chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CHILLS; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number not reported) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced chills, and fever (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever. This report was non-serious. This report was associated with product quality complaint:90000207912 The suspected product quality complaint has been confirmed to be voided (did not meet criteria as reported complaints were adverse events) based on the evaluation/investigation performed. This case, involving the same patient is linked to 20211139224 (dose number in series 2).
really tired: Ibrance, Pfizer COVID vaccine; Does not have much energy; cold; sore arm: Pfizer COVID vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A 69-years-old female patient received bnt162b2 (BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 22Apr2021 13:15 (Age at vaccination 69 years old) (Batch/Lot Number: EW0169) as DOSE 1, SINGLE for covid-19 immunisation, IBRANCE, via an unspecified route of administration from Jul2018 (Batch/Lot number was not reported) and ongoing, at 100 mg, [21 days, off for 7 days] for an unspecified indication. Medical history included neoplasm malignant Cancer, diabetes mellitus, hypertension, hypothyroidism, neoplasm malignant from an unknown date and unknown if ongoing. Concomitant medication(s) included BABY ASPIRIN taken for hypertension, METFORMIN taken for diabetes mellitus, LISINOPRIL taken for hypertension, LEVOTHYROXINE taken for hypothyroidism, ATORVASTATIN CALCIUM taken for blood cholesterol increased, LETROZOLE taken for neoplasm malignant from Jul2018 and ongoing; VITAMIN B12, insulin NOVOLIN 70/30 taken for diabetes mellitus from an unspecified start date and ongoing. On 22Apr2021 the patient experienced sore arm, pfizer covid vaccine, really tired IBRANCE, pfizer covid vaccine does not have much energy, cold. The action taken in response to the events for palbociclib was dose not changed. Therapeutic measures were taken as a result of sore arm: pfizer covid vaccine (pain in extremity). Outcome of the event was Pain in extremity recovered on unspecified date of 2021, fatigue was not recovered, asthenia, nasopharyngitis was unknown.   No follow-up attempts are possible. No further information is expected.
p/vax pt had T100.6 & c/o bodyaches;on 10/19/99 pt felt worsened & sent to see family MD;MD advised pt was having adverse rxn to shot;
Rash on left sholder, went away after a day - rash on left thigh, getting better - pressure in left eye (history of symptoms without vaccine previously)
Received Johnson and Johnson vaccine on the 10 th of March, started having flu like symptoms early next Sunday morning, late Monday night my hands began to swell up and hurt when I was laying down. This got progressively worse and I started having pain when breathing, I called my doctor and was told my symptoms were normal for the vaccine and to go back to bed, and call after a day or so if no changes. The next day I called the advice nurse and was advised to go to the urgent care. I didn?t get any information on why this was happening to me, just a bad reaction to the vaccine, I was prescribed medication to help with my breathing, but the pain in my hands now includes my arms, legs and feet. I take a minimum of 600 mg of Advil liquid gels every 5 hours, I?m pretty miserable and cannot do normal life things.
32 year old male with lung cancer vaccinated on 10/16/03. Given Taxol/Carboplatin on 10/16/03. Presented to ED with urticaria, eyes swollen shut on 10/30/03. Unclear association with flu vaccine. No other new meds.
Pt received PREVNAR vaccine 1-14-04. Pt had fever of 102 degrees rectally.
Information has been received from a receptionist at a physician's office concerning a 23 year old female who "about a month ago" in approximately December 2006 was vaccinated with a first dose of Gardasil. Subsequently, the patient developed a sore arm. Additional information has been requested.
Pain in spine; Migraine; ELEVATED INFLAMMATION; Headache/slight headache; Pain in arm/sorearm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (Pain in spine), MIGRAINE (Migraine), INFLAMMATION (ELEVATED INFLAMMATION), HEADACHE (Headache/slight headache) and PAIN IN EXTREMITY (Pain in arm/sorearm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 25-Jan-2022, the patient experienced HEADACHE (Headache/slight headache), PAIN IN EXTREMITY (Pain in arm/sorearm) and FATIGUE (Fatigue). On an unknown date, the patient experienced SPINAL PAIN (Pain in spine), MIGRAINE (Migraine) and INFLAMMATION (ELEVATED INFLAMMATION). At the time of the report, SPINAL PAIN (Pain in spine), MIGRAINE (Migraine), INFLAMMATION (ELEVATED INFLAMMATION), HEADACHE (Headache/slight headache), PAIN IN EXTREMITY (Pain in arm/sorearm) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2022: Events Pain in spine, Migraine and Inflammation added. Dose regimen for non-company suspect drug added.
