chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (strength reported as 120 microgram, dose, lot# and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patients or less" received improperly stored GARDASIL that was exposed to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients identifiers were obtained. This report concerns one of the patients. On 30-JAN-2014, at 16:40 PM, the 26 year old female patient was vaccinated with the second dose of GARDASIL (lot # reported as J005661) into left deltoid (dose, route not reported). The medication refrigerator was out of range on the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26; Jan 09, 36/22; Jan 11, 26/40; Jan 14, 22/26; Jan 16, 26; Jan 20, 28/32; Jan 25, 22; Jan 27, 24/26; Jan 28, 20/20. This is one of several reports received from the same source. Additional information is not expected.
felt like she was going to get an allergy; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (felt like she was going to get an allergy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030MZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to arthropod bite (allergy to bees).    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (felt like she was going to get an allergy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in February 2021 for Allergic reaction, at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (felt like she was going to get an allergy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Patient took diphenhydramine because she felt like she would get allergic reaction 20 minutes after the shot, and she did not allow it to happen, she took it for 2 days and she was fine.
Case previously recorded as MA2009-3022. We received the following information via our legal contractor on 15 OCT 2009: A male patient was vaccinated in a pharmacy with influenza vaccine (manufacturer or batch no. unknown) on an unspecified date. The patient had an allergic reaction to the flu shot. He experienced numbness in his left arm and an increased heart rate. The pharmacist on duty administered an epipen shot. The paramedics were called and the patient was transported to the hospital. Interval between vaccination and onset of the symptoms or outcome is unknown. Addendum: Despite requests on 04 OCT 2009 and 21 OCT 2009 we did not receive any further information. No change in assessment.
Initial information received on 22-Feb-2019 regarding an unsolicited valid serious case received from a health professional via other company, Pfizer (Manufacturer Report Number: 2018528839). This case involves a patient of an unknown demographics who developed angioedema, allergy to vaccine, arm became swollen/severe pain, while he/she received vaccine DIPHTHERIA AND TETANUS TOXOIDS. The patient's past medical history included Drug hypersensitivity to Penicillins. The patient's past medical treatment included penicillin with Hives and Swelling/ Angioedema. The patient's past vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious angioedema, following the administration of DIPHTHERIA AND TETANUS TOXOIDS. This event was assessed as medically significant (IME). On an unknown date, the patient developed a non-serious allergy to vaccine and arm became swollen/severe pain (inflammation), following the administration of DIPHTHERIA AND TETANUS TOXOIDS. No lab test was reported. Final diagnosis was arm became swollen/severe pain, allergy to vaccine and angioedema. Corrective treatment was unknown. The outcome of the events was not reported. List of documents held by sender: none.; Sender's Comments: A patient of unknown demographics presented with angioedema, allergy to vaccine, peripheral swelling and severe pain after vaccination with DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer. Time to onset is unknown. Moreover, further information including patient's relevant medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
pt recv vax & inj site rxn characterized by severe swelling & inflammation;this is 1 of 3 patients from this site who exp the above sx
my arm was sore and now it has progressed into my underarm; It's almost like a pulled muscle like a tendon is pulled and contracted. I tried to pull myself up and it pull the muscle.; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (formulation: Solution for injection), (lot number/Expiry date: not reported) via unspecified route of administration on unspecified date as single dose for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. Patient experienced at first his arm was sore and now it had progressed into my underarm. It was almost liked a pulled muscle like a tendon was pulled and contracted. I tried to pull myself up and it pull the muscle on unspecified date. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Following vaccination patient developed symptoms of extreme fatigue, body aches/chills for 3 days. After day 3 she developed dizziness/vertigo, extreme headaches with intermittent blurred vision and difficulty focusing. She was seen in office by this provider 6/4/21 and labs ordered to rule out blood clot. She was seen again 6/14/21 and is feeling somewhat improved but has developed significant abdominal pain with nausea. She has been treated with observation and hydration. Declined medication.
