chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A serious report of respiratory distress and wheezing was received from a physician concerning a seven-year-old male. The patient had a history of allergic rhinitis but did not have a history of wheezing or asthma. Concomitant medications include Zyrtec and Flonase nasal spray, both taken once a day for allergic rhinitis since Aug 2007. The patient received FluMist on 16-Oct-2007. On 18-Oct-2007, the patient presented to the reporting physician's office complaining of respiratory distress and wheezing, which started on 17-Oct-2007. The patient's chest x-ray was normal. Per the reporter, the patient "cleared" with Xopenex but returned later in the day with increased distress. The patient was admitted to the hospital for 24 hours and was discharged on oral steroids and Xopenex treatments. The patient recovered from the wheezing. No outcome was provided for the event of respiratory distress. The discharge summary has not been received. Rechallenge is not applicable. The reporter did not provide an assessment of causality for the events. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
4/8/21, all day: Headache (Migraine) Grade 3 acetaminophen did not help. 4/8/21, all day:  Anthralgia Grade 3, acetaminophen helped but not much. All major joints hurt to the point where I could barely get out of bed. Most painful ones were hips and lower back. Skin at painful joints was redder and much hotter than adjacent skin but I did not have a fever.  4/8/21, all day: Myalgia, right arm around injection site.  4/9/21, all day: nausea, mild anthralgia, and mild myalgia around injection site.
Numbness and tingling around mouth. Benadryl 25mg given at 1054am  v/s at 1058am 145/82 p 74 r18 96% v/s 131/71 68 16 97% numbness and tingling resolved at 1122am
The day after the first vaccine I briefly passed out in my shower. When I came to, I heaved and almost vomited. I then began having bouts of diarrhea. Later in the day I had a fever.  I continued to have bouts of dizziness for months. The bouts of diarrhea continued to this day. I received the second vaccine. I had a fever the next day and as before, continued to have daily diarrhea that I had never experienced prior to the first vaccine.  After the third vaccine, I had a fever the next day and I had a lump under my left armpit the size of an orange for approximately 7 days. I continuted this whole time to have worsening diarrhea and right sided deep burning abdominal pain. I went from having migraines a few times a year to 2-3 per week.  The diarrhea and pain have persisted and are daily since the vaccine. I have to work from home and can rarely leave my home due to how sick I now get. I am sometimes bedridden from how sick I get now. I cannot go to holidays, family events or my son's school events due to how much my health has affected me.
6 days p/vax pt exp severe muscle & joint pain w/h/a; progressed to fatigue & depression; currently cont to have joint difficulties in lt shoulder; MD felt serum sickness & to take APAP;
PNEUMOVAX was suggested to me as I developed pneumonia twice this summer. The subcutaneous injection was administered on Tuesday October 9th at approximately 5pm. Note, the nurse administering the injection did not clean the area prior to administration - this potentially could have caused the reaction. By late in the evening I was experiencing minor pain at the site of administration; which is expected with any vaccination. After 24 hours a rash had developed around the site, same rash was approximately 2 inches by two inches in size. After 72 hours the rash had covered the majority of the deltoid area, extending to the elbow. I was unable to move the arm due to pain, and became febrile. I was seen multiple times in emergc as Doctors believed it was an allergic reaction and chose to initially treat it with BENDARYL. After 24 hours of BENADRYL - with no improvement, in fact, the rash had spread further and had started to raise in different areas, appeared to bubble, doctors decided to try oral KEFLEX. After three doses of this antibiotic, the rash continued to spread and my fever remained high, I was then put on IV Cefazolin and remained on this for 4 days. During this time I was in and out of the hospital and seen by a home care nurse. After 4 days of this medication the IV was discontinued. I am currently, again on oral KEFLEX. The site appearance and pain continues to improve. Please note: I was unable to continue to the next screen in this questionnaire without selecting every option in the questions above. To clarify and provide the proper responses: 1. Adverse Event, Product Use Error. 2. Hospitalization- initial or prolonged.
