chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Aug2022 as dose 3 (booster), single (Lot number: FP7138) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: PCN" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Benzoyl peroxide, reaction(s): "Known allergies: benzoyl peroxide", notes: Known allergies: benzoyl peroxide. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: This was a report about COVID Treatment. Other medical history included none. Patient received anti-viral product Paxlovid (Pfizer) from 20Dec2022 till 24Dec2022 for treatment of COVID-19. Had reoccurring symptoms started the following Wednesday 28Dec after finishing Paxlovid, received no treatment and was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported events "drug ineffective", "COVID-19".
No adverse event; Patient got administered with dose 1 on 9 Feb 2021 and dose 2 on 2 Mar 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got administered with dose 1 on 9 Feb 2021 and dose 2 on 2 Mar 2021) and NO ADVERSE EVENT (No adverse event) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown, if the patient was ever tested or diagnosed with COVID. It was unknown if the history was related to mentioned event and both Acute and Chronic illnesses at the time of vaccination. It was unknown that patient had chronic or long-standing health conditions.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got administered with dose 1 on 9 Feb 2021 and dose 2 on 2 Mar 2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got administered with dose 1 on 9 Feb 2021 and dose 2 on 2 Mar 2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got administered with dose 1 on 9 Feb 2021 and dose 2 on 2 Mar 2021).    It was unknown that patient had prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination or at the time of adverse event. It was unknown if patient experienced allergies (medications, food and other products). It was unknown if patient ever had COVID positive test or diagnosis. It was unknown if patient received other vaccines within 1 month prior to Moderna COVID-19 vaccine. It was unknown if adverse event cause patient to seek medical care. It was unknown if patient experienced similar event in past.   No concomitant medication was provided.  No treatment medication were provided.   This case was linked to MOD-2022-637964 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2022: Follow-up received contains non significant information.
Myalgia, Arthralgia, injection site pain Narrative: Employee reports experiencing injection site pain/discomfort, bodyaches, and joint aches beginning the day after receiving the vaccine. Reports all symptoms have since resolved. Employee reports took tramadol 50mg x 2 doses, and Tylenol 1 tablet every 8 hours.
vision problems; hearing problems; balance problems; This spontaneous report was received from a lawyer and a currently 69 year old female patient regarding a case in litigation. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On or about 09-MAR-2013, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose, route of administration, anatomical location not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unspecified date, she was treated by providers for the following injuries resulting from patient's ZOSTAVAX use: vision problems, hearing problems and balance problems. At the reporting time, the outcome of the events was unknown.  The reporters considered vision problems, hearing problems and balance problems to be related to ZOSTAVAX.
No adverse event; primary series vaccine/booster doses today to patients who intended to received bivalent vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (primary series vaccine/booster doses today to patients who intended to received bivalent vaccines) and NO ADVERSE EVENT (No adverse event) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (primary series vaccine/booster doses today to patients who intended to received bivalent vaccines). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (primary series vaccine/booster doses today to patients who intended to received bivalent vaccines) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (primary series vaccine/booster doses today to patients who intended to received bivalent vaccines).    Concomitant medications were not reported.  All doses were given by intramuscular injection at 0.5mL between 8:30-9:00 AM today. The patient was intended to receive the bivalent dose but were given monovalent vaccine as booster dose.  All these patients were over the age of 65 and were males.  This case contains information for the 1st  of 3 male patients described by the reporter.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-656976, US-MODERNATX, INC.-MOD-2022-656975 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-656975:(Same reporter) US-MODERNATX, INC.-MOD-2022-656976:Same Reporter
Patient at about 7pm became extremely tired. Slept 2 hours. Couldn't sleep rest of the night. Headache; felt like head was 'going to explode' till 4am. Hallucinations; unkown duration. Still has headached presently at 1300 11/25/2020. Sore at the injections site, swollen.   Pt did notify PCP.   Had back surgery 1 month prior; October, out-patient.
