chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lymph nodes swollen under armpit the size of a half mango; Lymph nodes started hurting really bad and aching in his left arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Lymph nodes started hurting really bad and aching in his left arm) and LYMPHADENOPATHY (Lymph nodes swollen under armpit the size of a half mango) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-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 13-Apr-2021, the patient experienced LYMPH NODE PAIN (Lymph nodes started hurting really bad and aching in his left arm). On 16-Apr-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes swollen under armpit the size of a half mango). At the time of the report, LYMPH NODE PAIN (Lymph nodes started hurting really bad and aching in his left arm) and LYMPHADENOPATHY (Lymph nodes swollen under armpit the size of a half mango) had not resolved. Not Provided          Action taken with vaccine was not applicable. No concomitant medication was reported. No treatment information was provided.
No adverse event; received Bivalent Moderna COVID-19 vaccine on 28SEP2022. Another HCP from the same company administered a 2nd Bivalent Booster on 20DEC2022 by mistake; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (received Bivalent Moderna COVID-19 vaccine on 28SEP2022. Another HCP from the same company administered a 2nd Bivalent Booster on 20DEC2022 by mistake) and NO ADVERSE EVENT (No adverse event) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Dec-2022, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On 20-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (received Bivalent Moderna COVID-19 vaccine on 28SEP2022. Another HCP from the same company administered a 2nd Bivalent Booster on 20DEC2022 by mistake). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (received Bivalent Moderna COVID-19 vaccine on 28SEP2022. Another HCP from the same company administered a 2nd Bivalent Booster on 20DEC2022 by mistake) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (received Bivalent Moderna COVID-19 vaccine on 28SEP2022. Another HCP from the same company administered a 2nd Bivalent Booster on 20DEC2022 by mistake).    Didn't had any parental vaccine exposure.  Concomitant product use was not provided by the reporter.   Patient didn't received any other vaccines on the 4 weeks prior to COVID-19 vaccine.  It was reported that on 20-Dec-2022 at 11:53 AM, pharmacist called to report about 2 patients, were received Bivalent Moderna COVID-19 vaccine on 28-Sep-2022. Another HCP from the same company administered a 2nd Bivalent Booster on 20-Dec-2022 by mistake.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689943 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689943:same reporter
Ringing in ears,. 6 weeks after J& J dose. Still ringing I will be going to a specialist . Course of ring in ears 2 weeks doesn?t go away . Tinnitus . I had Johnson  and Johnson didn?t see it above to check manufacturer
I started to feel sore in my right shoulder in the front about 2 weeks after my second shot.  It feels like something is torn.  It is very uncomfortable and hard to sleep.  It has not gone away.  I was thinking it was just sore so i was giving it time to heal. I got the booster shot in my left arm because my right arm was still hurting.  about 2 weeks after that shot, halfway down my bicep to my elbow and halfway up my forearm is super sore, like pulled muscles.  I can't really pick a whole lot of weight up because i lose strength and it hurts. I also have not had a period in 2 months since my booster shot and prior to that it was intermittent.  It never was like that before.
Myocarditis (CP, elevated troponin, cardiac dysfunction). Steroid burst with normalization of function and improvement in troponins
vomiting 7 times over 2 days diarrhea 30+ times over 4 days fever around 103 for 4 days intense stomach pain ruptured appendix and appendectomy
Bell's Palsy, Paralysis of right side of face.  Had bad headache night before and numbness of face early AM (4 AM or so),  awoke to right side of face paralyzed.  He was at camp, where he was working in the kitchens.  He was taken to the Hospital that morning (6-19-2016)  They did a tick panel, blood work, diagnosed him with Bell's Palsy, prescribed Doxycycline, prednisone, and an anti-viral that I do not have the name of with me at the moment.  Sent him home to be evaluated by his primary care physician -seen 6-22-16, saw an eye doctor on 6-23-16, recheck with Dr on 7-6-16--no improvement so sent to a Neurologist Dr (7-11-16)--he ordered an MRI (7-13-16)and physical therapy (2x a week for 6 weeks) (Dr may have ordered the therapy).  On 8-3-16, I was talking to a friend who has had Bell's Palsy and she said that she was told that hers was caused by the chickenpox/shingles virus.  I said that he was vaccinated, that he had never had chicken pox, then I remembered that we had a vaccine boosted at the physical.  When I checked my records and discovered that it was the chicken pox vaccine that we boosted, I felt that it was significant enough to report it.  I plan to call the doctor to report it as well.
