chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by a health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 72-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the local Health Authority at that time. It was reported that no adverse reactions were reported by any patients.  No treatment medication information was provided.   This case was linked to MOD-2022-501575 (Patient Link).
Tinnitus, ear aches (both ears), sinus ache (uncommon); 102+ fever, chills, etc. (common)
Fever, swelling from shoulder to elbow, tender to touch, redness, unable to move arm.
I?ve had heart pain and severe migraines that had not gone away since my second dose. I cannot function or return to work due to migraines.
This patient had a 3 inch diameter, red hard, warm, area on her left arm, a fever, migraine with sensitivity to light and sound, left arm pain, wrist and elbow pain, with movement over 1/2/ inch.
Pt inadvertently administered Tdap and Hep B vaccines that were ordered for father of the same name. Parents notified of error and scheduled for revaccination of appropriate vaccines. Monitored pt for adverse reactions for ~1 hour. No complications, pt tolerated. Parents educated on s/s reactions and when to seek medical care. Management notified via internal incident reporting system.
oFirst Covid-19 Vaccination (J & J / Janssen) received on 4/4/2021 @ 8:44 am. Lot: 1808980 oFirst Covid-19 Booster (Pfizer) received on 11/10/2021 @ 3:43 pm Lot: 330268D - No side-effects. All was well after the shot except for some soreness at the site of the injection.  oSecond Covid-19 Booster (Pfizer, updated version) received on 9/9/2022 @ 12:45 pm Lot: GH9694 - Started experiencing strange things happening a little over a week after receiving the booster shot. Went to Dr. for annual physical and notified him of all the symptoms.   See attached pages Patient - New Symptoms Occurring After Pfizer (updated) Covid-19 Booster (second booster)'
This report was received from the investigator of a trial on 12 April 2010. A 57 year-old male subject received ACAM2000 vaccine, lot number not reported on 24 February 2009, and anthrax vaccine (other manufacturer and lot number not reported) on 17 February 2009. On 09 March 2009 (13 days after vaccination with ACAM2000 the subject was diagnosed with unspecified disease of the pericardium. The subject had a history of abnormal electrocardiogram (date not provided). On 25 February 2009, the subject had an electrocardiogram which was abnormal. On 11 March 2009, the subject had an echocardiogram which was normal. The outcome was not reported. There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
This case meets criteria for vaccine breakthrough review. SxS include cough, weakness, abdominal pain.
up a lot during  the night after vaccination, lots of body ache, temp 100.2  dizziness  during the day on 1/12
Healthcare facility administered the vaccine. I do not have the lot number or vaccine site. He has also had the #2 vaccine given just over 7 weeks ago. Given his history of atrial fibrillation, it is entirely possible the CVA was a result of this, however he has been anticoagulated with  Eliquis for a few years without recurrent stroke. He is still hospitalized with intention of transfer to rehab facility as mobility is impaired.
Patient described having extreme fatigue and muscle pains in her neck after receiving. She has not been evaluated by physician for other underlying causes. Timing started days to weeks after vaccination
Dermatitis lasting until June 5,2021 from April 12, 2021 only responsive to solumedrol dose pack. No steroid creams helped. I had redness itching discomfort wear underclothes.
slightly sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date 1st dose was received refer case no US2021AMR058889).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. Six months after 1st vaccination patient had recived second dose of vaccine and had almost no side effects other than a slightly sore arm. The reporter enquired was it normal to have almost no side effect after the second shot. This case has been linked with US2021AMR058889 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR058889:same patient - 1st dose
Chills, then over heating, then back to chills. Body hurt all over, left arm feels heavy, hurts to touch it or lift. Nauseous. Arm itches. Legs  felt restless. It?s been 43 hours and I still have symptoms
Itchy face began at 11;55 am, achy body at 8:20 pm, awoke in middle of the night with a fever, joint pain, headache and body aches. Could not stand up or sit up, extreme fatigue. Could not move on Tuesday all day, remained in bed with same symptoms, severe head ache. Nausea, could only eat 1/2 PB & J at 1:30 pm and then 1/2 cheese sandwich at 8:00 pm. Remained in bed throughout evening with same symptoms. Did not sleep. Wednesday, was still brain fog, fatigue and joint pain, headache disappeared. No fever. Large rash on left arm appeared, hot to touch, itchy. Pulse rate elevated, normal 62 resting rate, pulse was fluctuating between 80 - 95. Thursday, exhaustion, continued elevated pulse between 70 - high 80's. Restless, not feeling right. Friday, brain fog, fatigue, heart rate in high 70s.  Took blood pressure, elevated, 144/88 left arm, 129/84 in right.  Took Tylenol at 7:00 am, no other medication taken.
