chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu lkie; fatigue; beddriden; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2019, the patient received the 1st dose of Shingrix. On an unknown date, between 1 and 3 months after receiving Shingrix, the patient experienced influenza-like symptoms, fatigue and bedridden. On an unknown date, the outcome of the influenza-like symptoms, fatigue and bedridden were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fatigue and bedridden to be related to Shingrix.  Additional details were received as follows: The patient experienced flu-like symptoms, fatigued, could only lay around for 2 days then they recovered.  The reporter consented to follow up.  This was 1 of the 4 cases reported by same reporter
Patient post 2nd dose vaccination about 10 minutes into observation began to feel lightheaded dizzy and a syncopal sensation. Patient identified herself to staff, during assessment increase diaphoresis, pale, decreased heart rate and weak radial pulses. Placed supine with no signs of rash, no SOB, no Chest pain,  no difficulty swallowing.  secondary assessment on cardiac monitor of Sinus brady 58,  100% room air, rate of 24 and blood pressure supine 110/68.  10 minutes post incident, remains awake x3, color improved, radial pulses strong, no other verbal compplaints. Placed to a sitting position, no signs of dizziness, lighteaddness, pulses remain strong.  NSR 84, 20 with  pulse ox @98%, 124/80. Patient is refusing treatment to Emergency room.
Patient had a red, inflamed 1 1/2 inch diameter circular area around the injection site that was.
Pt states he felt a flush of warmth through his body for 10 minutes.  Had a drink water, take off his jacket and wait.  Seen by NP, symptoms resolved.  VSS @ 1400 BP 170/98, Pt has history of High blood pressure but did not take medications.  HR 88, O2Sat 98%, T: 97.5F.  VSS @ 1420 Discharge, T: 97.5, HR 86, OSat 99%
PATIENT RECEIVED A PFIZER BIVALENT BOOSTER ON 10/25/2022.  PATIENT RECEIVED ANOTHER MODERNA BIVALENT BOOSTER ON 12/8/2022.
Had an area 7.5 cm by 6.5 cm of erythema, induration, and warmth at site of DTaP injection.  This began soon after injection and increased until the visit 48 hours later
Patient administered expired vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered expired vaccine after the manufacture date of expiration) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered expired vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered expired vaccine after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The vial did not undergo any temperature excursions. Date vial initially stored in the refrigerator was unknown. Total of 168 doses were given from LOT 048C21A. Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received non-significant information: reporter address updated
OUTSIDE OF REFRIGERATED TEMPERATURE 6 HOURS; This spontaneous report received from a pharmacist concerned multiple patients. 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 (suspension for injection, route of admin not reported, batch number: 1855194, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced outside of refrigerated temperature 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of outside of refrigerated temperature 6 hours was not reported. This report was non-serious.
Received both doses only 2 weeks apart; Both doses were expired; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received both doses only 2 weeks apart) and EXPIRED PRODUCT ADMINISTERED (Both doses were expired) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received both doses only 2 weeks apart) and EXPIRED PRODUCT ADMINISTERED (Both doses were expired). On 01-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received both doses only 2 weeks apart) and EXPIRED PRODUCT ADMINISTERED (Both doses were expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received the 2 doses with less than 25 days apart, and both of them were expired.  No concomitant medications were reported.  No treatment information was reported   This case was linked to MOD-2021-343937 (Patient Link).
