chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hard nodule in the arm then the next day this turned into a knot; swelling and redness then diffused over the arm; Initial information received on 26-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves two patients (demographics unknown) who experienced hard nodule in the arm then the next day this turned into a knot (nodule), swelling and redness then diffused over the arm (inflammation), when they received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE prefilled syringe lot number and expiry date not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced a non-serious hard nodule in the arm then the next day this turned into a knot (nodule), swelling and redness then diffused over the arm (inflammation) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was swelling and redness then diffused over the arm and hard nodule in the arm then the next day this turned into a knot.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported for the events.   Information on the batch number was requested.  List of documents held by sender: none.
Got shots still got it/suspected vaccination failure; got it; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shots and still got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
This spontaneous report has been received from a consumer regarding his/her father, a 53 year old white patient.There was no information about the patient's concurrent conditions, medical history, any known allergies, reactions or concomitant medications. On 12-APR-2017, the patient was vaccinated with ZOSTAVAX 19400 "PFU", injected into triceps not deltoid due to clothing in the way and injected sub-cutaneous and not intramuscular due to injection into tricep, for prophylaxis (dose, route of administration, lot number and expiration date were not reported). After the vaccination, the patient experienced vaccination site erythema with red, swollen and painful rash. The injection site reaction began to spread across back of arm. Subsequently, the patient who is physician self-prescribed prednisone 20 mg x 5 days starting on 14-APR-2017. The outcome of the events was unknown as well as the causal relationship between the events and the ZOSTAVAX. Additional information has been requested.
1) Right arm soreness at and surrounding injection site which radiated the entire length of R arm (no pain in R hand or in R upper back/neck). It was sore enough that using R arm to push off the bed to stand up  was uncomfortable to arm. 2) brain fog 3) general malaise
Hi,  I was vaccinated with the Moderna vaccine (1st administration) on 1/13/21. I have had persistent and very significant swelling since that day and it has not abated as of today, 1/20/21. The reason for this report is that I believe the swelling is not typical axillary swelling which I believe would be right under the arm where the lymph nodes are; rather it is located lower down and much farther away from where the lymph nodes are under my arm. It is a large swelling that is located to the side of my chest on the same side of the body as my vaccinated arm (which was my left arm).   I have not checked fever but do not think I have any. I do have headache as of today. Can you advise on whether this swelling is a typical reaction and whether there are any steps I should take at this time ?  Thanks very much,
This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 26-OCT-2012 02:39, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
PSA levels were much more aggressive; This spontaneous case was reported by a consumer and describes the occurrence of PROSTATIC SPECIFIC ANTIGEN INCREASED (PSA levels were much more aggressive) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A. and 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Prostate cancer.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PROSTATIC SPECIFIC ANTIGEN INCREASED (PSA levels were much more aggressive). At the time of the report, PROSTATIC SPECIFIC ANTIGEN INCREASED (PSA levels were much more aggressive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Prostatic specific antigen: increased (High) PSA levels were much more aggressive.         Patient was not sure to get his booster shot.  No concomitant medication reported.  No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow-up received includes non-significant information. On 07-Oct-2021: FU 2 contains no new information.
22 y.o. male PT w/reaction to smallpox vax. Scattered erythema and urticaria lesions over chest and back. More erythema and more vesicles noted surrounding bandage to left arm.
Had pain in the arm where I got the shot and the pain goes from my shoulder and my arm and that is basically six days after I got the shot; Had pain in the arm where I got the shot and the pain goes from my shoulder and my arm and that is basically six days after I got the shot; Had pain in the arm where I got the shot and the pain goes from my shoulder and my arm and that is basically six days after I got the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 23Feb2021 (Batch/Lot number: unknown) at the age of 79 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION SITE PAIN (non-serious), ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 01Mar2021, outcome "unknown" and all described as "Had pain in the arm where I got the shot and the pain goes from my shoulder and my arm and that is basically six days after I got the shot". Therapeutic measures were taken as a result of vaccination site pain, arthralgia, pain in extremity.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately 2 weeks post dosing child broke out in severe hives on head, face, torso, hands, arms, legs and feet. Hives were large raised blotches, red and noticeable swelling in hands, face and feet. Reaction lasted approximately 6-7 days.
I got the first dose of Moderna on 1/6/21. I had very minimal side effects, limited basically to pain in my arm. Then I woke up on 1/18/21 and had erythema and edema in a circle on my left arm where the injection had been given almost 2 weeks prior. This was not painful, I just noticed it was there. It lasted about 24-36 hours after that and has since resolved.   I got the vaccine when I was 16+3 weeks pregnant. The reaction appeared when I was  18+1 weeks pregnant. I am now 19+3 weeks pregnant. I am due 6/20/21.
