chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling in checks/Swelling at the top of the forehead/Puffy cheeks; Lips swelling/Lips are puffy; Sleepy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIP SWELLING (Lips swelling/Lips are puffy), SWELLING FACE (Swelling in checks/Swelling at the top of the forehead/Puffy cheeks) and SOMNOLENCE (Sleepy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included FAMOTIDINE for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced SOMNOLENCE (Sleepy). On 20-Jan-2021, the patient experienced LIP SWELLING (Lips swelling/Lips are puffy). On 28-Jan-2021, the patient experienced SWELLING FACE (Swelling in checks/Swelling at the top of the forehead/Puffy cheeks). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, LIP SWELLING (Lips swelling/Lips are puffy), SWELLING FACE (Swelling in checks/Swelling at the top of the forehead/Puffy cheeks) and SOMNOLENCE (Sleepy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
It started on day one with sinus, sneezing, red eyes, watering eyes, runny nose. I had a fever, sore throat. I could barely talk, cough, headache, chest congestion, head cold, shortness of breath, sinus pressure in my head. I also had body aches and joint pains. I had a viral infection about a week before. I then got in touch with an on-call provider via telehealth on 01/06/2022 and they prescribed PAXLOVID for treatment.
Fever, chills, body aches for 10 hours, headache, tiredness, swelling of lips/gums/fingers/toes for 3 hours, mild nausea
One hour after receiving injection nausea, weakness and vomiting x 2.  Went home and vomited x 1.  On 11/19/2009 still nauseated, has abdominal pain, weak.  Telephone consult with Dr.'s office says observe and keep hydrated.  Stomach flu is going around per M.D.'s office so not sure if it's from injection or community acquired.
Report A0369042A describes warm inject site in a 27 y.o. female vaccine who received Hep B vaccine recombinant (Engerix-B). This report was received from a PT and has not been verified by a physician or other health care professional. The vaccinee had no concurrent medical conditions and was taking no concurrent medications. She had no adverse experiences following receipt of prior immunizations. On 5/13/02,the vaccinee received an injection of Engerix-B. On the same date, post immunization, the vaccinee experienced an elevated temp. reported to have been "104". On 5/14/02, the inject site was reportedly red, warm, tender, and swollen. Treatment was not provided. The most recent info. provided on 5/16/02, reports the outcome to be unresolved.
inc temp of 106 per mom hx;taken to Er w/104 documented temp;febrile sz documented;
pt recvd vax & exp muscle spasms in neck & shoulder @ 2PM;  t102 ax; lt leg swollen-crying for several hrs;
Adult vaccine was given to this 9 year old in the amount of 0.2ml which is double the 5-11 year dose There were no adverse events
No additional adverse events.; Medical Assistant reports on 5/5/2020 an improperly stored VARIVAX was administered to a patient.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 05-MAY-2020, the patient was administered an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S025913, expiration date 20-AUG-2021, strength, dose and route were unknown) for prophylaxis. The Merck sterile diluent that was used to reconstitute the vaccine was properly stored.  Administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) was stored at -14 degree Celsius to -10 degree Celsius (-11.2 degree Celsius) for 9 hours and 58 minutes; -9 degree Celsius to 8 degree Celsius (3 degree Celsius) for 13 hours and 35 minutes. There was no previous temperature excursion reported. No additional adverse events.
Spleen infarct; A spontaneous report was received from a physician concerning a 63-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced spleen infarct/splenic infarction.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number: unspecified) on first week of January.    On 01-Feb-2021, approximately twenty-two days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: unspecified) via an unknown route for prophylaxis of COVID-19 infection.  On 23-Feb- 2021, the patient developed spleen infarct and was hospitalized for 2 days. While in the hospital, the patient had a computerized tomography (CT) scan which showed no malignancy. The patient also had a lupus anticoagulation test which showed a mild elevation.   Treatment for the event included Synthroid (not specified)  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The event, spleen infarct, was considered recovered on an unspecified date.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
This spontaneous report was received from Medical Assistant referring to an unknown number of patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. It was reported that, on unknown dates, the patients were vaccinated with improperly storage doses of GARDASIL for prophylaxis, lot # K016966 with expiration date of 12-MAY-2017 (dose, route and frequency were not reported). No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 34.9 degrees Fahrenheit (F) for 4 hours. No previous temperature excursion was reported. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. Additional information has been requested.
Information has been received from a female RN consumer who in 1999 was vaccinated with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The consumer reported that she had a recent titer that did not show that she had developed seroconversion to the mumps portion of the vaccine. Unspecified medical attention was sought and no treatment was required. No product quality complaint was involved. Additional information has been requested.
