chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hard lump; radiating down my arm; feels like a big bruise; radiating down my nerves; muscle in my arm where I got the shot has been getting more and more sore; This spontaneous case was reported by a non-health professional and describes the occurrence of MASS (hard lump), PAIN (radiating down my arm), CONTUSION (feels like a big bruise), NEURALGIA (radiating down my nerves) and MYALGIA (muscle in my arm where I got the shot has been getting more and more sore) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 072C21A or 002C21A, writing unclear) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021, the patient experienced MASS (hard lump), PAIN (radiating down my arm), CONTUSION (feels like a big bruise), NEURALGIA (radiating down my nerves) and MYALGIA (muscle in my arm where I got the shot has been getting more and more sore). The patient was treated with NAPROXEN SODIUM (ALEVE MAX) (oral) ongoing since an unknown date for Pain, at an unspecified dose and frequency and LIDOCAINE HYDROCHLORIDE (LIDOCAINE [LIDOCAINE HYDROCHLORIDE]) ongoing since an unknown date for Pain, at a dose of 1 dosage form. At the time of the report, MASS (hard lump), PAIN (radiating down my arm), CONTUSION (feels like a big bruise), NEURALGIA (radiating down my nerves) and MYALGIA (muscle in my arm where I got the shot has been getting more and more sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medicine include Aleve and 4% Lidocaine roll-on pain reliever
pt recvd vax; devel mild case of rubella which she thought had been brought on by rubella virus vax;f/u info from reporter indicated that there was no pt involved;
pt recv vax; 1 hour later, felt warm, became mottled, shaking, not alert for 5 min.  Saw us 2 hr later & PE WNL but temp 101 degrees
I am a registered nurse. In order to comply with my employers policy that employees who do not receive the flu vaccination will be required to wear a mask when within 6 ft of another individual, I took the flu shot on 10/7/14 at my workplace. Two days later I began feeling numbness near my left rib cage. This feeling was not present prior to 10/9/14. When it did not resolve after 1 week, I sought treatment from my healthcare provider on 10/17/14 and was prescribed a prednisone taper: 40 mg for 3 days, 30 mg for 3 days, 20 mg for 3 days and 10 mg without results. I returned to my provider on 10/29/14 and thoracic MRI was ordered then done on 11/11/14 without contrast which showed a demyelinating lesion at T 6-T 7. I was seen by a neurologist who ordered a repeat MRI of my thoracic spine to be done this time with contrast. MRI of brain and cervical spine both with and without contrast were ordered and done on 12/4/14 (brain) and 12/8/14 (thoracic and cervical). Another demyelinating lesion was seen at C2 level of spinal cord but no demyelinating lesions were seen in the brain. At this time I did not think it was significant. However, when my neurologist diagnosed me with demyelinating disease of central nervous system, I began researching possible causes other than multiple sclerosis, as I do not meet criteria for MS as evidenced by lack of brain lesions and a normal neurological exam. What I found from research is as follows: "In primary demyelinating disorders, cause is unknown, but an autoimmune mechanism is suspected because the disorder sometimes follows a viral infection or viral vaccination". "It's possible that activating the immune system could trigger an autoimmune reaction. This occurs only in a few individuals with hypersensitive immune systems. Some children and adults experience "acute demyelinating syndromes" after exposure to certain vaccines such as those for influenza or HPV". After reading the above, and with flu shots again being offered by my employer for this season, it prompted me to look back at when I had had the flu shot last yr when my symptoms appeared. (Hence the almost 1 yr delay in reporting this adverse reaction). The date was 10/7/14, 2 days before my symptoms appeared. I immediately notified my neurologist who advised me not to take the flu shot because he feels that the vaccination could absolutely have triggered an immune response in me that attacked my myelin. He said he's seen it happen before. He himself does not take a flu shot. My treatment is ongoing with repeat MRIs needed to follow for further demyelination and my symptoms (numbness at left rib cage and weakness/heaviness of right leg) are still present one yr later. If I can provide any additional information, please feel free to contact me or my neurologist. Thank you and please provide follow up with me regarding this matter.
