chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 year old boy, born at 39 + 1 via c-section without complications. No significant past medical history. Presents to the clinic with scattered, umbilicated lesions over bilateral forearms, left medial thigh and bilateral lower legs. Lesions were first noted on 9/6/2022 in the afternoon. They looked like big bites, firm, non tender, non pruritic and had no umbilication. By Friday 9/9/2022 the lesions had umbilicated and by Saturday 9/10/2022 they developed a crust in the umbilicated area. Lesions never oozed. He had a peds appointment on Friday but had to be cancelled and therefore he had not seen anybody until today.(9/12/22) His mother is a physician and received dose #1 of intradermal live-attenuated non replicating Jynneos vaccine on 8/30, one week prior to the child developing lesions. Mother states that on 9/1/2022 she felt a pimple like lesion on the hair line behind her right ear but due to location, was unable to see it and had husband take a picture of the lesion (poor quality picture). The lesion disappeared on its own in 24h and she did not develop any other lesions. Neither the child nor the mother developed fever, chills or any oral/genital/mucosal lesions. The child has been eating, sleeping and playing well. Now the 1 year and 11 month old sister has a noticeable red bump lesion over her right lower leg and seems like she is developing 2 other lesions that are still not red in the same leg. The child comes for MPX testing There is concern for MPX vs vaccinia generalized rash.
This spontaneous case, was initially received on 08-Dec-2017, from a consumer, concerning a 58-year-old female, adult patient. The patient's historical condition included stones in right kidney (on an unspecified date) and it was removed (on an unspecified date in Sep-2017). It was reported that no stones found in left kidney. The patient's current conditions included, diabetes, obstructive sleep apnea and atherosclerosis since and unspecified date. The concomitant medications included CRESTOR, Diltiazem, valsartan, glipizide, omeprazole for unknown indications. The patient had history of flu shot in the past without any adverse events. On 24-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: XF34509, expiry date: 30-Jun-2018). On 25-Nov-2017, the patient experienced sudden flank pain on left side (reported as bad) thus, on the same day, the patient went to the ER. On the same day, the patient was hospitalized and underwent CT scan, which revealed inflammation of kidney and kidney stones were unchanged. No other tests were done. The patient was unable to void even for urine specimen; hence a Foley catheter was placed, but there was no urine output for 18 hours. Creatinine level was 1.5 initially and went up to 3.5 and potassium level was 5.9 (baseline value was unknown) on 25-Nov-2017. On 26-Nov-2017, the patient underwent bilateral stent insertion for ureter inflammation and urine flow (for obstruction). The patient was given IV. On 04-Dec-2017, creatinine level was 1.3, potassium was normal (value was not provided). Protein was observed in patient's urine. On 14-Dec-2017, the renal stents were planned to remove. At the time of this report, the patient had recovered from the event Inflammation of kidney and urine obstruction. The reporter considered the event inflammation of kidney as serious due to hospitalization and assessed the causality between the events and suspect vaccine as related. The reporter did not provided the seriousness and causality of the events creatinine increased, and potassium increased. Follow-up received from consumer on 09-Jan-2018: The current condition kidney stone was change to historical condition right kidney stone (which was removed in Sep-2017). The concomitant drug valsartan (started in Aug-2017, no dose changed) was withdrawn by the patient on an unknown date. It was reported that no tests other than CT was performed (ANCA antibody titer was not done) in ER and the consumer had no details of the diagnosis. Added events ureter inflammation and obstruction. The stents were placed for ureter inflammation and obstruction. Narrative was amended accordingly. Follow-up received from consumer on 25-Jan-2018: The consumer confirmed that patient had stones in right kidney only and reported that no stones were found in left kidney and it was confirmed that stents were placed due to ureter inflammation and obstruction. Narrative was amended accordingly.
Bug bite looking reactions on elbow, hands and feet; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Bug bite looking reactions on elbow, hands and feet) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced RASH (Bug bite looking reactions on elbow, hands and feet). At the time of the report, RASH (Bug bite looking reactions on elbow, hands and feet) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
tinnitus: continuous and ongoing high pitched ringing in ears for 10 months straight. Has not subsided.
Pt. Reported an enlarged lymph node in axilla of (L) arm. Same side vaccine was given. Lasted approx. 2 days.
