chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: COVID infection following COVID vaccine series 03/19, Pfizer, dose #1 07/16, Pfizer, dose #2 05/20 CXR impression: 1. Stable chesrt with probable persistent air trapping. 07/27 COVID-19 SCR Eval: not detected 08/18 COVID swab, result: detected 08/19 pt cc: dyspnea exposure; unknown 08/31 COVID-19 SCR Eval: not detected
fever, (100-102); aches; chills; nausea; vomiting; headache; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9266, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 15:00 as 2nd dose, single dose for covid-19 immunisation. Medical history included drug hypersensitivity. Concomitant medication(s) included simvastatin (SIMVASTATIN)10mg; meloxicam (MELOXICAM)75mcg; levothyroxine (LEVOTHYROXINE)15mg. Patient had history of allergy to sulpha drugs. Patient previously took 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 02:30 PM as 1st dose, single dose for covid-19 immunisation. On 13Feb2021 03:00 The patient experienced fever, (100-102), aches, chills, nausea, vomiting, headache. Patient not tested positive before vaccination and tested post vaccination. The patient underwent lab tests and procedures which included body temperature:100-102 on 13Feb2021, sars-cov-2 test negative on 17Feb2021, 24Feb2021, 03Mar2021 respectively (covid test type post vaccination was other and covid test name post vaccination was PCR pool testing). The outcome of events recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Information has been received from a Registered Nurse (R.N) concerning a patient (gender not specified) who was vaccinated with a dose of PNEUMOVAX 23. The nurse reported that the patient had a large reaction to PNEUMOVAX 23 vaccine within the last couple of months. The outcome was unknown. No other information was reported. Additional information has been requested.
At the site of the injection (on her upper arm), the patient's arm was red, swollen, painful and very hot to the touch.  The red swollen area got bigger and bigger over the next few days, then it went away over a few days time.  It was very painful for her.  We tried ice to reduce swelling and pain but it was too uncomfortable for her.
Fever up to 101.6, headache, chills, fatigue for about 36 hours.
soreness at the injection site; headache; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP).  A 49-year-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection), administration date 27Feb2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness at the injection site"; HEADACHE (non-serious), outcome "unknown", described as "headache". Therapeutic measures were taken as a result of headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A non-serious report was received from a consumer involving lethargy, sore throat, clogged sinuses and "feeling crazy" concerning a 27-year-old male. No medical history or concomitant medications were reported for this patient. The patient was administered FLUMIST vaccine on 08 Nov 2007. On 09 Nov 2007, the patient experienced sore throat, clogged sinuses, lethargy and "feeling crazy". No information was reported. The events of lethargy and "feeling crazy" resolved on an unreported date. The events of sore throat and clogged sinuses remain unresolved after three days. Action taken with FLUMIST was not reported. The reporter did not provide a causality assessment for the adverse events reported. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Doses were administered after the 30 day BUD; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD).    No concomitant medications were reported. HCP confirmed that doses were administered after the 30 day BUD and had 3 lot numbers,but the does not have information regarding the situation. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.Previous COVID-19 vaccination doses information was unknown. No treatment information was provided.
Burning sensation in forearms (from 1Nov to present) (feels like sandpaper scratching), muscle pain in fingers and forearms
Painful arm; This is a spontaneous report from a contactable consumer (patient) via COVID-19 Vaccine Reporting System . A 43-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Feb2021 13:45 (Batch/Lot Number: En6201) (at the age of 43 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. There were no known allergies. Patient has no COVID prior vaccination. Patient was not tested for COVID post vaccination. The patient experienced painful arm on 13Feb2021 with outcome of unknown, with no treatment.    No follow-up attempts are possible. No further information is expected.
RA swollen and red around injection site and warm. Instructed parent to give child Benadryl. Take Tylenol for fever. Report to PMP if site does not get any better.
