chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via sales rep and described the occurrence of fever in a 22-year-old male patient who received BEXSERO (batch number 1514101A, expiry date unknown) for prophylaxis. On 28th July 2016, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On an unknown date, unknown after receiving BEXSERO, the patient experienced fever, lethargy, diarrhea, myalgia, chills and back pain. The patient was treated with MOTRIN and TYLENOL. BEXSERO was discontinued. On an unknown date, the outcome of the fever, lethargy, diarrhea, myalgia, chills and back pain were recovered/resolved. It was unknown if the reporter considered the fever, lethargy, diarrhea, myalgia, chills and back pain to be related to BEXSERO. Additional details were provided as follows: The patient refused to received 2nd dose due side effects of 1st dose. This case has been linked with case US2018117629, reported by same reporter.
I revived the Tdap vaccines and immediately developed significant pain at injection site. About 15 minutes later I developed redness, swelling, hives - all local to the affected arm. About 10 hours later developed low grade temps, chills, muscle aches. About 5 hours after the above symptoms developed vomiting.
Initial unsolicited report received from a health care professional (Nurse) on 13 October 2015. This case involves a 55 years old female patient whose was vaccinated with a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (ADACEL) (batch number, dose, dose number were unknown) via unspecified route in right deltoid and also received a dose of INFLUENZA QUADRIVAL A-B VACCINE (FLUZONE QIV) (batch number, dose, dose number were unknown) via unspecified route in left deltoid both vaccines on 9 October 2015. Patient's medical history includes penicillin allergy and rheumatoid arthritis and concomitant medications was not reported. It was reported that, on 10 October 2015 (1 day after vaccination), patient developed a large area of redness warm and itchiness with inflammation localized, localized itching and tender to touch. Lab data was reported as none and corrective treatment was not reported The outcome of the events were not recovered at the time of this report. List of documents held by sender: none.
Received TD for burn prophylaxis and by the weekend (4 days) noted tenderness and swelling on left deltoid. Evaluated by MD who noted erythema increasing by day 7. Treated with Keflex 500mg and referred to specialist).
severe chills, rash on arm, low back pain, shoulder pain, sick with flu like symptoms all day
Information has been received from a physician concerning a 16 year old female who on an unspecified date was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), injection (form). Concomitant medication was not reported. Subsequently on an unspecified date, the patient experienced local reaction at injection site where the area was "lumpy" for two weeks after receiving the HPV rL1 6 11 16 18 VLP vaccine (yeast). Unspecified medical attention was sought. Subsequently on an unspecified date, the patient recovered from local reaction at injection site where the area was "lumpy". No product quality complaint was involved. No further information is available.
Couldn't sleep; Burning up; Fever; Chills; Muscle pain; Headache; In so much pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep), BURNING SENSATION (Burning up), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle pain) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced INSOMNIA (Couldn't sleep), BURNING SENSATION (Burning up), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle pain), HEADACHE (Headache), PAIN (In so much pain) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. At the time of the report, INSOMNIA (Couldn't sleep), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle pain), HEADACHE (Headache), PAIN (In so much pain) and FATIGUE (Fatigue) had not resolved and BURNING SENSATION (Burning up) outcome was unknown.            No concomitant medications were reported.  Treatment medication also included cold compress.
12/23/20 0000AM constipated like symptoms started; 0200AM woke up to severe stomach discomfort with refluxing feelings with body chills; 0300AM had bouts (at least4) of violent vomiting with very thin, liquid greenish vomitus, vomiting lasted for about 20 minutes then followed by loose bowel movements consecutively (about 6 times) with very liquid, greenish stools; stomach discomfort somewhat subsided right after but body chills remain and joints and back started to ache. Noticed that exposure to cold air would trigger bowel movement. Was afebrile all this time until about 1100AM where it was recorded to be mildly febrile at 37.8, took some tylenol with gatorade after which mild fever seem to subside. For much of the day of 12/24/20, body aches continues with intermittent loose bowel (especially after eating or drinking anything)still averse to cold, took some tylenol again 6 hrs. later for the body aches mostly. 12/25/20 felt much better for most of the day then at 1100PM reflux symptoms and body aches started again but no vomiting this time, still afebrile. 12/26/20 at the time of this reporting, stomach still feels queasy and still having loose bowel and body aches. No other symptoms experienced except for the ones described above.
