chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; body ache; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever) and MYALGIA (body ache) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and MYALGIA (body ache). At the time of the report, PYREXIA (fever) and MYALGIA (body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment information provided.
Allergic reaction - Based on the timing of urticarial type rash the same day as Hepatitis A shot, it is likely that it was a reaction to the Hepatitis A vaccine. (also no history of any other new exposure that day)  The continued hives and itching are likely related to a heightened level of histamine from the initial allergic response. Excorations are from chronic scratching. We will treat the continued urticaria with Zyrtec 5 mg and Zantac 75mg daily for 1 week. Would not recommend her getting 2nd vaccine in future--instead check her antibody levels if needed for school. 995.3: Allergy, unspecified, not elsewhere classified.
facial breakout/allergic skin reaction very painful burning sensation on face bruising and "crusty" feeling on face raised bumps that are not quite bumps and not quite hives
Itchy skin and hives all over the body, including chest, back, arm, and leg
Constant ringing in the ears,  Tinnitus.  Stronger on in the right ear
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 67-year-old female patient who received SHINGRIX (batch number ZX3YA, expiry date 28th April 2020). On 13th April 2018, the patient received SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The pharmacist received a call from the patient on 19th April 2018. The pharmacist called and reported that the patient experienced a rash on the face which was heading towards the nose.
mom states pt was given vax 1/2 hrs a/immun; APAP was repeated 4 hrs later; pt felt very warm 4PM 5JAN93; APAP repeated (had been crying for 2 hrs w/sore arms-woud not move arms); t104 ax; red swollen lt arm; pt has been irritable;
rash across the mid section of his chest; This case was reported by a consumer via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The reporter was the patient's wife. The patient received the dose of Shingrix and experienced rash across the mid-section of his chest. The reporter could not found any information, if this was common or should he be concerned, and not get a second dose.
I have a case of clinical COVID, test positive on 9/12/2022.  I am making no association between my latest vaccination and this clinical case.  My 14 yr old son tested positive on 9/11/22 and presented with predictable signs of upper respiratory disease at that time.
Stiffness; It is like I can't turn over or nothing and then it hurts all night; Stiffness; It is like I can't turn over or nothing and then it hurts all night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Lot number: EL9267) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "Diabetes mellitus" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EN9581), administration date: 15Feb2021, when the patient was 76 years old, for Covid- 19 immunisation. The following information was reported: PAIN (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset 09Mar2021, outcome "unknown" and all described as "Stiffness; It is like I can't turn over or nothing and then it hurts all night". The event "stiffness; it is like i can't turn over or nothing and then it hurts all night" and "stiffness; it is like i can't turn over or nothing and then it hurts all night" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain, musculoskeletal stiffness.  Additional information: Patient has an unspecified blood pressure and diabetes concomitant medications. Patient reported that last night (09Mar2021), she was having problems with her right side where she got the shot at. She got stiffness and she can't (incomplete sentence) it was like she can't turn over or nothing and then it hurts all night. So, she didn't know what was going on and because of this has called the family doctor. He said she had to call Pfizer to find out what might be done for this. Patient inquired on what to do.  No follow-up attempts are possible. No further information is expected.
Very Weak; Lightheaded; Low Blood Pressure 130/60 mmHg; High Resting Heart Rate 80 BPM.; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Very Weak), DIZZINESS (Lightheaded), HYPOTENSION (Low Blood Pressure 130/60 mmHg) and HEART RATE INCREASED (High Resting Heart Rate 80 BPM.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID- 19 Immunisation.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced ASTHENIA (Very Weak), DIZZINESS (Lightheaded), HYPOTENSION (Low Blood Pressure 130/60 mmHg) and HEART RATE INCREASED (High Resting Heart Rate 80 BPM.). At the time of the report, ASTHENIA (Very Weak), DIZZINESS (Lightheaded), HYPOTENSION (Low Blood Pressure 130/60 mmHg) and HEART RATE INCREASED (High Resting Heart Rate 80 BPM.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 80 80 BPM.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Per MD after sick visit, bilateral buildup of fluid in middle ear behind ear drum due to clogged eustacian tubes resulting in 95% hearing loss and tinnitus in right ear. Symptoms are still present today.
