chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 15Dec2020 as dose 1, single (Lot number: EH9899), in right arm, as dose 2, single (Lot number: EJ1686), in right arm and on 29Sep2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 59 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 17May2022 as dose 4 (booster), single (Lot number: 038A22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "DMII" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN oral, start date: Jan2018; VALSARTAN+HYDROCHLOROTHIAZIDE oral, start date: Jan2018; TADALAFIL oral, start date: Jan2018; AMLODIPINE oral, start date: Jan2018.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body mass index: 30, notes: Obesity BMI 30; SARS-CoV-2 test: Positive, notes: Rebound COVID symptoms with positive antigen test 10 days after finishing Paxlovid; Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid from 24May2022 to 28May2022 via oral route for treatment of COVID-19. Rebound COVID symptoms with positive antigen test 10 days after finishing Paxlovid. Patient not had any known allergies. ; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Cant move a Lot of the left side of face, almost seems like bell palsy., left eye waters a bit as i cant independently blink my left eye, unless 8 close them both...cant move left cheek (can only smile on one side)  difficulty drinking since i cant curve my lip on the left..talking challenges (lisp) since it seems im speaking out of one side of my mouth.  When eating, a little hard to feel it on the left aide in jaw area.. I have zero pain, just unable to completely move all parts of the the left side of my face in general..  I had my shot on thursday, first felt this on saturday when i woke up.... hasnt gotten any worse, just the same (its 420pm on sunday now)  - havent had any treatments, not usre if its temporary
Swelling, redness to injection site, width of arm Narrative: Started to experience redness and swelling the width of arm, 10 days after receiving vaccine.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Medical history was not reported. The reporter stated that M-M-R II underwent a temperature excursion. It was reported that on 25-NOV-2014 the patient was vaccinated with the improperly stored M-M-R II, 0.5 ml, subcutaneous injection, lot number K007107, expiration date 16-MAY-2016. Concomitant medication was not reported. No adverse effect was reported at the time of the report. This is one of several reports received from the same source. Additional information has been requested.
HIGH BLOOD PRESSURE; BRAIN FOG; FATIGUE; ANAPHYLACTIC SHOCK; PARALYSIS IN LEFT HAND; LIGHTHEADED; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pre-diabetic, and other pre-existing medical conditions included the patient had no known drug or non-drug allergies. The patient had no illness 30 days prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) 1 total dose was administered at left arm on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021 at 14:35, the patient immediately felt tingling in left arm (like ben gay) after vaccination, 10 minutes later he felt tingling in neck and cheek. His left hand turned purple. He became unconscious (he did not remember anything). He had cardiac arrest (patient remembers yelling code). He was taken to emergency room. He thought people in emergency room said anaphylactic shock and gave him epinephrine (patient was not sure). He had paralysis in left hand when he woke up for a few minutes. His blood test and Electrocardiogram were normal. He went home in couple of hours (on 31-MAR-2021). On 02-APR-2021 (two days later) he was light-headed, he went to his doctor. His blood pressure was high, he felt little bit of fatigue and brain fog.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lightheaded, anaphylactic shock, paralysis in left hand, high Blood pressure, fatigue, and brain fog. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210443005-covid-19 vaccine ad26.cov2.s- anaphylactic shock, paralysis in left hand. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Mild flushing 5 min post injection, resolved within a couple minutes. Woke up Wednesday, 5 am with swelling around mouth. Broke out with tiny bumps (filled with clear fluid), very red and irritated. Lips very chapped. Worked a normal day 7:30-4. One way home last night face started burning pretty badly, became hot and sweaty, shaky, palpitations. Took 2 benadryl and had to put cold, damp washcloth on face for relief. Around around mouth still irritated, lips chapped and face still burning slightly. Currently at work (Cardiology office)
Experiencing like something in her throat / like a sore throat; inflammation on her throat; she had normal reaction; Allergic reaction; is in a lot of pain; rash in her throat; body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Experiencing like something in her throat / like a sore throat), INFLAMMATION (inflammation on her throat), VACCINATION COMPLICATION (she had normal reaction), ALLERGY TO VACCINE (Allergic reaction) and PAIN (is in a lot of pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Experiencing like something in her throat / like a sore throat), INFLAMMATION (inflammation on her throat), VACCINATION COMPLICATION (she had normal reaction), ALLERGY TO VACCINE (Allergic reaction), PAIN (is in a lot of pain), RASH (rash in her throat), MYALGIA (body aches) and PYREXIA (fever). At the time of the report, OROPHARYNGEAL PAIN (Experiencing like something in her throat / like a sore throat), INFLAMMATION (inflammation on her throat) and ALLERGY TO VACCINE (Allergic reaction) outcome was unknown, VACCINATION COMPLICATION (she had normal reaction), MYALGIA (body aches) and PYREXIA (fever) had resolved and PAIN (is in a lot of pain) and RASH (rash in her throat) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient was treated with antibiotics and steroids.   This case was linked to MOD-2021-339220 (Patient Link).
