chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pea size knot, very sore to touch, slightly raised and has had warmth to area
Shoulder pain--patient notes that developed shoulder discomfort after the shingles vaccine was administered; she had the initial vaccine reaction of fever and body aches for 48 hours but now her shoulder is still hurting; tearful on the call; report difficulty dressing and driving due to the pain; reviewed need for patient to do abduction of the shoulder to move the fluid out of the shoulder as that tends to be the major issue; rec she do abduction 20 times, 3 times/day over the next week; if it is not continuing to improve or is not resolve, then she should plan to see us for evaluation; rec naproxen 220mg, 2bid for the next week;
HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) 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. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.).    No concomitant medicine were reported. No treatment medicine were reported. This case was for 16th patient out of 16 patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697687 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697687:Master case
that was delivered late and deemed not viable by the wholsaler; no adverse effect reported; patient was inadvertently administered, was delivered late and deemed not viable; This spontaneous report has been received from a Medical Assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, and concomitant therapies were not reported.  On 20-SEP-2019, the patient was inadvertently administered a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), valid lot number S006159, expiration date 10-NOV-2020 (also reported as 10-NOV-2010, conflicting information), orally as prophylaxis (strength, anatomical location and dose  were not provided) That was delivered late and deemed not viable (product distribution issue) by the wholesaler (poor quality product administered). No adverse effect reported.  Information about the product temperature, time frame, use of data logger and previous temperature excursion was not provided.  The outcome of product distribution issue was unknown.  The causality assessment between Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) and product distribution issue was not provided.
After receiving the 2nd dose of the COVID-19 vaccine he was diagnosed with polymyalgia rheumatica, and it is managed now. He was then able to start taking 5mg of prednisone instead of 20mg where he started. Then after receiving the COVID-19 booster he went for a hike one day on a Wednesday and walked a few miles. When he came back the white part of his left eye was blood red. There was no change in his vision, and he said it didn't hurt. On the next day, Thursday, both of his eyes were red. Then Friday they were even more red. We called his doctor on that Friday but he didn't answer so we contacted a rheumatologist. The rheumatologist called us back and thought it could be giant cell arteritis so he changed the prednisone to 60mg for a few days. When he had tests did it was confirmed that he had giant cell arteritis. Since then he has been able to bring the prednisone down to 15mg. They have also added a monoclonal antibody infusion that he has to take monthly now.
10 hours later severe pain in the tragus of both ears which woke me up; Headache within 5 minutes which lasted until the next day; This is Spontaneous report from a contactable Other-HCP (patient). A 57-years-old female patient (No pregnant) received first dose bnt162b2 (BNT162B2, lot: EL1284), via an unspecified route of administration on 30Dec2020 17:00 at single dose on Right arm for covid-19 immunisation.  Medical history was none. Concomitant medication included celecoxib (CELEBREX), black cohosh [cimicifuga racemosa] (BLACK COHOSH [CIMICIFUGA RACEMOSA]) and multivitamins. The patient previously took erythromycin and experienced drug hypersensitivity. The patient experienced Headache within 5 minutes (30Dec2020 17:05) which lasted until the next day, then about 10 hours later (31Dec2020 03:00) severe pain in the tragus of both ears which woke her up. It felt like someone was grabbing them with pliers. Still recurs mildly from time to time. No treatment received. The events were reported as non-serious.
