chrisvoncsefalvay/vaers-outcomes huggingface dataset:
serious joint pain in shoulder in the same arm as injection, left non-dominant arm; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (serious joint pain in shoulder in the same arm as injection, left non-dominant arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure (high).   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.  On 23-Mar-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 ARTHRALGIA (serious joint pain in shoulder in the same arm as injection, left non-dominant arm). At the time of the report, ARTHRALGIA (serious joint pain in shoulder in the same arm as injection, left non-dominant arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) high.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication was reported.  It was not reported if the patient was received any corrective treatment for the event.
reported diff breathing so severe pt could not sleep;pt stated hurt so bad;pt had a catch in lt chest area; couldn't take a deep breath;any deep breath causes that pain;couldn't hardly move either arm, they were sore;took Ibuprofen
Pain under left arm close to put of arm. Between arm pit and mammary gland. Vaccine give in left arm. It also feels a little swollen. Did not feel this way the morning of start last night around 10 pm.
Urticaria the evening that the vaccine was given, cluster of urticaria around the injection site with other scattered urticaria on body. Benadryl 12.5mg given due to itching. Hives nearly resolved by 11/7/23 except one spot on arm and one spot on leg.
My flu vaccine was admin in my right shoulder, too high. The needle went in very easy without any pain until the medication was admin and there was a burning sensation. I experienced extreme pain and limited mobility within minutes of the administration. but pain began to increase to a point where I was unable to move my arm without being in severe pain. I was off work for several days for a planned period of time off. I sent a message to my Manager regarding the the extreme pain. I sought treatment from our employee health doctor who sent me for an MRI which showed:1 Supraspinatus tendinosis with mild to moderate partial-thickness undersurface tearing; 2 Mild infraspinatus tendinosis; 3 probably tear of the superior labrum 4 Moderate subcapularis tendinosis with intrasubstance tearing, 5 Mild proximal biceps tendinosis.  I have never had shoulder pain or an injury to my shoulder before. A referral was made to an orthopedic specialist, Dr who ordered physical therapy, Celebrex and oral steroid. The oral steroid relieved some pain and allowed me to sleep through the night. Physical therapy started with minimal relief. Celebrex allowed some relief but did cause stomach issues. When stopped severe pain returned and mobility again was very limited. A steroid injection was admin Nov 6. To this date, I still have pain in my right arm, throbbing continues; pain runs down my arm to my thumb. Physical therapy continues to this date.
This spontaneous report as received from a pharmacist refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with M-M-R II. It was reported that unspecified patient was administered 4 dose of M-M-R II. The reporter stated that the patient was currently in the pharmacy and will be administered fifth dose of M-M-R II on 11-MAR-2016. No adverse effects reported. The outcome of the event was unknown. Additional information has been requested.
tested positive for the COVID virus/she was having a symptom, she lost her sense of smell; tested positive for the COVID virus/she was having a symptom, she lost her sense of smell; sinus infection; tested positive for the COVID virus/she was having a symptom, she lost her sense of smell; Her nose being stuffed; tension headache on the back of head; her deltoid was hurting for 24 hours; active infection after getting the first dose; This is a spontaneous report from a contactable pharmacist (patient). A 37-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the right deltoid on 18Dec2020 at single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. The patient had active infection after getting the first dose, consult if it was still recommended to get the second dose next week or she should be delaying getting the second dose. The patient got the COVID vaccine on the 18Dec2020. Then on the 24Dec2020 she tested positive for the COVID virus. She was due to get the second vaccine on 08Jan2021. She was asking should she still get the 2nd dose of the vaccine since came up positive. The patient was having a symptom, she lost her sense of smell of 22Dec2020. She lost her sense of smell on the evening on 22Dec2020, it still had not come back at all. She did have sense of taste on the tongue. She thought it was sinus infection, because her head didn't hurt and she was not stuffed anymore. She stated that after the vaccine, she had a tension headache on the back of head, and her deltoid was hurting for 24 hours. Her headache started the same day in the evening, went on till lunch time next day. Her nose being stuffed which she thought was a sinus infection started on Tuesday 22Dec2020, it was more located in the front middle of her forehead. Her nose being stuffed which she thought was a sinus infection started on Tuesday 22Dec2020, it was more located in the front middle of her forehead. She did not have her Card to provide Lot and Expiry, it was at work at the hospital. She was administered the vaccine on the right deltoid, since she didn't want to sleep on it. Prior to vaccine she has had no positive test for Covid. Caller stated that this was super unfortunately coincidental. She had had no antibody test. She had no reactions to vaccines in the past. Test: Respiratory Panel. Result: Negative on unknown date. The outcome of events drug ineffective, COVID-19 and sinus infection was not recovered. The outcome of event tension headache and muscle pain was recovered in Dec2020. The outcome of rest events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of subject vaccine cannot be excluded for the reported events of LOE, COVID 19 and other events, based on temporal relationship.  There is very limited information provided in this report.  This case will be reassessed upon receipt of follow-up information.