Pt received DTaP left deltoid at hosp on 8/9/09 c/o redness 3in x 3in with swelling at site of injection. Assessed by PA, local allergic reaction. Treatment cool compress and TYLENOL. Pt gave birth on 8/8/09.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild
DIZZY, NAUSEA, FAINTING, VISION BLACKED OUT. LAID DOWN TO REST.
pt recv vax 8OCT97 & 2 days later pt exp an inj site rxn consisting of redness, warmth & tenderness;
Sores/Canker sores on the side of the patients tongue were reported 3 days after administration of her 1st dose of Moderna COVID-19. Pt stated that she noticed a sore tongue in the evening after getting the vaccine and it appears that the next day she realized they were like canker sores. They continue to persist
Information has been received from a health professional concerning a 6 year old male, with seasonal allergies, "depth perception," mild growth and motor delay secondary to a 35 week emergency c-section from a placenta prevaera, and who was exposed to his mother who had chickenpox on 22-FEB-2006, who on 09-OCT-2000 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included loratidine (CLARITIN). On 06-MAR-2006 the patient experienced lesions. The patient was seen in the office on 9-MAR-2006 with less than 20 lesions, diagnosed as chickenpox. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 5/12/2006.  Follow-up information from a health professional indicated that on 09-MAR-2006 the patient came into the physician's office having been exposed to his mother, who had chickenpox on 22-FEB-2006.  It was reported that the patient had several bumps, described as red spots and blisters that itched.  It was noted that the patient had one spot two days prior, on 07-MAR-2006, five spots on 08-MAR-2006, and ten spots on 09-MAR-2006.  There was no fever, but the patient had a cough and mild congestion.  It was reported that the patient also had eczema and peeling feet.  The plan was to provide routine symptomatic care.  Follow-up information from a physician indicated that the child was seen on 09-MAR-2006 with less than 20 lesions from a chickenpox outbreak.  It was reported that there were no further concerns.  Additional information is not expected.
Narrative: COVID infection following COVID vaccine series 12/22/2020, Pfizer, dose #1 (non-facility) 01/01/2021, Pfizer, dose #2 (non-facility) 08/18 pt cc: cough, dyspnea, exposure: unknown 08/18 COVID swab, result: detected 08/18 SARS-COV-2 Variant Sequencing result: pending 08/18 FIBRINOGEN result: 541 08/18 DDIMER result: 0.63 08/18 Ferritin result: 271.2 08/18 LEGIONELLAAgUR result: negative 08/18 S.PNEUMONIAE AG result: negative 08/18 CTA PE impression: no evidence for PE: Findings which may represent bronchitis.08/19 CXR impression: Mild interstitial thickening in both lungs, increased compared to prior study, may represent chronic changes versus atypical pneumonia/edema. 08/19 FIBRINOGEN result: 365 08/19 DDIMER result: 0.64 08/18 ESR result: 35 08/20 FIBRONOGEN result: 431 08/20 DDIMER result: 0.47 08/20 ESR result 13
Syncopal episode about 10 min after administration of vaccine.  Pt fainted in the lobby.  Regained consciousness quickly- all symptoms resolved within 5 minutes.  Observed patient in office - complete resolution of symptoms prior to discharge
Mother called stating baby was fussy, inconsolable at times had vaccines in AM at the office.
Pt wanted to get Pfizer Bivalent, but she got regular Pfizer. Pt didn't have any symptoms.
Right hand started itching, and then my leg, the next day it was both hands, both legs, back, abdomen, face, neck, eyes. After my eyes started itching I couldn't see clearly. I went to the doctor many times but no help. I can only sleep 1-2 hours. At night I have worse itching and cannot sleep at all. I have to go outside to get cold to help and i walk around all day and all night with this itching. Lost my job, I cannot drive because of the itching
Information has been received from a pharmacist concerning an elderly female patient. The patient's medical history was not reported and previous dose(s) of pneumococcal vaccine (manufacturer not provided by reporter) was administered on an unspecified date. The patient's concomitant medications were unknown. On an unknown date, the patient came in requesting a shot of ZOSTAVAX (dose, frequency, route of administration, lot number and expiration date were not reported) for prophylaxis, when coming in for the last pneumococcal vaccine (manufacturer not provided by reporter). The pharmacist reports that after administering ZOSTAVAX, he discovered that the patient had already received ZOSTAVAX in 2011. It was unknown if the patient experienced any adverse reactions to the ZOSTAVAX dose provided by the pharmacist. Relevant laboratory data was unknown. As of 22-MAR-2017, it was unknown if the patient continued to receive ZOSTAVAX and the outcome of the second ZOSTAVAX dose provided by the pharmacist was unknown. Additional information has been requested.
