chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Where I received the injection there is a big knot; Itchy (at injection site); Red (at injection site); Cold all day and thought she might have had a fever; Cold all day and thought she might have had a fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (Where I received the injection there is a big knot), INJECTION SITE PRURITUS (Itchy (at injection site)), INJECTION SITE ERYTHEMA (Red (at injection site)), NASOPHARYNGITIS (Cold all day and thought she might have had a fever) and PYREXIA (Cold all day and thought she might have had a fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE NODULE (Where I received the injection there is a big knot), INJECTION SITE PRURITUS (Itchy (at injection site)), INJECTION SITE ERYTHEMA (Red (at injection site)), NASOPHARYNGITIS (Cold all day and thought she might have had a fever) and PYREXIA (Cold all day and thought she might have had a fever). At the time of the report, VACCINATION SITE NODULE (Where I received the injection there is a big knot), INJECTION SITE PRURITUS (Itchy (at injection site)), INJECTION SITE ERYTHEMA (Red (at injection site)), NASOPHARYNGITIS (Cold all day and thought she might have had a fever) and PYREXIA (Cold all day and thought she might have had a fever) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MODERNATX, INC.-MOD-2021-078257 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-078257:first dose case
The COVID vaccine that the patient received on 4/27/22 at 3:52 pm was from a vaccine vial that was initially punctured on 4/26/2022 at 11:35am. Meaning the vaccine expired on 4/26/2022  at 11:35pm. The vial should have been wasted at that time but it remained in the vaccine refrigerator and was given to this patient on the following.
This spontaneous report as received from a healthcare worker refers to a 12 months old patient of unknown gender. Concurrent conditions and medical history were not reported. On 18-SEP-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L010142 and expiration date 24-SEP-2016, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
subjective fever, fatigue, bodyache, chills, headache, nausea, vomiting, epigastric pain
pt recvd flu vax on 21OCT92 & on 25OCT92 & devel pruritic rash over neck & supraclavicular area which lasted 5 days; MD felt was allergic reaction; cont w/burning & itching;
Headache, NauseaVomiting, R arm red, hot, & hard. Sinus drainage. Narrative:
She has been a nervous wreck; Have done nothing but cry; Can't get any rest or sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 13Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, right arm), administration date: 19Jan2021, for Covid-19 immunization. The following information was reported: NERVOUSNESS (non-serious) with onset 13Feb2021, outcome "unknown", described as "She has been a nervous wreck"; CRYING (non-serious) with onset 13Feb2021, outcome "unknown", described as "Have done nothing but cry"; INSOMNIA (non-serious) with onset 13Feb2021, outcome "unknown", described as "Can't get any rest or sleep".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe Neck Pain about a month after the shot.  Required ER visit.  Three of my colleagues at work had the exact same adverse event happen to them. We all had the Moderna shot.
p/ pt recv vax approx 2yrs later pt devel mild breakout of chickenpox, it was rpt pt skin had numerous erythematous, fever 104f & strep throat
Rash; itchy; This spontaneous case was reported by an other and describes the occurrence of RASH (Rash) and PRURITUS (itchy) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0316(orL)20A) for COVID-19 vaccination.     No Medical History information was reported.   No concomitant medication of the patient was reported.  On 24-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose.   On 03-Mar-2021, the patient experienced RASH (Rash) and PRURITUS (itchy).   At the time of the report, RASH (Rash) and PRURITUS (itchy) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Dryness and lacrimation of right eye progressed to inability to close right eye and right sided facial weakness (inability to smile, spit or to puff cheek on right side). Patient was subsequently seen at different provider and diagnosed with Bell's palsy and placed on prednisone (80 mg for 4 days and then tapered) and Valtrex.  Pt has finished meds and reports some improvement at time of this report.
About 5 minutes after first dose, patient complained of feeling weak, tired, and lightheaded. Staff noticed she looked pale. She was transferred to a wheelchair, became unresponsive and slumped, and had decorticate posturing for about 15 seconds. Patient awoke and was immediately oriented. Patient was taken from clinic to ED via wheelchair. Of note, patient stated she has a history of syncope, which is worse when needles are involved, and has had similar episodes with phlebotomy in the past. Discharged home in stable condition.
severe itching on the site administration; pain on the site administration; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (severe itching on the site administration) and VACCINATION SITE PAIN (pain on the site administration) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (severe itching on the site administration) and VACCINATION SITE PAIN (pain on the site administration). At the time of the report, VACCINATION SITE PRURITUS (severe itching on the site administration) and VACCINATION SITE PAIN (pain on the site administration) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitantly, patient was taking arthritis medications. Patient was not taking any treatment for symptoms.
