chrisvoncsefalvay/vaers-outcomes huggingface dataset:
moving in slow motion; could not control her muscle/could not move very well/moving like jello; muscle weakness; Initial information received on 27-Oct-2023 regarding an unsolicited valid non-serious case received from patient.  This case involves a 77 years old female patient who experienced muscle weakness, moving in slow motion and could not control her muscle/could not move very well/moving like jello after receiving vaccine Influenza Quadrival A-B High Dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past vaccination(s) included FLUZONE HIGH DOSE Quadrivalent in 2022 and COVID-19 vaccine  The patient's past medical history and family history were not provided.  On 07-Sep-2023, the patient received 0.7 ml high dose (frequency: once) of suspect Influenza Quadrival A-B High Dose HV vaccine (formulation, lot number and expiry: not reported) via unknown route in unknown administration site for immunization. Information on the batch number was requested.  On 08-Sep-2023, the patient developed muscle weakness (muscular weakness), moving in slow motion (bradykinesia) and could not control her muscle/could not move very well/moving like jello (dyskinesia) 1 day following the administration of Influenza Quadrival A-B High Dose HV vaccine.  Reportedly, patient reported that she received a FLUZONE HIGH DOSE Quadrivalent on 07September2023 and the next day, 08September2023 she had an episode of "moving like jello". She says it seems like she was moving in slow motion, and could not control her muscle. She also says there's muscle weakness and she could not move very well. She says it resolved on the same day however, after 5 days, she had another similar episode so she decided to go to ER. Patient is stating these episodes are adverse event of FLUZONE HIGH DOSE Quadrivalent because that's the only product administered to her prior the episodes. She says she had received several vaccines in the past, but this is the only vaccine that caused her this event. She says she remembered getting a COVID vaccine in the past that caused her adverse reaction, too, but she says it was as expected. She then says she remember receiving FLUZONE HIGH DOSE Quadrivalent in 2022 as her flu shot, but this event never occurred back then.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all events.  At time of reporting, the outcome was Unknown for all events.
Nausea, chest pain, asthsma, diarrhea. 7/17/09 Medical records received DOS 7/13/09 to 7/17/09. PAP test and Gardasil administered. Next day patient c/o pain at injection site, mild chest pain. Doesn't feel well, sent home from work. Wheezing, stomach pain, diarrhea. Advised to see PCP.
Patient has a spot at the injection site that appears to be a subdermal bruise. She reports that the area started itching on 08/07/2021 and became warm and inflamed. She also reported tenderness in the area. She reports that the itching has subsided. I counseled her that I would report the incident but that she would need to keep an eye on it and if the area worsened or did not improve that she would need to get a physician to look at the area. She did not report any fever or fatigue.
Information has been received from a physician concerning a pt who was vaccinated on 01/19/00 with varicella vaccine. On 06/06/00 the pt presented with a mild varicella rash of approximately 10 to 15 lesions. The pt recovered with no further adverse experiences.
Patient presented to clinic with urticaria noted to scalp, bilateral cheeks, left jaw line, right ear, bilateral arms/legs and buttock.
Patient developed post-menopausal bleeding & associated pelvic cramping 2 months after receiving the second dose of the Moderna Covid-19 vaccine. First dose info above. Second dose: Moderna, lot  014C21A , IM L deltoid, 5/13/2021.
Facial swelling, rash on R arm (opposite of immunized arm) X 2 hrs. Given benadryl and Zantac PO. Diffuse itching hives on chest and armpits.
Lip swelling bottom lip & numbess, Rash on stomach Dizzy,  Weak, Intermitrent Chest pains,  lowered Oxy Sat to 93 & 92. In addition to the more normal symptoms of vomiting, Diarhhea, headache, fatigue, cold & alternating sweats   GI pain,
Started run a fever 103F and vomited at 0100 AM had a fever straight through til 10:00am when he had a seizure and we called 911.
Pfizer given instead of the Moderna 21 days from the  dose of Moderna as described above. A dose of Moderna was given on 01/06/2022 followed by a dose of Pfizer on 01/27/2022. Client was contacted and expressed feeling "funky and depressed", she also referred headache, no other complaints other than those previously stated. She was vaccinated at a homeless shelter where she is currently living.
12/29/21 presents to ED for "shortness of breath ". PMHx of "HTN and  pulmonary HTN"
Patient was injected with Moderna Spikevax when she did not request it. She had requested the Flu shot and was incorrectly given the COVID vaccine.
pt recvd DTP/HIB/OPV AM 26OCT92 by 2PM 26OCT92 mom reported rt leg edematous from thigh to foot & red in color; pt afebrile; referred to MD; seen in office that PM; MD suggested unusual local reaction but to cont DTP series;
PATIENT WAS ACCIDENTALLY GIVEN ADULT DOSE INSTEAD OF PEDIATRIC DOSE BUT NO ADVERSE EVENTS WERE REPORTED.
