chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Licensed practical nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. The patient was vaccinated with yellow fever vaccine, and subsequently, 5 days later, the patient was vaccinated with M-M-R II (dose, units, frequency and route not reported) (lot# and expiration date not reported) subcutaneously. No adverse symptoms were reported. No product quality complaint was involved.
A non-serious spontaneous report of Strep throat, fever and headache has been received from a consumer/mother concerning her eight-year-old daughter, subsequent to FLUMIST. The patient had no relevant past medical history and was not taking concomitant medications. The patient received FLUMIST on 15-Sep-2009. On 17-Sep-2009, the patient developed a fever of 100 degrees Fahrenheit and a headache. Her mother treated her with ibuprofen as needed and phoned the patient's physician. Per the patient's mother, the physician's office did not believe the events were caused by FLUMIST. On 19-Sep-2009, the fever resolved and the headache continued. On 21-Sep-2009. the patient's headache continued. Her mother took to her physician's office for evaluation. A rapid Strep test was performed and was positive. She was treated with a ten day course of amoxicillin. The headache resolved on 22-Sep-2009 and the Strep throat was considered resolved 23-Sep-2009. Additional information was received on 16-Oct-2009 and incorporated into the narrative: included clarification of the date of vaccination, onset and cessation dates of adverse events, diagnosis of Strep throat and treatment information.
Vaccine Breakthrough COVID Case. Pt. had two doses of Pfizer COVID-19 vaccine 3/16/2021 &      4/14/2021. Presented to ED with shortness of breath & fatigue, sx onset 6/29/21. Known exposure to (+) HCW on 6/24/2021.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021 at 1:13 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Oct-2021 at 1:13 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial was moved from freezer to refrigerator on 19-Nov-2021, when the Moderna COVID 19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer or refrigerator, otherwise it was maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions were reported.   This case was linked to MOD-2021-402935 (Patient Link).
Diagnosed with Covid 19; This is a spontaneous report from a contactable consumer (patient).  A 52-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FA7435 or FA7485) via an unspecified route of administration, in right arm on 03Aug2021 (at the age of 52-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included diabetes mellitus from an unknown date and unknown if ongoing. Reporter states he had been diabetic for years and years. The patient concomitant medication was not reported. Patient had not received any additional vaccines same date of the pfizer suspect. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Aug2021, the patient had been diagnosed with covid-19 a week after first dose of Pfizer COVID Vaccine. Event was considered as serious (hospitalization) by the reporter. The patient was hospitalized for diagnosed with covid-19 for 4 days. Reporter stated that the event resulted in emergency room visit and physician office visit. The patient underwent lab tests and procedures which included a result of sars-cov-2 test positive on an unspecified date in Aug2021. It was reported that he had testing done while he was hospitalized with COVID. The outcome of the event was recovered on an unspecified date in 2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Client c/o's of pain and numbness in left shoulder radiating down arm; pain continued throughout the week, client reported some redness and swelling but not severe; took 1200 mg ibuprofen on 3/22/12 and then had problems breathing/mouth swelling.  Seen by MD for allergic rx to ibuprofen and for shoulder/arm pain.  Pain continued on Friday at which time see contacted an orthopedic MD who gave her a cortisone injection.  Denies any relief from pain.  Prescribed Lortabs which have not decreased pain effectively. Came to health dept on 4/5/12 to report continued pain, numbness and limited movement.  Recommended to contact MD again for further evaluation.
Tdap administered on 11/16/2015. Pt reports pain and erythema at injection site within 24 hours of administration that gradually worsened over the course of the next few days. Pt evaluated and txed at clinic 11/21/2015 for this c/o.
Information has been received from a physician concerning a 8 year old white male with no past medical history who on 12-Aug-1997 was vaccinated with a first dose of varicella virus vaccine live (site unknown) (SC) (lot #622680/0086E). The patient was reportedly healthy at the time of immunization, on no medications, and did not have any significant illnesses prior to or after immunization. I was also noted that the patient did not receive any other vaccinations that day or in the year of 1997. After exposure to one known child with natural varicella at his school in April 2003, the patient was evaluated in the office on 25-Ap-2003 with a two day history of fever, frontal headache, and a vesiculopapular rash scattered on his face, scalp, torso, and groin that ultimately totaled about 50 to 100 lesions. The patient reportedly had a varicella infection. Laboratory . That evening he developed a pruritic rash which started on his upper torso. In the office, he had a vesiculopapular rash on his face, scalp, torso, and extremities that ultimately totaled about 50 to 100 lesions. The patient reportedly had a varicella infection. Laboratory evaluation showed a rapid strep test that was positive, a throat culture with growth of group A streptococcus, a VZV IgG antibody was 2.0 with 1.1 or greater indicating immunity and his VZV Ab IgM, EIA was 0.18 which was well within the negative reference range. The patient was treated with a 10 day course of amoxicillin for streptococcal pharyngitis and was advised to stay home from school until the rash crusted/resolved. The patient returned to the doctor's office on 16-May-2003 for follow-up and convalescent antibody titers.  The patient's rash was resolving with a few scabbed lesions remaining on his forehead and scalp. His VZV IgG antibody had increased to 5.2 and his VZV Ab IgM, EIA had increased to 2.93 which was within the positive reference range of greater than 1.1. The patient reportedly recovered in May 2003. It was noted that the patient did not have any adverse events following prior vaccinations. It was reported that the patient subsequently infected his father (who was not vaccinated) and his two brothers and sister who both had been immunized with varicella virus vaccine live. It was reported that the patient's other siblings also developed symptoms (WAES #0305USA02704, WAES #0304USA02848 and 0304USA02849). All were previously vaccinate. Additional information has been requested.