has a hard time driving around; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 87-year-old female patient received BNT162b2 (BNT162B2), on 22Nov2021 as dose number unknown (booster), single (Lot number: EP7534) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: IMPAIRED DRIVING ABILITY (non-serious), outcome "unknown", described as "has a hard time driving around".  Additional information: The patient got her first booster dose on 22Nov2021 and still up until now did not get the second booster dose of Pfizer COVID Vaccine. She had a medical inquiry regarding any recommendations for her. No one had been talking about it and she thought she had better check to see what's the matter. One of her lady friends from church said she better go have that checked, and then they told her it was too late to get the second booster dose of Pfizer COVID Vaccine. She called to ask if that was right, what the recommended duration between the first and second booster dose was. She mentioned that she was 87 and had a hard time driving around.
11-year-old female who was admitted to medical center on 1/2/18 with a sudden onset of weakness of the lower extremities. The father states that she was in her usual state of health until the morning of 1/1 at which time she complained to her father that her legs and shoulders were hurting when she was walking to the bathroom. She stated that she felt weak and was unable to walk to the bathroom without help. The father states that the rest of the day she was unable to ambulate without help because of the weakness. There was no history of pre-existing symptoms such as URI symptoms, cough, congestion, vomiting or diarrhea. No one else was sick at home either. The weakness and pain worsened so she was brought to the emergency room. There was no history of numbness or tingling associated with this. She did come from another country approximately 1-1/2 years ago and has not returned. There were no known sick contacts. She was admitted to the pediatric ICU for further management. Neurology consult was obtained who recommended an LP in addition to blood work and MRI of the head and spine. The MRIs were unremarkable as was the blood work. She was started on IVIG. They did send a respiratory virus panel which was negative. I was consulted today because she now has a fever associated with this weakness. Overnight her condition worsened requiring intubation and mechanical ventilation. There is no family history of similar type symptoms in anyone in the family. The father states that she is normally a healthy 11-year-old female attending 4th grade. Her vaccines are up-to-date according to the father. She is currently intubated and sedated. She was started on IV ceftriaxone because of fever.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 07/26/2022 with a home test. I had congestion, achiness and fever. I was on travel and contacted my doctor and he prescribed PAXLOVID which I was able to get. When I started taking PAXLOVID, I felt better within 24 hours.
Vaccine administered in left arm. Pain spread down left arm into middle 3 fingers at 10 minutes. Pain spreading up to left shoulder at 10 minutes. Told I could leave facility at 15 minutes. Tingling and facial tingling starting at left jaw line and spreading up to left sinus cavity then around left eye and back to left ear at 30 minutes. Tightness, tingling and discomfort described above lasted 48 hours. Tightness and Tingling turned into swelling, numbness and drooping all on the left side of the face and left side of tongue at 48 hours post dose. Medical attention sought at advice of PCP at Urgent Care at 50 hours post dose. Diagnosos: Bell's Palsey Treatment: Steroid and antiviral, plus home care. Return or go to ER if symptoms worsen. Referral to neurologist, if needed.
Patient states flu vaccine was not administered in her deltoid. Had asked for re-administration to deltoid and administrator refused. Site was red, edematous, tender to touch. 10/14/16. Patient declined vitals.
Erythema, patchy blotches to the left leg. Increase in girth to that thigh compared to the other.  Tenderness with palpation to the anterior and lateal sides. No area of induration or intense erythema directly over the injection site. It appeared more patchy scattered over the entire thigh.  The rest of the exam was unremarkable.
