chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of chills in a 62-year-old female patient who received SHINGRIX) for prophylaxis. On 31st December 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced chills and pain. On an unknown date, the outcome of the chills and pain were recovering/resolving. It was unknown if the reporter considered the chills and pain to be related to SHINGRIX. Additional details were provided as follows: The patient, who was a consumer reported that she experienced chills and achiness that has gotten better but still continues today. The patient asked the question before but want to double check that could she be with her granddaughter aged 8 months as the patient experienced a reaction of chills and body aches. All of a sudden, the patient could no longer hear the caller and the call was disconnected. The patient did not report the reactions to the vaccine to GSK before as she did not think they were serious enough. Actually she read just about reporting them from this site just now. The patient did actually report it to the pharmacy where she got the vaccine. The patient was agree to contact to her physician. No further information was available.
fear of death/doom; I went into a full Anaphylaxis shock; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EW0150) via an unspecified route of administration, administered in Arm Left, at the age of 32-year-old,  on 06Apr2021 09:45, as SINGLE DOSE for covid-19 immunisation.  Medical history included allergy to shrimp. The patient was not diagnosed with COVID nor was he tested post vaccine. The patient's concomitant medications were not reported.  On 06Apr2021 at 10:00 am, 15 mins after the vaccine, a large hive appeared on his forehead and then 1.5 hours later the patient went into a full Anaphylaxis shock with difficulty breathing, throat closing up, fear of death/doom, tingling sensation in whole body, heart pounding rapidly, chest pain, dizziness. The patient went to the emergency room/ urgent care and was hospitalized for 1 day. Therapeutic measures taken in response to the events included administration of Steroids, antihistamines, and pain killers. Outcome was recovering at the time of the report.
pt became lightheaded, sat in a chair, and fell forward lacerating his head after receiving the dose. Ems was called and transported the patient
Initial misuse report received on 08-Oct-2013 from a health care professional. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of PENTACEL (lot number, route and site of vaccination was not reported) on an unspecified date. It was reported patient have received expired PENTACEL. As of 08-Oct-2013, Patient did not have any adverse events. List of documents held by sender: none.
An abnormal left atrial enlargement; Possible pulmonary nodules on her lungs; This spontaneous case was reported by a consumer and describes the occurrence of LEFT ATRIAL ENLARGEMENT (An abnormal left atrial enlargement) and PULMONARY MASS (Possible pulmonary nodules on her lungs) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 053C21A) for COVID-19 vaccination.     The patient's past medical history included Bronchitis (had it two times in a row) in December 2019. Concurrent medical conditions included Diabetes, Hypercholesterolemia and Non-smoker (Does not partake in cigarettes or liquor). Concomitant products included LOSARTAN for Blood pressure.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced PULMONARY MASS (Possible pulmonary nodules on her lungs) (seriousness criterion medically significant). On 30-Jul-2021, the patient experienced LEFT ATRIAL ENLARGEMENT (An abnormal left atrial enlargement) (seriousness criterion medically significant). At the time of the report, LEFT ATRIAL ENLARGEMENT (An abnormal left atrial enlargement) and PULMONARY MASS (Possible pulmonary nodules on her lungs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, Chest X-ray: abnormal (abnormal) showed an abnormal left atrial enlargement and possible pulmonary nodules on patient's lungs. On 30-Jul-2021, Electrocardiogram: abnormal (abnormal) showed an abnormal left atrial enlargement and possible pulmonary nodules on patient's lungs. On an unknown date, Blood pressure measurement: low (Low) Blood pressure was down. On an unknown date, Heart rate: high (High) High.         No relevant concomitant medications were reported. It was reported that prior to second dose on Monday 19JUL2021, patient stopped taking losartan that Sunday and Monday. The patient also had an upcoming CT scan and echocardiogram with a cardiologist. Treatment information was not provided.  Company Comment: 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 linked to MOD-2021-277027 (Patient Link).; 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.
