chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Her BP went down to 80/60 with a pulse of 50.; sudden light headiness/light headedness; pulse of 50; Slurred speech; extreme sleepiness/sleepiness that there was no other focal deficit; felt like she was under anesthesia, was unable to move her legs/felt like she was under general anesthesia trying to wake up but unable to open her eyes or move her arms or legs; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date were not reported, via an unspecified route of administration on unspecified date at a single dose for immunization. Medical history was none. The patient's concomitant medications were not reported. It was reported that the patient (a doctor) received the vaccine and had a sudden light headiness, slurred speech, and extreme sleepiness with outcome of recovered. She felt like she was under anesthesia, and was unable to move her legs. Her BP went down to 80/60 with a pulse of 50. All of these episode lasted about 2 hours. The patient became alert, but she still felt a bit light headed. She felt normal the next day. The patient said that at the sudden onset of the side effects: light headedness, slurred speech, and sleepiness that there was no other focal deficit. She felt like she was under general anesthesia trying to wake up but unable to open her eyes or move her arms or legs. The outcome of the events Her BP went down to 80/60 with a pulse of 50, sudden light headiness/light headedness, Slurred speech, extreme sleepiness/sleepiness that there was no other focal deficit and felt like she was under anesthesia, was unable to move her legs/felt like she was under general anesthesia trying to wake up but unable to open her eyes or move her arms or legs was recovered on an unknown date.  Information about lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of low blood pressure/ low pulse with dizziness cannot be excluded, considering the plausible temporal relationship.  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
Pins and needle sensations that moved to the rest of body; Sinus pressure; Tingling that started in the feet; Loss of appetite; Headache; Nausea; Dizziness; Fatigue; Pressure in back and abdomen; Pressure in back and abdomen; Chest tightness; Malaise; This is a spontaneous report from a contactable consumer (patient) reported that: A 29-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185; formulation: solution for injection; Expiration date: unknown), via unspecified route of administration in left arm on 01Jun2021 at 15:00 (at the age of 29-years-old) as second dose, single dose for COVID immunisation in Health Clinic/Administration facility. The patient medical history included Sulfa-Drugs with allergies. The concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient known allergies included Sulfa-Drug. Device timestamp was reported as 05Jun2021. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not received other medications within two weeks of vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736; formulation: solution for injection; Expiration date: unknown), via unspecified route of administration in left arm on 11May2021 at 14:00 (at the age of 29-years-old) as first dose, single dose for COVID immunisation. On 02Jun2021 at 11:00, the patient experienced Pins and needle sensations that moved to the rest of body including feet, legs, pelvis, buttocks, back, abdomen, chest, arms, neck, cheeks, back and front of head as well as occasional sensation in right eye, Sinus pressure, Tingling that started in the feet, Loss of appetite, Headache, Nausea, Dizziness, Fatigue, Pressure in back and abdomen, Pressure in back and abdomen, Chest tightness, Malaise. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The adverse events resulted in Emergency room/department or urgent care. The patient did not received treatment for the events. The outcome of the event was not recovered.
Facial swelling, low grade fever, tightness in chest, nasal congestion, coughing, fatigue, achy, nausea/loss of appetite, diarrhea, metallic taste in mouth.
Extreme nausea and vomiting post Covid Shot, patient became syncopal with the vomiting episodes and was admitted to the hospital
Vasovagal reaction immediately after receiving injection.  Ongoing headache and tingling in hands.  Lethargy.
Joint pain in both shoulders; More intense nerve pain in legs; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient had no 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 levetiracetam (MANUFACTURER UNKNOWN); taken for unspecified indication from unknown date and unknown if ongoing. The patient previously 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 an unknown date (also reported on 01Apr2021 at 08:15), as a single dose for COVID-19 immunisation. On 30Apr2021 at 06:00, the patient experienced joint pain in both shoulders. More intense nerve pain in legs than typical for a patient with multiple sclerosis. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events more intense nerve pain in legs and joint pain in both shoulders was not recovered 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.
(1) Upper at arm swollen below deltoid all the way to elbow swollen & red. (2) Left arm 2 cm by 2 cm.
pt recv vax & devel an axillary temp of 104 2 to 3 hr post vax;this occurred despite APAP prophylaxis & APAP use @ home;pt also became lethargic, no longer playful or as active as prev LMD visit;pt reported to have mild URI @ time of vax;
Pt's vax dose was given to high. She reportedly felt an electrical shock when the injection went in. The pt experienced swelling into bicep with burning and pain with tingling immediately. Reportedly the pt had her fibromyalgia set-off again and was seen by a physician who has been treating the pt for this condition. The pt is still experiencing a big lump under arm the size of a golf ball with a lot of pain.
