chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4252543-00 (Agency).  A 28 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 18Aug2021 (Batch/Lot number: unknown) at the age of 27  as dose 3 (booster), single, intramuscular, administration date 29Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 08Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for crohn's disease. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "not recovered" and all described as "COVID-19". The action taken for adalimumab was unknown.  Causality: Causality of : PFIZER BIONTECH COVID-19 VACCINE and events were reported as Possible and causality of HUMIRA and events were not reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE  and covid-19 and BNT162B2.
Client received Moderna over at on 4/3/21. Father brought son over to for his son second dose of Moderna. Nurse RN explained to the father that his son should have not received the Moderna due to his age, Pfizer is only given to 16yrs of age at that time of injection. So nurse called Dr. no response then called Nursing Supervisor for concerns. In the mean time Pharmacy was present and stated that he can receive the Moderna vaccine since he already received the 1st dose per Moderna guidelines so client received his 2nd dose of Moderna at Rec Center on 5/19/21 at 11;30am. Note: Nurse is educated on CDC guidelines and CDC states must be age appropriate. Will follow up tomorrow to assess condition.
tested positive for coronavirus; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 17Mar2021 (Batch/Lot number and Expiry was not reported) as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient was tested positive for coronavirus. It was reported that the patient received first dose of 17Mar2021 and next Sunday tested positive for coronavirus. Laboratory tests on an unspecified date included sars-cov-2 test positive. Patient was scheduled for second dose on 07April2021. Patient wanted to cancel the appointment. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
This spontaneous report was received from a 57 year old non pregnant female patient reporting on herself with depression, chronic pain, fibromyalgia and drug reactions or allergies to fentalyl and LYRICA. The patient's concomitant therapies included levothyroxine sodium (manufacturer unknown), nabumetone, meclizine, oxybutynin chloride, fluvoxamine maleate, atorvastatin, clonazepam, clomipramine hydrochloride, trazodone hydrochloride (manufacturer unknown), chlorzoxazone, metformin, gabapentin, morphine and multivitamin. On 08-DEC-2017, the patient was vaccinated with a shot of PNEUMOVAX 23 on an unspecified arm for the prevention of pneumonia (dose, route of administration, lot number and expiration date were not reported). On 08-DEC-2017, the patient began to experience identical welts in the area on both arms and those had developed into large, swollen and hard bumps on each arm that felt hot and extended under the arms. The reporter stated that it looked like ringworm or like a burn and both hands and both arms are hot and swollen and appear to be getting worse. It was also reported that the patient experienced so bad pain that she could not get off the couch for 2 days and slept for 2 days straight. Furthermore, the patient seek medical attention and had been treating the affected areas with ice. At the time of the report, the outcome of urticaria, hypersomnia, dysstasia, pain, feeling hot, mass, thermal burn, tinea infection and peripheral swelling was reported as not resolved. Additionally, the reporter did not provide causality assessment between the events and vaccination with PNEUMOVAX 23.
Pt. states that after receiving the 1st dose of Boostrix-Tdap 11/07/2021, started experiencing symptoms 11/14/2021 of pain throughout the right arm, pain continuing throughout the neck area, and difficulty with range of motion within shoulder area. Self-treating with over-the-counter pain medications. Primary communications 11/17/2021 via email, waiting for recommendations.