Clinical Summary Patient is a 58 y.o. male with a history of CAD with multiple PCIs, recent hospitalization at hospital 12/7/22-12/17/22 for multivessel CAD s/p CABG with Dr. 12/9/22, IDDM2 who presented to hospital 12/23/22 with sudden onset shortness of breath, episode of chest pain and hypoxia. Found to have suspected CHF exacerbation with CXR showing pulmonary edema and NT Pro BNP up to 5,579 in the ED and subsequently found to have COVID.      1. Acute hypoxic respiratory failure: Hypoxia noted by medics, briefly required BiPAP in ED transitioned back to O2 by NC therafter. Suspected due to pulmonary edema. CTPA - neg for PE. Covid-19 + on 12/23/22. Treatment as below for pulm edema. Resolved and on RA. 2. Covid - 19: Tested + on 12/23/22 same day as Symptoms onset. Given hypoxemia and presentation, Case discussed with Dr. and Dr. (on Call ID) and pt started on IV Remdezivir x  5 days which ended on 12/28/22. Symptoms resolved. 3. Acute on chronic HFrEF with acute pulmonary edema/pleural effusion: CXR noted interstitial edema in ED. NT Pro BNP 5,579 (increased from 2,775 two weeks prior). Preop EF 35-40%, repeat TTE done 12/23/22 in ED noted slightly improved EF of 46% with regional WMA consistent with ischemic cardiomyopathy. No pericardial effusion. Left pleural effusion noted on TTE and CXR and CTPA on admission. IV diuresis initiated and switched to lasix oral as an outpatient per recs with BID for 3 days with daily after for a week.  4. Acute chest pain: Episode occurred en route to hospital at rest and self-abated. Troponin elevated as below but down significantly from recent admission. EKG in ED without acute ischemic changes. CTPA neg. CTS followed 5. CAD with recent CABG: CABG x4 12/9/22 with Dr. (CTS). Continued home aspirin, statin, BB and amiodarone. CTS followed 6. Paroxysmal atrial fibrillation: Occurred in the setting of CAD/CABG. S/p LA maze and clipping of left atrial appendage 12/9/22. Home BB continued. Not on AC. Rate controlled.  7. IDDM2: Last A1c - 9.1% BG 142 on admission. Home meds include Levemir + Lispro + Metformin. Will need to follow with pcp for glucose control.
Child started convulsing at home 3/28/2019 @ 0100, was taken to hospital where he was kept for approximately 5 hours, discharged with DX Febrile Seizures R/T vaccine administration. Followed up Monday with PCP, mother stated no more episodes.
A mild?severe allergic reaction that caused massive swelling (face, tongue, and neck), severe pain, a rash/hives, shortness of breath, and minor asphyxiation.
**No Adverse Effect Reported** We called Moderna and they said that the dose should not be repeated.  Problem- Part of the medication spilled out during administration
Fatigue; injection site pain got worse couldn't sleep on my right side; injection site pain got worse couldn't sleep on my right side; Headache; Muscle aches; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received second dose of bnt162b2 (lot number: EN5318), via an unspecified route of administration, at Arm Right, on 05Feb2021 11:30 at Single dose for COVID-19 immunisation. Medical history included allergies to medications, food, cardio vascular disease, glaucoma, high BP, all from an unknown date. The patient's concomitant medications were not reported. The patient previously took tramadol, Lisinopril, statins, lactose and experienced allergies. The patient historical vaccine included first dose of bnt162b2 on 15Jan2021 at Right arm, for COVID-19 immunisation. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. The patient experienced injection site pain got worse couldn't sleep on his right side, headache unusual for him transient but sharp, woke up at 1:00AM serious muscle aches and fatigue like his legs and arms were made of lead. Adverse event started from 06Feb2021 12:00 AM. 90% of all above side effects abated by 8:00AM this morning 06Feb2021. No treatment ae. The outcome of the events were recovered on unspecified date.
Sweating; Soreness of arm; Dizziness; Headache; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Soreness of arm), DIZZINESS (Dizziness), HEADACHE (Headache) and VOMITING (Vomiting) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Soreness of arm), DIZZINESS (Dizziness), HEADACHE (Headache), VOMITING (Vomiting) and PYREXIA (Fever). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) at a dose of 1 dosage form. At the time of the report, HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Soreness of arm), DIZZINESS (Dizziness), HEADACHE (Headache), VOMITING (Vomiting) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by reporter.
Pt. states he received vaccine at 1450 and started feeling symptoms at 1505.  States itchy sensation, no hives on back, neck, left arm, left leg, down to foot. No rash/hives.  At apprx. 1515 144/73, afebrile, 76, 99% on room air. At 1525 bp 134/80, HR 70, 98% room air.  Presents only 1 raised red area behind right ear.  Employee Health RN assessed skin and no rash, irritation, hives, or redness present.  Pt. was ok to return to work after receiving 125 mg of oral diphenhydramine.
