chrisvoncsefalvay/vaers-outcomes huggingface dataset:
indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; COVID-19 Vaccine - Manufacturer Unknown, 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: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; DULOXETINE; ZYRTEC ALLERGY; PEPCID AC; NALTREXONE. other medication in 2 weeks of product include Naltrexone, Pepcid, Multivitamin, Zyrtec, Duloxetine and Bupropion. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. anti-viral details for COVID-19 Treatment was started on 27Apr2022, treatment stop date was 28Apr2022. Indication was treatment of COVID-19. Extreme vomiting and uncontrollable diarrhea started as a result of this treatment with paxlovid. Start date was 27Apr2022 at 11:30 PM and patient recovered, adverse event stop date was 01May2022. No treatment was taken for this  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Feverish; Achy; Headache; The patient received fourth (booster) dose of BNT162B2; The patient received fourth (booster) dose of BNT162B2; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP).  A 13-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) on 07Sep2022 as dose 4 (booster), single (Lot number: BIV GH 9694) at the age of 13 years, Intramuscular in left arm for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EN5318), administration date: 12May2021, when the patient was 12 years old, for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0185), administration date: 02Jun2021, when the patient was 12 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: FJ5683), administration date: 10Jan2022, when the patient was 12 years old, for COVID-19 immunisation.  The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 07Sep2022, outcome "unknown", and all described as "The patient received fourth (booster) dose of BNT162B2"; PYREXIA (non-serious) with onset 08Sep2022, outcome "recovering", described as "Feverish"; PAIN (non-serious) with onset 08Sep2022, outcome "recovering", described as "Achy"; HEADACHE (non-serious) with onset 08Sep2022, outcome "recovering". Therapeutic measures were taken as a result of pyrexia, pain and headache.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Treatment included ADVIL for pyrexia, pain and headache. Since the vaccination, the patient had not been tested for COVID-19.
Pneumonia diagnosed and treated by medical center on 20Nov06. had fever for 1 week before treatment. Vaccine administered on 05Nov06. Treated with Moxifloxcin 400 mg.  MR received for 5 day hospital admission due to pneumonia and hypotension.  Pt. developed fever 3 days post Flumist and continue to have fever x 1 week prior to admission.  Treated with abx.  with good response except for residual febrile episodes. Discharged home after 5 days. DX: Pneumonia.
Patient had received Moderna vaccine on 4/24/2021. Was here for her second Moderna vaccination. Received Pfizer vaccination instead of Moderna.
Dizziness and weakness immediately upon standing up from the chair. I didn't think much of it at the time because I often get light-headed with needles. And the room was stuffy, alcohol scent. After the 15 minutes, I drove home. During the drive home I started to think I wanted to be in bed. I got home, was hungry, ate lunch, and went to bed. I got up around 5, still feeling weak but not tired. I went to bed again at my normal bed time but did not sleep well. In the morning I still felt weak, but was fine by early afternoon. Then the next day in the afternoon I got a pinpoint headache in the back right of my head. Also started feeling weak again. Today the headache is still there but not localized. Still feel weak.
Rash that about size of palm. Pt stated that it started after week after receiving vaccine.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Hyperventilation-Mild, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Weakness-Medium.
legs were hurting more; sinus pressure; does not feel the same as he did before; chills; arm sore; wheeze; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore), WHEEZING (wheeze), PAIN IN EXTREMITY (legs were hurting more), PARANASAL SINUS DISCOMFORT (sinus pressure) and FEELING ABNORMAL (does not feel the same as he did before) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced WHEEZING (wheeze). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm sore), PAIN IN EXTREMITY (legs were hurting more), PARANASAL SINUS DISCOMFORT (sinus pressure), FEELING ABNORMAL (does not feel the same as he did before) and CHILLS (chills). The patient was treated with ALBUTEROL SULFATE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm sore), WHEEZING (wheeze), PAIN IN EXTREMITY (legs were hurting more), PARANASAL SINUS DISCOMFORT (sinus pressure), FEELING ABNORMAL (does not feel the same as he did before) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
I had pain in my abdomen when standing, walking, sitting, but nothing was comfortable. Started in center and went toward the left side of my stomach. Went to my doctor's clinic, sent me to the ER from the clinic. ER visit= gave me a couple different shots (Don't know what types of shots) (made me sleepy, but no longer felt pain after the CT scan), gave me a drink for the CT scan= Normal.
