chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discharge Provider: MD Primary Care Provider at Discharge: MD Admission Date: 7/28/2022 Discharge Date: 8/2/2022  HOSPITAL PROBLEMS 1. Tension pneumothorax 2. COVID-19 infection 3. Severe sepsis 4. Elevated troponin 5. Hypomagnesemia 6. Diaper dermatitis 7. Depression 8. Dementia 9. Hypertension 10. Hypothyroidism 11. GERD   HOSPITAL COURSE: Patient is a 91 y.o. female who presented to the hospital via EMS after being found unresponsive and short of breath.  Oxygen saturations on arrival were found to be in the 30s. Patient was placed on a INR be with increased saturations to the 80s.  Physical exam revealed left-sided tracheal deviation absent breath sounds on the right.  X-ray showed large right-sided pneumothorax. Emergent needle decompression to the right hemithorax was performed which improved oxygenation. After discussion with patient's family a chest tube was placed and patient was bolused 1 L normal saline due to soft blood pressures. Notably patient was positive for COVID-19 on 08/01/2022 and had recently suffered a fall at that time. CT head and spine was performed which showed improved previously identified subdural hematoma, with no acute changes. She was noted to have a mild increase in troponins likely due to severe hypoxia and hemodynamic stress. Patient was also noted to have low magnesium levels.  She was admitted to the general floor for tension pneumothorax.   On the general floor, patient steadily improved with chest tube in place which was demonstrated by serial CXR's. Her electrolyte abnormalities corrected with magnesium supplementation. Her home medications were resumed without complication.  She completed 4 days of Decadron for COVID 19 infection and maintain oxygen saturations in the 90s at rest and while working with PT. Patient's chest tube was accidentally removed on 07/31/2022 but repeat CXR demonstrated resolution of pneumothorax and did not require replacement of chest tube. Patient was considered medically and vitally is stable for discharge home.
Patient's arm has swollen and causes pain. Warm to touch. Pain unresolved by OTC pain medications.
bright red shoulder @ inj site, w assoc swelling cervical & axillary adenopathy extremely painful;sx x 1wk;breast pressure (swollen) x 3wk;pt did not notify until p/event;
had one shot a couple of months ago and didn't get second one; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had one shot a couple of months ago and didn't get second one) in a female 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 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 (had one shot a couple of months ago and didn't get second one). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had one shot a couple of months ago and didn't get second one) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Preferred Term updated from Product dose omission issue to Inappropriate schedule of product administration. Verbatim updated.
He got both his vaccines at the same time, and within 4 hours he blew up with fluid.  His feet started burning and they burn all the time now like he walks on fire, and has affected his respiratory system, also has had headaches, which he has never had before.  He could not move once he started swelling and could not walk to the bathroom, and it took him about an hour to get there.  He took 3 Benadryl which made him sleep.  He went to the doctor the next morning who did not tell him anything, and said that they did not know which vaccine it was, and did some blood work.  He has had CAT scans, US, blood work, a lot of stuff done and they still will not admit that it was related to a vaccine even though it was only 4 hours post the vaccines.  He has not had fluid retention problems in the past.  He now is not able to do anything due to the swelling.  He has gained 33 pounds of fluid.    He was put on three different diuretics.  He will drain some at night when he's sleeping but it comes back the next day, is doing fluid restriction of only 2 quarts a day and still nothing is leaving his body.  He goes back to his PCP tomorrow.    He has been to the ER 4 times and gave him some diuretics, drained the fluid off of him, did a CT scan once, did an US once and did other tests.  Every time he went it was something different that they did testing wise and they did not find them.  He has been to two different hospitals for his ER visits and neither one can tell him what is wrong.    He has had the COVID vaccines and did not have any problems with those.
p/vax pt exp fine papular pruritic rash over arms, legs, trunk;
Went to gym after vaccination for a strength/cardio workout. Developed headache that night. Next day had top to bottom "pulsating pain". Chills the following day and that night woke up in a sweat. Seen in the office 03/24/2018 with complaints of severe pain in both shoulders up to neck. Was afebrile in the office, never took her temp at home. History of shingles on right shoulder 10 years ago.
Teen became dizzy and diaphoretic after the shots within 5 minutes of administration. The teen stated he had not eaten today. Had teen lay down on clinic exam table and examined by FNP. VS taken  - WNL. Cool compress placed on forehead and juice/snack given. Had teen stay for 40 minutes. Stated he felt better, walked out with standby assistance.
