chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had bad case of shingles 2 years after he got the vaccine/suspected vaccination failure; had a bad case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-APR-2022  Reporter's Comments: This case was received from the patient's wife via interactive digital media. The patient had bad case of shingles 2 years after he got the Shingle vaccine.  The reporter stated that vaccine did not always work Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Per patient report upon presentation to hospital: Received vaccine 6/9 during the day, in the evening developed typical symptoms (headache, vomiting, warm to the touch) and has chest pain that seemed to resolve with ibuprofen. On 6/12 at 0400 patient woke up with severe chest pain (localized to the middle of the chest), no tachycardia or shortness of breath. Pain does not change when moving arms/neck. No recent fevers, URI symptoms, known sick contacts. On presentation 6/12 troponin was elevated to 9.69, repeat on 6/13 decreased 6.03. Diagnosed with myocarditis, initial ECG was abnormal, repeat ECG has not shown any ischemic changes. Patient will have repeat EKG, ECHO, troponin, and likely discharge from hospital
proximal Supraventricular tachycardia  random heart acceleration for extended periods of time
Left deltoid redness and swelling at injection site. Instructed to use ice pack to left deltoid and take Ibuprofen for discomfort.
Information has been received from consumer and a medical assistant concerning an approximately 18 year old female with no pertinent medical history or known drug allergies who on 14-JUN-2010 was vaccinated with 1st dose of GARDASIL (lot # 0318Z) and hepatitis A virus vaccine inactivated (manufacturer unknown) and PPD. On 26-AUG-2010 the patient was vaccinated with 2nd dose of GARDASIL (lot # 0765Z) and influenza virus vaccine (unspecified). On 04-JAN-2011 the patient was vaccinated with 3rd dose of GARDASIL (lot # 1231Z). The patient came to office on 25-JAN-2011 with complaints of joint pain in bilateral shoulders, knees and hands. The mother of the patient noted that the joint pain began sometime between the 2nd and 3rd GARDASIL doses. On 31-JAN-2011  rheumatoid factor was drawn, results 52. X-ray of hand was normal. On 16-FEB-2011 the patient was diagnosed with rheumatoid arthritis and was referred to a rheumatologist. The treatment for this AE was change diet. The outcome of the patient was unknown at the time of this report. Rheumatoid arthritis is a condition of special interest. Additional information has been requested.
muscle pain; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (muscle pain) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle pain). At the time of the report, MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Feb-2023: Non-significant follow up received.
Patient called 4 days after getting FLUZONE HD saying she was severely sick, 2-3 hrs after getting flu shot on 10/3 - vomiting, severely dehydrated, incoherent; pt. called on 10/7 and was feeling a bit better.
March 2021, he started having frequent urination and checked his blood sugar and it was quite high... diagnosed with Diabetes.  In June 2021 started having short term memory loss.
Pt recvd vax 19MAY92 & the same day devel vertigo, h/a, nausea, vomiting, puffy eyes, low grade fever of 100, lab eval showed a pos test for bile; seen by MD;
I started to feel like I was getting a sore throat and getting very tired.  Then I felt like I was maybe coming down with the flu or something.  I did not have a fever.  I went to bed early and slept late.  I felt better in the morning but in the afternoon I feel the tired sore again.
This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer reported for herself. A 72-year-old female patient of an unspecified race received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date at single dose for immunisation, XELJANZ XR, via an unspecified route of administration from an unspecified date at 11 mg, for an unspecified indication and influenza vaccine, via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and the patient's concomitant medications were not reported. The patient experienced ended up getting the flu as well as pneumonia on an unspecified date with outcome of unknown. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Patient was determined to have an anaphylactic reaction by MD's on site. Benadryl was administered, followed by Epinephrine 10minutes after Benadryl. EMS was called at that time and patient  was transferred to higher level of care via ambulance.
mom reports 1hr p/vax pt had a screaming episode of 3hr;pt was unable to be consoled;pt cried self to sleep;mom took pt to MD the next day;MD said it was rxn to vax;t101 R
arm pain; This spontaneous report was received from an employee, referring to a 12 years old male patient (employee's son). The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.     On an unspecified date in 2020, the patient received his second dose of unidentified Merck hpv vaccine (name and lot number not provided) (strength, route and expiration date were not reported) injection for prophylaxis.    On an unspecified date in 2020, the patient experienced arm pain. There was no redness or inflammation and no swelling. The patient did not seek medical attention. On 05-AUG-2020 (also reported as 06-AUG-2020) (reported as today) the patient had no longer any arm pain. The causalty assessment was not provided.
