chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I tested positive for COVID-19 on 11/23/22. I had a sore throat, congestion, difficulty breathing, a terrible headache, and a terrible cough. I was prescribed Prednisone and Paxlovid. I am feeling much better, but I am still dealing with most of the symptoms.
I saw the patient 12/26/07 for new onset of moderate to severe exercise induced bronchospasm.  She has no atopic history, no history of allergies, eczema or asthma and no family history.  Symptoms developed about 6 weeks after receiving her first dose of Gardasil.  I have begun her on empiric therapy, yet am concerned her condition may have been prompted by the Gardasil.  She had her second dose, however, this past week before I became concerned about a connection between the vaccine and her bronchospasm.  I am following her very closely.    1/11/08 Reviewed office notes of 12/28-30/2007 which reveal patient experienced exercise induced bronchospasm.  Telephone conf w/parent revealed patient getting very SOB & winded w/minimal exertion despite meds & inhaler.  Referred to pediatric pulmonologist.   2/19/08 Reviewed outpatient clinics medical records which reveal patient initially seen by pulmonogy 1/3/08.  Had SOB & dyspnea w/onset of any vigorous exercise, 1st occurring 6/2007 & 8/2007 both times after biking long distance. Then in 12/2007 developed SOB w/stridor, thoat pain & chest pain while running in soccer. PCP had placed on dual inhalers w/o any improvement in s/s.  Dx w/probable vocal cord dysfunction.  Inhalers d/c & referred to laryngologist.  Seen by laryngology on 1/23/08.  Dx w/paradoxical vocal fold motion.  Referred to cardio & speech tx. FINAL DX:  paradoxical vocal fold motion.
Pain, redness, swelling in the 48 hours following the shot. Seven days post injection onset of itching, large rash, heat at injection site, and arm pain.
Hot to touch at injection site; flu like symptoms; Not feeling well; Rash at injection site; COVID ARM (Tropical red Puffy Hot Skin); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch at injection site), INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (Not feeling well), VACCINATION SITE REACTION (COVID ARM (Tropical red Puffy Hot Skin)) and VACCINATION SITE RASH (Rash at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031620A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 09-Mar-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 WARMTH (Hot to touch at injection site), INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (Not feeling well), VACCINATION SITE REACTION (COVID ARM (Tropical red Puffy Hot Skin)) and VACCINATION SITE RASH (Rash at injection site).   At the time of the report, VACCINATION SITE WARMTH (Hot to touch at injection site), INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (Not feeling well) and VACCINATION SITE RASH (Rash at injection site) outcome was unknown and VACCINATION SITE REACTION (COVID ARM (Tropical red Puffy Hot Skin)) had resolved.      Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-086745 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Patient's mailing address updated, second dose details updated and event information added.
On 8/21/00, the pt developed a temperature of 101 which lasted 5 days. Also, she had swelling of her knees and she couldn't walk it was so painful.
09/22 COVID vaccine dose #1 10/21 COVID vaccine dose #2 01/19/22 pt reports to PCP that he received moderna vaccine, per two dose on sept and Oct/21 but developed memory problems, heart inflammation (Palpitations), with sob, high fever, eyes burning, clumsy, ha, lymph node painful, fatigue, nauseas, cough, sore throat, loss of smell/taste that was developed after covid, but according to pt. Also burning sensation that last up to Nov/21,
Covid Arm - red arm circle around injection site, whole arm sore, few small bumps like hives
dizziness; shortness of breath; her throat is tight; Sore Arm; Swollen; Warm/Hot; Painful; has a sore arm with swelling and warmth; has a sore arm with swelling and warmth; Sore Arm; Swollen; Warm/Hot; Painful; This is a spontaneous report from a contactable consumer reporting for herself. A 42-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 27May2021 10:00 (Batch/Lot number was not reported) as single dose (age at vaccination 42 years) for covid-19 immunization. Medical history included covid-19 from Jan2021 to Jan2021. The patient did not administer additional vaccines on same date of the Pfizer Suspect. Family Medical History Relevant to adverse events (AEs), AEs following prior vaccinations and Prior Vaccinations (within 4 weeks) was reported as none. There were no concomitant medications. It was reported that, got 1st dose and on 27May2021 at 19:00. she has dizziness and Shortness of Breath feels like she was kind of holding her breath; feels breathing pressure. It feels like when she has a food allergy. Her throat was tight. She has a sore arm with swelling and warmth. Also reported as Sore Arm; Swollen; Warm/Hot; Painful. Patient stated, she was concerned, and she knows she has to report it, but most people have common things like arm pain and fever. Caller asking if this is a normal reaction of if she should be concerned, she has had Covid before and this feels worse. Caller states she was also concerned because her kids were getting their shots next week and she doesn't want them to feel like this. Caller states when she feels breathing pressure, she starts freaking out. Treatment: None. Caller states she opened the windows and laid back to try and open the airway. Caller states she doesn't know if she should go to the hospital or not. Caller states she was searching for information, but it didn't seem to be a common side effect. Caller states is feels like she is kind of holding her breath. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Jan2021. The patient did not visit Emergency Room for AE. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Patient reports his back started hurting the day after the vaccine.  He states it feels like a muscle reaction.  He states that he cannot walk without the pain.  When he applies heat it feels better, but the pain returns to prior level after the heat is removed.
