chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Jynneos vaccine administered intradermally; Jynneos vaccine administered at dose 0.1 ml; Jynneos vaccine had a temperature excursion; Affected Jynneos was administered; Case reference number US-BN-2022-002049 is a spontaneous case report initially received on 23-Aug-2022 from a nurse via Communications (reference number: USBAV22-1123) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On 18-Aug-2022, Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP00003) had a temperature excursion (explicitly coded as 'product storage error').  On 22-Aug-2022, the patient was vaccinated with the affected Jynneos vaccine (batch number: FDP00003), at dose reported as 0.1 mL, administered intradermally (explicitly coded as 'underdose', 'inappropriate route of vaccination' and 'product administration error'), for monkeypox prophylaxis.   At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received from on 24-Aug-2022 included the local case ID.  The case is linked to cases US-BN-2022-002030, US-BN-2022-002045, US-BN-2022-002046, US-BN-2022-002047, US-BN-2022-002048 and US-BN-2022-002028, concerning the same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated with Jynneos vaccine, at dose reported as 0.1 mL, administered intradermally, for monkeypox prophylaxis, and Jynneos vaccine had a temperature excursion prior the vaccination, which is considered as underdose, inappropriate route of vaccination, product storage error and product administration error. No associated adverse events have been reported with the reported medication error. The events of underdose, inappropriate route of vaccination, product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Underdose, inappropriate route of vaccination, product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with Jynneos vaccine, at dose reported as 0.1 mL, administered intradermally, for monkeypox prophylaxis, and Jynneos vaccine had a temperature excursion prior the vaccination, which is considered as underdose, inappropriate route of vaccination, product storage error and product administration error. No associated adverse events have been reported with the reported medication error. The events of underdose, inappropriate route of vaccination, product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Underdose, inappropriate route of vaccination, product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Itchy rash that began on chest and progressed to neck, face, entire trunk/ back
painful, sore and achy; felt sick; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain and feeling unwell. On an unknown date, the outcome of the pain and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the pain and feeling unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient reported that just be prepared the Shingles shot was painful and felt sick, sore and achy for days.
Dizziness, Angioedema, CoughWheeze, Nausea,Vomitting, Tachycardia, Skin flushing Narrative: Employee started to notice symptoms roughly 10 minutes after vaccinations. She presented to clinic Emergency Room shortly after symptoms developed. She was subsequently provided treatment to help alleviate her symptoms. Employee given IM epi 0.3mg, Prednisone 60 mg, IV fluid bolus, Zofran and Diphenhydramine inj (50mgIV)
On 2/23/01, the pt noticed chicken pox has approximately 7 blisters.
Patient returned back to Vaccine clinic after she left, she reported she felt dizziness with ambulation. Pt reports history of HTN, Anemia, and asthma. 1324 BP 134/82, HR 84, RR 16, O2 sat 100%. At 1332, Pt reports decreased dizziness but subsequently complained of increase in dizziness, heat to head, and feeling like she may pass out. Patient taken to ER. In ER reported patient had be fasting.
Low grade fever x 2 days, vomiting and mucusy diarrhea without blood x 1 week, change in demeanor with increased fussiness x 1 week, decreased appetite x 3 days. Supportive care only.
Redness, swelling  around injection site and down the right arm.  Called PCP, PCP advised him to go to the ED. At ED, he was not treated but there is an underlying concern of an infection that he plans to follow up on.
This is an 87 year old male, patient of Dr, with past medical history significant for HTN, HLP, CAD, s/p stents who presented to the ED with complaints of SOB, DOE and Cough. In the ED his Covid AG was +. He is fully vaccinated x 3 with Pfizer. A Chest xray showed subtle ground glass opacities bilaterally. His BNP ws 1062 and first troponin 1.61 with EKG changes. An EKG also showed new onset Atrial fibrillation, rate controlled. He was given 1x dose of IV Lasix. A CTA of the chest showed no evidence of PE, small bilateral pleural effusions , right greater than left, severe coronary artery calcified plaques, atrophic left kidney, severe atherosclerotic disease.
I had congestion, upset stomach, headache, slight sore throat, earache, body ache, no fever. I went to the Urgent Care to get tested for the influenza and COVID-19, the test for influenza came back negative, COVID-19 came back positive. I was given benzoate for the cough and something to help break up the congestion. Aside from the coughing and head and chest congestion I am feeling better.
