chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe (excruciating) continuous headache with dizziness; Severe (excruciating) continuous headache with dizziness; extreme joint pain (even my ankles); nausea; vomiting; extreme fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Aug2021 14:15 (Lot number: FC3180) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypothyroid that is well-managed" (unspecified if ongoing). Concomitant medication(s) included: NP THYROID taken for thyroid disorder; MULTIVITAMIN [VITAMINS NOS]. Past drug history included: Codeine, reaction(s): "rash"; Codeine, reaction(s): "itching"; Morphine, reaction(s): "vomiting"; Tramadol, reaction(s): "vomiting". Vaccination history included: Bnt162b2 (dose number: 1,, lot number: FA7484,, lot unknown: False,, administration date: 20Jul2021,, administration time: 03:30 PM, vaccine location: Left arm), administration date: 20Jul2021, when the patient was 60 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious), DIZZINESS (non-serious) all with onset 12Aug2021 05:00, outcome "not recovered" and all described as "Severe (excruciating) continuous headache with dizziness"; ARTHRALGIA (non-serious) with onset 12Aug2021 05:00, outcome "not recovered", described as "extreme joint pain (even my ankles)"; NAUSEA (non-serious) with onset 12Aug2021 05:00, outcome "not recovered", described as "nausea"; VOMITING (non-serious) with onset 12Aug2021 05:00, outcome "not recovered", described as "vomiting"; FATIGUE (non-serious) with onset 12Aug2021 05:00, outcome "not recovered", described as "extreme fatigue". Therapeutic measures were not taken as a result of headache, dizziness, arthralgia, nausea, vomiting, fatigue.  Additional information: Facility where the most recent COVID-19 vaccine was administered  reported as Pharmacy or Drug Store, The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination reported as NP Thyroid 90mg/daily; multivitamin. No Prolonged Hospitalization as result of events. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
I have had pain, itching,  and swelling at the injection site. I have had some joint pain. Since this morning I have experienced a rapid heart rate on and off when resting. My normal resting heart rate is 82 but it is going as high as 115 even when I am laying in bed. Because I noticed this I looked at my heart rating using a fitbit, an oximeter, and well as me checking my own pulse.
Information has been received from a health professional concerning a patient who on an unspecified date, was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) and developed a generalized rash after receiving the vaccine. It was indicated that on an unspecified date, the patient had recovered. A product quality complaint was not reported. Additional information has been requested.
Severe headache with sharp pains in neck and head; sharp pains in neck; severe muscle and joint pains entire body from feet to hands; severe muscle and joint pains entire body from feet to hands; mild chills; fatigue; mild nausea; temperature 101.7; This is a spontaneous report from a contactable Nurse reporting for herself. A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0140), on 12Jan2021 at 12:30 at single dose intramuscular in left arm for COVID-19 immunisation. The patient was vaccinated at hospital. Age at vaccination was 50 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140) on 22Dec2020 at 12:45PM, at single dose intramuscular in left arm. Medical history included Long QT syndrome, chronic pain, and depression. The patient has no known allergies. Concomitant medications included metoprolol, bupropion, fluoxetine, omeprazole, pregabalin (LYRICA), cyanocobalamin (VITAMIN B-12), vitamin D3. On 12Jan2021 at 08:30PM the patient experienced severe headache, with sharp pains in neck and head; severe muscle and joint pains entire body from feet to hands; mild chills, temperature 101.7; fatigue, mild nausea. The patient received the following treatments for the events: treatment medications (Metaxalone, Vicodin, Lyrica) and OTC meds (Tylenol, Advil, Aleve, vitamin B-12 & D3). The events resolved on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19.
reinfection despite boosted; reinfection despite boosted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 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's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; LEXAPRO. Past drug history included: Bactrim, reaction(s): "allergies: bactrim". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 15Jun2022, outcome "not recovered" and all described as "reinfection despite boosted". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Other medication in 2weeks was reported as Yes. Antiviral details: product: COVID 19 Treatment, Brand: Pfizer, Treatment start date: 07Jun2022, Treatment stop date: 11Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a health professional concerning a patient who on 12-APR-2006 received his first dose of Recombivax HB. The patient received a second dose on 19-JUL-2006 of Recombivax HB and the third dose on 19-OCT-2006. It was reported on an unspecified date, that the patient's hepatitis B antibody test was negative. Current patient status was not reported. A product quality complaint was not reported. This is one of three cases from the same source.