Symptoms of malaise, chills, fever, headache, and body aches and lose of appetite started about eleven and one-half hours after 2nd injection. Treatment Tylenol and Benadryl.
6/11/23 I had my blood pressure taken and it showed high blood pressure. I am not sure for how long this had been going on. On 6/12/23 , I went to Urgent Care and my blood pressure was high. I was told to change my lifestyle and monitor my blood pressure. I will make a return appointment next week.
Since receiving Pediarix, Hib and Prevnar this morning patient has been very fussy, crying constantly. No fever. No other symptoms. Mother has given her tylenol. On examination, color is good, well perfused, normally responsive and fussy when awake.
The patient called the pharmacy on 12/08/2017 to describe reactions they believed to be from the vaccine they received 11/03/2017. The patient stated they experienced significant weakness, fatigue (particularly in the legs), and confusion/memory impairment for 3 to 4 days beginning approximately 24 hours after vaccination. The patient stated on the second or third day after the vaccination both eyes were swollen shut, which resolved 2 to 3 days after that with application of ice to the area. The patient also stated they felt like they had indigestion/heartburn and they were afraid to eat, beginning a day or two after vaccination. The patient did not have to have a Dr visit, ER visit, or hospitalization as a result of these suspected adverse events. The patient stated that all adverse events were resolved within one week, with the exception of still feeling more tired than usual at the time of reporting these adverse events.
Initial report received on 18 June 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 12-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; received on 28 June 2011, 30 August 2011 and 18 November 2011 (lot numbers, routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 01 May 2012, approximately five months after the last dose. On 15 May 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 03 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 05 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 36 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Discomfort in various parts of upper body on exposure to cold, taking off clothes, sitting down on a cold chair, drying with a towel after a shower, touching skin, lasting for just a second
Information has been received from a medical assistant concerning a male who on 27-APR-2004 and 22-MAY-2008 was vaccinated with his first and second dose of VARIVAX (Merck) respectively.  Subsequently the patient was diagnosed with chickenpox on an unspecified date.  The patient had sought medical attention via office visit.  Additional information has been requested.
Information has been received from a registered nurse concerning a 19 week old infant who was vaccinated on 10-Oct-2006 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown demographics. No patients' concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with improperly stored doses of VAQTA 50/1.0 U/ml injection (lot #, expiry date, dose, route and site of administration were unspecified). The administered vaccine underwent the temperature excursion at 34.5 degrees Fahrenheit for 15 minutes. There was no previous temperature excursion. It was not the case of a "data logger". No concomitant medications were reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 01-DEC-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L028666; expiry date 04-NOV-2016, (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
pt recvd vax & noticed immed rxn of erythema @ site of inj radiating to shoulder, pt c/o pins & needles, shakiness & anxiety;gave Epi;pt c/o dizziness, numbness of extremities, clamminess;c/o tightness of throat & SOB
This spontaneous report was received from a patient of unknown age and gender referring on her/himself. Medical history and concurrent conditions were not reported. On 06-APR-2015, the patient was vaccinated with a dose of ZOSTAVAX. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. On 07-APR-2015, the patient experienced injection site swelling, injection site pain and injection site erythema, reported as redness, swelling and soreness at injection site. The outcome of injection site swelling, injection site pain and injection site erythema was unknown. The causality was not reported. Additional information has been requested.
Initial report received from a healthcare professional on 23 September 2013. A 55-year-old female had received an intramuscular dose of FLUZONE vaccine (lot number: UH888A, dose number not reported) in the left deltoid on 22 September 2013. The patient had medical history of immune system problems, PCN allergy and no acute illness at the time of vaccination. On 22 September 2013 about 1 hour post vaccination, the patient had complained of metallic taste in her mouth. Laboratory investigations and corrective medications were not reported. At the time of this report, the outcome was unknown. Documents held by sender: None. Additional information received on 02-Dec-2013: reported that physician didn't use FLUZONE.
Rolled over the following morning and experienced vertigo, which caused me to projectile vomit. A week later, I fell on my head. The hospital did a complete workup and all of the tests were negative. The vertigo got progressively worse to where I couldn't function. I couldn't drive, turn my head, roll over or reach. I pretty much vomited every time I moved and I had to be careful that I didn't trip or lose my balance. I had a few visits with my PCP and was given nausea meds. I then saw a physical therapist and was taught Espley maneuvers to correct the vertigo. I went to PT for about 4 or 5 weeks. I had a few episodes afterwards, but I just did the exercises and took care of it at home.