Initial report received from nurse on 01 Dec 2009: This patient, who was a child younger than 4 years, received FLUVIRIN lot number 1008132P, 0.5 ml intramuscular on 13 Nov 2009. No adverse event was reported.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to M-M-R II. Additional information is not expected since all scheduled correspondence was received. Sender's Comments: US-009507513-1706USA006147: US-009507513-1706USA006151: US-009507513-1706USA004143: US-009507513-1706USA006150: US-009507513-1706USA006146: US-009507513-1706USA006148.
Patient states c/o pain and swelling started at night after shot large red swollen/ red area onside of left arm 4 1/2" x  3 1/2". C/O pain tenderness with swelling continue today post injection next day patient c/o watery eyes, runny nose allergy type symptoms took Tylenol cold and symptoms went away.
shingles after 9 months of Shingrix/suspected vaccination failure; shingles in brain; felt like hit me with pick ax; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 9 months after receiving Shingrix, the patient experienced vaccination failure (Verbatim: shingles after 9 months of Shingrix/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles in brain) and feeling abnormal (Verbatim: felt like hit me with pick ax). The outcome of the vaccination failure and shingles were unknown and the outcome of the feeling abnormal was not reported.   The reporter considered the vaccination failure, shingles and feeling abnormal to be related to Shingrix.     The company considered the vaccination failure, shingles and feeling abnormal to be related to Shingrix.   Additional Information: GSK receipt date: 31-Mar-2023 The case was received from the patient via interactive digital media. The patient got the Shingrix vaccine and nine months later got shingles, it settled in his left side brain felt like someone came up and hit him with pick ax right above ear horrible Shingrix was 90 percent well and got the 10 bs. The reporter denied to follow-up. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
pt started feeling light headed, and nauseated.   to first aid room vital signs taken , BP 134/74, P 82 R 16  , )2 sat 100% .  Md here  visited with pt , ordered zofran for nausea, and to continue to obs. .last  BP 117/80, 92.
Severe itching and red spots, hives that proceeded to get worse on my arms and legs.  Still dealing with it a week later.  Using Benadryl and cortisone cream.
Fever, chills, fatigue, headache, body aches, weakness, low oxygen saturation of 88-93
Complained of feeling weak, stomach cramps, lower abdominal cramping, upper quadrant pain right and left sides, bright orange urine, runny gray stools with loss of appetite and nausea starting about 1 hour after vaccination. Yellow skin and eyes occurred approx. 3 days after vaccination.
Information has been received from a registered nurse (RN) concerning a 4-month-old patient who was vaccinated with the first dose of ROTATEQ. Unspecified medical attention was sought and no problems were reported. Additional information has been requested.
Approximately 11:30 PM, Wednesday, 3/27/2019, I awoke and began 6 hours of simultaneous vomiting and diarrhea. It finally stopped after 5:00 AM Thursday, 3/28/2019. I slept all day Thursday and late that afternoon ate 1 saltine cracker. Friday I began feeling better, but still did not want to eat until Saturday except for small occasional portions of bland food. This was the most violent vomiting combined with diarrhea I have ever experienced. And almost 50 years ago, I had a case of Amoebic Dysentery. This was worse. I realize that vomiting and diarrhea are symptoms of the SHINGRIX vaccine, but I did not expect those two to occur together at the same time. I am a small woman, about 90 pounds and I wonder if this vaccine should be given in a lower dose for smaller people. Not everyone weighs 150 pounds! Please consider that. My doctor has advised me to wait 6 months before taking the 2nd vaccine.
Chills and fever from 7:00pm-12 midnight 5/13 Muscle aches and headache from 7pm 5/13 to the evening of 5/14
Per mother, around 12:00 on 1/26/01, right arm began to turn red and swell. Child began to complain of headache. Mom also began to notice child had chills and seemed to be acting like she was ill. Gave Tylenol for mild fever but temperature continued to climb. By 1/27/01 AM, child's temperature was 105F and arm had swollen to "the size of an orange". Per mom, her also was red and hot. Took child to ER, where they were told that she had had a vaccine reaction and released her home with Motrin. Follow-up visit with PMD arranged. Saw PMD and was told to use ibuprofen and continue with Motrin. Per mom, no redness or swelling, now.
