chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: GK3642), in right arm, on 12Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 11Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep Apnea" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "had prostate cancer" (unspecified if ongoing), notes: but had prostate removed and am now cancer free with PSA of 0.0; "had prostate removed" (unspecified if ongoing), notes: but had prostate removed and am now cancer free with PSA of 0.0; "Latex allergy" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN C, start date: 01Jan2022; ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE], start date: 01Jan2022; MONTELUKAST SODIUM, start date: 01Jan2022; AMLODIPINE BESYLATE, start date: 01Jan2022; TRAZODONE, start date: 01Jan2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Prostatic specific antigen: (unspecified date) 0.0; SARS-CoV-2 test: (unspecified date) Positive, notes: tested positive for COVID on day; (02May2023) Negative, notes: then tested negative for 2 days in a row (May 2nd & 3rd); (03May2023) Negative, notes: then tested negative for 2 days in a row (May 2nd & 3rd); (12May2023) Positive; (14May2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a physician refers to a 11 year old female patient with no known allergies who on 17-JUN-2013, was vaccinated with a dose of GARDASIL (lot number H021194, Exp. Date: 15-AUG-2015), 0.5 ml, intramuscular in the right deltoid. At the same office visit the patient also received MENACTRA and ADACEL. The physician reported that on 17-JUN-2013, the patient lost consciousness for 15 second after vaccination with GARDASIL. The patient laid down for approximately 15 minutes and after that time, pupils were equal round and reactive. The patient had minimal swelling to skull, from the fall. No treatment was given for the experience. The patient was released to go home and had recovered (date not provided) in approximately June 2013. The relatedness for lost consciousness and minimal swelling to skull from the fall and GARDASIL was unknown. Additional information has been requested.
Client in the immunization room for Tdap, Hep B and VZV titers and PPD. Client said he was going to nursing school and needed these test. Questioned client about passing out in the past. Client stated no. Tdap injected in right arm, no bleeding round bandage. Attempted blood draw in left antecubital and was unable to get any blood. No blood when needle removed, cotton ball and bandage was put on left antecubital. PPD skin test was placed on left forearm. Blood received from right antecubital 2 vials and client started to become very pale and stated felt dizzy. Client would close his eyes but when stated his name he always opened them. Very diaphoretic, pale, skin wet to touch. Vitals every 3-5 minutes, after symptoms started. 0925 BP 70/40, 48 pulse, 96 O2 sat. O2 was given for about 1-2 minutes but the O2 stayed 100% without O2 so it was removed. At 0927 BP 72/38, pulse 58. At 0930 BP 80/56, pulse 57. At 0935 BP 87/55, pulse 57. At 0942 BP 87/57, pulse 56. EMS was called and arrived around 0946. They took BP, talked with him, walked him in the room. Client agreed to have someone pick him up at the HD and drive him home and not to drive for the rest of the day. EMS left at 0958, by this time client had pink color skin, dry skin, states not dizzy. Drank 2 10 oz Cokes. Client placed in the front lobby and was watched by front desk until his ride picked him up at the front door.
Soreness at site, redness in upper arm, discomfort in arm with raising about head.
1/20/22  I've been sick since Sunday, today's test came back positive. (Telephone message.)
Pt recv vax on 1/13/99; 5 min post vax pt exp urticaria over entire body x 20 min; tx=Benadryl
I feel as if something is lodged in my throat upon swallowing, and I can feel it in my throat when talking. It doesn't prevent me from swallowing or talking though. I had this symptom post-flu shot last year as well, approximately 3-6 hours afterwards.