Coughing; Headache; Soreness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), HEADACHE (Headache), PAIN (Soreness) and FATIGUE (Fatigue) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Coughing), HEADACHE (Headache), PAIN (Soreness) and FATIGUE (Fatigue). At the time of the report, COUGH (Coughing), HEADACHE (Headache), PAIN (Soreness) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Covid + on 10/28/2021 and received Pfizer vaccine with 1st dose on 03/06/2021 EN6202 and 2nd dose on 03/27/2021 ER 2613 H & P: 61 yo male with h/o HTN / CAD / S/P stent / S/P CABG / pulmonary hypertension, DM, hyperlipidemia, COPD / former smoker / pulmonary hypertension, arthritis / DJD of hips - S/P L hip THA / h/o L hip prosthesis infection - S/P removal of L hip prosthesis / lumbar radiculopathy / sciatica / S/P MVA, renal insufficiency, peripheral neuropathy / debility, peripheral vascular disease, L heel ulcer - osteomyelitis, overweight, h/o substance abuse, gastroparesis / anemia / h/o remote abdominal trauma / +FH of colon Ca / diverticulosis / hemorrhoids and urinary retention. Patient was seen in ER for complaints of shortness of breath and hypoxia. Patient had recently been admitted for intractable vomiting and was diagnosed with gastroparesis. During that admission patient was also treated for chronic L heel ulcer and osteomyelitis. After intractable vomiting resolved and patient was medically stabilized, he was discharged to ECF to complete course of IV antibiotics for a left heel ulcer with osteomyelitis. While residing at ECF, patient developed shortness of breath and was found to be hypoxic and he was transferred to ER for further evaluation. Patient had shortness of breath but there were no complaints of cough, wheezing or sputum production. There was no reported history of fever or chills. There were no reported complaints of any other URI symptoms such as sore throat or sinus congestion and there were no known sick contacts or COVID-19 positive contacts. Patient had dyspnea but there were no complaints of chest pain, diaphoresis or palpitations. There were also no reported complaints of orthopnea or PND. Patient did not have any complaints of nausea/vomiting, abdominal pain or diarrhea. There were also no complaints of dysuria, frequency or hematuria. In ER, patient was found to be hypoxic on 4 L of oxygen but improved with increased to 6 L. CXR showed previous CABG, patchy atelectasis in both lower lobes - left greater than right and questionable mild interstitial edema. EKG showed sinus rhythm with first-degree AV block, left axis deviation and right bundle branch block but there were no acute ischemic changes. X-ray of the left foot showed increased osteopenia, new indistinct cortical bone about proximal navicular - ?osteomyelitis?, indistinct cortical bone of posteroinferior calcaneus is similar to previous - ?osteomyelitis?, fracture of calcaneus - again noted with displacement at the subtalar joint and a metallic foreign body suspected in region of second digit soft tissue unchanged. Labs were significant for anemia with Hb = 7.6, elevated ProTime /INR = 15.3/1.31, elevated BUN = 34,  elevated troponin = 0.09 and elevated proBNP = 4795. COVID-19 PCR was negative. Patient was admitted for dyspnea / hypoxia - ?CHF exacerbation vs. COPD exacerbation? and evaluation of left heel ulcer / osteomyelitis.
Site: Swelling at Injection Site-Mild, Additional Details: Patient has no other complaints.
pt reported nausea, dizziness and sob immediately post vaccine. no history of reactions in the past. called 911 due to increasing sob. all symptoms resolved within 20 min. pt reported a very light breakfast and no hydration previous to vaccine. advised pt to eat and drink prior to vaccines in the future. pt did not leave with ems. ekg, bp, sugar all wnl when checked by ems
swelling of the lymph nodes under armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swelling of the lymph nodes under armpit) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swelling of the lymph nodes under armpit). At the time of the report, LYMPHADENOPATHY (swelling of the lymph nodes under armpit) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Recurrent uti (culture me show e. Coli) with antibiotic resistance, raised blood pressure, flare of heat rash across hands, feet, and face
Patient reports that approximate at 4:00pm shortly after vaccine patient began to feel short of breath and having chest pain. Patient reports," I took Nitro and felt better, but chest pain and shortness of breath has continued to worsen. Patients vaccine card identifies Moderna as the brand, however computer report Pfizer. This also is a concern.
pt recv vax 7APR97 & mom reports swelling to rt side of neck & spreading down rt arm;mom states they started p/MMR vax given & is progressively worsening;23APR97 f/u mom reports pt treated for staph infect & sx resolved p/ATB;
Positive COVID-19 test with no symptoms; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9262, expiration date 31May2021), via an unspecified route of administration on 22Jan2021 at 15:15 (at the age of 34-years-old) as a single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included ethinylestradiol, norgestimate (MILI), oral from an unknown date for birth control (taken for two years). The patient did not receive other vaccines within 4 weeks prior to vaccination. On 28Jan2021, the patient experienced a Positive COVID-19 PCR test without symptoms. The clinical outcome of the event COVID-19 was unknown.
Information has been received from a woman in a medical office concerning a 12 month old male patient who on 03/22/2004 was vaccinated in the left arm with a first dose of varicella virus vaccine live (Oka/Merck) (lot#646358/0569N).  Concomitant vaccination in the right arm on 03/22/2004 included a first dose of measles virus vaccine live (Moraten) mumps virus vaccine live, rubella virus vaccine live (lot#645434/0276N).  The patient was well at the time of vaccination.  On 04/02/2004, the patient developed a rash breaking out on several areas of the body and a runny nose.  Symptomatic treatment was noted, but medical attention was not sought.  Subsequently, the patient recovered.  Additional information is not expected.
