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 70-year-old female patient (not pregnant) 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 69 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Total cholesterol greater than 200" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood cholesterol: Total cholesterol greater than 200; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course details: The patient received Paxlovid on 19Dec2022 for the event and the treatment stopped on 24Dec2022. The patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
COUGH; CHEST CONGESTION; TIRED; MUSCLE ACHES; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included fall and concurrent conditions included high blood pressure, seasonal allergies and bleed on the brain. The patient experienced drug allergy when treated with ciprofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. Concomitant medications included metoprolol tartrate for blood pressure. On 13-MAR-2021, the subject experienced cough. On 13-MAR-2021, the subject experienced chest congestion. On 13-MAR-2021, the subject experienced tired. On 13-MAR-2021, the subject experienced muscle aches. On 25-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 97.2 Unit Not Reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cough, chest congestion, tired, and muscle aches. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Missing second dose appointment; Got COVID after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID after first dose) and PRODUCT DOSE OMISSION ISSUE (Missing second dose appointment) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced COVID-19 (Got COVID after first dose). On 25-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missing second dose appointment). On 25-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Missing second dose appointment) had resolved. At the time of the report, COVID-19 (Got COVID after first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Caller reported, that his brother, received his first dose of Moderna Vaccine on 25-Feb-2021 and 2 weeks later contracted COVID. Brother's wife didn't get the vaccine and also tested positive for COVID at the same time her husband did. He had the virus for ten days now, doctors say that he was still recovering from it,  but COVID was almost over. Brother's second dose was scheduled today but he won't be able to get it.
This case was considered medically important (OMIC). Information regarding HIB-TITER vaccine was received from a mother regarding her 4 year old son who developed autism. At 13 months of age, the patient received the third dose on 4/27/01. The patient's concurrent illness includes asthma. Indication for HIB-TITER was immunization. Product was administered on 4/27/01. The dose regimen was 1 dose (IM). Additional suspect medication included Acel-Imune Vaccine. Concomitant therapy included Flintstones Multiple Vitamins. On 7/29/04, a 4 year old male patient was diagnosed with autism. Approximately one year ago, the child's teachers expressed concern over his unusual behavior. The child's mother stated that her son is small for his age but has been in excellent health other than a couple of bouts of asthma when he has been sick with the flu, cold or virus. No additional information was available at the time of this report.
HARD TO FOCUS VISION, IMPROVING AFTER 5-10 MINS, CHECKED I WITH PARAMEDICS .  LEFT BY HERSELF AFTER RECOVERING.
I was inadvertently given un-diluted Pfizer vaccine, I was informed later by the Pharmacy Coprorate office the adminstered vaccine of 150 micro ram (undiluted) equivalent to five times allowable dose, in otherwords I was overdosed with the Pfizer vaccine.
have stayed in the bed all day; got my 1st one in August then went yesterday to get my second one, it; aching and hurts all over; fever; This case was reported by a consumer via interactive digital media and described the occurrence of generalized aching in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had chickenpox when patient was kid). Concomitant products included SHINGLES VACCINE (NOS) (SHINGLES VACCINE).   On 19th September 2021, the patient received the 2nd dose of Shingles vaccine. In September 2021, less than a week after receiving Shingles vaccine and an unknown time after receiving SHINGLES VACCINE, the patient experienced generalized aching and fever. On 19th September 2021, the patient experienced drug dose administration interval too short. On 20th September 2021, the patient experienced mobility decreased. On an unknown date, the outcome of the generalized aching and fever were not recovered/not resolved and the outcome of the mobility decreased and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the generalized aching, fever and mobility decreased to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the first shingle shot in august. The patient received second dose one month early, which led to shortening of vaccination schedule. The second shot did not hurt when patient got the vaccine but sometime during the night it started aching and hurts all over. The patient was running a fever and on the day of reporting patient stayed in the bed all day, hurting and running a fever. The patient would not ever get another one . The patient would better think twice before getting one.