Initial information regarding this clinically sponsored solicited case was received on 28-Mar-2016 from patient's wife via the Patient Support Program. This case concerns a male patient of unknown age who had multitude of health issues, COPD and he came down with influenza B an unknown duration after commencing treatment with influenza vaccine and PRALUENT. No information on any past drug, concomitant drug, medical history or concurrent condition was reported. On an unknown date, the patient commenced treatment with influenza vaccine (dose, form, route, frequency, lot/batch number and expiration date: unknown). On an unknown date, the patient received alirocumab injection at a dose of 75 mg every other week subcutaneously (lot/batch number and expiry date unspecified) for other and unspecified hyperlipidemia delivered via prefilled pen. Patient's wife reported that the patient took the flu shot and came down with influenza B on an unknown date (latency: unspecified), because the patient had COPD (date and latency: unknown) so he was placed in the hospital. The patient was taking TAMIFLU as corrective treatment and was getting better. The reporter informed that the patient expired in April and that he had a multitude of health issues (onset and latency: unspecified). It was unknown whether an autopsy was done or not. It was reported that the patient had two injections up to that point. Action taken: Unknown for both the drugs. Outcome: fatal for multitude of health issues, Recovering for other events. Seriousness criteria: Hospitalization, patient died from multitude of health issues. Reporter causality: Unknown with respect to alirocumab and not reported with respect to influenza vaccine for multitude of health issues and unknown for both the drugs for other events. Company causality: Not associated with respect to both the drugs. Additional information was received on 23-May-2016 from patient's wife: new event "multitude of health issues" added, action taken updated, form of alirocumab added and text updated accordingly. Reported Cause(s) of Death: multitude of health issues.
still not feeling well; I feel a little run down; little of bit congestion; This is a spontaneous report from a contactable Other HCP (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported he felt a little run down and little of bit congestion and asked 'if he is still not feeling well should he get the second dose'. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
On 08/12/2021, at 8:30am I began vomiting. I could not eat for 3 weeks without vomiting and went to my doctor and the referred me to a endocrinologist. A scope was performed and I began bleeding out of my mouth. I was picked up by the ambulance and sent to the hospital were it was determine an artery was cut during scope. Surgery was performed and two ulcers were found. I was hospitalize for 4 days. I return home and began vomiting again, i return to the hospital and was hospitalized for 3 days. I was prescribed omeprazole.
patient got COVID-19 after 1st dose; patient got COVID-19 after 1st dose; This is a spontaneous report from a contactable consumer or other non-healthcare professional via Pfizer sponsored program. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration, on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, patient got COVID-19 after 1st dose. On an unknown date patient underwent covid-19 test which resulted as positive. At the time of report event outcome was unknown.  Follow-up attempts are needed. Information about lot/batch number has been requested.
I have been swollen for more than 8 weeks with my lymphatic glands on the left side of my neck.  I went to the doctor on the first day of this symptom and  they gave me ibuprofen 600ml because the painful situation.  I feel like something is stuck in my neck. A month ago I got a stye in my left eye I still have it. The doctor  gave eye drops and I was using warm compresses but it doesn?t go away. So stressful.
Mild fever, flu-like symptoms, achiness, itchy eyes and hives face, stomach and upper extremities. Pt. took aspirin for fever and achiness. Hive complete resolves 3-4 days later.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 02/24/2021, 03/24/2021, and 12/01/2021. They tested positive for COVID-19 on 09/03/2022. It appears they were hospitalized for the illness (the import of the lab report indicates hospital admission) but I do not have a discharge date available.  I can see they had a urine sample sent to a lab on 09/22/2022. The individual died on 10/05/2022.
This spontaneous report as received from a registered nurse refers to a 63 year old patient. The patient's medical history included respiratory failure. On 13-NOV-2001, the patient received the first dose of PNEUMOVAX23 0.5 ml, lot #, route unspecified, when the patient was 59 years old. On 18-OCT-2005, the patient received the second dose of PNEUMOVAX23 0.5 ml, lot #, route unspecified, when the patient was 63 years old. No adverse effect reported. The outcome of the patient was unknown. Additional information has been requested.
Patient started feeling lightheaded and sweaty after their vaccination. We gave patient water and some ice to help cool down. Also had patient sitting with their leg elevated. Patient stated that this happens every time she gets a shot or tattoo. Patient stayed in pharmacy area until 11:45AM when she cooled down and felt better to leave.
Patient started to have trouble breathing about 24 hours after receiving them. Couldnt breathe and was "turning blue" per sister. Was taken to the hospital for possible anaphylactic reaction.
