chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Lot number: 939909) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) positive, notes: On Sunday 5/29 I had no symptoms, tested positive. On Wed. 6/1; (01Jun2022) negative, notes: tested negative. On Sunday, 6/5,; (05Jun2022) positive, notes: woke up with head cold and dry cough, tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient took Pfizer anti viral drug from 24May2022 to 29May2022 for treatment of COVID-19. Adverse event reported as On Sunday 29May patient had no symptoms, tested positive. On Wed. 01Jun, tested negative. On Sunday, 05Jun, woke up with head cold and dry cough, tested positive. Event occurred on 05Jun2022. Patient was recovering without treatment. Known allergies was reported. Patient did not take any other medication within 2 weeks. Vaccine administration time was reported as 02:00 PM.
few minutes after injection, developed chest pain with tightness. brought to obs, resting on stretcher, given water, states 6/10 chest pain intitially. 1020a bp 158/89 hr 63 rr 18 sats 97% on ra. denies hx of htn. 1025a bp 154/89 hr 67 rr 18 sats 99% on ra, states cp and tightness improving to 4/10. denies other s/s. 1035a bp 138/82 hr 72 rr 18 sats 99% on ra. improving s/s per patient. 1055a bp 147/86 hr 62 rr 18 sats 99%. says feeling much better and tightness/pain almost completely resolved. 1056 standing bp 155/89 hr 60 rr 20 sats 99% on ra. discussed further eval at ed but patient resistant. instructed to seek futher intervention if s/s return or worsen. escorted to private vehicle without issues.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (dose, frequency and route of administration were not provided) lot# N017700 and expiration date: 09-JUN-2019. The VARIVAX was reconstituted with properly stored dose of sterile diluent (manufacturer unknown). No adverse effect was reported. The vaccine was stored in between 15 degrees Fahrenheit (F) to 46 F for 1 hour and 9 minutes. Previous temperatures excursions were in between 6F 14F for 76 minutes and in between 15F to 46F for 1 hour and 23 minutes. The digital data logger was involved in recording the temperature excursion. Sender's Comments: US-009507513-1711USA002012.
This vaccine was used after BUD.  Parent did not report any adverse reaction after receiving this vaccine.
DOCUMENTATION INDICATES  THAT A PEDIATRIC DOSE WAS ADMINISTERED TO A CHILD 12 YEARS OF AGE
little sore arm; She is 32 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (She is 32 weeks pregnant) and PAIN IN EXTREMITY (little sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 27-Aug-2020 and the estimated date of delivery was 03-Jun-2021. On 06-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (She is 32 weeks pregnant). On an unknown date, the patient experienced PAIN IN EXTREMITY (little sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy.  On 06-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (She is 32 weeks pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (little sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were Baby aspirin, Prenatal. Treatment medication were not reported.
Hives / on their feet / arms, legs, and stomach/ hives were accompanied by a terrible itch; hives were accompanied by a terrible itch; This case was reported by a consumer via call center representative and described the occurrence of hives in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st May 2021, the patient received the 1st dose of Shingrix. On 23rd May 2021, 2 days after receiving Shingrix, the patient experienced hives and pruritus. On an unknown date, the outcome of the hives and pruritus were recovered/resolved.   It was unknown if the reporter considered the hives and pruritus to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient had received first dose of Shingrix and experienced hives. The patient reported that the hives had began on her feet, then spread to arms, legs, and stomach and the hives was accompanied by a terrible itch. The reporter was unsure of how long it took hives to resolve, after first dose, but reported that they did eventually resolve. The reporter did not consent to follow-up. For tolerance with second dose, refer case US2021AMR162087.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR162087:same patient/reporter (2nd dose)
VACCINE ERROR - PATIENT REQUESTED BOOSTRIX AND WAS ACCIDENTALLY GIVE PFIZER COVID19 INSTEAD. PATIENT HAD ALREADY RECEIVED 2 DOSES OF THE PFIZER COVID19 VACCINE IN APRIL 2021. SO THIS WAS AN ACCIDENTAL 3RD DOSE. NO ADVERSE REACTION REPORTED TO THIS DATE.