swollen arm; fever; Wrong Route of Administration; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th July 2019, the patient received the 2nd dose of Shingrix (subcutaneous). On 17th July 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On 18th July 2019, the patient experienced swelling arm and fever. On an unknown date, the outcome of the swelling arm and fever were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the swelling arm and fever to be related to Shingrix.  Additional details were provided as follows: The reporter was a pharmacist and also the patient. The age at vaccination was not reported. The patient reported that, Shingrix was given subcutaneously, which led to intramuscular formulation administered by other route. After vaccination, the patient experienced fever in spike and his arm was swollen. The patient was transferred to medical information for questions. The patient was unable to ask, if it was ok to follow up with his physician. The patient consented to follow up.
This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Around August, I had a pain in my lower quadrant abdomen. The pain was going on and off randomly.  I went to see the doctor. He ordered me an ultrasound. The ultrasound highlighted liver cyst. There is no treatment. I have not recovered from this AE.  I feel this pain every once and while. Unless it gets worse there is not much we can do.
NO ADVERSE REACTIONS. PATIENT GIVEN EXPIRED VACCINATION (EXP DATE 9-21-21)
Pt recvd DTP 9AUG91, on 10AUG91 t101 fever got progressively higher; 12AUG91 t104 hospitalized;
Generalized pruritus onset 24 hours after immunization persisting for 2 weeks.  Treated with Zyrtec for 7 days.
Intense fever and chills 24 hours after second vaccine dose given. Woke up this morning (05/13/2021) with non-itchy rash all over torso, specifically under both breasts and scrawled towards back, around navel, and around crotch area. Splotches are an angry red but neither itchy nor warm to the touch.
Expired dose of VAQTA administered to patient; This spontaneous report was received from an office manager and refers to a 12-year-old patient. The patient's concurrent conditions, medical history, concomitant medications, drugs reactions or allergies were not provided.   On 05-APR-2021, the patient was vaccinated with expired hepatitis a vaccine, inactivated(VAQTA), 0.5 ml, intramuscularly ( lot # S030587 with expiration date: 06-JAN-2021) for prophylaxis.(expired vaccine administered). The vaccine had no temperature excursions prior to administration. The vaccine was not available for retrieval.
States she became tachycardic on 1/5/2021 while at work. State HR 105-153 x 1 hour while at work. State she was at rest when this happened. She also had CP and SOB. Later on same day, employee had fever T100 F and body aches.
Information has bee received from a 19 year old female patient for GARDASIL, concerning herself with no pertinent medical history and no known drug allergies who on 01-OCT-2008 was vaccinated with the first dose of GARDASIL (lot # not provided). There was no concomitant medication. In December 2008 the patient became pregnant. LMP was 20-NOV-2008, and EDD was 27-AUG-2009. In December 2008, the patient experienced pregnancy symptoms like dizziness and nausea. Home urine pregnancy test was performed (no result provided). At the time of this report, the adverse events were ongoing. The patient sought medical attention via contacting physician. Additional information has been requested.  No further information is available.
Tdap given 8/15/07 per RN. Pt. states she felt "tingling sensation" in (L) arm immediately upon receiving Tdap. (L) arm has continued to hurt in (L) arm/shoulder joint ever since injection, in spite of usual comfort measures (Tylenol, cold compress). As of 8/23/07 pt. still c/o arm/shoulder joint pain. Pt has maintained full ROM and no redness or swelling ever since injection but because of c/o pain - referred to FNP. N meds given. They will re-eval next week.