Delayed Inflamed swelling at injection site; Delayed Hot area on arm; Delayed redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Delayed Inflamed swelling at injection site), FEELING HOT (Delayed Hot area on arm) and VACCINATION SITE ERYTHEMA (Delayed redness at the injection site) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced INFLAMMATION (Delayed Inflamed swelling at injection site), FEELING HOT (Delayed Hot area on arm) and VACCINATION SITE ERYTHEMA (Delayed redness at the injection site). At the time of the report, INFLAMMATION (Delayed Inflamed swelling at injection site), FEELING HOT (Delayed Hot area on arm) and VACCINATION SITE ERYTHEMA (Delayed redness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
This spontaneous case report was received from medical assistant regarding a patent of unknown age and gender. Patient's concurrent conditions and medical history was not reported. On 07-DEC-2015, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 with lot number # K010016 (expiry date 08-AUG-2015) (dose number, dosing regimen, anatomical location and route were unknown). Concomitant medications of the patient were unknown. No adverse event was reported. The outcome of the event "expired vaccine used" was unknown. No product quality complaint was reported. Additional information has been requested.
Site: Swelling at Injection Site-Mild, Systemic: Pitting of the skin at injection site.  Chief Complaint of it being visually unappealing-Medium, Additional Details: Patient has what looks like loss of muscle mass in the area of injection.  The skin is pitted in an area of a couple of inches wide.  She stated that she has no additional weakness or loss of range of motion.  No pain or abnormal swelling after injection.
COVID-19; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) 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 medications were reported. No treatment medications were reported.
Have sinus headache; This is a spontaneous report received from a contactable consumer (patient) to a Pfizer Sponsored Program.  A female patient of an unspecified age received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown) via an unspecified route of administration on Mar2021 as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced have sinus headache on Mar2021. Caller received second vaccine shot yesterday and have sinus headache and wanted to know if she can take Excedrin. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Diffuse urticaria joint pain requiring treatment with oral steroids and antihistamines. Symptoms persisted x 4 days. Child seen in office twice and E.D. twice for worsening symptoms. Resolution of symptoms reported 10/12/08
Pt recvd 1st dose of Engerix-B 08APR91; 12 hrs post inject pt exp fever 102, & vomiting x 2 days; No tx given; Events resolved; 2nd dose of Engerix-B given 06MAY91 was uneventful;
Client reported to his health care provider this AM (4/26) with a shingles like rash described as a cluster of vesicles under left axilla and at left nipple area with a linear vesicular rash on left side of back.  Pt also c/o pain.  Per PA-C.
the injection bumped up and had some bleeding; the injection bumped up and had some bleeding; Patient experienced swelling at injection site; This spontaneous report as received from a pharmacist refers to a 84 year old female patient.      The patient's concurrent conditions, medical history, and concomitant medications were not provided.  On 04-JAN-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (Lot # T039322, 09-SEP-2022) 0.5 mL, intramuscularly in the right arm for prophylaxis (The dose number was not reported).    The patient experienced swelling at injection site (vaccination site swelling) after the administration of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The pharmacist reported that the patient has thin arms and reported that the injection bumped up (vaccination site mass) and had some bleeding (vaccination site haemorrhage). The pharmacist reported that the swelling was going down.   The outcome of the events was reported as recovering. The causal relationship between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Pain from fibromyalgia; Sore body; This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (Pain from fibromyalgia) and PAIN (Sore body) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second 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) Citrate free. In April 2021, the patient experienced PAIN (Sore body). On an unknown date, the patient experienced FIBROMYALGIA (Pain from fibromyalgia). In 2021, PAIN (Sore body) had resolved. At the time of the report, FIBROMYALGIA (Pain from fibromyalgia) had not resolved.            No concomitant medications were reported. 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.   This case was linked to MOD-2021-622971 (Patient Link).
Area feels warm to the touch; Noticed rash that has developed around injection sight; Area looks a little inflamed.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Area feels warm to the touch), VACCINATION SITE RASH (Noticed rash that has developed around injection sight) and VACCINATION SITE SWELLING (Area looks a little inflamed.) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 13A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Area feels warm to the touch), VACCINATION SITE RASH (Noticed rash that has developed around injection sight) and VACCINATION SITE SWELLING (Area looks a little inflamed.). At the time of the report, VACCINATION SITE WARMTH (Area feels warm to the touch), VACCINATION SITE RASH (Noticed rash that has developed around injection sight) and VACCINATION SITE SWELLING (Area looks a little inflamed.) 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.   Concomitant product use was not provided by the reporter.  No treatment information was provided by the reporter
a patient that got the PENTACEL vaccine but was only given the one vial of liquid (DTaP/IPV) and not the powder (ActHIB) component with no reported AE; Initial information from received on 17-Feb-2022 regarding an unsolicited valid non-serious case from other Healthcare Professional.  This case involves a patient of unknown demographics who got the pentacel vaccine but was only given the one vial of liquid (dtap/ipv) and not the powder (ACTHIB) component with no reported AE (adverse event) while receiving vaccine Diphtheria/Tetanus/5 Hybrid AC Pertusis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel].  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HIB Vaccine CONJ (TET TOX) (ACTHIB) for Immunization.  On an unknown date, the patient received a suspect Diphtheria/Tetanus/5 Hybrid AC Pertusis/IPV(MRC5)/HIB(PRP/T) Vaccine (dose, route, strength, batch number and expiry dates: unknown) suspension for injection in an unknown administration site for immunization.  On an unknown date, patient got the pentacel vaccine but was only given the one vial of liquid (dtap/ipv) and not the powder (Acthib) component with no reported AE (incorrect product formulation administered) (unknown latency) following the administration of Diphtheria/Tetanus/5 Hybrid AC Pertusis/IPV(MRC5)/HIB(PRP/T) Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event (incorrect product formulation administered).  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 the guidelines. 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.
