unusual local reactions to injection site.  Only mild redness.  Patient nursed well in office.  Rec. Acetaminophen for fever.  Mother was contacted at 10:00 am the next morning and reports child to be well, happy, smiling, no fever or rash.
Complaints of numbness in lips, and hard to swallow; Treated in OP setting withIV Normal Saline at 125 ml/hr; Famotidine 20 mg IV push; Benadryl 25 mg IV Push; Solumedrol 125 mg IV push; Ofirmev 100 mg IV piggyback.
This spontaneous report as received from a 46 years old male consumer as part of a marketing research program. The patient's medical history and concurrent conditions were not reported. On 17-SEP-2015, the patient was vaccinated with PNEUMOVAX23 dose 1, intramuscular (dosage, frequency, lot# not reported). No concomitant medications reported. The patient reported having a sore arm on an unknown date of September-2015 that he did not consider very bothersome after receiving a pneumo vaccine. He was unsure where he received pneumococcal vaccine. The adverse event sore arm was recovered with on 26-SEP-2015, after stopping suspect therapy. The event was not appeared after restarting suspected therapy. The reporter considered sore to be related to PNEUMOVAX23. Additional information is not expected since the reporter did not wish to discuss further.