She was tired; Weakness; Whole body aches; This is a spontaneous report from a contactable consumer (patient's mother). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller stated she was calling regarding the Pfizer Covid 19 shot and stated that she was calling about her daughter and that she was tired, had weakness and whole-body aches on an unspecified date. Outcome of the events was unknown.  Information about lot/batch number has been requested.
This case was reported by a healthcare professional and described a 4 year old subject of unspecified gender who experienced redness at the injection site subsequent to receiving Infanrix. Initially the nurse reported "many of their 4 year old pt's, however, no pt identifiers were provided. On an unspecified date, the subject received an injection of Infanrix (dose and lot numbers not specified). At an unspecified time after administration of Infanrix, the subject experienced redness at the injection site. At the time of reporting, on 8/12/05, the outcome of the event was unknown.
chills; headache; fever; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number and Expiry date: unknown) (age at the time of vaccination was 50 years), via unspecified route on an unknown date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown)  (age at the time of vaccination was 50 years), via an unspecified route of administration, on an unknown date as dose 1, single for COVID-19 immunization. On an unknown date, after receiving the second dose of the Pfizer COVID-19 vaccine. That night, the patient experienced chills, fever, and headache through the night. The patient got gradually better the next day.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
After receiving a second Pfizer BioNTech Booster I had these side effects: non-stop coughing for 2+ weeks, 3 consecutive days of severe migraine (10's on a 1 to 10 scale), 5 severe migraines in that first week, sore throat, weakness, 3-4 hr naps for 2+ weeks due to heavy tiredness. Lack of mental focus - foggy. Blurry vision In my 75 years I have never had a side effect from a vaccination. Two subsequent Covid tests were negative.
Very sore arm (which I had the 1st dose) but also became warm to touch, headache and body aches, nausea, shivers, extremely tired. I, at first, thought it was just coincidence and I was coming down with the flu. I had to leave work early and then missed the next day as well. I have had little relief taking TYLENOL or ADVIL. It is now evening (1/17/19) - I feel a little better but still achy. Arm remains very sore and warm to touch - ice has helped a little bit.
Starting in the evening of 9/26/23 all over body aches, worsening headache; 9/27/23 Slight sore throat and sinus congestion; 9/28/23 laryngitis.  Patient also listed more symptoms:  cough, swelling of lower legs and feet, lightheadedness and also a rash on the front of both thighs.
patient reported not feeling well ~ 2 hours after administration and reported feeling dizzy and having chest pain like something was sitting on his chest.
pt was given 0.2ml of pediatric pfizer vaccine but should have received 0.3 adult pfizer vaccine pt did not have any adverse reactions
Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------  PULMONARY EMBOLISM, UNSPECIFIED. 10/23/2021 CHRONIC ANEMIA
since shingrix, has had 4 outbreaks of shingles/ Suspected vaccination failure; shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 16th October 2020, the patient received the 2nd dose of Shingrix .5 ml. On 11th July 2020, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 13-JUN-2022 Reporter's Comment: The patient self-reported this case. The patient stated that since she had gotten her Shingrix vaccine, she had about 4 outbreaks of shingles. The patient's outbreaks lasted about 10 days to 2 weeks. The patient did not currently had shingles.  The patient did not have any further information about the lot number and expiration date of vaccine. The reporter did not consent to follow-up. Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding the laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Caller is the patient stating that since she has gotten her shingrix vaccine, she has had about 4 outbreaks of shingles.  She states that her outbreaks last about 10 days to 2 weeks. She doesn't currently have shingles.  She doesn't have any further information about the vaccine; i.e. lot # or expiration. Did not consent to follow-up. Call Notes:No HCP for follow up
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 31-DEC-2018, the patient was not able to received first dose of GARDASIL 9 due to  particulates being noted with lot# N001533 with expiration date on 16-OCT-2019 after the vial was agitated for prophylaxis (product quality issue). However, no adverse effects were reported. The causal relationship and the outcome of the event product quality issue was not reported.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (with a horrible shooting pain down her right side that starts at the hip & goes down to the ankle) and VACCINATION SITE ERYTHEMA (after her 2nd dose that she described as a big red square at the injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN (with a horrible shooting pain down her right side that starts at the hip & goes down to the ankle). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (after her 2nd dose that she described as a big red square at the injection site). In 2021, PAIN (with a horrible shooting pain down her right side that starts at the hip & goes down to the ankle) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (after her 2nd dose that she described as a big red square at the injection site) had resolved. Patient reported her experience after receiving 2nd dose of the Moderna Covid-19 Vaccine all in the left arm. She said she woke up with a horrible shooting pain down her right side that started at the hip & goes down to the ankle. She said that the same thing happened last year after her 2nd dose, it lasted for about a month, & got better after she went to a walk-in orthopedic clinic & got a steroid injection. She said that she also had Covid arm after her 2nd dose that she described as a big red square at the injection site, and said that she did not had that now. No concomitant medications details were reported. This case was linked to MOD-2022-525987 (Patient Link).