Several hours of dizziness, headache, and cold hands/feet. Resolved after a few hours with tylenol + benadryl.
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized with right knee, hip and back pain. Vaccination took place 3/13/08. According to the physician, the relationship to reatment is 'None'. We would be happy to forward the Study's SAE Reporting Form upon request. 12/15/05-records received-C/O right knee, hip and back pain on 3/13/08-Hospitalized 7/15-7/25/08.
Pt noticed red swollen bump (about 2.5 inches wide) at injection site on 6/25/121 that felt warm. Site started itching evening of 6/26/12.
patient became dizzy, nauseated, received vaccine 10:00, at 10:09 patient became dizzy, lightheaded, nauseated, bp 125/85 p-85, sat 100%, 10:14 134/91 99% sat on room air, P- 98, 1020- BP 155/92, 1025 - 142/87, 1029- 98% on room air P-98, 1030- 129/91, 1047- sat 99% on room air, P- 89, 134/92, patient still feeling nauseated and dizzy transferred to Urgent Care
Warm, red, bumpy, and itchy rash at injection site about 3 inches in diameter.  This showed up about 8 days after receiving the first dose.  Before that, I had no issues other than the expected tenderness at injection site which lasted about a day.
Information was received from a licensed practical nurse referring to a 13 year old patient of unknown gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On 09-SEP-2016, the patient received a dose of PROQUAD (lot #, expired date, dose and route were unknown)  for prophylaxis (inappropriate age at vaccine administration). On 12-OCT-2016, this patient then received a dose of M-M-R II and a dose of VARIVAX (dose, route, lot# and expiration unspecified) for prophylaxis (drug use for unapproved schedule). No adverse effects were reported. Additional information has been requested.
Information has been received from a nurse concerning a female who on 06-OCT-2010 was vaccinated with PNEUMOVAX 23 lot # 665924/0930Z, expiration date 17-JUL-2011. Subsequently the patient developed adverse events of 3 to 4 inch swelling at injection site, rash and edema. The patient's 3 to 4 inch swelling at injection site, rash and edema persisted. The patient sought unspecified medical attention. The nurse reported that for two patients that vaccination was their first vaccination of PNEUMOVAX 23. It was also reported that the route of vaccination was IM for one patient and SC for two patients. The nurse requested a lot check. A lot check was initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number (665924/0930Z) in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Fussy, diarrhea, gassy, c/o head hurting - Photophobia, temp 100 night of vaccine.
This case was reported by a physician via sales representative and described the occurrence of injection site hives in a child male subject who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of INFANRIX (unknown, unknown thigh). Approximately 48 hours after vaccination with INFANRIX, the subject experienced injection site hives and injection site blisters. The subject developed hives and blisters on the injection site (thigh) 48 hours post injection. The next time the subject came into the clinic, the subject received PREVNAR (other manufacturer) and experienced the same reaction. Immunization series with INFANRIX was discontinued. At the time of reporting the outcome of the injection site hives and injection site blisters were unspecified.
Patient received TDaP in right deltoid on Monday. On Tuesday (approximately 27hrs) later, patient began having burning and redness to injection site, redness increased throughout day Wednesday. Somewhat better today but still red and sore.
hot, flush all over; itchy; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in arm left on 08Mar2021 at 10:30 at the age of 44-years-old as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient experienced hot, flush all over and itchy on 09Mar2021 at 15:00. Therapeutic measures were taken as a result of both events which included BENADRYL. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Pt rcvd vaccine about 0855 and was being monitored for a minimum of 30 minutes per protocol. Pt without complaints initially while in 30 minute monitoring area. At approximately 0950 pt c/o feeling lips/eyes were swelling. Pt taken to tent w/ c/o HA. Volunteer MD assisted with monitoring: VS 165/96 HR 78 reg rate/rhythm, O2 sat 98 % on RA, lungs clear, skin warm slight diaphoresis noted. Supine on cot, cold compress provided, ice pack provided/to neck as requested. C/o lips eye are, face feeling swollen, c/o continued HA. Lip/facial swelling not visibly noted. Continued monitoring w/ VS 150/96, HR 74, sats 98% resp regular & lungs clear. Pt reported BP usually 120-125/70 and states she reacts to "a lot of things". Desired Benadryl, Volunteer MD gave pt 50 mg Benadryl. Pt desired sister to be called. Pt continued to c/o HA. BP 160/97 and pt reports taking her BP medications in am as prescribed. EMS called at 0955, EMS arrived, pt transported to ED per her request at 1010 for further monitoring. Reported by nurse, lead Monitoring RN.