Fever, chills, aches, difficulty breathing, confusion,  shaking,  Swollen joints  hands, neck, throat, and tongue lasting from 4/15-4/18.  Convulsions began 4/16-4/17.   Treated with benadryl and ibuprofen and Tylenol and albuteral inhaler.
my cpk levels had spiked to 2300; Rhabdomyolysis; abdomen muscles were very sore and hurting terrible; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 19Aug2021 16:00 (at the age of 37-years-old) (Batch/Lot Number: EW0167) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included none. Concomitant medications included diclofenac (VOLTAREN [DICLOFENAC]); and amlodipine besilate (NORVASC). After a day or two after vaccination on 21Aug2021, it was reported that the abdomen muscles were very sore and hurting terrible. The patient went to the doctor and described what was going on, they took blood tests and found that the cpk levels had spiked to 2300. The patient was sent to the emergency room and put on iv's, he had to stay in the hospital overnight on iv's as they monitored his cpk levels. They began to go down and he was released after 24 hours. The was diagnosed with Rhabdomyolysis. The patient was hospitalized for my cpk levels had spiked to 2300, and Rhabdomyolysis from 21Aug2021 to 22Aug2021, both assessed as Life-threatening. The patient underwent lab tests and procedures which included blood creatine phosphokinase: increased on 21Aug2021 cpk levels had spiked to 2300, blood test: unknown results on 21Aug2021, sars-cov-2 test: negative on 10Sep2021. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering. The patient did not have COVID prior vaccination. The patient was covid tested post vaccination, nasal swab on 10Sep2021, negative.
Patient immediately developed respirtory distress and wheezing concerning for anaphylaxis. Was given an IM injection of epinephrine alone with albuterol nebs which didn't improve her symptoms. She was not responsive to 4 albuterol nebs and an epinephrine drip and ultimately require intubation and mechanical ventilation. She stabilized on the ventilator but required a MEDEVAC to a civilian hospital for ongoing care.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/15/21,pfizer,Lot# 2nd dose: 02/06/21,Pfizer,Lot#  Diagnosed covid positive:07/23/21 symptoms started:07/20/21 Exposure:Unknown Symptoms:Muscle aches.
Chills, body aches, nausea, headache, soreness at injection site, fatigue.
metallic taste in her mouth; lightheadedness; headache; nausea; tingling lips; This is a spontaneous report received from a non-contactable health care professional (HCP). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6205), on unspecified date (at the age of 41-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history included that patient mentioned having a history of anxiety and she took her duloxetine and WELLBUTRIN the day of the present report (05Mar2021). The patient's concomitant medications included duloxetine and bupropion hydrochloride (WELLBUTRIN), both from unspecified date for anxiety. She denied use of her lorazepam (ATIVAN) recently. It was reported that during her 15 minutes waiting period after the injection, the patient began to experience lightheadedness, headache, nausea, tingling lips and a metallic taste in her mouth. She denied rash, difficulty breathing, difficulty swallowing, throat tightness, facial swelling and lip swelling. Treatment included paracetamol (TYLENOL) and water. Response to treatment was good. She noted some lightheadedness prior to discharge but other symptoms were improved. Reporter walked patient around the bay area and she was feeling okay. Her vitals were stable. Patient was escorted out of the facility. As per patient discharge it was reported stable to go home and follow-up with primary care physician (PCP). The outcome of the events was resolved.  No follow-up attempts are possible. No further information is expected.
On 3/7, 5 days after my 1st dose on 3/2, I noticed a hard lump on my left collarbone first thing in the morning. As the day wore on the bump became larger and softer and the soft tissue above my collarbone swelled. By the evening of 3/7, my swollen lymph node began to drain into my armpit, and those lymph nodes became swollen. they both remain swollen and very tender for about 48 hours.   Then on 3/9, I developed a welt-like red spot on the top of my left shoulder. It persisted until 3/12. It was about 3 inches long by 1.5 inches wide, with a darker red outline. It was not sensitive or tender to the touch.  As of today, 3/12, I still have a small, hard lump on my left collarbone, but it is no longer swollen or tender.
This spontaneous report as received from a pharmacist refers to a 68 years old female patient with no pertinent medical history or drug allergy. On 28-JAN-2012 the patient was vaccinated with live ZOSTAVAX(lot# reported as H0187B; expired date: January 2014). There is no concomitant medications. On 16-FEB-2013, the patient experienced generalized itching all over her body, with no rash present. The outcome of the event was reported as not recovered. No lab tests were performed. The patient had sought medical attention via calling pharmacy and pharmacy visit. Additional information has been requested.