Pt had swelling, redness and tenderness around injection site.  Area was warm to the touch. Arm is improving.
Vaccine underdose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Vaccine underdose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Vaccine underdose) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Vaccine underdose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Vaccine underdose).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live significant Follow-up appended: Patient details (age group) was added..
Delayed motor skills; Extreme pain in vision aura's; Complex migraine; Vomiting; Slight headache / extreme pain in headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (Delayed motor skills), EYE PAIN (Extreme pain in vision aura's), MIGRAINE (Complex migraine), FATIGUE (Tired) and VOMITING (Vomiting) in a 19-year-old female patient who received mRNA-1273 (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced FATIGUE (Tired) and HEADACHE (Slight headache / extreme pain in headache). On 09-Apr-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (Delayed motor skills), EYE PAIN (Extreme pain in vision aura's), MIGRAINE (Complex migraine) and VOMITING (Vomiting). The patient was treated with BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency. At the time of the report, JOINT RANGE OF MOTION DECREASED (Delayed motor skills), EYE PAIN (Extreme pain in vision aura's), MIGRAINE (Complex migraine), FATIGUE (Tired), VOMITING (Vomiting) and HEADACHE (Slight headache / extreme pain in headache) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No relevant concomitant medications were reported.
This spontaneous report as received from a physician refers to a 18 years old male patient, who in April 2012 was vaccinated with the second dose of 0.65 ml GARDASIL subcutaneously (lot number was not reported) and on 22-JAN-2013, was vaccinated with the third dose of 0.65 ml GARDASIL subcutaneously (lot number was not reported). No other co-suspects were reported. Concomitant medications included: influenza virus vaccine (unspecified). The physician reported that received the third dose of GARDASIL and 4-6 hours later, had urticaria. The patient took BENADRYL for the adverse event. It was reported that the patient was going to check in with HCP on 23-JAN-2013. The patient  sought medical attention, she called to the office. At the time of the report, the patient's outcome for the adverse events was unknown. The relatedness for urticaria was unknown for GARDASIL. Additional information has been requested.
Upon beginning the Tyhoid Vaccinee immediately on the next day (Thursday) I began to notice weakening of the limbs and some behavioral changes.  That night I did not sleep and began having nightmares.  Friday I took the second pill of the series and I noticed more mood changes and more weakness.  That evening I did not sleep as well.  I did not get any sleep until Saturday evening which only provided a couple hours at the most.  By that time I was delusional and mentally not there.  Sunday I took another pill as I still didn't know that the drugs were messing me up.  Upon hearing that a friend died I did something that I don't normally do, I drove for 3 hours straight with no destination in mind, just drove.  I came back to the city and then walked around for a couple hours.  I was in a fog and I was getting more and more weak and dizzy.  I managed to get home where I passed out in my living room for about 10 minutes, don't really know.  I called up a friend and while talking to her on the phone telling her that I was not okay I passed out again on the kitchen floor.  The friend sensing that something was wrong immediately came over and with the help of another friend proceeded to take me to the hospital.  I was in a complete state of mental disarray.  I didn't know where I was and who anyone was.  (That's what everyone tells me, I dont remember anything of the last two weeks).  I was put on a IV and was given a CAT Scan.  That evening I was also given a spinal tap to rule out Meningitis.  It came back good and from that point on I fought the most god awful headaches in the world.  I will still very weak from the Typhoid.  I couldnt squeeze anything with my hands and I couldnt even resist when my feet were pressed against with a slight touch.  I was so weak that I couldnt stand on my own two feet.  Through out the rest of the week I fought spinal headaches, nausea, behavioral changes, mood swings, violent nightmares, backaches, dizziness, and other symptoms all at once.  I still am fighting some of this stuff but with less frequency and severity. Nurse follow up on 10/14/04 states: "symmetric weakness, confusion, stumbling gait, diarrhea, malaise, and dehydration." Hospital d/c summary reviewed. Discharge diagnoses were malaise, weakness, and diarrhea probably secondary to oral typhoid, and allergic rhinitis. Upon admission patient's temp was 97.9 and BP was 161/100.   A few fire ant bites were noted around his ankles and pt recalled a tick bite within the past year, but without apparent sequelae. Pt is a student and works in a landscaping businesss. Pt has a strong FH of depression and he admitted he had had an episode of depression with suicidal thoughts one year ago. However he obtained counseling at that time and has had no further problems. He continues to see a counselor weekly and has been under some stress in his personal life recently, but is clearly not depressed. He took 3 doses of the oral typhoid prior to admission - 8/11/04, 8/13/04, and 8/15/04. He was admitted on 8/15/04 and discharged on 8/17/04. Discharge meds were FLonase and Percocet.