Within 2 hrs after injection: wave of nausea with dry heaves and dizziness, elevated Blood pressure and heart rate. Severe headache frontal involving left eye, upset stomach, jittery feeling inside like anxiety attack( never had before), cough. Few days later add wheezing, shortness of breath
1-5 cm firm, nodular, mobile swelling with pain to touch, no redness, no fever
Fever for 24 hours Chills Lightheaded Nausea Extreme fatigue Pain at site of shot  Chest pains New left axillary Adenopsthy -CT scan 2/11/21
pain; Had left hip replaced 29Dec2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "spinal surgeries" (unspecified if ongoing), notes: Had three spinal surgeries on unknown dates; "brain surgery", start date: 26Jul2012 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: ER8734), administration date: 02Apr2021, when the patient was 47-year-old, for COVID-19 immunization, reaction(s): "getting small fiber neuropathy in his left foot", "first shot: both of his hips died (polymyalgia rheumatica or osteonecrosis)", "first shot: both of his hips died (polymyalgia rheumatica or osteonecrosis)", "Necrosis", "first shot: pain in both hips", "numerous nerve and bone issues", "numerous nerve and bone issues"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: HIP ARTHROPLASTY (non-serious) with onset 29Dec2022, outcome "not recovered", described as "Had left hip replaced 29Dec2022"; PAIN (non-serious), outcome "not recovered".  Additional information: the patient after fourth shot had Left hip replaced happened on 29Dec2022 and has not recovered 100% it still hurts.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300207966 same patient/drug, different dose/event;
On Wednesday, 11/17/21 I developed an intense sense of vertigo anytime I bent my head down. Extreme arm pain at injection site (right arm).  On side of body shot was given (right side) all glands became, sensitive to touch, swollen, and red. Right armpit lymph node swelled to the size of baseball between armpit and right breast.   As of present day, I am still sick. Symptoms include sinus pressure, cough, congestion, headache, ear pain, sore throat, fatigue, taste altered.   I was 26wks 2 days pregnant. Estimated delivery date: 2/21/22. This is second pregnancy.
Background: Nov. 26, 2019, annual physical, all test results within acceptable limits, overall good health, exercising/swimming 6 days/week. 5'11", BMI approx. 23. Flu-Hi dose vac. 10/14/19; Recommended Shingrix due to previous shingles/PHN. Dec. 3, 2019, 1st dose of Shingrix. Approx. 3-4 weeks later, slight pain and slight swelling in left knee, no known cause or injury. Rested, ice, pain and swelling increased, Appt. 1/14/20 Primary Care, recommended Appt with Orthopedic Dr., Appt 1/21, X-rays non-conclusive, Ordered MRI, Pain grew severe and wide-spread, both knees, hips, shoulders, arms. Left Knee significantly swelled, warm. Appt. Ortho Dr. 2/29, reviewed MRI, nothing significant. Dr. withdrew left knee fluid, after visual inspection, admitted me to hospital, possible fluid infection or sepsis, Hospitalized 1/29-1/31/2020. Knee fluid didn't show infection after culture time complete. Blood samples didn't show infection after culture wait time complete. Dr. of Rheumatology ordered x-rays of right knee and hip, Initial diagnosis: Chondrocalcinosis, Arthropathic psoriasis unspecified. Pain continued from 1/31 to 2/7, Prednisone/Methotrexate etc. prescribed. Question: Could the Shingrix have over-stimulated neutrophils production resulting in calcium pyrophosphate crystals being released and triggering a severe flare of Chondrocalcinosis, Arthroscopic Psoriasis or both?
