chrisvoncsefalvay/vaers-outcomes huggingface dataset:
positive for COVID; he had mild symptoms; breakthrough of COVID infection; This is a spontaneous report from a contactable consumer. This report is for caller's husband. This consumer (patient's wife) reported for patient (Reporter's husband) that a 67-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: EN6201, expiration date: 30Jun2021) via an unspecified route of administration, administered in arm right on 12Feb2021 as DOSE 2, 0.3 ML SINGLE for COVID-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: EL3302, expiration date: 31May2021) (Age at vaccination 67 years) via an unspecified route of administration, administered in arm right on 22Jan2021 as DOSE 1, 0.3 ML SINGLE for COVID-19 immunisation. The patient did not have medical history. No concomitant medications. On an unknown date, the patient experienced positive for COVID. On 05Jul2021, breakthrough of COVID infection and on an unknown date, he had mild symptoms. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 05Jul2021. It was reported that the reporter was calling to report that my husband and I both had two doses of my Pfizer COVID-19 vaccine. We both had a breakthrough of COVID infection while traveling to the UK. My husband had mild symptoms. I had no symptoms after the infection so the vaccine did it's job. I saw the doctor in UK and not in the US. I wanted to make sure it's reported in the United States. Caller and her husband both traveled to UK where they got COVID19 infection and they both had received both doses of COVID19 Vaccine. Husband said he had mild symptoms where as the wife said she had no symptoms at all after getting the infection. The caller was pleased that the vaccine worked with her not having symptoms and she just wanted to make sure it got documented because they got COVID19 infection when in the UK. It was reported that COVID19 infection: he was diagnosed on 05Jul2021. He quarantined for 10 days. Stop date would be 15Jul2021 and he recovered completely. Patient did not administered additional vaccine on same date of the Pfizer suspect. Patient was not visited to emergency room and physician office. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The clinical outcome of event breakthrough of COVID infection was recovered on 15Jul2021, while other events were unknown.  Follow-up attempts are completed. No further information was expected.
Strong muscular pain in the arm, almost mobile since the date of the second vaccine dose. It has been almost three weeks with an aching arm.
This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown, Expiration Date: 31Jul2021), via an unspecified route of administration, administered in left arm on 12Mar2021 at 10:00 (at the age of 86 years old) as first dose, single for COVID-19 immunization at a Senior Center. The patient has no medical history (including any illness at time of vaccination) and family medical history relevant to the adverse event. No adverse event prior to vaccination. The patient's concomitant medications were not reported.  On an unspecified date in Mar 2021, the patient started having problems where he would wake up at night and his right hand would be asleep and did not think anything of it since it had happened once in a while over the years. The patient further stated that he has had numbness in his fingers and the right hand only and then would have problems during the daytime where he would be sitting around and notice like the tip of his thumb, whole hand would go numb, or two fingers would go numb that would last several minutes up to 10 mins and then would slowly disappear. The patient also reported that this started getting worse a week in a half ago or 2 weeks. On an unspecified date in Apr 2021, his whole right arm was aching really bad and that lasted for about 15, 20, or 25 minutes and that continued to get worse but had has not happened during daytime. The night before the day of the report, the patient tried using a heating pad, tried sleeping in a chair, and tried to apply vibrations since it was so bad. The patient stated this started at 2 o'clock this morning and was still hurting at 6 o'clock and he thought he would have to go to the emergency room so he got up and showered and shaved and then all the symptoms disappeared. He was back to normal and it was getting pretty bad. The patient stated that his doctor did not think it could be with the vaccine. The patient was calling to see if these symptoms had been reported since he was worried about the extreme pain in his right arm that he had when the numbness happened. The events resulted to a physician office visit. Treatment was done in response to the events which included heating pad, tried sleeping in a chair, and tried to apply vibrations. Outcome of all events was not recovered. The patient received the second dose of BNT162B2 (lot number and expiration date: unknown), via an unspecified route of administration administered in left arm on 02Apr2021 at 10:00 as single dose for COVID-19 immunization. Information on the lot/batch numbers has been requested. Further information was expected.
