chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Facial edema, angioedema, urticaria with pruritus, and chest pain
Dizziness, Headache, Myalgia, Arthralgia, Fever & NauseaVomiting Narrative:
This spontaneous report was received from a nurse and refers to unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. The nurse reported that between 13-JUL-2015 to the 17-JUL-2015, the unspecified patients were vaccinated with doses of (Oka/Merck) VARIVAX, 0.5 ml, subcutaneously, once, (strength, anatomical location, lot number and expiration date were not reported), which were improperly storage. Other suspect and concomitant therapies were not reported. No adverse events were reported. Additional information has been requested.
A few days after the vaccine I developed an under arm pain that led me to seek med attention from my PCP on 1/11 who scheduled an ultrasound.  The ultrasound found a large lymph node and have a followup scheduled in March
Information has been received from a nurse, referring to an unspecified number of  patients (ages and genders not reported). The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M047519 with expiration date on 04-AUG-2018 (strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. The vaccines had a temperature excursion of 47 Fahrenheit (F) to 77 F during 240 hours, it was also confirmed that the vaccines did not have previous temperature excursions or a digital data logger involved. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA007410; US-009507513-1706USA007411:
severe diaaherra; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diaaherra) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, COPD and Hypertension.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (severe diaaherra). The patient was treated with LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) for Diarrhoea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (severe diaaherra) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were asthma medication, chronic obstructive pulmonary disease medication, and blood pressure medication.
Patient is a 61 year old man, known to Dr., treating for MDS with venetaclax and dacogen, C9 on 12/13-12/17.  He is currently holding for evaluation for cholecystectomy.  He was found to have acute cholecystitis in December, but was determined to not be a surgical candidate at that time due to pancytopenia.  Surgery recommended fu in 6-8wks for OP cholecystectomy.    He has been transfusion dependent.  He was recently admitted overnight to medical center after presenting to facility with hypotension, profound anemia, and hypoxia on 1/25.  He was admitted overnight for stabilization, blood transfusion, and monitoring.   He was d/c on 1/26 after being monitored overnight.  BC on 1/25/22 1/2 bottles positive for staph hemolyticus.  Patient was started on Levaquin 750mg daily and give 2G of vanc x1 on 1/27.  He does not have a port or a PICC line.  Patient presented to the ER on 2/2 w/ weakness and lightheadedness.  ER included CBC that revealed pancytopenia: WBC 2.8; hgb 8.3; plt 22k-- this is about his baseline. LA 3.6, down to 3.0 and PCT 0.5. Blood pressures initially 60s over 40s, HR/O2/respirations have all looked good though. He is on RA.  He is currently off all bp meds since December.  His BPs improved to 90s over 70s with MAPS in the 80s after 2L of LR.  He complains of DOE, weakness, and dizziness when standing or exertion.  Denies abdominal pain, n/v, diarrhea, constipation.  Blood cultures, UA/urine culture, CT CAP are all pending.  Will admit for infectious work up.      DISCHARGE SUMMARY IS PENDING IN MEDICAL RECORDS.
Pt recvd vax & w/in 1 hr of vax pt exp numbness, tingling & pins & needles sensation on the 4th & 5th fingers of lt hand; pt seen by MD & exam was nl; PB 98/65;
Client verbalized feeling nauseous and weak.  Client was evaluated by rescue and released to go home at 10 am.
Child's head shaking side to side/convulsing for 10-30 seconds.  Baby was swaddled so unsure of rest of body.
sore arm; This is a spontaneous report received from contactable reporter (Consumer), Program ID. A 67-year-old male patient received BNT162b2 (BNT162B2), on 14Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "medical condition with the lungs", start date: 2017 (ongoing); "wheelchair" (ongoing); "he has a paralyzed lung that has been stable" (unspecified if ongoing); "has oxygen" (unspecified if ongoing), notes: the lungs that he had already in 2017 and has oxygen for that and that was stable. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1; lot number: ER8737), administration date: 24May2021, when the patient was 66-year-old, for Covid-19 immunization, reaction: "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: He has other underlying health conditions that are under control. The patient received a third and fourth dose.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
appt # 1507818 After my mother returned home approximately one hour after the vaccination, she suddenly did not feel well and lost most of her strength in her legs and could no longer stand.  We placed her in a wheelchair and she then said that her throat was closing up.  She said that it felt like someone was choking her.  A moment later, she felt like her jaws felt huge.  We quickly gave her about four or five large glasses of water  (one right after the other) and quickly took her blood pressure which went up to 170/80.  We then gave her one of her blood pressure pills.  After this, she started to finally feel better.