Started with itchiness at site of injection - right arm then low grade fever that NOC - 99.5.  Site and below site became red/swollen and itchy.  Mother gave Benadryl - 2 days after vaccines administered, mother reports is no better.  Had mother contact physician.  Event/vaccine admin 3-11-08 with itchiness and fever that day - lasting 2 days later.
On 3/8/21 around 4:45 pm I got the first dose of Pfizer COVID vaccine.  In the evening around 11 pm, I experienced difficulty in breathing and had a slow heart rate.  In addition to muscle pain on my left arm where I got the shot, whenever I almost felt into sleep I was startled and woke up from short of breath.  I wore a watch to check on my heart rate.  On the low end it went into 53 ~ 54 especially when I felt short of breath.  On the high end it was around 67 ~ 70 which is my normal heat beat when at rest.
Injection site red/hot and hard in the center. Left side of glands on neck swollen. Fever night before.
On 11/30, 15 minutes after injection, felt like tongue went to sleep and ants were crawling on tongue. At same time as these sensations, also felt very sleepy. No difficulties breathing or swallowing, no chest pain, no rash or pruritis. At 0400 12/01/05, right side of face felt heavy and swollen. Also with headache over right eye. At time of clinic visit 12/01/05 at 1140, face felt less heavy/swollen and headache less severe. Complaining of dizziness. Right arm BP 162/116. Referred to ED at local hospital and to be taken by daughter, son, husband who accompanied her to clinic this am. Denied problems at injection site. Slightly warm to touch and slightly tender- no site edema, erythema or bruising.
Abdominal pain for 5-7 days prior to ED, diarrhea, irregular bowel movements for 1+ month, shortness of breath, elevated troponin, sinus tachycardia  Sigmoid diverticulitis, elevated CRP, leukocytosis, hypokalemia, + D-Dimer,
Woke up running low grade fever; achy; chills; joint aches; headache; sore throat; hoarseness; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Jan2022 11:45 (Lot number: FD0810) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Psoriatic arthritis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Chronic bronchitis" (unspecified if ongoing); "known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0153, Location of injection: Leg Right, Vaccine Administration Time: 11:15), administration date: 09Apr2021, when the patient was 50 years old, for covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Right, Vaccine Administration Time: 11:45), administration date: 19Mar2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Jan2022 11:45, outcome "unknown", described as "booster dose"; PYREXIA (non-serious) with onset 03Jan2022, outcome "not recovered", described as "Woke up running low grade fever"; PAIN (non-serious) with onset 03Jan2022, outcome "not recovered", described as "achy"; CHILLS (non-serious) with onset 03Jan2022, outcome "not recovered", described as "chills"; ARTHRALGIA (non-serious) with onset 03Jan2022, outcome "not recovered", described as "joint aches"; HEADACHE (non-serious) with onset 03Jan2022, outcome "not recovered", described as "headache"; OROPHARYNGEAL PAIN (non-serious) with onset 03Jan2022, outcome "not recovered", described as "sore throat"; DYSPHONIA (non-serious) with onset 03Jan2022, outcome "not recovered", described as "hoarseness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain, chills, arthralgia, headache, oropharyngeal pain, dysphonia. No follow-up attempts are possible. No further information is expected.
I received Botox on 2/19/21 In the right arm for post stroke treatment of muscle spasticity. Then I received the COVID-19 shot in the right arm on 3/12/21. Coincidentally within the following week, I developed extreme weakness in the right leg. It is severe enough that I'm still having trouble walking at all even with help. So I'm wondering if there was an interaction between the vaccine and the Botox that caused this. I've had adverse interactions between medications before.
