chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for covid /COVID 19 Treatment; tested positive for covid/COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EL0142), on 12Jan2021 as dose 2, single (Lot number: EL0142) and on 14Oct2021 as dose 3 (booster), single (Lot number: EW0186) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Known allergies: Seasonal Allergies" (unspecified if ongoing), notes: known allergies: Seasonal Allergies. Concomitant medication(s) included: ZOLOFT, start date: 09Oct1998; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01May2022; SINGULAIR, start date: 05Jun2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for covid/COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: When I tested positive for covid I was eligible for Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid.        Other medication details: Other medication in 2weeks product=Antidepressant, Other medication in 2weeks product=Zoloft, Other medication in 2weeks start date=09Oct1998  Other medication in 2weeks product=Antihistamine, Other medication in 2weeks product=Zyrtec, Other medication in 2weeks start date=01May2022  Other medication in 2weeks brand=Singulair, Other medication in 2weeks start date=05Jun2020  Adverse event: When I tested positive for covid I was eligible for Paxlovid. I started treatment on Sunday, 11Sep in the evening. My treatment ended the morning of Friday, 16Sep. By Monday 26Sep, I was achy, had increased coughing, increased shortness of breath, my lungs feel like they are burning, sore throat and sinus congestion. Adverse event start date: 12Sep2022 Adverse event start time: 04:00 PM AE resulted in: [None of the above] If treatment AE: Unknown  Known allergies: Seasonal Allergies  Other medical history: Asthma, Depression; Sender's Comments: Based on the known safety profile of the vaccine BNT162b2, a causal relation between the reported events Covid-19, Vaccination failure and the administration of the vaccine cannot be excluded.
The caller tested positive for COVID-19 yesterday; The caller tested positive for COVID-19 yesterday; Right arm sore; Body was sore for a week; Tired for a week; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female consumer (reported herself). The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), via intramuscular in right arm on 18Mar2021 at 13:00 as a single dose for COVID-19 immunization. The patient's familial medical history included that the patient's son passed away 10Jun2020, he had type 2 diabetes.  He went to hospital with Pneumonia and keep him for 3 weeks and released him and passed away the next day. The patient's medical history included soreness. The patient's concomitant medication included ibuprofen. On 18Mar2021, the patient experienced that in the morning when she woke up around 08:00the patient's body was sore for a week and she felt tired in the afternoon around 16:00-17:00. The patient's right arm was sore at 14:00, but not much. The patient went to work and used her arm and by the end of a day it was less sore and by the next day, it was almost normal. The patient's body was so sore, like doing exercise for a couple of days. On 18Apr2021, the patient was scheduled to receive her 2nd vaccine and patient tested COVID-19 vaccine and resulted positive so that the patient was sent to home. The patient would like to know when can get the second dose. Prior to the vaccination the patient received pills for high blood pressure. The patient did not received any vaccination 4 weeks prior to the COVID vaccine. The outcome of the events body was sore for a week, right arm sore and tired for a week was recovering and other events was unknown.  No follow-up attempts are possible. No further information is expected.
Sudden onset idiopathic left 6th cranial nerve palsy with diplopia and strabismus on 8-2-2021 = 4+months after second dose COVID-19 vacc.  This delay may indicate no relationship, but was told to report it anyway.
I started waking up in the morning seeing fireworks in my left eye, which is weaker than my right one. By Sunday, it was getting worse. I held my hand my right eye to measure the eye sight of my left eye. I could see a line cutting through my line of vision; I could see above the line, but couldn't see anything below the line. I went to a clinic and was referred to a retina specialist. They called a Neural Ophthalmologist and asked if I could be seen that day. I went to the neural ophthalmologist who knew exactly what the problem was and how to treat it. I was diagnosed with NAION (Non-Arteritic Ischemic Optic Neuropathy) where half of one eye loses vision. He prescribed three medications and a low dose aspirin to reduce swelling around my optic nerve.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 25Mar2022 at 16:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEXAPRO; VITAMIN D [VITAMIN D NOS]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Antigen test: (Jun2022) T on my atigen test that day came up quickly; SARS-CoV-2 test: (19Jun2022) Positive; (25Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received paxlovid to treat drug ineffective, covid-19. Treatment start date: 19Jun2022, stop date: 24Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
MODERN 0.5 ML FOR IM LOT 036A21A EPX:08/26/2021 No known adverse events.
Information has been received from a physician concerning a female patient who on 17-APR-2007 was vaccinated with a dose of Proquad (Lot # 656312/0297U). It was reported that the patient developed redness, swelling, tenderness and induration at injection site on an unspecified date after vaccination, approximately April 2007. Additional information has been requested. This is one of several reports received from the same source,
Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 20-OCT-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L018499; expiry: 25-FEB-2017 (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Pt received 2nd ROTATEQ on 8/18/08 and was admitted and treated for intussusception on 8/27/08.  12/30/2008 Reviewed hospital medical records of 8/27-8/28/2008. FINAL DX: ileocolic intussusception, enema reduced Records reveal patient experienced decreased activity, reduced oral intake, emesis which became bilious, excessive sleepiness & fever.  Admitted overnight s/p enema reduction of IS.  Progressed well & tolerated diet w/o complication.  D/C to home.