Rash onset Sunday April 6, 2014, afebrile. appetite good, rash increasing in quantity fast since onset. Constant cough one day (sunday), nasal congestion since date of immunization.
No additional AE reported; Patient was administered Improperly Stored, Separate PROQUAD; This spontaneous report was received from registered nurse and refers to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On 12-OCT-2022, improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, albumin status: recombinant human albumin (rHA), lot #W002785, expiration date: 24-JUL-2023 (dose, route of administration and anatomical location were not provided) were administered to patient for prophylaxis. The vaccine experienced a temperature excursion of 70.65 degree Fahrenheit for 4 hour and 15 minutes on 09-OCT-2022 (product storage error). There was previous temperature excursion of 14 degree Fahrenheit up to 46 degree Fahrenheit for 2 hours and 47 degree Fahrenheit to 77 degree Fahrenheit (68.9 degree Fahrenheit) for 2 hours on 23-SEP-2022. No additional adverse event was reported.
After about 5 hours of injection, started feeling like in a different world and developed a severe headache, later a slight fever and muscle pain. Took tylenol every 6-12  hours for two days. After about 30 hours symptoms went away but had a headache frequently. Last night I got a poor eye sight and my right arm was numb and had a pain on left side of head including ear. I went to the emergency room. Some of tests were done and they came up normal. I was prescribed butalbital-acetaminophen-caff for migraine.  I am not sure whether this is related or not. But, I have my second dose scheduled to 22 nd of April and I am concerned about the side effeccts.
It was found the morning after that the vial had expired on 10/10/21, Vaccine was administered 10/12/21. Patient has had no symptoms or experienced any illness since administration.
Client with short term memory issues came to COVID vaccination clinic requesting his 2nd vaccine.   Staff person, RN looked client up in Immunization Information System and it was found that client had had 1 dose listed.  Client was given his "second dose."    Later, it was found that client had 1 dose at Pharmacy, but this was apparently not entered into  IIS, therefore, client received a 3rd dose on 5-25-21.  Client has been monitored since this dose and has denied any side effects.
Second day after vaccine, developed mild neck pain but by 3rd day, pain severe enough to limit neck movement (like unable to look up) without pain.   Same on 4th day after vaccine, aspirin and heat no positive effect.  5th day took 50mg pill of diclofenac, next day great improvement and mobility almost fine but with some lingering neck pain for a week.
Approximately 10 minutes after vaccine injection the left side of my face started feeling numb and tingly, started near jaw line, left side of my mouth, radiated up toward left cheek.  A few minutes later my left eye felt weird, then I could feel something not normal in my left ear.   This whole episode lasted approximately 1 1/2  to 2  hours, with decreasing symptoms as time went on.     No treatment was given, I was quite scared and tried to rest and relax in my vehicle in the clinic parking lot for about 30 minutes.   Since the symptoms did not worsen I left and kept monitoring and being aware.
Large red welt on upper arm immediately, measuring about 6 inches. Persists 6 days. Two weeks later, fingertips become numb and abnormally smooth. 4 days later skin on fingers starts to peel and overnight a large red lesion appears on right cheek. Myriad keratoses erupt on back and shoulders, some on upper arms, forehead, scalp, back of hands, 3 on abdomen. Mild diarrhea. Five weeks after injection, skin on feet begins to peel, eventually producing inch-long peels. Mild peeling on elbows; elephant-skin-like patches on knees. Warts on back of hands, with mild peeling. Two months after injection, feet and hands still peeling.
Patient called and presents with itching, rash and flare up on the right arm, extending from shoulder to elbow of arm where FLUZONE HD and PNEUMOVAX were given on 11/3/17. Pt had used Hydrocortisone but no improvement until told to use BENADRYL gel. Condition has improved and patient is okay.
Area of erythema and induration at Dtap site. Size 14 x 13 cm.