This spontaneous report as received from a certified nursing assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were inadvertently vaccinated improperly stored VAQTA (strength, dose, route and site of administration, lot # and expiry date were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Blood Clot Right Thigh-diagnosed on Thursday 10/28/21-Swelling, redness, warm to touch and PAIN Blood Clot RIght Lung-diagnosed on Saturday 10/30/21-shortness of breath ED also did blood tests to look at other factors related to clots to determine course of treatment Prescribed 15mg 2 times daily of Zarelto for leg blood clot on 10/28/21-recommended continued treatment for lung clot as well.
TIREDNESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.   No concomitant medications were reported. On an unspecified date, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tiredness was not reported. This report was non-serious.
24 hours after immunization, pt had a febrile seizure. No known temp between time of immunization and seizure. No temp elev. at visit.
severe back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "severe back pain".  Additional information: Caller asked if he could take hydrocodone after taking the first dose.   No follow up attempts were possible. Information about Lot/batch number could not be obtained.
COVID-19 Vaccine  Pt received her 1st dose of Covid-19 vaccination in her left deltiod at 1340. 12 min later, pt stuck her head out of the doorway of her room to notify  LPN that she was feeling lightheaded. LPN went to pt's room to assess. Patient laid back in exam chair. Patient mask removed. Color palor. Skin clammy, Vitals obtained, patient reports tingling in arms, legs, and feet. Patient vitals 96/67. Provider at door for eval and advised EMS notification. Patient vitals monitored. 20G IV placed at 1358 left forearm by  RN x1 NSL. Color begins to return. Patient tilted back up in chair, vitals obtained and WNL. At 1423 patient stood up with stand by assistance, placed mask on herself and reports does not feel can stand at this time. Patient A&O x4. Reports lightheadedness and dizziness. Patient asks what she is to do about her second vaccine and was advised that she needs to consult with her PCP.  Pt states will take Benadryl. Pt again advised to check with her PCP before having second dose or taking Benadryl with second dose. Patient advised per EMS to bring second person with for transport if cleared to receive second dose. At 1428 reports no lightheadedness or dizziness with standing. At 1429 patient ate three PB crackers with water. At 1432 patient ambulatory in halls with Medic staff by side. At 1434 back to room, reports 95% better with head, tinglining in feet and hands 90% improvement. At 1445 vitals WNL patient A&O x4. At 1449 IV pulled by  RN. At 1452 patient discharged to home per self.
Flu-like symptoms; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) and PYREXIA (Fever) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) and PYREXIA (Fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications include Ibuprofen and Paracetamol.   This case was linked to US-MODERNATX, INC.-MOD-2021-109499 (E2B Linked Report). This case was linked to MOD-2021-109560 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109499:Crosslink(MOD21-086966)
Itching at injection site 2 days after, itching torso, scalp, face 3 days after, still itching at 5 days after injection.
Swollen clavicle; small rash; This is a spontaneous report from a contactable consumer (for herself). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration, administered in left arm on 20Feb2021 14:30 as a SINGLE DOSE for covid-19 immunisation. Medical history included drug Allergies to: Penicillin (Allergies to medications, food, or other products: Penicillin). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Facility where the most recent COVID-19 vaccine was administered was Hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced swollen clavicle (non-serious) on 21Feb2021, small rash (non-serious) on 21Feb2021.  The patient underwent lab tests and procedures which included X-ray: unknown results on unspecified date in 2021. Therapeutic measures were taken as a result of swollen clavicle (bone swelling), small rash (rash). treatment received for the adverse event: Yes: Methylprednisolone. For events, outcome was not recovered.  Information on the lot/batch number has been requested.
FEVER INITIATED ON DAY 6 AFTER VACCINES ADMINISTERED. HAD EVALUATION IN OFFICE ON DAY SEVEN, WHERE SEIZURE OCCURRED,  TRANSFERRED TO LOCAL ED, BY AMBULANCE , WHERE PNEUMOCOCCAL MENINGITIS WAS DIAGNOSED.
Redness, swelling on the injection site-53mm. Overall fatigue, headache. T99.1.
pt currently hosp, family requesting info concerning past vax given per MD request; pt is being treated for uncontrolled sz activity;
Headache, body aches, pain at injection site, cold chills and low-grade fever. Approximately 14 hours after booster (the next morning) and symptoms lasted about 8 hours after.
Itching all over, tongue felt funny and tingly lips felt puffy. Felt shaky all over. Took Benadryl for 2 days.
Patient developed hives on her extremities and trunk the day after receiving Flu vaccine. No swelling. No difficulty breathing.
Pain at injection site, Redness at injection site, Hot to touch-injection site, Vomiting-administered Benadryl & Augmentin
Pt received DTP/OPV the following morning developed temp of 103 axillary. No ther symptoms. when seen in peds clinic on 21-SEP-90 temp was 101.5R Mom had been giving Tylenol 60mg q 4 hrs.
PATIENT PRESENTED TO THE OFFICE WITH RASH ON CHIN ARMS AND BACK.
