chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of green sputum, common cold and sinus infection has been received from a mother/consumer concerning a five-year-old male, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received a total of two doses before onset of the event with the last dose given in Nov-2009 and first dose was given on 26-Oct-2009. In late Nov-2009, the child experienced clear dry cough every 2-3 mins almost continually with no fever. In Dec-2009, patient went to the physician who diagnosed common cold but no fever and no bacterial infection. In Jan-2010, coughing got worse and sinus infection was diagnosed. The patient received amoxicillin and clavulanate potassium, amoxicillin, mometasone furoate monohydrate and saline nasal drops at different times over four to five months. The patient experienced an increase in cough severity. On 19-May-2010, the patient was taken to the doctor with a cough that produced a green sputum and was prescribed amoxicillin and clavulanate potassium for ten days. The outcome of all reported events was unknown.
Information has been received from a physician concerning a patient who was vaccinated IM with the second 0.5ml dose of PNEUMOVAX. After getting the second dose, the patient arm swelled up like a balloon. At the time of this report, the patient was recovered (date unspecified). This happened some time ago. The patient was seen for medical attention. No further information is available.
The pain in the upper arm, then moves up to the shoulder blade. It is basically all day. I ice the upper arm and shoulder. Feel relief very temporary.
Shot #1, March 17 @ 11:15am. By 9pm same night; chills, shaking, 101 fever,, to bed.  Thursday morning woke up to 102 fever.  In bed all day; fever between 100-101.7.  Friday morning woke up to 102 fever again.  mid day; fever settled.  Friday night; fever back up 101 and chills.  Night sweats.  Woke up Saturday morning.  fever seems to be gone.  Very weak, tired and wobbly.
pt recvd vax;19 days p/ vax devel 15 lesions mostly on torso & leg;md reported that on 12aug95 devel 15-20 intensely pruritic, nickel quarter sized,erythematous maculopapular lesions w/ a papule centrally located in many of them;
The decedent was last seen alive at approximately 0130 when the decedent's next of kin (NOK) heard the decedent walking around the residence. The decedent complained of arm soreness and indigestion; the decedent received a second COVID-19 vaccination (Moderna) on 04/12/2021. The decedent went to the living room to sleep on the couch due to the health and soreness complaints. At approximately 0750, NOK entered the living room and found the decedent unconscious and not breathing.
Patient with a history of Raynaud's Syndrome began complaining of tingling and numbness after receiving her vaccination.
Starting in January 2022 into February 2022, I had a very heavy period. March and April were much less and have not had a period since. I have the Mirena IUD that allows me not to get my period and so it was shocking. I was wondering why this was happening. I?ve had this IUD in for 2 years now. I remember briefly how I got my period last spring as well when I got my first two doses of Moderna. The same thing has happened. That led me to believe that this could be a cause. I am planning to see an OGBYN in August 2022.
Systemic: Bell's Palsy-Severe, Systemic: Exhaustion / Lethargy-Medium, Additional Details: Md called to report incdent .According to the provider patient had reaction to the vaccine she received  , Bells palsy. Md confirmed that he is treating  patient. RPH was able to reach out to patient and discuessed  her concernas well . Patient has Rx filled for tramadol,valtrex and prednisone,from same dr today at the Pharmacy location patient usually goes
The physician is reporting that the patient recieved improperly stored vaccine at an unspecified date; This spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On unknown date, the patient was vaccinated with an improperly dose of recombinant Human albumin Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) one dose, lot number S007075, expiration date 06-SEP-2020 (route of administration was not reported). Administered dose of vaccine experienced the temperature excursion of 32.5 degrees Fahrenheit (°F) for 8 hours. Data logger was involved. There were no previous excursions reported.
This is a spontaneous report from a contactable consumer (research scientist at Pfizer) reporting for her brother-in-law. A 67-year-old male patient received pneumococcal 13-val (manufacturer not provided) via an unspecified route of administration, on 24Feb2016, at single dose. Medical history included rheumatoid arthritis. The patient was taking unspecified medications. Since an unspecified date in Feb2016 the patient arm was inflamed and red and they were trying to get him to the urgent care because it looked like an infection. The reporter mentioned that the arm was red where the shot was given and se had seen the picture and it looked like cellulitis or the beginning of it. No treatment was received. Events outcome was unknown. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj in the reporter's country. This may be a duplicate report in situations were another Marketing Authorization Holder of pneumococcal 13-val con vac has submitted the same report to the regulatory authorities.    This is a spontaneous report from a contactable consumer (research scientist at Pfizer) reporting for her brother-in-law. A 67-year-old male patient received PREVNAR 13 (manufacturer not provided) via an unspecified route of administration, on 24Feb2016, at single dose. Medical history included rheumatoid arthritis. The patient was taking unspecified medications. Since an unspecified date in Feb2016 the patient arm was inflamed and red and they were trying to get him to the urgent care because it looked like an infection. The reporter mentioned that the arm was red where the shot was given and she had seen the picture and it looked like cellulitis or the beginning of it. No treatment was received. Events outcome was unknown. Pfizer is Marketing Authorization Holder of PREVNAR 13 in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of PREVNAR 13 has submitted the same report to the regulatory authorities.
it was rpt fr MD concerning a pt who was vax & subsequently exp a diffuse rash, described as papular w/pustules.