Mom called to report pt has red area around injection area at 2 1/2 inches around, size of egg, not swollen, no fever.
Patient recieved Moderna dose 1 02/23/2021, dose 2 03/25/2021. Nausea and vomitting after 2nd dose, found unresponsive by son on 04/17/2021, taken to ER and diagnosed with new onset Afib with RVR, sepsis with shock. Deceased 04/18/2021
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 55 year old Hispanic or Latino female. Initial information was processed along with the additional information received on 14-JAN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy. The patient previously received covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin not reported, and batch number: 1808980, expiry: Unknown) dose was not reported, 1 total administered to right arm on 06-MAY-2021 for prophylactic vaccination. No adverse events were reported following vaccination with covid-19 vaccine ad26. cov2. s. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, and batch number: 211A21A expiry: UNKNOWN) dose was not reported, 1 total administered to right arm on 05-NOV-2021 for prophylactic vaccination. The patient used to take medicine for allergy. On 13-JAN-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced sore throat, runny nose, headache, loss of taste and felt it may be due to covid (coded as suspected covid-19 infection, suspected clinical vaccination failure) (Dose number in series 2). Laboratory data included: COVID-19 PCR (polymerase chain reaction) test (NR: not provided) not reported, was awaiting results. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220123821 (dose number in series 1). This case is associated with product quality complaint: 90000211932.; Sender's Comments: V0-20220124204- covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
recurrence of eyes and lips swelling; lips swelling; massive diarrhea; malaise; fatigue; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6201), via an unspecified route of administration, administered in Arm Left on 17Feb2021 12:15 (at the age of 69-year-old), single dose, for Covid-19 immunisation. The patient's medical history included rheumatoid arthritis (RA), four back surgeries and allergic sinusitis. Patient did not receive any other vaccination on the same date, and she did not receive any other vaccine in four weeks of Pfizer vaccine. Patient was not diagnosed with covid-19 prior to Pfizer vaccination, and she was not tested positive since vaccination. Concomitant medications included prednisone, indometacin sodium trihydrate (INDOMETHACIN AGILA), tolterodine l-tartrate (DETROL), metoprolol succinate (TOPROL) and famotidine (FAMOTIDINE). The patient previously took ibuprofen, morphine and sulfonamides and experienced allergy; and patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: E l3247), via an unspecified route of administration, administered in Arm Left on, 22Jan2021 at 11:30 AM, for Covid-19 immunization and experienced swelling of face (lips, eyes, cheeks), severe itching of both hands, difficulty swallowing, massive diarrhea, extreme tiredness, and swelling of eyes and lips. On an unspecified date in Feb2021 (one week after the second dose), the patient experienced recurrence of eyes and lips swelling (on 24Feb2021 or 25Feb2021) and on an unspecified date in 2021, she continued to have massive diarrhea, malaise and fatigue until after administration of methylprednisolone 03Mar2021. Still taking Allegra twice a day (BID). The patient received treatment with prednisone, Benadryl, Allegra, and prednisone injection, as a result of adverse events. The outcome of events was resolving.   No follow-up attempts are possible. No further information is expected.
PATIENT REPORTED FEELING WEAK, "WALKED FUNNY," TEMPERATURE 100 DEGREES FAHRENHEIT, NAUSEA, HEADACHE.  PATIENT HAD A DERMATOLOGIST APPT AFTER VACCINE APPT AT PUBLIC HEALTH FOR CRYOTHERAPY FOR PLANTARS WART ON LEG.  PATIENT DENIED HAVING ANY BREAKFAST PRIOR TO IMMUNIZATIONS. MOTHER TOOK PATIENT TO LOCAL ER FOR THESE SYMPTOMS.  CALLED PUBLIC HEALTH THE NEXT MORNING AND REPORTED US OF THESE SYMPTOMS POST VACCINATION.
Unable to process thoughts shortly after injection.  Brain fog.  Off balance that turned into extreme repeated episodes of dizziness with wretching for 24 hours.  Continue to have some brain fog today.
2.5 days post vaccination, patient had a seizure due to extremely low blood pressure.  This was most likely due to an adverse reaction to the prescriptions that were prescribed to him post surgery.   He was taken to the ER and admitted to the hospital for 2 days.  All tests - other than blood pressure of 80/38 on a man with high blood pressure, were normal.
