chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm 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 and concomitant medications were not reported. 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: SARS-CoV-2 test: (May2022) Negative, notes: Tested negative within 6 days; (30May2022) Positive, notes: 5 days later tested positive again and symptoms returned. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The Paxlovid worked well, felt great within 24 hours. Tested negative within 6 days. 5 days later tested positive again and symptoms returned. The patient had no known allergies. The other medications received in 2 weeks was unknown.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The vial was initially stored in the refrigerator on 09Jun2022. The vial was first punctured on 14Jul2022; Patient received Moderna Covid-19 vaccine more than 12 hours after the vial had been punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine more than 12 hours after the vial had been punctured) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 09Jun2022. The vial was first punctured on 14Jul2022) in an 85-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 049L21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-May-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Jun-2021, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2022 at 10:30 AM, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2022 at 10:30 AM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine more than 12 hours after the vial had been punctured). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 09Jun2022. The vial was first punctured on 14Jul2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine more than 12 hours after the vial had been punctured) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 09Jun2022. The vial was first punctured on 14Jul2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. The vial was initially stored in the refrigerator on 09Jul2022.  The vial was first punctured on 14Jul2022 at 9:30 AM.  The post puncture vial was stored in refrigerator. The vial did not undergo any temperature excursions. The total amount of time the vial was exposed to room temperature range (8 degree to 25 degree C, 46 degree to 77 degree F) under 12 hours. No treatment medication was provided by reporter.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: 9266), on 10Mar2021 as dose 2, single (Lot number: EN6199), on 01Oct2021 as dose 3 (booster), single (Lot number: FF8839) and on 03Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION. Past drug history included: Vicodin, reaction(s): "Known allergies: Vicodin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment.Anti viral details: product:COVID 19 Treatment, brand: Paxlovid, treatment start date:06May2022, treatment stop date:10May2022, indication=Treatment of COVID-19.Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200735225 Same patient, different product and event
I realized I had ovulated around the November 4, the time I had gotten these vaccines. I was taking the mini pill, Norethinedrone daily.   On November 27 I am shocked to find out that the birth control failed and that I am pregnant. I have pain and bleeding the next day and in the ER and find I have a Pregnancy of unknown location.   Now I have been diagnosed with ectopic pregnancy and have been receiving treatment for this. It?s been very painful and traumatic.
Falling asleep in school tiredness; Falling asleep in school tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 9 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Nov2021 14:00 (Lot number: FkS127) at the age of 9 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history:Asthma. The patient's concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious), FATIGUE (non-serious) all with onset 05Nov2021 09:00, outcome "not recovered" and all described as "Falling asleep in school tiredness". Therapeutic measures were not taken as a result of somnolence, fatigue.  Additional information: patient had no allergies. Not tested covid post vaccination and prior vaccination.  No follow-up attempts are possible. No further information is expected.
On 2/14/08 she developed erythematous plaques and patches on her left upper arm and left side of neck.  Within 2 days, multiple vesicles within these areas consistent with herpes zoster.  She came into our clinic on 2/19/08 for evaluation.  Treated with 7 day course of Valacyclovir.
10:15 AM Stomach cramps.  11:15 AM Felt cold.  3:00 PM Itchy and hives.  4:30 PM Felt terrible all over and went to emergency room.  BP 50/20.  Admitted to intensive care unit at hospital.
This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over her body) and PRURITUS (itchy hives all over the body) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives all over her body) and PRURITUS (itchy hives all over the body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in March 2021 for Adverse reaction, at an unspecified dose and frequency and CORTISONE (topical) in March 2021 at an unspecified dose and frequency. At the time of the report, URTICARIA (hives all over her body) and PRURITUS (itchy hives all over the body) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.