Parent or Guardian  appeared to knowingly fill out a consent form with the incorrect year of birth and specifically wrote down the wrong age. Essentially it appears we were intentionally mislead about his age. Will not be giving second shot until patient turns 12.
Some lip and facial swelling noted by patient upon arising in morning 10/08/2009. Approximately 4pm on 10/08/2009 patient was taken by sister to local ER. Patient stated that the ER doctor informed them that he had a reaction to the lisinopril and the flu injection. Patient was told to stop lisinopril. In ER patient received prescription for Prednisone 10 mg tapering dose over 4 days and Benadryl 25 mg every 6 days. Patient followed up with primary care physician on 10/23/09 and lisinopril was restarted. All symptoms had resolved by 10/23/09 visit.
Heart rate 145 beats per min; Shortness of breath; Panic attack; Severe dehydration; Cannot quench thirst; Numb tongue and mouth; Fever of 104 F; Aches; Chills; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced heart rate 145 beats per min (bpm), fever of 104F, shortness of breath, panic attack, severe dehydration, cannot quench his thirst, numb tongue, numb mouth, aches and chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received a dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced a fever of 104 F, elevated heart rate of 145 bpm, severe dehydration, cannot quench his thirst, numb tongue and moth for 3 days and aches and chills for 3 days. He sought medical attention at his doctor's office. A urinalysis was completed which resulted normal. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events, heart rate 145 beats per min, fever of 104F, shortness of breath, panic attack, severe dehydration, cannot quench his thirst, numb tongue, numb mouth, aches and chills, were considered resolved on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
4cm red indurated warm patch, lt proximal humerus;rt atarax, declox;
Feeling nauseous with vomiting and diarrhea for 1 week. Passed out on the bathroom floor and son found him shaking and unresponsive.  Diagnosed with Syncope with Convulsions; COVID-19 Infection; Essential Hypertension and GERD
Fever for 18 hours (100.4), chills, nausea, vomiting, severe headache, and exhaustion.
loss of mobility; felt like someone punched me in the arm; Searing joint pain, feels like pain in joint, shoulder pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-May-2021 and was forwarded to Moderna on 04-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Searing joint pain, feels like pain in joint, shoulder pain), MOBILITY DECREASED (loss of mobility) and MYALGIA (felt like someone punched me in the arm) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced ARTHRALGIA (Searing joint pain, feels like pain in joint, shoulder pain). On an unknown date, the patient experienced MOBILITY DECREASED (loss of mobility) and MYALGIA (felt like someone punched me in the arm). At the time of the report, ARTHRALGIA (Searing joint pain, feels like pain in joint, shoulder pain), MOBILITY DECREASED (loss of mobility) and MYALGIA (felt like someone punched me in the arm) had not resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided. The action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-101918 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up received on 07-jun-2021 and no new information were provided On 20-Jun-2021: Follow-up received on 20-jun-2021 and No new information is provided.
p/1st DTP pt screamed & had involuntary flailing of arms & legs for @ least 2 hrs; mom reported this episode on 9SEP93;
Injection site soreness, chills, headache, general weakness and drowsiness. Lasted 16-20 hours. Treated with rest and sleep.
lymph node swelling; acute pain in the upper right side of my chest; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced lymph node swelling and acute pain in the upper right side of my chest. It was reported that after the first dose the patient had some lymph node swelling which was believed the side effect and then this morning it was about 10 minutes of acute pain in the upper right side of chest and then it stopped. Abruptly as it started so the patient wanted to know if that was the vaccine side effect. The outcome of the event acute pain in the upper right side of my chest was recovered while the outcome of the event lymph node swelling was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
After the second dose, I began outbreak bleeding for about 2 months. It's never happened before. My cycles are very regular. I also passed a solid mass the size of a quarter.
