chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of fever in a 54-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 20th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 20th July 2018, less than a day after receiving SHINGRIX, the patient experienced fever, general body pain and chills. On 22nd July 2018, the patient experienced itchy rash and erythematous rash. On an unknown date, the outcome of the fever, general body pain and chills were recovered/resolved and the outcome of the itchy rash and erythematous rash were not recovered/not resolved. It was unknown if the reporter considered the fever, general body pain, chills, itchy rash and erythematous rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the medical assistant on behalf of the patient. The patient received SHINGRIX on left deltoid. On the same day after receiving SHINGRIX, the patient experienced fever, chills and body aches. The caller stated that on Sunday, 2 days after receiving SHINGRIX, the patient noticed an itchy reddened rash on her left arm that was approximately 5 inches away from the injection site.
little swelling at the injection site; muscle between her shoulder elbow inside burns off and on, when ever she moves her hand; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (little swelling at the injection site) and MYALGIA (muscle between her shoulder elbow inside burns off and on, when ever she moves her hand) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 17-Apr-2021, the patient experienced VACCINATION SITE SWELLING (little swelling at the injection site) and MYALGIA (muscle between her shoulder elbow inside burns off and on, when ever she moves her hand). At the time of the report, VACCINATION SITE SWELLING (little swelling at the injection site) and MYALGIA (muscle between her shoulder elbow inside burns off and on, when ever she moves her hand) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Client c/o of joint pain, increased tiredness, dizziness and nausea off and on the day after Tdap vaccination lasting 6 days. She also reported that she is "seeing 3 lines". Advised client to seek immediate medical attention.
about 6 to 7 hours post immunization pt states that she felt a burning from her ears/face/throat, states that she never felt like she had any trouble breathing and then without any treatment the symptoms went away on their own after about 1 to 2 hours
13 hr after injection fever (up to 102.9), myalgia, terrible headache, chills, and night sweats. Lasted 24 hours.
Pain, swelling, stiffness-hands, wrists, shoulders, knees, ankles and feet. Extreme fatigue-pain medication also Prednisone, anti-inflammatory med. Have seen several doctors. Arthritis caused by Lyme vaccine. The medical records confirm diagnosis of rheumatoid arthritis previously coded as well as pre-existing conditions of gout, mild arthritis, and DM already coded. Pancreatitis is mentioned, but it was diagnosed 2 years after the onset of the AE.
pt recvd vax; exp high fever; swelling to  below the elbow around inject site;
Hot; Kind of a knot; Itched; Red at injection site; Cellulities type reaction; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulities type reaction) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Clindamycin), Drug allergy (Levaquin), Atrial fibrillation paroxysmal, Coronary artery stenosis (Cardiac Stenosis, Bilateral), Chronic fatigue, Peripheral arterial disease, Atrial fibrillation since 05-Jan-2021 and Parkinson's disease. Concomitant products included APIXABAN for Clot blood, AMANTADINE, ATORVASTATIN, FUROSEMIDE and DILTIAZEM for an unknown indication.   On 13-Jan-2021 at 5:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021 at 5:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021 at 9:00 AM, the patient experienced CELLULITIS (Cellulities type reaction) (seriousness criterion medically significant). On 25-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot), VACCINATION SITE MASS (Kind of a knot), VACCINATION SITE PRURITUS (Itched) and VACCINATION SITE ERYTHEMA (Red at injection site). The patient was treated with HYDROCORTISONE for Vaccination site pruritus, at a dose of 1 UNK; Manual therapy (Cold compresses) for Cellulitis; Manual therapy (Cold compresses) for Vaccination site warmth; Manual therapy (Cold compresses) for Vaccination site mass; Manual therapy (Cold compresses) for Vaccination site pruritus and Manual therapy (Cold compresses) for Vaccination site erythema. On 02-Feb-2021, CELLULITIS (Cellulities type reaction) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot), VACCINATION SITE MASS (Kind of a knot), VACCINATION SITE PRURITUS (Itched) and VACCINATION SITE ERYTHEMA (Red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CELLULITIS (Cellulities type reaction) to be related. No further causality assessments were provided for VACCINATION SITE WARMTH (Hot), VACCINATION SITE MASS (Kind of a knot), VACCINATION SITE PRURITUS (Itched) and VACCINATION SITE ERYTHEMA (Red at injection site).    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.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up ADR form received: Updated patient details, concomitant medication, second  vaccine details, event changed to potentially serious and outcome of event were added.; 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.
Skin leisons that could be consistant with autoinnoculation, or generalized vaccinia. Discharge summary states viral illness. Medical record states itching.
This spontaneous report as received from a Registered Nurse concerning a patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ, oral. On an unknown date the patient received a second and third dose only one week apart. No adverse effects were reported. Additional information has been requested.