4-8-22 Fri 2am-Can't breath bringing dog in, almost passed-out. Can't walk 5 feet w/o Hyperventilating. From 2:15am till 6am, I'm sitting in the kitchen using Diltiazem ER 120 mg, to stop A-Fib and catch my breath. 4:27am-1 Diltiazem. 5:17am Wheelchair to bedroom and back to kitchen, quite winded. 101 BPMin w/Oxg Meter at 92 %. Hyperventilating to get air. 5:25am-2nd Diltiazem. Feel alert but Jettery. 7:08am Morning Medications (Flecainide, Metoprol and Asprin 325mg) 93 BPMin / 92% Oxy. I feel things settling down and I go to bed at 7:10am.  Getup at 10:35am. 87 BPMin / 89% Oxy. At home test for Covid is Negative. Blood Glucose is 255%. I'm out of breath with little movement. I'm at 90% Oxy but it's not getting to  lungs. I decide to call my sister and have her take me to the Emergency Room. 2pm at the Emergency Room. They finally do a CT Scan of my chest and see Blood Clots in both my Lungs. Right side has Larger clots. They put and IV in my arm giving me Heparin (anti-coagulant) and decide to ship me to another hospital. 6:30pm I'm leaving Emergency Room. 7pm in Ambulance going to the other hospital. 8pm At the hospital and up to the 6th Floor. I was hospitalized from April 8th / Fri till April 11 / Mon - Discharged at 1pm. They did many blood test, Blood Sugar level test, EKG Scans, Heart Echo Scans, had me on a Telemetary Heart Monitor and had an IV in my arm for Heparin medication. I was discharged and told to take Xarelto 15mg / 2x/day and on May 1st take Xarelto 20mg 1x / day - this was for Bilateral Pulmonary Embolism. I was switched to Diltiazem 30mg (quick acting) for palpiations if and when Paroxysmal atrial fibrillation is present, for relief. I was given Insulin shots and now will start Lantus Insulin glargrin at 5 units at Bedtime. I was not told: How long this would last, What the outcome will be, What caused this, or how to prevent it, or if I should be concerned about future Covid vaccinations, so the outcome of this event is "Up in the Air".  I was told to keep using my support shoe for my right foot and use Diclofenac Sodium Gel for Pain relief.  Three other vaccines were listed as: Pfizer, Purple 12+Yrs. This 4th is listed as: Pfizer, TRI-SUCR (Grey-12+Yrs). I was concern at the listed difference. Are they the same ?.
No adverse effects reported; On 29-MAY-2019, the patient was inadvertently administered an expired dose of MMRII (Lot N013869 exp. 04-MAY-2019); Information has been received from a nurse, referring to a 13 months old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-MAY-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # N013869 (expiration date on 04-MAY-2019) for prophylaxis. That was reconstituted with properly stored sterile diluent. No adverse effects were reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 25Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 14May2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "4 torn arteries - carotid and vertebral", start date: 2015 (unspecified if ongoing), notes: 4 torn arteries - carotid and vertebral in 2015. Stroke in recovery after stent inserted in 2015.; "Stroke in recovery after stent inserted", start date: 2015 (unspecified if ongoing), notes: 4 torn arteries - carotid and vertebral in 2015. Stroke in recovery after stent inserted in 2015.; "Known allergies: Sulphur meds" (unspecified if ongoing), notes: Known allergies: Sulphur meds. Concomitant medication(s) included: PLAVIX, start date: 01Nov2015; EMGALITY [GALCANEZUMAB], start date: 01Jul2020.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: Took Paxlovid for 5 days and after 5 days tested negative; (2022) positive, notes: 11 days after finishing Plaxlovid I tested positive; (2022) positive, notes: Next day tested positive with home test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Took Paxlovid for 5 days and after 5 days tested negative. Travelled to withheld and day the patient returned the patient started to feel sick - very tired headache sore throat and high temp. Next day tested positive with home test. 11 days after finishing Paxlovid the patient tested positive. The patient's husband also had COVID first time and took paxlovid but has not tested positive with the patient the second time. The husband did not travel with the patient to withheld. The patient have severe chest pain and burning and very tired with sore throat and high temp. The patient don't have a cough that time.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
itching, redness, swelling to inj site w/mild throat irritation will apply hydrocortisone ointment to site BID & take DPH;
Beginning 6/30/21, fever (102), cough, congestion,headache, nausea, short of breathe, loss of taste/smell, lasted almost 3 weeks. Early nasal swab PCR test was negative but antibody test at 2.5 weeks was positive for recent or active infection
Pt reports seizure that lasted and estimated 15 minutes.  Seizure onset was about 35 hours post-vaccination.  Pt has no history of seizures.  Pt reports being hospitalized overnight and given IV Keppra in the Emergency room.  Pt stable now and has not experienced any seizures since.  Reports some memory loss since seizure.