Discharge Provider:  MD Primary Care Provider at Discharge:  MD  Admission Date: 5/14/2022 Discharge Date:  5/29/2022  PRESENTING PROBLEM: Weakness [R53.1] Generalized weakness [R53.1] Acute pain of right knee [M25.561]   HOSPITAL COURSE: The patient is a 91 y.o. female with a past medical history of hypertension, hypothyroidism, DVT on Eliquis, cancer breast, insomnia who presents today with generalized weakness.  Patient was noted to have a fever and elevated CRP.  She had recently received her 4th COVID booster shot approximately 2 days ago.  Her symptoms were considered likely secondary to sequelae from this vaccine.  She was seen by Neurology who recommended treatment with Neurontin.  Patient was started on low-dose at 100 mg TID, titrated to 200 mg TID which she tolerated well.   She was noted to have a urinary tract infection concurrently.  She was started on Keflex and finished a 5 day treatment course.  She was started on supportive management.  Patient was monitor for resolution of her symptoms. PT / OT worked with her who recommended SAR which was arranged by care management.   As the patient was clinically stable, and had been cleared from COVID isolation she was discharged to skilled nursing facility on 05/29/22
Hypersensitivity; Development of hives after 0.1cc of vaccine; hives; "patient reacted after 0.1cc and remaining .4cc was not used and determined patient is allergic; Vaccination site reaction; This spontaneous report was received from a nurse and refers to a 4-year-old female patient. The patients current condition included unspecified food allergies and milk intolerance. The patient's historical condition included febrile seizures as an infant. Concomitant therapies included epinephrine hydrochloride (EPIPEN).  On 07-AUG-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, subcutaneously, lot # R035702, expiration date 09-DEC-2020, for measles, mumps, rubella prevention. Other suspect therapies included sterile diluent subcutaneously, lot # S008564, expiration date 05-AUG-2021.  The reporter considered that, 4-year-old patient received second dose in measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) immunization series in quarter increments at 10 minute intervals by unspecified allergist and experienced a hive after 0.1cc of vaccine administered. Nurse stateed a certain (unspecified) process including dilution occurs in skin testing. The reported considered that, prior to actual dose, allergist did skin testing and results were negative. Nurse stated that the patient did have measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) at 15 months of age and did have an unspecified local reaction. Allergist report stated that patient reacted after 0.1cc and remaining. 4cc was not used and determined that the patient was allergic to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) The outcome of the events was reported as recovering. The event of allergy to vaccine was considered to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and sterile diluent. The causality assessment between the remaining events and suspect therapies was not provided.; Sender's Comments:  US-009507513-1908USA003510:
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 38-year-old female subject who was vaccinated with hepatitis B (manufacturer unspecified). Concurrent vaccination included tetanus toxoid, reduces diphtheria toxoid and acellular pertussis vaccine, adsorbed; manufacturer unspecified given on an unspecified date (with either the 1st or 3rd dose of hepatitis B vaccine). On unspecified dates the subject received 1st dose, 2nd dose and 3rd dose of hepatitis vaccine (1 ml, unknown route, unknown deltoid). The series was completed in 2009. On 4 June 2011, 2 years after completion of the vaccination series with hepatitis B vaccine, the subject experienced not responding to therapy. On 4 June 2011 titers were drawn and were less than 0.1 (units not provided). At the time of reporting, the subject was repeating the vaccination series and had received ENGERIX B on 14 June 2011 and 14 July 2011. This case involves a pharmaceutical product complaint. The healthcare professional reported that she had seen an increase in non-responders to vaccination with ENGERIX B and was concerned about the vaccine. It was noted that all the vaccines are monitored by several methods for temperature excursions. The healthcare professional reported 7 cases of not responding to therapy following hepatitis b vaccination. This is case 5 of 7 (see case IDs A0947199A, A0947239A-A0947241A, A0947243A, A0947244A for details of the other reports). Follow-up received from the reporting healthcare professional on 18 October 2011: On 03 June 2011, the subject's hepatitis B surface antibody was less than 0.1 mIU/mL (immunity was noted by the healthcare professional as greater than 0.99). The healthcare professional reported that the hepatitis B series was currently being repeated with doses of ENGERIX B administered on 14 June 2011 and 14 July 2011.
Information has been received from a registered nurse concerning a 79 year old caucasian female with polycythaemia and basal cell carcinoma who on 09/10/2004 was vaccinated with a first dose of pneumococcal 23V polysaccharide vaccine (lot 648139/0009P), intramuscularly in the left deltoid.  Concomitant therapy included clopidogrel bisulfate (Plavix), hydroxyurea (Hydrea), calcium, risedronate sodium (Actonel) and high blood pressure medication.  On 09/11/2004 the patient's left upper arm reddened and was warm to touch.  The patient did have local swelling.  The patient was treated with prednicarbate (Dermatop) cream and ice.  No product quality complaint involved.  The patient recovered.  No additional information is expected.
FEVER, NAUSEA, BODY ACHES, HEADACHES, EXTREME CHILLS, NO APPETITE, EXTREME FATIGUE, UPPER RESPIRATORY PROBLEMS, POSSIBLY PNEUMONIA, WILL SEE TOMORROW.
Breakthrough vaccine case - patient tested positive for COVID more than 14 days after receiving full vaccine series.  Asymptomatic.