chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DISCHARGE DIAGNOSES: COVID 19 Recurrent malignant pleural effusions   HOSPITAL COURSE: 31 y.o. female with with history of metastatic breast cancer s/p chemo/surgery. She was found to have right pleural effusion earlier 01/2022.  She presented to our ED 1/30/2021 for evaluation of shortness of breath. She was seen by pulmonary medicine, underwent diagnostic/therapeutic thoracentesis and discharged home.  She had 1.7 L taken out and further thoracentesis was halted due to pleuritic chest pain.  Now presenting with worsening shortness of breath and increased heart rate on 2/1/22.    Cytology was positive for malignancy.  She was seen by IR and underwent U/S guided R thoracentesis and had 870 cc pleural fluid removed on 2/1/2022.  D/w CTS, Dr. regarding pleurodesis or drain placement.  He advised outpatient follow-up with her outpatient oncology team so that she does not get fragmented care. She was also seen by pulmonary service given recurrent effusions.  Pulmonary recommended at the treatment of the effusion is chemo/cancer treatment.  She was also advised to control the effusion, she will need either periodic thoracentesis, pleurodesis or an indwelling Pleurx catheter for home drainages.   Per Pulm, this will largely depend on her prognosis, goals of care and degree of which effusion is symptomatic.  She was advised to follow-up for this closely with her oncologist.     She was started on low-dose Toprol 25 mg due to symptomatic tachycardia.  This is likely multifactorial given acute viral illness, underlying malignancy, pleural effusions, dyspnea, cough.   On day of DC, patient is eager to be discharged home.  She is feeling much better.  She reported some sore throat and had an low-grade fever 100.4 on 2/1 late evening.  Given fever, her blood cultures were repeated.  UA negative.  No leukocytosis.  Procalcitonin negative x2.  She tested positive for COVID-19 on 2/2/2022 and I suspect that her cough, sore throat, fever are likely related to acute COVID-19.  She is not hypoxic and does not meet criteria for steroids.  She is requesting be discharged home, which is reasonable.  She was strongly urged to follow-up with her oncologist this week so that long-term management of her effusions can be arranged.  She was also advised to follow-up with her PCP to discuss for outpatient treatment of COVID-19.
Headache, Fever, CoughWheeze, runny nose Narrative:  Other Relevant History:
developed Whooping Cough; Initial information received on 17-Dec-2019 regarding an unsolicited valid serious case received from a consumer.  This case involves a 17 years old male patient who experienced whooping cough (pertussis), while he received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Jun-2013, the patient received standard 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U4612AA and expiry date: 20-Sep-2015) via unknown route in the left deltoid.  On 06-Jul-2019, the patient developed a serious whooping cough (pertussis) 6 years 22 days, following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. He continues to have the cough. This event was assessed as medically significant.  No lab data was reported.  Final diagnosis was whooping cough.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as  not recovered for whooping cough. He continues to have the cough; Sender's Comments: This case concerns 17 years old male patient who experienced pertussis after vaccination with ADACEL. The time to onset is compatible. However, there is no information regarding patient's condition at time of vaccination, immune status, predisposition to respiratory tract infections. There is no confirmation of the infection through lab tests. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
Information has been received from the mother of a 13 year old female who was vaccinated with a second dose of VARIVAX (Merck) in approximately July 2009. The dates of the first vaccine were not reported. The mother reported that her daughter passed out after severe menstrual cramps following a second dose of VARIVAX (Merck). It was reported she passed out less than a year after receiving the second dose of the vaccine. It was reported that medical attention was sought, and the patient was seen in the doctor's office. This is one of two reports from the same source. No further information is available.
MODERNA COVID-19 vaccine EUA Received first shot yesterday (2/10/21 @ 2:42pm) had chills off and on overnight and sore arm. Got up at 6:30 am today (2/11/21), used the bathroom, felt very dizzy and lightheaded, started sweating profusely, tried to make it back to bed, took 4 steps and passed out, hitting my face on dresser.  This has only happened one other time, 16 years ago when I was pregnant, flying on vacation and hadn?t eaten, blood sugar dropped and I passed out momentarily. No history of fainting, not diabetic, no health issues whatsoever. Healthy weight, fit and in shape.