Normal soreness of deltoid muscle after IM injection, but several days later red blotch rash developed just below injection site last thru to report date of 9/18/15. Aprox. size 3 inches by 4 inches.
Took a fall and broke her hip; Took a fall and broke her hip; This spontaneous case was reported by a consumer and describes the occurrence of HIP FRACTURE (Took a fall and broke her hip) in a female patient of an unknown age 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HIP FRACTURE (Took a fall and broke her hip) (seriousness criteria hospitalization and medically significant) and FALL (Took a fall and broke her hip). At the time of the report, HIP FRACTURE (Took a fall and broke her hip) and FALL (Took a fall and broke her hip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded but is unlikely according to the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded but is unlikely according to the reporter.
1APR97 10AM change from usual behavior was staring into space;pt full time breast feeding;ate breakfast;12noon lunch;12:30 staring off & 5min later vomiting x 3, quiet-not usual self;
Injection site is quite red and swollen and painful.  It is hard to elevate my arm.
achiness of her joints and muscles; Her arm was also sore; low grade fever; tired and so forth; headache; achiness of her joints and muscles; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st), for Covid-19 immunization, reaction(s): "Tired", "sore arm". The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "low grade fever"; MYALGIA (non-serious), ARTHRALGIA (non-serious), outcome "recovered" and all described as "achiness of her joints and muscles"; FATIGUE (non-serious), outcome "recovered", described as "tired and so forth"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Her arm was also sore"; HEADACHE (non-serious), outcome "recovered", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, myalgia, arthralgia, fatigue, pain in extremity, headache.  Additional information:The next day Patient had a low grade fever with achiness of joints and muscles. Patient was unsure which of the 2 may have been sore. Patient also was tired and so forth.Arm was also sore. Patient states it seems that after booster dose having very similar symptoms was hoping the immune system is working as strongly as it was working before hand. After 1st vaccine the caller notes having a sore arm and not much else, maybe tired. The 2nd vaccine hit much harder, sore for several days, headache that night and low grade fevers. Patient had not taken any medication due to side effects and noted that coffee worked. Patient reports having achiness for several days after the vaccine, also notes that sore arm was not as bad as the first injection and last night arm was very sore.They had been so careful for 1.5 years and just hearing about breakthrough cases.Patient is hoping that the vaccine is working as efficiently as expected despite taking 2 Advil prior to the injection for a headache Patient was developing prior to the vaccine administration. Patient did not take Advil before her 1st and second doses and she is having similar reaction this time around as she was after her 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nausea,  vomiting x 14 hours, dizzy, muscle and joint pain,  fever, headache,  insomnia
Rash at site of injection that started 13 days after vaccination- still present 4 or 5 days after starting
pt recvd vax & states screamed for 4 hrs p/vax; pt recovered & parents did not call but they stated they did not want any further pertussis;
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 25-JAN-2017, the patient was vaccinated with GARDASIL 1st dose (route of administration, lot# and expiration date were not provided). On 25-FEB-2017, the patient received GARDASIL 9 2nd dose, lot# L038917, expiration date: 20-FEB-2018 (route of administration was not provided). On 03-OCT-2017, the patient returned to the office for GARDASIL 9 3rd dose, lot# L038917, expiration date: 20-FEB-2018 (route of administration was not provided). No adverse effects were reported.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2022 at 10:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Mar-2022 at 10:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') 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.   The patient received vaccine past its 30 day expiry date on 13-MAR-2022 at 10:30:20 AM, booster dose. Vaccine went into 2 to 8 degree Celsius thaw state on about 24-Dec-2021. The vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.  No treatment information was provided.   This case was linked to MOD-2022-542869 (Patient Link).
Patient is 13 years old and was administered Pfizer 5-11 y/o vaccine
ITCHING AT SITE OF INJECTION LASTING 26 DAYS AND CONTINUING STILL
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Apr-2021, VACCINATION SITE PAIN (sore arm) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment included ice.
Started with headache at 1200 on 5/21/19.  Went to school nurse.  Had temp of 100.6 and slight redness around site of pneumococcal 23 injection on right deltoid.  Early am of 5/22/19 pt had temp of 101.   Saw in office at 1200.  Induration on right deltoid was 6 x 8.5 cm.  Temp was 101.2
Medical Imaging Associate - Received vaccine on 12/18/20 @ 0845hrs. Associate has developed neck/arm soreness, chills, and hives/welts on her face, neck, back, and thighs. The associate is taking Benadryl and self-monitoring her symptoms currently from home. The associate was instructed to seek medical attention if symptoms worsen.