Patient had vomiting one time the same evening she had the Td and PPD shots given. Also had unrestful sleep.
Chills, dizziness, blurred vision, bones ached, stomach pain, fatigue throughout the night.
Both of them are positive (confirmed as COVID positive); Both of them are positive (confirmed as COVID positive); This is a spontaneous report from a Pfizer Sponsored Program of Pfizer via a contactable consumer (patient).  A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history were not reported. On an unspecified date, after receiving first dose of vaccination, patient was tested positive for COVID-19. On an unspecified date patient underwent lab test of COVID and tested positive. Patient was due for second dose on the date of report and asked if she could take the dose. Outcome of the events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Dark red papular rash 8 days post immunization. Next day targets and central clearing trunk(3rd day on trunk), arms, legs. Dx-erythema multiforme
Cough, shortness of breath fatigue, headaches, congestion or runny nose, lightheaded and sore throat, chills, fever, sinus pressure, sinus pain, diarrhea and nausea, back pain and myalgias
Pain at injection site that spread throughout the day. Major headache, weak/achy limbs by 4pm. Nausea/vomitting started by 9pm same day and continues to present report. No solid food since day of injection. Struggle to keep down water/gatorade/pedialyte/pepto. Currently feeling weak, shaky, and nauseous.
moriblliform rash & fever started 8 day p/vax; rash & fever 103; DPH given by MD;
From 3:00pm on 1/8 to the morning of 1/12, experienced high fevers, severe body aches, chills, fatigue, night sweats, and headache. My heart rate was consistently in the 110s-120s and my blood pressure was in the 100s/40s. My highest temperature was 103.5. My fiancé is a nurse who took care of me at home. I alternated Tylenol and ibuprofen for the aches and fever. I slept the majority of each day and was unable to perform my activities of daily life or exercise. I lost my appetite for about 1 week. I had no sense of taste in Sunday, which slowly returned over the next week. I was concerned about the loss of taste so I scheduled a COVID-19 swab which came back negative on 1/11.
Fever to 104 today after waking from nap-- TYLENOL given night before, and every 6 hours while awake (last dose of TYLENOL was 2 hours prior to highest temp). Fussy, difficult to console (very different from normal disposition). Pulling at ears and hair/back of head. Poor oral intake today (taking 0-1 oz of formula/feed--normal amt is 4 oz). Decreased wet diapers (only 1 all day--only slightly wet).
Red, hot, swollen, itchy left upper, lateral arm Duration 8 days, ongoing
Patient had itching and some redness on the nape, lower lip, upper mid chest, bilateral shoulder and shoulder blades. She said her throat is also itchy.
Uncontrollable screaming for about 1 hour, resolved spontaneously and started again 15 hours later. Infant seen at local ER, who could not R/O intussusception and transported to another hospital. Abd X ray and Abd ultrasound done to R/o intussusception. Infant seemed fine and was discharged from ER.  11/27/06 Received medical records from PCP which reveal patient had 2 episodes of unconsolable crying with a lot of gas.  Took to ER where intussusception was ruled out with abd x-ray & US of abd./ss 11/14/06 Letter faxed to hospital to request medical records/ss 12/4/06 Received medical records from hospital which reveal patient seen in ER 11/6/06 having been transferred from outlying hospital.  Complaints of continuous screaming for several hours.  Eval by ped surgeon in ER & r/o IS. LABS: KUB from 1st hospital reportedly showed diffuse bowel gas & US was equivocable.  Birth Hx: full term vaginal. Dx: colicky abdominal pain & crying./ss
The next morning 1-5-2021 I woke with left arm pain. By 4 pm (approximately 24 hours after injection) I had diffuse muscle and joint pain. The next morning  (post day 2) 1-6-2021 I woke feeling exhausted and could not get out of bed.  After sleeping 3 hours I weighted 1.5 lbs less.