sore arm; This is a spontaneous report from a contactable nurse (patient's daughter) via Medical Information Team. A 72-year-old female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as unknown, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient's daughter stated that her mother had sore arm after she got the shot. She wanted to know about dizziness and how long it lasts. The outcome of the event was unknown.   Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
feeling short of breath; Difficulty swallowing; bilateral leg weakness; Pain; Fatigue; Losing voice; Itching at the injection site; Redness, swelling and itching at the injection site; Redness, swelling and itching at the injection site; Headache; Cough; Congestion; A spontaneous report was received from a customer who was also a 37-years-old female patient who developed congestion, cough, aphonia, headache, shortness of breath, dysphagia, fatigue, bilateral leg weakness and pain, and redness, swelling and itching at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 08 Jan 2021, the patient received her first of two planned doses of mRNA-1273 vaccine intramuscularly (site was not reported) for prophylaxis of COVID-19 infection. Approximately 2 hours later, the patient developed cough, headache, congestion, and redness, swelling, and itching at the injection site.   On 09 Jan 2021, she experienced worsening coughing, and she began losing her voice.   On 10 Jan 2021, the patient experienced shortness of breath, dysphagia, and bilateral leg weakness and pain. She was subsequently admitted overnight in the emergency room where she received intravenous fluids, diphenhydramine hydrochloride, and dexamethasone. A computerized tomogram scan, chest X-ray, and laboratory tests were performed and produced normal results.  On 11 Jan 2021, the patient was discharged home, and she reported feeling much better. However, she still felt fatigued and continued to experience headaches.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, shortness of breath, dysphagia, cough, and aphonia, was considered recovering. The outcome of the events, headache and fatigue, was considered not recovered. The outcome of the events, bilateral leg weakness and pain, congestion, and redness, swelling, and itching at the injection site, was not reported.; Reporter's Comments: Based on the limited available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
We did not discard the extra volume in the vial during our initial clinics. I came to realize this was not authorized under the EUA after the fact and ceased the practice after the first four clinics on 3/10, 3/11, 3/12 and 3/12 and 3/13/21. When reported the extra doses, we were advised to cease pooling doses and report to VAERS, citing EUA guidelines. We gave 21 extra doses on 3/13/21 but no adverse reactions have been reported related to this issue.
stomach problems, pain; stomach burning; gas; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach problems, pain), DYSPEPSIA (stomach burning), FLATULENCE (gas) and PAIN IN EXTREMITY (arm hurt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder and Allergy.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm hurt). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach problems, pain), DYSPEPSIA (stomach burning) and FLATULENCE (gas). On 30-Jan-2021, PAIN IN EXTREMITY (arm hurt) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (stomach problems, pain), DYSPEPSIA (stomach burning) and FLATULENCE (gas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were Allergies medication, Thyroids pills for drug use for unknown indication. Treatment medications includes Tums, antacids and Nexium. Patient Went to see GI doctor did endoscopy she was on special diet and checked gall bladder.    This case was linked to US-MODERNATX, INC.-MOD-2021-048047 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up contains treatment details updated and new events were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-048047:Second dose
Vaccines given by CMA at approximately 4:40 pm. Physician went to speak with patient's mother roughly five minutes later; physician noticed redness, swelling, hives at site of varicella vaccine. Watched in office x20 minutes then gave 3.75mL infants acetaminophen.
urticarial rash; no swollen lips, or difficulty in breathing; resolved in 12 hrs; DPH;
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On an unknown date, the patient was vaccinated with improperly stored VARIVAX (strength, dose and frequency were unknown; lot # was  L048468 with expiration date 02-DEC-2017). No adverse effects were reported. This is one of several reports that received from the same reporter. Additional information has been requested.
This case was reported by a physician via call center representative and described the occurrence of pedal edema in a infant male patient who received ENGERIX B (batch number N002202 ?, expiry date unknown). On 6th September 2017, the patient received ENGERIX B. On an unknown date, less than a year after receiving ENGERIX B, the patient experienced pedal edema (serious criteria hospitalization) and sepsis (serious criteria GSK medically significant). The patient was treated with Ampicillin and Gentamicin. On an unknown date, the outcome of the pedal edema was recovered/resolved and the outcome of the sepsis was unknown. It was unknown if the reporter considered the pedal edema and sepsis to be related to ENGERIX B. Additional details were provided as follows: The patient was admitted to the hospital, kidney function tests were performed, the patient received a work up for sepsis. Expiration date was unknown. The reported lot number (N002202 ?) for ENGERIX B does not match any GSK lot number.
Pt gave incorrect information and stated no previous vaccinations. Pt had rev. do 1 dose Moderna and rev cd 2nd dose of Pfizer today. No adverse events noted while pt was in clinic
After the 1st dose he felt a bit tired and had a sore arm but had no other untoward reaction. After the 2nd dose he started to feel tired and a bit weak. He did not have fever that he was aware of. He went to bed as usual time. On waking the next morning, he was quite weak and unable to ambulate. His wife came to his assistance and found him to be confused and somewhat disoriented. He had a low-grade temperature of 99° at home. He was brought to the emergency room for evaluation. During his emergency room stay, his condition has improved. He states he feeling much better at this time. His wife thinks his personality and communication skills have returned to baseline.
swelling in arm; chills; body ache/body is starting to hurt; joint pain; Vaccination site swelling; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in arm), CHILLS (chills), MYALGIA (body ache/body is starting to hurt), ARTHRALGIA (joint pain) and VACCINATION SITE SWELLING (Vaccination site swelling) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling in arm), CHILLS (chills), MYALGIA (body ache/body is starting to hurt), ARTHRALGIA (joint pain), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, PERIPHERAL SWELLING (swelling in arm), CHILLS (chills), MYALGIA (body ache/body is starting to hurt), ARTHRALGIA (joint pain), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided by the reporter.