flu like symptoms; headache; some muscle ache; This is a spontaneous report received from contactable consumer (patient's husband). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 16Aug2021 (lot number: FA7485) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced flu-like symptoms, some muscle ache and headache on an unknown date Aug2021. Consumer stated, "Now the symptoms are very mild just got some muscle ache and headache. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
her own adverse reaction following her first dose of Moderna COVID19 Vaccine; heart was racing; felt terrible like I was going to die; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (her own adverse reaction following her first dose of Moderna COVID19 Vaccine), HEART RATE INCREASED (heart was racing) and FEELING ABNORMAL (felt terrible like I was going to die) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (her own adverse reaction following her first dose of Moderna COVID19 Vaccine), HEART RATE INCREASED (heart was racing) and FEELING ABNORMAL (felt terrible like I was going to die). At the time of the report, VERTIGO (her own adverse reaction following her first dose of Moderna COVID19 Vaccine), HEART RATE INCREASED (heart was racing) and FEELING ABNORMAL (felt terrible like I was going to die) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Redness and swelling of upper right arm with itchy, red rash, and hives.
lethargic feeling for about 24 hours; first dose in JAN 2021 and second dose in MAY 2021; I had my second shot with a low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic feeling for about 24 hours), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose in JAN 2021 and second dose in MAY 2021) and PYREXIA (I had my second shot with a low grade fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Medical history was not provided.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced LETHARGY (lethargic feeling for about 24 hours), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose in JAN 2021 and second dose in MAY 2021) and PYREXIA (I had my second shot with a low grade fever). On 08-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose in JAN 2021 and second dose in MAY 2021) had resolved. At the time of the report, LETHARGY (lethargic feeling for about 24 hours) and PYREXIA (I had my second shot with a low grade fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive.         No Concomitant drug reported No Treatment drug reported..   This case was linked to MOD-2021-081493 (Patient Link).
This spontaneous report was received from a consumer via Pfizer (MFR control# 2017532915) regarding her relative, a female patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL (lot #, expiration date not reported) for prophylaxis. On an unknown date, after receiving the first shot of 3 shot series of GARDASIL, the patient had 18 seizures back to back in one day. On an unknown date, the patient was brought to the hospital and was life flighted where she was in a coma for 8 months. The patient was tried to be taken off the medication in June 2014 (reported as 3.5 years ago as on 11-DEC-2017). Outcome of the events was unknown. Causality was not reported for the events. Upon internal review, coma and seizure was determined to be medically significant.
Information has been received from a registered nurse concerning a 5 year old white female with no allergies or medical conditions who on 14-MAY-2002 was vaccinated SC in the left arm with a first dose of Varivax (lot # 638367/0198M). Concomitant vaccination on the same day included an IM fourth dose in the left arm of HIBTITER (lot # 480-695). Illness at the time of vaccination included allergic rhinitis. On 02-JUN-2006, in the p.m., the patient developed small papular lesions scattered on the abdomen. Some were crusted. The patient was seen at the doctor's office and treated with BENADRYL and AVEENO baths. No diagnostic laboratory tests were performed. The patient recovered on an unspecified date. It was noted that the patient had no adverse events following prior vaccination. Additional information is not expected.
Person experienced itching in the injection site and down the arm.  She was given 5 ml of Benadryl and a cool compress.  Her BP was checked and was normal. approximately 130/80
Patient received Shingrix #1 on 14Dec20, COVID (Pfizer) #1 on 21Dec20, COVID (Pfizer) #2 on 8Jan21, and Zoster #2 on 11Jun21.  Around Feb/Mar, the patient developed pain near his right costal margin near the midline.  No skin disruption, no mass, just pain.  Over the last few months in addition to pain, the patient developed burning and itching.  Symptoms come/go. The patient questions shingles, now post-herpetic neuralgia as a possible complication of vaccinations.
Ascending paralysis & cranial nerve weakness x 5 days. Diagnosed with GUILLAIN-BARRE. Began tx with IVIG x 5 days.