patient received vaccine and syncopized with loss of consciousness, then tonic-clonic seizure for 2 minutes. post-ictal with cognitive slowing for 2 days.  now back to usual state of health
Caller informed the administration of improperly stored ROTATEQ.; No additional AE/PQC reported; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender (caller unable to provide patient and administration date information). Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On an unknown date, the patient was vaccinated with an improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (unknown dosage regimen) orally, lot # S017642 with expiration date 28-FEB-2021, administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 31 degree farenheit (°F) for 1 hour on 16-SEP-2020; a previous temperature excursion was reported of 47.7 °F, for 9 hours  This case was classified as non-valid due to no patient identifiers.
Redness, fever, induration size of nickel. Pt given BENADRYL oral and ims to continue to give q 6 hrs see MD if no improvement.
DIZZY AND LIGHT HEADED . LOWER PT TO FLOOR AND OBSEVER FOR ADDITIONAL 30 MIN.
pt recv vax 26FEB96&that day devel t104&febrile seizure;pt presented to ER but was not admitted;pt recovered;
ACHE JOINTS, BLOOD ANEMIA, BALANCE:DIZZY UPON STANDING, BLOOD HIGH CHOLESTEROL, DEPRESSION, ENERGY LOSS, HEADACHES MIGRAINE, HEARING: POOR TOLERANCE FOR LOUD NOISE, INSOMNIA ,NERVOUSNESS (ANXIETY), VISION: POOR TOLERANCE FOR BRIGHT LIGHTS, WALKING TROUBLE (BALANCE), CHARLIE HORSE, KNEE PROBLEMS, LOW BACK PAIN.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The patient had shingles shots twice, and still got shingles. The patient had shingles now. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
5 days after the 2 vaccine I experienced large swelling in the lymph node area between my jaw and ear lobe on the right side.  My vaccine was on the left arm.; This is a spontaneous report from a contactable consumer. A 73-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6203), via an unspecified route of administration, administered in left arm on 21Feb2021 12:00 as single dose for covid-19 immunisation. Medical history included tachycardia. Concomitant medication(s) included aspirin, amlodipine, omeprazole, Multivitamin and Vita. The patient previously took tetracycline, tramadol and codeine for all experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Feb2021 18:00, the patient experienced 5 days after the 2 vaccine I experienced large swelling in the lymph node area between my jaw and ear lobe on the right side. My vaccine was on the left arm. The patient did not receive any treatment. Outcome of event was not recovered.  No follow up attempts are possible. No further information is expected.
4/13/2021 heartburn like symptoms started. 4/20/2021 admitted to emergency room, received diagnosis of 3 blood clots in the heart, 4/27/2021 died as a result of blood clots in heart
Patient said the injection site was red and felt like a blister. In addition, the site itched. This occurred Monday evening when the patient received the immunization for the flu shot. The patient is presently taking an antihistamine and the site is still the same (but has not become worse).
RN gave second dose as Pfizer instead of Moderna. Language barrier involved. Interpreter used.  Dizziness reported. Provided water and emotional support. Dizziness resolved in approximately 10 minutes
Severe migraines, very swollen injection site, muscle aches, dizziness, high blood pressure
Fever; Arthralgia; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), ARTHRALGIA (Arthralgia), CHILLS (Chills) and FATIGUE (Fatigue) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 26-Feb-2021, the patient experienced PYREXIA (Fever), ARTHRALGIA (Arthralgia), CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), ARTHRALGIA (Arthralgia), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.            Concomitant medications were not provided.  Action taken with the drug in response to the events was not applicable.
Information has been received from a mother concerning her 13 year old daughter who on 14-SEP-2007 was vaccinated with the first dose of Gardasil. Subsequently the patient experienced a delay in her menstrual cycle by 3 weeks. "A few weeks" after she received Gardasil estimated to be 28-SEP-2007, she also went to the emergency room with a severe headache, weakness, and numbness in her arm and scrambled speech. The hospital diagnosed it as a severe migraine. Medical attention was sought in the emergency room. Follow-up information received on 27-NOV-2007: The mother reported that her daughter did end up getting her menstrual cycle around the time of November 20, 2007. No further information is available.