When I got my first half of vaccine I did have a swollen lymph node along my collar bone on the left side; This is a spontaneous report from a contactable nurse. This 47-year-old female nurse reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: EK5730) at single dose in the left upper arm for vaccination on 21Dec2020. Relevant history included Hypertension. Relevant concomitant drug included Lisinopril 10 mg daily for blood pressure, Omeprazole 20 mg daily,  Vitamin Supplements. The nurse stated, " When I got my first dose of vaccine I did have a swollen lymph node along my collar bone on the left side which is on the side where I got the shot and it didn't really change much. It just kind of stayed the same size and it remained there for whole three weeks.  This small one along my collar bone that started right after the first vaccine and that has stayed the whole time. But got bigger after my second."  No treatment was received. The outcome of event was not resolved. The patient believed the swollen lymph nodes were due to the Covid 19 Vaccine.
pt devel a sore lt arm w/in 3hr p/vax;that evening pain increased extending to lt thigh & radiating to neck & across chest;pt stated could not move arm d/t extreme pain;went to MD given med;MD felt pt had rxn to vax;
Metallic taste in mouth; constant urine smell; arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the right arm on 17Jul2021 at 15:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and allergy to latex and coffee. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously took lidocaine hydrochloride (LIDOCAINE), benzocaine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the right arm on an unknown date in 2021 as a single dose for COVID-19 immunisation. On 17Jul2021 at 16:00, the patient experienced metallic taste in mouth, constant urine smell and arm soreness. The adverse event did not result in doctor or other healthcare professional office/clinic visit and 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 metallic taste in mouth, constant urine smell and arm soreness was not resolved at the time of this report.
This spontaneous report as received from a medical assistant refers to a 17 year old female patient. The patient had no known pertinent medical history, drug reaction or allergies and concomitant therapies. On 19-FEB-2018, the patient was vaccinated with the first dose of GARDASIL 9 (lot # N021571; expiry date: 29-APR-2020) for prophylaxis. Dosing details were not reported. In approximately 2018, the patient missed 2 cycles of menses since receiving GARDASIL 9. The patient did not receive any treatment for the adverse event. At the time of the report, the patient had not recovered from the event of menstruation delayed. Causality assessment was not provided by the reporter. No product quality complaint was involved.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02 Apr 2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02 Apr 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02 Apr 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02 Apr 2022) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 11:07 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 11:07 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02 Apr 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02 Apr 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    No concomitant drug information was provided.  Patient received second booster dose of Moderna COVID-19 vaccine on 02-Apr-2022 at 11:07:53. The 30 days Expiry date vaccine went into 2 to 8 °C thaw state on or about to 24-Dec-2021, this vaccine administered until its Mfg exp date of 04-Apr-2022.  No treatment drug information was received.   This case was linked to MOD-2022-542869 (Patient Link).
This spontaneous report as received from a nurse refers to a patient of unknown age and gender (demographics unspecified). Medical history and drug reactions/allergies were not reported. On an unknown date, two doses of M-M-R II that were improperly stored may have been administered (lot, dose and route not reported). Concomitant medication was not reported. No adverse event reported. Additional information is not expected.
I had just finished my cycle the day before. I woke up Mon morning to thick, clotted blood. I contacted my provider and I was instructed to take a pregnancy test, which was positive. I went in for an exam on the 12th and they confirmed that I was indeed pregnant. They tested my Beta Hcg twice. I didn't get my results immediately due to one site being closed due to COVID. I could've gone to the hospital and received the results immediately, but my doctor didn't want to take the chance due to the hospital having a lot of COVID. They confirmed that I was pregnant on the 19th or 20th. I bled for a few days after that. The final Beta Hcg was done and my level was 0.
PATIENT PRESENTED IN IMMEDIATE CARE A COUPLE HOURS AFTER VACCINE ADMINISTERED COMPLAINING OF CHEST PAIN, SHORTNESS OF BREATH, THROAT FELT TIGHT, HIVES AND DIZZINESS. EMS WAS CALLED AND PATIENT WAS TRANSPORTED TO EMERGENCY ROOM.  PATIENT RECEIVED IV FLUIDS AND PRESCRIBED STEROIDS.
Urticaria, Rash on neck, back, arms & hands 48 hours post Hep B given, Zyrtec with improvement post 7 days now dry hypopigmented rash on (?), non-pruritic
According to patient's mother patient developed hives about 6pm on 8-9-07. She gave her Benadryl 25mg. Mother called our office about 6pm on 8-10-07 to report reaction. She was advised to increase Benadryl to 50mg every 4-6 hours. Patient was seen in our office on 8-11-07 - confirmed reaction and prescribed Prednisone 60mg daily for 3-5 days.
Tested positive for Covid-19; This spontaneous case was reported by a nurse and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for Covid-19) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for Covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, SARS-CoV-2 test: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication were not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up received on 04-JUN-2021 contains Non Significant information. Contact information updated. On 02-Jul-2021: Follow up information received on 02-Jul-2021 and determined causality was updated as per medical reviewer comment.; Sender's Comments: This case concerns a 25-year-old female with a nonserious unexpected event of COVID-19. Event onset within 1 month after first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
t103-104R started approx 5hr p/vax;930PM 29MAY96;by 8:30 30MAY96 temp dec to 102R;remains cranky but alert;vomited x 1 about 8:30;
Patient came into pharmacy on 7/4/19 stating she had received a Pneumovax-23 vaccine the day before and had a reaction to it. Her left arm was swollen from the injection site down to her elbow. The area was red, swollen, and warm to touch. The patient stated she did not have any other symptoms. I, the pharmacist, told her to take a Benadryl and monitor it.