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX vaccine, on or about 06-DEC-2016, at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles and other complications. On or about 01-MAR-2017, the patient was treated at a medical clinic for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles. The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient c/o "feeling funny" following vaccination of 2nd dose of the Pfizer-BioNTech HX. HTN-L/S clear-bilat  0 wheezing  Patient being evaluated by EMS. Vitals assessed Recommend transport. Patient refused
Patient, a homebound patient received the COVID19 Pfizer vaccine 0.3 mL  IM on 6/4/2021 at 3:07PM. The COVID19 Pfizer vaccine was prepared on 6/4/2021 at 8:20AM. Patient received the his second dose of Pfizer vaccine 47 minutes outside of the required 6 hours window after reconstituting the vaccine. Patient did not have any adverse reactions to the Pfizer vaccination. Follow-up call 6/8/2021, no issues as per patient.
Duplicate administration of Tdap vaccine 7/21/10. Pt received already 11/2009.
Myalgia, Fever, CoughWheeze,  nasal drainage, sore throat, Narrative:
Patient stated the next afternoon she started having red dots form on the body, and still had a cough
Initial report received consumer on 01 November 2013. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE (route, lot # UH894AA and site of vaccination was not reported) on 30 October 2013. Reporter stated that three patients who received FLUZONE on 30 October 2013 and that day began experiencing headache, nausea, and stomach cramping. Also stated symptoms continue to today, on 01-November-2013. List of documents held by sender: none.
Patient admitted to the hospital on 4/27/21, diagnosed with Gillian Barre Syndrome.
Anterior deltoid swelling anterior to the shot. Had no ROM of his left arm for a few hours after shot, but improved after swelling and bruising went away.
Persistent low frequency tinnitus and hearing loss immediately following vaccination.  Every day, ongoing since vaccination booster was received.
Most of the vaccine went down the patient's arm while administeration, no AE.; while adminstering vaccine fluzone HD squirted out at the connection between the syringe and the needle,no AE.; Most of the vaccine went down the patient's arm while administeration, no AE.; Initial information received on 16-Dec-2019 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves patient (age and gender unknown) who was vaccinated with the dose of  INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number UJ308AA and expiration date 30-Jun-2020), while administration most of the vaccine went down the patient's arm (underdose) (exposure via skin contact) and the pharmacist gave additional vaccine since most of the first vaccine was not administered via unknown route in the left deltoid and vaccine fluzone hd squirted out at the connection between the syringe and the needle (syringe issue) on an unknown date.  The medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to underdose, exposure via skin contact.  It is also a case of syringe issue.  No adverse event reported at the time of reporting.  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 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.
testing positive; testing positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old male patient received BNT162b2 (BNT162B2), on 26Nov2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 24 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11May2022, outcome "recovering" and all described as "testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 12May2022 to 16May2022. Clinical course: No other medication were received in 2weeks. Patient started having symptoms of COVID the night of Wednesday 11May2022. And started taking Paxlovid on Thursday 12May2022 after testing positive that morning. By Tuesday 17May2022 felt pretty much good as new. On Thursday 19May2022 began feeling a little congested, and symptoms got worse over the next two days. Patient was writing this on Saturday 21May2022 and feel congested and tired. No Known allergies.
congestion; headache; chills; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of NASAL CONGESTION (congestion), HEADACHE (headache) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced NASAL CONGESTION (congestion), HEADACHE (headache) and CHILLS (chills). At the time of the report, NASAL CONGESTION (congestion), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Patient began feeling faint after vaccines were given.  Patient was sweaty and pale, told patient to sit and put legs up on another chair.  Checked patient's blood pressure and it was 88/62.  Gave the patient some water to drink and told patient to eat the peanut butter crackers he was given.  Asked the patient if he was dizzy or feeling better after five minutes.  Patient stated he was feeling better.  Rechecked blood pressure and it was 98 over 78.
The morning after and for 2 days following the vaccines, patient experienced heavy sweating/soaking, feeling freezing, and body aches (without any fever). On the third day, she started feeling better, but then all of a sudden her heart started pounding, her vision starting graying and going up and down, and she had eye and head pressure. She then went to Hospital which sent her to another hospital since they supposedly did not have the expertise to help her. She was hospitalized at for 2 days and was hydrated with IV fluids, given toradol, and some other medication the patient cannot remember for her head.  At CMC, doctors told her she had extremely high diastolic blood pressure and found a hole in her heart.  They also did an MRI on her head.  They don't know exactly what is going on, but diagnosed her with non-specific migraine in the mean time.   She is still experiencing persistent migraines (7/10 pain scale) and is waiting to see a neurologist. She is also currently wearing a heart monitor and is most likely going to have to get heart surgery to repair her heart.
On 02/09/2021 just felt weak and very tired, I stayed in bed for 15 hours. July 18th I began having symptoms of covid, on July 20th and was tested for Covid and on the 21st of July it was positive. My symptoms lasted for 3 weeks, the first two days fever of 101.
Dizziness; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and VERTIGO (Vertigo) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced DIZZINESS (Dizziness) and VERTIGO (Vertigo). At the time of the report, DIZZINESS (Dizziness) and VERTIGO (Vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-054759 (Patient Link).