"pins and needles" sensation that happens "on-and-off" and soreness in the arm where she received the vaccination; "pins and needles" sensation that happens "on-and-off" and soreness in the arm where she received the vaccination; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program Support. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 25Jan2021 at a single dose on the arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced "pins and needles" sensation that happens "on-and-off" and soreness in the arm where she received the vaccination. She wanted to know if this is commonly reported and how long the soreness usually lasts. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Bruising directly above the injection site (left arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruising directly above the injection site (left arm)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J and J (1st dose with lot number 1805029) on 15-Mar-2021, FLU VACCINE VII in October 2021 and PFIZER BIONTECH COVID-19 VACCINE (1st booster dose with lot number 301358A) on 29-Oct-2021. Past adverse reactions to the above products included No adverse event with FLU VACCINE VII, J and J and PFIZER COVID-19 VACCINE. Concurrent medical conditions included Diabetes (She takes metformin, glipizide and pioglita for diabetes) and Drug allergy (Allergies to Codeine, Demerol and Hydrocodone.). Concomitant products included METFORMIN, GLIMEPIRIDE (GLIPIRIDE) and PIOGLITAZONE HYDROCHLORIDE (PIOGLITA) for Diabetes.    On 15-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2022, the patient experienced VACCINATION SITE BRUISING (Bruising directly above the injection site (left arm)). At the time of the report, VACCINATION SITE BRUISING (Bruising directly above the injection site (left arm)) was resolving.            The patient had no COVID-19 diagnosis prior to or after getting the Covid-19 vaccines.   The patient reported bruising directly above the injection site on the left arm after getting the Moderna Covid-19 vaccine for her 2nd booster dose.. At the time of report it was resolving.
vasovagal response Narrative:  Initial Vital Signs: Temp: BP: 83/38 HR: 44 RR: O2 Sat: Primary Reason for Call: CODE WHITE in vaccination observation area Staff concern, worried Explain: pale, diaphoretic Situation: Pt received covid vaccine at 0802-0805 staff noticed that pt was pale and diaphoretic, laid pt on the floor, BP in the 60's, On arrival pt resting on floor a/o x3. States that this happens with injections. Report BP 83/38, 44. After a period of time BP increased to 116/72, 64. Pt assisted to wc with BP sitting 125/81, 70, taken to the ED for evaluation and observation. Nurse who administered the vaccine stated the patient said she was afraid of needles and was very nervous prior to the injection. ED provider: FEMALE who presents to the Emergency Dept. "passed out after getting the Covid shot". Triage note as above, patient went for covid vaccine this morning and afterwards and she felt dizzy and passed out. She is known for having passing out with previous vaccination as well. No preceding chest discomfort, feeling fine now no nausea vomiting or other focal complaints. She regained consciousness soon after that.
Initial unsolicited report received from a non-healthcare professional via other company (Pfizer) on 02 December 2015. Manufacturer control number: 2015420182. This case involves a male patient (age reported as "2") who was vaccinated with a dose of influenza vaccine (manufacturer: unknown, batch number, expiry date, route and site of administration were not reported) and a dose of MMR (manufacturer: unknown, batch number, expiry date, route and site of administration were not reported) both vaccines were administered on an unspecified date. The patient medical history and concomitant  medications were not reported. On an unspecified date, following the vaccination, the patient regressed into autism. It was reported that he was fine prior to that, he took a bullet for the head and resulted in an injury to his brain. Lab data and corrective treatment were not reported. The outcome of event was not reported. Upon internal review, the case was considered serious because of important medical events; injury to his brain and autism. List of documents held by sender: none.
