chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient experienced a lot of pain at time of flu shot vaccination. The nurse took a very long time to inject the solution. Not even 30 minutes afterwards, could barely move the arm because of the pain. Patient couldn't lift arm to dress and undress. Thought the pain was due to the shot but 4 days later, still in a lot of pain and can't use arm properly. Patient can't lift it without pain and feels tingling and ache in shoulder and upper arm. Patient read people can suffer nerve and/or muscle damage after any vaccination because of where the needle was inserted and is afraid that's what the patient has.
Patient states she started to develop shingles on her right side on her back post vaccination. Also, had pain in the liver area.
Initial unsolicited report received from other non-health care professional on 19-Dec-2016. This case involves 58-year-old male patient who was vaccinated with fourth dose of FLUZONE QIV (batch number: UI441AC, expiry date: 30 Jun 2016) via intramuscular route in right (unspecified date) on 11-Oct-2016. The patient's ongoing illness, medical history, risk factors were revealed that patient had HTN (Hypertension) and Hyperlipidemia. Any other vaccinations within four weeks of vaccinations and Illness at time of vaccination were denied. Concomitant medications were not reported. On 17-Oct-2016, six days following the vaccination, the patient experienced pain to hip and had severe muscle aches and pain. On an unspecified date, approximately two weeks following the vaccination, the patient had syncopal episode. On an unspecified date, post vaccination, the patient had experienced difficulty in walking and extreme weakness. After receiving corrective treatment, patient continued having difficult with severe lethargy and muscle weakness. On an unspecified date, post vaccination, the patient's arms and legs feeling extremely heavy. On an unspecified date, the patient was diagnosed with myalgia. It was reported that, on an unspecified date, post vaccination the Tumor was found on spinal cord but physician stated it was incidental finding and not related to his current symptoms. Patient required ER or doctor visit. Laboratory investigations include CT scan and MRI of brain and spinal column. It was reported that, many other lab test was also done. Corrective treatment includes Prednisone and LYRICA. Patient was given prescription for therapy. The outcome of events was reported as unknown. Upon internal review, the company decided to consider the event serious because of important medical event spinal cord neoplasm and syncopal attack. It was reported that neurologist felt diagnosis was secondary to flu vaccine. List of documents held by sender: none. Sender's Comments: This case concerns 58 year old male patient who received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED and developed pain to hip, muscle aches and pain, syncopal episode, difficulty walking, extreme weakness, severe lethargy, muscle weakness, arms and legs feeling extremely heavy, pain continues and myalgia. CT and MRI revealed spinal cord tumor which might be incidental finding. Time to onset is compatible for pain in hip, muscle pain. However in this particular case very limited information has been provided. Further information regarding etiological work up, concurrent condition at the time of vaccination, concomitant medication, and investigation results to rule out the alternative cause are needed for complete assessment of the case.
Tested positive yesterday; Tested positive yesterday; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 77-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "TIAs" (unspecified if ongoing), notes: Transient ischaemic attack. The patient's concomitant medications were not reported. Patient had no Covid prior vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Jun2022, outcome "not recovered" and all described as "Tested positive yesterday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (08Jun2022) Positive, notes: Nasal Swab (reported as, covid tested post vaccination). It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course was reported as, Patient attended graduation, returned home and started not feeling well. Tested positive yesterday. Very lethargic and minor cough.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of LOE.
Received FLUMIST @ 4:00 pm - at 5:00 pm - blurring vision for 1/2 hour, then felt seeing things in slow motion - especially when he moved his head - lasted 12 hours a little motion sickness, felt cool breeze down spine, mild headache.
