chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2022 as dose 4 (booster), single (Lot number: fk9729) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sjogren's syndrome" (unspecified if ongoing); "mgus" (unspecified if ongoing); "Contrast Dye" (unspecified if ongoing), notes: Verbatim:Contrast Dye. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative; (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment, brand=Paxlovid
Patient received Hep A in afternoon clinic and returned to night clinic and received Hep A again along with other immunizations brought in by the mother.
No additional AEs; Patient received GARDASIL 9 vaccinations of 21-JUN-2012, 14-MAR-2013, 14-JAN-2021 and 12-MAY-2021. Patient was 15 years old when series began.; Patient received GARDASIL 9 vaccinations of 21-JUN-2012, 14-MAR-2013, 14-JAN-2021 and 12-MAY-2021. Patient was 15 years old when series began.; This spontaneous report was received from a registered nurse and refers to a 15-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-JUN-2012, the patient was administered first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not provided) for prophylaxis. Subsequent doses of the vaccine were administered on 14-MAR-2013, 14-JAN-2021 (inappropriate schedule of product administration) and 12-MAY-2021 (extra dose administered). No additional adverse event (AE) reported.
This spontaneous report as received from a licensed practical nurse refers to a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-OCT-2015, the patient was vaccinated with the dose of GARDASIL (lot # L010596, expiration date unknown; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
arrived from home by EMS. Pt tested COVID+ on 8/13, c/o weakness and lethargy, intermittent SOB. Denies n/v/d, abd pain
started itching at the injection site and around it; soreness at the injection site; swollen; redness; tenderness,if she lay down her arm it is tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE SWELLING (swollen), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE PAIN (tenderness,if she lay down her arm it is tender) and VACCINATION SITE PRURITUS (started itching at the injection site and around it) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Osteoporosis, Hypertension, Renal disease, Vitamin D deficiency, Chronic back pain, Lumbosacral (joint) (ligament) sprain and Constipation. Concomitant products included AMLODIPINE for Hypertension, METOPROLOL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE SWELLING (swollen), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PAIN (tenderness,if she lay down her arm it is tender). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (started itching at the injection site and around it). At the time of the report, VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE SWELLING (swollen), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE PAIN (tenderness,if she lay down her arm it is tender) and VACCINATION SITE PRURITUS (started itching at the injection site and around it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included white alcohol.
Shortly after my second dosage on May 10th, I began having extreme shortness of breathe, as well as heavy nasal congestion.  Although those conditions lessened within 4-6 weeks, I suffered a pulmonary embolism and fell down half a flight of stairs on July 19th and was hospitalized for four days.
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if the patient had ever been diagnosed with or tested positive for COVID-19.     On 24-Sep-2022 at 6:51 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 24-Sep-2022 at 6:51 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           No concomitant product reported by the reporter. Patient received 0.5 (units unspecified) of Bivalent vaccine in deltoid. Patient had received previous 3 doses of COVID-19 vaccine, intramuscular with anatomical site as deltoid.  It was reported that refrigeration excursions identified, state vaccine was housed in the units. There were excursions noted. The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. No adverse reactions reported to their knowledge for the patient. No treatment medication reported by the reporter.
Altered mental status starting approx 7 hours after injection.  Confusion, dizziness, disorientation, inability to walk unassisted noted around 1730, as well as loss of bladder control resulting in incontinence of urine.  Back to baseline mental status at approximately 2300 hours on day of vaccination.  Could not remember approximately 5 hours of time, remembers leaving work around 4pm not feeling well, with no memory of events until finger was pricked for glucose check in Emergency room.
Information has been received from a physician concerning a female patient who was vaccinated with three doses of GARDASIL (lot # not given). The patient's mother stated that she believed GARDASIL caused anti-ovary antibodies to be produced. The patient sought unspecified medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Hives on one side per patient. Patient not sure which vaccine caused this because they got both on same day.
difficulty moving her arm; her arm was hot to the touch; red from the top of arm to the elbow; soreness; Information was received from a pharmacist referring to a 67 years old female patient. The patient's concomitant medication was unknown by reporter. The patient was allergic to aspirin and codeine.      On 21-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot#R017900, expiration date 26-MAR-2020, dose and strength were unknown) intramuscularly to prevent pneumonia.         On 22-OCT-2019 (reported as subsequently), the patient experienced soreness, difficulty moving her arm, arm hot to touch and red from the top of arm to the elbow. On 23-OCT-2019, the reporter stated that the patient was moving her arm "better today" and the patient stated that her arm "doesn't feel as hot today". The outcome of the other two events were not provided by the reporter. Patient sought for medical attention by contacting the pharmacist. Ice was applied for the events. The causality was not provided by the reporter.
