chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 75 y.o. female with history of  ESRD presented to the Hospital with shortness of breath.  Patient admitted with acute hypoxic respiratory failure secondary to fluid overload from missed hemodialysis as well as found to have COVID-19 infection, sepsis with possibility of bacterial pneumonia.   Acute hypoxic respiratory failure  Likely due fluid overload COVID 19 infection  Chest X ray showed: Mild vascular congestion is suggested.There appears to be increased density in the left lung base which may be due to a small left-sided pleural effusion.  There could be underlying atelectasis or infiltrate. -Overnight respiratory status decompensated, placed on BiPAP -Likely due to pulmonary edema from missed hemodialysis -S/p hemodialysis with improvement -Weaned down to 2 L O2 -Given high O2 requirement, elevated procalcitonin also initiated on broad-spectrum antibiotics. -Continue to wean O2 as tolerated, aggressive pulmonary hygiene. Qualified for home O2 at discharge     Covid-19 Virus Infection Date of onset of symptoms: Unknown Symptoms present on admission: Yes Date of covid positive test: 1/19/2023 Vaccination status: vaccinated Imaging: Chest x-ray with increased density left lung base Oxygen requirements on admission: Nasal cannula 2 L Current oxygen requirements: 6 L NC Medical therapy: remdesivir and steroids Finish 10 day course of dexamethasone. Completed 4 days of remdesivir Consultants following: Infectious disease Anticipated special isolation end date: 1/29/2023  SIRS- sepsis ruled out Possible CAP -Leukocytosis noted at 15 suspect reactive -Procalcitonin 0.8, CRP 27 -Given mildly elevated procalcitonin,  and SIRS  started on ceftriaxone and azithromycin -Continue to monitor -patient oliguric - Improved over all - Transitioned to oral antibiotic for total 7 days   ESRD  Hyponatremia likely hypervolemic  Hyperkalemia on MWF Follow nephrology recommendations regarding hemodialysis Improved overall   GERD On Protonix    Typ II DM insulin-dependent Hold glipizide Monitor insulin sliding scale Stable   Essential HTN  Not clear if she is on Norvasc or Nifedipine Hold losartan and Norvasc Continue with labetalol and nifedipine Stable BP   Elevated troponin  Likely due to ESRD
2am the night the shots given broke out in rash on trunk and arms, itching, eyes burning. Saw Dr told allergic reaction to one of the 3 shots given told to use Benadryl caps 3x day.
Administration of expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs were reported. Reporter stated that no treatment was given to the patients.  Reporter stated that vaccine was stored in freezer and took out one or two vials. The vials were placed in fridge as needed.
Swelling and redness at the injection site, spreading in size. Localized  itching, area is hard and hot to touch.
-very sore in right arm where it hurts to move it, and the pain travels up into my throat -pain in throat (same as the pain in the R arm) -chills; feels like there is ice in my chest and throat; no associated fever currently on 3/9 evening (reporting this around 8pm EST) =progressively getting more fatigued and not like being tired at the end of the day, but a drowsiness -off and on headache that lasts for a short period of time, increasing in frequency
Arm pain; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) and LYMPHADENOPATHY (Swollen lymph nodes) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included IBUPROFEN for an unknown indication.  On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and LYMPHADENOPATHY (Swollen lymph nodes). The patient was treated with IBUPROFEN for Pain in arm, at an unspecified dose and frequency. On 15-Jan-2021, PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Day 1 and 2 extremely tired; hard to focus Day 3 very tired Day 4 diarrhea
SIGNS/SYMPTOMS Chest pain/angina SOB Reduced Ejection Fraction  TREATMENT ECHO ECG/EKG Nuclear stress test Left heart catheterization Heart Monitor
Began with local redness at site of injection on (R) thigh. No fevers. No fussiness. Exams showed pink, poorly demarcated patch surrounding injection site. No meds given.