No adverse event; Patient received a dose administered 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose administered 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 62-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011h22a) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 11-Jun-2022 and Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 23-Dec-2022 at 11:28 AM, 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 23-Dec-2022 at 11:28 AM,  after starting , the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose administered 12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a dose administered 12 hours post puncture) 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 EXPIRED PRODUCT ADMINISTERED (Patient received a dose administered 12 hours post puncture).    No relevant concomitant medications were reported.   Date the vial was initially stored in the refrigerator 14-Dec-2022.  Date and time vial was first punctured 22-Dec-2022 3:42PM.  Date and time of administration of vaccine 23-Dec-2022 11:28 AM.  The vial was stored at room temperature post puncture.  The vial did not undergo any temperature excursions.  Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 20 hours.  No treatment information was provided.
Drowsiness for about two days after the vaccine was administered.  Moderate diarrhea (foul-smelling and oddly-colored, in a breast-fed baby) lasting six days (so far) after the vaccine was administered.  Within the most recent 2-3 days she has also been having what appears to be periods of constipation/difficulty having a bowel movement (again, in a breast-fed baby).  Also, she occasionally seems to have a mild fever and just seems generally uncomfortable/not herself (strange cry/grunting noise has developed within the past few days).  She has also had trouble eating the past few days.  We have been giving her some infant Tylenol (generic brand) at night and occasionally during the day, but that is mostly to help with teething pain that she has been having (and was having prior to the vaccinations).
This spontaneous report as received from a consumer's mother refers to a female patient of unknown age. Concomitant medication and pertinent medical history is not provided. On an unknown date the patient was vaccinated with a third dose of GARDASIL (dose and route were not provided). The reporter stated that the patient "began having seizures and falling down" after having had a third dose of GARDASIL. The patient had sought unspecified medical attention. It is not specified whether patient received treatment or not. The outcome of the adverse event was reported as not recovered/not resolved. The causality relationship between GARDASIL and the adverse event was not provided by the reporter. Upon internal review, seizure was considered to be medical significant. Additional information has been requested.
Patient received MMR, Varicella, and Hep A at 10:40 AM Patient was leaving with parent. At 11:10 AM patients face became flushed no fevers, injection sites looked normal. Patient breathing was normal. Face was just red and flushed gave BENADRYL per Dr monitor patient for 1 hour. Was good to go home. Vaccines order today by Dr. Patient's mother was aware she was on antibiotic at time of visit/injections given.
pt recv vax & c/o fatigue, blurry vision, neck ache & bradycardia;reportedly the pt has not been able to work for  2wk;treating MD is reportedly unsure if these are vaccine related exp;
Pt recv vax on 10/16/95; on 1/20/98 pt exp fever, runny nose, cough, weak/ fatigue/ pale; on 1/22/99 pt exp chicken pox rash
Pt with IM flu shot in (R) hip on 12/13/10. Later same day with hip pain. TMS progressed to hip/back pain. Then noted rash. Pt came for OV 12/20/10 & noted Zoster in same distribution over L1 dermatome on (R).
Patient had been receiving hospice care through pallative care. COVID + and DNR status on admission. Continued comfort care with palliative care assisting. Agonal breathing persisted. Medicatied to keep confortable. Patient declined tracheostomy in last hospitalization.