21 Oct 2008 4:46 PM, Pts mom called and states that pts daughter was in on Thursday for the GARDASIL inj and noticed on Saturday a pimple like rash all over her back/stomach/legs/arms...mom would like to know if it is due to the INJ. It was her 2nd dose. Pts mom also states no pain/not itching no fever or other side effects. Mom would like a call back on cell phone. PT's mom also made an appt for derm on 11-6-08.  21 Oct 2008 8:15 PM, Dr  inform mom that it is less likely related with the injection site not first time but always possible. Asked her if she would like me to evaluate her before derm appointment...ok to have her come in this week to be seen.
Routine fevers started, odd skin rashes, and with each episode the lumps at the injection sites would become red and warm to the touch.  To this day, he still has periodic fever and terrible itching and swelling in those spots.  Spoke with the doc's on several ocassions...finally got someone to tell me that there was an issue with the shots and to do heat therapy on the legs to dissolve the lumps.  This worked for a while but recently they flamed up with a vengeance and we're back at square one. He received DTaP on 2/10/11...and hib and MMR together on 3/9/2011. All lumps are still there and flaring to this day. Recently he has started awaking at night with leg spasms and having episodes of inconsolable crying...with each event he is reaching at his thighs where the shots were.  The itching is almost non-stop for him.
24 hours post vax the pt noticed a ver foul odor much like rotten eggs. Nothing would eradicate this nauseating odor 24 hours a day. After 24 more hours the pt experienced a severe headache and general muscle aches. These symptoms lasted about 2 weeks. The pt had a reoccurrence of the foul odor occasionally for 1 month following the vax.
At 10:00 patient started to experience severe headache/malaise.  patient was seen by military sick call and given Motrin 800mg.  Patient was experiencing fever at this time of 99.2.  Patient states he took the Motrin as prescribed.  At approxmiately 4:00PM the patient arrived home and was experiencing body chills and suffered an event of syncope.  Patient stated he woke up an hour later and went inside his home and took oral temperature (103.5) patient then called Change of command -patient advised to take Tylenol 650mg.  15 minutes later fever was still 103.5.  Patient was advised to call 911.  Patient was seen at hospital.
a patient received Daptacel that had expired one day prior to administration/ No AE; Initial information was received on 15-May-2020 regarding an unsolicited valid non-serious case from a nurse via sales representative.  This case involves patient of unknown demographics who received  DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] that had expired one day prior to administration (expired product administered),  Medical history, concomitant medication, medical treatment, vaccination and family history were not provided. Concomitant medication was not reported.   In May-2019, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number not reported and expiry date May-2019) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used. It was reported that the vaccine was expired by a day while administered and parents of the patient did not want the patient to have to receive another injection.  At a time of reporting no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.  Follow up information was received on 26-May-2020 regarding an unsolicited valid non-serious case from a nurse via sales representative.  Event as reported was updated.  Follow up information was received on 26-May-2020 regarding an unsolicited valid non-serious case from a nurse via sales representative.  Suspect product details (start date and expiry date) were updated.
Received immunizations - seen in MD office 24 hours later with redness and swelling at site (left arm) - instructed to take Advil every 8 hours for 1 week. Follow up - arm normal size- no redness.
In July or early August of 1999, subsequent to receiving one dose of varicella virus vaccine live, the pt developed chickenpox. The pt was seen by a physician on 08/20/1999 and showed no signs of chickenpox. No further information is available.
Information has been received from a physician, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 34 year old female with no drug allergy and no medical history who on 06-SEP-2011 was vaccinated with a first dose of VARIVAX (Merck). No concomitant medication. The patient emailed the patient's primary care physician on 19-SEP-2011, and the patient informed the paitent's primary care physician that the patient was pregnant. Urine pregnancy test was performed (no details reported). The patient's LMP was unknown. Patient received no treatment. Follow-up received. A call was placed to the first physician's office and was told that there was no physician by that name who worked there or any record of the patient. A call was placed to the second physician's office. The office staff told that there was no record of the patient in their files and thus had no outcomes to report. Case was lost to follow-up. Additional information is not expected.
At approximately 2:00 pt  arrived at our COVID vaccination  site for his second dose of Pfizer vaccine. admin filled out a Moderna assessment sheet, and failed to switch to a Pfizer assessment sheet after the pt answered "yes- Pfizer" to the question have you ever received a COVID 19 vaccine. admin marked yes on the form, and wrote Pfizer on the form. Once the pt arrived at the vaccination bay, contract LPN did not appropriately review the assessment sheet, and inadvertently administered Moderna vaccine instead of Pfizer.