Left outside of tongue became slightly numb.  Numbness continued to left side of mouth on left lips side.  Felt like the wearing off of a novicane shot.
Dizziness, near syncope, low blood pressure, headache, body aches, chill, and arm pain
Headache; nose that runs like a faucet; Chills; Sore throat; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown) via an unspecified route of administration on 26Mar2021 as 2ND DOSE, SINGLE DOSE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient took first dose of bnt162b2 (Solution for injection, Batch/Lot number was not reported) on an unspecified date for Covid-19 immunization. It was reported that, She got the second dose of the Pfizer covid vaccine on 26Mar2021. Starting last Saturday she got a headache, a nose that runs like a faucet and chills. She started off with a sore throat in 2021 and that went away. Also reported that, She did not know if it was from the vaccine or if she was sick from something else. Her family thought,  it too long after the vaccine to experience side effects. She was asking if this was normal to experience this long after the second dose. She breezed right through her vaccines. Outcome of the event, 'sore throat' was recovered on 2021 while for other events was unknown.   Information about batch/ lot number has been requested.
Rash covering 90% of body appeared 10 days after 2nd shot; Treatment was described earlier in this document but have been seeing dermatologist since February initially e/o week; still fighting rash on legs and hands;  (please contact Dr.  at  Dermatology office for detailed treatment and list of medications administered and some still in use to fight the disease.
Red, very itchy, swollen eyelids 3 days after receiving the vaccine. Right eyelid was worse than left eyelid.
Extreme muscle pain, extreme tiredness, total loss of apatite, intermittent headache, occasional shivering, occasional sweating, confined to bed for 36 hours, took no food for 48 hours, 50% resolved after 48 hours, 90% resolved after 72 hours
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13 (Lot number: T78676, Expiration date: Feb2020), via an unspecified route of administration on 01Dec (year unspecified) as a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on 01Dec and came into the pharmacy on 06Dec with a reaction of just redness and itchy. The area extended from the shoulder to about 2/3 of the way down the arm. No pain or swelling, just redness and itchiness. The outcome of the events was not recovered.
No additional AE reported; M-M-R II has been administered to a patient since the excursion occured; This spontaneous report was received from a nurse referring to a patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided.     On 09-JUN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status of recombinant human albumin (rHA)) (M-M-R II) (strength, dose, route were unknown, lot # T007235, expiration date 27-FEB-2022) for prophylaxis since the excursion occurred. The temperature was 53 Fahrenheit degree for 1 hour and 15 minutes. There was no previous temperature excursion. The call was because of a data logger. No additional adverse event or product quality complaint was reported.
This is a spontaneous report from a contactable healthcare professional, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 30Mar2021 at 10:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not allergic to medications, food or other products. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 09Mar2021 at 10:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. 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 25Mar2021, the patient underwent a Nasal Swab test (colour anterior nares PCR Test) and the result was found to be Negative. On 01Apr2021 at 18:30, the patient experienced Axillary adenopathy - swollen lymph tissue across left underarm. The patient did not receive any treatment for the reported event. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome for the event axillary adenopathy was recovering at the time of the report. No follow-up attempts are needed. No further information is expected.
Patient went to the hospital Monday.  He received the Janssen single-dose Covid vaccine on Thursday, April 8 and by Saturday, April 10 he was starting to develop fairly significant peripheral edema without any breathing  difficulties.  This  persisted and was worse by Monday, April 13  EKG showed global nonspecific T-wave abnormalities and ST segment changes so I had him sent to the ER. As it turned out he had a pancytopenia (mostly neutropenia and thrombocytopenia) so he was admitted to the hospital. This seemed to resolve pretty much on its own and so they attributed everything to his hepatitis C. Indeed his LFTs are elevated in the 300 range and imaging showed  hepatosplenomegaly.  they also did a bone marrow biopsy for which there are no results yet
This spontaneous report was received from a nurse via a company representative and refers to a 11 (reported as 11 years and 11 months) year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-AUG-2017, the patient was vaccinated with a dose of GARDASIL 9 injection, intramuscularly (strength, exact dose, lot # and expiration date were not reported) for the prevention of human papillomavirus (HPV). The patient was also administered with doses of meningococcal vaccine (unspecified) and diphtheria toxoid (+) pertussis vaccine (unspecified) at the same time, but in the opposite arm. On the same day, the patient fainted after being administered with GARDASIL 9. The patient was in the office at time of the adverse event. The patient's vitals were checked, and coherence questions were asked, she was then given a popsicle. The patient recovered 30 minutes after the injection. Causality assessment was not provided.
