chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mom passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Mom passed away) in a female patient of an unknown age 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) 1 dosage form. Death occurred on September 2021 The patient died in September 2021. The cause of death was not reported. It is unknown if an autopsy was performed.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use information was not provided by the reporter. Treatment information was not provided.   Company comment: This is a spontaneous case reported by the patient's son, concerning a female patient of unknown age with no reported medical history, who experienced the unexpected serious (death and medically significant) event of death. The event occurred after the unknown dose number of mRNA-1273 vaccine administration. The cause of death was not reported. It is unknown if autopsy was performed. No other information surrounding the event was reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-594693 (Patient Link).; Sender's Comments: This is a spontaneous case reported by the patient's son, concerning a female patient of unknown age with no reported medical history, who experienced the unexpected serious (death and medically significant) event of death. The event occurred after the unknown dose number of mRNA-1273 vaccine administration. The cause of death was not reported. It is unknown if autopsy was performed. No other information surrounding the event was reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
aching, chills, pain from injection site radiation to left side neck. dry hacking cough
COVID arm, red, raised, itchy blotch on site of vaccine inoculation, approximately 3 inches in diameter.
a child was given the adult dose of Havrix.; a child was given the adult dose of Havrix.; This case was reported by a physician via call center representative and described the occurrence of adult product administered to child in a 1-year-old patient who received HAV (Havrix 1440 adult) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 28th May 2021, the patient received Havrix 1440 adult. On 28th May 2021, unknown after receiving Havrix 1440 adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.  Additional details were provided as follows:  This case was reported by a medical doctor (pediatrician). The patient was given the adult dose of Havrix, which led to adult product administered to child and overdose. The reporter consented to follow-up. This was 1 of the 9 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021120523:same reporter US-GLAXOSMITHKLINE-US2021120532:same reporter US-GLAXOSMITHKLINE-US2021120528:same reporter US-GLAXOSMITHKLINE-US2021120526:same reporter US-GLAXOSMITHKLINE-US2021120521:same reporter US-GLAXOSMITHKLINE-US2021120519:same reporter US-GLAXOSMITHKLINE-US2021120516:same reporter US-GLAXOSMITHKLINE-US2021AMR121314:same reporter
Rash developed on chest and back arms and legs. Has about 15 lesions total. Treat symptomatically.
Autoimmune Disorder; POTS; orthostatic intolerance; autonomic dysfunction; dizziness; fatigue; headache; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 23-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced autoimmune disorder, postural orthostatic tachycardia syndrome (POTS), autonomic dysfunction, orthostatic intolerance, fatigue, dizziness, and headache. Reported date of injury was unspecified date in 2013. The outcome of the events were not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the event of autoimmune disorder was determined to be medically significant.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Runny nose; Cough; Body aches; Pain in the body; Couldn't focus; Draining felling; Chills; Fatigue; Can´t smell; Can´t taste; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), COUGH (Cough), MYALGIA (Body aches), PAIN (Pain in the body) and DISTURBANCE IN ATTENTION (Couldn't focus) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced ANOSMIA (Can´t smell) and AGEUSIA (Can´t taste). On an unknown date, the patient experienced RHINORRHOEA (Runny nose), COUGH (Cough), MYALGIA (Body aches), PAIN (Pain in the body), DISTURBANCE IN ATTENTION (Couldn't focus), DEPRESSED MOOD (Draining felling), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, RHINORRHOEA (Runny nose), COUGH (Cough), MYALGIA (Body aches), PAIN (Pain in the body), DISTURBANCE IN ATTENTION (Couldn't focus), DEPRESSED MOOD (Draining felling), ANOSMIA (Can´t smell), AGEUSIA (Can´t taste), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
AT SITE OF INJECTION:  3 INCH X 3 INCH RED, SWOLLEN, ITCHY AT SITE.
On March 18th I experienced normal side effects (fatigue, body aches, chills, along with soreness of the injection site).  Starting on March 19th, I experienced mild shortness of breath for 3 days.  I checked my O2 sat throughout those 3 days and never dropped below 98%.  My wife experienced the same shortness of breath for the same period of time with a low of 97% on her O2 sat.  She received a Covid test on the last day of her symptoms and received a negative result.  Now, on March 25th I have developed a red, circular rash at the injection site (upper portion of left arm).  It is itchy, warm, and has a firm feel, roughly 2.5 inches in diameter with a slight, inward, crescent-shaped curve of the red patch on one side.
Patient presented to urgent care with chest pain that started on 4/30/2021.  EKG with diffuse ST elevation, consistent with Pericarditis.  Sent to ED for further care and management.
Narrative:  COVID infection following COVID vaccine series 03/19, Pfizer, dose #1 04/09, Pfizer, dose #2 12/25 COVID swab, result: detected 12/23 pt cc: rhinorrhea, sore throat exposure: unknown 12/25 pt admitted to ED cc: "sore throat, headache, body aches, and requesting testing" dx: Covid positive status, acute pharyngitis, LOS: 1 day 12/26 SARS-COV-2 Variant Sequencing: pending 12/29 clinically resolved
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. In 2015, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
On 01/21/21, patient was in the next booth over and she stated the shot got her really sick. She stated she went to work and was extremely dizzy that night, and the next day she stated she felt even more dizzy, shaky, nauseated, and ended up vomiting a small amount that was all acid she stated. She fell asleep after vomiting, and stated she felt back to normal the next day.
