chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lightedness, tightness in neck, anterior and posterior aspects without chest pain, without SOB Vital Signs: BP 140/82 HR 67 Resp 20 O2sat 96  Skin Signs: Warm and dry   Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally  Initial treatment: nsg vs, assessment - resp, neurological  Physician assessment performed by Dr.  at 13:48 PM  13:50 PM  Vital Signs: BP 122/82 HR 72 Resp 70 O2sat 97  Skin Signs: Warm and dry  Circulation: Cap refill <2sec Wait an additional 15 minutes in observation in addition to 30 min wait observ time  Did not have lunch, only breakfast this am - gave him apple jc and nuts as a snack  Disposition: Home by Self
This case was reported by a physician via other and described the occurrence of swelling in a adult male patient who received SHINGRIX for prophylaxis. Co-suspect products included PREVNAR for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose and PREVNAR at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling and chills. On an unknown date, the outcome of the swelling and chills were recovering/resolving. The reporter considered the swelling and chills to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. An attendee (doctor) at primed conference mentioned that after vaccination with SHINGRIX it resulted in adverse events that were mostly resolved. They did not specify when exactly they received the dose. This case has been linked with the case US2018GSK103584, reported by the same reporter.
Soreness and tenderness near injection site; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 15:00 at single dose for COVID-19 immunization. The patient was vaccinated at a workplace clinic. Medical history was not reported. Concomitant medications included diphenhydramine hydrochloride (UNISOM), and diphenhydramine hydrochloride, ibuprofen (ADVIL PM). The patient was not pregnant at the time of vaccination. The patient experienced soreness and tenderness near injection site on 02Feb2021 20:00. No treatment was received for the adverse event. Clinical outcome of the event was not recovered.
This spontaneous report as received from a nurse refers to a 67 year old patient. Medical history and concurrent conditions were not reported. On 21-FEB-2014, the patient was vaccinated with PNEMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Fatigue, from around 6:03 pm on the 12th. I am continuing to have affects on 05/13/2021 at 12:39 pm.
Pt developed local erythema and edema, + fever after receiving influenza and pneumococcal vaccine in upper left arm.  Originally rec'd diphenhydramine for hypersensitivity rxn, however symptoms did not improve, eventually treated for soft tissue infection.
Bell's Palsy/right side of my face is completely paralyzed; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1283), via an unspecified route of administration on 21Jan2021 17:45 at single dose (left arm) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products and patient was not pregnant. On 23Jan2021, the patient experienced Bell's Palsy about 48 hours after receiving the vaccine. The right side of her face was completely paralyzed. The patient was treated with prednisone and valacyclovir. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of event was not recovered.
Pt received Anthrax shot #4 because the system did not have her listed as receiving the vaccine on Aug 16 2007. She was given another vaccine Sep 2 2007 out of the country. Within 12 hours pt. Became Dizzy extreme vertigo and nauseated. Symptoms lasted 3 wks and unable to work. She still has mild Intermittent vertigo.
This spontaneous report was received from a 65-year-old female patient with no drug reactions or allergies in the past, who was reporting on herself. The patient's concurrent conditions included degenerative disc disease, synovial cyst on spine, osteoarthritis, hypertension, high cholesterol and obesity. The patient's medical history included hysterectomy. On 01-JUN-2017, the patient was intramuscularly vaccinated with PNEUMOVAX23 injection (dose, lot # and expiration date were not reported), in her right upper arm. Concomitant therapies included LIPITOR, diclofenac, aspirin (manufacturer unknown), unspecified calcium, unspecified vitamins and glucosamine. On 01-JUN-2017, 2 hours after receiving PNEUMOVAX23, the patient experienced pain at injection site and developed "swelling the size of a baseball" at the injection site. Then, when she stood up "her right leg went out". The patient stated that she was on the couch until 20-JUN-2017 icing and elevating her leg. She sought medical attention. On 20-JUN-2017, the patient was seen by her family physician and she was prescribed dexamethasone (manufacturer unknown) for a period of 7 days. The reporter stated, that on an unknown date in June 2017, after she finished dexamethasone, the pain went away. However, on an unspecified date in approximately 2017, after finishing dexamethasone, the patient began having "pain in right leg and it felt weak and tingly". On 03-AUG-2017, she saw an orthopedist and received a "cortisone shot" in her right knee. On an unknown date the x-ray of the back was performed (results were not provided). The outcome of the event of pain in right leg/pain was reported as not recovered. The outcome of the events of "her right leg went out/ was on the couch until 06/20/2017 icing and elevating her leg", "it felt weak and tingly" and "swelling the size of a baseball at the injection site" was not reported. The relatedness between the adverse events and PNEUMOVAX23 was not reported. No product quality complaint was involved. Upon internal review, the events of "her right leg went out/ was on the couch until 06/20/2017 icing and elevating her leg" and "it felt weak" were determined to be medically significant. Additional information has been requested.
