chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse via field representative refers to a patient of unknown age and gender. Patient was relocated. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date (also reported as a while ago), the patient was vaccinated with M-M-R II, intramuscularly, (dose and frequency were not provided). On an unknown date, later patient developed the measles for an unspecified amount of time. Nurse stated that adverse experience happened "a while ago" she did not know much information. No product quality complaint (PQC) was involved. The outcome of measles was unknown. Causality was not provided. No further adverse event information was given. This is one of two reports received from same reporter (linked with MARRS# 1503USA014690). Additional information has been requested.
Fine, erythema, maculopapular rash all over body. Injection of the conjunctiva and profuse rhinorrhea.
Rash all over my body; Rashes are bad; Fever; Stomach problems; Chills; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 71-years-old female patient received first dose of bnt162b2(PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number: EN6206, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 15Mar2021 as dose 1, single for COVID-19 immunization (age at vaccination: 71-years-old). The patient medical history and concomitant medications was not reported. The patient experienced rash all over my body; rashes are bad (rash), fever, stomach problems and chills. Therapeutic measures were taken as a result of rash all over my body; rashes are bad (rash). It was reported that patient got a cream to rub on, her doctor prescribed the cream to rub on her body and it was Triamcinolone Acetonide Cream. The outcome of the event rash was not recovered, and rest of the events outcome was unknown.  No follow-up attempts are possible. No further information is expected.
Progress Notes (Nurse Practitioner) ? ? Nurse Practitioner Cosigned by: MD at 3/18/2021  2:51 PM Expand AllCollapse All    3/18/2021    Subjective Patient is a 18 y.o. female who was seen at COVID Vaccine site today for her first  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience left arm numbness and tingly..  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting.   Complained of numbness and tingling in the left arm (shot arm) after shot.     ALLERGY REVIEW OF SYSTEMS:  All other systems negative   Patient complains of muscle aches   CONT negative HENT negative Eyes negative Respiratory negative Skin negative GI negative Neuro negative     Previous Reactions: None    Objective    Vitals Vitals:   03/18/21 1120 03/18/21 1140 BP: (!) 141/81 125/74 Pulse: 88 85 SpO2: 99% 99%          Physical Exam Constitutional:      Appearance: She is well-developed.  HENT:     Head: Normocephalic and atraumatic.     Right Ear: External ear normal.     Left Ear: External ear normal.     Nose: Nose normal.  Eyes:     Conjunctiva/sclera: Conjunctivae normal.     Pupils: Pupils are equal, round, and reactive to light.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Abdominal:     General: Bowel sounds are normal.     Palpations: Abdomen is soft.  Musculoskeletal:        General: Tenderness present. Normal range of motion.     Cervical back: Normal range of motion and neck supple.  Skin:    General: Skin is warm and dry.     Capillary Refill: Capillary refill takes less than 2 seconds.  Neurological:     Mental Status: She is alert and oriented to person, place, and time.     Comments: Numbness in left fingers        Assessment/Plan  Treatment included: water Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Pt left at 12:06.  Numbness resolved in left hand       Electronically Signed 3/18/2021 12:07 PM
Patient's daughter reported a fever of 101.3 for 2 days with chills followed by petechiae and cellulitus of upper extremeties.
fever of 100F; headache; chills; left arm hurt; left arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 100F), HEADACHE (headache), CHILLS (chills), VACCINATION SITE PAIN (left arm hurt) and PAIN IN EXTREMITY (left arm sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 037A21B) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PYREXIA (fever of 100F), HEADACHE (headache), CHILLS (chills), VACCINATION SITE PAIN (left arm hurt) and PAIN IN EXTREMITY (left arm sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-May-2021, PYREXIA (fever of 100F), HEADACHE (headache), CHILLS (chills), VACCINATION SITE PAIN (left arm hurt) and PAIN IN EXTREMITY (left arm sore) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Non significant follow up received on 13-MAY-2021, Events outcome was updated to Recovered/resolved.
terrible headache; very tired; aches like she had the flu all day; temp 102.1°F; didn't feel well; very nauseated; sore arm; hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), BODY TEMPERATURE ABNORMAL (temp 102.1°F), FEELING ABNORMAL (didn't feel well), PAIN (hurt) and NAUSEA (very nauseated) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included LOSARTAN POTASSIUM for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and PAIN (hurt). On 05-Mar-2021, the patient experienced BODY TEMPERATURE ABNORMAL (temp 102.1°F), FEELING ABNORMAL (didn't feel well), NAUSEA (very nauseated), FATIGUE (very tired) and PAIN (aches like she had the flu all day). On 06-Mar-2021, the patient experienced HEADACHE (terrible headache). The patient was treated with IBUPROFEN for Fever and Ache, at an unspecified dose and frequency. On 06-Mar-2021, FATIGUE (very tired) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), BODY TEMPERATURE ABNORMAL (temp 102.1°F), FEELING ABNORMAL (didn't feel well), PAIN (hurt), NAUSEA (very nauseated) and PAIN (aches like she had the flu all day) outcome was unknown and HEADACHE (terrible headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 102.1 (High) 102.1°F. On 06-Mar-2021, Body temperature: 100 100 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Vaccine was expired on 24-OCT-2021 and administered on 25-OCT-2021 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-OCT-2021 and administered on 25-OCT-2021 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-OCT-2021 and administered on 25-OCT-2021 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-OCT-2021 and administered on 25-OCT-2021 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 102 doses.   The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information.
