chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient got COVID before receiving her 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Patient got COVID before receiving her 2nd dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced COVID-19 (Patient got COVID before receiving her 2nd dose). At the time of the report, COVID-19 (Patient got COVID before receiving her 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment information was provided. Reporter stated that the patient's isolation period will end on Saturday. CC: This spontaneous case concerns a 73-year-old female patient with no medical history experience the Unexpected AESI event Covid-19 in association with mRNA-1273. The event occurred 26 days after the first dose of mRNA-1273. The patient was tested positive for SARS-Cov-2 infection. Details of treatment, follow-up, outcome were not reported. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 73-year-old female patient with no medical history experience the Unexpected AESI event Covid-19 in association with mRNA-1273. The event occurred 26 days after the first dose of mRNA-1273. The patient was tested positive for SARS-Cov-2 infection. Details of treatment, follow-up, outcome were not reported. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
The FLUZONE vaccine was injected into the high deltoid muscle of my left arm, while I was seated at the request of the intern who remained standing. It felt like the needle passed through two different densities of tissue, an odd and different sensation from any previous vaccination. Also unlike any previous flu shot, pain and soreness were immediate. The following morning, my left arm was very sore, stiff and hard to move. There was no redness, no swelling, and no apparent change in the appearance of the shoulder. After three months of no improvement with heat, ice, a prescription muscle relaxant (that the pharmacist requested from my family doctor) and a variety of NSAIDS, I made an appointment with a shoulder specialists at orthopedic clinic that led to an X-ray (negative), a cortisone shot, an MRI (full-thickness tear in the rotator cuff), and physical therapy sessions. None of the treatments were helpful for long, and the shoulder has continued to become weaker, less mobile, and remains painful. Surgery is planned for early January, 2015.
Information has been received from a licensed practical nurse and the patient's mother for GARDASIL, a Pregnancy Registry product, concerning a 14 year old female patient with no pertinent medical history or drug reactions/allergies who at the "sometime in the beginning of the year" was vaccinated with the first dose of GARDASIL. On 30-JUN-2011, the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL (Lot # 666596/0766Z) into her left arm. There were no concomitant medications. Subsequently, on 06-JUL-2011, the patient found out that she was "almost 8 weeks pregnant". No adverse effect was reported. Follow-up information of prospective pregnancy report was received from licensed practical nurse. The patient's history of previous pregnancies and live births is not known. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient's estimated delivery date (EDD) was on 20-FEB-12 and based on that the last menstrual period (LMP) was calculated as of 16-MAY-2011. The patient was exposed to GARDASIL during the first and second and third trimester. It was reported that on 06-FEB-12, the patient delivered a male infant via vaginal delivery without complications. The infant's APGAR scores are not available. Upon delivery, the infant was noted to be a normal, healthy newborn. The infant weight 7lbs and 8 oz, length 20 inches. No congenital anomalies reported. Additional information is not expected.
P/3 vax pt seroconverted but did not attain protective titers bet DEC 90 & JAN 91 hospitalized for total 18 days; Ligation & stripping of varicose veins; skin grafts to stasis ulcer; was re-hospitalized for embolus; on bedrest;
Tingling in legs, muscle ache and stiffness, fever, left upper arm around injection site for pneumococcal 23 was swollen, 3 inch red raised rash developed, skin was warm, and infection developed. Cephalexin 500 mg twice a day prescribed for 7 days.
epilepsy; cognitive problems/cognitive and memory problems; memory problems/cognitive and memory problems; occasional visual disturbances; reduced physical stamina; Fatigue; headaches; Other symptoms; This spontaneous report was received as an online article via company representative refers to a female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. It was also reported that the patient was a fit and healthy teenager previously. On an unknown date the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (strength, dose, frequency, route, lot# and expiry date were not provided) for prophylaxis. On an unknown date within weeks of second dose of vaccine, the patient developed epilepsy. She had cognitive and memory problems (cognitive disorder; memory impairment), reduced physical stamina (asthenia), fatigue, headaches (headache), occasional visual disturbances (visual impairment) and other symptoms (adverse event). The patient's mother told that the conditions were debilitating. The studying, writing, and recalling facts all suddenly had become difficult. The patient's mother found that dealing with patient's bi­monthly seizures had curtailed her independence and her social life dramatically. As a family they had to alter their lives to make sure the patient was never alone and to get her to the medical appointments. Currently the patient was coping with life at university and managing her studies with support. The patient's mother was angry and frustrated with the fact that there were no investigations and the sadness about what had happened was always on their minds. Four years later the epilepsy was still uncontrolled. The outcome of events cognitive disorder, memory impairment, asthenia, fatigue, headache, visual impairment and adverse event was unknown. The causality assessment was not provided by the reporter.  Upon internal review, the event epilepsy was determined to be serious (medically significant).  This is one of the multiple reports received from the same reporter.; Sender's Comments:  1906CAN005269:
Symptoms of yeast rash seemed to have spread all over, not only diaper area, but face also. Took her to the ER. They said she was allergic to the Nyzoral cream. Gave Zyrtec and Nystatin. Two days later on Monday the 15th of August, the rash had exploded all over her body. Took her back to the ER and they said it was a reaction to the MMR vaccine. No fever, or other cold like symptoms, just the rash. Doctor said it was classic Rubella markings.