Information has been received from a 78 year old male with high blood pressure, rheumatoid arthritis and a bad case of chickenpox at age 13 and a penicillin allergy who on approximately "12-OCT-2007" was vaccinated with a single dose of ZOSTAVAX. Concomitant vaccination administered on that day included a dose of influenza virus vaccine (unspecified). Concomitant drug therapy included allopurinol; aspirin, VYTORIN, folic acid, hydrochlorothiazide, PLAQUENIL, methotrexate, LOPRESSOR, ACCUPRIL, ZOCOR, terazosin hydrochloride and other blood pressure and rheumatoid arthritis therapy. On 16-OCT-2007 the patient felt like he was getting a cold sore on his upper lip. Then he began experiencing itching on the buttock and his wife looked at and said it looked like a bunch of spider bites. The patient then developed small liquid filled lesions all over his body. The lesions have turned black and the liquid inside had dried up and started to crust. Medical attention was attempted by the patient contacting the physician without a call back. No labs or diagnostic studies were performed. The patient was noted to be recovering. There was no product quality complaint. Follow-up information has been received from a registered nurse indicating that the patient with a history of prostate cancer, coronary artery disease, hypertension, benign prostatic hyperplasia, hyperlipidemia and rheumatoid arthritis was vaccinated on 12-OCT-2007 with a SC dose of ZOSTAVAX (658839/1411U) in the left deltoid/arm. Concomitant vaccination administered on that same day included an IM dose of influenza virus split virion 3v vaccine inactivated (lot# U2528AA) in the right deltoid. Other concomitant drug therapy included allopurinol, ACCUPRIL 10 mg, HCTZ 25 mg, LOPRESSOR 125 mg, ezetimibe (+) simvastatin 10 mg/40mg, PLAQUENIL 200 mg BID and methotrexate 2.5 mg. On 16-OCT-2007 the patient developed a painful rash on his buttocks. No medical attention was sought. The outcome was unknown. Additional information has been requested.
Arm pain; Fever on 2nd day; This is a spontaneous report from a contactable consumer. A 12-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Jun2021 at 15:45 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 15May2021 at 14:00 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Jun2021, the patient experienced arm pain and fever on second day. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm pain and fever was recovered on an unknown date in Jun2021.  The batch/lot numbers for BNT162b2, was not provided and will be requested during follow up.
Rashes on right arm; Itching near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes on right arm) and VACCINATION SITE PRURITUS (Itching near the injection site) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rashes on right arm) and VACCINATION SITE PRURITUS (Itching near the injection site). On 11-Feb-2021, VACCINATION SITE PRURITUS (Itching near the injection site) had resolved. On 14-Feb-2021, RASH (Rashes on right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. Treatment include unknown cream or ointment.; 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.
This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 43-year-old female patient who received FLULAVAL QUADRIVALENT (batch number H33J2, expiry date 31st May 2016). Concomitant medications included levofloxacin, nitrofurantoin, omeprazole and pantoprazole. On 21st September 2015, the patient received FLULAVAL QUADRIVALENT .5 ml. On 22nd September 2015, 1 days after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site swelling, injection site warmth, injection site erythema and injection site tenderness. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site erythema and injection site tenderness were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site erythema and injection site tenderness to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was reported by a medical assistant. On 21st September 2015, at 8.30 am, the patient received FLULAVAL QIV. On the day of reporting, the patient returned to the medical assistant's office and reported redness, tenderness, warm to the touch arm with a raised bump and swelling at the injection site. No other vaccines were administered on the same day or within 4 weeks of injection with FLULAVAL. No additional details were available at the time of reporting.
PATIENT FAINTED WITHIN 20 SECONDS OF RECEIVING PFIZER COVID-19 VACCINATION.  PATIENT'S FATHER AND STORE MANAGEMENT CALLED 911.  FATHER AND ADMINISTERING PHARMACIST MONITORED PATIENT; PATIENT REGAINED CONSCIOUSNESS SHORTLY AFTER FAINTING.  PARAMEDICS ARRIVED APPROXIMATELY 10 MINUTES LATER AND FURTHER ATTENDED TO PATIENT.  PARAMEDIC DIAGNOSED VASOVAGAL SYNCOPE.  PATIENT AND FATHER WENT WITH AMBULANCE TO HOSPITAL FOR FURTHER EVALUATION.
06/15/2021 give a chemical stress test that he failed. Chemical stress test 06/29/2021 angiogram and a stent and was 99% blockage. Hospitalized overnight.
Severe pain immediately following vaccination. A "bubble" formed just beneath skin at vaccination site at 6:10 PM. Complaints of muscle/arm stiffness at 7:00 PM. Loss of appetite and mild stomach cramps evening of 08/24/2011 & morning (6:15 AM) of 08/25/2011. By 1:00 PM 08/25/2011 swelling in injection site was the size of a quarter with continuous pain and fever at injection site. 08/26/2011 6:30 AM injection site had swelled to just larger than a Kennedy half-dollar with tightness. Visited pediatrician and was told to administer Benadryl, Tylenol, and ice packs. 08/27/2011 9:00 AM swelling had increased to approximately 3 1/2 inches diameter with a rash covering entire area and feels warm to touch with tightness. Complaints of extreme itching and shoulder muscle soreness. 08/28/2011 rash, warmth, itching, muscle soreness in shoulder, tightness in injection site. Swelling is now approximately 4 inches in diameter.
