chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchy; Red; Red rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE RASH (Red rash around the injection site) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0301420A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history 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 VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE RASH (Red rash around the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE RASH (Red rash around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
ACUTE NON ST ELEVATION MI ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/16/2022,  12/17/2022,  12/18/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This spontaneous report has been received from a registered nurse refers to a 33 years old male patient with allergy to penicillin and medical history of abscess who was vaccinated SC with a 0.5 ml dose of PNEUMOVAX23 (Exp Date: 20-OCT-2013) on 25-JUL-2012. No other co-suspects were reported. Concomitant medications included ZANTAC, HYPROMELLOSE (artificial tears), calcium (unspecified) and ribavirin. Nurse reporting the patient was received PNEUMOVAX23 and the right arm was swollen to the elbow, red and hot to touch and patient experiencing nausea, vomiting, diarrhea, and loss of appetite on 27-JUL-2012. The patient was seen on 20-JUL-2012 for an abscess and given ROCEPHIN prior to vaccination. Patient sought medical attention by calling to nurse. There was no lab diagnostics performed. At the time of report, the patient was recovering. This is one of the several reports with the same reporter and the other two were 1208USA000450 and 1208USA001635. Additional information has been requested.
Pt passed out 2 minutes after receiving flu shot. Pt was caught by friend/wall and did not get hurt. Pt had low blood sugar reported by EMS at scene.
I couldn't raise my arm after the vaccine, the doctor said it was called frozen shoulder. He injected me with a shot, I have also been going to physical therapy which has helped me a lot.
Sore arm; Itchiness on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE PRURITUS (Itchiness on arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for Immunisation.     The patient's past medical history included No adverse event. Concomitant products included HYDROCHLOROTHIAZIDE for an unknown indication.    On 24-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) injection. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE PRURITUS (Itchiness on arm).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-073122 (Patient Link).
5 hours after the shot, I was achy, nauseous, feeling vertigo. I went to bed. I was in bed for probably 4 days. I couldn't lift my head off of the pillow. I ached all over, I had really bad vertigo and dizziness. I couldn't go anywhere from Sunday night- the following Saturday morning.  I was starting to feel better on Saturday 8/28 and the best 8/29.
covid arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 VACCINATION SITE REACTION (covid arm). At the time of the report, VACCINATION SITE REACTION (covid arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
He felt "heat sensation and dizziness" after receiving H1N1 vaccine, but better after 10 minutes. Then this a.m. felt "weaker than normal "and headache and "slight dizziness."
Had severe chills, nausea with abd. pain, pale, headache about 3 1/2 hrs after receiving BEXSERO (Men B) vaccine. He was seen in ED.
t105 & irritability-referred to clinic;t104 had never filled rx;pt was given Ibuprofen;advised to get rx filled STAT & call if further concerns;
This spontaneous report received from a nurse regarding multiple unspecified patients of unknown demographics. No medical history was reported. On multiple unspecified dates, multiple unspecified patient were vaccinated with improperly stored VARIVAX lot # L008270, expiry date: 11-MAR-2017 (dose, route and frequency: unknown). No adverse effects were reported. No Product Quality Complaints (PQCs) was involved. This is one of the several reports from the same reporter. Additional information has been requested.