Light headed after 1 hour, lasted for 7 days Body aches after 4 hours, lasted for about 3 days Chills after 7-8 hours, lasted for 1-2 days Fever after 8 hours, lasted about 24 hours  Joint pain after 8-9 hours, lasted about 2 days  Severe fatigue after 8-9 hours, lasted about 2-4 days  These symptoms occurred after first dose injection as well as the second dose injection.
Headache, Myalgia, Arthralgia, NauseaVomiting, Fatigue/Chills/Swollen Glands Narrative:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 at 16:00 as dose 2, single (Lot number: En6203) at the age of 76 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not have any other medication in 2 weeks. The patient did not have known allergies. The patient started Paxlovid treatment from 29Sep2022 to 30Sep2022 for covid-19.
Upon Disease Investigation 8/19/21 - case reported symptom onset of 8/12/21 which included fever, runny nose, headache, fatigue, cough and nausea.
DTaP-HiB Combo given before 15 months of age.  No side effects reported.
Received only1 vaccination 4 years ago; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received a dose of shingles vaccination 4 years ago from reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-OCT-2022 Reporter's Comment: This case was received from the patient via interactive digital media. The patient received only one vaccination over 4 years ago. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of shingles vaccine, which led to incomplete course of vaccination. The case had been linked to US2022AMR144727, reported by the same reporter, for different patients. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR144727:Same reporter
Swelling with warmth to injection site.  Upper left arm swelled about 5 cm noticed 24 hours after injection of varicella.
I can't eat anything; I feel like I'm going to throw-up; tired all day; pain in my arm; bloody stool/ blood in my stool; felt the left side back bone like an electric shock around my kidney; I didn't feel good; felt uncomfortable; could not sleep; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 13Mar2021 at 18:45 (batch/lot number: ep7534) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated he took the vaccine on Saturday first dose, 13Mar2021 at 6:45 pm. At 8:30 pm when he was home, he felt the left side back bone like an electric shock around his kidney. At night time, he didn't feel good, felt uncomfortable and could not sleep. On Sunday (14Mar2021), he was tired all day and had pain in his arm. Also had bloody stool and then last night again around 12:30 am, he had blood in his stool. He can't eat anything, he felt like he was going to throw-up. He was scared, he doesn't have a family doctor. He asked if Pfizer provides help with primary care for health situations. The outcome of the events was unknown.
Several (5-6) bumps (shingle like) in small area surrounding injection site- Very itchy (continues 4 days later). Does not feel well- no fever no appetite.
Intermittent Dizziness started within 24 hours.  has continued for 6 days.  Dizziness initially lasted several hours regardless of position (prone, seated, standing) and transition to different positions.  By day 4-5, it was 3-4 hours and worse in the morning.  By day 6, it is getting less severe.
covid symptoms 11/23/21 incl abdominal pain and diarrhea, altered mental status
Gross hematuria x 5 days fatigue continues still at this point acute renal insufficiency, proteinuria + ANA  2/18/21 pt has not gotten a second dose and is not going to He is not back to 100%
I felt very fatigued, low energy. I was coughing and sneezing a lot. The worst part was the no energy. This lasted for about 1 week. I started to get better so I went to work after a week. Light housekeeping and walking would send me to shortness of breath and raised heartrate. Over time, this got a little better for me.
Patient with new diagnosis SCC of right tonsil, presenting to emergency center 2 days following vaccination for dehydration and uncontrolled pain. Recent radiation to neck. Patient discharged from emergency center.
Started feeling flu symptoms, fever and achy. Took home COVID-19 test and was negative. Two days later tested positive with home test. Called Dr. and got a prescription for PAXLOVID.
My blood platelets count dropped to 19 from 140 in Apr2021; dose number: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Oct2021 09:30 (Lot number: FF2687) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 01Oct2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "Heart bypass" (unspecified if ongoing); "colon cancer" (unspecified if ongoing); "Gall bladder removed" (unspecified if ongoing). No known allergy. No covid prior vaccination. Concomitant medication(s) included: TOPROL; LISINOPRIL. Vaccination history included: Bnt162b2 (Dose Number: 1,Batch/Lot No: PFREL3246, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 09Jan2021, when the patient was 79 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9262, Location of injection: Arm Left, Vaccine Administration Time: 12:00 AM), administration date: 01Feb2021, when the patient was 79 years old, for Covid-19 immunization. No other vaccine in four weeks. The following information was reported: IMMUNISATION (life threatening) with onset 01Oct2021 09:30, outcome "unknown", described as "dose number: 3"; PLATELET COUNT DECREASED (life threatening) with onset 10Nov2021, outcome "unknown", described as "My blood platelets count dropped to 19 from 140 in Apr2021". The event "my blood platelets count dropped to 19 from 140 in apr2021" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (unspecified date) unknown results; platelet count: (Apr2021) 140; (10Nov2021) dropped to 19. No covid tested post vaccination. Therapeutic measures were taken as a result of platelet count decreased including Prednisone and MRI.