I have fibrocystic breasts, with many cysts and 3 fibroadenoma tumors. I occasionally experience mild soreness before my period. After receiving the Moderna booster (my previous vaccine on 5/2/2021 was J&J) within a few days I noticed a little bit on f breast pain and noted that it was uncommon to have pain in my left breast which has fewer/smaller cysts. I assumed my period was coming and there must just be more swelling this time. I took Tylenol a few days to  alleviate  the  pain. On January  5 my period did start. It came and went and the pain did not go away as it normally would. On January 11 I noticed that I could see a slightly raised area of skin below the nipple of my right breast, and when I touched it I felt a hard lump right below the surface that feels about an inch long and is similar in feeling to my fibroadenomas. However, it is in the same area where I have a cluster of large cysts that span 60mm at my last ultrasound in October 2020. This lump is either new or an existing one that moved or grew. I am still waiting on a referral for another ultrasound and having to take daily Aleve for the pain. In the meantime the pain has become constant in the right breast.  It is sharp pains behind and around the nipple. The left breast experiences less sever zaps of pain. I?ve talked to several other women in the Facebook group for women with Fibrocystic breast and many are reporting the same issue; pain after receiving an mRNA vaccine, growing or changing of fibroadenomas, swelling of breast.  One said it mostly went away after a couple of months, while others have reported no changes even months after their last vaccine.  There seems to be a correlation between the vaccine and fibrocystic breasts and I think this needs to be researched ASAP!
ANAPHYLAXIS(THOAT ITCHING, TONGUE SWELLING, PROBLEMS TALKING, WHEEZING), EPIPEN ADMINISTERED, PATIENT RETURNED TO "NORMAL" AFTER A SINGLE DOSE OF EPIPEN
Low grade headache starting immediately after shot - continuing through present; Lethargy and sleepiness starting 1/30 and continuing to present;  Deep chest cough and tightness in chest starting 2/2/21
66 yo F PMH osteopenia, endometrial CA s/p hysterectomy, chronic urinary incontinence, presented to the ED with atraumatic bilateral leg weakness L>R and low back pain, inability to ambulate for 1 week. MRI in the ED showed multileval canal stenosis in the cervical and lumbar spine. She was noted to have severe spinal cord compression C4/5 - C6/7 and L1-L5 with moderate L5/S1.   She is now s/p C3-7 Laminoplasty with plate reconstruction C4/5 posterior lateral fusion, L1-S1 laminectomy, Right L2/3 discectomy, Repair of durotomy near right L4 nerve root 5/9/22 w Dr.    She denies any trauma but states that she works at Pharmacy and her job involves a lot of bending, twisting, and lifting. She would like to find work that is a little easier on her physically.    When medically stable, the patient was discharged to health center for  acute inpatient rehabilitation of functional and cognitive deficits.   Symptoms related to these abovementioned conditions and events were well-controlled, and the patient was discharged medically stable and improved. There were no significant acute episodes that affected length of stay or tolerance to therapies.    The patient was also provided orthotics / durable medical equipment to ensure improved function and safety in the rehabilitation and home setting.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 2:12 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 2:12 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 33.99 for dose administered on 11-Jan-2021.  No concomitant medications were reported.  Batch number 041L20A underwent temperature excursion on 11-Jan-2021 with temperature 34 degrees Fahrenheit at 09:00 AM, and 35 degree Fahrenheit at 02:00 PM. This vial was moved to fridge on 08-Jan-2021 and beyond use date for the vial was reported as 07-Jan-2021. Product moved to clinic on 11-Jan-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
inflammation in his arm; beyond fatigue; achy; I was hot; gave me suicidal ideation; depression got worse; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (depression got worse) and SUICIDAL IDEATION (gave me suicidal ideation) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included MIRTAZAPINE, VALPROATE SEMISODIUM (DIVALPROEX), CLONAZEPAM, LISINOPRIL, LEVOTHYROXINE SODIUM (SYNTHROID), FOLIC ACID, ACETYLSALICYLIC ACID (BABY ASPIRIN), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM WITH VITAMIN D 3), DOCUSATE SODIUM (STOOL SOFTENER), SIMETHICONE, PRAVASTATIN and ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE (MINTOX) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DEPRESSION (depression got worse) (seriousness criterion medically significant), SUICIDAL IDEATION (gave me suicidal ideation) (seriousness criteria medically significant and life threatening), PAIN (achy) and FEELING HOT (I was hot). On an unknown date, the patient experienced INFLAMMATION (inflammation in his arm) and FATIGUE (beyond fatigue). At the time of the report, DEPRESSION (depression got worse), SUICIDAL IDEATION (gave me suicidal ideation), INFLAMMATION (inflammation in his arm), PAIN (achy), FEELING HOT (I was hot) and FATIGUE (beyond fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt vaccinated with DTP described as extremely fussy for 24 hrs following the vaccination.