Sudden loss of hearing in left ear.  Loss occurred over 3 hour period.  09/07/2003-present
Vaccine was given at different facility. Pt came in today, 8 days after vaccine with red rash across anterior/posterior trunk, legs, arms, and tops of feet. Denies pruritis, states it started 2 days after the vaccine. Denies sx of anaphylaxis. Recommended Benadryl for sx at this time. Pt to contact office with additional sx. Supposed to have second vaccine in September.
This case was report by a pharmacist and described age and gender who was vaccinated with FLUARIX, (GlaxoSmithKline).  I October 2008, the subject received a dose of FLUARIX (.5 ml, unknown).  In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint.  The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site.  At the time of reporting the outcome of the events were unspecified.  For the other 79 linked subjects please see cases: A0756483A - A0756502A, A0756504A - A0756562A.  The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A.  With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA).  On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA) : AFLUCA320, AFLUA320A, and AFLUA320B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA.  On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA) : AFLUCA350 and AFLUA350B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Chills, body aches, headache, fatigue, stiff neck, pain at injection site. Symptoms began 7 hours after injection and last for about 36 hours.
Severe shaking and muscle contractions, entire body, lasting approx 4 hrs.  Whole body pain, headache lasting 24 hrs.  Softball size red, itchy spot at injection site appearing at 48 hrs.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (dose, route and lot # not reported). No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Symptoms: Chills, full-body shakes, body aches, headache, malaise, nausea, vomiting, loss of appetite  Signs: Frank blood in the urine Length: 72 hours
Legs were heavy, unable to walk, headache, fluid in ear drum was ringing, eye lid inflammation full of puss that resulted in patient going to eye doctor.
Pt received Varicella vaccine on 4/30/09. On 5/1/09 pt's parent reporting approximately 1" swollen area around injection site. Was seen in clinic on 5/2/09, site had 1" x 1" warm induration. Rx'd home care: cold pack, TYLENOL.
Hives roughly 30 - 40 with vaccine. Pt took 1.25 mg BENADRYL. Rxt not us red. Told pt to report Q4-6 hr and call PCP tomorrow - Upon discussing allergies at time of vaccination, pt stated had none by marking VAR consent box "no". After pt came in about 5pm - states she may have had a topical rxt to neomycin, in NEOSPORIN, but has never had it internally. Then went onto state at this time, 5pm - has codeine allergy and possible allergy to "some" antibiotics but doesn't know which ones. Also stated she is an RN and had shot before w/no rxt at time of vaccine. Called pt  9/20/09 430 pm - Pt states she continued use of BENADRYL x 2 days and rash was resolved after 3 days. Pt also states she had the flu at age 45yo and took shot yrly until present w/o any reaction.
Patient's right arm became swollen, warm to touch and red. Redness was larger than patient's palm. Patient took BENADRYL after noticing reaction and symptoms cleared shortly after taking medication.
#1 dose Moderna vaccine received on 1/8/21. 1/17/21,  9 days after vaccine receipt, developed reddened area over left deltoid (site of injection), measuring 4? L x 2.5?W. Initial soreness at site resolved by 1/11/21.  No local heat or tenderness noted. No fever or other untoward Sx.
Headache, sweats, dizziness, and fainting twice. My husband found me on bathroom floor blacked out, then helped me to feet once he was able to wake me, walked me to bed where I again fainted.
Onset facial swelling and diffuse macular, non-urticarial rash within 24 hours of vaccination.
Inconsolable crying. Started 2 hours after vaccines. Lasted for 8 hours.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender. On 08-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # not reported) that had expired on 22-AUG-2014. No adverse effects were reported. Additional information has been requested.
Information has been received from a nurse concerning a 36 month old patient who on 08-FEB-2010 was vaccinated with a dose of VARIVAX (Merck) (lot# 665409/1157Y). The nurse mentioned that on 07-MAR-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This spontaneous report as received from a registered nurse refers to a 3 years old female patient (child) with no illness at the time of vaccination. The patient's medical history included eczema and wheezing (no dates provided). On 08-FEB-2010 at 15:00 PM, the patient was vaccinated with a first dose of VARIVAX (Merck) subcutaneously (SC.) in right leg (dose not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on 07-MAR-2012, the patient came to clinic with a rash described as "scattered vesicular lesions a few that were grouped, most lesions found on arms and trunk, a few lesions were excoriated". It was also stated that the patient was diagnosed with varicella (date unspecified). No testing was done. The relatedness for the patient's event was not reported for VARIVAX (Merck). This was one of the several reports from the same source. A lot check has been initiated. Additional information is not expected.