Pt. was given expired vaccine (DTAP) lot # below only to see this happened after I administered it. Call Sanofi Pasteur got CDC recommendations, notified doctor then called mom on phone to notify her.
No additional AE reported; Dose of ROTATEQ involved in the temperature excursion was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.  On 23-DEC-2021, the patient was vaccinated with one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2.0 ml, (lot # 1707499 and expiration date reported as 30-MAR-2022) involved in the temperature excursion for prophylaxis (Product storage error).  The temperature of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), was stored at 13.9C for 2 hours 50 minutes. No previous temperature excursion involved. No additional AE was reported. No PQC reported.
Uncomfortable tightness in chest, high resting heart rate (normal resting heart rate ~60 bpm, during this episode the resting heart rate was around ~80 bpm. This was even laying down and doing nothing for hours at a time. Even slight movement, walking could increase heart rate above 90-100 bpm. This side effect persisted until some point at night. Upon waking up, the symptom had disappeared and heart rate had returned to normal.
Pain in shoulder that radiates into neck and down arm. Pain in muscle of arm. Not able to arm above shoulder, not able to lift objects in right arm.
Slight fever, night if vaccination. Body rash, two nights after vaccination. Relieved by allergy medication
Breakthrough case after 3 vaccines Moderna 2/1/21 Lot# 011L20A;  Moderna 3/1/21 Lot# 029L20A;  Moderna 11/5/21 Lot# 076C21A;
Pimple like rashes all over the body, neck and upper extremities that he only noticed morning of 10/04/23. Patient was prescribed  Prednisone 20 mg PO, Calmoseptine cream, Diphenhydramine 25 mg  PO, Clotrimazole 1% topical cream.
Severe itching; Redness; Big red blotch; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (Severe itching), ERYTHEMA (Redness) and RASH ERYTHEMATOUS (Big red blotch) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00042780) for COVID-19 vaccination.     No Medical History information was reported.    On 18-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 PRURITUS (Severe itching), ERYTHEMA (Redness) and RASH ERYTHEMATOUS (Big red blotch). At the time of the report, PRURITUS (Severe itching), ERYTHEMA (Redness) and RASH ERYTHEMATOUS (Big red blotch) outcome was unknown.        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.   Treatment and concomitant medications were not provided by reporter.
pt lives in a living facility; 12/23/21 pt tested positive in facility for COVID; occasional cough, diarrhea; pt continued to decline and passed away in the facility
pt recv vax in JUN96 & AUG96 pt exp a rash on legs in forms of purple dots under the skin on legs;sx cont;pt has reported this to a MD & will be seen by dermatologist;
Information has been received from a nurse practitioner concerning a 21 year old female with no known drug allergies or pertinent medical history who on 27-AUG-2009 was vaccinated with the first dose of GARDASIL (lot no.663454/0672Y). Concomitant therapy included ORTHO EVRA. On 27-AUG-2009 the patient experienced seizure 30 seconds following vaccination and quickly recovered. In follow up, the nurse practitioner reported there were no laboratory or diagnostic tests performed and no treatment necessary. Upon internal review seizure was considered to be an other important medical event. No further information is available.
Provider administering vaccines accidentally administered Moderna instead of Pfizer.   Within 6 hours of the administration the individual developed headache, nausea and swelling.  Symtpoms lasted approximately 36 hours and returned to normal.
From initial information received on 11/04/2003 from a physician regarding an adverse event occurring in the U.S.A., it was reported that a 47 year old female patient received a dose of FLUZONE SV '2003-'2004 USP, lot number U1123AA, administered intra-muscularly in the left deltoid on 11/03/2003 at 1:55 PM. The patient had received the influenza vaccine four times in the past. Two hours after receiving the vaccine on 11/03/2003, the patient developed body itching. The patient inspected her skin approximately a half hour later and found three red, raised, circular areas with white centers measuring about one inch in diameter. She took one dose of Benadryl 25 mg. and awoke the next morning at 6:00 AM with swollen hands and knees. She was seen by the reporting physician the following day at 9:00 AM and the hand swelling was gone. It was noted that she had three red papules measuring approximately 1.5 cm, which she treated with topical Benadryl. The papules were located on her medial thigh, left hip and left neck. The physician stated that the patient did not have any difficulty breathing or anaphylaxis with these events. Reportedly, the patient recovered from these events.