COVID Vaccine Breakout Case  Pfizer Dose 1 3/2/21 (EN6203) Pfizer Dose 2 3/23/21 (EN6207) COVID Positive 11/20/21  11/20/21: Patient is a 69 year old male who presented to ED via EMS with complaints of shortness of breath.  Per chart review EMS was called while the patient was drinking at a bar when he became acutely hypoxic.  The patient had 1 episode of emesis and was noted to be hypoxic on room air at 80%.  EMS placed the patient on BiPAP and he improved his oxygen saturations to 92%.  He has a past medical history significant for atrial fibrillation anticoagulated on Eliquis, CHF, OSA, morbid obesity and hypertension. Patient is intoxicated and a poor historian at this time. He is unaware of all his medications. He does take Eliquis and a water pill but is unsure of dosing. He does not recall the events leading up to EMS being called. He denies daily ETOH use but admits he has been drinking daily for the past several days, a few beers per day. He has been Covid vaccinated. He denies tobacco use and does not report a history of COPD. He denies any recent fevers or body aches. He does endorse shortness of breath at this time. Denies chest pain.  On arrival to ED the patient was hypertensive 148/105. Laboratory findings were significant for hyponatremia 128. Transaminitis ALT 222, AST 211 and ALP 124. Lactic acidosis 2.5.  ProBNP 1400. CK 292. Hypoxemic/hypercapnic respiratory distress pCO2 62 and PO2 136. ALC 187. C-reactive 2.50. Rapid Covid positive. Patient was started on azithromycin and ceftriaxone in ED.  Solu-Medrol 125 mg and DuoNeb treatment given in ED.  Lasix 20 mg IV given in ED  11/23/21: Patient is a 69-year-old male with history of diastolic heart failure, atrial fibrillation on Eliquis, OSA, COPD, CPAP use,  alcohol abuse, presented to the emergency department from bar after emesis and hypoxia. Diagnosed with COVID-19 pneumonia and possible bacterial pneumonia, treated for alcohol intoxication.  Also had diastolic heart failure exacerbation for which he was on Lasix.  He became euvolemic.    Successfully weaned off oxygen.  Had transient hyperglycemia most likely related to steroids use.  Otherwise was back to baseline and was stable for discharge.
Starting out with sore arm where injection was- which was normal- then gradually the weakness and pain in arm got worse and now after 4 months has graduated to severe pain when using right arm- lifting my arm or using arm muscles at all causes pain and weakness in the exact spot of the injection-upper right arm.
No adverse reactions. Extra dose of hep B given before MICR will recognize but was given at least 8 weeks after the previous injection.
Patient was vaccinated with Pfizer dose 1 on 6/7. No symptoms.
pt received imz on 3-23 said she felt bad that night  symptoms were diarrhea and vomitting, went to ER was treated and released that night for dehydration
SWOLLEN LUMP AT THE  INJECTION SITE THAT IS WARM TO THE TOUCH; SORE ARM; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight was 165 pounds, and height was 60 inches. The patient's past medical history included tubal ligation, and concurrent conditions included non-alcoholic, and smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage, patient had no past medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: unknown) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced warm, swollen lump at the injection site. On 26-MAY-2021, the subject experienced sore arm. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, and had not recovered from warm, swollen lump at the injection site. This report was non-serious.
My Thyroid (which had been perfectly normal in all blood tests prior) went hyperthyroid and we believe I have sub-acute thyroiditis. My heart rate is constantly in tachycardia, I?ve had fever, my neck has hurt because the right lobe of my thyroid is now twice the size of the left lobe.
Severe headache, nausea, total body ache, dizziness, extreme fatigue lasting 30 hours
@ about 730PM on day of vax pt began running t103; arm very sore & pt would not move it; screamed & cried most of noc in spite of APAP & ice pack; also sweated through noc; finally fell asleep & 6-7AM next day;
15May90 pt vax;  28May90 dx of idiopathic thrombocytopenic purpura was made.  Pt hosp & tx w/ gamma glob inj & discharged.  Hosp again & tx w/ gamma globulin & predisone.
pt bleed a little and developed a small knot; pt stated she had been bleeding easy at home and reported a history of blood clots
Patient developed hives starting at injection site and spreading over entire body. + itching. No respiratory symptoms. Patient used Benadryl without relief and was referred to her PCP for follow up.
The pt developed local redness and induration on left thigh (2cm in size). Treated with cool compresses and Tylenol.