This spontaneous report was received from a pharmacist and refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 22-AUG-2018, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 lot # N025384, expiration date 19-APR-2019, for prophylaxis (dose and route were not reported). No adverse effects reported. The temperature involved was 47 degrees Fahrenheit to 77 degrees Fahrenheit for 1 hour. A previous temperature excursion was not reported, and a data logger was involved.
Patient developed a headache 24 hr after vaccine. Neck pain and stiffness occurred 48 hr after vaccine. Pain and stiffness have decreased slowly over time.
Severe Headache; Low grade fever; A spontaneous report was received from a 57 year old female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced low-grade fever and severe headache.  The patient's medical history was not provided. Concomitant medication use was not provided by the reporter.  On 30 Dec 2020, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.   On 03 Jan 2021,  the patient developed a low-grade fever (temperature was not reported). On 04 Jan 2021 she began to experience severe headaches. The intensity and severity of the fever and headache before and after treatment, was not provided. The patient was due for her second dose of vaccine on 28 Jan 2021. However, the patient would like to be informed regarding the implications of her symptoms.  The patient reported to have taken Acetaminophen, Ibuprofen, and Naproxen to treat her symptoms.   Action taken with mRNA-1273 in response to the events, headache and fever, was not provided.  The outcome of the events low grade fever and severe headaches was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
20 minutes after my throat swelled up slightly  It started Under the  left side of my tongue but it was slight. It startled me ... it stopped about 10 minutes after it started.
headache, whole body muscle ache, diarrhea  from  10:00pm on 4/25,  took one pill of the pain reliever . no diarrhea from 8:00am on  4/26. all other symptoms gone from 7:00pm on 4/27/2021.
Patient became diaphoretic and nauseated about 10 minutes post vaccination with Moderna Covid-19 vaccine.  Patient was assisted to stretcher who he had dry heaves and stated he felt nauseated.  HR was low around 38 and we were unable to determine a B/P but patient had a very weak radial pulse which at times was unable to be felt at all (due to low B/P).   Decision made to transport patient to the ED for further evaluation.   Patient eventually discharged from emergency department.
patient received MMR on 10/4/2018 instead of MMR-V as ordered. Patient was not immunized with Varicella on this date. Varicella was given on 7/10/2019 as a catch up dose. No varicella outbreak during lack of coverage.
Information has been received from a nurse concerning a male patient who in 1999 was vaccinated with a dose of varicella virus vaccine live (lot # 625387/0313H). On 1/30/04 the patient came to the office with about 10 chicken pox lesions. It was noted that there was another boy in the patient's class who had chicken pox. No lab diagnostic studies were performed. No product quality complaint was involved. Additional information has been requested.
This 76 year-old female presented to the Emergency Department complaining of flu-like symptoms that had persisted for several days.  Recently, this was accompanied by nausea, vomiting, diarrhea, and difficulty breathing with increasing supplemental oxygen requirements.  Relevant medical history included chronic obstructive pulmonary disease and type 2 diabetes associated with end-stage kidney disease requiring chronic hemodialysis.  Because of the acute respiratory illness, she had been unable to attend her last two scheduled dialysis sessions.  She tested PCR positive for SARS-CoV-2.  Accordingly, her admitting diagnosis was acute hypoxemic respiratory failure associated with COVID-19 infection.  She was initiated on treatment with IV dexamethasone and remdesivir along with heparin thromboprophylaxis, adjusted insulin therapy, and daily dialysis targeting 2 L of fluid removal.  Clinical improvement ensued and she is medically stable with follow-up healthcare plans in place including discharge to her home and rearrangements for chronic hemodialysis.