Hands numb right and left, and pain thru right hand center; hand veins bulge; Extreme allergic skin rash on hands thru wrist; Entire body swollen; Extreme headache, eyeache and dizziness; Fever of 99.6 (96 degrees normal on thermometer I have); Every old injury site reactivated--could not put weight on right hip and ankle/foot pain, back pain; Appeared to activate neurologic injuries negatively.  Extreme pain, inability to concentrate, sore throat. VERY weak. Could not grasp with right hand--too swollen to hold a cup. Strange dreams and old memories surfaced. Face had flushed red immediately after shot, but severe reaction the next morning. Afraid of further swelling to do shot #1 - 8th day arm swelling and heat.  Left arm still bruised from shot # 1.  Just tired and slight reactions after the bad day of 4/23.  Symptoms subsiding.
pt started having fever & gen convuls on 17SEP97 approx 1AM;mom called & told to go to ER;pt was intubated & was transferred to children hosp;
Patient developed itching 2 hours post vaccination. On 3/10/2010 patient developed rash on abdomen pinpoint not raised, lowgrade fever on and off, headache, malaise and fatigue.  Called family Physician, per patient they stated it was an adverse reaction and recommended that she did not receive the second hepatitis A.  Phoned patient on 3-16-10 and she stated that she was completely better.  Rash lasted 24 hours.  Fever was 2 days on and off and lips were puffy.
Pt had shortness of breathe, said can't breathe, mom drove to urgent care for help..they gave an epinephrine and Benadryl injection.
pt recvd vax & cried from 1230PM-530PM, screamed almost cont then was very fussy til 10PM; no hx of sz, unusual movements, limpness, pallor or lethargy; no fever; did well p/that;
Strong menstrual cramps and bleeding for 4 days. I have had an IUD in place for years and do not get a period anymore. This was abnormal for me.
Tdap & MENACTRA given in (L) arm at CP on 8/24/12, mom calls next day, site red, hot to touch, hard painful, no streaks. Limited ROM. Afib. Referred to ED for eval. By 8/27/12 arm better & good ROM.
Per secondhand report, client collapsed a few hours after receiving vaccine.  She was taken to ER by ambulance and then was released to home after being seen.   Client never responded to outreach attempts.
Approx 1-2 min after injection pt c/o feeling hot - palm hand - red splotches 5-10 min lump in the throat - nauseous.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 20-SEP-2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-OCT-2015 through 15-OCT-2015, the patient was admitted to the hospital for the inpatient treatment of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, zoster ocular disease, and zoster conjunctivitis (conditions of zoster infections with interference into the eyes). The patient was prescribed intravenous acyclovir and NEURONTIN for management of her painful symptoms. The patient sought subsequent treatment for neuropathic pain and is monitored by ophthalmologists for her eye disorders attributable to the vaccine. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Upon internal review, zoster ocular disease was considered medically significant. Additional information has been requested.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On 28-JUL-2016, the patient was vaccinated with improperly stored M-M-R II (lot number: K014833, expiry date: 14-SEP-2016). No adverse effect was reported. Reporter also mentioned that the patient would be scheduled for revaccination in the future. This is one of the several reports received from the same reporter. Additional information has been requested.
Moderate arm pain, burning when trying to tense muscle beginning 4h after vaccine and at worst by bedtime. Palpable fatigue on day of and day after vaccination. Sore throat and swollen tonsils day after vax.
Chills x 2d. (+) malaise, body aches, temp 99.5 post Tylenol. Red erythemic blister; palpable lymph nodes to L axilla and L brachial. Large induration of approx. 2cm x 2cm around vaccine site. One cm round blister. 24 hours QTRS.