Extreme debilitating vertigo throughout the day continuing for the next 6 months at a lesser extreme
REQUIRED MD VISIT.2 DAYS S/P VACCINE ADMIN OF TDAP, PT SEEN FOR REDNESS/TENDERNESS, GIVEN KEFLEX RX.
chills, headache, sore arm, redness at injection site and swelling, fever, muscle aches Narrative:  With first vaccination, patient reported 7 days post vaccine redness, warm to touch at injection site and below and took 7 days to clear. With second dose, redness showed on day two and lasted a few days.  Other Relevant History:
Discovered during data entry that today's vaccine was her 3rd dose. Her first 2 doses were given at another facility and only one dose was recorded on her vaccine card.
Mom states pt fainted for the first time yesterday morning (07/07/2021). Pt stated she woke up thirsty but did not feel dizzy. Pt asked mom for water and as she was going to the kitchen she fainted. Mom states pt looked pale and her hands were cold. Pt states she does drink lots of liquids everyday. Pt states she does not have any stressors at this time and actually feels really happy. The only thing is pt did receieve the first dose of the Covid-19 vaccine on Tuesday (07/06/2021).  Today pt states she feels much better. No other symptoms or concerns at this time.
Pt came in for shingrix #2 and noted she had neck stiffness after first inj in October. Patient states she has had soreness in her neck since then and has to take ibuprofen prn. Recommended office visit to evaluate but patient declined. She also declined second shingrix vaccine.
itching with first dose; swelling of arm; rash; achy body; pain of arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching with first dose), PERIPHERAL SWELLING (swelling of arm), RASH (rash), MYALGIA (achy body) and INJECTION SITE PAIN (pain of arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 027A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, ATORVASTATIN, LEVOTHYROXINE and VITAMIN D NOS for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PRURITUS (itching with first dose), PERIPHERAL SWELLING (swelling of arm), RASH (rash), MYALGIA (achy body) and INJECTION SITE PAIN (pain of arm). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Rash, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) for Headache, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching with first dose), RASH (rash) and MYALGIA (achy body) had resolved and PERIPHERAL SWELLING (swelling of arm) and INJECTION SITE PAIN (pain of arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-043665 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Suspect batch number updated, concomitant medication information updated, outcome and reporter causality of rash, myalgia and pruritus updated.
Had PAP at Gyn which came back positive for high risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56 after receiving 3 dose GARDASIL 8/11/06, 1/2207, 6/13/07. Not yet sexually active during immunizations. Will undergo colposcopy.
Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a health professional, Nurse. This case involves a 10 months old patient (gender unknown) who received only ACTHIB portion of vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation. On 08-Aug-2018, the patient received a 0.5 ml third dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine, lot C5426AA (expiry date:04-Oct-2019) via intramuscular route in left thigh. It was a case of actual medication error due to Inappropriate reconstitution technique. It was unknown if patient experienced any 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 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.
Pain in shoulder the following day of vaccine which has gotten progressively worse and now is almost intolerable.
Developed a large, itchy rash on my left arm on the 17th. It covers the majority of my bicep and is hot to the touch. It is painful to the touch and hot. It has continued until the 18th. Additionally, I started menstruating suddenly on the 18th of March.
In mid-afternoon of the day I received the vaccination (and for the next 3 to 4 afternoons), I experienced joint and muscle aches.  I had difficulty standing up from a seated position, which is abnormal for me, and experienced aches running down my legs.  I have arthritis so joint aches are nothing extraordinary for me, but these were a good deal stronger and more persistent than the usual.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jan2021 as dose 1, single (Batch/Lot number: unknown), on 30Jan2021 as dose 2, single (Batch/Lot number: unknown), on 12Oct2021 as dose 3 (booster) single (Batch/Lot number: unknown) and on 30Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "arthritis" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Dec1997; AMLODIPINE, start date: Dec2019. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Positive covid test; Negative, notes: negative test. Therapeutic measures were taken as a result of covid-19, vaccination failure.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sore arm; Achy upper body; Feverish without fever; Headache; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 18Mar2021 at 12:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin d nos (VITAMIN D), cetirizine hydrochloride (ZYRTEC), ethinylestradiol, norethisterone acetate (JUNEL) and multivitamins (MANUFACTURER UNKNOWN), for unknown indications from unknown dates and unknown if on going. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 19Mar2021 at 13:00, the patient experienced sore arm for 4 to 5 days, achy upper body, feverish without fever for 3 to 4 hours in 24 hours after first dose and headache for most of the next day after the first dose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events sore arm, achy upper body, feverish without fever and headache was recovered on an unknown date in Mar2021. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 17Apr2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
swollen lymph nodes; Difficulty opening mouth wide and swallowing; Mild sore throat; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 28Mar2021 at 09:30(at the age of 46-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 15:00 the patient experienced Sore throat and difficulty opening mouth wide and swallowing. On 02Apr2021, the patient experienced swollen lymph nodes. The patient did not receive any treatment for the events. The clinical outcome of the event Sore throat, difficulty opening mouth wide and swallowing and swollen lymph nodes was not recovered.  No follow-up attempts are needed. No further information is expected.
shingles; Information has been received from a lawyer and a male patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.