12 hours after booster there was 12 hours of symptoms of cerebritis with headache, photophobia, mild confusion, and wooshing tinnitus. The tinnitus has remained after six months but after five months decreased in its intensity by about 50%. It does not interfere when I am working or occupied. It does not disturb my sleep.
The vaccine did not prevent shingles as intended; herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. On or about 25-JUL-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) at a Pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2015, the patient was treated by a physician, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
This spontaneous report as received from a pharmacist refers to a multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX. The VARIVAX was reconstituted with properly stored sterile diluent (MERCK). No adverse effects were reported with any patients. The digital data logger was involved in recording the excursion. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA010210.
No other adverse events were reported.; This pharmacist states that they administered Pneumovax 23 to an elderly male patient on 09Sep2022 then realized it had expired 4 months ago; This spontaneous report was received from a pharmacist referring to an elderly male patient. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.     On 09-SEP-2022, the patient was administered a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #, dose detail, expiration date, route of administration, vaccination site were not specified) for prophylaxis, which had expired 4 months ago (expired product administered).  The patient did not experience any adverse event.
summer 1993 pt exp unusual fatigue, lightheaded pressure feeling, occasional stumbling;
This case was reported by a pharmacist via call center representative and described the occurrence of swelling in a 71-year-old male patient who received SHINGRIX (batch number ZN22Z, expiry date 2nd February 2021) for prophylaxis. On 26th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced swelling (serious criteria other: as per reporter) and pain (serious criteria other: as per reporter). On an unknown date, the outcome of the swelling and pain were unknown. It was unknown if the reporter considered the swelling and pain to be related to SHINGRIX. Additional details were provided as follows: As per the reporting pharmacist, the patient complained of pain and swelling that was the size of a goose egg following the dose of SHINGRIX received in the right deltoid.
Patient's parent put the wrong date of birth on the form. When billed to the insurance we were informed this was incorrect, and the patient's actual birthday is different then listed on the form, which is under the recommendation for Pfizer.  We will contact the primary care physician with this information to inform of the discrepancy and proceed with their recommendations for further action.
administered one dose of the expired vaccine with no adverse event; Initial information received on 27-Sep-2021 regarding an unsolicited valid non-serious case from other health professional, consumer/non-healthcare professional and physician via Agency (under reference 00786940).  This case involves a patient (unknown age and gender) who received one dose of the expired QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) [expired product administered].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received 0.7 mL dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (Total, lot UJ764AA and expiration date: 30-Jun-2021) via unknown route in an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (same day latency).  It was reported "Caller states that they received a shipment of vaccines on 27Sep2021 at 9am, and received an email later that day that the vaccines may have been expired due to being in shipping for too long. The caller states that they have already administered one dose of the vaccine by the time they received the email. Caller informed they have already spoken with customer service and were transferred over to medical information. Caller would like to know how to proceed after administering the expired dose? Caller was unable to provide patient information at this time since they do not have access, they were able to provide vaccine information, administering nurse, and prescribing physician information which is listed below."  At time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Redness and swelling started one day after injection. Two days later, swelling of lymph node in right axilla. Advised to use ibuprofen and cold compress.
