chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered improperly stored VARIVAX; no additional AE; This spontaneous report was received from a consumer and refers to her son, currently a 1-year-old, male patient. His medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not provided.  On an unknown date, the patient was vaccinated with improperly stored first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, strength, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (product storage error).   The nurse informed the patient's mother, that revaccination (repeating the 1st dose) would be needed on an unknown, future date, due to the affected, administered vaccine being stored incorrectly in refrigerator instead of within the freezer. No additional adverse event (AE) occurred (no adverse event). The reporter requested product prescribing information. An unsuccessful attempt was made to collect additional information; the reporter had refused to provide additional information when prompted. She did not wish for physician or her to be contacted in the future regarding the event. The patient's mother was referred to Healthcare Provider's clinical judgement/discretion.
Information has been received from a registered nurse (RN) through a Merck pregnancy registry concerning a 13 year old female with attention deficit/hyperactivity disorder and no known drug allergies and a history of being a rape victim who on 15-OCT-2007 was vaccinated intramuscularly in the right deltoid with a first 0.5 ml dose of GARDASIL vaccine (yeast) (Lot #655849/0263U). On the same day the patient also received concomitant vaccinations of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA), hepatitis A virus vaccine (manufacturer unknown) and influenza virus vaccine (unspecified). The patient was in her menstrual cycle at the time of vaccination. On 15-JUN-2008 the patient had a normal live birth, female child. Unspecified medical was sought. Additional information has been requested.
PT CALLED STATING LUMP ,BRUISING ON LEFT INNER THIGH. PT NOTICED BRUISING HAS BEEN INCREASING. WE RECOMMENDED TO GO TO ER OR CONVENIENT CARE TO EVALUATE .
I don't know if it's related to vaccination or not, but I got an earache in left ear 3-days after vaccination.  Ear and Face were swollen, warm to touch, painful and could not hear.  I am still having difficulty hearing in that ear (3-25-2021), sounds like liquid in that ear.  I called a tele doc service on Sunday, 02/14/2021, they prescribed Amoxicillin -Clav.  Temperature and swelling went away, still having difficulty hearing in that ear.
No adverse effects; a patient received a vaccine following a temperature excursion; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information on patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.      On 25-OCT-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, dose, route of administration and anatomical location were not provided) following a temperature excursion, for prophylaxis. The vaccine underwent excursion with the lowest temperature below 36 Fahrenheit degrees/ 2 Celsius degrees (35F) in a time frame 430 minutes. There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported.
This non-serious initial spontaneous case, was received from other health professional (pharmacist) on 05-Oct-2017, concerning a 54-year-old adult female patient. The patient historical condition included stroke (unspecified date). The patient's current conditions included hypertension, hyperlipidemia, migraine, sleep apnea, depression, asthma, lupus and egg allergy (since an unspecified date). The patient concomitant medications included atorvastatin, clopidogrel, hydroxychloroquine, mycophenolate, pantoprazole and eye drops: brimonidine, dorzolamide, latanoprost for an unknown indication. It was reported that, the patient was already hospitalized for his different unspecified conditions. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration, batch number, expiry date and anatomical location: not reported). On the same day, at 19:30 hrs, after 1 hour of vaccination, the patient experienced hives on face, back and lot of itching. The patient was treated with diphenhydramine. On 05-Oct-2017, at 17:00 hrs, the patient was recovered from the events. The reporter assessed the events as non-serious.
Patient was given a high dose flu vaccine when he should have had regular dose flu due to age.  No adverse reactions or outcomes at this time.
pain in the back of my neck; chills; pain in the arm; headache; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain in the back of my neck), CHILLS (chills), VACCINATION SITE PAIN (pain in the arm), HEADACHE (headache) and NAUSEA (nauseated) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021 at 9:00 PM, the patient experienced NECK PAIN (pain in the back of my neck), CHILLS (chills), VACCINATION SITE PAIN (pain in the arm), HEADACHE (headache) and NAUSEA (nauseated). At the time of the report, NECK PAIN (pain in the back of my neck), CHILLS (chills), VACCINATION SITE PAIN (pain in the arm), HEADACHE (headache) and NAUSEA (nauseated) had resolved.            It was reported that all the symptoms lasted for about 4 to 5 hours.  Advil were reported as a treatment medication used for unspecified/unknown indication. Concomitant information were included diabetes medication, asthma medication, cholesterol medication,  blood pressure medication.   This case was linked to MOD-2021-379422, MOD-2021-379419 (Patient Link).