Pain and tenderness in both armpits (particularly on the side of the injection); This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route of administration in the left arm on 13Apr2021 at 12:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. 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 ubidecarenone (COQ10), prasterone (DHEA), vitamin d nos (VIT D), unspecified multivitamin and chinese herbs; all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received trimethoprim (MANUFACTURER UNKNOWN) and experienced drug allergy. On 15Apr2021, the patient experienced pain and tenderness in both armpits (particularly on the side of the injection); pain was continuing and she was two weeks post vaccination. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event pain and tenderness in both armpits (particularly on the side of the injection) was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Had COVID-19 Virus; Had COVID-19 Virus; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 15Apr2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that she have the first dose of Pfizer Vaccine around March and she doesn't remember the exact date and was supposed to get 2nd dose on 15May2021, however the patient had COVID-19 Virus on an unspecified date 2021 and she missed her 2nd dose and she want to know is she eligible or supposed to get the 2nd dose now. She was also stated that, I got my vaccine card, my first shot was 15Apr2021 and then I was due to get my other shot 15May2021. I had COVID-19 on, that was a week before Mother's Day, so I didn't get my shot of course. So, my question is can I get the 2nd shot. The outcome is reported as unknown.   Information related to batch/Lot no. was requested.
Bloody nose in my right nostril. I rarely get bloody noses and am unsure if it?s related to the vaccine. It took approximately 10 minutes of heavy bleeding to cease.
Lethargy weakness sleeping a lot head drops seizure like activity not urinating hypoglycemia low muscle tone no eye contact gasping episodes dehydration jerking right arm and leg stiffening and arching of back spitting up.
Mild fever, mild nausea, tiredness. Took some Tylenol (1000mg) and felt somewhat better. Went away around 8pm the same day.
Patient said the evening after receiving her flu shot she starting coughing. She coughed for 4 days and also developed runny nose and drainage along with occasional diarrhea. List lasted for about 1 wk total.
Inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 009D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. patient was given first and second dose of the Moderna COVID-19 vaccine 2 weeks/14days apart instead of the recommended window.
Information has been received from a registered nurse concerning a 29 week old infant who was vaccinated on 28-DEC-2006 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Injection site became hard and swelled immediately upon vaccination. Area did not feel excessively warm to touch. Patient complained of being lightheaded with blurry vision that resolved upon sitting. Patient sat around for 10-15 minutes with no further reaction. Advised TYLENOL and BENADRYL for any reaction problems that are bothersome. EPIPEN not warranted, no difficulty breathing.
Blood glucose level 280; This is a spontaneous report from a contactable pharmacist. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the left arm on 29Apr2021 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medical history included diabetes, dizziness and feeling sick. The patient did not have any allergies to medications, food or other products. Concomitant medications included metformin (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 29Apr2021, the patient experienced blood glucose level 280. Denies symptoms of active illness. The patient stated that would be more cautious and take the prescribed medications. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab test and procedure which included blood glucose and the result was shown as 280 (units unspecified). The clinical outcome of the event blood glucose level 280 was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
6:30 am when I got up after sleeping I had hives on my left side neck, left arm, back of neck, stomach.  I took a claritin antihistamine at 7 and hives subsided for two hours and then reoccured.
Reporter indicated that 5 employees have not converted; soe employees recvd 2 courses (6 doses) of Engerix-B; some employees recvd 1 course (3 doses) of Engerix-B & 1 course of Recombivax-HB (3 doses);
developed localized skin reaction rt. upper extremity with small axillary nodes, low grade fever, pain at site,
HEART PROBLEMS; This spontaneous report received from a patient concerned an 81 year old male. The patient's height, and weight were not reported. 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, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced heart problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart problems was not reported. This report was non-serious.
Vaccines given in left thigh area. Patient seen at clinic and left thigh noted to be swollen and red rash noted around injection site. MD assessed leg.
GI intolerance; Initial information regarding an unsolicited valid non-serious courtesy case received  via physician received on 23-Feb-2023.  This case involves elderly female patient who experienced gastrointestinal (GI) intolerance after receiving vaccine Influenza Vaccine (Flu Vaccine).  It was unknown if the patient had any medical history, concomitant disease, or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect Influenza Vaccine produced by unknown manufacturer at (unknown: formulation, strength, dose, lot number, route, administration site) for prophylactic vaccination.  On an unknown onset and latency, the patient developed a non-serious GI intolerance (gastric disorder) following the administration of Influenza Vaccine.  Action taken with Influenza Vaccine (Flu vaccine) was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown.