Patient is a 39 y.o. male who is Covid vaccinated, who presents today with shortness of breath has been ongoing for last week.  He has had a 2-day history of loss of taste and smell.  He now is having dyspnea at rest.  He endorses multiple other viral symptoms.  On exam, he is tachycardic and has a low fever.  His work of breathing has slightly increased.  Lungs are clear with good breath sounds.  IV was started.  Labs were drawn.  He was treated with oral Tylenol.  X-ray reveals infiltrates to suggest pneumonia.  Unfortunately, his Covid screen came back positive.  Certainly, his clinical symptoms are most suggestive of Covid infection.  Given the x-ray findings, however I am concerned about a bacterial suprainfection, thus he was started on cefdinir and Zithromax. After hydration and antiparesis here, the patient does feel improved.  I discussed with him the diagnosis.  I discussed with him the use of a pulse oximeter.  I think at this point he can be discharged, but understands that he needs to return for worsening symptoms.
Resident tested positive for COVID on 01/06/2021. Resident received out patient IV fluid bolus (D5NS 1 liter) on 01/15/2021..
Initial information received on 02-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional (medical assistant). This case is linked to cases 2018SA182241, 2018SA182252, 2018SA182253, 2018SA182254 and 2018SA182255 (same reporter). This case involves an Infant patient (age and gender not reported) who received 0.5 ml dose of IPOL lot N1K931M via Intramuscular route on an unknown date, which reached 52.8 F, for 43 minutes, product reached 48.2 F for greater than 30 minutes. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to product storage error. Laboratory test was not reported. It was not reported if the patient received a corrective treatment. 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. Document held by sender: None.
Pt. reports swelling by evening after vaccine, tender to touch and stiff upper arm, followed by erythema the next day. Seen in clinic 99 temp, defined redness deltoid to elbow, then to clavicle. 3 cm difference in bicep but is right hand dominant.
Patient presented to ER the following day after receiving first dose with hemolytic anemia.  He is still receiving work-up, but at this time, the cause of this event is unknown.
About 15 minutes after vaccination, patient reported symptoms of lightheadedness and feeling flushed.  BP was high but otherwise vital signs within normal limits.  Symptoms resolved.
4 hours post: significant headache and beginning body aches. 10 hrs post: severe body aches, significant chills/rigors, temp 102.6 with 800 mg Ibuprofin on board for headache, cold sweats. Mild headache remains until morning 12/30/20.
A pharmacist reported that a 2 month old male received Acel-Imune, Comvax and IPV vaccines. 10 days post vax, the infant developed a cough, fever, and irritability. The infant was seen by a physician and a chest x-ray was performed. The x-ray revealed an enlarged heart, which had been of normal size at birth. A diagnosis of cardiomyopathy was made, and the infant was hospitalized at a tertiary care center to undergo heart transplantation. Copies of this report have been forwarded to the manufacturers.