11 days later began with itchy elbows, 12th day woke up with rash on knees, feet, hands, elbows, difficulty breathing, 13 day hives on butt and upper thighs and difficulty breathing- required hospital visit, benadryl & 10 day steroid course- 5 days prednisonse, then 5 days tapered dose of prednisone, fexofenadine, benadryl, prevacid
Caregiver had the J&J Vaccine on 3/19/2021 and tested positive for COVID at the county health dept on 4/7/2021 and notified the office.
positive test for COVID-19; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (positive test for COVID-19) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 immunisation.     Concomitant products included ESTRADIOL (ESTROGEN), CITALOPRAM, MONTELUKAST SODIUM (SINGULAIR), SALBUTAMOL (ALBUTEROL HFA) and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced COVID-19 (positive test for COVID-19). At the time of the report, COVID-19 (positive test for COVID-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.; Sender's Comments: Based on reporter's causality the event is assessed as unlikely related to mRNA-1273.
Menactra site, given 2 days ago on 06/7/05, 5 1/2 inches wide - 10 inches long at left arm, red/heat/swelling/pain.
Eight days after the initial injection, I experienced itchiness of the upper left arm/area of injection. On the ninth day, I awoke to the injection site being swollen, hardened, itchy, with a red rash about 3 inches in diameter with lighter/skin color center. The area hurt to use it. I called my primary physician that morning. She thought it was odd to be an allergic reaction 8-9 days from the initial injection. She was concerned about a skin infection and prescribed an antibiotic and advised me to take Benadryl 25-50 mg every 4 hours. The antibiotic was twice a day for 5 days. I also applied hydrocortisone cream to the area. After 2 doses of the antibiotic and 50 mg of Benadryl the evening of 02/10/2021, the next day (day 10) the swelling was nearly gone and the injection site was not hardened. The redness faded, but doubled in size (almost like an armband). The itchiness also continued. As of today 02/16/2021, the only symptom that remains is the redness. I discontinued the Benadryl on Monday, 02/15/2021. I am still applying the hydrocortisone cream twice a day to hopefully diminish the redness.
diarrhea; achy; Tired; sore shot arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore shot arms), DIARRHOEA (diarrhea), MYALGIA (achy) and FATIGUE (Tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Diverticulitis (three one feet sections of his intestines removed and wore an ostomy bag for one and one-half years), Heart attack in 2015, Hartmann's pouch procedure in 2016 and Arterial stent insertion. Concurrent medical conditions included Type 2 diabetes mellitus.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore shot arms), MYALGIA (achy) and FATIGUE (Tired). On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, PAIN IN EXTREMITY (sore shot arms), DIARRHOEA (diarrhea), MYALGIA (achy) and FATIGUE (Tired) outcome was unknown.            The patient had sensitive stomach and got diarrhea from eating too much beef, fish, dairy products. His diarrhea has been yellow and smelly and severe. Concomitant medications were not provided. Treatment information was not reported.    This case was linked to MOD-2021-043706.
STEMI (heart attack) - Patient had some dyspnea on exertion for several weeks and then developed chest pain around 10/25/21 - the chest pain became severe on 11/5/21 so he went to the local Hospital ER and was diagnosed with STEMI (heart attack) - he was life-flighted to alternate Hospital and had cardiac catheterization and a drug-eluting stent was placed in his left anterior descending coronary artery (all on 11/5/21)
This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (Shingles), INFLAMMATION (Internal inflammation) and VACCINATION SITE PAIN (pain on Left side/The side that had the shot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (    No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Specific product reported as yes, specific product known from provided information.  Concurrent medical conditions included Dust allergy, Allergy to animals and Diabetic. Concomitant products included APIXABAN (ELIQUIS), DILTIAZEM and METFORMIN for an unknown indication.       mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient stated that shortly after her first vaccine she started getting pain on her left side. The side that had the shot and it was diagnosed as Shingles but with no redness and blisters, later It moved to the right side and was going for physical therapy to get rid of it.
The patient presented to the pharmacy with a red swollen rash that extended from her shoulder to elbow on the outer arm. She said it was warm and itchy.
Pt came in today at clinic and was given H1N1 vacc. Dose given was 0.25 ml. Called Imm. Program-stated to have the child come back today for another dose of H1N1 0.25 ml. Dr. called parents to bring child back into office.