Patient had COVID with terrible cough and was very drained and tired; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient had COVID with terrible cough and was very drained and tired) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    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 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient had COVID with terrible cough and was very drained and tired). At the time of the report, COVID-19 (Patient had COVID with terrible cough and was very drained and tired) had not resolved.            No concomitant medications was reported.  No treatment medications was reported.  The patient had COVID with terrible cough and was very drained and tired. Reporter assessed event COVID-19  as possibly related to Moderna COVID-19 vaccine. Reporter did not provided causality for event COVID-19 with Rinvoq. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Company Comment:    This is an spontaneous case concerning an unknown year-old  female patient with medical history of Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis who experienced the unexpected AESI of COVID-19, unknown days after 3 doses of mRNA-1273 vaccine.  At the time of the report, COVID-19 (COVID-19) had not resolved The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: Company Comment:    This is an spontaneous case concerning an unknown year-old  female patient with medical history of Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis who experienced the unexpected AESI of COVID-19, unknown days after 3 doses of mRNA-1273 vaccine.  At the time of the report, COVID-19 (COVID-19) had not resolved The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
PATIENT WAS GIVEN A DOSE THAT WAS PASS DUE THE EXCURSION TIME TABLE OF VACCINE VIABILITY. DOSE WAS 26HOURS PASS DUE EXCURSION TIME OF 12HOURS AFTER 1ST PUNCTURE OF THE VIAL
Case completed primary series and booster for Covid in October 2021, then was hospitalized for Covid in January 2022. Hospitalized. * COVID-19 virus infection Assessment & Plan This is the cause of her acute weakness/anorexia/and recrudescence of old stroke symptoms. Diagnosed at time of previous discharge on 1/20. Was exposed to family members with covid on 1/16 prior to that admission. Was asymptomatic at time of previous discharge. Currently it appears to be causing exacerbation of previous stroke symptoms as well as nausea and malaise. O2 sats low-normal and CXR w/o infiltrate. Fully vaccinated including booster but at high risk of worsening. - Sotrovimab given on 1/21 - Technically met criteria for dexamethasone since O2 sats <94%, but suspect this was due to atelectasis rather than covid given lack of infiltrate on CXR. Additionally pneumonia would be uncommon this early in the disease course. Therefore dexamethasone was not started. Still not requiring supplemental O2 - pt needs 4 more days of quarantine, then can return.
Swelling of the lips. Has had lip fillers 1 year and 4 months prior
Diffuse morbilliforme rash involving entire body coalescencing. Facial puffiness.
pt recvd vax 22AUG95 & 7SEP95 pt devel 7-10 generalized lesions of macular papular nature & arthritic pain in major joints;no further details were provided;
LOCAL REACTION AT INJECTION SITE ON LEFT THIGH. 7.5MM RAISED RED NODULE OBSERVED BY MOM WHO CALLED FOR AN APPOINTMENT.
when the technician administered the vaccine there was a bleeding and some swelling and she thought that she hit the vein; when the technician administered the vaccine there was a bleeding and some swelling and she thought that she hit the vein; when the technician administered the vaccine there was a bleeding and some swelling and she thought that she hit the vein; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE HAEMORRHAGE (non-serious), VACCINATION SITE SWELLING (non-serious), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious), outcome "unknown" and all described as "when the technician administered the vaccine there was a bleeding and some swelling and she thought that she hit the vein". Additional information: Adult patient with question regarding new Pfizer covid 19 vaccine (2023-2024): would it still work if it would go into a vein? Should she get another? (refer to HCP). Per caller: when the technician administered the vaccine, there was a bleeding and some swelling and she thought that she hit the vein, caller was wondering if the vaccine hit the vein and if any of the vaccine came out with a bleeding because there was a decent amount of bleeding. Asked will her vaccine still work, or should she get another one.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Pt recvd 3 doses of Hep B vax 11OCT90, 11NOV90, & 11APR91 for coverage fr getting Hep B; was pos (having antibodies) & then was checked again now 5NOV91 & neg having very low antibodies;
Patient experienced a syncope episode Friday 2/27/09.  Transported to emergency room via ambulance.  Labs and CT of head negative.  Most recent health event was GARDASIL vaccine 2/26/09 administration. 3/18/09-records received for DOS 2/27/09-presented to ED with questionable passed out not responding. Eyes rolled back and not responding per witness.  PE: doesn't speak but will sit up and open mouth when asked. Rolling eyes side to side, fluttering lids, DTRs 2/4.  Impression resolved altered LOC. Probable anxiety.
Information has been received from a pharmacist concerning a female who on 10-FEB-2009 was vaccinated with her first dose of VARIVAX (Merck) (lot number and site not reported) 0.5ml SQ. There was no concomitant medication. On 10-FEB-2009 after receiving a dose of VARIVAX (Merck) the patient experienced a generalized rash. The rash was described as macular and itchy. The patient's generalized rash persists. Additional information has been requested.