stomach pain; an uncomfortable feeling in my intestines; very loose stool; I can eat, but not like used to do; fatigued; felt a little listless and not as active; felt a little listless and not as active; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LISTLESS (felt a little listless and not as active), DECREASED ACTIVITY (felt a little listless and not as active), PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (stomach pain) and ABDOMINAL DISCOMFORT (an uncomfortable feeling in my intestines) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced LISTLESS (felt a little listless and not as active), DECREASED ACTIVITY (felt a little listless and not as active) and PAIN IN EXTREMITY (sore arm). On 07-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain), ABDOMINAL DISCOMFORT (an uncomfortable feeling in my intestines), DIARRHOEA (very loose stool), DECREASED APPETITE (I can eat, but not like used to do) and FATIGUE (fatigued). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 07-Feb-2021, LISTLESS (felt a little listless and not as active), DECREASED ACTIVITY (felt a little listless and not as active) and PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (stomach pain), ABDOMINAL DISCOMFORT (an uncomfortable feeling in my intestines), DIARRHOEA (very loose stool), DECREASED APPETITE (I can eat, but not like used to do) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
My first dose was 1/14. I found out I was pregnant on 1/26/21 and I miscarried at about 10 weeks. About 15 mins after I got the vaccine, I had a racing heartrate and my palms were hot, but it went away. Around 3pm, I had a right frontal headache. I took a nap and it went away. About 5am Fri, I woke up to severe arm pain and it felt like I was being stabbed in the stomach. I took about 400mg of Ibuprofen, went to sleep and was fine when I woke up. About 5pm Friday, I began having vaginal bleeding. I called my doctor and was able to get in on Feb 11th. At my OB/GYN appointment, they tested my blood and urine, which confirmed my pregnancy. The NP examined me and told me that the bleeding was coming from my cervix, so they sent me for an ultrasound the following week. That's when I was given my calculated date of 10 weeks. A gestational sac was observed, but they weren't sure if a fetus was present. I had to see my doctor every week since I was still bleeding and that continued until March 18th, when I lost the pregnancy completely. I took my specimen to the doctor the following day. They told me that they were sending it out to be tested, but I'm not sure if the results are back. They did confirm that it was a fetus.
got shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingles shot, the patient got shingles twice. Note-Since the dose number was not provided  but as comment, was considered as the patient only had 1st dose only.
Redness and slight swelling near injection site. This did not appear until more than a week after the injection, after the daily check-ins had stopped.
Pt was given pneumococcal vaccine, 3 days later she presented in clinic with cellulitis at injection site, was c/o warmness, redness and itchy at injection site. She was treated with antibiotics.
Within 24 hours post vax, pt developed rash and itching on back of neck and trunk. Pt was given Benadryl. 05/30 Symptoms persisted and rash spread to head and more on trunk.  Pt was given 20 mg Prednisone for 5 days. Rash continues to spread to face and limbs.  Pt taking Benadryl and Aveeno baths.
I was dizzy and nauseous off and on for 4 days but only bad enough to miss work the first 3 days.  I normally have very bad Constipation due to my meds so to get explosive diarrhea has only happened once since my accident in 2010 and that was when I was hospitalized for 2 months with echoli, salmonella and Clostridioides difficile.  It  sucks but not to the point of missing work as have a bathroom 3 feet from my office.  So ther than that just a very sore arm for 24hrs.  Dreading 2nd shot but work on base and infection rate has exploded in the past 4 days.
Extreme arthritis like pain in joints and back of legs and brief waves of head pain.  On May 10, 2021 a foot doctor prescribed Gabapentin 100 mg for nerve pain in foot and I could not take it for more than 3 days.  I had extreme and worsening arthritis type joint and body aches and by the third day my brain hurt and I was worried I would have a seizure so I stopped taking it.   I have had quick incidents of this type of pain since the vaccine, but I always thought arthritis.  On June 29, 2021 I began having really bad joint pains and pains down the back of my legs and the waves of headache.  I could never figure what was triggering these incidents and it was so bad that on June 30, 2021 I went to the doctor.
Client was given Pfizer 2nd dose but should have received Moderna 2nd dose.