Patient had a very large and swollen area approximately 6" in length around injection site the next day. It resolved in a couple of days with ice / cortisone treatment.
Vertigo and headache. The following day he developed headache and vertigo that continues today. Headache is 6/10 with standing and is improved with sitting and laying. No fever. He has been drinking good PO fluids and eating well/normal. He has had nausea but no vomiting or diarrhea. His injection site in his arm is swollen but the overlying skin does not demonstrate erythema like an infection. The swollen area is warm to touch and mildly tender.
COVID Positive 07Aug2021; COVID Positive 07Aug2021; This is a spontaneous report from a contactable physician. This physician reported for a 93-year-old female patient.  A 93-year-old (non-pregnant) female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date in 2021 (at the age of 93-year-old) as dose number unknown, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history includes Cardiac valve disease from unknown onset to unknown ongoing, Chronic obstructive pulmonary disease from unknown onset to unknown ongoing, Diabetes mellitus from unknown onset to unknown ongoing, Hypertension from unknown onset to unknown ongoing and Chronic kidney disease from unknown onset to unknown ongoing. The concomitant medications were not reported. Patient past drug events include codeine induced drug hypersensitivity on an unspecified date. Prior to vaccination, the patient was diagnosed with COVID-19 was unknown. On 07Aug2021, after the vaccination, the patient experienced covid positive in SARS-CoV-2 test, which caused hospitalization but not prolonged. Patient received treatment with Decadron and Oxygen. Since the vaccination, the patient had been tested for COVID-19.  The patient underwent lab test and procedure includes SARS-CoV 2 RT PCR test positive nasal swab on 07Aug2021. The outcome of the event was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.
One day after Dose 2 of Pfizer 4/30/21 she reports throbbing of neck, lightheadedness, and BP of 194/125, prompting ED visit. Reports leaving ED without treatment after BP WNL 125/75 but having to return to ED the next day with BP of 190/110. Work up done in ED WNL. PCP feels it is related to vaccine.
This spontaneous report as received from a physician via Company Representative refers to a female patient in her 80's. Patient had history of a transplant recipient (organ not specified). On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, lot number and route were not reported). Patient was taking unspecified concomitant medications. Physician reported that patient received ZOSTAVAX and developed shingles on her eyelid and round her eye. The patient was diagnosed with Herpes Zoster Ophthalmicus. Physician stated that "the patient should not had received ZOSTAVAX because she was an organ transplant recipient". The patient's prior physician was the healthcare professional who prescribed the ZOSTAVAX vaccine and direct the patient to the pharmacy to received ZOSTAVAX injection. The outcome of herpes zoster ophthalmicus was not reported. It was reported that the patient received unspecified type of treatment. The physician considered that herpes zoster ophthalmicus as disability because it affected the vision. Causality was not reported. Additional information has been requested.
dvt; diarrhea; okay for him to get the second dose outside of the recommended 3 weeks ( 6 weeks and 2 days ).; This is a spontaneous report from a contactable consumer. This male consumer reported for himself. A 63-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 23Mar2021 as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date patient experienced side effects such as diarrhea and DVT on their left leg. As second dose scheduled on 06May2021 wanted to know if it is okay for him to get the second dose outside of the recommended 3 weeks (6 weeks and 2 days). He would like to know if Diarrhea and Blood Clots are side effects of the vaccine as he is currently experiencing these adverse events. The Outcome of the events were unknown. Follow-up (05May2021): This is a Follow-up spontaneous report from a Pfizer-sponsored program. This contactable male consumer reported side effect from the first dose, second dose scheduled on 06May2021. Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information: Yes: Customer and/or medical inquiry forwarded or referred to MI. Information about lot/ batch number has been requested.
A 4th dose of HPV vaccine given, unaware of first 3 doses Immunization given by accident.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age with no pertinent medical history and no drug reaction/allergy. The patient was vaccinated with the first dose of GARDASIL on 09-FEB-2012, and the second dose on an unspecified date in 2012. There was no concomitant medication. It was reported that the patient experienced soreness around injection site after receiving first two doses of GARDASIL. The patient stated that soreness lasted about an hour after injection. No treatment information was given. The patient sought medical attention via office visit. Additional information is not expected.
Patient reports to hospital from assisted living facility for altered mental status, with  a positive covid test 10 days prior.  Admitted to step down unit on 3 LNC.  Chest Xray showing lungs under expand with atelectasis.  She was started on dexamethasone.  She was not  a candidate for additional covid therapies due to significant renal failure.  Patient made comfort care and expired on 12/27/21.
Two days post vax pt was seen in the ER subsequent to developing an injection site reaction characterized by a 9 X 8 cm area of redness, warmth, and swelling in the right thigh. The circumference of the right thigh was 30 cm while the circumference of the left thigh of 26 cm. Pt also became fussy.