No additional AEs; Caller reported 2 month old child inadvertently received MMR II and VARIVAX.; It was also reported that VARIVAX and MMR II were administered IM instead of the recommended SQ route.; MMR II, VARIVAX and HAVRIX were inadvertently administered.; This spontaneous report was received from a nurse referring to a 2-months-old patient of unknown gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 13-SEP-2022, the patient was inadvertently vaccinated with doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin, rHA) (M-M-R II), dose of 0.5 mL, administered intramuscularly, lot number: U006486, expiration date: 26-FEB-2023 (dose number and anatomical location were not reported), varicella virus vaccine live (oka/merck) (VARIVAX), dose of 0.5 mL, administered intramuscularly, lot number: U032852, expiration date: 20-OCT-2023 (dose number and anatomical location were not reported) (product administered to patient of inappropriate age, incorrect route of product administration) and hepatitis a vaccine inact (HAVRIX) for prophylaxis (wrong product administered). No additional adverse events (AEs) or product quality complaint (PQC) were reported (no adverse event). On the same date, the patient was vaccinated with dose of diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX), ROTATRIX, hib vaccine conj (tet tox) (ACT HIB) and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), which were scheduled vaccines.
Extreme discomfort and pain at injection site. Followed by rash that covered left arm, left breast and side, extremely itchy. Rash remained and finally was relieved with two doses of Benedryl and ice compress. Left arm remains sore after one week.
This spontaneous report as received from a pharmacist refers to a 67 year old female patient. The concomitant medication included an unknown number of unspecified medications. On 01-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot number: K008880, expiration date: 09-SEP-2015) (dose and frequency were unknown) subcutaneously. On an unknown date in 2014 after receiving ZOSTAVAX the patient experienced pain at the injection site. The current condition of the patient included allergies with penicillin and codeine. There was no treatment given for the adverse event. No lab diagnostic studies were performed. The patient had called the pharmacy for medical attention. The outcome of the event was reported as not recovered. The causal relationship of the event and ZOSTAVAX was unknown. Additional information has been requested.
Admission Date: 4/7/2023 Discharge Date: 4/14/2023  PRESENTING PROBLEM: Acute respiratory failure with hypoxia           HOSPITAL COURSE:    Patient is a 61 y.o. male with a hx of essential hypertension, type 2 diabetes mellitus, hypothyroidism, and chronic obstructive pulmonary disease among other comorbid conditions who presented to the Emergency Department on 04/07/2023 with complaints of worsening shortness onset approx 4 days prior to presentation. On evaluation in the ER he was hemodynamically stable, afebrile, but noted to be hypoxemic, requiring 2-3 L of supplemental oxygen via nasal canula at rest. Laboratory studies were largely unremarkable but infectious work-up revealed COVID-19 infection. Imaging studies including a CXR in the ER did not reveal any acute pathology.  He was admitted to the Hospitalist Service for further management and coordination, and started on Dexamethasone therapy in addition to bronchodilator therapy and other supportive measures. On the morning of 04/09/2023 the patient's supplemental oxygen demands increased and he required 6L of supplemental O2 to maintain adequate oxygenation. As a result a CXR was obtained which did not reveal any acute changes that might explain the acute clinical decline. Though he was started on Lovenox on admission, there was concern for acute pulmonary embolism given COVID-19 infection thus a CTA thorax was ordered. Pulmonary embolus was not present but there were findings suggestive of atypical pneumonia. On 04/09/2023 he was started on Remdesivir and the pulmonology team's input was requested. They agreed with Dexamethasone and Remdesivir therapy and added community acquired pneumonia coverage as well.    61 year old with COPD and continued tobacco abuse, presented with SOB and hypoxia. Last summer had Covid and was discharged with oxygen, but never used it and had it picked up. He used a pulse-oximeter and says he was doing well and tanks would not have lasted long enough, anyway. Noted he has had markedly elevated hemoglobin 6/2022 and on this admission. He was tested for JAK 2 for polycythemia 6/2022 and was negative. It is likely secondary to chronic hypoxia. Also discussed hypercapnia with patient and wife (RN) and risk of decline with increased morbidity and mortality. He was willing to try again overnight and have a Bipap at home.      During hospitalization he was noted to have increased hypercarbia and was trialed on Bipap. 4/12/2023 night he refused after 2 hours. Following night he tried longer and willing to use this and oxygen at home. Also willing to try and quit smoking. Reviewing his hemoglobin elevation it is indicative of chronic hypoxia.