Fainted for 30 seconds after standing up and walking. Ambulance came to the house and recommended a trip to the ER where I received an IV.
A diffuse rash occurred beginning on April 11th, 2021 at about 7:30PM.  The rash consisted of raised red areas with vesicles. It extended from the top of my right thigh up my right side onto my back and right buttock. There was a separate area around my belly button. I called my dermatologist on April 15th, 2021 and sent him pictures of my rash. We will be doing a video appointment on April 16th, 2021 at 8:45 AM.  He contacted me by message through the patient portal and made his diagnosis of shingles. He prescribed  Valacyclovir 1gm dose to be taken 3 times daily for one week. I have no outcome to report as I will be starting the treatment  today.
Yeast infection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FUNGAL INFECTION (Yeast infection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FUNGAL INFECTION (Yeast infection). At the time of the report, FUNGAL INFECTION (Yeast infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided  No Treatment medications were provided
symptoms started 8:00 pm 12/16/20 as of 3:00 pm on 12/17/20 she still had symptoms, headache, body aches, chills shortness of breath and fatigue. 12/21/20 RN called patient  the symptoms have all resolved at this timel.
red, swollen, hot & sore rt deltoid-site approx 3" wide & 4 1/2" long;referred to MD;
Patient unable to move arm for 24 hours, patient complains of bruising on upper arm.
Headache, fatigue,  soreness at the injection site. Lasting at least 24 hours.
This spontaneous report as received from a 63 year old female patient refers to herself. The patient's medical history included shingles (outbreak was near her eyes) in 2009. On 30-JAN-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were not reported). On 30-JAN-2013, the patient was still experiencing burning in her eyes. No other symptoms were present. The patient sought medical attention via talking to doctor. There was no treatment given for AE. The outcome of burning sensation in eyes was reported as not recovered. Additional information is not expected, because the physician did not wish to be contacted.
Initial and follow up information has been received from a registered nurse and a physician concerning an 87 year old white retired male patient with a history of fatigue, dizziness and a penicillin allergy who on Nov 04 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot  649732/0513P). On Nov 05 2004 at 9:00 am the patient developed a severe injection site reaction with severe swelling, pain, redness and cellulitis. He was not hospitalized and is improving. It was reported that his edema, redness and soreness lasted for 4 days and the patient was fine. There was concern expressed regarding the lot. Additional information has been requested. the records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. It was reported that the patients wife had a similar experience (WAES0411USA01465).
Patient was given vaccine. she stood up and was talking with her sister. I gave the father his vaccine after and instructed the family to wait for 15 minutes. I returned to the pharmacy and a minute or 2 later the older sister came back stating her sister had fainted. When I arrived, the younger sister was sitting in a chair, sweating profusely and conscious. I got her a bottle of water and contacted management. Management contacted EMS who took the patient to the hospital for observation. Before returning to the pharmacy, dad had asked the daughter if she had breakfast, she said no.
Pain, swelling, redness of deltoid and "egg size" lump in axilla. Right arm.
Difficult breathing and severe stuffy nose. Called doctors office. Prescription for Astepro renewed. Started taking Astero and ventral in inhaler.
hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives). The patient was treated with PREDNISONE for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives) outcome was unknown.            Concomitant medications details were not reported by the reporter.
Chills-lasted 6 hours, headache-4 days, body aches-2 days, fatigue 2 days, low back pain- 1 day, hip pain-1 day, nausea-1 day.  I took Tylenol.