On 03-04-2021 I started to experience respiratory problems, my nose was clogged up with mucus, had some difficulty breathing and was having like an asthma attack. I do not suffer from asthma prior to this vaccine. I experienced headaches, fatigue, congestion, my ears were plugged and I also developed a rash on my arms and I also noticed a lymph node in my neck that I did not have prior to the vaccine. When I went to see my doctor my symptoms were not as prominent and the lymph node in my neck is decreasing in size.
This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 06-FEB-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On an unspecified date, the vaccine had a temperature excursion for 24 hours in which the lowest recorded temperature was 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Child nauseated, lightheaded, dizzy immediately after injection.  Needed to lie down for 30 min.  Eventually recovered with no other effects.
bad itching; big red rash on their arm; sore arm; A spontaneous report was received from a consumer concerning, a male patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sore arm/pain in extremity, had a bad itching /pruritus and a huge red oblong circle, pretty large, like 3x4 inches.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 28 Jan 2021, prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On an unknown day post receiving the vaccine, the patient had a sore arm for a day and a half. Seven days later the patient woke up in the middle of the night with a bad itching, and had a huge red oblong circle, pretty large, like 3x4 inches. The patient had their redness gone but still had itching.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event(s) was not reported.  The outcome of the events a sore arm, a huge red oblong circle, pretty large, like 3x4 inches were resolved at the time of this report and the outcome of the event had a bad itching was not resolved at the time of this report.
rash down her arm; swollen vaccination site; rash around Vaccination site; headache; tired; Itching vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash down her arm), VACCINATION SITE PRURITUS (Itching vaccination site), HEADACHE (headache), FATIGUE (tired) and VACCINATION SITE SWELLING (swollen vaccination site) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itching vaccination site). On 24-Apr-2021, the patient experienced HEADACHE (headache) and FATIGUE (tired). On 01-May-2021, the patient experienced RASH (rash down her arm), VACCINATION SITE SWELLING (swollen vaccination site) and VACCINATION SITE RASH (rash around Vaccination site). At the time of the report, RASH (rash down her arm), VACCINATION SITE PRURITUS (Itching vaccination site), HEADACHE (headache), FATIGUE (tired), VACCINATION SITE SWELLING (swollen vaccination site) and VACCINATION SITE RASH (rash around Vaccination site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Arm swelled, temp. of 102, weak and muscle pain on the first day. Second day temp down to just under 100 arm swelling down, but not back to normal, and has a headache. Third day temp still not back to normal, arm still slightly swollen, still has headache and weak.
Moderna COVID-19 Vaccine  initially no adverse reaction to injection (2/5/21).  Beginning on 2/12/21, intermittent intense itching and burning sensation at site of injection.  Rash developed around site of injection on 2/13/21.  From about 11pm 2/13/21 until about 1pm 2/15/21 extreme fatigue (basically slept for 36 hours, no food, no liquid.  Water tasted "funny").  Evening of 2/15/21 intermittent itching and burning sensation returned, but not as intense.  Rash is diminishing.
Arm was MUCH more sore- felt like I had been punched, about 16 hours after receiving vaccine, I had 102 fever, chills and blothiness on my arm ( side of shot injection)  this did not hurt- was just red.  Sunday- no fever or chills but had no energy to do anything.  By Monday, all was ok except arm was still a little sore and red blotchiness was still there- finally went away  around Wednesday.
temp of 100.5; headache; Could barely move her arms and legs; This case was reported by a other health professional via sales rep and described the occurrence of fever in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, 1 day after receiving Bexsero, the patient experienced fever, headache and mobility decreased. On an unknown date, the outcome of the fever, headache and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the fever, headache and mobility decreased to be related to Bexsero.  Additional details were as follows: The age at vaccination was not reported, but it could be 17 year or 18 year. It was reported that patient received the 1st Bexsero vaccine few months ago and the next day of vaccination patient expereinced temp of 100.5 degree F , headache and could barely move her arms and legs and the events subsided after the 48 hrs. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR201424:2nd dose
On April 1  2021 I had a grandmal seizure  I have never been sick
Patient was scheduled to receive vaccine only 2 weeks after the first dose.  No obvious problems here in the clinic. Error was not uncovered until after patient left office.