30 day beyond use date of vial was 30-SEP-2022 and was administered on 13-Oct-2022; No adverse event; Received Expired Monovalent booster after 30-day Use By Date; Received Monovalent instead of Bivalent Booster by mistake; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent booster after 30-day Use By Date), WRONG PRODUCT ADMINISTERED (Received Monovalent instead of Bivalent Booster by mistake), PRODUCT STORAGE ERROR (30 day beyond use date of vial was 30-SEP-2022 and was administered on 13-Oct-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent booster after 30-day Use By Date) and WRONG PRODUCT ADMINISTERED (Received Monovalent instead of Bivalent Booster by mistake). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (30 day beyond use date of vial was 30-SEP-2022 and was administered on 13-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent booster after 30-day Use By Date), WRONG PRODUCT ADMINISTERED (Received Monovalent instead of Bivalent Booster by mistake), PRODUCT STORAGE ERROR (30 day beyond use date of vial was 30-SEP-2022 and was administered on 13-Oct-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent booster after 30-day Use By Date), WRONG PRODUCT ADMINISTERED (Received Monovalent instead of Bivalent Booster by mistake) and PRODUCT STORAGE ERROR (30 day beyond use date of vial was 30-SEP-2022 and was administered on 13-Oct-2022).    Concomitant drugs were not reported. It was reported that  the monovalent 6 years to 11 years individual vial of size 2.5 mL was unknown when initially stored in refrigerator but 30 day beyond use date was 30-Sep-2022. The patient was supposed to receive Bivalent vaccine. The vial did not undergo any temperature excursion. Treatment medications were not provided. This case was reported for patient 3.   This case was linked to US-MODERNATX, INC.-MOD-2022-659434, US-MODERNATX, INC.-MOD-2022-659439 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659434:same reporter US-MODERNATX, INC.-MOD-2022-659439:same reporter
Agitation, Depression, Headache, Arthralgia, Fever,  fever 101.5, chills, back pain, tearful and "I cannot explain, I just don't feel well"  Narrative:
She got her vaccine, went home and has been real sleepy, drained and tired.  She has a rash on her neck real bad and itchy, patchy type which grew to other parts of her neck.  She cannot get anything done due to the fatigue and loss of appetite.  These reactions still continue as of 4/28/21.   She has not taken anything for this reaction.  She is going to call her PCP today.
Patient is a 68 y.o. male patient of local MD with a history of SOB   Discharge Diagnoses:   Assessment/Plan: Patient is a 68 y.o. male who presented to local Hospital 2/8/2023 with shortness of breath, weakness.   1. SIRS s/t PNA a. CT CAP without contrast: BLL consolidation/opacities c/w pneumonia 2. Lactic Acidosis a. 5.4 on admission, 3.0 (2/9) 3. Acute Hypoxemic Respiratory Failure (RESOLVED) 4. Bacterial Pneumonia BLL (CAP POA) a. Vanco stopped due to Cr level b. Rocephin continued Day #2.   5. Positive Blood Cx - S. Pneumoniae a. Blood PCR positive for S. Pneumoniae.  b. Was on Vanco and Zosyn, transitioned to IV Rocephin Day #2. Vanco stopped due to Cr.  6. COVID-19 Infection a. Date of onset of symptoms:  2/2/23 b. Symptoms present on admission: Hypoxemia c. Date of covid positive test:  2/8/23 d. Vaccination status:  x2 vaccines e. Imaging:   CT CAP with BLL pneumonia f. Oxygen requirements on admission:   3LPM g. Current oxygen requirements: RA h. Medical therapy: Decadron i. Consultants following:  Cardio, Nephrology consulted j. Anticipated special isolation end date 2/18/2023 k. CRP and Sed rate monitored--elevated 2/9 7. AKI on CKD a. Nephrology states okay to discharge. Recommends Lasix 40 mg daily  b. Likely multifactorial including COVID-19 creatinine has improved to 2.4 8. Hyperglycemia, Type II DM a. Elevation noted due to steroid use.  b. Will increase NPH dosing as current BG running 250-300s. 9. HF with mild reduction in EF, chronic a. Reviewed echo from 5/2022: EF 43%, grade II diastolic dysfunction, moderate LVH, moderate enlargement of the LA chamber, mild MV regurg, mild TV regurg, pulm HTN RVSP 43mmHg b. Continue antiarrhythmics and Eliquis per home regimen 10. Other Chronic Conditions include: CAD, HTN, H/O MI, H/O stent to LAD, H/O AFIB s/p ablation x1.