I was given the first shot of the Pfizer vaccine on September 8, 2021. On the morning of September 9, 2021, my heart was rapidly beating, and I felt tightness in the chest.  By the afternoon the symptoms had lessened but I still had the typical symptoms of tiredness, chills, and stuffiness in the head.  I did not reach out to seek medical attention because I thought these symptoms were normal side effects of the Pfizer vaccine. I did inform my doctor during a visit.
Employee was treated in the ED. Symptoms: skin rash to  Lt arm that was red, raised, macular, with hives, swelling, Lt arm erythema, itching and cough. Medication Prescribed: Medrol dose pak, Pepcid 20 mg, Benadryl.
dizziness, nausea & vomiting 2 mins after vaccine administration. 2 episodes of vomiting vitals obtained - WNL, patient reports "feeling better" but was referred to ER for further eval.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. In 2018, the pt was inoculated with zoster vaccine live(ZOSTAVAX)(dose, route of administration, anatomical location, lot#, expiration date were unknown) at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live(ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.
pt adm to hosp on 17MAR99 for cellulitis of rt thigh;discharged on 20MAR99 w/impression of local rxn to immun, possible abscess formation;
ACUTE NON ST ELEVATION MI ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE
"Patient up to date on COVID vaccines who admitted to hospital with COVID detected PCR and hypoxia.  Provider d/c note:  ""80-year-old female with significant past medical history of Afib, CHF, COPD, DM, HTN who presented to hospital with weakness and shortness of breath.  Patient was diagnosed with COVID-19 on 10/25, completed molnupiravir therapy at home. Since her diagnosis she has increased weakness, exertional shortness of breath, generalized fatigue, and mild productive cough due to post nasal drip. Prior to admission, patient complained of significant lightheadedness without pre-syncope or syncopal event. EMS was called to her home due and found her hypoxic into the 80's. At baseline she uses home oxygen at 2 LPM due to asthma, but only uses at night. Upon arrival to the ED was found to be bradycardic into the 30's and 40's with hypotension. She was given one liter NS, with subsequent improvement in her blood pressure. In addition, she continued to require supplemental oxygen to maintain her SpO2 in the mid-90s.    Hospital Course:  The patient's home metoprolol and propafenone were held due to symptomatic bradycardia. Cardiology was consulted. Overnight there were no significant events. Patient reported significant improvement in her symptoms with improved vitals prior to discharge. Telemetry was significant for sinus bradycardia with HR 50s. Echo was not performed as patient recently completed study with outpatient Cardiologist in August 2022. Pharmacology was consulted to aid in Warfarin dosing. Cardiology recommendations included discharge with outpatient follow-up and to hold home metoprolol and propafenone until further discussion with the patient's Cardiologist. She was discharged home in stable condition.
Developed a red, swollen, painful area around the injection site. Seen Dr. Taking Tylenol.
about a week after the shot I began to develop a rash on my lower neck, top of my shoulders, chest, stomach and upper arms 9No rash on lower arms, buttocks, legs, hands or feet).  It peaked about a week ago - bumps, some with red dots, splotchy and is better now.  I thought it was dry skin or heat rash, itched a little from time to time.  I started applying Ceravae about a week to 10 days ago and it seemed to help. I haven't had any diet changes, no changes in laundry soap or been anywhere around poison ivy, oak of sumac.  The only change we can think of preceding there rash  during this period was the COVID vaccine.
12 hours after injection there was increase swelling around the injection site and spreading into the Lt shoulder and upper back. Nausea, tightness in left neck and left upper back with swelling. Went to bed with ibuprofen and ice on swelling.  Woke up 18 hours (5am) feeling sweating, difficult breathing, chest was tight with more swelling in left arm and left upper back. Got up to ask for help and fainted. Called father, mother we checked blood pressure was low (98/40),  and was heart rate was low (46). Got her sitting up and blow pressure and heart rate returned to normal.
Woke up in middle of night with burning and itching on elbow in right arm, same arm as vaccine. There were bumps resembling insect bites or poison ivy on elbow and red area, Botches of red spread up right arm to head, causing itchiness. Next day, the blotches were gone, but the redness and bumps on elbow remained. Two days later, the bumps, itchines and redness remain on the elbow, and some bruising has appeared. The shot was administered in the upper right arm. Not sure if this attributable to the vaccine, but there's nothing else that has changed.
Rash on nasal bridge started 1 day after vaccination now improving but still present. No treatment.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. Since 07-OCT-2015 (until the reporting time of 03-DEC-2015), the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # L013067 with expiration date 14-APR-2017, lot # L017142 with expiration date 13-MAY-2017, dose and route not reported). Information regarding concomitant medications was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Heart fluttering/skipping beats shortly after receiving and periodically continuing up to this date.  Numbness feeling in face and jaw several hours after receiving that continues today.  Feel pressure on forehead and nostril area.