Pt said morning of 12/15 her eyes were swollen shut, PT has been taking Benadryl everyday. As of 1/4/2022 they are flaking because of the swelling
Patient had LLE swelling and pain, went to see PV provider the next day who recommended pt go to ER.  Pt was diagnosed with nonocclusive SVT in the L short saphenous vein via ultrasound.  Good prognosis, no CP or SOB.
Gave 0.5ml third full dose instead of half shot booster.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.). On 02-Nov-2021, ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported No treatment medication were reported   This case was linked to MOD-2021-374517 (Patient Link).
12/21/09 Notified by spouse that patient had reaction to Raster vaccine. Call to patient. Admitted to swelling, blister, pain at injection site 2 days later with red streak down arm-3". Did not see physician "It went away in a couple days."
popped blood vessel in the eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (popped blood vessel in the eye) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE SWELLING (popped blood vessel in the eye). At the time of the report, EYE SWELLING (popped blood vessel in the eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment details were provided.   Reporter did not allow further contact
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 23-JUL-2015, the patient was vaccinated with an improperly stored dose of VAQTA 25U/0.5 ml injection (lot # K005323, expiry date 10-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified), lasting for 48 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degree Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Per patient this is is due to TDAP vaccine on the right shoulder; eventhough we gave her Flu vaccine on the right shoulder. Since the vaccine patient cannot move the arm up or backward without a pulling pain.
Pt recvd 2 doses of Hep B vax on 16OCT91 & 20NOV91 & following 2nd dose exp serum sickness;
1st VZV in 1998, 2nd VZV 02/25/2015. Pt called on 02/26/2015 c/o upper arm swollen at injection site. Also red & warm to the touch with itchy sensation. No s.o.b. or tightness to chest or swelling of tongue or lips. Tx advise cold packs to site, to reduce swelling & redness. Watch for additional swelling redness if increases or rash & itching increases seek help from PCP or ER since she has a severe allergy to Benadryl. May require additional intervention.
Before vaccine, was suffering from health problems. Starting 2/18/21 (day after first Moderna vaccine) - defibrillator went off, went to hospital and was sent home. then 2/19 the defibrillator went off again at home, stayed at hospital for a couple days, 4 days after arrived home got another defibrillator shock - back to hospital, was treated for hypoxia. Patient was on hospice 2.5 months and then passed 5/20/21.
I got a call from the pharmacy saying 1st dose we got may have been expired.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I got a call from the pharmacy saying 1st dose we got may have been expired.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (I got a call from the pharmacy saying 1st dose we got may have been expired.). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (I got a call from the pharmacy saying 1st dose we got may have been expired.) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Patient states that she and her husband received both doses of the Moderna Covid-19 vaccine. Reports she received got a call from the pharmacy saying that their 1st dose may have come from an expired vaccine. She was asked to return for a 3rd dose and it would be treated like the1st dose. Patient don't know if it is right to get another dose. Concomitant product use was not provided by the reporter.   Treatment information was not provided   This case was linked to MOD-2021-232805 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Aug-2021: Follow-up received contains non-significant information
I feel like my left ear is plugged.  I don't feel any pressure, like when you are on an airplane and you ears need to pop but I can't completely hear out of that ear.
Starting on the second day after vaccine I started to get itchy, first my arms and back and eventually all over. On the third day I started to see pumps on my itchy skin.  I started to take benadryl 25mg on the 26th and 27th. Doubled the dose to 50mg at night time for 5 days. Took medicated baths and Sarna cream, along with benadryl  cream.  The symptoms started to subside. I took only benadryl 25mg on January 2nd and 3rd. Now  I am still somewhat itchy but only using topical creams. I do have seasonal eczema and dry and itchy skin in the winter but this was definitely something more than my winter symptoms.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: ER8735), in left arm, on 26Apr2021 as dose 2, single (Lot number: EW0169), in left arm and on 09Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bipolar Disorder" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "lactose intolerant" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE, start date: 01Aug2020; HYDROCHLOROTHIAZIDE;LISINOPRIL, start date: 01Feb2022; BENZONATATE, start date: 31Jul2022; ALBUTEROL SULFATE, start date: 31Jul2022. Past drug history included: Cozart, reaction(s): "Known allergies: Cozart". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: The patient has received other medication in 2 weeks include Congestion & Cough Tablets started on 31Jul2022. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot ER8735 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. Analytical release test results were also reviewed. The final scope included the reported finished goods lot ER8735, fill lot EP8687, and the formulated drug product lot EP8574. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There was no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.