Info has been received from a physician concerning a 40 year old female who in 2001 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Following her vaccination in 2001, the pt found that in approx March 2002 her titer was negative. The physician reported that titers were drawn several times, the earliest in approx March 2002 and latest in Sept 2002. The physician indicated that the pt had told her that she had been immunized at another practice, but there were no records of the vaccination. The physician further indicated that the pt was a "pretty reliable" historian. As of 10/24/2002, the physician was trying to determine whether to re-immunize the pt who was soon to be started on intravenous immunoglobulin (IVIG) if a titer was negative following a dose of pneumococcal vaccine 23 polyvalent in 2001. In follow-up, the physician indicated that she did not give the original immunization. The physician further indicated that she did not have nor can she get any additional info. The pt sought unspecified medical attention. Additional info is not expected.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 08-JUL-2016 a dose of improperly stored M-M-R II (lot# L027591, rHA, expiration date 23-JUL-2017) was given to the patient. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reported received from the same source. Additional information is not expected as there is no consent to contact the physician.
weird smell that would come and go/ thought it was propane gas/ weird gross smell, stinky; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (weird smell that would come and go/ thought it was propane gas/ weird gross smell, stinky) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included Joint reconstruction (shoulder reconstruction). Concurrent medical conditions included Breast cancer. Concomitant products included ANASTROZOLE for Breast cancer, LEVOTHYROXINE, CLONAZEPAM (CLONOPIN), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), ARIPIPRAZOLE (ABILIFY), METOPROLOL, VITAMIN D3, CALCIUM and MONASCUS PURPUREUS (RED YEAST RICE) for an unknown indication.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PAROSMIA (weird smell that would come and go/ thought it was propane gas/ weird gross smell, stinky). At the time of the report, PAROSMIA (weird smell that would come and go/ thought it was propane gas/ weird gross smell, stinky) had resolved.            It was reported that, the smell did not last very long when it came. It went away sometime between 15-May-2021 to 02-Jun-2021.  Treatment information not provided.
Red rash around injection site approx 2" x 3" in size. Swollen lymph node (axilla). Dr stated pt has cellulitis. Presented day after immunization. Pt treated with cephalexin x 7 days.
Rosacea flared up; face turning red and burning/severe redness; face turning red and burning/burning my cheeks; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 10:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for Covid-19 immunisation at Hospital. Medical history included ongoing Rosacea and Known allergies: sulfa and sulfur from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took dose 1 of BNT162B2 as single dose for covid-19 immunisation on 23Feb2021. There were no other vaccine in four weeks and no other medications in two weeks. There was no Covid prior vaccination and patient did not tested Covid post vaccination. The patient experienced Rosacea flared up, Face turning red and burning my cheeks, burning/severe redness on 23Mar2021 about a week later after vaccine second dose. Stated it was pretty upsetting because she had it under control. Patient went to her general doctor to see if the vaccine affected my biome or the bacteria in my system; she said try a probiotic for a month. AE resulted in: Doctor or other healthcare professional office/clinic visit. Treatment was received for adverse events (AE). AE treatment was topical cream, probiotic. The outcome of events was not recovered.  Batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
p/vax pt w/SOB;pt used routine asthma inhalers w/o relief;also used proventil in nebulizer to get relief;also states approx 3" below inj site noted 5x5" area of hematoma;also c/o swelling & soreness to arm;
GI Bleed 02/02/2021 emergency room 2 unit of blood Hemoglobin dropped below 5. Diagnostic could find source of bleeding Colonoscopy, Endoscopy upper GI. Duration of hospital for 2 half days local hospital. Felt week for two weeks.