On 7/10 within 24 hours after vaccinations received on 7/9 patient was seen in the ER with fever and seizure.
Information has been received from a farther of a patient, Merck employee, pharmacist, concerning the 12 month old male patient. The reporter stated he was calling in from home, to report his son's adverse reaction to vaccinated with M-M-R II and VARIVAX (Merck). On 09-FEB-2015 at 09:15 (also reported as yesterday) the patient was vaccinated with a dose of M-M-R II (dose, lot# and route were unknown) and a dose of VARIVAX (Merck) (dose, lot# and route were unknown), separate vaccines. The reporter stated the day care sent his son home from school on 10-FEB-2015 (also reported as today at 3:30 this afternoon) because he had a fever of 102.1 F. The reporter stated he was calling his son's primary healthcare provider as soon as this call was finished. No treatment was given for the event. The outcome of event was not recovered. Additional information has been requested.
After vaccine bleeding noted, hard bump and then bruise, hot, sore - 24 hours after ice pack times 15 min. Bruise 1 3/4" X 1 1/2" Bump 1" X 1".
Patient received first dose of pfizer at 12:10pm, at 12:25pm patient reported tingling (from elbow to fingers) that lasted 10 min. Patient said after 10 min, it went away. He left after 30 min of observation
FEVER STARTED FRIDAY NIGHT WOKE UP WITH FEVER AND A SEVERE HEADACHE. BODY SKIN BONES HAIR HURTED. RUNNY NOSE SORE THROAT . VOMITING COULDN'T EAT. SITE OF SHOT WAS RED HOT PAINFUL ITCHY. SIZE OF TENNIS BALL IN ARM WHERE I RECEIVED THE SHOT. FELT LIKE THIS UNTIL SUNDAY MORNING. SUNDAY FELT PRETTY BAD WITH FEVER HEADACHE AND BODY ACHE BUT WAS LESS INTENSIVE. GRADUALLY GETTING BETTER.   * SATURDAY FELT FATIGUE LITURGY COULDN'T MOVE. VOMITING CONSTANTLY.  CHILLS WITH FEVER.  WENT TO DOCTOR 1/24/2022
Became dizzy in shower, felt heart racing and shortness of breath.  Went to urgent care medical office for evaluation, saw cardiologist and neurologist.
Low grade fever the night of the vaccination. Redness, tenderness, and swelling just below the vaccination site began day following vaccination. The redness eased a bit but developed into a hard lump the side of a quails egg in the same location.
I start feeling really bad headache; now I have difficult to breath; I start feeling really bad headache; now I have difficult to breath; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: Not Reported, Expiry Date: Unknown) via an unspecified route of administration on 14Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that the patient took the 1st dose on 14Apr2021, and the patient had the appointment for 2nd dose on Friday but that last Friday (28Apr2021) the patient started feeling really bad headache, then the patient had difficult to breath. Patient stated, ok so I take the 1st dose on 14Apr2021and I have the appointment for my 2nd dose on Friday but this last Friday I start feeling really bad headache, now I have difficult to breath. I took the Covid test that was negative but now I have difficult to breath, so it's okay to do the second dose on Friday or should I wait. The patient underwent lab tests and procedures which included covid-19 that was negative on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
it seemed she was so close to anaphylactic reaction; slight itching; swollen eyes; itchy throat; super red ears; generalized hives; rash; progressive hypersensitivity reaction; anxious; This is a spontaneous report from a non-contactable nurse(patient). An adult female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Jan2021 at single dose for COVID-19 immunization. Medical history included skin asthma with severe eczema and severe allergy when she moved. Day 1 to 7 post-vaccine, there was no reaction, the patient was super fine. The patient remembered that on Day 4, she had slight itching relieved by loratadine (CLARITIN), just like her usual allergy symptoms. From Day 8 to Day 12, she had progressive hypersensitivity reaction that led to her swollen eyes, itchy throat, super red ears and generalized hives. It started as a rash similar to her usual allergy. She ended up going to urgent care by herself since her husband was at work, because it seemed she was so close to anaphylactic reaction (?). At first, loratadine was working but at the time of report, it did not work for the events. She was not admitted because there was no shortness of breath. The patient was on close monitoring for progression of symptoms starting on 22Jan2021. She was anxious and was having second thoughts of getting the second dose of the vaccine. According to her, she had skin asthma with severe eczema, so maybe, the vaccine was not to be recommended to persons with severe allergies like her. She had severe allergies when she moved and was planning to see an allergologist soon. The outcome of slight itching was recovering, of the events were not reported.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: Based on the time association and drug's safety profile, the event anaphylactic reaction is possibly related to suspect vaccine BNT162B2 administration. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Headache, chills,  vomiting, and diarrhea. Diarrhea has now lasted  3 days.