I was diagnosed with Pulmonary Embolism in the Emergency Room on 7/31/21  (blood clots in my lungs)
On 3/24 I woke up feeling swollen in my armpits. It felt more swollen on the left arm (same arm as the injection) than on the right. The swelling  lasted all day and went down by the next morning (3/25). On the evening of 3/25 I noticed that my arm at the injection site felt itchy. When I scratched it I noticed it was hard surrounding the site. The diameter of the itchy hard area is about 2.5 inches.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 28-MAR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). On unspecified dates, the PNEUMVAX 23 vaccine had six temperature excursions of 0 Celsius Degrees (32 Fahrenheit) for 256 hours, 0.55 Celsius Degrees (33 Fahrenheit) for 128 hours, -1.11 Celsius Degrees (30 Fahrenheit) for 288 hours, -1.66 Celsius Degrees (29 Fahrenheit) for 256 hours, -0.55 Celsius Degrees (31 Fahrenheit) for 552 hours and 1.11 Celsius Degrees (34 Fahrenheit) for 72 hours, respectively. The vaccine status was reported as "in excursion" and the type of excursion and storage criteria were reported as "refrigerator (R)". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Anaphalactic Shock, collapse (passed out), amnesia, severe headache for 48 hours (not relieved by analgesics). 2 degrees fever for 36 hours.  (No seizures)
Patient experienced headache and body aches on tuesday. On wednesday, patient reported injection site reaction of arm being red, swollen, warm to the touch, and itchiness.  Recommended patient to take 1 benadryl tablet by mouth to alleviate the symptoms and if they worsen, advised to go to emergency department.
Lymph nodes swollen on left side of body; same arm where vaccine was received.; Dose Number: 3; offlabel use; Dose 1, brand: Moderna/ Dose 2, brand: Moderna / Dose 3, brand: Comirnaty; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 44 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 23Nov2021 11:30 (Batch/Lot number: unknown) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Route of Administration: Intramuscular), for COVID-19 Immunization; Moderna (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Route of Administration: Intramuscular), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021, outcome "unknown", described as "Dose Number: 3"; OFF LABEL USE (non-serious) with onset 23Nov2021, outcome "unknown", described as "offlabel use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 23Nov2021, outcome "unknown", described as "Dose 1, brand: Moderna/ Dose 2, brand: Moderna / Dose 3, brand: Comirnaty"; LYMPHADENOPATHY (non-serious) with onset 24Nov2021, outcome "not recovered", described as "Lymph nodes swollen on left side of body; same arm where vaccine was received.". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: It was reported that the patient had no known allergies. The patient had no covid prior vaccination and not tested for covid post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Originally had the J&J vaccination on April 10, 2021. Chose Moderna Booster on November 6, 2021. On November 7, 2021 lymph node in right armpit was swollen to the size of a golf ball. Very painful. Took Ibuprofen and hydrocortisone ointment. Went away in a couple of days. Body aches, low grade fever, pain at injection site.
Per patient: "Severe enough weakness, myalgias, lightheadedness and fever the next day that I had trouble working (had to lie down myself during clinic)?. I went home and slept for 16 hrs. By Saturday (2 days after vaccine), able to function fairly well.  By Sunday (3 days after), near 100%."
headache started at 830 am , took 1000mg Tylenol. ate breakfast a bagel  1030 was doing my job in the ER and my sugar dropped. was tested and was at 62. ate candy and drank juice. blood pressure was 131/60, also had some palpitations. went to lay down.  chicken salad for lunch and at 1:oo massive headache....took 800 mg of Advil was tired the rest of the day next day had a headache not as severe took 1000mg of Tylenol was okay slept during the day (took a nap) woke and was still tired all day had swollen glands. Next day worked and had a worse headache took 100mg of Tylenol and was tired most of day glands still swollen Next day was home and was trying to get up early and could not ? tired... once awake glands were swollen but also was losing voice, intermittently and neck was somewhat swollen on one side (all my glands were large). no other swelling.   next day felt better no swollen glands only headache at end of day. Tylenol taken. 12/30 only slight headache at this writing no medication as of yet.
This spontaneous report was received from a physician via company representative and refers to a 3 month old patient of unknown gender. The patient concomitant medication, pertinent medical history, drug reactions and allergies were not provided. On an unknown date (reported as at age 3 months), the patient was vaccinated with ROTATEQ, orally (strength, dose, lot number and expiry date were not reported) for prophylaxis. Other suspect therapies included ROTARIX (strength, dose, frequency, route of administration, lot number, expiry date and indication were not reported), which was administered when the patient was 2 months old. No adverse effect was reported.