pt recv vax 28AUG95 & 14MAY97 pt devel breakthrough chickenpox w/a number of lesions;
Worst heaviness in the chest/heart immediately after first and 2nd primary shot/Less Severe heaviness in the chest/heart immediately after first booster shot; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (Worst heaviness in the chest/heart immediately after first and 2nd primary shot/Less Severe heaviness in the chest/heart immediately after first booster shot) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A, 038A21A and 064H21A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease. Concomitant products included METHADONE for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced CHEST DISCOMFORT (Worst heaviness in the chest/heart immediately after first and 2nd primary shot/Less Severe heaviness in the chest/heart immediately after first booster shot). On 12-Mar-2021, CHEST DISCOMFORT (Worst heaviness in the chest/heart immediately after first and 2nd primary shot/Less Severe heaviness in the chest/heart immediately after first booster shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Immediately after each shot, she had Heaviness in chest and heart, but it was worst with the first two shots. The heaviness in the chest disappeared after 1 day. She stated that she has reported the side effect to V-Safe.  No treatment information was provided.
For the last 3 months, my cycle has been off. I was spotting for 7-16 days before my period and my period was 10 days late for 2 of the months and 10 days early for the last month. I never spotted so far in advance.
12 min post vaccination patient c/o of "itching" on hands and arms.  No other s/s report by patient or nurse.  No urticaria, angioedema, or respiratory distress. 25 mg of diphenhydramine administered and patient under monitoring X 30 min by nurse.  BP 112/74, O2 100%, HR 80. Pt returned to work.  Approximately 2 hours and 40 min later the patient returned to state itching and mild nausea had returned but no other symptoms. 12.5 mg diphenydramine administered and pt monitored by nurse(s) again without progression of symptoms. RN recommended transport to physician office, urgent care, or ER for further evaluation and observation as mild symptoms of itching and nausea continued.  Pt transported in private vehicle by friend to physician office.
Acute respiratory failure due to COVID-19 (CMS/HCC) Assessment & Plan Symptom onset: 9/13/2021 Test date: 9/18/2021    Elderly male who received 2 doses of Moderna vaccine, last on 6/23.  Symptoms consistent with mild to moderate Covid infection with hypoxemia.     Following discussion with the patient will initiate therapy with Dexamethasone and Remdesivir COVID steroid recommendations are for 10 days duration or stopped on discharge, whichever comes first. Remdesivir is a typical 5 day IV duration, however can be stopped earlier if recovery is unexpectedly rapid Prophylactic Lovenox dosing, monitor d-dimer for 2500 level where empiric therapeutic dosing is indicated, refer to BH covid treatment guidelines Monitor closely for progression to advanced O2 management devices.  Discussed expectations of care Encourage incentive spirometry and self proning
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 08-OCT-2014, an unspecified number of patients were vaccinated with improperly stored PEDVAXHIB lot # J016186, expiration date: 24-OCT-2016 (dose and route of administration were not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Developed tinnitus in both ears which I still have after five months. Also have some hearing loss in one ear.
Side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effect). At the time of the report, VACCINATION COMPLICATION (Side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
I got the 3rd dose of Moderna on a Friday at 9 am. It's now the following Monday at 10 am, and I'm still feeling sick. I truly feel like I have COVID. I fluctutate back and forth between being too hot and srenching in sweat, and getting intense chills and shivering violently enough to make my jaw hurt from all the chattering. I have headaches that come and go, all over body aches that are bad enough to keep me from wanting to get out of bed or move around too much in my bed, fatigue, and a low grade fever over the last 3 days. I barely had any reactions to the 1st and 2nd dose, but the 3rd dose has left me feeling abnormally sick.