This spontaneous report as received from a certified medical assistant refers to multiple patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # L033693, expiration date: 31-MAY-2017, (dose and dose number were not provided). There were no concomitant medications reported. The certified medical assistant was unable to provide exact temperatures at the time of reporting, but stated they "went to 32 degrees Fahrenheit or lower" and they were out of range for "15 minute increments, 40 times". No specific cumulative time was reported. The temperatures were recorded by a data logger and according to the reporter they were back in range at the time of report. There were no prior excursions reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.
extreme tinnitus. Tinnitus started after the second shot and remained light. After the booster it's tripled in volume and unmanageable.
Arrived with congestion, palpatations and cough x4 days. Admitted for COVID pna. Fully vaccinated Jan 2021. O2, rocephin/azithro, steroids, zinc, singulair, remdesivir. Was eventually able to wean O2 down to 3L NC and was discharged to Rehab.
Information has been received from a physician concerning a patient who was vaccinated with a dose of GARDASIL and experienced a vasovagal reaction. Additional information is not expected.
Patient presented with rash on face, upper extremities and trunk spreading to top of thighs 11 days after receiving mmrv vaccine and seen in the office on 2/12/21. Had exposure to covid the day before. Rash was believed to be consistent with post- MMRV vaccine.  Patient seen again on 2/14/21 for non-blanching rash that was still slightly spreading and now on left cheek. No fever, cough, sore throat or headaches. Laboratory work was ordered (see next question) On 2/15/21, patient went to the emergency room for acute onset right upper leg pain. Given setting with severe thrombocytopenia, was advised to go to Hospital Emergency Department.  2/16/21 Seen at Hospital Emergency department. Diagnosed with ITP (Idiopathic thrombocytopenic purpura) and positive for covid. Patient was discharged home with instruction to return if leg pain persists or fever develops 2/18/21 Patient seen via telemedicine for a follow-up appointment. Started with fevers 100.4-101.8 and right leg pain. Advised to go to  emergency room.
This spontaneous report was received from a 69 year old female patient who with cortisone allergy and pain killers allergy and no pertinent medical history who on an unknown date was vaccinated with a dose of ZOSTAVAX (route not provided). Concomitant therapies included levothyroxine sodium, PREVACID and hydrochlorothiazide. No other co-suspect therapies were provided. The consumer reported that after receiving ZOSTAVAX she developed shingles in September 2012. She stated that it was a severe case of shingles. She also reported that that she was given unspecified shingle pills, which were not efficacious in treating her shingles outbreak. No laboratory tests were performed. At the time of the report, the patient's outcome was not provided. Additional information is not expected.
Symptoms Within 3 minutes of having the vaccination I slumped over and couldn?t move. Was having difficulties breathing, blood pressure dropped, eyesight became intermittent with kaleidoscope images and could not move my upper body. My body had a hot sensation and flushing. Had a huge appetite for the next 2 days. For the next few weeks I had a headache that wouldn?t go away no matter what I took, I was extremely tired and fatigued.  Over the next few months I had strange symptoms : Pelvic Floor issues, burning sensations down the left side of my body, severe anxiety, foggy brain, cystic acne, hives and clumsiness.
3-4 heavy days of cramping and menstruation, followed by 3-4 days of light cramping and menstruation/Patient is almost (age)years old and has not had a period in over 16 months; 3-4 heavy days of cramping and menstruation; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 22Mar2021 13:30 (at the age of 55-years-old) (Batch/Lot Number: EP7534) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history was none. There were no concomitant medications. She had no known allergies. The patient was not pregnant. The patient had no other vaccine in four weeks prior to COVID-19 vaccine. It was reported that the patient had 3-4 heavy days of cramping and menstruation, followed by 3-4 days of light cramping and menstruation. Patient was almost 56 years old and had not had a period in over 16 months. The events' onset was on 25Mar2021 08:00 AM. The event has recovered without treatment. The patient had no covid prior vaccination.
Tingly tongue, sensation level 5/10 or so. Took Benadryl and Claritin. Felt better after 2-3 hours.