My lips are tingly; Face swelling w hives; Face swelling w hives; Face sensitivity; My lips are swollen; My face keeps turning red; Allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 27 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: ER2613) via an unspecified route, administered in Left Arm on 21Mar2021 at 14:30 (at the age of 27-Years-old) as Dose 1, Single for Covid-19 immunization. Vaccination facility was reported as school or student health clinic. The Patient's medical history included Chronic migraines. The Patient's concomitant medication included ondansetron (ZOFRAN); amoxicillin and zolpidem tartrate (AMBIEN); alprazolam (XANAX) within 2 weeks of vaccination. The patient had no allergies to medications, food or other products before vaccination. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021, her face swelling with hives, lips tingled and face sensitivity. On an unknown date in Mar2021, patient had her lips are swollen, her face keeps turning red and had allergic reaction. This had never happened before. Something triggered it now when she ate. Her photos of different days to show for help of visual. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received Actone and steroid cream for her face as treatment medication except for face swelling with hives, face sensitivity. At the time of this report, the outcome of events was not recovered. The reporter assessed the seriousness of the events as non-serious.  No follow-up attempts are needed. No further information was expected.
Pt has hives and erythema  multiforme after 24 hours of administration . Pt is on Prelone and Benadryl.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2011, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 08-JUN-2016, the patient was treated by at a medical facility for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
severe swollen&severe pain left shoulder, upper left back, lower left back, left buttocks, left thigh, chills, headaches, extremely difficulty walking, triggered swelling to prior right knee ,unable to reduce swelling, loss of appetite,  coughing
At first symptoms were mild and then they began to increase approximately 9 hours after the injection. Overnight I had experienced a sever chill in a home heated at 75 degrees. I was feverish and was covered in sweat across my entire body. The following morning those symptoms subsided. The next morning approximately 7:00 AM, I witnessed 2 severe rashes on my upper thigh. This rash included sharp pain to the touch and extreme discomfort when wearing  pants. Each rash was approximately 2 square inches and appeared as small red dots with white heads. I was prescribed antibiotic ointments and oral pills to see if it would clear up. However, the rash did not subside until November 29, 2021. The rash was fading over time but it was not completely gone until the stated date.  In addition, on October 31 at 6pm, I began to lose the ability to close my right hand effectively. This symptom occurred for approximately 6 hours before I was able to regain full function after approximately 6 hours after first symptoms set in. I do not do any physical or tedious labor using my hands and have done nothing outside of a normal routine. The loss of control was accompanied by a loss of feeling with a tingle in my right hand unlike anything I have ever experienced.
sharp pains; dizziness; swollen lymph nodes in neck; nausea; Numbness down left side of left arm hand foot and leg; burning sensations; pins and needles feelings; This is a spontaneous report from a non-contactable consumer or other non-HCP. A 38-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Ew0180), dose 1 via an unspecified route of administration, administered in Arm Left on 04Jun2021 18:00 (at the age of 38-year-old) as single dose, and dose 2 via an unspecified route of administration, administered in Arm Left on 25Jun2021 18:00 (Batch/Lot Number: Ew0180) (at the age of 38-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. On 04Jun2021 18:00, the patient experienced numbness down left side of left arm hand foot and leg, burning sensations, pins and needles feelings, sharp pains, swollen lymph nodes in neck, nausea and dizziness. The adverse events resulted in visit to doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive treatment for the adverse events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.