Pt. reported itching redness and swelling at injection site, and also reported nose and chest itching within 10 minutes of injection.  Treated with Benadryl and symptoms resolved.
I started having heart palpitations. My blood pressure went up. That lasted a couple days. I was also having cramps in my hands like arthritis. I went to my family Dr. who couldn't diagnose me with anything. I went to the ER in April. They suggested I go to a cardiologist. Before vaccination, heart rate was in the 60's. I was very active prior to the vaccine. My heart rate is gradually returning to normal. The palpitations have lessened. I was on beta blockers for tests. I was also on another medication, but it did not agree with me. At the ER, they did blood tests, EKG, chest X-rays. I honestly felt like I was having a heart attack. The doctors did confirm I was not having a heart attack, but my heart rate was elevated. As of current, I do feel I am better. I am definitely doing better than I was initially.
Information has been received from a health professional who reported that a male with a family history of ventricular arrhythmia, on an unspecified date was vaccinated with GARDASIL. Subsequently the patient experienced an unspecified arrhythmia arrhythmia. On an unspecified date the patient died. The cause of death was not reported. This is one of several reports received from the same source. No further information is available.  10/29/09 Medical records received for date 9/18/09. DX: episodic chest pain, dyspnea, and syncope. Ectopic atrial tachycardia documented on one occasion. Presenting SX: chest pain, syncope f/u eval.  Pt states most recent episodes x2 9/09. Pt. states develops chest pain shortness of breath, then syncope, pulse taken, 160bpm. Pt states feel increase in HR with these episodes. Pt parent states sx. began in 5/09 after gardasil vax. Assessment: cardiac:WNL will order holter monitor.  12/9/09-it was learned that the pt did NOT die.
she received the Pfizer-BioNTech Covid-19 Vaccine .She said she tested positive for Covid-19 after being exposed to someone infected with the virus last Christmas; she received the Pfizer-BioNTech Covid-19 Vaccine .She said she tested positive for Covid-19 after being exposed to someone infected with the virus last Christmas; after being exposed to someone infected with the virus; This is a spontaneous report from a contactable Physician (patient). A female patient of an unspecified age receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient she received the Pfizer-BioNTech Covid-19 Vaccine on 18Dec2020. She said she tested positive for Covid-19 after being exposed to someone infected with the virus last Christmas (25Dec2020). Now, she wanted to know if she can still take the 2nd dose. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: A causal association between reported event and BNT162B2 cannot be excluded.
I was sitting on my couch resting on New Year?s Eve, 12/31/2021 about 8 pm when suddenly my ears started ringing loudly. It startled me. I thought it would pass, but after a couple of weeks, I went to my doctor and then he sent me to the ear nose and throat doctor to have my hearing tested. I had hearing loss. It was shocking to me because first, the ringing started so suddenly out of nowhere, and second, I?ve always had really good hearing.
Patient received pfizer vaccine at 2:25 pm. At 2:34 pm patient complained of headache and dizziness to EMT on site in observation holding area. Patient reported working with clorox prior to visit and already having headache. Blood pressure slightly elevated at 2:34 pm 148/97 Heart rate 79, O2 sat 98. At 2:41 blood pressure 147/100, heart rate 80 O2sat 100. At 2:54 Blood pressure 146/96 heart rate 79 O2 sat 98. EKG normal sinus rhythm. Patient requested transportation to hospital via ambulance due to feeling dizzy. Patient transported as requested via ambulance at 3:07 pm. Patient not in distress at time of Departure. I do not believe this was due to the vaccine.
Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 24 months old patient who was vaccinated with a 0.5 ml dose of PENTACEL (lot C5428AA) via intramuscular route in the right thigh on 24-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medication includes PREVNAR 13 not produced by Sanofi Pasteur lot number not reported. It was a case of actual medication error due to inappropriate reconstitution technique. It was not provided any information confirming whether the patient experienced any adverse event. The patient had a clinic visit on 24-Sep-2018. 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. List of documents held by sender: none.
no adverse effect; improperly stored PEDVAX HIB were administered/patient received one dose; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 18-APR-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, lot # R027320 with expiration date on 08-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The vaccine underwent the temperature excursion of above 47 (55.4) degrees Fahrenheit for 10 hours 45 minutes and below 36 (34.4) degrees Fahrenheit for 20 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1904USA012614: US-009507513-1904USA012967: US-009507513-1904USA012968: US-009507513-1904USA012969: US-009507513-1904USA012970: US-009507513-1904USA012972: US-009507513-1904USA012973: US-009507513-1904USA012974: US-009507513-1904USA012975: US-009507513-1904USA012976: US-009507513-1904USA012977: US-009507513-1904USA012978: US-009507513-1904USA012979: US-009507513-1904USA012980: US-009507513-1904USA012981:
The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date. Per Moderna, the vaccine will maintain the necessary effectiveness against COVID-19. There is no further follow up needed with the patient. The patient's estimated due date is 04/03/2022.
Headache, Myalgia, Arthralgia, Chills, Fatigue, Injection Site Pain Narrative: Adverse reaction lasted 3 days, employee did not report to work on day 3 after vaccine.
Information has been received from a pharmacy intern concerning a 78 year old female patient who on 01-SEP-2010 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Merck) (lot number reported as 664631/0747Y valid for VARIVAX (Merck)). The pharmacy intern reported that 2 days after vaccination the patient experienced a bruise at the injection site under the skin and itching at the injection site. The pharmacy intern reported that the patient still had the reaction but it was getting better. The patient sought medical attention by contacting the pharmacy. No further information is available.
Systemic: Diarrhea-Mild, Systemic: Vomiting-Medium
fever (100.6),  shivering, fever, earache (only L ear), headache, muscle/joint pain (general aches), nausea
Fever first noted 07/16/2002 at 8:30pm-99.5 degrees-also fussy 07/17/2002 in morning 102.5 degrees-rash noted. macula papular rash on legs, torso, and face- course rash, rather than fine- smaller than chicken pox also remarkable diaper rash- possibly not related.
Heart palpitations, profuse sweating, fever above 100F, severe muscle and joint pain(worse than normal); headache; chronic fatigue; chills; numbness in arm vaccine was administered.
high pitched cry, face red, then limp;required brief CPR w/breaths;drowsy for a short time then returned to nl activity over 30-60min not sure if pale;(shock-collapse rxn);
Redness, swelling, pain, febrile. Tx: BENADRYL Allergy, Amoxicillin/Clavulanate Potassium.
Redness and Swelling of upper arm. ER MD diagnosis cellulitis with Rx of Cefixlone.  Exam on 2/22/10 shows minor swelling and crusted lesions at vaccine injection site along with approximately 20 small crusted satellite lesions.
About 20 minutes into her 30 minute wait period after vaccine, patient became diaphoretic and her hands began to shake. Patient confirms she is a diabetic but states she ate a large breakfast. She was provided with juice and vital signs taken by nurse. BP-144/89 (patient states normal for her) and pulse 125 (patient states not normal). Patient states she has felt anxious and has a "couple stressful weeks". 5 minutes later, manual pulse taken- 110. 5 minutes later, manual pulse taken-100. 5 minutes later, manual pulse taken-82. Patient states she feels better and does not feel shaky anymore and believes it was her blood sugar dropping. She said she felt well enough to leave and her friend came to pick her up. She was assisted out to her car and was advised to call 911 if she experiences any later issues.
Over all flu-like symptoms - body aches, at injection site pt had a 3 inch circular red - warm wheal, then around that was a "pinkish" patch about 7 inches circular.
This spontaneous report as received from a nurse refers to a 10 months 13 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Erythematous mass about 1 inch above site of DTaP injection. Size .5in x 1 in.
shrill cry, limp, lethargic, t102.3-4 hrs p/vax;
This spontaneous report as received from a patient's father refers to a 15-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 22-JUN-2017, the patient was vaccinated with GARDASIL 9 injection (intramuscularly; 3 doses given on months 0, 2 and 6; lot# and expiration date were not provided), for prevention of Human Papillomavirus (HPV). Immediately after a physician administered an injection with GARDASIL 9, the patient fainted, hit her head on the floor and experienced seizure-like-convulsions. The patient did not seek medical attention and no treatment was given for the adverse events. The father reported, that the patient recovered from the adverse experiences (approximately in June 2017) and that no additional adverse experiences occurred. The relatedness between the adverse events and GARDASIL 9 was not assessed. Upon internal review, the event of seizure-like-convulsions was determined to be medically significant. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA011266.