Pfizer vaccine- 1st dose Lot EN6199 administered 3/23/2021 at 11am. Patient began feeling nauseous and very lightheaded 10 minutes post-vaccine. She agreed to be evaluated in the ED. Clinic staff took patient to ED for evaluation.   Reviewed by Risk, in review  of the EMR ED MDM Provider notes on 3/23/21 @ 11:13am;   "Patient was seen by myself and staffed Dr. who also saw the patient here in the ED. Patient is a 90-year-old female past medical history of CLL who presents to the emergency department today with concerns for nausea mild lightheadedness and generalized weakness after receiving her 1st COVID vaccine this morning 15 minutes prior to arrival. On exam she is afebrile nontoxic appearing she is in no acute distress. CBC with differential revealed leukocytosis with a white blood cell count of 69.6. This is just slightly increased when compared to September 2020, WBC 62.7 at that time. H&H stable. Platelets stable. No bandemia noted. Suspect this is due to her CLL. BMP revealed initially elevated potassium with a K of 5.3 this was repeated 3.9, suspect that the initial potassium was hemolyzed. Urine dipstick negative for nitrites and blood, small leukocytes noted. Urine culture pending.   Chest x-ray revealedpatchy left basilar atelectasis and/or scarring, decreased since previous exam. Severe degenerative changes left shoulder, moderately severe degenerative changes right shoulder; somewhat increased since previous exam.   Patient was given Zofran here in the ED. I suspect her symptoms related to recent COVID vaccine. She will be discharged home with Zofran as needed for nausea. Recommend she have close follow-up with her PCP. She is encouraged to return to the ED immediately with any new or worsening concerns. Stable at discharge."
Around dinner time I developed fatigue and significant arm pain. By 10pm I had a 101 degree fever, cold sweats, chills, full body aches, and nausea. My fever reduced to 99 degrees around 0730am and remained as such through the following day (1/28/21) as the chills, nausea, and cold sweats gradually faded away. I was deeply fatigued and unable to work.  Sometime mid afternoon I developed a crippling frontal headache That worsened in the light and standing. I have no history of headaches or migraines. I was still repulsed by the thought of eating. I took acetaminophen with a protein shake and it helped the headache And residual body aches enough for me to sleep. 1/29/21 I awoke still fatigued  with a minor headache.   I am a pro athlete with no underlying conditions. I have had my flu shot yearly with no side effects. I am extremely fit and eat a healthy balanced diet, maintain a healthy athletic weight, sleep 7-8 hours a night, do not drink alcohol, smoke tobacco, or use recreational drugs. I was absolutely floored at how sick this shot made me.
body aches/in pain and freezing under 3 blankets; chills; Nausea; minus vomiting; abdominal tenderness; Overall extremely uncomfortable; in pain and freezing under 3 blankets; preventing sleep; Hours after initial and immediate soreness of arm; prolonged headache about an hour after vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). This consumer reported for a female patient (sister)   A female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 21Apr2021 12:45 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC DAIICHI; XOPENEX HFA. Vaccination history included: Bnt162b2 (Dose 1, single, administration time=10:45 PM, vaccine location=Left arm.), administration date: 31Mar2021, for COVID-19 Immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Apr2021 13:30, outcome "recovering", described as "Hours after initial and immediate soreness of arm"; HEADACHE (non-serious) with onset 21Apr2021 13:30, outcome "recovering", described as "prolonged headache about an hour after vaccine"; PAIN (non-serious) with onset 21Apr2021 23:30, outcome "recovering", described as "body aches/in pain and freezing under 3 blankets"; CHILLS (non-serious) with onset 21Apr2021 23:30, outcome "recovering", described as "chills"; SLEEP DISORDER (non-serious) with onset 21Apr2021 13:30, outcome "recovering", described as "preventing sleep"; NAUSEA (non-serious) with onset 21Apr2021 23:30, outcome "recovering", described as "Nausea"; ABDOMINAL TENDERNESS (non-serious) with onset 21Apr2021 13:30, outcome "recovering", described as "abdominal tenderness"; DISCOMFORT (non-serious) with onset 21Apr2021 13:30, outcome "recovering", described as "Overall extremely uncomfortable"; FEELING COLD (non-serious) with onset 21Apr2021 13:30, outcome "recovering", described as "in pain and freezing under 3 blankets"; VOMITING (non-serious) with onset 21Apr2021 23:30, outcome "recovering", described as "minus vomiting". Therapeutic measures were taken as a result of pain in extremity, headache, pain, chills, sleep disorder, nausea, abdominal tenderness, discomfort, feeling cold, vomiting.  Additional information: Facility type vaccine was reported as other. Adverse events were treated with self-administered tylenol and advil. COVID was not an prior vaccination and not tested post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mother calling about her  14 year old son ; he received an injection of h1n1 vaccine on 11/19/2009.  The next morning 11/20/2009 he had a fever, a headache, and  an upset stomach, these symptoms lasted for 48 hrs.    Then one week later he was talking and  everything went black ;he became really dizzy and eventually passed out for a short period, a matter of seconds, then got back up and "appeared to be fine".  All symptoms resolved on their own.