Client is only 10,  Moderna formulation for persons over 12 years of age was given to her for her 2nd dose.
At 10:12am client received the Janssen COVID-19 vaccine and at 10:14am client the stood up and walked to the front of table waiting for his vaccination card. His eyes then rolled to the back and he fell backwards on the floor hitting his head. Onsite MD was called out to the floor for triaging. Client stated he did not have anything yo eat or drin today. Client was put in a wheelchair, paramedic arrived at 10:30am and client refused to go to the hospital. Client mother was present with him today and she drove client home.
Dizziness, Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Pain/Redness/Swelling/Itching @ injection site, Sore Throat Narrative:  Other Relevant History:
Pfizer booster given 1/31/22 was given 4 months early.
Hives shortly after receiving DTaP, IPV, MMR. Increased pulse 160 and respiratory rate increased. Pulse oximetry 96%. Called ER; gave Epipen and transported to ER via ambulance.
Received a fever and Heart palpitations checked my inr before shot 3.5 checked day of the day of heart palpitations 1.8 inr.  The palpitations lasted about 2 days every few hrs or so I would receive them with breath being taken away.
Patient reported:  Difficulty breathing; Swelling of your face and throat after 3rd dose.  Patient had called in (10.26.2021)  with facial swelling, throat swelling and difficulty breathing at 1041 this morning after receiving third dose of Pfizer SARS-COV-2 vaccine (10.20.21).
This literature case, initially received on 26-Mar-2018, was reported by other health professional, concerning a 32-year-old, adult, male patient. The patient's current condition included recurrent idiopathic pericarditis and persistent hypotension (since unspecified dates). It was reported that, the patient was admitted in hospital with persistent hypotension. During hospitalization, the patient was examined and examination revealed elevated ACTH (Adrenocorticotropic hormone), low DHEA-S, positive ACTH stimulation test and positive 21-hydroxylase antibody consistent with autoimmune Addison disease. The patient's therapy included hydrocortisone, 20 mg in the morning and 5 mg at night as well as fludrocortisone 0.05 mg daily. The patient was counseled on the use of emergency dexamethasone injection pens. One month after discharge, patient had normal sodium and potassium levels and a renin level of 3.0 ng/mL/h. On an unspecified date, the patient was administered with INN flu vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported) and non-company suspect products- Tdap and pneumococcal vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). Six hours after immunization, the patient developed fever, myalgia, abdominal pain and vomiting that prevented intake of oral steroids. In the emergency department, vital signs revealed fever of 39.5 degree Celsius and hypotension of 88/54 (results not reported) with hyponatraemia and hyperkalaemia. Upon admission to the intensive care unit for adrenal crisis, he received 4 l of normal saline and stress-dose IV (intravenous) hydrocortisone for 24 hours. The patient's gastrointestinal symptoms quickly resolved after steroid administration and his sodium and potassium normalized. Patient was discharged home with steroid regimen and was instructed to triple his home steroid regimen with any future vaccinations. The patient had recovered from the events (abdominal pain, vomiting, hypotension, hyponatraemia and hyperkalaemia). Outcome of the other events adrenal crisis, fever, myalgia and hypotension was not reported. The reporter assessed this case as serious due to hospitalization. The reporter assessed the causality between events and suspect vaccine as related, as the vaccine can cause gastrointestinal symptoms in adult at a incidence of 6.5 percent and also the patient developed febrile illness with vomiting after receiving all the three vaccines (influenza, Tdap and pneumococcal vaccine) at once which resulted in adrenal crisis.
Information has been receive from a licensed practical nurse concerning a 60-70 yea old male who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 654977/088F). Subsequently, last week the pt developed redness, swelling and pain in the injection are. The pt was treated with Benadryl. It was reported that the adverse event lasted 2-3 days. The reporter considered redness, swelling and pain in the injection arm to be disabling. Additional information has been requested.