Immediately after receiving the second doze my mother told family members that something was not right and she didn't feel well.  At first is started as flu like symptoms but that is to be expected.  On the morning of the July 26th I found her face down, not breathing well and unresponsive.  She was taken to Hospital and has a temperature of 107.  She was immediately placed on a ventilator and her health declined.  She passed away on August 29th.
pt recvd vax @ 230PM on 25APR94 in rt anterolateral thigh; healthy & afebrile @ that time; pt was brought back to the office 745 w/a fever of 104.0 R; having recvd APAp @ 630PM; pt was cranky but consolable; no other sx of illness;
TINY BRUISE AT RIGHT ARM AT INJECTION SITE; RIGHT ARM AT INJECTION SITE HURTING AND IT IS HOT; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included overweight, and concurrent conditions included arthritis, penicillin allergy, and sulfa drug allergy. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim, and morphine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced tiny bruise at right arm at injection site. On 10-APR-2021, the subject experienced right arm at injection site hurting and it is hot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiny bruise at right arm at injection site, and right arm at injection site hurting and it is hot. This report was non-serious.
STARTING FEELING SLUGGISH/ TOOK A NAP/ THEN WHEN AWOKE COULD NOT MOVE LEFT SIDE OF BODY/ WENT TO ER AND WAS DIAGNOSED WITH MINI-STROKE WITH POSSIBLE MS ---STILL FEELING WEAK
At age 5 pt was to received a DTaP, and received a Boostrix instead.  She had no reaction at all.
vomiting; severe headache; nausea; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting), HEADACHE (severe headache), NAUSEA (nausea) and DIARRHOEA (diarrhea) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (vomiting), HEADACHE (severe headache), NAUSEA (nausea) and DIARRHOEA (diarrhea). At the time of the report, VOMITING (vomiting), HEADACHE (severe headache), NAUSEA (nausea) and DIARRHOEA (diarrhea) had not resolved.            No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Mar-2021 and was forwarded to Moderna on 19-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting), HEADACHE (severe headache), NAUSEA (nausea) and DIARRHOEA (diarrhea) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (vomiting), HEADACHE (severe headache), NAUSEA (nausea) and DIARRHOEA (diarrhea). At the time of the report, VOMITING (vomiting), HEADACHE (severe headache), NAUSEA (nausea) and DIARRHOEA (diarrhea) had not resolved.            No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Patient stated she didn't feel well and requested a glass of water.  RN assisted patient with her mother to lay down on a cot.  Patient had a brief episode of syncope while RN was assisting to cot.  RN gently lowered patient to floor with her mothers assistance and then the patient immediately gained consciousness.
THIS IS A QUALITY EVENT HAPPENED AT THE STORE FOR WRONG SELECTION OF VACCINE. THIS PATIENT WAS SUPPOSED TO GET KIDS PFIZER VACCINE 5 YEARS TO 11, INSTEASD WAS GIVEN PFIZER 12 AND UP GRAY CAP VACCINE (  NO DILUENT NEEDED). THIS WAS DULUTED WITH DILUENT AND GIVEN AT KIDS DOSE 0.2ML ON 02/21/22. STAFF REALIZED ON 02/23/22. CONTACTED THE PARENTS ASAP . CHILD A FEVER ON THE MORNING OF CONTACT DAY AND GOT DOWN BY THE EVENING.
Pt received the Johnson and Johnson shot on Sunday. On monday, she had the "worst headache ever", intermittent chest pain, and left sided facial numbness. Symptoms continue today, was told to present to the ER by her PCP.
Case number PHEH2015US019955, is an initial spontaneous report from a nurse received on 06 Oct 2015. This report refers to an 8 months old female. Past medical history and concomitant medications were not reported. The patient (8 months old neonate) was vaccinated with FLUVIRIN (batch number: 15735P, expiry date: not reported) at a dose of 0.25 ml intramuscularly on 05 Oct 2015. No adverse event was reported following this administration error.