Came into office for (L) arm edema, ecchymosis and warmth to touch. C/O pain in upper (L) arm radiating to forearm.
Began losing hair in September. After booster shot of Moderna (939904) on  10/26/2021 hair Loss  accelerated. By December over 60% of hair lost.  Regular doctor referred me to a dermatologist who prescribed Methylprenisolone 8mg and Tacrolimus .1% Still losing hair.
Received vaccinations (L) arm 1/26/12 & developed redness & pain that evening. Went to ER 1/27/12 afternoon with increased (L) arm pain, redness & swelling, nausea, nausea, fever, SOB. Given Vancomycin IV & Doxycycline p.o. Returned to ER 1/28 with increased pain & redness. Dx cellulitis. Given Vancomycin IV. Returned to ER 1/29 for recheck. Decreased swelling & redness. Rx Doxycycline.
Vial was initially stored in the refrigerator on 02-Jun-2022 and vaccine was administered on 08-Jul-2022.; Moderna vaccine was given beyond the refrigeration use; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was given beyond the refrigeration use) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 02-Jun-2022 and vaccine was administered on 08-Jul-2022.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.   No Medical History information was reported.  On 08-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was given beyond the refrigeration use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 02-Jun-2022 and vaccine was administered on 08-Jul-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was given beyond the refrigeration use) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 02-Jun-2022 and vaccine was administered on 08-Jul-2022.) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The vial was initially stored in the refrigerator on 02 Jun 2022. The vial did not undergo any temperature excursions. No treatment medications were provided.
Within 10 minutes of receiving vaccine, got really dizzy, light headed, chest tightening and hot. Felt like I couldve passed out.
BEGAN WITH SMALL SWOLLEN AREA TO VARICELLA ADMINISTRATION SITE ON LEFT ARM. HAS INCREASED IN SIZE OVER THE PAST FEW DAYS. SWOLLEN, RED, RAISED AREA WITH ITCHING AND TENDERNESS.
Tinnitus. Primary doctor care, antibiotics. Anxiety, panic attack. Emergency room care. Mental health inpatient/outpatient. Daily anti anxiety medication. ENT doctor visit. Hearing test. Audiologist visit, hearing test. Chiropractic care. No change in symptoms.
Vaccine at 4pm. At 5pm started having a sharp, shooting, electrical shock sensation under Left side of tongue. Around 7:30 I had localized redness and swelling under the left side of my tongue and a weird tingling sensation throughout my body. The next day the swelling increased with difficulty eating and drinking that lasted through 9/14/21. The following day 9/9/21 I had swelling of my left tonsil and left side of throat, bilateral nasal turbinate swelling, bilateral ear pressure and 99.5.F temp. The following day, 9/10/21, I had red blotches in my throat and on my tonsils, my swallowing felt different/weird/a little more difficult, my throat and tonsil swelling worsened, the nasal turbinate swelling worsened where I could barely breath through nose, I had nerve pain and sensitivity behind My left ear that radiates down my neck and to My left shoulder, I had midline upper back pain/pressure, and at 3pm had sharp stabbing pain to my right lower quadrant of abdomen/uterus/ovary (this resolved after an hour). All symptoms have continued through 9/14/21. 9/13/21 I felt very fatigued, unable to do much of anything, barely ate much due to fatigue.  I woke up at 1pm on 9/14/21 with A heart rate of 148 just standing and 125 resting which continued for the past 8-9 hrs. Chest discomfort toward the 7 hour mark, slightly winded with some dizziness and HA. My nerve pain behind my left ear had moved up into my l face, forehead, and behind my left eye. Had ekg that showed just tachycardia. All other Vital signs were normal. My nasal turbinate, throat and tonsil swelling was beginning to improve but not resolved and the tongue swelling and pain had resolved. I had fluids to help with the heart rate. And Sudafed and Afrin to try  to help with the nasal turbinate swelling. Continue to nave some nasal turbinate swelling and congestion, left tonsil swelling with blotches in the throat and ear pressure as well as fatigue.