COVID breakthrough. Patient claims she tested positive on 1/7/22 at home. Presented to the hospital on 1/24/22 with asthma exacerbation and tested positive. Patient recovered and was discharged home on 1/25/22.
Prevnar given on 4/4/01. Mom states pt had a fever of 103F-104F within 48 hours, post vax, that lasted until 4/9/01. CBC, blood culture, urine culture and stool done and all were negative.
Severe arm pain the first 3 days after vaccination (couldn't lift my arm). The severe pain subsided by day 4 but arm pain continues to date (4/4/2021); enough to where I have to take otc ibuprofen and apply otc topical pain cream.
6 minutes after vaccination, patient developed trouble swallowing, pallor, diaphoresis, tachycardia,  & irregular heartbeat. Patient moved to supine position with legs elevated. Elevated blood pressure, 146/96. Oxygen saturation >90. EMS called and determined patient was hypertensive. Heart rate 80's and irregular. Approximately 50 minutes after vaccination, patient able to stand and walk to vehicle with parent. Remained pale with trouble swallowing and hoarse voice. Benadryl 25mg given by mother.
Child started to break out in a rash...over the next few days it spread all over her body.  Also had diarrhea...diarrhea lasted for one month (even after rash went away which was after about 5 days).
CONTACTED PARENTS, PARENTS WERE INFORMED OF THE ISSUE AND GIVEN THE OPTION TO REVACCINATE THEIR CHILD, THEY WERE ALSO CONSULTED TO CONTACT THEIR PEDIATRICIAN
The daughter reported that her mother had experienced vomiting, severe chills, weakness that she could barely walk, the night after the vaccination given. She suspected that it must be the flu vaccination given that day.
Information has been received from a registered pharmacist concerning a 68 year old female patient, who on 25-OCT-2010 was vaccinated IM with a dose of PNEUMOVAX 23 (Lot # not reported). On 27-OCT-2010 the patient developed a large red area about the size of a coffee cup around the injection site. The reporter did not know if there was any pain or warmth. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. No further information is available.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, ARM PAIN, CHILLS, FATIGUE AND EAR PAIN Narrative:
Patient with a 2 week history of subacute vertiginous dizziness, right arm paresthesias, and right-sided weakness, found to have acute basilar artery thrombus in setting of PFO.
Then my right knee was hurting like i had tore something there to for 7 day; Starting an hour after the vaccine, For 5 days it felt like i had tore my rotator cuff in my left arm. After that went away,; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old male 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 31Mar2021 at 14:00 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 15:00, starting an hour after the vaccine, the patient felt like he had a tore in his rotator cuff in his left arm for 5 days. After that it went away. On an unknown date in Apr2021, the patient experienced that his right knee was hurting like he had torn something there for 7 days. No therapeutic measures were taken for the reported events. The clinical outcome of the events rotator cuff tear in his left arm was recovered on an unknown date in Apr2021 and the clinical outcome of the event right knee hurting like he had torn something there was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Profuse sweating, diaphoretic, heart rate dropped to 50, vision turned black, shortness of breath. Skin cold to touch.
Rt arm swelling/redness/achy/fever 2 days ago. Warm compress/MOTRIN.
Adverse effect of other vaccines and biological substances, initial encounter on 2022-07-05.
Expired 3rd dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
*No adverse event or reaction occurred*  Extra dose was given Pt was inadvertently given a 3rd dose 1 week 6/14/2022 after the 2nd dose was given 6/7/2022 Miscommunication among staff members  Pt has had no complaints or problems.
After administration, area below injection site was a little pink and hot. Patient waited for 15 minutes in store and area did not appear to be concerning.  After she returned home, site began to increase in redness and diameter.  After 8 days, angry red, hot area below site of injection had increased to 4 inches in diameter. Patient  had not reported any adverse reaction until April 1st, when she returned to pharmacy and showed her arm to pharmacist. Patient was told to contact her primary care physician (she had access to telemedicine) and to get advice on management/treatment.