While Nursing Supervisor was auditing chart it was noted that the MMRV was given at age 14 yrs old. MMRV is licensed for 12 months - 2 yrs of age and not for 13 yrs or older. Unable to contact pt, will continue to try to contact pt and parent.
Rash appeared about 1.5 hr following vaccine administration. Pt received Benadryl by aid station, given Epipen to take home with him. 3 days after vaccination, presented to the ED with sloughing of oral mucosa and ulceration on tongue. Admitted for evaluation for possible Stevens-Johnson Syndrome, not found. Pt was discharged in stable condition after 1 day.
5 minutes after receiving vaccine became very dizzy, and flushed with fast heart rate ,  dropped to the floor near syncope.  Laid down and took off mask for air.  Was offered water and Benadryl. Drank some water then felt better.. Refused the Benadryl.  10 minutes after someone noticed a possible rash on my forehead. Went ahead and took some Benadryl. Later that night had same feelings.. fast heart rate and dizziness. The next day development flu like symptoms with fever up to 102.9. Took a half Tylenol. The next day just felt achy . The day after that had diarrhea.
Recvd vax in the AM; pt slept 11AM to 11PM; had to awaken for bottle; "listless & looked funny" t104 w/APAP; MD ordered DT, 2 older children couldn't take pertussis;
Information has been received from a physician concerning a 9 year old male, with no known medical history or allergies, who on 09/30/1996 was vaccinated with a dose of varicella virus vaccine live.  There was no concomitant medication.  On 09/22/2004 the patient experienced a papular rash, later vesicular, with 50-100 papules.  Unspecified medical attention was sought and the patient was treated with ibuprofen and acyclovir was started.  There was no product quality complaint involved.  Follow up information from a registered nurse indicated that the patient developed a mild outbreak of chickenpox after being vaccinated in 1998.  She reported that the patient was fine.  No additional patient information was available.
1)  Muscle pain in upper left arm, almost immediately after injection, not treated, disappeared after approx. 3 days 2)  Fatigue, next morning after injection, not treated, disappeared after 1 day 3)  Swelling and sensitivity of lymph node in left armpit next day after injection, not treated, disappeared after approx. 3 days 4)  Minor headache next day after after injection, not treated, disappeared same day 5)  Spontaneously occuring extreme itchiness of skin in various places at various times all over my body, initially without any other visual signs. After approx. 2-3 days, minor rashes and welts would appear in same place where itichness was occuring. Rash, welts, and severe itchiness of skin suddenly appear in 2-3 different spots simultaneously, duration approx. 30-60 minutes, then disappear only to re-appear at different parts of body and so on. Itchiness feels like it's coming from inside of body (internal) as opposed to stemming from an external source. First occurred approx. 10 days after injection. From 10/17/2023 treated with L-Carnitin and Alpha Lipoic Acid supplements, resulting in no relief of symptoms. Then treated with 1 tablet daily Antihistamine Fexofenadine HCI 180 mg starting 9:00pm 10/19/2023 resulting in significant reduction of all symptoms from next morning. Discontinued treatment after 3 doses (10/19, 10/20, 10/21), resulting in return of all symptoms from 10/23 onwards. Was hoping that symptoms would dissipate, however since they continued with same severity, restarted prior Antihistamine treatment as before at 9:00pm on 10/28, resulting in significant reduction of symptoms from this morning (10/29).
On 12/23/2021, I had left ear inflammation and swelling. The next day, I went to Urgent Care. They told me that it was not an infection and that it was from my mask. I had not worn my mask, so I did not believe that was correct. I went to my doctor on 12/28, Dr., and was diagnosed with relapsing polychrondritis. This is Deterioration of the cartilage may affect any site of the body where cartilage is present. I am now in my second month of seeing specialists because this attacks the any cartilage throughout my body.