09/08/22 presents to EC ED for "chest pain, abdominal pain, shortness of breath". PMHx of "CVA, DM, breast ca s/p mastectomy and reconstruction, HTN, COVID, open ankle fracture s/p surgical repair"
Refrigerator excursion, temperature dropped to 33.8 for approximately 10-15 mins on 8/25/2021 between 1:44pm- 2:04pm.
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
pt began experiencing tingling and numbness in face and head area 3 days after receiving vaccine and also blurred vision 4-5 days after. Patients dr ran mri's with and without contrast of brain and spinal cord and also "mra" test to check blood flow and an autoimmune panel. All turned out negative. Pt also had eye dr check her eyes and he stated nothing wrong with optic nerve. Both drs attributed her reaction the the vaccine despite her not experiencing those symptoms with the first dose. All adverse reactions were resolved in about 2 weeks.
Patient received a vaccine on 08-Apr-2022 which had got expired on 07-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine on 08-Apr-2022 which had got expired on 07-Apr-2022) in a 72-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine on 08-Apr-2022 which had got expired on 07-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine on 08-Apr-2022 which had got expired on 07-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that total of 173 doses were administered having Lot number has 070H21A.  The dates of administration were 08-Apr-2022, 12-Apr-2022 and 13-Apr-2022 .  No information was reported on date of the storage of vaccine in refrigerator.  Vaccine was expired on 07-APR-2022.  The vial did not undergo any temperature excursions.  Treatment information was not reported.  HCP administer expired vaccine to patients, after the manufacture date of expiration and wanted an assessments on the case.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non-significant information-Additional Patient identifier were added.
By Monday evening, he was developing tenderness at the inj site and by 12/15 evening, he had noted extensive redness involving the left upper extemity with low grade fever and general feeling of ill health. Vancomycin 1gm IV q 24 hrs.
Stomach pains, Nausea, Extreme tiredness, Headache, and Diarhea
Feeling high; felt like he didn't exist, felt out of his body, was spacey, couldn't carry a coherent conversation; had psychedelic side effects and experienced visual disturbances; arm hurt and achy all over; was "really tired" and had to go to bed early; This spontaneous case was reported by a consumer and describes the occurrence of EUPHORIC MOOD (Feeling high), FEELING ABNORMAL (felt like he didn't exist, felt out of his body, was spacey, couldn't carry a coherent conversation), VISUAL IMPAIRMENT (had psychedelic side effects and experienced visual disturbances), PAIN (arm hurt and achy all over) and FATIGUE (was "really tired" and had to go to bed early) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced EUPHORIC MOOD (Feeling high), FEELING ABNORMAL (felt like he didn't exist, felt out of his body, was spacey, couldn't carry a coherent conversation), VISUAL IMPAIRMENT (had psychedelic side effects and experienced visual disturbances), PAIN (arm hurt and achy all over) and FATIGUE (was "really tired" and had to go to bed early). On 07-Apr-2021, EUPHORIC MOOD (Feeling high), FEELING ABNORMAL (felt like he didn't exist, felt out of his body, was spacey, couldn't carry a coherent conversation) and VISUAL IMPAIRMENT (had psychedelic side effects and experienced visual disturbances) had resolved. At the time of the report, PAIN (arm hurt and achy all over) and FATIGUE (was "really tired" and had to go to bed early) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Vaccine had been out of the fridge since 10:15 am of 20-Oct-2021 and was administered at 12:26 pm of 21-Oct-2021; 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 (Vaccine had been out of the fridge since 10:15 am of 20-Oct-2021 and was administered at 12:26 pm of 21-Oct-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine had been out of the fridge since 10:15 am of 20-Oct-2021 and was administered at 12:26 pm of 21-Oct-2021). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine had been out of the fridge since 10:15 am of 20-Oct-2021 and was administered at 12:26 pm of 21-Oct-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The vaccine had been out of the fridge since 10:15 am on 20-Oct-2021, exceeding the 12 hour window outside of fridge.   Dose administered after exposure to room temperature was >24 hours.  Total amount of time the vial was exposed to room temperature range 8 degrees to 25 degree C equal to  46 degree to 77 degree was given as unknown.  No treatment information was provided by the reporter.