Severe back pain in spine - the ordeal of 2 surgeries recently I have walked in the hills of mountains and here - 1.0 hour without any pain. The following morning since the flu shot I have been in serious pain - hardly able to walk at all!
Information has been received from a nurse practitioner concerning a female with a history of tension headache who was vaccinated with the third 0.5ml dose of GARDASIL. After receiving her third dose, on approximately 16-MAR-2009, "last week", the patient experienced tension headache. The patient recovered from tension headache "last week". The patient sought unspecified medical attention. No further information is available.
Fever staying between 103-104. Tylenol and Motrin and baths bring fever down some. Hearing voices with high fever, loss of appetite and lying around, tired, nausea, headache. Arm (right) swollen , red, hot below shot site. Right arm stiff to move.
Within 2 hours very sore arm  at injection site and muscle. 10hrs later started with chills, 101.7 fever through the night, slept thru it with no meds, woke up with fever. Gone by 10 am, achy muscles  over whole body all day til 6 pm. Didn?t go to work.
Woke up with bright red rash - around entire torso between boobs and hip bones.  Rash continued the entire day on 4/22/2021.  On 4/23, rash was much lighter but very itchy.  On 4/24, rash was very light but very itchy.
Started with a fever. It followed with a rash that started at the injection site has spread from the legs to the arms to the head.
Hives on both arms upper torso Benadryl every 4 hours is planned
Information has been received from a medical assistant to multiple, unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (strength, frequency and route not reported, lot # M004116 and Expiration date 12-OCT-2017). The vaccines were exposed to 11.7 degree Celsius for 84 minutes. There was no previous temperature excursion. The temperature was back in range. No adverse effects were reported. This one of several reports received from the same reporter. Additional information has been requested.
The patient was given a Moderna vaccine that was left out of the fridge over night (longer than 12 hours). There were no adverse events encountered.
2/2/21, over all body aches, felt lousy, low grade fever 2/3/21, fever of 102.7, severe body aches, severe headache 2/4/21, fever of 102, continued body aches, headache 2/5/21, fever of 100, body sore and exhausted
Pt states feeling anxious prior to vaccine & has history of fainting after blood draws.  Nurse saw her faint, diaphoretic lasting several seconds.  Taken to Observation Area to cot x 40 minutes.   Drinking juice, bottled water & ate crackers.    Left without assistance.
Area was discolored and painful. Patient reported to doctor and he recommended warm compress and ADVIL - ached for 3 days - then severe pain.
Painful half dollar size warm red lump. Lump is both below and on top of skin.
Is diarrhea part of any symptoms from having the shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Is diarrhea part of any symptoms from having the shot) in a patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Is diarrhea part of any symptoms from having the shot). At the time of the report, DIARRHOEA (Is diarrhea part of any symptoms from having the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information were provided. No treatment information were provided.
Pt. developed a red, maculopapular rash with few vesicles throughout face, chest, back & extremities.