Red itchy rash appeared surrounding injection site 10 days after vaccination. Rash is 2.5 inches long and 1 inch wide.
About five days later began having chest pain, dizziness , high pulse rate and general discomfort. Went to urgent care, own internist, then hospitalized over night on August 28-29. Working dx is Peritonitis.  Saw cardiologist on 8/31. He redid EKG... much improved  since discharge. Believes it is Peritonitis, possibly due to 3rsd  series Moderna vaccine. BP, dizziness, pain and heart rate are  now normal.  Medications are high does ibuprofen and colchocaazine
No additional adverse events reported; PROQUAD that was administered after improperly stored; This spontaneous report was received from a certified medical assistant (CMA) and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 11-OCT-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml, lot # U002534, expiration date 24-JUL-2022 (dose number, route of administration and vaccination site were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursion of 8.5 degrees Fahrenheit for 18 minutes and 11.9 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. No additional adverse events were reported.
ADMINISTRATION ERROR; PUNCTURED VIAL WAS LEFT AT ROOM TEMPERATURE PAST THE 2 HOUR LIMIT; This spontaneous report received from a pharmacist concerned 5 multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 213D21A. expiry: 11-APR-2022) dose was not reported, administered on NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On NOV-2021, the patient experienced administration error. On NOV-2021, the patient experienced punctured vial was left at room temperature past the 2 hour limit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error and punctured vial was left at room temperature past the 2 hour limit was not reported. This report was non-serious. This report was associated with product quality complaint number: 90000205013.
Passed out after 5 minute of immunization-Did not feel well for about an hour-symptoms of dizziness, nauseated, shaky, chill, no vomiting
Patient said her throat fels funny at first but was not closing on her. later in the evening 7 hours later have swollen lymph nodes, sore body, tremors, fever, congestion, and diarrhea.
This spontaneous report was received from a consumer concerning her co-worker of unknown age and gender. On an unknown date, the patient was vaccinated with a dose (dose 1) of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified) in the past without adverse reaction. On an unknown date, the patient was revaccinated with a dose (dose 2) of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date, the patient experienced arm swelling and had to seek treatment with their local urgent care for treatment. It was reported that the reaction was so severe that the patient had to be absent from work to recooperate. The outcome of arm swelling was unknown. The relatedness for arm swelling was unknown for PNEUMOVAX23. This is one of the two reports from the same source. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: resolved after about 10 minutes (reaction developed within 5 minutes of vaccine administration)
Fainted approximately 5 minutes after receiving flu shot. Already seated. Immediately laid down with feet elevated and regained consciousness.
On 09/09/2022 in the morning around 8:00AM. I was feeling tired and I slept a lot that day. In the evening around 6:00 PM I had a fever of 99.00, cough and runny nose. I took at home COVID-19 test which was positive. I called the doctors office and they advised me to monitor my symptoms. An hour later I called again and she told me to take TYLENOL. On 09/12/2022 I went to get the antiviral infusion.
Information has been received from a Registered Nurse concerning a 14 year old female patient who was vaccinated IM with a third dose of Gardasil. The nurse reported that 2 months after the vaccination patient was diagnosed with a bleeding arteriovenous malformation. It was reported that patient was hospitalized (date and duration not reported) and had a craniotomy. The patient had a magnetic resonance imaging (MRI) diagnostic test done but no result was available. No other information was available. The outcome was unknown. The reporter considered the event as disabling and life threatening. The reporter felt that patient having arteriovenous malformation was a serious other medical event because it required craniotomy. Additional information has been requested.
Chills; Headache; 63 year old patient received Fluad Quadrivalent; This spontaneous case was received on 08-Oct-2021 from a pharmacist via Med Communications (reference number: SEQW21-03564) and concerned a 63-year-old, male patient.  The patient's medical history was not reported. The patient's concomitant medications included trazodone, zaleplon, Xanax (alprazolam), Aspirin (acetylsalicylic acid), metoprolol and Xalatan (latanoprost), all used for an unreported indication.   On 07-Oct-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, anatomical location: deltoid and route of administration: intramuscular) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 312873 and expiry date was 30-Jun-2022.  On the same day, after receiving Fluad Quadrivalent, the patient experienced chills and headache overnight.  At the time of initial reporting on 08-Oct-2021, the patient was feeling much better and was recovering from the events of chills and headache.  The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  Company comment: A 63-year-old patient was vaccinated with Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient experienced chills and headache. Causal role of the suspect vaccine is assessed as possibly related, considering biological and chronological plausibility. Product administered to patient of inappropriate age is assessed as unrelated per company conventions.; Sender's Comments: A 63-year-old patient was vaccinated with Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient experienced chills and headache. Causal role of the suspect vaccine is assessed as possibly related, considering biological and chronological plausibility. Product administered to patient of inappropriate age is assessed as unrelated per company conventions.
This spontaneous report was received from the registered nurse regarding a 14 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 28-AUG-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.