Information has been received from a nurse practitioner concerning a 16 year old female patient, with no pertinent medical history and no allergies/drug reactions, who on 28-OCT-2008 was vaccinated with GARDASIL (lot # 661530/0575X).  There was no concomitant medication.  On 29-OCT-2008 the patient experienced fatigue, achiness and menstrual period was late.  The patient sought medical attention via telephone.  The patient had not recovered as of 21-NOV-2008.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/12/2008.  On follow up the patient's mother reported that menstruation finally came almost two weeks late.  Additional information is not expected.
Faint, hot and red head, painful heart, nausea,  shaky, dizziness,  weakness, headache,, stiff neck.It happened about 20 to 30 seconds after shot. After my bandage was on and we were checking why I hadn't received a text reminder to sign up for 2nd dose.  Nurses put me in wheelchair and took me to bed. Kept me for 30 mins.  Its been 1.5 hours since shot and I'm still dizzy, weak and I have joint pain. I threw up. I still have headache and my heart still hurts.
if one gets sick after taking the Moderma vaccine it means you were carrying some of the viruds; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-May-2021 and was forwarded to Moderna on 31-May-2021.    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 ILLNESS (if one gets sick after taking the Moderma vaccine it means you were carrying some of the viruds) 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 ILLNESS (if one gets sick after taking the Moderma vaccine it means you were carrying some of the viruds). At the time of the report, ILLNESS (if one gets sick after taking the Moderma vaccine it means you were carrying some of the viruds) 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
The symptoms started the morning after around 9am, with muscle aches, chills and exhaustion. For treatment I took acetaminophen 500mg with Ibuprofen 500 mg twice in the morning and at night for roughly six days.
pt recvd vax 2PM; mom reports started screaming 6PM for about 3 hrs; described high pitched crying; no other sx reported; did not seek medical care;
5 mins after admin of vaccine, client developed approximately 10 cm in diameter over Left clavicle, also stated she felt hot. Administered liquid Benadryl 50 mg PO x1. By 3 PM hive was faded and pt stated felt better. At 2:40 pm BP was at 162/88. At 4:50 BP 142/84 with pulse of 88.
arm was sore; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 77 year old female patient who had arm was sore (pain in extremity), while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious arm was sore (pain in extremity) unknown latency following the administration of INFLUENZA VACCINE.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case
Child developed redness and swelling at the Left thigh injection site, then parents noted hives. Child was taken to the emergency room for evaluation and treatment.  Tmax was documented as 99.4 F.  Child was treated with  oral prednisolone 15mg bid x 5 days and advised to use diphenhydramine 12.5mg every 4 hours as needed for hives. Patient was seen in follow up three days after the ER visit.  No further hives were present. Left thigh injection site remained mildly indurated and  red, but no swelling was evident. No site reaction was noted on the Left arm.
Initial report received from a health care professional on 13 Dec 2010: This patient was vaccinated with MENVEO (batch number unknown) intramuscularly on an unspecified date. The patient received only MenCWY liquid conjugate component of MENVEO. No adverse event was reported. Follow up report received from health care professional on 03 Jan 2011: The patient had medical history of brain surgery. The patient received MENVEO (batch number: 090601A) intramuscularly on 22 Nov 2010 morning. The patient also received Tdap on the same day intramuscularly.
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 1-year-old male subject who was vaccinated with Pediarix for prophylaxis. The subject had no adverse events following receipt of prior immunizations. The subject had no pre-existing medical conditions. The subject's concurrent conditions were not reported. There were no concurrent medications. On 12 December 2006 at 10:00 a.m. the subject received 4th dose of Pediarix in the right arm. Pediarix is not recommended as a booster (or 4th dose) in the diphtheria and tetanus toxoids and acellular pertussis vaccine or inactivated poliovirus vaccine immunization series. On 12 December 2006, the subject also received Hib vaccine and influenza virus vaccine at unspecified sites of administration. On 13 December 2006, 1 day after vaccination with Pediarix, the subject experienced redness and edema at the injection site of Pediarix. On 14 December 2006, the subject was seen at a physician's office and was diagnosed with injection site cellulitis. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with Rocephin and Augmentin. At the time of initial reporting, 14 March 2007, the events were resolved.
On 3/21, 10 days post vaccine, I experienced ocular migraine with severe vertigo.  Felt like I was going to pass out.  Called 911 as I was alone at the time. BP was elevated..likely general anxiety.  The vertigo subsided as did the ocular migraine but had slight headache the rest of the day.  Notified my PCP.