KICKING MY ASS; FELT SYMPTOMS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On MAY-2021, the subject experienced kicking my ass. On MAY-2021, the subject experienced felt symptoms. On MAY-2021, the subject experienced fever. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from fever on MAY-2021, and had not recovered from felt symptoms, and kicking my ass. This report was non-serious.
Post-vaccination autoinoculation. On 7/5 presented to medical center with 2 vesicular pustular lesions on neck, right shoulder and a few on chest. No fever, no general malaise, good appetite, pleasant affect. Developed a possible lesion on left eye when seen by optometrist. No corneal damage, no vision problems. Treated with Verioptic for 9 days.  Nurse follow up on 08/02/04 states: "Complete."  Nurse follow up on 08/03/04 states: "vaccinia, vaccinia ocular."
My daughter had severe Migraines, that would occur 2 to 3 days after vaccination.  Each Booster of the HPV Gardasil shot she was sent to the ER.  Stayed at hospital for a week. Second vaccine was 05/27/2013, 3rd vaccine was 09/30/2013. Each time was debilitating, Severe pain.
On 3/19/02, the vaccinee received his 2nd injection of Engerix-B. On 4/1/02, 13 days post immunization, he experienced total body urticaria and low-grade fever. On 4/4/02, he experienced arthralgia. He was seen in the ER twice. During the 2nd ER visit, the events were treated with IV Solu-Medrol and Benadryl, 50mg IV push. The events resolved on 4/12/02. On 10/22/02, the subject's Allergist reported that the events were possibly related to Engerix-B administration. The Engerix-B immunization series was discontinued. This report was initially considered GSK medically serious. On follow-up, it was reclassified as non-serious.
CHIEF COMPLAINT/REASON FOR VISIT Chest pressure   HISTORY OF PRESENT ILLNESS Patient is a 71 y.o. man with history of CAD status post LAD stenting in 2013, diabetes mellitus type 1, hypertension, hyperlipidemia on statin therapy, OSA, and medically complicated obesity who I am evaluating in the ED given left elbow discomfort, chest pressure, and abnormal chest CTA.     Patient followed on an outpatient basis with Dr., with most recent evaluation in early 2020 including an exercise stress echocardiogram that was mildly positive for myocardial ischemia in an inferior distribution.  A conservative approach was selected with continued medical therapy, inclusive of 3 antianginals (isosorbide mononitrate, amlodipine, and metoprolol).  Increase in outpatient diuretic was utilized for exertional dyspnea.   Patient tells me that overall he has done well.  He has been outside in the woods ambulating as he prepares for deer and bear hunting season.  He is in the process of moving and earlier today was going up and down a ladder while working in his garage packing and moving boxes.  While doing so, he noticed reduced level of energy.  He has had an intermittent cough but denies fever.  He developed left elbow discomfort that he describes as "heaviness" or an "ache".  Because of this, he went inside and sat down noted that he was diaphoretic.  He noted mild chest pressure.  He took a sublingual nitroglycerin which improved his discomfort.  His wife contacted emergency services and by the time of paramedic arrival his pain had improved but had not completely subsided.  Discomfort resolved in the ambulance and out.  Initially, he was hypotensive.  He denies any dyspnea, palpitations, recent changes in weight, or chills.  He did not experience any chest discomfort or elbow discomfort preceding his prior stent.   On arrival to the ED,  patient receive some fluids given low blood pressure, with resultant normotension.  D-dimer was elevated.  ECG demonstrated no interval changes compared to prior.  CT cardiac angiogram triple rule out was performed (report below).  First troponin was 16.  COVID swab was positive.