Temperature went up and actually got to 105.3; Chills and could not get warm; A spontaneous report was received from a consumer concerning a 80 years old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Chills and could not get warm, Temperature went up and actually got to 105.3(pyrexia).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Jan 2021, 11 am prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch:unknown ) via unknown route for prophylaxis of COVID-19 infection.  Patient had the virus in July, previously checked several times to see that still had the antibodies. On 15 Jan 2021 6:15 pm patient experienced  Chills and could not get warm, Temperature went up and actually got to 105.3.  No treatment information was provided.  On 15-JAN-2021 laboratory information included body temperature of 105.3 degree F.  Action taken with mRNA-1273 in response to the events was not reported.   The events  Chills and could not get warm, Temperature went up and actually got to 105.3 concerned to be unknown.; 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.
One patient was given the Moderna COVID-19 Vaccination after the vial was punctured for more than 12 hours.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (One patient was given the Moderna COVID-19 Vaccination after the vial was punctured for more than 12 hours.) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (One patient was given the Moderna COVID-19 Vaccination after the vial was punctured for more than 12 hours.). On 28-May-2021, EXPIRED PRODUCT ADMINISTERED (One patient was given the Moderna COVID-19 Vaccination after the vial was punctured for more than 12 hours.) 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.   Concomitant product information was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Non Significant Follow-up added
Plaque psoriasis flare up/ Occasional spots on buttocks; Moderna vaccine caused brain fog; Moderna vaccine caused fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Plaque psoriasis flare up/ Occasional spots on buttocks), FEELING ABNORMAL (Moderna vaccine caused brain fog) and FATIGUE (Moderna vaccine caused fatigue) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic plaque psoriasis).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Plaque psoriasis flare up/ Occasional spots on buttocks), FEELING ABNORMAL (Moderna vaccine caused brain fog) and FATIGUE (Moderna vaccine caused fatigue). At the time of the report, PSORIASIS (Plaque psoriasis flare up/ Occasional spots on buttocks) had not resolved and FEELING ABNORMAL (Moderna vaccine caused brain fog) and FATIGUE (Moderna vaccine caused fatigue) outcome was unknown.            No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was reported.  The reporter causality for the events of Moderna vaccine caused fatigue, Moderna vaccine caused brain fog with co-suspect Skyrizi was no reasonable possibility. The reporter causality for the event plaque psoriasis flare up/ occasional spots on buttocks with co-suspect Skyrizi was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-619486 (Patient Link).
throat started to swell/went from having a double chin to a triple chin; arm is a little sore; This spontaneous case was reported by a patient and describes the occurrence of PHARYNGEAL SWELLING (throat started to swell/went from having a double chin to a triple chin) and PAIN IN EXTREMITY (arm is a little sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A22A, 025D21A, 140M20A and 012L20A) for COVID-19 vaccination.     The patient's medical history and history of allergies were reported as none. The patient did not have COVID positive test or diagnosis.  Concomitant products included LOSARTAN, AMLODIPINE, PRAVASTATIN and LEVOTHYROXINE for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced PAIN IN EXTREMITY (arm is a little sore). On 18-May-2022, the patient experienced PHARYNGEAL SWELLING (throat started to swell/went from having a double chin to a triple chin). At the time of the report, PHARYNGEAL SWELLING (throat started to swell/went from having a double chin to a triple chin) and PAIN IN EXTREMITY (arm is a little sore) outcome was unknown.            The patient had not received any treatment. It was reported that the patient had no issues with the previous 3 vaccinations.
TOOK THREE UNREFRIGERATED DOSE; MISSED THE LAST DOSE; This spontaneous case (PVX2019-773) was received from a pharmacist on 29-Mar-2019. It describes a female consumer who "took three unrefrigerated dose" and "missed the last dose", while being on Vivotif for an unknown indication.   Case report: The consumer took three unrefrigerated doses of Vivotif and also missed the last dose.  Action taken with Vivotif was not applicable.   The clinical outcome of the events "took three unrefrigerated dose" and "missed the last dose" was unknown.  Company's Comment: The causality of the event "took three unrefrigerated dose" and "missed the last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took three unrefrigerated dose" and "missed the last dose" was considered as not applicable.