Received Vacccine on 8/8/20. Rt arm soreness 9th thru 14th.  Aug 14th 2:30am awoke with severe vertigo, sweating, nausea, GI symptoms,  I took Dramamine 24 hr less drowsy med (1tab) at 4am. Got up around 10am. Noticed redness on Rt upper arm from deltoid down to about 3 inches above elbow, same area that has been sore all this time. temp 99.8 and slightly chills. Severe lethargy all day from dramamine, vertigo continues. Aug 15 vertigo less severe initially, took 1/4 of dramamine tablet.. Vertigo continues if I move head suddenly or lean forward. Sunday August 16th vertigo contines but less severe, Took another 1/4 tab of Dramamine.  Temp normal.
Mild headache, frequent diarrhea, intestinal gas (burping more frequent that normal).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), in Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The patient wasn't taking any other medications/products within 2 weeks of starting COVID-19 treatment. Consistent with Paxlovid rebound. Paxlovid for COVID 19 Treatment from 01Jul2022 to 05Jul2022. Took full dose of Paxlovid. Felt better symptoms went away. Felt normal. 3 Symptoms returned on 09Jul. The patient was recovering. known allergies not that know of.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medications were not specified. On 08-DEC-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection (lot # L022795, expiry date: 05-NOV-2016, dosage regimen not reported) intramuscularly for prophylaxis (expired product administered). No side effects reported. No further information was available. No product quality complaint (PQC) was involved. Additional information has been requested.
Administered VARIVAX 10/01/08 Rt deltoid, in office 10/3/08 with large red edematous - Lot#0970X
Sore neck started on 1/18/21.  Did exercise that day Discovered a tender palpable lump just above clavicle bone on left side - same side as the injection on 1/19/21
The pt received vaccines at 11:00 AM on 5/2/00. The mother of the pt returned the pt to the clinic at 11:15 stating the pt was moving around in the Car seat and she noticed "bumps" on his face. Red raised area present on Pt's torso, arms, legs, and left side of face and neck. No itching or difficulty breathing.
Pt had 1st,2nd & 3rd doses of Engerix-B for prophylaxis of hepB on 7/4/96,8/22/96(ENG2130A2), & 4/3/97 (ENG2206A2). Following 3rd dose,summerof 1999,pt dx w/autism. Slow language skills,attention prob,social problems.
Within 2 hour, Severe upper body hives,urticaria, took bendryl 50 mg twice in next 24 hours.  Day two, felt like I had the flu, temp of approx 100 degrees for about  8 hours.  Short episode of diarrhea.
muscle aches, shivering chills, fever, headache, one day+ in bed.at home. Out of bed today, but still weak and recovering.  More thanthe "none to minimal" side effects as described in materials.
41 Y female who presents to the Emergency Department  for evaluation of her rash. The onset of rash was gradual beginning 2 days ago with progression since that time. The rash began on the abdomen 2 days ago and 1 day after her second immunization with Pfizer COVID-19 vaccine.  The rash over the next 24 to 48 hours spread to the back, the chest, the arms, and inguinal folds, and popliteal areas.  This morning she woke up with itching and hives on her scalp.  She has used Benadryl with some relief.  Patient denies shortness of breath, chest pain, nausea, or vomiting.     There is no lip swelling or itching, tongue swelling or itching, sense of throat closing, or shortness of breath.  There is been no nausea vomiting, no palpitations.   She has no hx of similar previous allergic reactions. She denies exposure to new medications, shampoos, detergents, soaps, lotions, sprays or allergens.
Immediately after I got my first vaccine, I sat down in a chair and I felt a rush go to my head.  I told a nurse that I felt faint.  She took my blood pressure. It was 159/85.  After about 10 minutes they took my blood pressure again and it dropped to 135/83.  It was not recorded though.  I left.  But normally I have regular to low blood pressure (I recently gave blood and they told me my blood pressure was low at the time).  I did tell my doctor at the Clinic when I got home (via My Chart).  I am okay now.  But I thought you would like to know.  I wish they would have recorded my blood pressure because I was at the Clinic campus.  But it was a worker nurse and not sure if she was a Clinic nurse.  But she would probably remember me.  I don't think I want to get the second shot because that scared me.