exacerbate autoimmune issues with hair loss; exacerbate autoimmune issues with hair loss; alopecia/ hair loss; Initial information was received on 21-Jun-2021 regarding an unsolicited valid serious case from a physician.  This case involves a two-year-old female patient who had a exacerbate autoimmune issues with hair loss (autoimmune disorder with symptom of alopecia), after she received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] and YELLOW FEVER VACCINE - US [YF-VAX].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MEFLOQUINE HYDROCHLORIDE (LARIAM) (1/4 tab weekly) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) was administered via arm.  On 18-May-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On 10-Jun-2021, the patient received a 0.5 ml dose of suspect YELLOW FEVER VACCINE - US [lot number: UJ372AA, expiry date not reported] via subcutaneous route at right thigh for prophylactic vaccination.  On 10-Jun-2021, the patient received a 0.5 ml dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE [lot number: T1A671M, expiry date not reported] via subcutaneous route at right thigh for prophylactic vaccination.  On an unknown date the patient had a serious exacerbate a potential autoimmune issue with hair loss (autoimmune disorder, condition aggravated with symptom of alopecia), (unknown latency) following the administration of YELLOW FEVER VACCINE - US, TYPHOID VI POLYSACCHARIDE VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. These event was assessed as medically significant.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment for the events.  At the time of reporting, the patient's father was asking if theses vaccines could exacerbate a potential autoimmune issue with hair loss that his daughter is experiencing.  At the time of reporting, the event outcomes were unknown.; Sender's Comments: This case involves a two-year-old female patient who experienced exacerbated autoimmune issues with hair loss after vaccination with MENACTRA, TYPHIM VI and YF-VAX. The time to onset was unknown. Concomitant medications included LARIAM and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccines cannot be assessed.
sudden back and muscle spasms lasting 2-3 weeks, mild overall but persistent and reported back to us as PCP clinic. Seemed to resolve by shot 2 on 2/11/21
Patient is a 80 y.o. female who presents with:   2 months of itchy rash that started 2 months ago after 1st COVID vaccine.  Was only on her lower leg.  After the 2nd shot a month ago the resh got worse.    It is on her arms, chest, upper and lower legs.  It itches and she has been scratching it and picking it to where it is all scabbed up and hurting with redness.   Discharged with Cellulitis, unspecified cellulitis site    -  Primary    Relevant Medications   clindamycin (CLEOCIN) 300 MG capsule   mupirocin (BACTROBAN) 2 % ointment   fexofenadine (ALLEGRA) 180 MG tablet  Came back to doctor office 8 days later with complaints: Patient was seen on 3/30 and was treated with Clindamycin and Mupirocin.  Patient did not f/u with Derm.  Per patient and husband everything seemed to be healing except an area over her right breast and her left lower leg is now hot and swollen.     Patient still complaining of itching and admits to itching until she breaks skin.     NO fever reported.  Admission to hospital for IV antibiotics
2nd Vaccination injected with Jansson COVID19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (2nd Vaccination injected with Jansson COVID19 Vaccine) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 203A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (2nd Vaccination injected with Jansson COVID19 Vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (2nd Vaccination injected with Jansson COVID19 Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medications include high blood pressure medications , diabetes medications, chronic pain medications.  Received Jansson COVID19 Vaccine for 2nd injection after receiving the Moderna Vaccine for 1st injection.
Delayed reaction.  On day 5, I woke up fatigued, with some body aches, and extreme cold.  I was lethargic all that day.  On day 6, more of the same above symptoms.  I stayed in bed most of those two days.  On day 7, I was improved and was able to function normally.  At no time, during these two days did I run a fever.  I realize most of these symptoms are common, but the reason I wished to report them is the fact that it was so delayed.
This spontaneous report as received from a nurse refers to 4 unspecified patients of unknown age and unknown gender. From 25-JUN-2015, the 4 patients were vaccinated with PROQUAD (Merck) (dose, frequency and route were not reported) (lot # K025760 and expiry date: unknown) which were improperly stored. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
HEART ATTACK; DEATH; This spontaneous report received from a consumer concerned a 64 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, dose number in series was 1, 01 total, administered on 24-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient had a heart attack which was diagnosed by his primary care physician (PCP). On 29-MAR-2021, as per death certificate, the patient died from obesity, hypertension (HTN) and diabetes. Reportedly, he was driving at the time he passed away (dose number in series was 1). Autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of death was fatal and the outcome of heart attack was not reported. This report was serious (Death, and Other Medically Important Condition).  .; Sender's Comments: V0: 20211258857-Covid-19 vaccine ad26.cov2.s- Death, Heart attack. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: OBESITY; HYPERTENSION (HTN); DIABETES