Patient began having chest pain, mild shortness of breath on exertion, and general malaise several days after receiving vaccination. Initially seen in the ED at Medical Center on 03/29/2019, had normal EKG, normal labs including troponin, CBC, CMP, and was discharged home. Continued to have symptoms, and was sent to the ED again from his clinic on 04/02/2019 as he had reported a fever orally of 101F on the evening of 04/01/2019. EKG, CBC, CMP again unremarkable; however troponin was elevated at 1.87. Given concern for myocarditis, patient will be admitted to Medical Center for Echocardiogram and further evaluation by medicine and Cardiology services.
Pt reports the night following the vaccine he devolved fatigue and a fever. The following morning he experienced a "tight feeling" in his shoulder which made it difficult to move. Patient also developed localized erythema and swelling extending from shoulder to elbow.  Patient has had an intermittent fever of 102. Treatment includes Mortin 800mg.
After 10-15 minutes after vaccination, patient had a red, rash like patch on her back and no other symptoms. Patient remained on site to be monitored. After another 30 minutes and patient had some water, rash site showed improvement. Mom brought Benadryl just in case. After another 2 hours, via phone call, mom stated rash resolved on its own  and child had no other symptoms.
It was reported that a female patient received a yellow fever, a meningococcal polysaccharide vaccine and a hepatitis-B vaccine on 30-Mar-2001. Reportedly sometime after the vaccination (date not specified), the patient developed a large local reaction at the injection site (site not specified)  From additional correspondence received on 14-May-2001, it was reported that the injection site reaction occurred at the yellow fever site on2-Apr-2001. Reportedly the patient recovered from this experience. This case is closed
2 days after MMR, DTaP, and IPV, patient developed rash over arms and back which responded to dephenhydramine.  One day later, she developed rash on her chest and face and significant facial swelling.  No difficulty breathing.  Was seen in ER, got 4 days of benadryl and prednisolone and fully recovered.
Moderna BV for children 6m-5y 0.2ml/10mcg dose was given to start series.  Per standing orders should have been 0.25ml/25mcg dose of Moderna BV (dark blue cap)
Information has been received from a registered nurse concerning a 13 year old female student (weight 107lbs, height 62-75')who on 19-SEP-2007 was vaccinated with the first dose of GARDASIL (Lot #658556/1060U).  On 29-NOV-2007, the patient was vaccinated with the second dose of GARDASIL (Lot #659435/1265U).  On 02-APR-2008, the patient was vaccinated with the third dose of GARDASIL (Lot #659653/1448U).  Concomitant medication was reported as none.  On an unspecified date in December 2007 a few days after the second vaccination, the patient experienced severe neck and shoulder pain.  The pain was severe enough that the patient was examined at the emergency room, but not admitted.  On 02-APR-2008 the evening of the third vaccination, the patient developed neck and shoulder pain which was not as severe as the pain following the second vaccination.  There was no local reaction at the injection site.  Unspecified medical attention was sought as the patient contacted the physician's office.  The patient's neck pain and shoulder pain persisted.  No product quality complaint was involved.  No further information is available.
Patient was admitted to hospital and was diagnosed with adenocarcinoma of colon with mets to liver and C spine. He required C5-T1 anterior fusion, C6, C7 corpectomy on 12/1 and he was sent to rehab. Re admitted 12/23-1/23 for radiation pneumonitis or pneumonia with COVID-19. He was discharged to rehab and re admitted to another hospital 2/3-2/7 for hematuria. He was discharged and re admitted 2/10 with worsening hypoxemia and bilateral infiltrates. He declined and was intubated 2/11. His course was complicated by ventilator dependency, sepsis, atrial fibrillation with RVR, COVID-19 pneumonia, right pneumothorax and ongoing blood loss requiring multiple transfusions. Patient underwent tracheostomy placement on 2/16. Palliative care met with family multiple times. Family understood mortality and poor prognosis, and decided to make patient DNR, but refused to withdraw care. They did not wish to escalate care. Patient became hemodynamically unstable on 3/3 and expired at 0116 hours.