Information has been received from a physician concerning a 9 year old female who on 15-JUN-2007 was vaccinated with her second dose of varicella virus vaccine live (Oka/Merck). On 18-JUN-2007 the physician was contacted because "over a 48 hour period after receiving the vaccine", the patient's arm where the injection was received was red, swollen, hard bump, and the size of an orange. It was noted the patient received her first vaccination of varicella virus vaccine live (Oka/Merck) around 12 months of age. The physician was concerned that this was cellulitis, but deemed this was not the case. Follow up information by the physician reported that the patient has recovered. Additional information is not expected.
Lip swelling with patchy redness but progressed after taking tylenol. Resolved next day at around 5pm.
The adverse event was severe heartburn/acid reflux.  This lasted for one month, following the second dose. I took every over the counter acid reducer medication that I could buy,  and I took a family member's prescription Omeprazole 20 mg. Finally, after one month, the acid reflux stopped.
ULCERATIONS IN HIS MOUTH; FREQUENT TOILETING; RESTLESSNESS; CHILLS; MALAISE; This spontaneous report received from a patient via a company representative 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) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 01-APR-2021, the subject experienced ulcerations in his mouth. On 01-APR-2021, the subject experienced frequent toileting. On 01-APR-2021, the subject experienced restlessness. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced malaise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, malaise, ulcerations in his mouth, frequent toileting, and restlessness. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Patient was given Pneumovax 23 instead of Prevnar. Parent denies any adverse events 3-4-08.
Numbness in hands and lower arms for duration of a low grade fever (about 5-6 hrs.)
lump sized and shaped as a half hard boiled egg; lump sized and shaped as a half hard boiled egg; warm lump; red lump; rash all over her back; very tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump sized and shaped as a half hard boiled egg), VACCINATION SITE INDURATION (lump sized and shaped as a half hard boiled egg), VACCINATION SITE WARMTH (warm lump), VACCINATION SITE ERYTHEMA (red lump) and RASH (rash all over her back) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE MASS (lump sized and shaped as a half hard boiled egg), VACCINATION SITE INDURATION (lump sized and shaped as a half hard boiled egg), VACCINATION SITE WARMTH (warm lump), VACCINATION SITE ERYTHEMA (red lump), RASH (rash all over her back) and FATIGUE (very tired). The patient was treated with OMEPRAZOLE at an unspecified dose and frequency; ZINC at an unspecified dose and frequency; CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) at an unspecified dose and frequency and MENADIONE (VITAMIN K [MENADIONE]) at an unspecified dose and frequency. On 01-Mar-2021, FATIGUE (very tired) outcome was unknown. At the time of the report, VACCINATION SITE MASS (lump sized and shaped as a half hard boiled egg), VACCINATION SITE INDURATION (lump sized and shaped as a half hard boiled egg), VACCINATION SITE WARMTH (warm lump), VACCINATION SITE ERYTHEMA (red lump) and RASH (rash all over her back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Follow up received on 1st May 2021 and it contains No New Information
Pt. developed infection at the injection site developed to cellulitis as confirmed by ER. Pt. is now on antibiotics.
three events back to back----- 1st ,  Left eye extreme bright flashes  constantly for 24 hours--like a flashlight and very bright  -- then went away and became dozens of  very large floaters for 3-4 days , immediately after  2nd --- severe right elbow pain ( I am left handed ) along the elbow ligament --- lasted 4-5 days , immediately after that went away 3rd--- I came down with a severe case of shingles that lasted 6 weeks . I am other wise very healthy , clean diet , no immune system issues , not overweight , exercise 5-6 days a week , don't smoke , don't drink  . I have never had eye flashes before , and my right arm issue wasn't from an accident .
Chronic Migraines. So far every month since December, lasting for about 12 days.
Patient experienced fever, chills and rash (4 inches) on arm at site of injection. Arm was warm and area was swollen.
The nurse stated she reconstituted the 5 to 11-year-old Pfizer COVID-19 vaccine with 1.8mL of 0.9% of normal saline instead of 1.3mL.
Patient said she started having symptoms 2 days after getting the vaccines. The injection site opened up and started leaking a clear fluid. She is having headaches, fever, fatigue and red spots on her skin.
pt recvd 1 dose of Engerix-B & 1 day p/inject 30JUN92 exp generalized itchy rash from toes to head; itchy maculo-papular, small wheal rash in torso & extremities tx DPH;