OFF-LABEL USE; VACCINE ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 17 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 18-SEP-2021) dose was not reported, administered on 01-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-AUG-2021, the patient experienced off-label use. On 01-AUG-2021, the patient experienced vaccine administered to patient of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off-label use and vaccine administered to patient of inappropriate age was not reported. This report was non-serious.
Approximate 1 pm, patient had a seizure lasting from 30 seconds to 1 minute. Mother took to ER for evaluation- pt had another seizure of same length, also had fever of over 102 per Mom. Dx with enterovirus and febrile seizures.
Developed Acute Inflammatory Demylenating Polyneuropathy (AIDP), Guillaine-Barre syndrome.  Numbness and tingling.  Admitted to hospital.  Treated with IVIG, some success, relapse while in hospital.  Started on plasmapheresis - 5 treatments.  Helped, released from hospital, third relapse.  still have numbness and tingling one month after release from hospital.
No additional AE reported; Office manager reports ROTATEQ was administered after a temperature excursion to 23 patients.; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.    On 29-JUN-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) once, (lot number W011279 has been verified to be a valid lot number, expiry date 02-NOV-2023) as prophylaxis (strength, dose, route of administration, and anatomical location, date were not provided) (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a temperature of 9 degree Celcius (C) for the time frame of 1 hour and 32 minutes. There was no previous temperature excursion.  No additional adverse events reported.  This is one of several reports received from the same reporter.
Developed sore right arm immediately after 2d Moderna shot. Within 6 hours, developed fever (100.6 degrees), body aches, chills, headache.  Was better 3 days later. Within 7 days developed painful sore left foot; shingles. 21 days later, developed screaming tinnitus right ear, shot side. No tinnitus before shot. Vertigo developed same time. In current treatment for Vestibular neuroinflammation and vertigo. 8 weeks later developed severe reactive arthritis in right knee, extreme paid, shot side. After MRI, received 2d cortisone shot in knee. Pain and swelling subsided with 5 days. 2 weeks later developed extremely itchy rash between buttocks and on thighs. Treated with highest level cortisone creme. Pain and itching subsided within 3 days.
Redness and swelling at injection site approximately 2 days after vaccination; went to physician for antibiotic and methylprednisolone.
Hematuria; fever; chills; fatigue; achiness; This is a spontaneous report from a contactable nurse. A 16-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 20Apr2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for unknown indication from an unknown date and unknown if ongoing. On 20Apr2021, the patient experienced hematuria which began the evening of having received the Pfizer COVID vaccine along with fever, chills, fatigue, and achiness. The adverse event resulted in a visit to the doctors or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of reported events and included treatment with antibiotics (unspecified). The clinical outcome of the event hematuria, fever, chills, fatigue, and achiness was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
54M presented with respiratory failure secondary to pleural effusion. The patient was admitted to medsurg and started on diuretics. Plans were made for us guided thoracentesis and likely paracentesis, as well. The patient decompensated, requiring emergent thoracentesis. He was placed on bipap at that time and started on zosyn. When I arrived to hospital day after admission, stat response was called to patient's room and he was rapidly transported to the ICU for intubation and to be started on vasopressors as he had become confused and hypotensive. It was not clear why. In the ICU, he was intubated and started on vasopressors. Central line was placed. He was transfused two units, but lactic started climbing and his hgb did not improve appropriately. Massive transfusion protocol was initiated. Patient's family was contacted by intensivist, and ultimately they decided to withdraw life sustaining treatment.    The patient expired on 10/3 @ 1650 due to hemorrhagic shock secondary to upper GI bleeding in the context of chronic decompensated cirrhosis of the liver.
Patient received a vaccine about 40 hours post dilution. Pfizer had stability data for 24 hours post vaccination and suggested to as for recommendation from CDC. After consulting CDC medical team, the recomendation was given to vaccinate patient ASAP. Patient came to the pharmacy same day and got revaccinated.
Confusion; Coffee taste in the morning today does not feel right; I feel I have headaches; Fever; Nausea; Fatigue; Major (mid night chills) chills; Muscle aces; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion), DYSGEUSIA (Coffee taste in the morning today does not feel right), HEADACHE (I feel I have headaches), PYREXIA (Fever) and NAUSEA (Nausea) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042821A and 003AZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included TRAZODONE, VALPROATE SEMISODIUM (DEPAKOTE) and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Depression, IBUPROFEN for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced CONFUSIONAL STATE (Confusion), DYSGEUSIA (Coffee taste in the morning today does not feel right), HEADACHE (I feel I have headaches), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Fatigue), CHILLS (Major (mid night chills) chills) and MYALGIA (Muscle aces). At the time of the report, CONFUSIONAL STATE (Confusion), DYSGEUSIA (Coffee taste in the morning today does not feel right), HEADACHE (I feel I have headaches), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Fatigue), CHILLS (Major (mid night chills) chills) and MYALGIA (Muscle aces) had not resolved.            The patient post receiving their second dose of vaccine felt like having headaches, fever, nausea, confusion, fatigue, major mid night chills, muscle aches and coffee taste in the morning next day. The patient felt a little bit better but reported that the symptoms were still ongoing.   The patient did not take any treatments to help with the symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up information received on 26-May-2021 contains non-significant information which included reporter's Email address.