24 hours post vax, the pt felt as though she had the flu, her left arm had some swelling and by 3:30 pm the arm was red and swollen to elbow and felt like it was going to fall off. She experienced hard chill, high fever, no appetite which lasted 3 days. She took Tylenol.
9/16- left arm sore and a little red, tired and stomach upset.  very painful 9/17-left arm really sore and swollen and red, very tired and very achy and had stomach upset.  Running a 101 degree temp.  Face Flushed and arm was very painful.  had to use ice on arm and head. 9/18- left arm very red and very swollen, very tired and achy/ slight fever 99 upset stomach.  very painful 9/19-left arm still red in spots and still painful, not as tired, slight upset stomach.  no fever today
Had shots on 9/15/02 was fine x 2d. On 9/17/02 left arm where DTaP given became reddened, itchy and warm to touch. Mom phoned us late afternoon told to ice pack it and give Benadryl. Called us again and stated it was somewhat better, no fever, no drainage, no spread of redness. On 9/20/02 I called them-mom reported the redness, itching was coming and going at time the area looks normal. Told to continue Benadryl and cool packs.
Site of injection has hard blister that is red in color; She mumbled they probably injected her with the wrong stuff that could kill her; Site of injection has hard blister that is red in color; Site of injection looks like puff pocket; Site of injection is hard; Site of injection had a little bump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Site of injection is hard), INJECTION SITE SWELLING (Site of injection had a little bump), INJECTION SITE VESICLES (Site of injection has hard blister that is red in color), ABNORMAL BEHAVIOUR (She mumbled they probably injected her with the wrong stuff that could kill her) and INJECTION SITE ERYTHEMA (Site of injection has hard blister that is red in color) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced INJECTION SITE SWELLING (Site of injection had a little bump). On 24-Apr-2021, the patient experienced VACCINATION SITE INDURATION (Site of injection is hard), INJECTION SITE VESICLES (Site of injection has hard blister that is red in color), ABNORMAL BEHAVIOUR (She mumbled they probably injected her with the wrong stuff that could kill her), INJECTION SITE ERYTHEMA (Site of injection has hard blister that is red in color) and INJECTION SITE SWELLING (Site of injection looks like puff pocket). At the time of the report, VACCINATION SITE INDURATION (Site of injection is hard), INJECTION SITE SWELLING (Site of injection had a little bump), INJECTION SITE VESICLES (Site of injection has hard blister that is red in color), ABNORMAL BEHAVIOUR (She mumbled they probably injected her with the wrong stuff that could kill her), INJECTION SITE ERYTHEMA (Site of injection has hard blister that is red in color) and INJECTION SITE SWELLING (Site of injection looks like puff pocket) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt died of suspected SIDS-pt had underlying severe hydrocephalus & chiari malformation was in good baseline hlth was found in prone position pt had very poor tone & head control at baseline;
SEVERE SWELLING REDNESS AND PAIN AT INJECTION SITE AND IRRITABILITY.
Information has been received from a physician concerning his wife who in 1996 was vaccinated with 2 doses of varicella virus vaccine live.  Subsequently, the patient failed to seroconvert.  The patient was re-vaccinated with 2 more doses of varicella virus vaccine live and again showed no immunity.  A product quality complaint was not involved.  Unspecified medical attention was sought.  Additional information has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021 at 9:02 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Feb-2021 at 9:02 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 51.35 No concomitant medications were reported. On 27-Feb-2021 at 09:00 A.M., the temperature recorded was 33 degree Fahrenheit, at 11:00 A.M., the temperature recorded was 35 degree Fahrenheit, At 12:00 P.M., the temperature recorded was 35 degree Fahrenheit, at 01:00  P.M., the temperature recorded was 35 degree Fahrenheit, at 02:00 P.M., the temperature recorded was 35 degree Fahrenheit, at 03:00 P.M., the temperature recorded was 34 degree Fahrenheit, at 04:00 P.M., the temperature recorded was 34 degree Fahrenheit, at 05:00 P.M., the temperature recorded was 35 degree Fahrenheit and respectively the vial was moved to the fridge 24-Feb-2021 and beyond use date was 26-Mar-2021 Product moved to clinic on 27-Feb-2021.  Vial was stored on cooler 1, on 27-Feb-2021, Excursion duration At 9 AM: 33, 10 AM: 36, 11 AM: 35, 12 AM: 35, 1PM: 35, 2 PM : 35, 3 PM: 34, 4 PM: 34 and 5 PM : 35.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.
There is redness and warmness with no itchiness or pain on both arms in upper parts at the location of injection of prevnar and Kinrix. Patient is in his regular appetite and activity. Hydroxyzine oral for 3-4 days. Outcome is unknown and will follow up.