Both breasts were swollen; Both breasts were swollen, and very sensitive to the touch; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in left arm on an unknown date (at the age of 41-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in left arm on 25May2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications were not reported.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID 19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18May2021, the patient had experienced both breasts were swollen and very sensitive to the touch. The patient had also reported that she experienced the event 2 weeks after receiving both shots. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported adverse events. The clinical outcome of the events, both breasts were swollen and very sensitive to the touch was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
today feels out of it; can't remember/recall things; This is a spontaneous report from a Pfizer Sponsored Program. A contactable other health care professional and a contactable male consumer (patient) reported that a 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 18Mar2021 (at the age of 49-years-old) (Batch/Lot number was not reported) as 2nd dose, single dose for COVID-19 immunisation; tofacitinib citrate (XELJANZ XR 11mg strength), oral from 04Mar2021, at 11 mg, daily for rheumatoid arthritis.  The patient's medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 on unspecified date for COVID-19 immunisation. The patient reported no missed doses.  On 18Mar2021, after start of therapy receiving his second coronavirus vaccine, the patient reported that he feels out of it and can't remember/recall things.The action taken in response to the events for tofacitinib citrate was dose not changed. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
-FATIGUE, CHILLS, BODY ACHES, HEADACHE, INJECTION SITE SORENESS -FIRST 2 COVID VACCINE DOSES WERE PFIZER (HAD SIMILAR REACTION TO FIRST DOSE OF PFIZER BUT THAT LASTED SEVERAL DAYS)
muscle aches; flu like symptoms; head cold; couldn't sleep the entire night; nausea; stiff neck; joints ache; bone ache; Lot of pain; Weakness; Felt sluggish; Felt like I was going to pass out; headache; neck pain; had hot flashes; chills; she couldn't keep her eyes open; she couldn't focus; lethargic; tired; she turned white like a sheet of paper; everything rushed to her head and she felt lightheaded; moist to the touch/I was wet to touch, I do not sweat that often but I was like moist, my skin was moist; This is a spontaneous report from a contactable other healthcare professional (patient) via medical information team. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EL9266, expiration date was not reported) via an unspecified route of administration, on 28Feb202111:15 (at the age of 70-years-old) a dose 1, single for covid-19 immunization. Medical history included lupus, arthritis, allergic to eggs, cannot eat a lot and allergic to wheat, nuts, and penicillin. There were no concomitant medications. The patient turned white like a sheet of paper; she laid down for 30 minutes instead of the normal 15 minutes, everything rushed to her head and she felt lightheaded, moist to the touch/wet to touch, she do not sweat that often but skin was moist, neck pain, had hot flashes, chills; it was like menopause type, she couldn't keep her eyes open, couldn't focus, lethargic and tired on 28Feb2021, headache on 28Feb2021 13:30. On an unspecific date, she experienced muscle aches, flu like symptoms; teeth, gums everything that come down with the flu (as reported), head cold, couldn't sleep the entire night, nausea, stiff neck; like a pull muscle in neck, joints ache, bone ache, lot of pain, weakness, felt sluggish and felt like she was going to pass out. It was also reported on an unspecific date about 05:30, she started having all the symptoms over again but nausea and the other symptoms were not as bad as the first two days when they occurred. There were no investigation assessments. It was reported that an ice pack was given to her for which she turned white and no other treatment was given for the other events. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Information has been received from a RN concerning her daughter a 24 yr old female with Crohn's disease and asthma who on 18Aug05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included polypharmacy. On 18Aug05 the pt developed intense swelling at the injection site and her entire body was aching. It was unk if medical attention was sought or if laboratory diagnostic tests were performed. She was treated with acetaminophen (Tylenol) and was recovering. There was no product quality complaint involved. Additional information has been requested.
Headache, nausea, chills, fever, hives, (within 5 hours) facial swelling ( right side) itching (1 day later)
Breakthrough COVID-19 case with symptom onset 8/25/2021: Fever, Shortness of breath/difficulty breathing, Fatigue or tiredness, Chills, Cough. Hospitalized 9/3/2021-9/6/2021. Pt was seen in the ED in late August with a positive Covid test. Pt was d/c home and told to come back if she felt worse. Xray was normal at that time. Pt was admitted when she came back to the ED on 09/03/2021. Pt then had a positive chest Xray for pneumonia
patient developed pain left shoulder and upper back approx. three days after vaccination then developed left-sided facial weakness, initially could not close his left eye, difficulty talking due to droop of lip
tenderness, redness & swelling to inj site lt deltoid;tx w/Ibuprofen PO;cold compresses to inj site;sx gone by 5/30/99;