Information has been received from a healthcare worker (office manager) referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of VAQTA (lot # reported as L043209, expiration date 17-SEP-2017; dose and route were unknown). No symptoms were reported. The vaccines were stored under 1 degree centigrade for 6 days in November 2015, 1 degree centigrade for 20 days in December 2015, 1 degree centigrade for 16 days in January 2016, 1 degree centigrade for 20 days in February 2016 (totally 62 days). No other excursions were involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pain radiating up my left arm/shoulder area into my neck.  I had a stiff neck for over two weeks and a headache for about one week.  I also still have a rash on my face.
Information has been received from a Certified Medical Assistant concerning a 15 year old female who in January 2008 was vaccinated IM with the first 0.5 ml dose of Gardasil (lot not reported). While in the office and after receiving the first dose of Gardasil (lot not reported) the patient fainted. No other symptoms were noted. The patient recovered. No further information is available.
localized edema, redness & warmth @ inj site, severe muscular & joint pain in lt shoulder, lt hip & lt leg, dec mobility lt side body, worst sx 11/15/98.
COVID-19 disease, symptoms started 3/5/21, deceased of COVID-19 on 3/14/21
Patient reports beginning to feel ill on 12/3/21. He reports worsening shortness of breath and limited ambulation. He reports increase in bilateral lower extremity edema. He had a positive sick contact with his daughter. He is COVID-19 positive in the ED. Patient's O2 saturation is 96% on 2L O2 by nasal cannula. He has received dexamethasone. Patient is being admitted to the hospital.
Rash and swelling on face, feet/toes, arms, fingers, and a little on back; Tonsils slightly swollen; Rash and swelling on face, feet/toes, arms, fingers, and a little on back; swelling on face, feet/toes, arms, fingers, and a little on back; swelling on arms, fingers; This is a spontaneous report received from a contactable consumer (patient) or other non hcp.   A 15-years-old (non-pregnant) female patient received BNT162B2 (PFIZER-COVID-19 VACCINE, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 11Jul2021 13:30 (at the age of 15-years-old) as dose 1, single for covid-19 immunization.Medical history included urinary tract infection from an unknown date and unknown if ongoing. Concomitant medication(s) included cefalexin taken for urinary tract infection, start and stop date were not reported.The patient previously took azithromycin for drug hypersensitivity and experienced rash, azithromycin for drug hypersensitivity and experienced swelling. On 13Jul2021 at 06:00 the patient experienced rash and swelling on face, feet/toes, arms, fingers, and a little on back, tonsils slightly swollen, joint swelling, swelling on arms, fingers. Adverse event resulted in patient visited Emergency room, department or urgent care. patient received treatment with Zyrtec.The patient did not tested for covid before and prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Device Date: 14Jul2021.The outcome of the events was recovering.   Information about lot/batch number has been requested.
it was rpt concerning pt who was vax & approx 1yr later pt sibling was vax & subsequent to the siblings vax the pt devel chickenpox. addl info req
unconscious about 2 minutes; moderate headache; I had a general unwell feeling; nauseated; incontinent; I became faint; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection), dose 2 via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient had received first dose of COVID-19 vaccine previously. The patient stated that they had their second Covid-19 vaccine on 16Feb2021. Approximately 10 hours (on 16Feb2021) afterward the patient developed a moderate headache, which 400 mg of ibuprofen eased. The patient had a general unwell feeling much of the following day (16Feb2021), so the patient rested and napped. About 36 hours after the injection the patient became faint, nauseated, and incontinent. The patient was unconscious about 2 minutes. The patient was taken by ambulance to the hospital and remained through the night for observation for the event loss of consciousness. To date, all the tests were negative. The patient received treatment for the event headache. The outcome of the event headache was recovering. The outcome of the events loss of consciousness, syncope, malaise and nausea was unknown.  Information about Lot/Batch number has been requested.