ADMINISTRATION ERROR: PATIENT WAS ELIGIBLE FOR BIVALENT COVID VACCINE BUT WAS ADMINISTERED NON-BIVALENT COVID VACCINE, FACILITY, PATIENT AND PRIMARY DOCTOR ARE BEING INFORMED. WILL FOLLOW UP TO SEE IF PATIENT/DOCTOR WANTS BIVALENT BOOSTER ADMINISTERED IN 2 MONTHS
12/18 VACCINATION 12/23 CAME HOME AT 7:30 AM FROM WORK. MY BODY WAS HURTING, SORE. SLEPT. WOKE UP 9-10; VOMITING BODY ACHES, HA. WENT TO ER. COULDN'T KEEP ANYTHING DOWN, EVEN MEDICINE.  GAVE ZOFRAN, COVID TEST (NEGATIVE) FELT LIKE I WAS KNOCKED OUT. DIDN'T GET OUT OF BED FOR DAY. TEMP GOT UP TO 102. WITH TYLENOL, IBUPROFREN. BODY WAS SORE. THESE SYMPTOMS ARE STILL PRESENT. LINGERING COUGH.  1/1/2021 FEVERS. LASTED 1-2 DAYS.  MUNICEX FOR COUGH AS NEEDED.  NOT 100% BETTER, MAYBE 95%
Breast became extremely sore. Mostly the left one. Also nausea and not feeling well.
pt recvd vax & 20 days later exp a macular eruption on trunk & extremities which has not subsided;
09/03/2021 Severe headache. My legs and arms started feeling really heavy on 09/05/2021 and I had to go to a different Hospital because I couldn't walk and headache was severe, I went to Hospital. The first hospital I didn't feel too comfortable, and it isn't as advanced as the second. I was also seen 09/08/2021 due to not being able to walk and headaches and it's still ongoing since then. I now see a neurologist, cardiologist, and psychiatrist due to the previous symptoms. I can only stand for no more than 5 minutes and walk with difficulties. I have never in my life been this sick or had any health issues until I got this vaccination. I feel like I'm going crazy with so many tests.
Acute-onset pressure-like 3-5/10 mid-sternal non-radiating chest pain worth with inspiration associated with palpitations and light-headedness
Experienced chills, hot flashes during evening and night. Syncopal episode this AM. Examined by MD. No cause for symptoms revealed on exam. No further treatment.
Information has been received from a consumer and a school nurse concerning 41 child patients who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approximately 2003, the patients developed mild cases of chickenpox.  Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that has experienced a chickenpox outbreak. The reporter notified the elementary school parents of the outbreak. Follow up information from the nurse indicated that 13 of the reported 41 patients were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chickenpox have recovered. One of the previously vaccinated patients was a 9 year old patient who on 08AUG1995 was vaccinated with a dose of varicella virus vaccine live. On 14MAR2003, the patient developed chickenpox. The previously vaccinated patients included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chickenpox. The other patients that developed chickenpox post vaccination with varicella virus vaccine live were also identified.  Additional information is not expected.
Pt reported feeling anxious because of light headed episode @ home after 2nd dose Pfizer.  Pt reported flushing/sweating and dizziness.  Pt was clammy to touch and pt state that he was breathing rapidly (not observed by RN) Vitals: 13:54 133/78, 59, 20, 98% -- > 14:06 135/76, 60, 18, 98% Pt walked to med bay and laid supine on cot until lightheadedness resolved.  Pt sat up and was given water and juice.  Pt reported feeling better and no more lightheadedness.  Pt ed. provided.  Pt left facility via ambulation, with steady gait, accompanied by staff.  NAD @14:10.  Pt stable and released from the vaccination site.
Headache, Myalgia, Arthralgia, Fever, flu-like symptoms Narrative: flu-like symptoms and missed 2 days of work after second dose.
First shot: immediately nauseous and slight headache. Within 5 hours felt run down. 8 hours later very dizzy for 8 days non stop. Still get dizzy laying down.  Second shot: very minimal headache immediately. Within 8 hours developed 101° fever, pressure headache and body aches in neck, shoulder, back and legs.
This patient received his first Moderna vaccine today, 6/18, however, it was discovered after administration of the vaccine that he is under the age of 18. The patient was observed for a total of 15 minutes post-vaccination and there were no reactions, complaints, or complications. For Item 20 - I entered unknown as there was no adverse drug reaction prior to his departure from the vaccine event which was offsite.