SEIZURE LIKE EVENT; This spontaneous report received from a health care professional concerned 3 male patients of unspecified age.   No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that, on an unspecified date, three patients experienced seizure like event after vaccination (within 21 days prior to this report). It was also reported that, the seizures happened without any type of warning and were dangerous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizure like event was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210627629.; Sender's Comments: V0: 20210632989-covid-19 vaccine ad26.cov2.s-seizure like event. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
a massive migraine; sweats; every bone in my body ached, like I got hit by Mack truck; body aches; I have a lymph node on my right collarbone that looks like a goiter; This spontaneous case was reported by an other health care professional and describes the occurrence of MIGRAINE (a massive migraine), HYPERHIDROSIS (sweats), BONE PAIN (every bone in my body ached, like I got hit by Mack truck), MYALGIA (body aches) and LYMPHADENOPATHY (I have a lymph node on my right collarbone that looks like a goiter) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced MIGRAINE (a massive migraine), HYPERHIDROSIS (sweats), BONE PAIN (every bone in my body ached, like I got hit by Mack truck), MYALGIA (body aches) and LYMPHADENOPATHY (I have a lymph node on my right collarbone that looks like a goiter). At the time of the report, MIGRAINE (a massive migraine), HYPERHIDROSIS (sweats), BONE PAIN (every bone in my body ached, like I got hit by Mack truck), MYALGIA (body aches) and LYMPHADENOPATHY (I have a lymph node on my right collarbone that looks like a goiter) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment information was provided.
Heart surgery and repeat respiratory infection; Heart surgery and repeat respiratory infection; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), RESPIRATORY TRACT INFECTION (non-serious), outcome "unknown" and all described as "Heart surgery and repeat respiratory infection". Therapeutic measures were taken as a result of cardiac disorder. Additional information: Reporter states a patient had heart surgery and a repeat respiratory infection after getting both doses of the Pfizer Covid vaccine, patient is scheduled for booster tomorrow, caller would like to know if it is okay for the patient to take the booster shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Complaints of severe shortness of breath, headache, body aches, fatigue, fever that started 1 day after getting Pfizer booster.  HR increased from 80 bpm to 130 bpm with walking a short distance and O2 sat dropped from 98% to 90%.
I was treated nice & had no symptoms from the first shot. The second shot, my arm was sore for a couple of days.
he got pretty sick after his 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (he got pretty sick after his 1st dose) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (he got pretty sick after his 1st dose). At the time of the report, ILLNESS (he got pretty sick after his 1st dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant and treatment medication was provided.   This case was linked to MOD-2022-465036 (Patient Link).
After receiving the shot at noon, I began to feel shortness of breath and chest pain by evening, and by night time, I was experiencing fever. I was shivering and sweating at the same time in my bed that night. The following day (today) the shortness of breath and chest pain are still present, although less intense.
mom noticed that around 5PM Friday evening pt rt leg was very swollen & extremely red;mom said child was very hot but did not take temp;did give APAP q 4hr;mom applied cold cloths through noc;also called MD & told to cont cold cloths & APAP
Vaccine given morning of 6/12/17. Pt states she developed redness/swelling in (L) arm from shoulder to elbow. She came to office on 6/13/17.
Site: Bruising at Injection Site-Mild, Additional Details: She notice bruise on hand. Not sure if from vaccine
Headache, Myalgia, Arthralgia, Fever, Chills Narrative:   Other Relevant History:
Waited the 10 min as the Dr requested. Go out to car and immediately get a headache, dizziness, and stomach cramps. Go into severe bowel and stomach problems losing all fluids from my body over the next 24 hours. Get up the next day so weak can not function. Go to the hospital where they infuse me with IV to bring my fluid level back up. Five days later and still having problems but drinking tons of water to try and bring myself back.
loss of appetite; weakness; dizziness; the whole body was aching so bad that wanted to cry; severe head ache; nausea; woke up with slight fever; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), ASTHENIA (weakness), DIZZINESS (dizziness), MYALGIA (the whole body was aching so bad that wanted to cry) and HEADACHE (severe head ache) in a 68-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.     The patient's past medical history included COVID-19 on 13-Nov-2020. Concurrent medical conditions included COPD and Hypertension.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced DECREASED APPETITE (loss of appetite), ASTHENIA (weakness), DIZZINESS (dizziness), MYALGIA (the whole body was aching so bad that wanted to cry), HEADACHE (severe head ache), NAUSEA (nausea) and PYREXIA (woke up with slight fever). At the time of the report, DECREASED APPETITE (loss of appetite), ASTHENIA (weakness), DIZZINESS (dizziness), MYALGIA (the whole body was aching so bad that wanted to cry), HEADACHE (severe head ache), NAUSEA (nausea) and PYREXIA (woke up with slight fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased heart beats per minute (High) Heart rate increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.
Fever of 102.6 for around 8 hours Body aches severe headache injection site pain fatigue
It was reported that a 29 year old female pt received a TD Adult vaccination on 08/23/2000. Reportedly on 08/25/2000, the pt developed redness, warmth, swelling and an induration of 7cm x 10cm at the injection site. Reportedly the pt recovered from this experience. From additional info received on 12/01/2000, pt identifier information was updated.