Patient received H1N1 and was instructed to wait 10 minutes. He and his dad waited in waiting room. Few minutes passed and yelled out to me b/c he was feeling dizzy, went over to check on him. Dad said that he passed out 1-2 minutes. Patient just felt sweaty. Patient had no breakfast and was a bit anxious about the shot. Took blood pressure and it was good. Patient would be with parents all day. He ate and said he was cool so patient was under blankets. Dad took blood pressure again at home and it was low. No symptoms otherwise. Dad was instructed to see/take him to a doctor if the patient felt different.
patient present to er 1/2022 with complaints of  pt states L arm ever since the second  covid shot has pain especially when he moves it from side to side down to his elbow.  patient states he has SIRVA -sequilla ? of the body's response to the COVID inj and the needle length- prolonged shoulder pain
Throat started to close; could not breathe; Rash broke out on back and arms; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of THROAT TIGHTNESS (Throat started to close), DYSPNOEA (could not breathe) and RASH (Rash broke out on back and arms) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020AB21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced THROAT TIGHTNESS (Throat started to close). 05-Apr-2021, the patient experienced DYSPNOEA (could not breathe) and RASH (Rash broke out on back and arms). The patient was treated with EPINEPHRINE (EPIPEN) at an unspecified dose and frequency. At the time of the report, THROAT TIGHTNESS (Throat started to close), DYSPNOEA (could not breathe) and RASH (Rash broke out on back and arms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, Blood pressure measurement: high (High) went up. On 05-Apr-2021, Heart rate: high (High) High.         Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-123438 (Patient Link).
Headache; Fatigue; Severe pain all over my body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Severe pain all over my body), HEADACHE (Headache) and FATIGUE (Fatigue) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN (Severe pain all over my body). On 15-Jan-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, PAIN (Severe pain all over my body), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
the following morning woke up in puddle of sweat; severe rigors lasting approximately 20 minutes followed by fever 103; mild fatigue; fever 103; This is a spontaneous report from a contactable nurse (patient). A 39-year-old male patient received his second dose of BNT162B2 (lot number: EK9231), intramuscular in the left arm on 05Jan2021 at 19:30 at single dose for Covid-19 immunization. Medical history included OSA (Obstructive sleep apnea). There were no concomitant medications. There was no other vaccine in four weeks nor other medications in two weeks. The patient received his first dose of BNT162B2 (lot number: EH9899), intramuscular in the left arm on 15Dec2020 at 19:30 at single dose for Covid-19 immunization. The patient previously took amoxicillin and experienced allergies. On 06Jan2021 at about 13:00 day after vaccine the patient exeperienced mild fatigue, by 19:00 very fatigued, at 22:00 severe rigors lasting approximately 20 minutes followed by fever 103; at 03:30am on 07Jan2021, (the following morning) the patient woke up in puddle of sweat. There was no treatment received for the events. No Covid prior vaccination and not tested for Covid, post vaccination. The events recovered on unspecified date.
ANEURYSM; This spontaneous report received from a consumer via social media concerned a 49 year old adult female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was in good health. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced aneurysm. The consumer reported as "I know someone else that died after jab from aneurysm. She was only 49 and in good health". On an unspecified date, the patient died from aneurysm. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of from aneurysm on an unspecified date. This report was serious (Death).; Sender's Comments: V0: 20211119575-COVID-19 VACCINE AD26.COV2.S-Aneurysm. This event is considered unassessable. The event 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.; Reported Cause(s) of Death: ANEURYSM
A small growth appeared on the inside of my right eyelid. It felt like a piece of sand was stuck in there. This happened the day after my first vaccination and the day after the second dose. By one day after the occurrence (for both) the growth was gone and I felt normal. The growth did not hurt, but it was very noticeable.
Patient has no adverse event.  Consent form was not given to patient to be filled out before administration. Vaccine prescription was processed a head of time in waiting bin earlier in the day; but the vaccine was given to the patient at a later time that day by an intern pharmacist when patient came.
This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (didn't feel good), ILLNESS (has been sick since then/kind a little sick), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), HYPERHIDROSIS (sweats) and INCOHERENT (incoherent) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ) for Blood pressure high. On 17-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, the patient experienced MALAISE (didn't feel good), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), HYPERHIDROSIS (sweats), NAUSEA (nauseous) and MYALGIA (body aches). On 20-Sep-2021, the patient experienced ILLNESS (has been sick since then/kind a little sick). On 22-Sep-2021, the patient experienced INCOHERENT (incoherent), DIARRHOEA (has diarrhea), VOMITING (throwing up/was spitting on the floor with throw up while on the toilet) and CHILLS (chills). At the time of the report, MALAISE (didn't feel good), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), NAUSEA (nauseous) and MYALGIA (body aches) outcome was unknown and ILLNESS (has been sick since then/kind a little sick), HYPERHIDROSIS (sweats), INCOHERENT (incoherent), DIARRHOEA (has diarrhea), VOMITING (throwing up/was spitting on the floor with throw up while on the toilet) and CHILLS (chills) had not resolved.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Sep-2021, Body temperature: abnormal (abnormal) 96F but could be wrong. No Treatment medications were reported. Patient went to the urgent care, they performed a COVID test, whose results is still pending.