Pt. came in with fever of 102.1, and cough. Pt. is on zinc, vitamin C, pantoprazole, cefcriaxone, lisinopril, aspirin
Not feeling well all week after first vaccine; Unable to get warm with body temperature 94 and 95 degree; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well all week after first vaccine) and BODY TEMPERATURE ABNORMAL (Unable to get warm with body temperature 94 and 95 degree) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No medical history reported.  Concomitant products included LISINOPRIL, SIMVASTATIN, PANTOPRAZOLE and SALBUTAMOL SULFATE (PROAIR DIGIHALER) for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced MALAISE (Not feeling well all week after first vaccine) and BODY TEMPERATURE ABNORMAL (Unable to get warm with body temperature 94 and 95 degree). At the time of the report, MALAISE (Not feeling well all week after first vaccine) and BODY TEMPERATURE ABNORMAL (Unable to get warm with body temperature 94 and 95 degree) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Body temperature: 94-95 degree (Inconclusive) 94-95 degree.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up received on 18-May-2021 included updated outcome of events to recovered. Patient declined to further follow up.
Red circle around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red circle around injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was reported.     On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red circle around injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red circle around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.
Loss of taste and smell; Loss of taste and smell; Bad fever; This is a spontaneous report from a contactable consumer, the patient's wife.  A 26-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient took the vaccination on monday and was still having a bad fever and lost his sense of taste and smell on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Papular rash on both Legs, no fever, no pain, non itchy, no abdominal pain.
CLIENT RECEIVED PEDIATRIC DOSAGE OF  HEP B (ENGERIX-B) INSTEAD OF RECEIVING ADULT DOSAGE OF HEP B (ENGERIX-B) CLIENT HAD NO ADVERSE EFFECTS/REACTIONS.
WOKE UP AT 3 AM WITH FEVER AND CHILLS AND TAKEN TYLENOL AT 4 AM. WENT TO WORK FELT FEVERISH AND TIRED. DAY 3 SYMPTOMS IMPROVED.
Reports having LEFT arm soreness on first dose. On the 2nd dose chills, weakness, lack of focus, nausea,poor appetite, soreness and "knot" on left arm, blister on the mouth. Narrative:
Information has been received from a health professional concerning a 5 year old female who on 9/25/96 was vaccinated with 1 dose of varicella virus vaccine live (site unknown) (lot 617312/0768D). Subsequently, it was reported that on 6/12/01, the pt was dx'd with "a mild case of chicken pox". Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. The reporter also indicated that the pt was not given close to the expiration date and that vaccine lot numbers were not similar in the other cases reported. Subsequently, the pt recovered. No further information is available.
she does not have an appetite; she cannot eat/she gags whenever she tries to eat; Patient received her booster (3rd dose) of the Moderna Covid-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (she does not have an appetite), RETCHING (she cannot eat/she gags whenever she tries to eat) and EXTRA DOSE ADMINISTERED (Patient received her booster (3rd dose) of the Moderna Covid-19 Vaccine) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack (Patient disclosed  that she had a heart attack in the past so she was on a lot of medications.). Concomitant products included ATORVASTATIN, CARVEDILOL, MELATONIN, NITROFURANTOIN, ACETYLSALICYLIC ACID (ASPIRINE), TICAGRELOR (BRILINTA), SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO) and BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]) for an unknown indication.   On 16-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient received her booster (3rd dose) of the Moderna Covid-19 Vaccine). On 17-Aug-2021, the patient experienced DECREASED APPETITE (she does not have an appetite) and RETCHING (she cannot eat/she gags whenever she tries to eat). At the time of the report, DECREASED APPETITE (she does not have an appetite) and RETCHING (she cannot eat/she gags whenever she tries to eat) outcome was unknown and EXTRA DOSE ADMINISTERED (Patient received her booster (3rd dose) of the Moderna Covid-19 Vaccine) had resolved.            The treatment information was unknown.