while in the Waiting Area, he passed out and fell out of his chair; after receiving his 2nd dose of Moderna COVID-19 vaccine. No physical injuries were reported. EMT was called
Moderna COVID-19 vaccine was administered to a 17 years old female; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID-19 vaccine was administered to a 17 years old female) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID-19 vaccine was administered to a 17 years old female). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID-19 vaccine was administered to a 17 years old female) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Nurse asked if this should be reported to a manufacturer as an adverse event, and also stated that she does not have all the information available at this time about patient and the vaccine administration. Consent given for Safety follow-up. Preferred contact method is email  Action taken with mRNA-1273 in response to the events was not applicable.
Immunization given 1-25-10 AM - on 2-2-10 in AM patient said she had a RXN to seasonal flu - fever, difficulty breathing, rash - swollen warm. Received nebulizer albuterol treatment in acute care on 1-25 - 1-26. Saw MD rec methylprednisolone dose pak.
10/19/2022 6pm - 10/20/2022 5pm: arm is sore to touch and move; 1.5? diameter around injection site is red, raised, warm, and hard; feel sleepy, fatigued, mild headache. 10/20/2022 5pm-5:30pm: apply ice pack to injection site for 30 mins. Soreness, redness, raisedness reduces  by 80% for about 24 hours. 10/21/2022 7pm: although injection site redness and soreness is still greatly reduced from 10/19-10/20, injection site becomes very itchy. No hives or rash seen. 10/22/2022 7am: injection site still feels itchy; applied OTC hydrocortisone cream to injection site, which stops the itchy feeling
Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient's friend. The age at vaccination was not reported. The reporter reported that the patient experienced flu like symptoms after receiving the dose of Shingrix. The report did not clarify what the flu like symptoms were. The reporter had limited information. The reporter did not consent to follow-up. The case has been linked with case US2021225705 and US2021225709, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021225705:same reporter US-GLAXOSMITHKLINE-US2021225709:same reporter
Received second vaccine on 2/2/21. Started having cough, sore throat, chills, fatigue, HA, muscle aches, congestion, and runny nose on 2/8/21. Went to urgent care and diagnosed with "Symptoms of upper respiratory infection."
pt recvd vax & began having hallucinations in PM; CAT Scan done neg; seen by MD ordered EEG; EEG neg; MRI neg; began olfactory hallucinations-smelled cigarette smoke;
Died; Increased respirations (22 and labored at times); Pulse 105; 94% O2 on RA; Labored breathing at times; leukocytosis; elevated BUN; left lower lung congestion; elevated creatinine; Temperature of 102.0F; Redness on face; A spontaneous report was received from a nurse concerning a 92-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness on face, increased respirations, labored breathing at times, temperature of 102F, pulse of 105, 94 percent O2, leukocytosis, elevated BUN, left lower lung congestion, elevated creatinine, and death.   The patient's medical history, as provided by the reporter, included dementia and reduced mobility.  No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient began to experience redness on her face, increased respirations (reported as 22 and labored at times), pulse of 105, and 94 percent oxygen saturation on room air. The patient had a fever of 102 degrees Fahrenheit. Laboratory tests revealed a negative influenza swab, elevated white blood cell count of 14.1, elevated BUN at 113, and creatinine 2.7. Chest x-ray showed mild, left lower lung infiltrate.   On 31 Dec 2020, the patient went under hospice care per her family request..    Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 01 Jan 2021, the cause of death was unknown.; Reporter's Comments: This case concerns a 92-year-old, female subject with medical history of dementia and reduced mobility, who experienced the serious unexpected events of death, respiratory rate increased, heart rate increased, oxygen saturation decreased, elevated BUN, elevated creatinine, left lung congestion and dyspnoea and the non-serious events of erythema and pyrexia. The events of respiratory rate increased, heart rate increased, oxygen saturation decreased, dyspnoea, erythema and pyrexia occurred 2 days after the first dose of the study medication administration, and the event of death occurred 4 days after the first dose of the study medication administration. Very limited information regarding the events is available at this time and no definite diagnosis or autopsy report have been provided.  Additional information has been requested.; Reported Cause(s) of Death: Died
Chills, Vomiting, shaking, cold sweats, This is ongoing at this time. I vomited several times this morning (10-11-2018 in the AM ). I am laying down and using cool cloths on my head, neck and face.