High blood sugar of 236; High blood pressure; Vomiting; Fever of 101F; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (High blood sugar of 236), HYPERTENSION (High blood pressure), VOMITING (Vomiting) and PYREXIA (Fever of 101F) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (High blood sugar of 236), HYPERTENSION (High blood pressure), VOMITING (Vomiting) and PYREXIA (Fever of 101F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BLOOD GLUCOSE INCREASED (High blood sugar of 236), HYPERTENSION (High blood pressure), VOMITING (Vomiting) and PYREXIA (Fever of 101F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Blood glucose: 236 (High) 236. On 25-Feb-2021, Body temperature: 101 f (High) 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
intense and sharp pains in her right side of arm; stiff neck; sore shoulder; chills; nauseas; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (intense and sharp pains in her right side of arm), MUSCULOSKELETAL STIFFNESS (stiff neck), ARTHRALGIA (sore shoulder), CHILLS (chills) and NAUSEA (nauseas) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (intense and sharp pains in her right side of arm), MUSCULOSKELETAL STIFFNESS (stiff neck), ARTHRALGIA (sore shoulder), CHILLS (chills) and NAUSEA (nauseas). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (intense and sharp pains in her right side of arm), MUSCULOSKELETAL STIFFNESS (stiff neck), ARTHRALGIA (sore shoulder), CHILLS (chills) and NAUSEA (nauseas) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medications reported by investigator     Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up received on 07-JUL-2021 and updated the events outcome as recovered and she said she don't want to take second dose.
5/8/03 Pt return to clinic with mother with complaints of itchiness and erythema all over left shoulder around where had DPT shot on 5/6/03; no fever, no pain. Poorly demarcated erythema over about 7 cm x 10cm area. No tenderness, no excoriation, adverse reaction to pertussis component of DPT.
local rxn to thigh of redness, distinct swelling & tenderness of 12cm diam;shot given 1030AM;rxn called by mom 3PM
This spontaneous report as received from a health care worker (also reported as office manager) refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On 17-MAR-2015 the patient was inadvertently vaccinated with ZOSTAVAX lot # J014812, dose 0.65 ml, subcutaneously that expired on 20-FEB-2015. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information is not expected as the reporter refused additional contact.
Heart Palpitations: Received 2 week Holter Monitor, and echo stress test.  After 4-5 months, heart palpitations went away  Red spots: on left arm (1 spot) and torso (6 or more).  Initially diagnosed as nummular eczema and given steroid cream.  Steroid cream helped, but spots came back after cream was used.  Finally, the spots have all disappeared after 5 months.
Headache (2 days), Mental Fatigue (2 days), Arm Soreness (1 week).   Treatment: 1 dose Tylenol upon onset of symptom provided temp relief.
Client states rash started under arm pits, spread to the abdomen by 6:00 PM, then spread to the back and buttock during the night.  Painful, reddish in color, raised bumps. A small amount of the raised bumps had small white heads on them, and a small amount were scabbed over.  Client states she was seen per Physicians Assistant on 11/01/2010.  Client states Antibiotic prescribed and also taking Tagament and Benadryl. Client states antibiotic didn't help. Client states she now has purple spots where the rash was present.
Admitted 8/23 InPatient Hospital with Shortness of Breath and Diarreah at hospital. Pt still hospitalized three days now
swelling and erythema at inj site, n/v, tenderness and soreness with movement
Patient received x2 Pfizer Covid vaccines on 4/7/21 and 4/29/21 with out any adverse events.  She then received her 3rd shot (booster) on 12/10/21.  On 12/11/21, she developed a headache.  Over the course of the next several days, she started having intermittent numbness on the right side of her body on 12/15.  She presented to emergency department on 12/15 PM where she then had a seizure.  MR, MRA, MRV showed extensive thrombus of saggital sinus.  She was started on Keppra and heparin drip and was admitted to the ICU.  Lab testing was unremarkable, including platelets which were normal.  The patient also has a family history of VTE and was on birth control pills.  On 12/16, she had LUE and BLE weakness. Repeat MRI on 12/16 showed increased volume of cortical acute infarction so patient was taken to interventional radiology for superior sagittal sinus thrombectomy with resultant good flow through SSS. .  On 12/17, the patient reports headache is improved. BLE and LUE weakness improved after procedure.  Hypercoag labs sent.  Plan is to stop oral contraceptives permanently and patient is to be worked up for hypercoagulable state (some workup will need to be completed outpatient).  No evidence of ongoin seizures.  The patient will be treated with heparin drip and ultimately will be converted to warfarin for anticoagulation.  On day of this report (12/17/21), the patient remains hospitalized and is transferring from ICU to general medicine floor.