Report of administration error, patient was administered 0.3mL of Pfizer Bivalent for pediatrics, this quantity was not diluted as usually done for pediatrics. The vial was confused for a Pfizer Bivalent 12+. The error was subsequently determined and reported up the chain. Plan includes having medical provider call patient, this VAERS information, Safety Event. Should there be a need, the medical provider will give the patient detailed information on plan to follow for any adverse effects if they do present themselves.
There was an excursion from the freezer; administered to 118 patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was stated that, there was excursion from the freezer on 01-Oct-2021 and nurse used the excursion tool but there was no option for the excursion they experienced. The only tool gives the options for excursion above one hour and not less than that so the nurse dose not known about the analysis. The nurse stated that her team know the recommended temperature and wants to know if the vials were still okay to use because they were administered to 118 patients. The storage condition at the time of the excursion was frozen, vial size was 7.5 mL and maximum or minimum temperature reached was as follows; minimum 4.2 degree F and maximum 5.7 degree F. It was also stated that excursion duration was 6 minutes. On visual inspection the vials were thawed before administration and there were no color changes or anything abnormal. Total 10 vials/doses were impacted.  No concomitant medications were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Significant follow-up-Patient demographics, Vaccine start date and Dose number of the vaccine were added
I woke up and had trouble breathing and my heart was racing and my arm felt like someone put a hot needle in there. It was swollen and red and hot to the touch. I took Benadryl repetitively. It lasted 3 days and then went away.
On day 7 post shot 1, injection site slight soreness. On day 8 post shot 1,  soreness increased to a about same level as  first 24 hours post shot 1 along with swelling approx 3? x 5? around injection site. No apparent redness or rash at this time.
On the third day, when I got up I feel pain in my arm and shoulder, towards my right clavicle and I feel a lot of burning in the place where they gave the vaccine and my armpits and breast begin to hurt (a constant and very strong pain), the pains come and go. I had neck and head pain for 3 days, I took Ibuprofen, I couldn't sleep and then suddenly it went away, except for pain in the armpits, breast and burning in the arm and my back and neck began to hurt. In August my knees were stiff and sore, I couldn't go downstairs, the days went on and the pain spread to my hips and heels. There came a time when my elbows and fingers hurt, the pain came and went, there came a time when I couldn't sit or stand. My joints were stiff (around). That's how I've been and then I went to the Internist (in October) they tested me on everything, but they didn't find anything. I started using natural "Arnica" pills, I asked to see a Neurologist because they told me that I might have had West Nile, the Neurologist sent me for tests, but he found nothing. I went to the Internist and he gave me other pills for joint pain only and sent me to a Rheumatologist. In October I also had kidney problems, I had 2 small stones and they came out with treatment, because they were in the duct, I had these stones for about 10 years and they never gave me a problem. I always felt burning, pain and stiffness in my hips.
Onset on Day 8 of all of the following: swollen lymph nodes in L armpit, 4" diameter rash around injection site, renewed muscle pain in L arm/shoulder (the initial soreness had gone away but it came back just like I had first gotten it), fever of 99.5, body aches, headache
I received my first shot on August 13th, and about 4-5 days later I began experiencing spontaneous pain all over my body. It feels like a needle is stabbing me and it happens randomly without anything triggering it. It can start on my wrist, then start on leg, then on the back of my head, then on my chest, and really just anywhere on my body. It?s not a traveling pain so it doesn?t start on my wrist and travel to my ankle, it?s spontaneous. It doesn?t feel like numbness. The pharmacist  advised me to report this since they had not heard anything like it.
Child received MMR #1 and PENTACEL #2 on 6/22/12 at 2:54 pm. Mother called MD office on 6/22/12 at 3:45 stating child had developed "rash & hives" over body, face & eyes. Directed to local ER.
Severe vertigo on Day-1 of the symptom -- room spinning.  Bed bound for 14+ hours. Subsequently, symptom occurs whenever getting out of bed, and sometimes when changing body position. Symptom persists 15 days after vaccination.
Hives, initially on wrists and arms, chest, then on face (very itchy), chest tightness
Cellulitis, with lymphangitis and tender large L axillary lymph node (3cm), vesicular and draining and pus. Started on levaPak