1 hour and 50 minutes after immunization, donor called to report chest pain and difficulty breathing. She was advised to seek emergency care immediately and was asked no further questions.
p/vax pt devel approx 6-10 varicella like lesions;pt was afeb & rash was semi pruritic;
Patient fainted while walking to the waiting area in the pharmacy. He was very hot, dilated pupils. We gave him water, crackers and a cold napkin. After 30 minutes he was able to leave and go home.
My face and neck  and head felt very hot after I went to take a seat in the store. No dizziness,no swelling of tongue and I was that way for about an hour. I left a message with my Pcp.
Information has been received from a 63 year old female patient with sinus infection, allergy to insect bites, tetracycline, penicillin and ampicillin, and a history of "bad poison ivy" 2 years ago who on 09-FEB-2011 was vaccinated with the first dose of ZOSTAVAX (Merck) (Lot #, expire date and route not reported). Concomitant therapy included Z-PAK, aspirin and vitamin D (unspecified). Patient stated that on 11-FEB-2011 2 days after receiving ZOSTAVAX (Merck), the patient experienced an injection site reaction with redness and slight itching. Patient stated that ZOSTAVAX (Merck) was not given deep into the muscle. On 12-FEB-2011, the patient experienced red rash at injection site and inner arm pain. On 15-FEB-2011, the area of her arm was dark red with slight itch, slightly raised and 1 inch wide by 5 inches long going down the arm. There were no blisters or open areas, no drainage or crusting. On 21-FEB-2011, the area had gradually faded and was very light. Patient had not contacted a health care professional. There was no prior history of herpes zoster. No treatment was given to the patient. There were no laboratory diagnostics studies performed. At the time of the report, the patient was recovering. Additional information has been requested.
Pfizer / BioNTech: Dose Number: 3, 2, 1; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: Dose Number: 3, 2, 1; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER7833), in left arm, on 19Apr2021 as dose 2, single (Lot number: EN0150), in left arm and on 07Jan2022 as dose 3 (booster), single (Lot number: FJ1611) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: CARVEDILOL, start date: Nov2018; ATORVASTATIN, start date: May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech: Dose Number: 3, 2, 1; Paxlovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible. No further information is expected.
Narrative:  Fully vaccinated patient admitted from LTC facility for acute hypoxic respiratory failure secondary to COVID-19 pneumonia with sepsis on 08/20/21. For COVID-19, received dexamethasone and remdesivir. Admitted with leg pain and swelling that improved on its own over the hospital course (on chronic warfarin). Had diarrhea on admission, constipation during hospitalization and normal BM on discharge. Treated empirically for bacterial pneumonia (ceftriaxone/azithromycin). Cough and SOB reported throughout admission. Ipratropium added, albuterol changed from PRN to scheduled to target respiratory symptoms. Initially on heated high flow oxygen due to tachypnea and SOB but on room air during/upon discharge. SOB improved. Cough persisted (despite antitussives and resumption of home furosemide). Repeat chest xray without overt heart failure and no acute process. Stable at discharge (8/31/21) Transferred back to care facility. Received notice after discharge patient dies 9/1/21. Cause of death unknown at this time; autopsy planned.
1421 Received flu vaccine. 1427 Sudden onset of severe headache, feeling hot all over, shortness of breath, wheezing, nausea. 1430 Taken to emergency room to receive treatment.
Headache, fatigue, diaphoresis for 2 days after vaccine, followed by sudden visual disturbance with worsened headache and one episode of vomiting. Headache persisted for a week despite patient's typical migraine treatment, which prompted patient to present to the ED (especially considering her history of hydrocephalus).
C/O redness and itching from injection site to elbow the 1/2 the circumference of the arm - arm edematous.
Experienced achiness in the right arm after second shot; fever around 100; felt achy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Experienced achiness in the right arm after second shot), PYREXIA (fever around 100) and MYALGIA (felt achy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Lot#022M20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (Experienced achiness in the right arm after second shot), PYREXIA (fever around 100) and MYALGIA (felt achy). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 24-Feb-2021, VACCINATION SITE PAIN (Experienced achiness in the right arm after second shot), PYREXIA (fever around 100) and MYALGIA (felt achy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.