chrisvoncsefalvay/vaers-outcomes huggingface dataset:
phlebitis in my Right leg; small blood clot; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 09Feb2021 (Batch/Lot Number: EL9269) as single dose for covid-19 immunisation. Medical history included many allergies. The patient has no COVID prior to vaccination. The patient had other medications in two weeks but no other vaccine in four weeks. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL9263) on 20Jan2021 at 10:00 administered in the right arm for Covid-19 immunization. On 20Feb2021 at 12:00 (also reported as "in February"), the patient had a phlebitis in her right leg, a week later (Feb2021) a vascular surgeon office did an ultrasound and found a small blood clot. The events resulted in doctor or other healthcare professional office/clinic visit. The events were treated with Eliquis BID (twice a day) for 45 days. The patient was not tested for COVID post vaccination. The outcome of the events was not recovered.; Sender's Comments: A causal relationship between BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) and the event thrombosis cannot be excluded based on temporal association.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate .
BREAKTHROUGH COVID INFECTION. PATIENT TESTED POSITIVE ON 09/13/2021. PATIENT WAS FULLY VACCINATED ON 04/16/2021.
the patient's second dose is more than 30 days since his first dose/big gap between the first and the second dose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the patient's second dose is more than 30 days since his first dose/big gap between the first and the second dose) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the patient's second dose is more than 30 days since his first dose/big gap between the first and the second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the patient's second dose is more than 30 days since his first dose/big gap between the first and the second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the patient's second dose is more than 30 days since his first dose/big gap between the first and the second dose).    No concomitant medication was reported.  A patient had received first Moderna dose (6 months to less than equals 6 year old) and was supposed to get the second dose but got postponed several times.  The second dose recommendation was 1 month apart and so the patient second dose was more than 30 days since his first dose. Reporter asked if the patient would get another dose 1 month after this second dose even if he might have any certain kinds of immunocompromise and just because of the big gap between the first and the second dose.  No treatment information was provided.
No additional AE's/PQC's were reported; Caller reported a temperature excursion for PROQUAD / PROQUAD lot: T0304081 was administered to (14) patients since the excursion occurred on 7/22/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 23-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dosage form, lot # T0304081, expiration date reported as 07-MAR-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported).      Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 13.02 degrees of Fahrenheit (F) for 1 hour and 30 minutes. There was a previous temperature excursion reported (from 14 degrees of F to 46 degrees of F (17.95 degrees of F) for 45 minutes). No symptoms were reported by the patient since the administration.  Lot # T0304081 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot # T0304081 does not match any Company product as confirmed by Lot Verification team.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000996: US-009507513-2108USA000995: US-009507513-2108USA000997: US-009507513-2108USA000998: US-009507513-2108USA000999: US-009507513-2108USA001007: US-009507513-2108USA001006: US-009507513-2108USA001005: US-009507513-2108USA001004: US-009507513-2108USA001003: US-009507513-2108USA001002: US-009507513-2108USA001001: US-009507513-2108USA001000:
Patient received 1st Covid vaccine on 4/12/21 without incident.  He received 2nd dose on 5/12/21.  Patient states he had chills and felt achy about 12-24 hours after vaccination, but was fine after that.  Approximately 2 days after 2nd vaccine, he developed a rash on his chest.  The rash was contained to the chest area.  It started as a rash, then patient states it blistered and was itching.  Patient saw his PCP on 5/25/21 about the rash and that was the first notification from the patient regarding the reaction.  No medication was prescribed, patient instructed to monitor and call if not improving.
arm was a little sore after receiving the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm was a little sore after receiving the 1st dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 937902) for COVID-19 vaccination.     Concomitant products included ATENOLOL for Blood pressure, ARTEMETHER (ARTANE [ARTEMETHER]), GABAPENTIN, CLONIDINE, METHOCARBAMOL (ROBAXIN), HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]), CELECOXIB (CELEXA [CELECOXIB]), VITAMIN C [ASCORBIC ACID] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, the patient experienced MYALGIA (arm was a little sore after receiving the 1st dose). At the time of the report, MYALGIA (arm was a little sore after receiving the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-320090 (Patient Link).