Patient is a 67 y.o. male h/o asthma, type 2 diabetes mellitus with CKD, hypertension, and chronic anemia who was recently diagnosed with COVID-19.  He presented to ER on 1/3/2023 with cough, shortness of breath, and fever and pulse ox was 88% on room air, he had extensive wheezing, chest x-ray showed nothing acute, and perfusion scan was negative for PE.          Assessment and Plan   Acute hypoxemic respiratory failure Covid 19 infection Asthma Exacerbation -He has asthma exacerbation in the setting of underlying Covid-19 infection, OSA, and obesity.  -Tested positive for Covid-19 by home test on 12/31/22. Respiratory PCR panel on admission negative for everything except for COVID. -Initial O2 sat was 89% on room air and he required up to 5 L O2 nasal cannula. -CXR on admission showed no acute process and VQ scan without perfusion defect. -At home on Trelegy inhaler and pharmacy equivalent started here along with albuterol and Decadron. -With incentive spirometry and pulmonary toilet oxygen was weaned off by 1/6/2023 and O2 sats were in the 90s on room air. -Home bronchodilator regimen (Trelegy and albuterol nebulizer as needed) continued as before and he was discharged to home with plans to complete 10 days total of once daily Decadron.   Obstructive sleep apnea -Followed by Dr. of pulmonology as an outpatient. -Continue CPAP at bedtime.   Type 2 diabetes mellitus with peripheral neuropathy Chronic bilateral lower extremity edema Diabetic ulcer of right foot -Foot ulcer managed with 3X weekly dressing changes with silver alginate applied to wound bed, 4 x 4's, ABDs, Kerlix guaze and Ace  -Wound care nurse followed during this admission and he will need ongoing follow-up after discharge.   CKD 3B due to type 2 diabetes Solitary kidney with history of renal cell carcinoma -History of right nephrectomy in 2012 for renal cell carcinoma -Followed by Dr. of nephrology as an outpatient. -Baseline creatinine was running around 1.4 but then was up to 1.9 in June 2022. -Currently 1.7 and generally stable. -Continue ongoing outpatient follow-up after discharge.   Type 2 diabetes mellitus on insulin and with hyperglycemia -A1c used to be around 9 but was 7.6 in June 2022. -Home Farxiga, Trulicity, and U500 insulin pump continued as before. -Blood sugars were under good control during this admission.   Anemia of chronic disease -Per review of outpatient labs, baseline hemoglobin appears to run around 9-11 and is generally stable. -Continue ongoing outpatient monitoring after discharge. Chronic HFpEF -Last echo February 2022 showed LVEF 72% with mild concentric LVH. -No evidence for acute decompensation -Continue bumetanide and lisinopril.   Essential hypertension -Continue amlodipine, lisinopril, and bumetanide -Blood pressure stable.  GERD -Continue proton pump therapy   Morbid obesity (BMI 42) -He would benefit from lifestyle modification
It started out as general body aches. Then twelve hours post vaccine I got a fever of 103.4. My fever was consistent for almost 36 hours. After it broke I would be fine and then have hot flashes and then become cold.  I had a horrible pain between my shoulder blades that radiated into my left chest. I had a headache that lasted for 4 days. No matter the pain reliever used nothing touched the pain. My head hurt so bad it made me nauseous and dizzy. I had excruciating left sided jaw pain. It hurt to open my mouth. It shot up through my jaw into my teeth. I was unable to chew anything on that side due to pain, but I ate very little.
MOTHER CAME IN TO GET HER SON'S SCHOOL VACCINATIONS. INADVERTANTLY ADMINISTERED TDAP NOT DTAP.
PT RECEIVED PFIZER-BIONTECH (NDC 59267-1025-04) INSTEAD OF INTENDED BIVALENT (59267-0304-02)
Patient received Janssen vaccine by registered nurse and was completing her 15 minute waiting period. She began to feel faint and an employee of our facility caught her as she experienced a near syncopal episode. She was promptly placed in Trendelenburg position and vitals obtained. BP was 90/58 with mild tachycardia to max of 130-140 bpm. Patient was given supportive treatment and monitored. BP improved to 110/70 after 5 minutes and 120/72 after 15 minutes. Patient continued to feel very dizzy and weak, however, and became tachycardic and diaphoretic each time she attempted to move to a seated position. After 1 hour of monitoring and vitals showing continued tachycardia, decision was made to transport the patient to ER for further testing. Patient expressed agreement and understanding of plan to transport to ER via ambulance.