Information has been received from a physician via medical records, concerning a newborn female with no known drugs allergies, who's mother was vaccinated on 03-SEP-2009 with a 0.5ml first dose of VARIVAX (Merck) (lot # 665103/1001Y). During pregnancy the patient was also exposed to vitamins (unspecified) and ONDANSETRON RL. She was a term newborn. She was found to be normal but quite tongue tied at birth with a heart shaped tongue. On 14-MAR-2010, the patient was doing well; the patient's mother decided not to breastfeed, she also declined frenulectomy. All the following laboratories came back negative: amino acidemias, biotinidase deficiency, congenital adrenal hyperplasia, congenital hypothyroidism, cystic fibrosis, fatty acid oxidation galactosemia and organic acidemias; hemoglobinopathies were normal. The infant passed her hearing screening. On 15-MAR-2010 at 12:00 the patient was discharged home in a stable condition with her parents. On 17-MAR-2010, the patient's mother was requesting frenulum clipping to ease some discomfort of breast feeding and to prevent speech problems later on. Discussed technique for this and both mother and father consent to this procedure. Using an iris scissors, the physician was able to get the baby crying and her frenulum was clipped. She did have improved movement of the tongue and no longer having the heart shaped indentation at the tip. Minimal bleeding less than 1 cc and patient tolerated the procedure well. She took a pacifier and calmed down immediately after. Metabolic screen was pending. Her physical examination was within normal limits. On 31-MAR-2010 the patient had another well-child check. It was noted that the patient had a little bit of nasal congestion and watering eyes, but otherwise she was doing well. Her parents have switched her over to formula full time. She was above her birth weight. Her metabolic screen was normal. She did have some normal watery eyes consistent with some mildly blocked tear ducts within normal. Physical examination was within normal limits. The mother's experience has been captured in WAES # 0909USA01277. No further information is available.
Felt lightheadedness after vaccine, BP128/80 HR98, provided water and monitored for 30 minutes, left in stable condition
pt recv vax & w/in 24 hr post vax pt exp numbness, paresthesias, & tingling in all 4 extremities;
The day after I received my shot, I had full body pain & brain fog. The pain went away in 24 hours but the brain fog remains a week later. (It dissipated for a moment a couple days in but came right back.)  It has been impossible to focus my eyes & it has been extremely difficult to think or do daily tasks or drive.  I looked in the mirror 2 days ago & noticed that my pupils were dilating & contracting rapidly; still doing it today.  I?m definitely more sensitive to light but also noticed that my sense of smell seems improved. This morning I still am feverish/chills but have added nausea to my list of symptoms.
pt recv vax 24JUL98 & 25JUL98 pt devel a 2x2inch red swollen area @ the inj site on rt arm & the arm felt heavy;
3/29/06 Flu symptoms. Saw PCP on 3/31/06 Flu symptoms 2nd wk-extremity/joint pain and muscle pain. 3rd wk tremors in neck, shoulder and hands. Dx: Carpal tunnel.
TOOK FIRST TWO DOSES WITH FOOD; This spontaneous case report was received from a pharmacist (PVX2019-375) on 11-Feb-2019. The report describes a male consumer who "took first two doses with food". The consumer was receiving Vivotif for an unknown indication.   It was reported that the consumer took the first two doses of Vivotif with food on 07-Feb-2019 and 09-Feb-2019, respectively.  The action taken with Vivotif with respect to the event "took first two doses with food" was not applicable.  The clinical outcome of the event "took first two doses with food" was unknown.  Company's Comment: The causality of the event "took first two doses with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took first two doses with food" was considered as not applicable.
Patient presented to pharmacy 3 days following vaccine administration with a red rash  approximately 3 inches in diameter on mid-upper arm at least 1-2 inches below thickest part of deltoid muscle. Patient reports that this is where vaccine was administered. Although the pharmacist who documented vaccine administration reported it was given IM in left deltoid, by observation 3 days later, it was evidently administered below the deltoid, more likely hitting subQ tissue.
pt recv vax 10FEB97 & 16MAY97 pt devel a mild case of varicella that was comprised of 20 lesions that were primarily on trunk & behind ears;some of the pimples were fluid-filled;
two hours after injection I ran across a road and my heart began to race and I felt like I couldn't breathe.  I slowly went into the post office and was offered a chair.  It was over as fast as it hit me and everything was fine after that. No other adverse effects since then
This spontaneous report as received from a healthcare worker referring to a male patient of unknown age. On an unknown date, the patient was vaccinated with two doses of VARIVAX (dose, frequency, route of administration and indication were not reported). On 28-OCT-2015 (reported as "about 2 weeks ago" (from 11-NOV-2015)) the patient developed chickenpox. The outcome of chickenpox was unknown. Causality assessment was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Moderna COVID vaccine administered on 12/31/2020 and the person had a couple of hyperglycemia episodes over 450 a few days later.