Per email from Pt: After shift I began to feel weak, sore and lethargic. This continued throughout the day (I took 2 naps on the 14th totaling 6 hours). Throughout the night I had cold chills and pretty severe joint pain. Upon waking up on the am of the 15th, most of my symptoms had gone away however I noticed that the injection site had severe swelling. It looked like someone had cut half an apple and placed it on my arm. After consulting with my family physician, he requested I come to either him or urgent care. I proceeded to Urgent care & spoke with the on duty Dr. His diagnosis was that the injection may have 1 of 2 things, either a blood vessel to burst & this resulted in a hematoma (although the doctor hadn't seen swelling like this before) or a possible infection in the muscle secondary to the injection. Because of the possibility of the infection he prescribed me an antibiotic.
Patient woke up on 15 of April 2012 at 7:30 am with redness on his left deltoid and swelling due to smallpox immunization. Patient also has many red bumps on his chest and abdomen as well as upper and lower back. Patient is not in distress no airway issuse. Patient went to clinic on 17 of April 2012 at 11:00am and was seen by Dr.
Chest rash 4 days after receiving dose, admitted to the hospital 10 days after the dose with atrial fibrillation with RVR and type II NSTEMI
arm hurts a lot; his arm hurts a lot and it is hard for him to lift up his arm; put heat or ice on his injection site to relieve pain.; This is a spontaneous report from a contactable consumer (patient).   A 76-year-old male patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2) at single dose on 09Jan2021 for Covid-19 immunisation.   The patient medical history and concomitant medications were not reported.  The patient experienced injection site pain and his arm hurts a lot and it is hard for him to lift up his arm. He placed an ice gel pack on the injection site to relieve pain in Jan2021. The outcome of events was unknown.   He wanted to know if it matters which arm he receives the 2nd dose of the Covid vaccine in. He wanted confirmation that he is to receive the second dose of the vaccine in 3 weeks.  Information on Lot/Batch number has been requested.
Moderna COVID-19 Vaccine EUA Severe arm pain about 12 hours after shot. Could not lift left arm  Extreme fatigue about 22 hours after shot  Fever at 100.8 about 23 hours after shot.  Felt symptom free after 48 hours
had shots, had it twice/suspected vaccination failure; had it twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shots, had it twice/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had it twice). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-Mar-2023 The case was received from the patient via interactive digital media. The patient had the shots and had them twice and it was terrible. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. The case was conservatively processed with suspected vaccination and shingles events considering that the patient received the shingles shots and had target disease.
Patient received Moderna Covid Vaccine on 01/25/2021 and second Moderna COVID vaccine on 02/22/2021 and was diagnosed with a left lower extremity deep vein thrombosis on 04/22/2021, patient was then subsequently admitted to the hospital on 05/05/2021 with acute on chronic respiratory failure and bilateral pneumonia requiring IV antibiotics and increased supplemental oxygen.
Within 1 day of receiving flu vaccine, pt developed nausea, vomiting, myalgias, malaise, fatigue, chills. Tx ondansetron and supportive care.
Pt received DAPTACEL vs Tdap, pt received extra dose of polio and MMRV. 10-28 - 10-30 (R) arm red, hot, and pain, swollen.
Hepatitis A given earlier than supposed to in place of Hepatitis B vaccine . No adverse reaction known
approx 2 hrs p/vax pt devel t103R; episode of vomiting & inconsolable for > 3 hrs x 3 days, vomiting lasted 4 days;