Breakthrough case admission after two doses Pfizer 4/27/21 Lot# EW0176;  Pfizer 5/18/21 Lot# EW0183
oval/ oblong red mark on the site of the injection; discomfort with movement; itching on the injection arm; swelling on the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (discomfort with movement), VACCINATION SITE PRURITUS (itching on the injection arm), VACCINATION SITE SWELLING (swelling on the injection arm) and VACCINATION SITE ERYTHEMA (oval/ oblong red mark on the site of the injection) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0121L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (discomfort with movement), VACCINATION SITE PRURITUS (itching on the injection arm) and VACCINATION SITE SWELLING (swelling on the injection arm). On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (oval/ oblong red mark on the site of the injection). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (discomfort with movement), VACCINATION SITE PRURITUS (itching on the injection arm), VACCINATION SITE SWELLING (swelling on the injection arm) and VACCINATION SITE ERYTHEMA (oval/ oblong red mark on the site of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The side effects came back again around the 20Jan2021  No concomitant medications were provided Treatment Aleve- when she received the shot
3/28/21 or 3/29/21 symptoms began. Center of tongue began to swell,  Sinuses became inflamed,  Rash around lips began, Lips were constantly dry, Muscle aches,  Substantial nasal congestion,  Eyes became watery and increasingly puffy,  Shortness in breath, Back pain.
First dose Jan. 5.   Site was sore.  Jan 14 arm became extremely itchy.  First notice injection site and entire front of arm extremely red,  hot, blotchy and swollen.   Symptoms  worsened Jan 15 ; I went to  my doctor's urgent care.  Dr. is the Covid doctor at this facility.  He said he had not seen anything like this.  He told me to watch it, document with photos (which I have done daily) and check my temperature 3 times daily.    He said if symptoms still exist in a week to make a return visit.  I have not had a fever..  Today Jan. 18 my arm seems a little less red.  I am applying hydrocordisone 2.5%  to ease the itching.
Extreme fatigue/debilitating fatigue; This case was reported by a consumer via call center representative and described the occurrence of fatigue extreme in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th March 2022, the patient received the 2nd dose of Shingrix. On 24th March 2022, less than a day after receiving Shingrix, the patient experienced fatigue extreme. On 25th April 2022, the outcome of the fatigue extreme was recovered/resolved.   It was unknown if the reporter considered the fatigue extreme to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-APR-2022 Reporter's Comments: The patient received 2nd Shingrix shot and experienced extreme fatigue since then, debilitating fatigue almost everyday. The reporter consented to follow up.
sore arm; nausea; chills; fatigue; rapid heartbeat; lightheadedness; brain fog; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (rapid heartbeat), DIZZINESS (lightheadedness), FEELING ABNORMAL (brain fog), VACCINATION SITE PAIN (sore arm) and FATIGUE (fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tooth extraction (Wisdom tooth extraction.) and PAP smear (Abnormal Pap smear of cervix). Previously administered products included for an unreported indication: TETANUS VACCINE on 18-Sep-2019. Concurrent medical conditions included Asthma (1990), Drug allergy (ibuprofen), Allergy to arthropod bite, Seasonal allergy and Cold intolerance. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthma, ALBUTEROL [SALBUTAMOL] from 10-Mar-2021 to an unknown date for Wheezing and Shortness of breath, LORATADINE (CLARITINE) and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) from 10-Mar-2021 to an unknown date for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PALPITATIONS (rapid heartbeat), DIZZINESS (lightheadedness), FEELING ABNORMAL (brain fog) and FATIGUE (fatigue). On 07-Feb-2021, the patient experienced NAUSEA (nausea) and CHILLS (chills). On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm). On 05-Feb-2021, PALPITATIONS (rapid heartbeat) and DIZZINESS (lightheadedness) had resolved. On 07-Feb-2021, FEELING ABNORMAL (brain fog) and FATIGUE (fatigue) had resolved. On 09-Feb-2021, NAUSEA (nausea) and CHILLS (chills) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 122/82 mmHg (normal) Blood Pressure normal. On an unknown date, Heart rate: 55 (Low) Heart rate decreased.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medications were reported.  Patient went to EENT doctor, had some tests and all look normal.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Follow up document was attached which contains VAER having additional information for Dose 1 events ( rapid heartbeat, lightheadedness, brain fog, chills, sore arm  and fatigue) and Dose 2 events
Vaccine was administered on December 1, 2021.  On Dec 3rd later afternoon/ evening, Patient was very tired and didn?t look himself. He went to sleep and on the morning on Dec 4th, he woke up at 6:30 and threw up. For the whole day on Dec 4th, Patient was very fatigued, looked pale, was nauseous, belly hurt and threw up again at 11:00am and 4:45pm. He went to bed at 8:15pm and woke up on Dec 5th completely back to normal.
Sandpaper itchy rash all over body, including mouth, bottoms of feet. Also broke out in a pimple like rash on body. Pimple rash is resolving, sand paper rash has not improved.