2 hours after immunization swelling and redness observed with without pain. Seen in office 24 hours later. Using Motrin and Benadryl. Arm circumference right 5 cm 7 left.
Swelling, and inflammation at injection site.  Pain and decreased mobility in the left arm. Large red rash on the shoulder at injection site.  Skin is hot to the touch on the left arm.
This case was reported by a healthcare professional (nurse) and described the occurrence of pain at site during injection in a 70-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included arthritic pains, depression and pedal edema. Concurrent medications included CELEBREX, CELEXA, Hydrochlorothiazide and Hydrocodone. The subject had no known drug allergies per the reporter. The subject had received flu shots in the past and had no reaction to previous flu vaccines. There were no adverse events following previous vaccinations. On 18 September 2013 at 12:00 the subject received a dose of FLUARIX (unknown details, left arm). On 18 September 2013, during vaccination with FLUARIX, the subject experienced pain at site during injection and cold feeling at injection site. On 22 September 2013, 4 days after vaccination with FLUARIX, the subject experienced injection site movement impairment. The nurse reported that the "administration felt cold and painful" to the subject when the FLUARIX was administered. On 18 September 2013, the nurse also reported "severe pain and severe muscle ache". On 22 September 2013, 4 days after vaccination with FLUARIX, the subject "cannot lift arm". The subject sought medical attention at the emergency room on 22 September 2013 but was not admitted to the hospital. The subject currently must wear a sling for the arm pain. The healthcare professional considered the events were disabling. At the time of reporting the events were worse.
Severe myalgias, fatigue, malaise, and local arm swelling for approximately 5 days. Generalized parasthesias. Patient called after resolution of symptoms and declined appointment.
Client states that 24 hrs following his 1st dose Pfizer COVID vaccine (LOT EW0173 Expiration date 08/31/2021) received on 04/29/2021 he experienced a tight throat, difficulty swallowing, headache, mild diarrhea and increase of mucus production in his throat that required frequent spitting up. He denied any chest pain, facial swelling or difficulty breathing. He stated the symptoms lasted 2 days and then resolved on their own. He reported taking 1x 300 mg Advil for the headache with little relief. Client denied reporting the symptoms to his primary care provider due to being in between insurances and in between providers. He also stated because the symptoms self resolved he figured they were normal side effects to the vaccine. Client denied any other significant medical history and medication use.
Dyspnea intermittent, patient states dyspnea more severe and prolonged than typically experiences with asthma. Used albuterol inhaler with moderate improvement in symptoms.
medication error due to administering dose post temperature excursion outside acceptable guidelines for excursion stability standard, with no reported adverse event; Initial information received on 19-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 36 years old female patient who experienced medication error due to administering dose post temperature excursion outside acceptable guidelines for excursion stability standard, with no reported adverse event while receiving vaccine Diphtheria-2/tetanus/5 ac pertussis vaccine [adacel].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation.  On 25-Mar-2022, the patient received a  dose of 0.5 ml of suspect Diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (strength :unknown) lot C5963AA, expiry date :03-jun-2023 via intramuscular route in unknown administration site for immunization.  On 25-MAR-2022 the patient developed a non-serious medication error due to administering dose post temperature excursion outside acceptable guidelines for excursion stability standard, with no reported adverse event (product administration error) (latency :same day) following the administration of Diphtheria-2/tetanus/5 ac pertussis vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (medication error due to administering dose post temperature excursion outside acceptable guidelines for excursion stability standard, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event medication error due to administering dose post temperature excursion outside acceptable guidelines for excursion stability standard, with no reported adverse event.     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 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.; Sender's Comments:  01068650: 01068813: 01068814: 01068816: 01068817: 01068825: 01068827: 01068828: 01068830: 01068832: 01068834: 01068835: 01068838:
On 10/2 the next day after receiving my pfizer booster vaccine, I experienced muscle pain, chills, joint pain, feeling unwell, swollen lymph nodes under my left arm (arm pit), left arm pain followed by numbness.  It is now 10/5 and the left under arm swelling has not resolved and I continue to experience numbness in my left arm.  I notified my doctor and I am waiting for a response.