Vaccine administration error occurred. Rather than mixing the pfizer bottle with diluent, 0.3 mL of the vaccine were administered to the patient. The patient's vital signs were taken immediately after the incident, the patient was monitored for 30 minutes, and the patient was counselled on potential side effects.
A lot of pain in arm; arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy; arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy; arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy; arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy; This is a spontaneous report from a contactable other hcp (patient).  A 49-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose bnt162b2 on 18Dec2020 for Covid-19 Immunization and experienced a lot of pain in arm which was normal. On 10Jan2021, the patient's arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy and on an unspecified date the patient had a lot of pain in arm. She had not taken anything other than acetaminophen (TYLENOL) 650 mg. The patient thought it was due to the vaccine (COVID-19 vaccine) she got the reaction. The outcome of the events was unknown.
Initial information has been received from a Licensed Practical Nurse concerning a 19 year old female patient with none pertinent medical history and none drug reactions / allergies. On 15-MAY-2013, the patient was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot number H021861 exp date 08-AUG-2015). Concomitant therapies included CLARITIN, doxycycline, DIFLUCAN and unspecified birth control pills, methylphenidate. On 15-MAY-2013, the patient experienced syncopal event after her first dose of GARDASIL. Right after patient was administered a dose of GARDASIL, patient's eyes rolled back little bit and for about 10 seconds she had very mild seizure-like movements. The nurse laid the patient down and observed her. The patient complained of nausea but no vomiting was reported. This incident was over in about total of 5 minutes. The patient complained of headaches and "not feeling well" for a few days after GARDASIL administration. Treatment was not given for the event. There was not laboratory studies performed. On an unspecified date, the patient recovered from the events. The patient sought medical attention by visiting physician's office and by phone calls. Upon internal review, mild seizure-like movements was considered to be medically significant. Additional information has been requested.
This spontaneous report has been received from a nurse practitioner concerning to 68 year old female patient with morphine reaction, hydrocodone reaction and none pertinent medical history. On 17-SEP-2013, the patient was vaccinated with PNEUMOVAX23 injection, 0.5 ml, intramuscular in the left deltoid region of the arm, lot # H018608 and expiration date: 02-JUL-2014. Concomitant therapies included: MOBIC, ZESTRIL, TOPROL XL, PREMARIN, folic acid (manufacturer unknown), cholecalciferol vitamin D3 (manufacturer unknown) and IMODIUM. On 17-SEP-2013, within an unspecified number of hours after injection, the patient experienced redness, swelling "the size of a golf ball" and pain at injection site. On 17-SEP-2013, an unspecified amount of time later in the day, the patient experienced that the redness had progressed to her whole body "from her neck down to her ankles", but the redness on her body was not itchy. On 18-SEP-2013, the patient called the nurse practitioner to report the incident and to be evaluated, it was also reported that the patient experienced a great deal of pain and was not able to raise her arm above her head. None Laboratory diagnostics studies performed. At an unknown date, it was not give a treatment for AE; however the patient scheduled an appointment on 19-SEP-2013, to reevaluate and determine the treatment to manage the symptoms. On 19-SEP-2013, the patient was still experiencing the whole body redness and inability to raise her arm due to the pain. The outcome of the rest of the events was reported as not recovered. It was reported that the patient did not received treatment for the adverse events and no laboratory tests were performed. Additional information has been requested.
Information has been received from an office worker concerning a 4 year old female who on 03/11/2005 was vaccinated with measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  On an unspecified date, following immunization, the patient developed swelling around the joint area on the limb at the injection site.  It was reported that the patient sought unspecified medical attention.  At the time of this report the outcome of the event was unknown.  Additional information has been requested.
The day after the vaccine the patient developed a fever lasting one day, and a very pruritic rash over his trunk, arms/hands as well as a few lesions over his scalp and face. The rash persisted, and per the photos that he emailed to the office was maculopapular in nature. I instructed the patient to take cetirizine 10 mg twice daily, and within 4-5 days the rash had completely resolved.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: patient became nauseas, lightheaded, and had mild flushing post administration. patient was given water and was sat down. patient recovered fully 10 minutes later and left with no further issues.