About 9 days after receiving Moderna booster, I developed itchy rashes and hives all over my body, but particularly my scalp, neck, torso, and groin. They have been remained present until today, 10 days after first appearance, and show no signs of abating. The hives get better and worse over the course of the day, but rarely completely disappear. They are not quite unbearable, but very itchy and unpleasant and get worse if I scratch.  I had only mild side effects to the first two shots (also Moderna) - arm pain and fatigue, but no skin issues. I have no known severe allergies (beyond a very minor walnut allergy) and have never had skin issues in the past. Nothing changed with my diet or exposure to detergents etc. I am healthy, normal weight.
Information has been received from a healthcare provider concerning an approximately 9 month old (reported as 8 months and 30 days age) patient of unknown gender. The patient's pertinent medical history and concomitant therapy were not provided. On 21-OCT-2015, the patient was vaccinated with a dose of M-M-R II (lot # K021950 with expiration date 10-NOV-2016, dose and route unspecified) and a dose of VARIVAX (Merck) (lot # L019999 with expiration date 02-JUN-2017, dose and route unspecified) at the same visit (inappropriate schedule of vaccine administration). No adverse effects were reported. Additional information has been requested.
On 09/03/2022 I had my vaccination. I woke up on 09/13/2022 with a cough congestion and some general fatigue. I took a at home COVID-19 test and it was negative. On 09/14/2022 I went to urgent care and tested COVID-19 Positive. I started Plaxovid on 09/14/2022. I am still having some chest congestion and cough on 09/20/2022.
Side effects understated: I developed shakes (not shivers) and cold (not chills) -- could not get warm (house temp was 78 degrees) the shakes were visible by others. This lasted about two hours. The next day (08/31/2011) very tired -- walking very slow. Today (09/01/2011) seem to be better. I think the side effects are grossly understated -- I've had flu shots before and NEVER experienced this!!! the name of this shot: Fluzone SPLT 2011-1 ---
Sciatic nerve back pain; I have essential tremors.; Could not breathe, it caused pain; Could not move; Could not walk; Could not sit; Could not lay down; fever; Arm swollen up bigger than a baseball; Dizzy to the point where I almost fell four times; Entire body had tingling; numbness; Sweating; headache; rash on my face for three days and my arm; rash on my face for three days and my arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 55-years-old female patient received bnt162b2 (BNT162B2, solution), dose 1 via an unspecified route of administration, administered in Arm on 05Mar2021 (Batch/Lot Number: EN6205) as dose 1, single for covid-19 immunisation. Medical history included neoplasm malignant, Low immune system, Respiratory and pulmonary issues, Neural issues, and Allergy. Concomitant medication included loratadine, montelukast, vitamin d3, primidone, salbutamol (VENTOLIN [SALBUTAMOL]) taken for an unspecified indication, start and stop date were not reported. Patient stated, I had been trying to get somebody to pick up through this the phone for two days here. I had a vision disability, so I can not go online to talk about the Pfizer vaccine side effects that were quite severe. Seemed to be signs and symptoms for the people I was close to who have the same chronic conditions, I didn't know if there's correlation. I was trying to get the data reported so the next vaccines that come out might possibly take this into account." Patient further stated, The side effects to the Pfizer's first dose. The first dose, I immediately had sciatic nerve back pain that lasted for the entire two days, so bad I could not move, I could not walk, I could not sit, I could not lay down, could not breathe it caused pain. I went to get a hold of the doctor who prescribed the medicines for that. Like I said, don't know if it's related because I also have a back inherent disabilities and I also have neural issues. I have essential tremors. I also had neural issues when I had disability with fractured hand. That was the worst from the first dose, there was a headache, there was rash on my face for three days and my arm, even though I was on the allergy medicine already that they prescribed was swollen up bigger than a baseball. I was also dizzy to the point where I almost fell four times. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.