4/10/19 received vaccine. 4/17/19 woke up with soreness at injection site 5/6/19 still sore at the injection site when touched or layed on at night.
This spontaneous report was received from a 68-year-old female patient regarding herself, with no drug reactions or allergies. Current conditions included lactose intolerance. Approximately on an unknown date in February 2010 the patient was vaccinated with a dose of live ZOSTAVAX (lot# and expiration date not reported) subcutaneously. On 14-FEB-2013, she began to develop a rash on her left leg and back that developed into blisters. She showed them to her doctor and he told her she had shingles. The patient stated the blisters were healing and she considered herself recovering. Patient was treated with acyclovir and CLOBET cream. No lab diagnostic studies were performed. Patient sought medical attention for the event. Causality was not reported. Additional information is not expected.
This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. Patients' medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored doses (temperature excursion) of oral, ROTATEQ (lot number reported as L027726 and expiration date 10-MAY-2017, dose was not reported). Concomitant therapy was not reported. No adverse effects were reported. There was no previous temperature excursion and it was not a data logger. No product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Extreme whole body shaking; had fatigue; nap the afternoon; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: EN10200; Expiration Date: unknown), dose 2 via an unspecified route of administration, in Arm Left on 23Feb2021 10:30 as SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. The patient didn't take any other vaccine in four weeks prior to vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.Concomitant medications included atorvastatin (ATORVASTATIN), protandim (LIFEVANTAGE PROTANDIM) taken for an unspecified indication, start and stop date were not reported. On 23Feb2021 22:30 the patient experienced extreme whole body shaking lasted for 4-5 minutes and shaking finally stopped and has not happened. On 23Feb2021,the patient experienced fatigue, nap the afternoon(slept 10.5 hours plus a 2 hour nap the afternoon). Now 2 days post injection feeling back to normal.The outcome of the events was recovered. No follow up attempts are possible. No further information is expected.
Patient received COVID19 Pfizer bivalent and Flublok shots in separate arms on 9/15/22. On 9/17/22, pt experienced sudden onset cardiomyopathy/pericarditis and was taken to hospital via ambulance and admitted. Patient left hospital AMA on 9/18/22 and followed up with her PCP and cardiologist. Cardiologist prescribed nitroglycerine and colchicine to help with pericarditis. Pt is stable and at home now.
Fussy after around 9 PM.  T 102 inconsolable.  Left thigh red & swollen at the injection site.  Gave TYLENOL.  4/21/10 seen in office, left thigh 1 cm redness X 1.5 cm induration.  Rx TYLENOL.  BENADRYL T 100.6 BIAXIN early LOM.
9/10/08 presented to office with joint pain (knees, ankles, elbows, wrists) and headaches X 3 weeks. 9/25/2008 Office notes received from PCP for OV 9/10/2008 for pt c/o joint pain x~3 weeks. Pain in all joints all over. Also c/o headache x 6 days.  PE (+) for joint tenderness. DX:  Arthragia/myalgia.
Mother reported to  nurse son wasn't feeling good.  Client had put head down on table.  When nurse got to him he was pale with thready pulse.  Lowered client to floor with feet elevated and ice pack placed on back of neck.  Client stated throat "hurt."  Blood pressure  was 80/52.  Client remained alert and oriented.  EMS was called.  Client then complained of  hands and legs tingling as well as his bottom teeth.  Encouraged client to take breaths.  EMS arrived at 4:17pm.  Blood pressure  100/68.  EMS took over care at that time.   4:40pm Client feeling better.  Wasn't transported to hospital for follow up.  Client walked out with the assistance of  mother.