Admitted on 8/22 with acute hypoxic respiratory failure with pneumonia.  Two bronchoscopies showed PJP pneumonia by PCR and was receiving bactrim and methylprednisolone. on 9/5 + covid test and treated with dexamethasone and remdesivir. On 9/26 developed worsening hypoxia and intubated. Developed wide-complex tachycardia and started on amiodarone as well as vasopressor support. Cardiology felt rate dependent left bundle branch block. Continued to deteriorate with renal failure and associated electrolyte abnormalities which were being treated. Family decided to pursue comfort care.
Received DTaP, Hep A, IPV andn MMR on 9/29/03. First MMR received on this date 9/29/03. Parent noticed right jaw and face swelling 10/6/03. Was seen in clinic 10/7/03 with diagnosis parotitis.
Child was only seen 1 time. Child was a twin. Immunization office found out child died from the mother of child. MOC received our letter advising of 2nd set of shots due 9/6/02 and came in to tell us child had died. Per medical records, ME requested copies of medical records to help with cause of death. Death certificate coy to be sent as soon as received at vital statistics.
Recipient called HD to advise the vaccine was received on 1/30/2021 and on 2/9/2021, recipient noticed arm was slightly red, itchy and warm to touch at injection site. Recipient called PCP who instructed recipient to take Benadryl and apply Cortisone on the site. PHN followed up with recipient 2/10/2021. Recipient verbalized the area had improved with no further complications.
A 43 year old male patient received a pneumococcal vaccine during his visit for an upper respiratory infection on 05/02/2005. He called the triage nurse on 05/03/2005 complaining of pain from the injection site radiating up his arm. The patient was given a same day appointment for evaluation but when he presented he was not seen due to copay issues. On 05/04/2005 the nurse spoke with the patient and he stated that the pain had stopped and denied any redness, swelling or heat at the injection site.
PATIENT RECIEVED VARIVAX ON 02-17-99 THEN PRESENTED IN OUR OFFICE ON 03-14-05 WITH CHICKEN POX.
Pt developed local reaction in arm with erythema, swelling, warmth. No neuro vascular deficit. Left arm.
Burning pain in chest that lasted for the weeks in between the two doses. Did not recognize the connection to the vaccine at the time and got the second dose. Symptoms worsened and on 4/12/21 felt extreme chest pressure like lead bar in center of chest. Pain and pressure have lessened in intensity since that time but has not gone away. Chest pain and/or  pressure has been present ever day for over 3 months now. During this time, I have also been experiencing consistent rapid and shallow breathing but without the experience of shortness of breath.
Pt was pre medicated with Zyrtec the night before and immediately after he was given Benadryl. When we got home about 45-60 mind later he took Neurofen (Motrin). I noticed the next night that he had the beginning signs of ELS. He had ELS from a flu shot back in 2017 and hasn't had it since but this started to show signs from the COVID vaccine. He had edema, redness, and the site was warm to touch. I gave him more Benadryl and Neurofen that night.
I am tired from not sleeping; Body hurt; 101 degrees fever; Started to feel bad; Could not sleep that night; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Started to feel bad), INSOMNIA (Could not sleep that night), FATIGUE (I am tired from not sleeping), MYALGIA (Body hurt) and PYREXIA (101 degrees fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Sep-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced FEELING ABNORMAL (Started to feel bad), INSOMNIA (Could not sleep that night), MYALGIA (Body hurt) and PYREXIA (101 degrees fever). On 13-Sep-2021, the patient experienced FATIGUE (I am tired from not sleeping). At the time of the report, FEELING ABNORMAL (Started to feel bad), INSOMNIA (Could not sleep that night), FATIGUE (I am tired from not sleeping), MYALGIA (Body hurt) and PYREXIA (101 degrees fever) outcome was unknown. Not Provided          Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Patient started to feel somewhat better after lunch on 13 Sep 2021.   This case was linked to MOD-2021-311034 (Patient Link).