Rash - Information has been received from a licened practical nurse concerning a 12 month old female who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generaton on 01 Nov 2000.  On 13 Nov 2000.  the patient experienced a rash and sought unspecified medical attention.  The licensed practical nurse stated that the patient had no fever and no other symptoms.  Additional information has been requested.
dry eyes; Could not open eyes right away after waking up; A spontaneous report was received from a consumer, concerning a 67-year-old, female patient who experienced  dry eyes and could not open eyes right away after waking up/ ocular discomfort.  The patient's medical history includes Sjogren's syndrome,. Concomitant medications included pilocarpine and artificial tears ophthalmic drops.  On 11 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection.   On 11 Feb 2021, same day of receiving the vaccine, the patient experienced symptoms of dry eyes and could not open eyes right away after waking up. She had Sjogren's syndrome.  Treatment included artificial tears ophthalmic drops.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, dry eye and ocular discomfort were unknown.; Reporter'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
gets flu shot every year & usually gets the flu; it didn't work because it was a different strain than they thought; Initial information received on 11-Nov-2023 regarding an unsolicited valid Social Media serious case received via consumer.  This case involves an unknown age female patient and the reporter stated gets flu shot every year & usually gets the flu and it didn't work because it was a different strain than they thought after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, expiry date, form, lot number: unknown) via unknown route in unknown administration site for Prophylactic Vaccination (immunization). Information on batch number was requested.  On an unknown date the patient had events of gets flu shot every year & usually gets the flu (influenza) and it didn't work because it was a different strain than they thought (vaccination failure) (unknown latency) following the administration of influenza vaccine.  Reportedly, Patient gets flu shot every year & usually gets the flu. Shes been told that it didn't work because it was a different strain than they thought. The whole thing seems to be a krap shoot, for her anyway  It was unknown if any lab data/test results available.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Unknown for the events.  Seriousness criteria: event of  it didn't work because it was a different strain than they thought was assessed as medically significant; Sender's Comments: Sanofi company comment dated 20-Nov-2023: This case involves an unknown age female patient and the reporter stated gets flu shot every year & usually gets the flu and it didn't work because it was a different strain than they thought after receiving influenza vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
All symptom onset 19 hours after injection administration. L arm hot, swollen, whelps. These symptoms resolved 5 days after symptom onset.  Developed what feels like swollen lymph node x 1 that persists but may be slightly smaller. Daily fatigue has persisted.
The patient is a 56y.o. female with history of recurrent nephrolithiasis She has had lithotripsy, percutaneous treatment, open removal, stent placements in past. She is presented to the emergency department complaining of right-sided flank pain. Patient was diagnosed with a 4 mm obstructing calculi on Tuesday. She was seen by urology (Dr.) on subsequent Wednesday and has been doing okay. She states that morning of admission she developed further pain in her right lower quadrant, fullness and hematuria. She did call the urologist office who recommended she come to the emergency department. Denied fevers, chills,chest pain, shortness of breath, dysuria, nausea, vomiting. Her last lithotripsy was in February and she has been monitoring her stones with urology. She was instructed to be on hiprex for the last ten days and has been taking. She also took a flomax today. Denied any fevers, chills, chest pain, recent sick contacts, or any other issues.    In the ED she was afebrile without leukocytosis, VSS. She had a CTAP that showed Distal right ureteral calculus measuring 5 mm with resultant mild right hydroureteronephrosis. Nonobstructing left renal calculi. UA significant for 3+ blood, 3+ leukocytes, 2-4 RBC, 21-50 WBC, negative epithelial cells, 1+ bacteria. Urology was consulted as well as ID. Patient had a cystoscopy with right retrograde pyelogram with intra-operative interpretation by surgeon and right stent and basket, ureteroscopy done on 12/7. She was stable for discharge from urology after procedure and was doing well. She was discharged with short course of antibiotics - cipro, pain releif, symptomatic relief or urinary symptoms and will continue flomax and also follow up in office with urology in 1-2 weeks. She had a COVID test done prior to OR and it was noted to be positive. Patient has no symptoms of COVID, saturating well on RA, no respiratory symptoms, she is fully vaccinated and even got her booster over a month ago. She will have a repeat PCR test outpatient to see if this is accurate or false positive.
Pt experienced anaphylaxis type rxn on 9/8/14 including difficulty breathing and reported throat swelling which was relieved by administration of epinephrine.
I went to the ER on 05/14/2021 because I had swelling in one ankle. I am pregnant so I was concerned. I was tested and a Deep Vein Thrombosis in my right leg. The swelling was in my left leg. There is no redness or swelling in that leg. I am taking subcutaneous injection of Lovenox 0.8 ml twice daily.  I was 27 weeks pregnant at the time.  I am currently experiencing injection site pain and I am seeing a maternal Fetal Medicine Specialist monthly. A birth plan has to made for when I deliver because of the medication.  The diagnosis states Right Popliteal and Proximal  calf DVT.  Due-Date-08-09-2021 Pregnancy-First Pregnancy