localized immun rxn lt tricep, erythema;pain @ site c/o feeling dizzy, tired
06/27 developed abdominal pain, diarrhea and headache. Also reports chest pain.
SEVERE SIDE EFFECTS FROM VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced severe side effects from vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of severe side effects from vaccine was not reported. This report was non-serious.
Lip swelling; This case was reported by a pharmacist via call center representative and described the occurrence of lip swelling in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   On 24th July 2019, the patient received the 1st dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced lip swelling. On an unknown date, the outcome of the lip swelling was unknown.   It was unknown if the reporter considered the lip swelling to be related to Shingrix.  Additional case details were reported as follows: The patient did not have any known allergies. The patient experienced lip swelling after receiving first Shingrix vaccination. The reporter gave permission to follow up.
"Mother states poor feeding. Baby crying like he is in pain" On 5/30 was diagnosed with bilat ear infection. Family calling to report "pain". On 6/1 transfered from ER to tertiary care center for surgry- diagnosis Intussuception.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 25Aug2021 (Lot number: FC3181) at the age of 59 years as dose 3 (booster), single, administered in arm left, administration date 28Apr2021 (Lot number: EW-0162) as dose 2, single and administered in arm right, administration date 07Apr2021 (Lot number: EW-0150) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Ankylosing Spondylitis" (unspecified if ongoing); "Type II Diabetic" (unspecified if ongoing). Concomitant medication(s) included: HUMULIN REGULAR; NPH INSULIN. The following information was reported: SWELLING (disability) with onset 07Apr2021, outcome "not recovered", described as "First Pfizer Covid-19 Vaccine swelling in neck behind ear down under arm in the lymph nods, face and the rest of my body swelled up so much I had no wrinkles left. After 7 days days the swelling went"; TINNITUS (disability) with onset 07Apr2021, outcome "not recovered", described as "I also had Tinnitus started with in a few hours of the vaccine that has not gone down or away it is here 24/7 everyday". The events "first Pfizer Covid-19 vaccine swelling in neck behind ear down under arm in the lymph nods, face and the rest of my body swelled up so much I had no wrinkles left. After 7 days days the swelling went" and "I also had tinnitus started with in a few hours of the vaccine that has not gone down or away it is here 24/7 everyday" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Oct2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of swelling, tinnitus. Clinical course: First Pfizer Covid 19 Vaccine swelling in neck behind ear down under arm in the lymph nods, face and the rest of my body swelled up so much I had no wrinkles left. After 7 days the swelling went down. She also had Tinnitus started within a few hours of the vaccine that has not gone down or away it is here 24/7 everyday. 2nd Vaccine same swelling, same went down after 7 days, 3rd Vaccine same swelling, 7 days later swelling just from the stomach down to my toes, BUT this time it has not gone down. She have iron leaking out of my capillaries in her feet, looks like red dots all over her feet. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The treatment included steroid dose packs, Lasix, Bumetanide, no results. Patient takes a lot more concomitant meds. Facility type vaccine was pharmacy or Drug Store. She had not taken any other vaccine in four weeks. Covid prior vaccination was unknown. She had tested Covid post-vaccination by Nasal Swab (BinaxNOW). She had known allergies. No follow-up attempts are possible. No further information is expected.