Patient c/o dizziness and nausea  3:25 PM  Vitals: BP 102/56 HR 71 Resp 16 O2Sat 90  Skin Signs: Cool, clammy, diaphoretic, other - pale  Initial Treatment: 3:24 PM patient states he feels tingling sensation in his hand bilaterally. Patient presents very pale, diaphoretic, and cool. Denies previous medical hx. 3:27 PM patient continues to improve, denies emesis but continues to present pale and diaphoretic.  3:40 PM  Vitals: BP 102/62 HR 68 O2Sat 96 Skin Signs: Diaphoretic, other - pale  Follow up Treatment: Continue to monitor patient. Advised patient to drink water and provided patient with juice.  3:55 PM  Vitals: BP 116/60 HR 52 O2Sat 97 Skin Signs: Warm and dry  Follow up Treatment: Patient continues to improve both in presentation and vitals. He stated he feels better and is ready to go home.  Home with SO driver.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received PAXLOVID as COVID 19 Treatment from 21Sep2023 to 26Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
DIZZINESS, FEELING HOT/SWEATY, SX RESOLVED, REFUSED TRANSPORT.
Patient was not acting like himself.He did not react to stimuli. He did not respond with his eyes. He was staring. There was no movement. When he took him on the shoulder he was limp and staring. It was like this for about 15 minutes then it started to react slowly. Days later he began to act slowly. As the week passed, he began to be more active until he returned to normal. He gave him something similar but milder two months later.
Extreme pain in left arm to the point that I cannot lift, hold or use arm. Pain is from shoulder to fingers and has not gotten better in 7 days.  Assuming reaction with connective tissue disease,  nodule forming at elbow and swelling in arm, elbow and fingers.  Pain has not eased one week after vaccination.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021 at 3:24 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 3:21 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 61.43 and 61.50. Concomitant products were not provided. On 02-Mar-2021, excursion time was 09 AM, 10 AM, 11AM, 12PM, 2PM and 3PM,  and temperature was 27, 29, 32, 33, 35 and 36 respectively, total doses given for the day was 177, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 02-Mar-2021. 16 vial was moved to clinic on 02-Mar-2021. Vaccine BUD date was 26-Mar-2021. Vial was stored on cooler 1, on 27-Oct-2021, Excursion duration At, 9 AM: 27, 10 AM: 29, 11 AM: 32, 12 AM: 33, 1PM : 36, 2 PM : 35, 3 PM: 36, 4 PM: 37 and 5 PM : 37. On 30-Mar-2021, excursion time was 09 AM, and temperature was, 33, respectively, total doses given for the day was 173, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 30-Mar-2021. 03 vial was moved to clinic on 30-Mar-2021. Vaccine BUD date was 22-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Rash; Achiness; Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Achiness), PAIN IN EXTREMITY (Arm Pain) and RASH (Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced PAIN IN EXTREMITY (Achiness) and PAIN IN EXTREMITY (Arm Pain). On 23-Feb-2021, the patient experienced RASH (Rash). On 21-Feb-2021, PAIN IN EXTREMITY (Achiness) and PAIN IN EXTREMITY (Arm Pain) had resolved. At the time of the report, RASH (Rash) was resolving.            Concomitant medications was not provided Treatment for the events included Benadryl for rash.   Reporter did not allow further contact
Expected sore arm...no more than first vaccine. Chills/aches and headache on Day #1, lessened but continuing on Day #2. Continuing tiredness, some chills and  headache Day #3.  Rash developing around site increasing throughout first week, including  itchy body rash on torso, with less on upper legs and face that worsened after first couple of days. Remaining headache on mornings of Days #5 and #6. I am reporting on Day #6. Rash remains but is not worsening. None of these symptoms are of a serious nature. I am reporting for record keeping purposes only.