OMG!  I had covid and this was worse!!!!  I got the vaccine at 9am.  around 4pm that afternoon i started feeling sick.  by 7:30pm I was in bed thinking I was going die!   By midnight, I got up and tried to walk to the stairs but i was to weak to walk.  I could not sleep.  I was up for 36 hours!  I was nauseous, dizzy, weak, exhausted.  Every inch of my body had pain!!!  I was tingling all over.  I  had the chills until midnight.  My heart would race and then stop... then race again... I was having difficulty breathing!  I tried standing up but I couldn't.  I would have driven myself to the emergency room but I couldn't walk.  by noon the next day, my heart regulated, I was able to breath easier.  I was still exhausted and full of pain and tingling.  Today, I still have some pain, but no tingling.
Vaccine was given on 2/6/2017 and had expired on 2/5/17. No adverse sign/symptoms occurred after administration.
tested positive for COVID after three doses of Moderna; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for COVID after three doses of Moderna) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022, the patient experienced COVID-19 (tested positive for COVID after three doses of Moderna). At the time of the report, COVID-19 (tested positive for COVID after three doses of Moderna) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, SARS-CoV-2 antibody test: positive (Positive) Positive.         No concomitant medication information was provided. No treatment medication were provided. The patient asked when second booster shot could be administered.  Company Comment: This is a Spontaneous case concerning a patient of an unknown age and gender with no previous medical history reported, who experienced the non-serious unexpected AESI of COVID-19. The event occurred on an unknown date after the third dose of mRNA-1273. Vaccination doses dates were not reported. Clinical course with treatment details were not provided. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2022: Follow up contains no new information.; Sender's Comments: This is a Spontaneous case concerning a patient of an unknown age and gender with no previous medical history reported, who experienced the non-serious unexpected AESI of COVID-19. The event occurred on an unknown date after the third dose of mRNA-1273. Vaccination doses dates were not reported. Clinical course with treatment details were not provided. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.
a patient took 1st shot of moderna COVid-19 vaccine, last week 21MAY2021 and the second dose was given today 29MAY2021.; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient took 1st shot of moderna COVid-19 vaccine, last week 21MAY2021 and the second dose was given today 29MAY2021.) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient took 1st shot of moderna COVid-19 vaccine, last week 21MAY2021 and the second dose was given today 29MAY2021.). On 28-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient took 1st shot of moderna COVid-19 vaccine, last week 21MAY2021 and the second dose was given today 29MAY2021.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
The patient fainted and threw up and her friend called EMS.  The patient refused the ambulance when they got there.  She did go she her primary and cardiologist the next week and they are doing a full work up.
This spontaneous report was received from a registered nurse regarding multiple unspecified patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with VARIVAX, lot # L028278, expiration date- 28-JUL-2017, lot no. L002121, expiration date- 10-JUN-2017 and lot #L019126, expiration date- 27-MAY-2017(incorrect product storage). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. Temperature -3 degree Celsius, Time frame was 6 hours and it was back in range. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
The patient experienced vasovagal syncope about 10 minutes after receiving the Pfizer BioNTech vaccine. Medical staff assisted the patient by checking response and lifting legs. Patient quickly regained consciousness in about 2 minutes. Patient rested and monitored for another 15 minutes. Symptoms did not return and patient was able to go home.
This spontaneous report was received from a male consumer of unknown date reporting on himself. The patient's medical history included an unspecified vaccine when younger (date and name unspecified), and then received it a second time later on in his life (date and name unspecified). On an unspecified date the patient was vaccinated with a dose of M-M-R II (dose, route, lot number and expiration date unknown). On an unknown date patient had negative results when tested for measles titers after receiving the M-M-R II. The outcome of negative measles titers was not reported. The relationship between the M-M-R II and the negative measles titers was not reported. Additional information is not expected.