back ache/back has been bothering me for over a week now; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got a back ache from the vaccine. Patient's back had been bothering for over a week now almost (Incomplete sentence). Patient didn't know it didn't seem to go away and took paracetamol (TYLENOL) and it didn't help and patient was wondering if that could be something that the vaccine would cause. Patient was just curious if it would affect back. Outcome of the event was unknown.  Information about Lot/Batch number is requested.
She died 23 hours later on 28Feb/Her cause of death on her death certificate was stated to be cardiac arrest; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 27Feb2021 at a single dose for COVID-19 immunisation. Medical history included heart disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient died 23 hours later on 28Feb2021 after first dose on 27Feb2021. She did not show any adverse symptoms after being vaccinated. The questionnaire before the vaccination asked "if you have a chronic health condition such as heart disease". It was stated that she has heart disease; still the vaccination was given. Her cause of death on her death certificate was stated to be cardiac arrest. The patient died on 28Feb2021. It was unknown if an autopsy was performed.  Information about Batch/Lot number has been requested.; Reported Cause(s) of Death: She died 23 hours later on 28Feb/Her cause of death on her death certificate was stated to be cardiac arrest
Cellulitis developed at injection site of either PNEUMOVAX or Td. Pt received both injections in same arm on same day due to previous axillary LN removal on unilateral side. Treated with antibiotics-KEFLEX and ROCEPHIN.
15 min. after vaccination, complained of vaccinated arm felt numb, then had numbness of face, cheek, and tongue, later in neck. She called her Neurologist, as she has a brain tumor and has also had seizures years ago. Symptoms of today resolved without treatment 10-20-2008.
Approximately 6 months post vax, the pt developed typical varicella skin lesions. 3 days prior he had developed nausea, vomiting and a fever of 103 along with increased irritability, decreased urine output and right foot pain with difficulty walking. The pt experienced crusted skin lesions, fever and anemia. The pt had progressively worsening joint pain, positive test for GABHS. The pt developed a diastolic murmur consistent with aortic regurgitation. Subungual hemorrhages also were noted. The pt developed and was placed on treatment for congestive heart failure.
Information has been received from a licensed practical nurse concerning a 4 year old female patient who on 29-MAR-2007 was vaccinated subcutaneously with a 0.5 mL dose of ProQuad (lot# 654474/0815F). Concomitant vaccination on the same day included a dose of varicella (lot# 654529/1045F). The nurse reported that the office confused the ProQuad vaccine with the MMRII in the freezer. Unspecified medical attention was sought. No problems were reported. A product quality complaint was not involved. The patient's twin sister had a similar experience after therapy with ProQuad (WAES # 0704USA01454). Additional information has been requested.
DaPT AND MMR INTO right ARM ON 9/11/2008 - red & hot R upper arm noted that night - worse the next AM, involving shoulder to elbow and more than 1/2 of circumference of upper arm  - taken to ER where parent told this was cellulitis and vaccine reaction - treated w/ clindamicin with improvement by next day. Still remained active - no meds given for pain. Today, area of redness approx 2 x 3 inch, minimal pain.
This spontaneous report was received from a nurse and refers to unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 21-DEC-2015, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L014427, expiration date 09-MAR-2018 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Monitored for 30 minutes after injection, no symptoms, released back to housing (cell). Approximately one hour later, presented to Health Care Unit with c/o itching, nasal congestion, watery eyes, lightheadedness, nausea, "hard time breathing". Very anxious. Administered 50 mg Benadryl IM without any relief. Patient was sent to local emergency department as precaution. Given epi SQ and additional Benadryl in the emergency department
PATIENT COMPLAINED OF SWOLLEN FEET AND LEGS, FLU LIKE SYMPTOMS, RASH ON BOTTOM OF LEGS, SOB ON WEDNESDAY MORNING AROUND 5 AM FATIGUE, BODY ACHES, CHILLS AND CONGESTION.
Pt received the 1st dose of varivax and 2nd dose of MMR less than 28 days from pts first dose of MMR ( live).  PT has not reported any adverse events however the timing was less than 28 days and the shots will need to be redone per ACIP recommendations.