Swollen lymph nodes under arm; Injection site swelling; Injection site redness; Sore arm; Fatigue; Chills; Fever; Nausea; Dizziness; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 29Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any medications within two weeks of the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration on 08Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021, the patient experienced swollen lymph nodes under the arm, injection site swelling and redness, sore arm, fatigue, chills, fever, nausea, and dizziness. The clinical outcome of the events swollen lymph nodes under the arm, injection site swelling and redness, sore arm, fatigue, chills, fever, nausea, and dizziness were not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Profoundly weak by Saturday the day after the injection (2/6/2021), hospitalized by Monday (2/8/2021), on a ventilator by Wednesday (2/10/2021) and died the following Monday, (2/15/2021) She was treated for HLH (hemophagocyticlymphoistiocytosis)
01/08/22 presents to ED for "syncopal episode". PMHx of "dementia and Bell's palsy".
Home call mother states right arm red and swollen, scratching and fever. Took child to MD 06/17/03 where Motrin and Benadryl was given. Reported to clinic by phone 6/18/03 1:15 PM.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX lot # (669692/0615AA) (dose and route not reported) on 04-AUG-2012. That expired on 02JUL2012. No treatment information was reported. Additional information has been requested.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. The patient experienced no adverse events.   This case was linked to MOD-2021-395985 (Patient Link).
This spontaneous report was received from a nurse prescribed regarding a multiple patients of unknown demographics. No pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored with GARDASIL 9 (lot # M013636, expiration date of 15-FEB-2018) (dose and route not reported). The administered dose experienced a temperature excursion of 9.6 degrees for 19 minutes and -9.8 degrees for 33 hours. No adverse effects were reported. No PQC (product quality complaint) filed. This is one of several reports received from the same reporter. Additional information has been requested.
Approximately 40 minutes after receiving vaccine patient complained of worsening headache that had occurred after receiving vaccine and feeling like something bad was going to happen inside of her.  Denied pain or shortness of breath.  No swelling, pain or redness at vaccine site.  Assisted supine position with legs elevated.  BP 118/64 HR 76 initially then to 108/66 with HR 64.  Resp unlabored at 18/min.  Symptoms did not resolve with rest and observation.  Student treated with supplemental oxygen with no resolution of symptoms, and then with IM epinephrine.  Student transported to emergency room via paramedics.  Evaluated and discharged home same day.
I had a sore throat and it progressed into a cold. Congestion, laryngitis. Because I'm in my first year of post kidney transplant they wanted to see me for any illness that's why I called the doctor.
hair loss started left top of head now coming down sides.  Endocrinologist did thorough blood tests for hair loss.  All were negative.  He also looked at my drug list and said none cause hair loss. My GP told me to see a dermatologist.  I did and ahw pulled on hair and it didn't come out.  She checked my eye brows and lashes which at this time are fine.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 20th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 20th July 2018, several hours after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced fever, tiredness and loss of energy. On an unknown date, the patient experienced incomplete course of vaccination. On 21st July 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the tiredness and loss of energy were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the fever, tiredness and loss of energy to be related to SHINGRIX. Additional details were provided as follows: The patient received vaccine in the morning. On the day of vaccination, at night she had fever which lasted about a day. The patient also noted that, she was tired and had no energy. The patient stated she knew it could cause the adverse events she experienced. The reporter declined pharmacy information and follow up with herself or healthcare professional.
I'm a 53 year old woman in deep peri menopause.  My cycles are usually over 100 days apart. I had a period a week and a half after my first shot and had more PMS symptoms than usual leading up to it, including tender breasts.  Then I got ANOTHER period one week after my second shot. This one was much heavier and longer than normal and I'd had more PMS leading up to that one too.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Fever-Medium
Immediate shortness of breath, lightheadedness, and palpitations following vaccination for 10 minutes. lightheadedness lasted rest of the day. Shortness of breath lasted next 3 days
Developed POTS (postural orthostatic tachycardia) Numbness in my legs, Brain Fog, Issues with equilibrium, Overall feeling of sickness
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On an unknown date the patients were vaccinated with oral, ROTATEQ (lot # K016261, expiration date 23-JUN-2016) (dosage, strength and route of administration not reported). There was no concomitant medication reported. At the time of the report, no adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Left upper arm - bruise.  Immediately after shot her arm "felt like something was traveling down it and also to back of neck".  Neck felt stiff.  Nurse told her to move arm around & that it was a ice volume of vaccine.  Left lower arm - redness around site with slight itch (2X1 inch).  Noticed this on Sunday 11-22-09.  Took ALEVE.  Today informed if symptoms worsened to seek medical evaluation.  States she feels fine.
Vesicular/pustular rash on rt lower trunk onset one day post vaccination with Pfizer #2.   Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21).