Fever, chills, body aches, dizziness, swelling and redness near injection site, fatigue (slept through entire next day)
After my 2nd dose of Covid Vaccine, I have experienced weekly flare ups of my fibromyalgia. It had been over 10 years since I had experienced any symptoms.; This is a spontaneous report from a contactable consumer (patient) and other HCP. A 57-year-old non pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported) dose 2 via an unspecified route of administration on an unspecified date (at the age of 57-year-old) as dose 2, single for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. The facility in which the vaccination was administered was other. Medical history included fibromyalgia (It had been over 10 years since I had experienced any symptoms), intervertebral disc degeneration. Patient had known allergies. Historical vaccine includes bnt162b2 (Lot number: EP7534) dose 1 via an unspecified route of administration, administered in the left arm on 01Apr2021 (at the age of 57-years-old) as dose 1, single for COVID-19 immunisation. No other vaccines were given within 4 weeks. Patient administered other medications in 2 weeks. Concomitant medication was not reported. Post vaccination, the patient was tested positive for COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 26Apr2021 the patient experienced after my 2nd dose of covid vaccine, I have experienced weekly flare ups of my fibromyalgia, it had been over 10 years since I had experienced any symptoms. No treatment was given for the events. The patient underwent lab tests and procedures which included sars-cov-2 test resulted negative on 20Aug2021. The clinical outcome of the event was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient experienced high fever (3 days), severe headache, congestion, cough and bronchial irritation/burning.
Seen for vaccines on 2/3/11. Returned to office on 2/6 with c/o intermittent rash on entire body, raise red itchy. Dx with hives ? due to vaccines. Had rec'd PCV13; PENTACEL in past w/o reaction. This was 1st flu vaccine.
Ache joints, stiff neck, feverish, chills. Raised, warm red area at inj site 6" x 2.5".
COVID-19; COVID-19; 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 male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Lot number: en6204), in Apr2021 as dose 2, single (Lot number: er8727) and in Apr2022 as dose 3 (booster), single (Lot number: fj5682) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "Known allergies: minor food allergies" (unspecified if ongoing), notes: Known allergies: minor food allergies. Concomitant medication(s) included: OLMESARTAN, start date: Jan2015. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Sep2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Sep2022) Positive, notes: Tested positive 04Sep; (10Sep2022) Positive, notes: on 10Sep still tested positive (faint line); (12Sep2022) Negative, notes: negative test; (13Sep2022) Positive, notes: test positive with faint line; (14Sep2022) Positive, notes: test positive with solid line (not faint); (16Sep2022) Positive, notes: 16Sep faint line on test for positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
She got her vaccine, had no reactions.   She woke up on 5/12/21 and had extreme headache, blood pressure was high, nausea and vomiting, extreme pain behind her eyes, blurry vision.  Later in the afternoon she had diarrhea.  She called her PCP that evening and he prescribed Ondansetron (Zofran).  On Thursday she continued to have the blurred and double vision with some nausea and dizziness and headaches which have been on-going, especially on the left side of her head.    She went to the ER on Friday evening 5/14/21 where her BP at it's highest point was 195/126 and a pulse of 99.   They started doing some actions to determine if she was having a stroke.  They did a CT scan and gave her medications to get her BP down, started an IV.  She was then admitted to HCF that evening.   They kept her overnight and did an MRI on 5/15/21, had to start wearing an eye patch on her left eye due to dizziness and was not able to walk without covering the one eye and needed assistance to walk across the room.   Everything was clear on the MRI and CAT scan.  She saw two resident internist and then she saw a neurologist while being in the hospital.  The neurologist diagnosed her with left third nerve palsy as a result from the vaccine and the high BP.  They released her that evening with instructions to see an Ophthalmologist the following week, which she did on 5/17/21 and saw Dr.  He concurred with the neurologist diagnosis and felt that there was really nothing that they needed to do and for it to run it's course and let it heal which will take anywhere from 2 weeks to 4 months.  She was informed to continue to wear the eye patch until the dizziness and double vision improve.  There is pain still behind the left eye, and still has high BP and have prescribed medications for that.   Her PCP started her on Amlodipine/HCTZ 10/12.5 mg.     She then ended up in the ER again last night on 5/19/21.  They put her on fluids as she started vomiting again and could not keep any of the medications down that she was prescribed.  So they gave her fluids and started a steroid in the IV fluids to help with the pain and inflammation behind her eye, as well as headache medications as well.  She was then sent home last night and now the pain in her eye is about a 5 since receiving the steroids.  She was also started on Prednisone 20 mg to start today as when she was in the ER they told her to start that.   She has not had any nausea or vomiting today, and seems to be OK, but is still taking the Zofran for this.  She was able to eat a little bit today and hold it down, but has not had much in the way of an appetite since receiving the vaccine.