Received DTP on 8JUN90 & had prolonged fever for a week's time
Allergic reaction to histamine. (Fermented foods, Tomatoes,  Eggplants, Spinach)
This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE (Insomnia due to pain and tenderness), the first episode of VACCINATION SITE PAIN (extreme pain and tenderness at the injection site of her left arm) and the second episode of VACCINATION SITE PAIN (extreme pain and tenderness at the injection site of her left arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included Bladder cancer (patient was diagnosed with bladder cancer five years ago), Sleep restless (patient is a restless sleeper.) since an unknown date and Cancer surgery (three surgeries to remove numerous tumors).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 07-Apr-2021, the patient experienced SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE (Insomnia due to pain and tenderness), the first episode of VACCINATION SITE PAIN (extreme pain and tenderness at the injection site of her left arm) and the second episode of VACCINATION SITE PAIN (extreme pain and tenderness at the injection site of her left arm). At the time of the report, SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE (Insomnia due to pain and tenderness) and the last episode of VACCINATION SITE PAIN (extreme pain and tenderness at the injection site of her left arm) outcome was unknown.    No concomitant medications were provided. No treatment medications were provided. Per patient the day after receiving the vaccine she felt fine and went shopping. During her shopping experience she did lift two cases of water. That evening, she started to feel extreme pain and tenderness at the injection site of her left arm. Patient reported after 1st dose she had no symptoms. It was injected in Right arm.
I received my second dose the evening of January 21. On the morning of January 22, I had only soreness of my left upper arm which was my only symptom with the first dose. But, about 2 pm today I began feeling malaise, achy, low grade temp and just don't feel well.
Narrative:  71yr h/o orthotopic heart transplant on immunosuppression (MMF, tacro), HTN, HLD, who presented as a transfer for COVID pneumonia + presumed CAP. Was on BiPAP 80% FiO2 due to worsening O2 status with RR in the 30s upon transfer to the agency hospital from another facility then transitioned to HFNC/CPAP at 50L/50%. COVID Therapeutics: Dexamethasone 6mg po daily and remdesivir x 5 doses and 1 dose of INV baricitinib. COVID Vaccination Status: Moderna (1/22 and 2/19) and received 3rd dose (9/24). Was fully vaccinated though doubtful mounted adequate immune response with 3rd dose given administered 3 days prior to admit. Hospitalization stay:24 days
within three hours of injection shoulder pain, fever spiking as high as 102 degrees,   fever  with spikes of up to 102 lasting for a period of about 8 days. Nausea and vomiting on day 4 after vaccine injection, increasingly   intense shoulder pain starting about 1 week after injection.  Prescription of Acetominophen and Ibuprofen eventually resolved fever, but not shoulder pain. Sudden facial drooping - visit to emergency room and diagnosis of Bell's palsy- three weeks after injection, resolved after 12 day course of Prednisone.  Currently ongoing  left shoulder weakness, limited, reduced range of movement,  loss of coordination and pain both when using and when resting left arm ( the injection site arm).
Chest pain, shortness of breath, wheezing, fatigue. Sx severe for several days, then waned, completely recovered as of 6/22/2021
Seriousness criteria: other-medically significant.  Initial non-serious report received from a consumer on 08 November 2007.  A male patient (age and date of birth not reported) had received a dose of flu vaccine (trade name, lot number, route/site of administration not reported) on an unspecified date in 2007 and approximately two weeks post vaccination, he started to develop a tingling sensation in the crown of his head, sometimes accompanied with headaches and dizziness.  The patient had experienced similar symptoms following flu vaccinations the previous two years.  At the time of the report, the symptoms were not yet as severe as last year.  No additional information was provided.  Follow-up information received on 04 December 2007 from the patient.  Following review of the reported events, this case was upgraded to serious.  A 62-year-old male patient had received a left deltoid, intramuscular injection of Fluzone Sv 2007-2008, lot number not reported, on 14 October 2007.  No other vaccines were administered within four weeks of the 14 October 2007 vaccination.  At the time of vaccination, the patient had a staphylococcal infection in his mouth.  Past medical history included leukemia which was in remission.  Other medications at the time of vaccination were none.  Fourteen days post-vaccination, the patient experienced a tingling/numbness sensation in the crown of his head, unspecified effects on balance, and blurry vision.  The current symptoms were reported as moderate to severe and wake the patient at night.  The event required examination by a physician.  At the time of this report, the patient had not recovered.  Contact information was provided for the patient's personal physician.  (The patient had been seen by a neurologist after experiencing events post-vaccination in 2006; and, at that time, an unspecified CAT scan was negative.  Per the reporter, "symptoms" had occurred in 2005 and 2006 following Fluzone vaccination and lasted eight to nine months).  The reporter of this case is the same as for cases 2007-03791 and 2007-03792, which involve the same patient who experienced tingling sensation in the crown of the head, headaches and dizziness following receipt of flu vaccine (trade name not reported) in 2005 and 2006.