This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (muscle weakness), CHILLS (chattering chill), HEADACHE (headache) and PYREXIA (fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced MUSCULAR WEAKNESS (muscle weakness), CHILLS (chattering chill), HEADACHE (headache) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Feb-2021, MUSCULAR WEAKNESS (muscle weakness), CHILLS (chattering chill), HEADACHE (headache) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-075700 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075700:second dose
Took her first and second dose consecutively; Took her first dose of Vivotif with food; A spontaneous report was received from a nurse practitioner on 08NOV2022. It described a 51-year-old female patient who "took her first dose of Vivotif with food" (PT: Wrong technique in product usage process) and "her first and second dose consecutively" (PT: Inappropriate schedule of product administration). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: 3003687) for immunisation. It was reported that the patient took her first dose of Vivotif with food on 03NOV2022 followed by the second dose on 04NOV2022. Reportedly, the patient did not experience any side effects. The outcome of the reported events was not applicable.  Action taken with Vivotif with respect to the reported events was not applicable.  No additional information was reported.  Company comment: It was reported that a patient took her first dose of Vivotif with food (wrong technique in product usage process) and took her first and second dose consecutively (inappropriate schedule of product administration). Vivotif dose should be taken at least one hour before a meal and should be taken every other day, and the causality of wrong technique in product usage process and inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a patient took her first dose of Vivotif with food (wrong technique in product usage process) and took her first and second dose consecutively (inappropriate schedule of product administration). Vivotif dose should be taken at least one hour before a meal and should be taken every other day, and the causality of wrong technique in product usage process and inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non-serious as per medical assessment.
Within a few hours of the shot, my right shoulder froze up. I could not lift my arm at all at the shoulder joint. The pain was intense. I was unable to sleep in a laying down position. I had go sleep sitting up.  The pain continued to get worse over the following week, with no ability to move my shoulder joint.
Patient was sitting in her seat and may have lost consciousness or zoned out for a minute after receiving her Flublok vaccine.  She regained consciousness upon her name being called out. Her temperature initially was 97.8F and lowered to 96.8F within approximately 5 minutes and stated that she is experiencing some shortness of breath. After remaining in her seat and drinking some water, within 15 minutes, patient recovered and had no other issues.
Patient got edema in the feet and legs on 9/1 and hasn't resolved as of 9/3/19
Covid vaccine documentation: PT admitted 12/11/21 ? 12/13/21. POC SARS COV2 ANTIGEN POS 12/11/21. PT had symptoms 10 days prior to arrival. History of COPD pn oxygen at home. PT received bamlanivimab. PT discharged home 12/13/21. Moderna dose 1 3/17/21 Lot 006B21A. Moderna dose 2 4/14/21 Lot 036B21A.
Dizziness, Anaphylaxis, UrticariaPruritus & NauseaVomiting Narrative:  Patient complained of nausea and numbness and tingling in fingertips 5 minutes after administration of vaccine and proceeded to bathroom. Patient with unwitnessed vomiting prior to RN assessment. RN assessed patient and taken safely to private evaluation room. AED pads applied per protocol. Epi-Pen administered. EMS called. Vital signs stable. Patient complained of itching and erythema in left arm around injection site. MD evaluated patient and advised to be further assessed in ER. Patient continuously evaluated by RN and EMS. Patient transported to ER in stable condition.
burning to left eye; blurry vision to left eye; jaw pain to the left side of her mouth; lower back pain; chills; headaches; muscle aches; fever; This spontaneous case was reported by a nurse and describes the occurrence of EYE IRRITATION (burning to left eye), VISION BLURRED (blurry vision to left eye), PAIN IN JAW (jaw pain to the left side of her mouth), BACK PAIN (lower back pain) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-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 1 dosage form. On 07-Apr-2021, the patient experienced EYE IRRITATION (burning to left eye), VISION BLURRED (blurry vision to left eye), PAIN IN JAW (jaw pain to the left side of her mouth), BACK PAIN (lower back pain), CHILLS (chills), HEADACHE (headaches), MYALGIA (muscle aches) and PYREXIA (fever). At the time of the report, EYE IRRITATION (burning to left eye), VISION BLURRED (blurry vision to left eye), PAIN IN JAW (jaw pain to the left side of her mouth), BACK PAIN (lower back pain), CHILLS (chills), HEADACHE (headaches), MYALGIA (muscle aches) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Got the shots. Still got shingles/ Suspected vaccination failure; Got shingles / mild case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received the Shingles shots and still got shingles. But relatively mild case. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided.
long term care facility requested vaccination for new resident, patient vaccinated with Janssen 07/13/2021.  When entering vaccination in state registry it was noted that the patient had previously received a dose of Pfizer 06/11/2021.  The facility acknowledged they were aware of the Pfizer being ordered but did not have confirmation of the administration. Pt was unable to answer if previously vaccinated and the previous facility was unable to locate confirmation of administration just the order.  Unsure if patient ever received Pfizer.