Had headache on 01/15/2021 which resolved on 01/17/2021. Reporting mild chills, joint pain and tiredness that started on 01/16/2021.
I had shots before I got the stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, single), administration date: 2021, for COVID-19 Immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "I had shots before I got the stroke".  Clinical course: Patient got 2 shots for COVID a year ago. Patient had not gotten the booster. First of all 6 months ago patient had a stroke that well patient was stuck and the result that patient didn't get the booster and later on patient found that there has not been any kind of study on people at patient age, patient was 80 So, patient wanted to know why was not there any studies on patient's age regarding the vaccine and regarding the booster. So, patient had not taken the booster. Patient doctor did not know either.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Generalized body aches 24 hrs after injection.  Generalized body aches and slight nausea 48 hours after injections. No fever, No other complaints.
Diffuse body rash that appeared to be papular vs small discrete hives.  Total body surface.  Rash started at Non the day following vaccines (9/18/19), persisted through the night and resolved by evaluation at 10 AM on 9/19/19.
Information has been received from a physician concerning a 66 year old male with drug hypersensitivity to chloroquine (diploplia) and a history of chickenpox at ten years of age, who on 12-NOV-2007 (also reported as 11-DEC-2007) was vaccinated into the left arm with 0.5 ml ZOSTAVAX (Lot # 658604/1088U).  Concomitant vaccinations included a 0.5 ml. dose of VARIVAX, and MMR II.  Concomitant therapy included ramipril (ALTACE), 2.5 mg daily, and cyanocobalanin (+) folic acid (+) pyridoxine hydrochloride (FOLBEE).  On 15-NOV-2007 (also reported as day three), the patient developed a fine vesicular rash that was wide spread described as a shingles rash.  The patient was reported to have felt poorly (fatigue, achy), and experienced discomfort from the rash, including pain and itching.  Dermatone was T 12 and extremities.  It was also noted that the patient's wife was vaccinated with ZOSTAVAX on the same day, but had no reaction.  The patient had been exposed to his granddaughter on 11 NOV 2007, one day prior to being vaccinated.  The granddaughter, who though not diagnosed at that time, was subsequently diagnosed with chickenpox.  Neither a direct fluorescent antibody nor specimens were obtained.  At the time of reporting it was noted that the rash was resistant with scaring, and the patient had not yet recovered.  The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  This is a consolidation of two reports concerning the same patient.  Additional information has been requested.
Information has been received from a health professional concerning an 8 year old patient who on 9/18/98 was vaccinated with a dose of varicella virus vaccine live (lot # 627330/1052H). Concomitant therapy that day included MMR and monovacc. On 10/5/05 the patient developed chicken pox breakthrough. Additional information has been requested.
Initial unsolicited report received from a pharmacist via other company (Merck) on 22-FEB-2017. This case involves a patient (age and gender not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date (about ten years ago). Patient's medical history and concomitant medications were not reported.  On an unspecified date, following the vaccination, the patient had severe reaction described as injection site really swelled up and experienced a lot of pain at injection site. Lab data and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Nausea, diarrhea, vomiting, severe burping, headache, chills, skin sensitivity, fatigue.  No treatment, rested for 2 days.
After shot given patient felt dizzy- patient sat down and we offered to call emergency , patient refused and wanted to call a family member, Patient was offered water and refused.  Patients husband came and pharmacist walked her out to the car.  suggested for husband to go to emergency room if continued to feel dizzy.
Approximately 4 days after receiving the vaccine, I had a very sharp pain in my shoulder area.  I thought that I was stung by a bee.  I looked and there was no bee or sting, but the sharp pain persisted for many days. I reported the reaction to my physician on Oct 5, 2022.   After a while the pain diminished to less severe but still persistent, especially at night which disturbs my sleep.  I used ice initially, and lidocaine, ointment and patches, and Voltaren cream.  I also use Tylenol and/or Ibuprofen, pills, especially at night.  I do not have a limited range of motion, and the pain is not bad during the day.  The pain is something I have not experienced before and it has not gone away after over 2 months. I am usually tolerant of pain and do not complain.  I felt the need to report this as it has not stopped.