Pain around injection site lasting a week.  After 7 days raised and red patch around injections site  still fading as of today May 2nd, 2021
Initial overdose report received from a healthcare professional on 31 May 2013. It was reported that PENTACEL and IPOL both vaccines were administered on the same day. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Body aches; Fever (100.4 - 101.1); Chills\ shivering; Shaking; Intense headache; Waves of nausea; Injection site soreness; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the right arm on 22Apr2021 at 13:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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. The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the right arm on 01Apr2021 at 13:00 hours (at the age of 51-year-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 23:45, the patient experienced fever (100.4 - 101.1), chills\shivering, shaking, intense headache, waves of nausea, injection site soreness and body aches. On 22Apr2021, the patient underwent body temperature and the result was 100.4 - 101.1 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever (100.4 to 101.1), chills\shivering, shaking, intense headache, waves of nausea, injection site soreness and body aches was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Discharge Provider: MD Primary Care Physician at Discharge: PA-C Admission Date: 1/6/2023 COVID positive Date 1/3/2023 PRESENTING PROBLEM: Acute respiratory failure with hypoxemia    HOSPITAL COURSE: 60 y/o female with hx of ESRD - s/p kidney transplant 2014(on Cellcept, prednisone and Prograf), HTN, DM-2, gastritis, left femoral DVT 7/2022 (Eiiquis) and anxiety disorder. She was seen at emergency department January 3 and at that time had complained of SOB and fatigue. She had been sick for 4 days with nausea, vomiting, diarrhea and was essentially bedridden. Workup in the emergency department revealed a COVID-19 infection and AKI. CXR at that time was without infiltrate.  She opted to be discharged at that point with close outpatient follow-up. She presented again on January 5 with similar complaints, was given a dose of dexamethasone, azithro and Rocephin. Chest CT on 1/6 showed patchy ground glass and consolidation predominately in right lung with scant patch of GGO in medial LLL,  and also a 12 mm x 6 mm x 10 mm pleural based nodule along medial RLL. CT of A/P without acute pathology. Labs significant for AKI, metabolic acidosis, elevated BNP, elevated D-dimer and normal WBC. She was intubated. Post-intubation ABG: 7.10/48/84 on 100% FIO2. She was started on a bicarb gtt which was later stopped d/t concern for volume overload as well as norepi for post intubation shock. LE dopplers (+) for acute left common femoral DVT with 5 cm segment free from vein wall and only tethered by more proximal thrombus. MRSA screen (+). Echo showed LVEF 75%, RV grossly normal. Hypoxemia and renal function continue to worsen. CRRT started 1/9 with negative fluid balance. Paralyzed 1/10. Proning was attempted but unsuccessful as CRRT wouldn't run when in the prone position. Developed fever 1/11, new blood cultures obtained. Went into afib with RVR. Given Cardizem x 1.Multiple family members arrived at bedside and were given medical update. All family in agreement that further aggressive care would not be in align with patient wishes. Patient transferred to comfort care once all family arrived. Passed away peacefully with family and chaplin at bedside,.
adverse event; This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter mentioned that a patient had an unspecified reaction to a flue vaccine.  No details given. The reporter declined to provide information.
pt recv vax 12JAN94 & 18APR95 pt was dx w/hepatitis B;no further details were provided;
Patient received 1st dose of Moderna Covid Vaccine at pharmacy. Patient was instructed to wait 15 minutes, but did not comply. Patient fainted but was fully conscious. Patient received some Gatorade and was ok after that. Paramedics were called to check on patient.