RIGHT BELLS PALSY 11/21/2022 -- RECURRENCE OF SAME SYMPTOMS
A non-serious spontaneous report of administration of expired product was received from a health professional concerning a 41-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 24-Dec-2008. The patient received expired FLUMIST on 10-Oct-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Pancytopenia; Malaise; Muscle aches; Fever; A spontaneous report was received from a physician concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pancytopenia, fever, malaise, and muscle aches.   There was no medical history provided. There were no concomitant medications provided.  On 16 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (Batch # unknown), for prophylaxis of COVID-19 infection.   On 22 Jan 2021, the patient experienced the serious event of pancytopenia. Additionally, on an unspecified date in Jan 2021, following in jection, the patient experienced the non-serious events of fever, malaise, and muscle aches. Relevant laboratory result included platelet count of 1000 and hemoglobin was decreased on 22 Jan 2021. There was no treatment information provided.  Action taken with mRNA-1273 in response to the events of pancytopenia, fever, malaise, and muscle aches, was not provided.  The event of pancytopenia was unknown. The outcome for the events fever, malaise, and muscle aches, was unknown at the time of this report.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of pancytopenia and non-serious unexpected event of malaise, non-serious expected events of myalgia, and pyrexia. The event of pancytopenia occurred 7 days after first dose of mRNA-1273, lot # unknown.  The event of myalgia and pyrexia occurred on an unspecified date after first dose of mRNA-1273, lot # unknown. Treatment was not specified. Very limited information regarding this event has been provided at this time.  Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
SWELLING AND REDNESS TO ARM 5 INCHES BY 4 INCHES.
The pt experienced cutaneous rash and itching all over the body on the morning of 2/9/00. Treatment was with dyphenhydramine and cetamehiasone.
Information has been received from Glaxo Smith Kline for Engerix B and was assigned manufacturer control number 20010170491. A physician reported an event concerning a female adult patient with no known allergies who on 09 JUL 2001 was vaccinated with a second dose of hepatitis b vaccine recombinant (yeast). Concomitant therapy included a first dose of yellow fever virus vaccine live (YF-VAX). On 09 JUL 2001, approximately 45 minutes after the immunization, the patient experienced numbness and tingling of the palate. It was reported that the sensation came in waves of decreasing intensity and that it resolved "hours later" that night. It was reported that the patient had no adverse experience following her first injection of hepatitis b vaccine recombinant (yeast) (Engerix B). Additional information has been requested.
The day following the vaccine, I experienced a sore left arm. Ten days following the vaccine, I began having extreme fatigue and muscle aches throughout my entire body. I felt inflamed. The fatigue impaired my ability to walk and do normal activities. I mostly wanted to sleep. At first I did not associate the symptoms with the vaccine, but then realized it was probably associated. The fatigue and muscle aches lasted about 7 or 10 days.
Worsening of allergic dermatitis, resulting in impetigo, persistent inflammatory rash in spite of oral antibiotics and topical steroids.
Patient received the first dose of Pfizer on 5/28/21 and during the 15 minute waiting time after the immunization, patient fainted. Patient did not fall or hit head, due to father being in the proximity and able to protect her from hitting the floor. Patient regained consciousness quickly within seconds and was moved to the floor while her feet were elevated. Patient stated that she saw a bit blurry and feeling shaky right before fainting. Patient was seen to be a bit pale in the lips but color came back after a few minutes. When patient's mother came, it was learned that the patient had a similar experience with an allergy shot in the past. Patient blood pressure was 110/71. Patient laid on the floor for a while before sitting back up.
The pt experienced erythema in the affected arm on the same days as vax. The pt contacted the clinic to report erythema at injection site and that the area was painful to touch. Treated with Keflex.
The patient felt dizzy after getting vaccine (about 1 minute).  Before getting vaccine he said he felt nervous with the syringe.He said he felt dizzy and his hands are numbing.  We let him sit down and drink some water.  He felt fine after 15 minutes and he left.