Developed chest pain about 10 minutes following vaccination which progressed to nausea, sinus drainage and dizziness. Blood pressure 108/52 at onset of symptoms. given diphenhydramine 12.5mg elixir po client was observed and vitals taken several times with gradual increase in blood pressure. Observed for about 40 minutes, left in stable condition with no c/o of chest pain or nausea. no c/o of dyspnea.  Called parent later in day around 5pm and he was doing well. No complaints.
Redness devel 12NOV91; rash on 13NOV91 continued to get worse, red & raised hard & hot shoulder to elbow lt arm; 14NOV91 taken to MD given meds; 15NOV91 looked better less redness but still hard & hot; wouldn't use arm much;
Tinutis - ringing in ears and loss of hearing, nerve damage - proven by a Hearing test
Chest pain; pain and soreness in kidneys. Both chest pain and kidney pain lasted for about 36 hours
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Menopause (Menopause at 40 years).  On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with IBUPROFEN for Pain, at a dose of 1 dosage form and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   Other treatment: cold packs No concomitant information were reported by the reporter   This case was linked to MOD-2021-365743 (Patient Link).
This spontaneous report as received from a nurse via a company representative refers to a 16 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date in 2000, at the age of 13 months, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX (exact dose, route of administration, lot number and expiration date were not reported). On an unknown date in 2008, at the age of 9 years and 2 months, the patient was vaccinated with the second dose of (Oka/Merck) VARIVAX (exact dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. At the time of the report, the patient had an active case of shingles on her face that started on an unknown date. The outcome of the event was reported as not recovered. The relatedness between the event and the (Oka/Merck) VARIVAX was not reported. Additional information has been requested.
Confusion, Headache, Myalgia,  fatigue, chills Narrative:  Felt "loopy" with sharp vision initially. Over 3 day period developed varying degrees of chills, headache, muscle aches. Fatigue on first day.
Sore shoulder started after a couple of hours and was moderate by evening. A general unusual feeling started within a couple hours of the shot.  By 7pm I started to experience chills and joint fatigue in legs (knees, toes).  Chills became severe and a low grade fever of 100.6 developed.  Chills lasted about 1.5hrs.  Fever broke overnight. By morning all previous issues were resolved and the only issue was a problem with equilibrium and balance (and sore shoulder)  It was a general feeling similar to drunkenness.  This issue persisted throughout the day and by evening I was experiencing mild vertigo when I closed my eyes. I went to bed feeling somewhat improved relative to all the symptoms but woke having experienced a cold sweat. My shirt was completely soaked. I noted several less significant sweating issues throughout this day with no other side effects. This was the final day with notable symptoms. At the time of this report I have minor shoulder pain as the only symptom that persisted throughout. The equilibrium symptoms were severe enough that I missed a day of work.
Pt received flublok on 10/15 at store and called pharmacy today (10/16) saying her arm is pretty tender and there?s a huge red spot where she got the shot and was concerned enough to call. I told her injection site reaction and tenderness is normal and to wait a few days to see if the redness and tenderness goes away. If it gets worse, contact doctor.
Patient was administered second dose of primary series Pfizer vaccine undiluted. Attempted to contact patient's parent multiple times to inform and to advise to monitor for potential local and systemic adverse reactions; no answer and unable to leave message because voicemail box was full.
9/26/14 - Immediately after vaccine, heavy discomfort on (L) deltoid area. 9/27/14 - Red/hot, swollen - 3" x 6" raised area took BENADRYL 50 mg and TYLENOL. 9/28/14 -Still sore, hot, swollen - 2" x 2" area. Pain less.
Stomach ache; Body ache; Severe Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach ache), PAIN (Body ache), HEADACHE (Severe Headache) and FATIGUE (Fatigue) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 03-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 ABDOMINAL PAIN UPPER (Stomach ache), PAIN (Body ache), HEADACHE (Severe Headache) and FATIGUE (Fatigue). At the time of the report, ABDOMINAL PAIN UPPER (Stomach ache), PAIN (Body ache), HEADACHE (Severe Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.