Strange dreams (vivid and more frequent); Mouth seems to be more irritated; Tongue feels bigger/swollen; Sense of smell is stronger; Toothache; Rush of energy; Arm was sore; Felt foggy; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Felt foggy), ENERGY INCREASED (Rush of energy), ABNORMAL DREAMS (Strange dreams (vivid and more frequent)), ORAL DISCOMFORT (Mouth seems to be more irritated) and SWOLLEN TONGUE (Tongue feels bigger/swollen) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to chemicals.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced FEELING ABNORMAL (Felt foggy). On 16-Jan-2021, the patient experienced INJECTION SITE PAIN (Arm was sore). On 17-Jan-2021, the patient experienced ENERGY INCREASED (Rush of energy). On 25-Jan-2021, the patient experienced TOOTHACHE (Toothache). On an unknown date, the patient experienced ABNORMAL DREAMS (Strange dreams (vivid and more frequent)), ORAL DISCOMFORT (Mouth seems to be more irritated), SWOLLEN TONGUE (Tongue feels bigger/swollen) and PAROSMIA (Sense of smell is stronger). At the time of the report, FEELING ABNORMAL (Felt foggy), ENERGY INCREASED (Rush of energy), ABNORMAL DREAMS (Strange dreams (vivid and more frequent)), ORAL DISCOMFORT (Mouth seems to be more irritated), SWOLLEN TONGUE (Tongue feels bigger/swollen), PAROSMIA (Sense of smell is stronger), TOOTHACHE (Toothache) and INJECTION SITE PAIN (Arm was sore) outcome was unknown.        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.   No relevant concomitant medications were reported. Treatment details included Ice; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
patient developed a black ring around the injection site the size of a nickel. The inside part was necrotic with pus and was about a dime size. It was extremely sore and bruised. This has not ever happened with the other Covid vaccines he has had. By 10/30 the pain was getting better
Bright red rash and swelling all over upper arm and around injection site with severe body aches and pains and fatigue.
lost all of my body hair; This is a spontaneous report from a contactable consumer. This male consumer (patient) of unknown age reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose 1, single and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 24Mar2021 the patient lost all of his body hair. He had questions about the third vaccine shot and asked if reported side effect and if those individuals who have reported had received the third dose. The event outcome was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101253532 Pfizer
Moderna administered at 17:22.   1740: Patient states that she is itching. Patient states that she has had panic attacks in the past and "this feels like a panic attack." She has "felt like this before" when she had another medication, but she can not remember what medication it was. "When this happens, then I go to the ER." She can not take benedryl due to increasing her HR and causes difficulty breathing.   She currently has redness on her back and is itching on her arms and legs. No audible wheezing.   17:40: 140/58 BP 94% SPO2 88 HR   Lungs clear to ascultation. Denies difficulty breathing. Denies throat itching or throat swelling. Patient is able to speak in full sentences and is AOx4.   Patient states that her lips and nose are itching.   Back has redness. She is itching and scratching on her arms, legs, back, chest. I offered cool towels. Unable to administer PO benedryl due to patient stating that she "can not take benedryl, Claritin, or zyrtec."   I asked if I could call her husband in, and she agreed. Another staff member went out to get husband.   17:52pm: Patient is states that her "throat feels funny" and she starts to vomit clear emesis/sputum. She is still itching. Patient is not able to speak in full sentences due to coughing and stating that she is having more difficulty breathing.   No wheals or bumps on skin. Face and back with redness.   EMS called.   2L NC put on for comfort: 1752 HR 104 156/67 99% on 2L NC.   1800: EMS arrived. Report and handoff given. Face sheet given to EMS.  Pt received steroids in ER. PCP visit on 3/12/21 PCP visit, still had rash.