Within 2 minutes of vaccination, Pt c/o dizziness. Dropped to the ground and tapped head on side of plastic chair. Instantly recovered. Drank water & ate breakfast bar. Sat in lobby for 15 minutes before release with Dad. Pt states" little pain @ left forehead". 14:40 called, spoke with Dad,
Sore arm 1 hour after shot- pain became worse went to ER on 10/21/2002. X-rays done. Feel nerve irratation- given Naprasyn and muscle relaxant (Flexeril). Also seen by MD group, Rx for Bextra. Going back to gruop, Wed 10/31/2002. States still has knot at injection. 10/28/2002 At 09:30 am, we received a telephone call from pt stating her left arm became very sore with radiating pain to her shoulder immediately after receiving her flu shot on Thursday, October 17, 2002. She states that she applied ice to her upper arm, and later heaat. However, paon became worse and she went to the emergency room at JFK on Monday, October 21,2002. She was given muscle relaxants and the doctor felt she developed a pinched nerve, advised her to see her private medical doctor. The pt states sh eonly has a cardiologist whom she has spoken to and he advised her to go to group. She was seen by MD, who also felt her spine was in spasm. She will be seeing another doctor in the group tomorrow. Pt states she has been out of work since 10/17/2002 as she could not use her left arm. i informed her that I did not feel the flu injection would cause a pinched nerve. Advised her to keep her appointment at the group and follow their instructions. I stated that I would speak to the nurse supervisor and call her back. RN.  10/28/2002 returned call to pt, she states that she didn't call sooner then 10/28/2002 as she felt the pain would go away. However, she has a knot in arm and shoulder is still painful. She states the arm never became red or swollen. Pt si an Orthrodontist Assistant and attending school. She states she hasn't been able to go to work and does not have any more sick time. Concerned she would not be able to complete her course, as it requires using both hands. She does have health insurance. Advised her to call the health depatment after her doctor appointment on Wednesday 10/30/2002. RN 10/30/2002 Telephone call to pt, states she was seen by MD, pain management physician, at group. Pt states MD stated injection caused problem with nerve in upper arm and pain in shoulder is due to muscle inflammation secondary to injection. MD ordered physical therapy for 3 weeks, 2-3 times a week. She will start therapy on Friday, November 1,2002 with . Pt stated she is going to try to return to work this afternoon. She questioned if she would be compensated finacially for money she was required to spend due to this incident. I advised her I would speak to my supervisor and get back to her. Also requested she call the health department to let us know how she was feeling after therapy. Per acknowlegdement letter- All missing information is already on form.
72y.o. male with hx of prostate CA, DM-II, HTN, CAD (mild), PAD, recurrent syncope, current smoker presented to the ED after a MVC. Patient was driving at around 45 mph when he hit a fire hydrant and his car flipped over in the city. Pt states he lost consciousness prior to the crash. On arrival in ED BP 181/78, O2 100% on RA. Labs revealed Cr 1.49, mild anemia hgb 11.9, trop negative x1.  UA negative. COVID-19 PCR positive in ED. CT hea/C-spine negative for acute process.  CT C/A/P negative for acute process. CXR negative for acute process or infiltrates.  He was cleared by trauma sx team for DC. However, he was admitted for further work up for recurrent syncopal episodes and cardiology is consulted.Patient states he had a similar episodes few months ago but he was not driving at, did not seek medical attention at that time. Patient denies any recent changes to his meds. Pt states he is vaccinated against COVID 19 x2 and boosted x2. He reports mild dry cough, but no shortness of breath, chest pain, or GI symptoms. Patient was not aware that he had COVID-19 infection a prior to the admission. States his mild dry cough started about couple days ago but he thought was related to allergies. All imaging studies including CT head/C-spine, CT C/A/P, CXR, pelvic XR all negative for acute process or fracture. Okay to discharge and schedule loop monitor implant outpatient.
3 expired vials of 10 dose each were used to give booster dose to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 expired vials of 10 dose each were used to give booster dose to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 expired vials of 10 dose each were used to give booster dose to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 expired vials of 10 dose each were used to give booster dose to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  This is a case of Expired Product Administered concerning a patient of an unknown age and gender with no relevant medical history, who experienced no other associated adverse events. The event occurred on an unknown date after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a case of Expired Product Administered concerning a patient of an unknown age and gender with no relevant medical history, who experienced no other associated adverse events. The event occurred on an unknown date after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Developed a sore throat on 01/01/2022, followed by a cough on 01/03/2022. Tested positive for Covid on 01/05/2022.  Prescribed  Hycodan cough syrup and Tessalon Perles on 01/06/2022.
I have developed an abscess in my arm pit that requires draining; This is a spontaneous report from a contactable other healthcare professional (patient). A 46-year-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 05Apr2021 (at the age of 46-years-old) as dose number unknown, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Prior to vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient not been tested with covid-19. The patient stated that she had developed an abscess in her arm pit that requires draining on 14Aug2021. The event led to the physician office visit. Therapeutic measures were taken as a result of event that included had to have it drained and now another apt drain. The outcome of the event was reported as not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event Subcutaneous abscess and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
LEFT ARM RED/SWOLLEN/HOT TO TOUCH/ITCHY; REDNESS MEASURED APPROX 100CM X 77 CM; SWELLING/INDURATION MEASURED APPROX 77CM X 82CM; TX WITH CLARITIN AND BENADRYL
Client reported dizziness, tingling, numbness to top lip, fingers and legs few hours after vaccine given.
Cross inoculation near original site, low grade fever, fatigue, dermatitis, and swollen lymph node.
LOT of second dose was EN6203 Weight gain (20 lbs), rashes (this is what caused me to initially go to the doctor...dermatologist believes the eczema to be hormone related and liked to my vaccine...I got a patch of eczema after the first dose, and my body has been going crazy after my second dose. The patches flare and subside with topical steroids but then show up on another body part. Every single day for the last couple of months), sinus infection (allergist thinks it's hormone related). My sex binding hormone is high (150), testosterone is low (0.3), and my DHEA is low (3). Those labs just  came back a few days ago. I have an appointment with my endocrinologist in two weeks. Allergist suspects PCOS.