Information has been received from a certified medical assistant concerning a 28 year old female with no pertinent medical history or drug reactions/allergies who in March 2007, May 2007 and October 2007 was vaccinated with a first, second, and third dose of Gardasil (lot # unknown) respectively.  There was no concomitant medication.  Following each of the vaccinations the patient experienced headaches which generally lasted one or two weeks following each dose of Gardasil.  Medical attention was sought.  On an unspecified date the patient had a magnetic resonance imaging test (MRI) performed and was within normal limits.  No other information was available.  Follow-up information was received from the patient.  The patient reported as having experienced severe headaches after her second and third dose of Gardasil and did not have this experience after her first dose.  After the second dose of Gardasil, the headache lasted non-stop for three weeks.  The patient was told by her OB/GYN that the headaches were not a side effect of Gardasil.  The patient started experiencing severe headaches 45 minutes after the third dose and is still experiencing it as of today 06-NOV-2007.  The patient has had two magnetic resonance imaging tests (MRI's) and a computed axial tomography (CAT) scan and no abnormalities were determined.  On an unspecified date at an office visit with her primary care physician, her eyes were bulging and the physician thought the patient was having a stroke.  The patient feels like "she has a knife in her head" and finds it difficult to take care of her children.  No additional information was provided.  Additional information has been requested. Follow-up received 04/16/2008. Follow-up information was obtained from the physician's office. The dates of the vaccinations for GARDASIL were 23-MAR-2007, 25-MAY-2007 and 25-OCT-2007 respectively. Additional information is not expected.
Bones hurting throughout body. Mucus build up in throat and nostrils. Coughing. Freezing and teeth were chattering. Eyes were itchy. No complaints with previous flu shots.
The next day, when I woke up I was unable to stand on my left leg. Pain in the posterior knee. Felt like I was walking through mud. Joints were all loose. Just a really bad left knee pain. They  a lower extremity doppler to that leg - to look for blood clot and that was negative. Physical therapy - taped my knee; pain was so bad I had to stay home a couple of times. My hands (both) were so painful. Like I had frostbite. Occupational therapy did hand massage and paraffin for the pain. And isotoner glove at night and that helps with the buzzing. I am 2 months out today from the vaccine and I'm starting to feel like normal. Took two months to fade away. It may have been because I was still having COVID antibodies. COVID antibodies on August started at 6.95. I'm not totally recovered right now but I'm close to normal.  Doctor visit - January 29, 2021 and February 5, 2021.and February 19th.  They put me on high dose of Steroids - 20 mgs Prednisone daily  and another round of blood thinner -ELIQUIS  mg which helped me with pain and joints.
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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EH9899), in right arm, on 30Apr2021 as dose 2, single (Lot number: EL1284), in right arm and on 01Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: QVAR; NASONEX.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 101, notes: Fever of 101; SARS-CoV-2 test: (2022) Positive, notes: Tested positive after being well for 5 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti-viral details: Paxlovid indicated for Covid-19 treatment. Treatment start date was 22Jul2022 and stop date was 27Jul2022. Tested positive after being well for 5 days Fever of 101, stuffy and runny nose. No known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201025193 Same product, same patient, different event, different dose;
Went to primary provider four days later, has cellulitis at injection site and surrounding area. Was prescribed antibiotics.
Moderna COVID-19 Vaccine EUA. No adverse reactions from first shot March 16, 2021. This reporting concerns the second dose April 14, 2021. Two weeks later I experienced locking and pain in both shoulders but more severe on the left side where the injection occurred. The shoulders would not rotate then "popped" , motion returned and the pain subsided.  The pain was quick and intense. Second issue, a similar locking pain across the shoulder blades that literally stopped my breathing until the pain subsided. Third issue, a similar cramping pain in the toes of both feet while walking, again slowly subsiding. All of these issues have occured daily since the second Moderna injection. I have contacted my primary care doctor for an appointment as well as reporting this here.