fever of 104 R for 3 days follwoing vax; also had body rash, poor appetite, & did not sleep well for 7-10 days; was seen by family MD in office 15OCT; treated w/APAP;
Bloody diarrhea; Surgery for bowel obstruction, intusseption.  2/2/09 Received hospital medical records of 10/27-10/29/2008. FINAL DX: complete small bowel obstruction, ileocolic intussusception, s/p open laparotomy. Records reveal patient experienced abdominal pain, vomiting, diet refusal, decreased activity & rectal bleeding x 1 day.  Had been seen at outlying ER & transferred to higher level of care.  Noted to have mild dehydration on admit.  Surgical consult & taken to OR.  Progressed well & d/c to home.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-083155 (Patient Link).
On the 30th I started getting a full body itching, My scalp legs and feet and my whole body. that lasted a week and I went to see the dermatologist about a week a go and she diagnosed me with Dermatographism and Hives. Now my skin it'll leave red marks like I scratch my skin. She said this is potentially from the vaccination. The itching went but the red patches is still there. She also gave me Zyrtec until the problem resolve so I'm still taking it.
Body aches, entire head ache, congested, sore eyes that lasted 36 hours
The morning after vaccine was given, swelling , 2 inch diameter rash, and warmth occurred around the site. Both of her arms and legs felt asleep and heavy.  This continued and got a little better, but continued, and on 10/16/20 she called to report the reaction.  She said she was still having pain and weakness in  joints of both hands and both ankles which is worse in the mornings.
Nauseous; Diarrhea; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 14:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient was not allergic to medications, food, or other products. Concomitant medications included NEW CHAPTER PERFECT POST NATAL, ATRANTIL and Cannabidiol (CBD) oil. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 15:00, 24 hours after shot, the patient started feeling very nauseous and then she had diarrhea and vomiting. The nausea stayed for 4 days. she was not sure if this was from the vaccine or not. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events diarrhea and vomiting was not resolved. The clinical outcome of the event nausea was resolved on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Headache; Was achy; Lump on her arm at the injection site; Not feeling well /  feeling awfully sick; She was tired / She feels exhausted; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2019, the patient received the 2nd dose of Shingrix. On 17th September 2019, less than a day after receiving Shingrix, the patient experienced feeling unwell and tiredness. On 18th September 2019, the patient experienced headache, pain and injection site lump. On an unknown date, the outcome of the feeling unwell, tiredness, headache, pain and injection site lump were not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, tiredness, headache, pain and injection site lump to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right arm.  The patient received her second dose of Shingrix, on day before reporting and last night she was not feeling well and she was tired and she felt exhausted.  The patient described her experience as feeling awfully sick on day of reporting. The patient went to bed at 8:30 PM and she awake with a headache and was achy.  The patient also reported a lump on her arm at the injection site. The reporter consented to follow up. In the XML document outcome of events was reported as recovering, but in system its mentioned as not recovered, so kept as reported in system.
1400 Client had a vagal response to in injection approximately 90 seconds after injection.  Client fell out of chair of chair onto floor hitting her head, no injury noted to head.  Client helped to her left side, then came conscious and set up.  1402 vitals b/p 102/64 hr 80 pso2   98%   Client taken to wheel chair to cot  to lie down.  b/p 108/76 pulse 90 pso2   alert and oriented x3 Due to hitting head from fall taken to ER via wheel chair for follow up care.   Parents called