Leaving the store I thought my vision was a little hazy but also I was really tired so didn't think too much of it. When my husband came home from work for lunch later that day, I asked him if his vision was hazy or blurry after his second dose. He said no; so again I just brushed it off and forgot about it. Then that evening around 5:30 pm, I was feeling a little headache pulse behind my left ear and I was feeling tired. I asked my husband to take a picture of me because I wanted to see how tired I looked. It was then that I noticed my eyes were asymmetrical; one looked different with a droopy eye lid (kind of like a lazy-eye look). My vision still felt a little off so I went inside to start cooking. 20 minutes later I felt like my vision was normal and eventually went to sleep. The next day I woke up and felt like symptoms were all gone, until I remembered my right eye situation. I looked in the mirror and the right eye was still asymmetrical (droopy lid). It feels like the right eye is having to work harder. It is hard to explain but the right eye does not feel normal to me. I made an appt with an eye doctor that day and my vision checked out ok but she did diagnose ptosis of the right eyelid. Although I do see some improvement of the droopiness of the lid, it has not returned to its normal pre-shot state and the feeling I described is still there.
Information has been received from a certified medical assistant concerning a 58 year old female with DILANTIN allergy who on 05 Dec 2006 was vaccainted with a first dose of pneumococcal 23v polysaccharide vaccine (lot 651437/0899F) (0.5ml), in the left deltoid. Concomitant therapy that day included a dose of influenza virus vaccine, in the right deltoid. On 07 Dec 2006 the patient called the office to report she developed swollen, red injection site reaction from deltoid around to the armpit of the same arm. The patient hurt so badly and thought she was swelling in other areas of the body. The patient went to the emergency room and was treated with Benadryl injection. The patient was not hospitalized. The patient recovered. The reporter considered the patient's experience to be an other medical event (OMIC). Additional information has been requested.
High Fever 105.8, High Blood Pressure, Disorientation, Nausea, shortness of breath,  tighness/heaviness in chest, severe muscle aches and pains headache, Pale, Shaking, unreponsiveness, Blueish/Purple feet, ringing in ears, dizziness, vomiting, hands and lips, redness rash and swelling from shoulder to elbow
Frozen shoulder Physical therapy started 10/19; corticosteroid injection received 01/22
Approx. 6 pm tired, went to sleep.  Woke around 9-10 pm in severe pain, very hot with fever. Got up to find thermometer.  Uncoordinated, could not think straight, couldn't find thermometer.  Everything hurt: teeth, skin, joints, back, headache.  Even felt like kidneys and liver areas were sore!  A little hard to breathe (tight chest). Dizzy and extremely exhausted, so went back to bed.  Took 1/2 Percocet.  Woke up later, felt I was burning up with fever. Took 1/2 Famvir (antiviral) and some Oscillococcinum a homeopathic remedy.  Called neighbor to check on me later.  Went back to sleep.  Slept until Saturday 9/29/2012, mid-day.  Fever broke.  I felt well enough to get up and find thermometer.  I thought fever was gone - but I had 2 thermometers.  One read just over 102 degrees.  The other read 102.5 degrees.  I felt cool to the touch - so my fever must have been very high before.  I felt much better Sunday, 9/30/2012, but developed a sore throat.  I take regular low-dose percocet for back pain, and the throat was still sore even with pain meds.  Also, I noticed on 9/30, there was a reactivation of an area on my right hip that tends to get recurrent shingles (?).  For that I started a regular dose of Famvir.  Have had flu shots for YEARS, and never had anything like this before.
welt at injection site, soreness, fever, chills, exhaustion, mild nausea
No adverse event; product storage error; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 04-FEB-2021, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 milliliter, oral, lot number 1687009, expiration date 28-JUN-2021 for prophylaxis, that underwent a temperature excursion.  The temperature excursion was 13.7 degrees Celsius (°C) fon 1 hour. There were no previous temperature excursions. The call was due to digital data logger.
Narrative: Patient received his 2nd dose of J&J on friday, called Monday reporting that since receiving the 2nd shot he had been having diarrhea, body aches, and head cold. Patient was advised to use OTC medications for relieve of symptoms and to seek more treatment at clinic if needed.
mo fever, pt complained of severe headaches w/pain radiating down her back; bp118/112; neurological symptoms, couldn't walk in a straight line; nausea, vomit; dx as sterile meningitis
This spontaneous report as received from a health care professional refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On unknown dates in July-2017 (reported as 'in the week of 24-JUL-2017'), the patients were vaccinated with improperly stored VAQTA (lot # N005274, expiry date: 03-APR-2018) (route: intramuscular) (incorrect product storage). The vaccine was stored at a temperature of 32°F to 35°F (34.4 F) for 15 minutes. The vaccine did not underwent previous temperature excursion. Digital data logger was involved. No other adverse effects reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA001330:
This spontaneous report was received from a healthcare worker and refers to a 9 month old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On 05-NOV-2014, the patient was vaccinated with VAQTA, 0.5 ml, intramuscularly (lot#, exp. date and anatomical location were not provided). No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested.