Received 2nd dose less than 25 days after receiving 1st dose; Received 1st dose of Pfizer and 2nd dose of moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose less than 25 days after receiving 1st dose) and PRODUCT ADMINISTRATION ERROR (Received 1st dose of Pfizer and 2nd dose of moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose less than 25 days after receiving 1st dose) and PRODUCT ADMINISTRATION ERROR (Received 1st dose of Pfizer and 2nd dose of moderna vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose less than 25 days after receiving 1st dose) and PRODUCT ADMINISTRATION ERROR (Received 1st dose of Pfizer and 2nd dose of moderna vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Nurse reported that a patient received 1st dose of Pfizer vaccine on 23May2021 and 2nd dose of moderna vaccine on 6Jun2021 on his left arm and the patient had no any adverse effects. The lot number of the 2nd dose of moderna vaccine is "022C21A". She gave the consent for follow up by safety.   Reporter did not allow further contact
12 19 pm:patient feel light headed and feel will pass out.                                                                                                                12 20 pm: 110/70,pls at 65/min, Sat at 98% patient put flat on floor with leg elevate, notofied EMS, site provider, and site director 12 23 pm:106/70,pls 71/min. sat 98% room air; patient feel better. patient still flat on floor. 12 25 PM:client drank water and seat upright 12 26pm:125/91,pls at 86/min. Sat at 99% patient feel better 12 27 PM: patient stand up 12 35 PM: 109/71,pls at 92/min,97% pulse Ox. feel OK. and Patient stated that she had similar issues in the past with blood drawn and vaccines.( feeling light headed).  Patient discharge, Ambulated, accompagnied by friend, following the approval from medical provider
At about four weeks after my second (Moderna) Covid vaccine I started having dizziness and light-headedness on and off which has persisted. It causes balance issues which I have never had before. I am a retired Nurse Practitioner.
lung cancer diagnosis; This case was reported by a pharmacist via call center representative and described the occurrence of lung cancer in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 9YD45, expiry date 2nd February 2021) for prophylaxis.   On 25th June 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced lung cancer (serious criteria GSK medically significant). The patient was treated with chemotherapy,nos (Chemotherapy). On an unknown date, the outcome of the lung cancer was unknown.   It was unknown if the reporter considered the lung cancer to be related to Shingrix.  Additional case details were reported as follows: The patient did not receive the 2nd dose of Shingrix within 2 to 6 month window due to diagnosis of lung cancer and undergoing chemotherapy. The reported batch number has been updated from 9YB45 to 9YD45, as per sales data sheet.
Throat hurts, shortness of breath, turned purple, all swollen. Admitted @ hospital for children for 1 day. Rx for Epi-pen injection.  05/24/2007 MR received for o/n admit (5/11-12/2007) for c/o anaphylactic event 5 minutes after receiving vax.  Pt. had swelling of eyes, (+) difficulty breathing, sore throat. PE: Swollen eyelids. Facial swelling. Facial urticaria. Txd with Epi, Albuterol, Benadryl, and Solumedrol. Discharge DX: Anaphylaxis.
can't sleep; feeling shaky and cold and achy; feeling shaky and cold and achy; feeling shaky and cold and achy; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (can't sleep), NERVOUSNESS (feeling shaky and cold and achy), FEELING COLD (feeling shaky and cold and achy) and PAIN (feeling shaky and cold and achy) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not reported by the reporter.  Concomitant products included INSULIN for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced INSOMNIA (can't sleep), NERVOUSNESS (feeling shaky and cold and achy), FEELING COLD (feeling shaky and cold and achy) and PAIN (feeling shaky and cold and achy). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) for Adverse event, at a dose of 2 baby aspirin. At the time of the report, INSOMNIA (can't sleep), NERVOUSNESS (feeling shaky and cold and achy), FEELING COLD (feeling shaky and cold and achy) and PAIN (feeling shaky and cold and achy) outcome was unknown.
Evening of injection: Chills, Nausea, Diarrhea & fatigue. 2nd day vomiting & fatigue persists.
Vaccine MMR received on 11-16-2017. Fever started 11.26/2017, Rash started 11/27/17 got worse 11/28/2017-covering body erythema multiforme.