Child was in car seat and began having seizure activity.  Mom pulled in to restaurant down the street and called 911.  Child unresponsive x 5-7 minutes per mom.  EMS arrived for transport to hospital.  No fever reported.
Developed acute respiratory distress with bilateral pulmonary infiltrates.  Suspicious for pulmonary edema.  CXR clear 2/6/21.
Parents brought her 7-1-13 for check of site of varicella. 2d ago they noted a red bump at presumed site - never blistered, no itch, non-tender, larger. Today 2cm horizontally with 1cm diameter vertically. Not hot. No bruising. Red. Deep mass. No fever. Diarrhea x10 since MN. I do not feel this is related.
Redness and swelling into bicep of left arm.  Intense nerve pain running into left hip and around front of left thigh.
On 04/26/2022 I has a very runny nose in the evening. My husband had symptoms on 04/20/2022 and took a home-test and that was positive on Wednesday morning 04/23/2022 and my at-home, Rapid, and PCR test was Negative. I took an at-home test on 04/25/2022 that was also Negative. I did take another at-home test on 04/27/2022 and that was Positive so I went to Urgent Care where a rapid test confirmed Positive. I was prescribed a Z-PAK and Steroids at that visit on 4/23/2022 because I had symptoms. After 04/27/2022 I had a slight headache and felt fuzzy-headed and that only lasted a half day and went away. I always have sinus drainage so I already had those symptoms around this time of year. As far of COVID-19 I had no other symptoms.
Fatigue; Hives; severely dry eyes; extreme joint pain; This case was reported by a nurse via call center representative and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fatigue, hives, eye dryness and joint pain. On an unknown date, the outcome of the fatigue, hives, eye dryness and joint pain were unknown.   It was unknown if the reporter considered the fatigue, hives, eye dryness and joint pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient experienced fatigue, hives, severely dry eyes, and extreme joint pain. The reporter declined to offer any more data.
Chills, fatigue, left arm hot, red, hard and sore,Nausea and vomiting. PCP ordered suppository
7/2/19 complaining of chills, body aches, headache, body on fire--7/3/19 wokeup headache better but body aches continue through today.  Left arm red and swollen in the elbow area, not at the injection site starting 7/5 making bending arm & movement difficult.  Seen by provider 7/9/19 area still pink, swelling decreased.
Narrative: 71 year old Patient presented to the emergency department with complaint of nasal congestion, sinus drainage, cough and mild sob. She reported shortness of breath onset 2 to 3 weeks prior. 02 saturation 77% at triage. Sat improved to 90% on 4L O2. No history of asthma, COPD or any other lung problems. Troponin and D-Dimer elevated. Unable to perform CT with contract due to elevated serum creatinine ((2.38) Patient reported she had COVID vaccine booster on 11/23 or 11/24. Specific vaccine type and lot number not available in database for booster vaccine. Likely received outside our facility. Patient had previous history of DVT/PE in September 2020. Review of anticoagulation notes show that apixaban therapy was discontinue in February 2021. While in ED, patient became unresponsive. CPR initiated and patient intubated. Patient expired at 1831 on 11/26/2021.
UNKNOWN.  THE PATIENT WAS GIVEN WITH MORE CONCENTRATED VACCINE WITH THE RIGHT DOSE ( 0.2 MG).   THE VACCINE WAS DILUTED WITH 0.13 ML  INSTEAD OF 1.3 ML OF DILUENT.
Next morning of shot, injection arm sore, minor muscle aches all over, legs shakey.
Information has been received from a medical assistant concerning a 9 year old female patient who on 29-OCT-1997 was vaccinated with a dose of varicella virus vaccine live. On approximately 28-DEC-2005, the patient developed chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
On 9/10/2017 starting feeling sick to stomach with diarrhea, with no fever, and headache which lasted til 09/21/2017.