Fatigue, Chills, Low grade fever, Muscle aches. Resident also developed cellulitis to lower portion of arm in which vaccine was administered within 24 hours or less of receiving vaccine and had no previous indication of abnormalities to arm or s/s of infection to arm.
Hypertensive crisis  and chest pain experienced after 2nd shot.  SBP>180 DSP>100.  Currently, I am still experiencing SBP>180 even on medication now.
Information has been received from a pharmacist concerning a 19 year old female with pertinent medical history and drug reactions/allergies reported as none who on 05, Mar 2007 was vaccinated with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), ( lot # 653937/0637F). Concomitant medication was reported as none. On 05, Mar 2007, 5 to 10 minutes after receiving the vaccination, the patient fainted. The patient sought unspecified medical attention. The outcome and causality of the event was not reported. Additional information has been requested.
Patient presented to the ED and was subsequently hospitalized for  Calculus of gallbladder without cholecystitis without obstruction within 6 weeks of receiving covid vaccination.
A non-serious, spontaneous report of tooth pain, facial pain and low grade fever has been received from a consumer concerning an 11-year-old male, subsequent to FLUMIST. Neither medical history nor concomitant medication was reported for this patient. On 30-Oct-2010, the patient received FLUMIST for an unknown indication. Seven to eight hours later, the patient experienced tooth/facial and fever (low grade) which has continued for the past four to five days. The patient was taken to the dentist and no problems with the patient's teeth and sinuses were noted. The outcome of the events tooth pain, facial pain and low grade fever was not resolved.
Client reports numbness in both arms with onset of 1-2 weeks post vaccination, has not resolved since.  Denies any other symptoms.
Felt throat constricting and had trouble breathing for about 15 minutes. Then felt a pop in my chest and was able to breathe again. Broke out in hives
no additional AEs; multiple TEs for PNEUMOVAX 23 dating back to 12/1/22 and confirms that vaccines were administered; This spontaneous report was received from a medical assistant and refers to a 78-year-old male patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 05-JAN-2023, the patient was vaccinated with improperly stored (product storage error) dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe, injection, 0.5 ml, once, lot # was reported and confirmed as: W004863, expiration date was reported and upon lot validation confirmed as: 21-AUG-2023 (dose number, site and route of administration were not provided) for prophylaxis. The vaccine experienced multiple temperature excursion dating back to 01-DEC-2022. No additional adverse event reported.  This is one of two reports received from the same reporter.
Fever (peak 103, duration 18 hours), chills, sweats, joint soreness, muscle soreness, headache, fatigue, soreness at injection site, chest pain near left armpit (swollen lymph node?).
Patient developed erythematous rash in both thighs. Pt was seen in local ER prior to office visit and given BACTRIM. Was improving at office visit. F/U in 2 days: Asymptomatic.
death U07.1 - COVID-19 J96.01 - Acute respiratory failure with hypoxia J12.82 - Pneumonia due to coronavirus disease 2019 N17.9 - Acute kidney failure, unspecified
Atrial fibrillation.  Medication prescribed immediately. Cardioversion 10/29/2021. Failed.
I had DVTs in my right calf that landed me in the ER a week after my first shot.; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 03Mar2021 at 10:45 AM (Lot number: UNKNONW), at the age of 33 years, as a single dose for COVID-19 immunization.  Medical history included protein C deficiency, drug hypersensitivity to Sulfa. 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. There were no concomitant medications. The patient reported "I had DVT's in my right calf that landed me in the emergency room (ER) a week after my first shot on 08Mar2021. Therapeutic measures were taken as a result of "I had DVTs in my right calf that landed me in the emergency room (ER) and included blood thinning medication. The clinical outcome of DVT was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Information has been received from a physician concerning a 9-year-old female who was vaccinated SC with a second 0.5mL dose of Varivax (Lot # 652725/0249F). There were no concomitant medication. On 27-JUL-2006 the patient developed erythema and a fever. The outcome is recovering. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.