This spontaneous report was received via company representative from a nurse, female patient of unknown age, refers to herself. The patient's medical history included two prior cases of shingles on unspecified dates. There was no patient's concurrent conditions, concomitant medications and drug reactions or allergies reported. On an unknown date, the patient was vaccinated with ZOSTAVAX injection (lot#, expiration date, dose, anatomical location and route of administration were not reported). On an unknown date, 3 years after receiving ZOSAVAX, the patient experienced shingles. No treatment was given and no lab diagnostics studies were performed. The outcome of the event was unknown. The patient did not seek medical attention. The relatedness between the event and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
extremely ill, fever, chills nausea headache for 36 hrs.  extreme tiredness two weeks after
Patient's arm was "very sore" the night of the vaccination and developed a pink, itchy, and swollen rash that resolved with ice. That night her arm hurt and was hard to sleep on it. The next morning the patient noticed redness and firmness at the vaccine site; the following day she noticed that the red area was extending proximally. Reports no fevers and no chills.
Nausea, mouth felt funny, swelling at injection site. Epinephrine administered.
no adverse event; incorrect product storage (temperature -8.66 C for 42 minutes); This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported.  On 19-AUG-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose, strength, route of administration and anatomical location were not provided) lot # T032315, expiry date: reported as 22-AUG-2022, however it was established as 22-SEP-2022; for prophylaxis. The vaccine underwent temperature excursion of -8.66 degree Celsius for 42 minutes. It was reported that there was also previous temperature excursion (-14.87 degree Celsius for 15 minutes). At the time of report, there was no adverse event (AE) reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA005796: US-009507513-2108USA005928:
Father reported temperatures to 104 degrees, light headedness, lost appetite, head aches with nausea and vomiting for the day after to 7 days after vaccination. No reports of swelling, redness or soreness at the injection site.
Received the COVID-19 Vaccine at approximately 15:03 on 12/30/20. Approximately 5 minutes later, the patient raised her hand to indicate to the monitoring physicians that she was not feeling well. Pt was noted to have mydriasis, facial flushing. Her head tilted back and and she was noted to have decerebrate rigidity. A rapid response was called.  On clinical exam, she was noted to be tachycardic  ( approximately 120's). She was lowered onto the floor. Pt was note to be unresponsive for less than 5 seconds. After she regained consciousness, she was able to indicate that she was feeling  "okay" and communicate. She was initially transferred to a wheel chair and then to a stretcher for transport to the ED.
The site injection given, left thigh has redness of 72mm x 55mm. Patient has pain, fever for 1 day.
Received 0.5ml of H1N1 vaccine instead of 0.25mls. No adverse reaction reported by mom. No treatment needed.
Patient received full dose (.50) of booster 1 of the moderna vaccine. Patient is not immunocompromised and should receive half of the dose (.25) instead. Patient did not note any adverse reaction to the vaccine at the time of administration. This HCP made note of it and advised the patient that a report will be filed.
Bells palsy, right sided; ED Note: 72-year-old male who is presenting with 2 days of right facial droop, not sparing forehead and as such concerning for a peripheral CNS etiology.  On exam, he is hemodynamically stable though slightly hypertensive, saturating well room air no acute distress.  Cardiopulmonary exam is unremarkable, abdomen soft and nontender, lower extremity with very mild trace edema.  On neurological exam, there is a right facial droop which does not spare the forehead, there is otherwise no other focal neurological symptoms, patient able to ambulate without any issues, no slurred speech or dysphagia.  His presenting symptoms is somewhat associated with a COVID-19 vaccine which he received recently.  Do not suspect a CNS pathology (no other symptoms except weakness, sensation intact), given that he has presented within the timeframe, will give patient prednisone 60 mg, artificial tears, eye patch and have recommended that he follow-up with an eye doctor.
Vaccine given 12/5/05 - Pt fussy that day through 12/7/05 when pt very fussy. Pt taken to ED. Seen in our office 12/8 for fussiness.
Mom states that when pt woke up she had a rash around the hairline which progressed down her face and neck. When she woke from her nap the rash had spread down her back and abdomin.
8 hours after I started having severe chills and was freezing and full body aches and fatigue
Large local reaction at site of injection DTaP and induration. 12x9 red indurated warm non-tender area right thigh.