A report was received from a health care professional on 13 November 2003 concerning a vaccinee who inadvertently received 2 doses of Fluvirin on an unspecified date. On an unspecified date the vaccinee inadvertently received 2 doses of Fluvirin. The vaccinee did not experience any adverse symptoms at the time of reporting.  There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Vaccine was administered by a clinician.  The patient left the vaccination table and walked down to the observation area.  When in observation, the staff was alerted that she has had a reaction to her first shot of the Pfizer vaccine, which comprised on whole body itchiness and some hives. Denied any trouble breathing.  The patient was itching all over and wanted to be evaluated at the hospital.  The patient was not given any medication by EMS personnel.
Rash from head to toe, slight itching, more burning effect. Reported on Oct. 20. Was told it wasn't vaccine, but allergies. Steroids and antihistamine shots. Prescription of steroids and antihistamine.
pt recv vax 14MAR97 & 23MAR97 pt devel 60-70 pox which scabbed over;cult obtained & sent for testing;VZV was positive;however it was not typeable;pt did not have a fever;pt exposed to chickenpox in daycare;
Patient presented to the ED and subsequently hospitalized on 2/23/2021, within 6 weeks of receiving COVID vaccination.
Information has been received from a licensed practical nurse (LPN), concerning a 74 year old male patient with cholesterol levels raised, hypertension and a penicillin allergy, who on 11-FEB-2008 was vaccinated IM in the deltoid muscle, with the first dose of pneumococcal 23v polysaccharide vaccine (lot # 658447/1132U). Concomitant therapy included clopidogrel bisulfate (PLAVIX), doxazosin mesylate (CARDURA), sildenafil citrate (VIAGRA), fluticasone propionate (+) salmeterol xinafoate (ADVAIR) and hydrochlorothiazide. On 12-FEB-2008 the patient developed a reaction on the inner aspect of the injection arm, the "reaction area is extremely red and warm to touch." The patient was seen in the office, and treatment included diphenhydramine (BENADRYL). At the time of this report, the patient had not recovered from the events. This is one of 2 reports from the same source. Additional information has been requested.
Patient received her first GARDASIL on 7-11-11. Two days later developed nausea, vomiting, diarrhea and abdominal pain. Symptoms continued over summer, fall & into winter. Weight loss of 26 pounds. Extensive evaluation non-diagnostic. Hospitalized for this & found to have Addison's disease and thyroiditis.
On October 27, 2022, I started having symptoms around 07:00PM. The symptoms included coughing, congestion, and a 101-degree fever. I took a COVID-19 test, and it was positive. The symptoms got progressively worse overnight. My wife called the primary care doctor on call. He called me back the next morning and prescribed PAXLOVID and Z-PAK. The medication worked well. It kept my symptoms from getting worse. After two days, the symptoms lessened, but they've lingered for 3 or 4 weeks. I still have a slight cough. I think I had COVID-19 back in February, but this case was worse.
rash; This is a spontaneous report from a Regulatory Authority. A contactable health care professional reported that a female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date (lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient developed a rash on an unknown date. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shakey and cold, reports having anxiety.  1:15 PSO2 98% pulse 70  Respirations even and unlabored. No sign or symptom of ditress.  Continued to monitor.  1:26 Pso2 99% pusle 65 continued to monitor.  1:38 client decided she was okay to leave still cold and shakey.  Informed she could stay longer to be monitored. Decided she would leave and try to warm up in her car.  Was informed to seek medical attention if any other problems.  Given V-safe information for follow up.
No additional AE/PQCs reported; Administration of improperly stored PROQUAD; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.         On 05-NOV-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) for prophylaxis, lot number reported as T015598 and expiration date as 02-NOV-2021 (dose, vaccination scheme and route of administration were not provided). No additional adverse event reported.             The vaccine had a temperature excursion of 20.5°F (degree Fahrenheit) for a time frame of 1 hour 54 minutes, and the data was recorded by a digital data logger. It was also reported a previous temperature excursion of 6°F to 14°F (12.3F) for 23 hours.
Eruption of erythemic plaque over injection site of Varicella vaccine - lateral aspect of R deltoid. Lesion is ~3.5cmx5.5cm diameter, ovoid shape, discrete borders. Lesion is non-tender, warm to touch. Erythema localized to lesion, surrounding skin unaffected. Lesion began to gradually decrease in size and color after one day, and resolved completely after two days. No treatment administered.