Tingling pain under his foot in both of his feet; Never had this kind of pain before; Bladder pain for over a week; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling pain under his foot in both of his feet), PAIN (Never had this kind of pain before) and BLADDER PAIN (Bladder pain for over a week) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LOSARTAN and HYDROCHLOROTHIAZIDE for Hypertension.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced PARAESTHESIA (Tingling pain under his foot in both of his feet), PAIN (Never had this kind of pain before) and BLADDER PAIN (Bladder pain for over a week). At the time of the report, PARAESTHESIA (Tingling pain under his foot in both of his feet) and PAIN (Never had this kind of pain before) outcome was unknown and BLADDER PAIN (Bladder pain for over a week) had resolved.            Patient had tingling pain under his foot in both of his feet for 7 days now. Patient had all his blood checked and had a normal ultrasound. No treatment information was provided.
Pain and soreness in left bicep muscle and shoulder at injection site. Most pain I've experienced from flu shot. Difficulty in moving left arm. Tenderness over large area, from shoulder to elbow, concentrated in bicep muscle. Lasted 3 days, but finally went away.
Patient reports that in the evening after receiving the vaccine on 11/12, she awoke in the middle of the evening due to arm pain, redness, swelling, and heat.  She reports that the initial affected area was approximately 4" x 4".  She took 3 doses of acetaminophen over the following two days and iced the affected area repeatedly.  As of 11/15, patient reports that the heat, redness, and size of the reaction have all significantly regressed, but she has not completely recovered as of yet. Patient did not seek medical treatment as she did not feel it was necessary.
diagnosed in-clinic with shingles; This is a spontaneous report from a contactable other hcp (patient herself). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982, expiration date not reported), via an unspecified route of administration, administered on the right arm on 14Jan2021 15:00 (at the age of 40-years-old) at a single dose for COVID-19 immunisation. Medical history included asthma (allergy-related asthma), drug hypersensitivity (Penicillin allergy), allergy to animal (pet dander), seasonal allergy (hay-fever), and seasonal allergy (pollen). The patient was reported to be taking other medications (unspecified) in the last two weeks prior vaccination. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. On 26Jan2021 09:30, two weeks following the first dose vaccination, the patient was diagnosed in-clinic with shingles. The event resulted to a physician office visit. Patient received anti-viral medication as a result of the event. The outcome of the event was recovered on an unspecified date.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Considering a plausible temporal relationship , a possible contributory role of suspect vaccine BNT162B2 to the reported event shingles cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Redness at injection site; Vaccination site pruritus; Rash at injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE RASH (Rash at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE RASH (Rash at injection site). On 12-Jan-2021, VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE RASH (Rash at injection site) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment details included Cortisone, Benadryl (diphenydramine).
delayed response initially and then 1 week and 2 days of upper arm pain, site swelling/hard nodule at site,  redness (about 5-7 inches in diameter), lymph node pain in axilla
Fever; temperature went from 98.4 to 103.6 in an hour and a half. Took ibuprofen and tylenol
Pain with shoulder rotation. Some movements begin with a sort of locked inhibition to move, forced motion causes a burst of pain. Could not continue normal exercise routine. Push ups exacerbate shoulder pain.
Symptoms ? EE reports she woke up on 1/14 with body aches, chills and fatigue.  + fever (Tmax 100.1) and advil taken.  EE reports she called off of work yesterday due to feeling ill.  EE reports today improvement in symptoms but still with mild HA and fatigue.  Temp 99.4 today, advil taken at 13:15.?  Last day of work and shift ? today Home remedies? -  rest and Advil  Any improvement? - yes Recommendation? EE encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns.  EE reports she called off work yesterday and heading to work at time of call.  EE educated on Illness in the Workplace Policy and to notify her manager if she needs to leave work and go home.   EE verbalized back understanding and denied further questions at this time.