Patient received Moderna 6-11 instead of the Moderna Bivalent booster as Booster dose
Hot-flashes; Difficulty breathing; Arm swollen like a baseball; Arm tender; Hear rate 194; Headache; Fatigue; Joint pain; Muscle pain; Fever of 101.9; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HOT FLUSH (Hot-flashes), DYSPNOEA (Difficulty breathing), PERIPHERAL SWELLING (Arm swollen like a baseball), TENDERNESS (Arm tender) and PALPITATIONS (Hear rate 194) in a 52-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 was provided by the reporter.  Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), MAGNESIUM and CALCIUM for an unknown indication.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 17-Apr-2021, the patient experienced HOT FLUSH (Hot-flashes), DYSPNOEA (Difficulty breathing), PERIPHERAL SWELLING (Arm swollen like a baseball), TENDERNESS (Arm tender), PALPITATIONS (Hear rate 194), HEADACHE (Headache), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), PYREXIA (Fever of 101.9) and NAUSEA (Nausea). On 19-Apr-2021, DYSPNOEA (Difficulty breathing) outcome was unknown. On 22-Apr-2021, HOT FLUSH (Hot-flashes), PERIPHERAL SWELLING (Arm swollen like a baseball), PALPITATIONS (Hear rate 194), HEADACHE (Headache), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), PYREXIA (Fever of 101.9) and NAUSEA (Nausea) had resolved. At the time of the report, TENDERNESS (Arm tender) and MYALGIA (Muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Body temperature: 101.9 f (High) outcome was recovered/resolved. On 17-Apr-2021, Heart rate: 194 (High) outcome was recovered/resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported
Awakened during night of 1/16 with significant pain in right deltoid, somewhat anticipated. By evening on 1/16, noted swelling, redness and warmth in same muscle. All of this gradually resolved by Tuesday - Wednesday, 1/20. Now, here's the strange event (to me): Upon awakening the morning of 1/24, noted that same area (entire R deltoid) was very itchy w/ rash type dots on skin, moderately painful, swollen, warm to touch,  & raised. Today, 1/25, I continue to experience all but the itching, w/ ibuprophen relieving some of the physical discomfort. I was worried about possible infection, but who knows. Fearful of calling Dr's office as they blow most things off.
11 days after the  Moderna booster 3rd shot I developed all over body itching and hives. Mostly on my back, stomach, legs , arms and feet. Intense spontaneous itching usually around evening time but sometimes during the day. Red spots and hives will occur near and around the itchy areas. Still persisting  today. Have never had allergies or hives in my life before.
Developed significant area of erythema on right anterior medial thigh, swelling 3  weeks after vaccine, warmth, tenderness, spanning about 3 inches  with raised dry center. Developed blisters near area of erythema one day after being seen in office. Placed on oral Keflex.  Resolved by 5 days with oral antibiotics.
This spontaneous case reported by a consumer, describes the occurrence of erythema (after first shot, arm was red) in a patient, of an unknown age (around 30 in age) and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced erythema (after first shot, arm was red). At the time of the report, erythema (after first shot, arm was red) outcome: unknown. For mRNA-1273 (Moderna COVID-19 vaccine), unknown route; dosing remained unchanged. No concomitant medications or treatment information provided. Upon internal review on Aug 4, 2021, age information added to narrative supplement. This case linked to MOD-2021-034326 (patient link).
Approximately 18 hours after vaccination, my blood pressure dropped from a normal range of 113/76 to 66/48. I slept almost continuously for 24 hours and almost fainted one time. I was so tired I didn't even think about the vaccination as a cause until the next day (March 15, 2010). I am on several medications for hypertension and atrial fibrillation.
acquired chicken pox 20MAR97;no fever some itching;drowsy #100 pox as of 27MAR97;starting to cry over @ this time;mom states totally covered w/pox;confirmed chicken pox by MD;
Patient presents for covid vaccination.  Vaccination administered, and patient was observed after 15 minutes for reaction.  Felt lightheaded and diaphoretic 15 minutes after vaccine administration- did not lose consciousness; thinks it is anxiety related.  Complete resolution of symptoms with supine positioning with slow elevation of head of bed over 15 minutes.
fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-090097 (Patient Link).   Reporter did not allow further contact
MRI of the breast, enlarged left lymph nodes; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th June 2022, the patient received the 1st dose of Shingrix (intramuscular). On 30th June 2022, 90 min after receiving Shingrix, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was not recovered/not resolved.   It was unknown if the reporter considered the enlargement of lymph nodes to be related to Shingrix.     Additional Information: GSK Receipt Date: 1st July 2022 Reporters Comments: The reporter was the patient. The patient was high risk group for breast cancer. The patient received Shingrix on an unknown arm. On 30th June 2022, ninety minutes after having vaccine she had a magnetic resonance imaging (MRI) of the breast. The results showed enlarged left lymph nodes.  The patient had nothing else to report. Consented to follow up was granted.