Headache, fatigue, flushing, reports that tongue feels swollen, shortness of breath
11/20/09 Symptoms of L side Bells Palsy. Saw MD, Lymes titer negative. Treated with prednisone. 11/30/09 Symptoms getting better. 12/2/09 Medical records received for date 11/25/09. DX: Bell's palsy. Consultation for new onset of bell's palsy. Pt was seen by this consulting MD approx 48hrs ago. Pt c/o occurrence of bells palsy as a result of receiving H1N1 vax. Assessment: left sided facial droop, ptosis on left. Neuro consult 11/20/09 DX:paresthesia and pain rt.antierior neck. No significant neurological disorder found.
Localized swelling of injection site to left upper arm.  Dr. notified, and was in to see patient.
fever x 4 days 22JAN99-25JAN99;rash on chest, abd, legs 25JAN99;sore throat x 1 days 25JAN99;
Within 4 minutes of receiving the vaccination I felt excruciating pulsating pain in the flank area. I felt as if something was gripping, or seizing my internal organs.   Radiating from the area of the kidneys or adrenals. Pain was so intense I was not able to catch my breath.
I experienced a breakthrough case of COVID-19 with a sore throat, congestion, runny nose, sneezing and a fever.
11:15 Client is a 37 year old female that recieved her Pfizer Booster vaccine today. She notified the vaccinator that she had a histamine reaction to her previous doses of the pfizer vaccine (rash), but had prophylactically took benadryl for her second dose and was ok, but forgot to this time. Client stated that 10 min into waiting in recovery area she started to feel swelling and have a fuzzy tongue. EMS was on site assessing client when this nurse arrived. Client A/O x3, verbal, no s/sx of distress. Nurse administered 1 Diphenhydramine HCl 25 mg, client was able to swallow medication with no problem. Nurse re-assessed client again at 11:27 and client states that the fuzzy feeling in her tongue has subsided and she is feeling much better and ok to leave. Nurse did teaching with client on monitoring for s/sx of worsening and appropriate action to take. client verbalized understanding.
pt recv vax 14OCT96 & pt exp a sl fever, & arms edematous, painful & tight;
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Mild, Additional Details: The patient did not lose conciousness. Was just light headed and dizzy. We monitored him. He left feeling fine.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of improperly stored  PEDVAXHIB lot # reported as M02784 with expiration date 19-APR-2019 (dose and route of administration not reported). The vaccine underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 30 minutes. Digital data logger was used to record the excursion. The vaccine already underwent previous excursion of 32 to 35 degrees Fahrenheit for 185 hours and 45 minutes. No adverse effects were reported. This is one of three reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1704USA005828: US-009507513-1704USA010519.
I had some wheezing at night with nasal congestion. I thought it was just a cold, and I got the post nasal drip for the wheezing.
Patient was hot, sweaty and turned pale 5 minutes after vaccine.  She felt like she was going to pass out.
Moderna COVID-19 vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered after temperature excursion) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered after temperature excursion). On 01-Sep-2021, PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.  It was reported that there was a temperature fluctuation that last for 15 hours (approximate 4:05pm through 6:50am the next morning). The lowest temperature was 32.7 with fluctuations until it was restored to 35 degrees and above at 6:50am).  It was also mentioned that when the vial was used, it was in a normal liquid state. The vial was moved from freezer to fridge on 31-Aug-2021 and was only in fridge for a day prior to administration. Because the vaccine did not get down to freezing, reporter did not send the excursion for evaluation.   Vaccine was administered intramuscularly in the upper deltoid and reporter was not sure which arm. It was stated that patients did not experience any adverse reactions following administration.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow-up received and does not contain any new information.
A third dose of Menveo was given to patient 10 months after the second dose was administered. There were no symptoms or reactions after giving the vaccine.