about 30min p/vax pt passed out w/skin becoming cold, clammy & pale around lips & on hands;pulse went to 64low in volume & Bp dropped to 90/70;
kidney hurt; my liver enzyme went up to 535; My muscle hurts; my liver was hurt; eyes are yellow; I have no energy; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation; atorvastatin calcium (LIPITOR), via an unspecified route of administration from 24May2021 (Batch/Lot number was not reported) to an unspecified date, at 18 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. Consumer stated, I am calling to find out what is happening, because the Lipitor has given me a serious side effect, I was on less than six weeks and have taken me to ER. I reported to my doctor that I started felt like medicine was making my kidney hurt, the more I took it, it makes more my kidney hurt and then my liver started to hurt me and did not stop, my liver enzyme went up to 535 and it has been like 5 weeks, and I am still dealing with it. I have no energy, my liver still hurt, eyes are yellow and my doctor still what the heck is doing. So now I am calling because I have missed the opportunity to start a job that I needed, it's really bad time for me. I don't know what cause the problem but my muscle hurts, my liver was hurt, my kidney was hurt, and I am still trying to recover 5 week later. When probed for the medication name as Covid-19 Vaccine, consumer stated, no, Lipitor, I did take the Covid vaccine though, its six week later only time things changed in my life when I got Lipitor and then Covid vaccine. When probed for adverse event from Covid-19 Vaccine, consumer stated, no that I am aware of I think it's from the Lipitor because like I said every day, I took it my kidney hurt more and more. I reported it to my doctor, but I didn't even to make it to 6th week, blood level check like, I was on it less than 6 weeks. I stop taking it for 2 weeks so I called my doctor and tell my doctor quit that medicine because the family member passed away and I have to go out of town in emergency, so I accidently left it here but I told 2 weeks that I didn't have it and felt better but they did get back on it and get them and I took 1 pill and went to emergency room that's all. The outcome of the events was unknown.  Follow-up attempts have been completed and no further information is expected.
Nearly passed out; Postural Orthostatic Tachycardia Syndrome; icy like pulsation through my blood occurred; fell to the ground; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient (not pregnant) received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), Lot number: EL9261, via an unspecified route of administration on 06Feb2021 12:30 at single dose in Left arm for covid-19 immunisation. Facility type Vaccine was Hospital. Medical history included anaemia, no known allergies. Patient had COVID-19 starting on 06Jan2021 and persisting through 16Jan. Her COVID symptoms were crushing chest pain, no fever, blood oxygen level never dropped below 98%. The patient's concomitant medications were not reported. There were no other vaccine in four weeks. Patient was experiencing Postural Orthostatic Tachycardia Syndrome. Nearly passed out going to the toilet when she first awoke. An icy like pulsation through her blood occurred first thing this AM, day after the vaccine. She fell to the ground and called for her husband to help her. He gave her 500mg acetaminophen and aspirin. She slept. Same thing happened with pulse 140+, he measured, as she showered. They stopped the shower, she laid down and recovered. When she got up immediately the pulse rises to 120+. Adverse events started from 07Feb2021 08:30 AM. Therapeutic measures were taken in response to the events. The outcome of the events was not recovered. Covid was not tested post vaccination.
vaccine on 2-25-2021. Headaches started on 2-26-21. Multiple times a day.  after 2nd shot on 3-18-21 the headaches became severe and debilitating. Diagnosed as Cluster headaches.  I have has 4 days without headaches since Feb 26th.  I have never had headaches as severe as these.
No adverse events reported.   Patient was given dose of vaccine 4 days past best use date.  Pharmacy contacted Moderna and received communication that no re-vaccination required...The vaccine maintained the necessary activity to provide protection.
Profuse sweating. Used cool washcloth to try to cool body off.  Went away within a hour.
COUGH, CHEST CONGESTION, HEADACHE, BODY ACHES, CHILLS, DIARRHEA STARTING 06/15/21
Patient had a mild rash/few bumps on the trunk under breast on opposite side of where the injection was given.
Information has been received from a nurse concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients might had been vaccinated with improperly stored VARIVAX (dose and route were unknown; lot # M023383 with expiration date 11-MAY-2018 and lot # M028553 with expiration date 07-JUN-2018). The vaccines were exposed under temperature of 3 degrees centigrade for 13 minutes. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.