Same day left arm pain.  Worsening in days two through five.  Arm pain so severe could not raise arm above hip. No overheard reach with L arm for approximately two weeks. L arm pain has continued when lifting arm laterally or when extending/reaching arm out in front or in back of the body. Arm pain so significant cannot lay on L arm.  L arm pain awakens me at night if I accidentally sleep on it. I have not sought medical attention as of yet.    When I received the third dose (booster), on 8/19/21 the person who administered it at the pharmacy stated the vaccine "was not going into the arm as it should" and she had to reposition her needle.    It is unknown if the arm pain is related to the repositioning of the needle or due to the vaccine. I am making an appointment with my medical provider but not sure if there is anything she can do.
Symptoms of Osteoarthritis in back. Severe pain in upper and lower back 4-5 AM since Fall/Winter 2001. Currently taking Vioxx for pain relief.
severe chills first night- couldn't sleep; lethargy & body aches and sore arm for 24-28 hours; runny nose constantly for about a week; followed by red and very itchy chest, face and scalp about 8 days later.
pt recv vax & came down w/fever & thigh swelled;swelling went from groin to knee;areas was really red stated mom;
Patient c/o dizziness, feeling hot, and headache @ 12:45PM.  1:05PM c/o sore throat, and difficulty swallowing.  Dr. consulted.  1:10PM patient given Benadryl 50mg po per order of Dr. 1:30PM patient calm, throat improved.  2:00PM taken to ER by Foster Mother/Guardian.  11/02/2009 School Nurse  reported patient is in school, no problems; Seen @ ER on 10/30/09 - evaluated, and released.  Patient ate supper that night, and felt better by next day.
This spontaneous report was received from a registered nurse and refers to a 12-year-old female patient. The patient did not have any medical history, concomitant medications and drug reactions or allergies. On 09-AUG-2017, the patient was vaccinated with the third dose of GARDASIL 9 intramuscularly lot # M040412 with expiration date on 03-JUN-2017 (the dose was not reported) as a prevention of human papilloma virus. On the same day, immediately after the administration of the vaccine, the patient passed out. An unspecified treatment was given for the event. The patient recovered from the event on the same day. The relatedness between the event and GARDASIL 9 was not reported. Upon internal review, the event of passing out was considered to be medically significant. Additional information has been requested.
REPORTED: 1.  REDNESS AT THE INJECTION SITE. 2. EXCESSIVE SWELLING AT THE INJECTION SITE DESCRIBED AS "A KNOT"  THE SIZE OF " A HOCKEY PUCK" 3.  "TINGLING" IN HER FINGERS - THE TIPS OF ALL FINGERS ON LEFT HAND
Social excitablility tactile issues. ADHD. PDO, delays, speech fine motor issues, anxiety fear, often high pitch screaming, regressions, soils in pants. Frequent meltdowns, temper tantrums, sensitivity to sounds, lights, tastes, low frustration , OCD tendencies since Sept. 03. fungal overgrowth in GI tract, Elevated peptides, heavy metal toxicicty, defiient in B6 and vitamin C, mercury and aluminium.
I developed a cold sore on my mouth after receiving my second shot. I even took Valacyclovir tablets as prescribed when needed and they did nothing to stop it from coming on.
Slip disk; This is a spontaneous report received from a contactable consumer 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: INTERVERTEBRAL DISC PROTRUSION (non-serious), outcome "unknown", described as "Slip disk".  Additional Information: The patient got his first dose, and his second dose is in 30 days, but that he has a slip disk in his back, and he wanted to know if he can take Ibuprofen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received her second coronavirus vaccination on March 18, 2021.  Shortly thereafter she became confused.  Patient developed anorexia and weakness after the second coronavirus vaccination. Patient presented to the emergency department 3/21/21 with confusion and hyponatremia and was discharged home. She represented to ED on 3/24/21 for altered mental status and was admitted with encephalopathy and hyponatremia after several days of confusion. Patient required Haldol as well as lorazepam and received 3% saline.  She had an MRI of the brain showing no acute intracranial process and radiograph of the chest showing no acute findings. She was discharged home 3/26/21 but then returned to the ED 3/29/21 for altered mental status, confusion and dehydration and was admitted with toxic metabolic encephalopathy. MD feels toxic metabolic encephalopathy related to second coronavirus vaccination.
This spontaneous report as received from a nurse practitioner refers to unspecified number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. The reporter stated that on an unkonwn dates from 13-OCT-2014 through 29-OCT-2014, 2 doses of improperly stored PROQUAD (Merck) were inadvertently administered to the patients. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD (Merck) was not reported. Product quality issue was not involved. This case is linked to #1411USA003380 via same reporter link. Additional information has been requested.