could hardly talk.; nausea; pain became extremely intense and terrible to tolerate/"the pain was like some one stabbing in my stomach multiple times"; weakness in my legs/weakness; I was freezing cold; I thought I might die,given the intensity of the discomfort.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN UPPER (pain became extremely intense and terrible to tolerate/"the pain was like some one stabbing in my stomach multiple times"), FEELING COLD (I was freezing cold), DISCOMFORT (I thought I might die,given the intensity of the discomfort.), ASTHENIA (weakness in my legs/weakness) and SPEECH DISORDER (could hardly talk.) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Aortic dissection on 10-Sep-2019. Previously administered products included for an unreported indication: STREPTOCOCCUS PNEUMONIAE and FLU. Concurrent medical conditions included Epilepsy (for 13 years.). Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN+HIDROCLOROTIAZIDA) and LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for an unknown indication.    On 05-May-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced FEELING COLD (I was freezing cold) and DISCOMFORT (I thought I might die,given the intensity of the discomfort.). On 07-May-2021, the patient experienced ABDOMINAL PAIN UPPER (pain became extremely intense and terrible to tolerate/"the pain was like some one stabbing in my stomach multiple times"), ASTHENIA (weakness in my legs/weakness) and NAUSEA (nausea). On an unknown date, the patient experienced SPEECH DISORDER (could hardly talk.). The patient was treated with PARACETAMOL (TYLENOL) (oral) on 08-May-2021 for Adverse event, at an unspecified dose and frequency. On 07-May-2021, DISCOMFORT (I thought I might die,given the intensity of the discomfort.) had resolved. On 23-May-2021, ASTHENIA (weakness in my legs/weakness) and NAUSEA (nausea) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (pain became extremely intense and terrible to tolerate/"the pain was like some one stabbing in my stomach multiple times"), FEELING COLD (I was freezing cold) and SPEECH DISORDER (could hardly talk.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow up includes patient demographics , event outcome updated On 22-Jul-2021: Follow up done. No new information received.
Patient received vaccine and within a few seconds passed out.  He was out for about 15 seconds.  Patient was disoriented for about 5 minutes.  He was able to get up and sit down on a chair.  Father states he has a history of passing out with vaccines. Paramedics were called and determined he was fine and allowed him to leave on his own.
The patient presented in the office with a firm knot on his right thigh (palpable) and an erythemic area at the injection site.
16 year old given Janssen not Pfizer vaccine.  parent notified.  No noted adverse reaction currently
Fully vaccinated patient admitted through ED for COVID pneumonia.  Patient received Zosyn, systemic steroid, oxygen , and heparin anticoagulation.  Patient continued to decline with ABG showing severe acidosis and kidneys not producing urine.  Collaboration with family who chose comfort care over continued aggressive treatment and intubation.  Patient died on 10/15/21.
Patient received a full vial of Pfizer vaccine, it had not been diluted. Patient's parents were contact immediately once it was brought to the attention of the administrator.
Hurt after the injection; Burned after the injection; Pattients experience rash after the vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain, burn and rash. On an unknown date, the outcome of the pain and burn were unknown and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the pain, burn and rash to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. During the call, the pharmacist initially mentions that she had patients experience rash after the vaccine, But later the reporter, clarifies that she has no patient details available. The patients in general have called the pharmacy and reported it hurt and burned after the injection. Pharmacist adds she has not seen a patient develop rash afterwards.  The reporter did not consent to follow up. The pharmacist stated that she has no further details and declines follow up. This case linked with US2019AMR190427, reported by same reporter.
Around 8pm the injection site started to get sore. I was moderately sore for approximately 48 hours. About one week after receiving the vaccine, around January 6, the injection site started to get itchy.  Not continuously itchy but now and then.  There were no marks on my arm at all at the injection site at any time.
feel "down" and weak; feel "down" and weak; her eyes, ears and head felt like they were "burning"; her eyes, ears and head felt like they were "burning"; her eyes, ears and head felt like they were "burning"; headache; chills; body aches; a little bit of fever; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Lot Number: ER8729), dose 1 via an unspecified route of administration, administered in Arm Left on 11Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She received the first dose of the Pfizer Covid 19 vaccine on Sunday (11Apr2021) and was having some reactions. Monday (12Apr2021), she reported having a headache, chills, body aches, a little bit of fever and she couldn't work. Tuesday (13Apr2021), she felt better in the afternoon. Wednesday (14Apr2021), her eyes, ears and head felt like they were "burning".  Today (15Apr2021), she felt "down" and weak. The outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: pt passed out for less than 1 min after administration. mother was advised to report to md office for follow up and to recieve 2nd dose