Five days after pt received the second dose of Pfizer vaccine, she noticed redness, swelling & itchiness on left eye & today it got worse, Pt took otc anti-allergy meds without effect.
Client received 1 dose Janssen vaccine 3/14/21.  Client tested positive for COVID-19 on 4/28/21.
Tongue swelled 32 hrs after injection. Blister in mouth 32 hrs after injection. As of 10/14/09 7:00 PM tongue still swollen - Patient taking BENADRYL.
Vaccine administerd 1 day after the beyond use date. Pfizer corporation and Meijer clinical coordinator have been contacted in regards to stability of vaccine and revaccinate will be determined in the future.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 21-OCT-2012 12:05, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
BOOSTER  WAS ADMINISTERED  TO  A 17  YEAR  OLD BUT NO ADVERSE  EFFECT REPORTED YET
Per patients daughter-the morning  following the administration of vaccine she was unable to move her right leg. She was transported to the emergency room. Imaging per the daughter noted that she had a relatively new compression fracture of her back that they felt might have contributed to her not being able to move her leg.
Stung really bad; It was on fire; Burned really bad as she was getting it; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE WARMTH (It was on fire), BURNING SENSATION (Burned really bad as she was getting it) and VACCINATION SITE PAIN (Stung really bad) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE WARMTH (It was on fire) and BURNING SENSATION (Burned really bad as she was getting it). On an unknown date, the patient experienced VACCINATION SITE PAIN (Stung really bad). At the time of the report, VACCINATION SITE WARMTH (It was on fire), BURNING SENSATION (Burned really bad as she was getting it) and VACCINATION SITE PAIN (Stung really bad) 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.   No concomitant and treatment medications were reported.
Uncontrollable shaking with minor muscle spasms in all parts of the body, especially arms and legs.
Information has been received from a Registered Nurse and a 21 year old female consumer, as part of a pregnancy registry for GARDASIL, reporting on herself with no pertinent medical history, drug reactions or allergies who on 24-FEB-2012, was vaccinated with the first dose of GARDASIL (lot number 667878/0180AA; dose and route not reported). Concomitant therapy included hormonal contraceptives (unspecified). The registered nurse reported that the patient went in February 2010 for her annual exam; at the tie she was on the pill and had not missed a period so she received GARDASIL. The consumer reported that on 28-FEB-2011 she found out she was pregnant. The consumer estimated that her last menstrual period was in the first week of February (on approximately 01-FEB-2012). The estimated delivery date was on 07-NOV-2012. No lab diagnostic tests were performed. The registered nurse reported that she did not have any information about an OBGYN for the patient. Follow up information received. Case was lost to follow up. Pregnancy outcome was not known. Additional information is not expected.
High fever of 103 the first day, then 102 the second day. Extreme muscle pain especially in the legs, Migraine headache for 3 days.  Fatigue for 7 days.  loss of appetite for 4 days . Felt like the flu for 3 days
FIRST VACCINE WAS ON 04/11/21 NO SIDE EFFECTS. SECOND VACCINE WAS ON 05/02/2021 AND HAD THE FOLLOWING SIDE EFFECTS: HEADACHE, STOMACH ACHE, HOT FLASHES, NAUSEA, FATIGUE, FEVER 101
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown dates (reported as since 01-DEC-2014), unspecified patients were vaccinated with ROTATEQ (lot number, dose, frequency and route unspecified) that was exposed to a supported temperature excursion on 01-DEC-2014. No adverse effect have been reported. The outcome of the events was unknown. The causality of the events with ROTATEQ was not reported. This is one of the several reports from the same reporter. Additional information has been requested.