Appendicitis requiring surgical removal of appendix. Patient experienced fatigue and fever of 100.4 F within 24 hours of vaccine administration. Fatigue continued over next several days. At approximately 90 hours post vaccination patient developed severe abdominal pain which localized to lower right abdomen followed by fever of 99.7 F. After 3 hours of severe pain patient checked in to ER where a CT scan was performed to confirm appendicitis. Surgical intervention was required to remove the appendix requiring anesthesia and extended recovery period. Patient has a recommended 3 week recovery period prior to returning to work with 2 months of modified activity level.
1. Severe headache. I developed a severe headache the next day that was a migraine but more resistant than typical. It was severe and limited activity completely--put me to bed. It eventually responded to treatment but returned once the medication wore off for a total duration of about 3 days. I have chronic migraine and the severity and frequency of migraine substantially increased and remained increased after this vaccine, despite treatment adjustments by my neurologist, for about 2.5 months. Afer 2.5 months there was improvement in migraine, however not yet to baseline before the vaccines. I also had a severe headache for 1 day after the 1st dose in the series on 3-18-21 and some lesser increase in my migraine disorder, but only for about 2 weeks and then seemed to settle down a week before the 2nd dose.  My ability to work is still limited because of this. I have limitations in work re-existing due to migraine that are worse since the vaccine. 2. Axillary swelling. The day after this vaccine, I noticed swelling and pain in my R axilla. It got worse over time. After about 3 days the pain subsided but the swelling persisted for about 10 days. At the worst, perhaps 3 days post-vaccine, I felt like I had a foam ball in my axilla when I had my arm resting against my body. I did not feel specific adenopathy or lumps. Just very soft swelling, filling the entire axilla.  I am reporting as myself but am an MD After the 1st dose I noted swelling in R axilla incidentally in the shower 1 week after vaccine. It was gone in a couple days and there way no pain at any time..   I also had fatigue, marked, starting several hours after each dose and lasting through the next day. I had chills and body aches the day after the 2nd dose, but not the first. However, I was not febrile.  Other than the migraine, my other side effects appear to have resolved.
I had a routine Colonoscopy the Doctor found  submucosal nodule in the rectum. The Biopsy turned out to be benign lymphoid infiltrate.  Only the top was scraped so it was still there and I was sent to a specialist as my Doctor wanted a endoscopic ultrasound which was done last week on 22MAR2023. The Doctor removed the nodule completely and the Ultrasound showed nothing and I await the biopsy results.
After influenza vaccine injection at about 2:30 pm, pt noticed that (L) upper arm was warm to touch, painful with movement and had developed a lump the size of a golf ball then increased to the size an egg. Also developed mild elevated temp to 99 degrees F, headache, dizziness.
Palpitations, BPs 154/88 (oulse 108), 166/83 (pulse 65), O2 sat 96%.
PT HAD 3 VACCINES AND HAD RASH ON ARMS, FACE , BACK AND NECK.
I woke up this morning with a swollen, warm and slightly itchy lump on my right arm, an inch or so below the vaccination was administered. It's been 9 days since my shot.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 19-JAN-2017,  the patient was vaccinated with an improperly stored dose of VARIVAX with lot number M025866 and expiration date of 24-MAY-2018 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at more than 5 Fahrenheit degrees but less than 14 Fahrenheit degrees for 51 hours and 15 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a 10 weeks old patient of unknown gender. Healthcare worker reported that a patient who was 3 month age, received the first dose of M-M-R II (dose, route and lot number were not reported) on 18-MAR-1999, and another dose in January 2004 (dose, route and lot number were not reported). Concomitant medications were not reported. No adverse effect reported. Additional information has been requested.