1600 pt passed out, in the lobby on their way out home. Became pale, non responsive, US taken & showed for few minutes as inquiry noted. MD notified. regained consciousness & recovered.
administered a dose of Adacel post temperature excursion due to a refrigerator malfunction, low temperature reached negative 2.1 celsius from 07-mar-2022 until 31-mar-2022 not due to a human error with no adverse event; administering dose post temperature excursion outside acceptable guidelines per stability standard, with no adverse event; Initial information received on 19-Apr-2022 regarding an unsolicited valid non-serious case received from health professional.  This case involves a 37 years old female patient who was administered a dose of diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] post temperature excursion due to a refrigerator malfunction, low temperature reached negative 2.1 celsius from 07-mar-2022 until 31-mar-2022 not due to a human error with no adverse event and administered dose post temperature excursion outside acceptable guidelines per stability standard, with no adverse event.     The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included influenza vaccine for Prophylactic vaccination.  On 31-Mar-2022, the patient received a dose of 0.5 ml total Frequency: once of suspect diphtheria-2/tetanus/5 ac pertussis vaccine lot C5963AA expiry date: 18-Jan-2024 via intramuscular route in right deltoid for immunization.  On 31-Mar-2022 the patient was administered a dose of adacel post temperature excursion due to a refrigerator malfunction, low temperature reached negative 2.1 celsius from 07-mar-2022 until 31-mar-2022  for 24 days not due to a human error with no adverse event (product storage error) and administered dose post temperature excursion outside acceptable guidelines per stability standard, with no adverse event  (Out of specification product use) (Latency: same day) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.   Action taken was not applicable.  Outcome was Unknown.     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 the 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.
RECEIVED PFIZER COVID VACCINE 1ST DOSE ON 02/13/21. WENT TO ER ON 02/28/21 WITH COMPLAINT OF BRADYCARDIA AND FELT FAINT. DIAGNOSED WITH SYNCOPE AND COLLAPSE AND ABCESS OF LOWER LEFT LUNG WITH PNEUMONIA. ADMITTED TO HOSPITAL.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm 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: "PMR" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "arthritis" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  Clinical course: This is a positive event. Patient had PMR. The Paxlovid stopped the Covid symptoms but also took away her PMR pain and felt better than had in a long time. Patient had finished the Paxlovid and now her symptoms were starting to return. She checked with other people who has PMR and taken Paxlovid and they felt great after taking this medication. Have you documented that this helps with PMR? treatment start date=10Jul2022, treatment stop date=15Jul2022,  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Breakthrough COVID case:   - The patient is a 49 y.o. male who presents for evaluation of shortness of breath.  Patient states he has had a productive cough and sore throat for 3 days.  He has had 2 doses of the Covid vaccine and is due for his booster tomorrow.  He denies any known sick contacts.  No recent travel.  He states he feels achy.  He has not received his flu vaccine.  He states he had a PCR done yesterday that was negative for the flu and is still pending for Covid.  Patient states his oxygen was 88% at home.  There are no other modifying factors or associated symptoms.
fever; body ache; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever) and MYALGIA (body ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and MYALGIA (body ache). At the time of the report, PYREXIA (fever) and MYALGIA (body ache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
I felt fine while monitored in the parking lot for 15 minutes following injection. On my way home at 25 minutes post injection I had an over-all body wave-type feeling (somewhat similar to a sustained hot-flash) and over-all disconcertingly odd feeling. This lasted about 4 minutes and was followed by shakiness that lasted about 5 minutes (total time a bit less than 10 minutes). Took my bp, pulse, O2 as soon as I got home (approximately 5 minutes post symptoms) and the readings were fine.
Began to notice a type of flush on neck, chest, shoulders, increased skin itchiness, edginess - moodiness, anxiousness to personality. A couple weeks or so before 12/10/12, this was noticed - it felt like allergic reactions (like I've had with certain antibiotics, but not on any meds at that time). On and after Dec. 10th, 2012, severe type flushing, itchiness, prickly sensations, reactive airway still have symptoms of this chronically, waxes and wanes.
Immunocompromised patient received half booster dose instead of 3rd full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received half booster dose instead of 3rd full dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient received half booster dose instead of 3rd full dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient received half booster dose instead of 3rd full dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.