chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an office manager concerning a female who in August 2007, was vaccinated with a dose of PNEUMOVAX 23 vaccine (lot #656439/0577U). On an unspecified date the patient developed cellulitis and was hospitalized. Subsequently, the patient recovered from cellulitis. This is one of several reports received from the same source. A lot check has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. Follow-up information was received from the office manager in the form of medical records concerning the 9 year old female patient with a history of pneumonia who on 15-AUG-2007 was vaccinated the second dose of PNEUMOVAX 23 vaccine (lot #656439/0577U) in the right arm. On 17-AUG-2007, also reported as 4 days prior to the admission, the patient had a fever, swelling of the right forearm and some induration of the forearm. On 17-AUG-2007, the patient was hospitalized. Upon admission, the patient had some lethargy, fever, diarrhea, and unusual behavior. The patient was also experiencing headache and eye blinking. The patient had a leukocytosis of over 24,000 white cells. The patient answered questions appropriately but could not remember some facts. The patient had also been on BENADRYL for this reaction post immunization. The patient was started on ROCEPHIN which was later changed to CLINDAMYCIN, and the patient was started on IV fluids. The patient was seen in consultation by doctor of infectious disease and also the patient was seen by pediatric neurologist. On 20-AUG-2007, the patient was afebrile. On an unspecified date the patient was diagnosed with myositis. Laboratory tests showed that blood cultures were all negative, and a CAT scan was within normal limits. On 21-AUG-2007, the patient had shown significant improvement. The impression at the time of discharge was cellulitis, myositis, diarrhea and immunization reaction. The patient had been thought to have a reaction also due to the BENADRYL which had appeared in some unusual behavior and neurological signs. At time of this report, the patient recovered from the events. Additional information is not expected.
Everything tasted funny; aches; chills; felt lousy; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Everything tasted funny), PAIN (aches), CHILLS (chills) and FATIGUE (felt lousy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020 and Seasonal allergy since an unknown date. Concurrent medical conditions included Diabetes. Concomitant products included LOSARTAN, SIMVASTATIN and METFORMIN for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced TASTE DISORDER (Everything tasted funny), PAIN (aches), CHILLS (chills) and FATIGUE (felt lousy). At the time of the report, TASTE DISORDER (Everything tasted funny), PAIN (aches), CHILLS (chills) and FATIGUE (felt lousy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test positive: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.
Information has been received from a Registered Nurse referring a patient of unknown age and gender. Information regarding concomitant therapy, concurrent conditions and medical history was not provided. On an unknown date, 18 months after receiving their first dose, the patient was vaccinated with the second dose of GARDASIL (dose, lot #, application site and route were not reported). No adverse effects reported. Additional information has been requested.
PT CAME IN  FOR TDAP AND MODERNA BIVALENT. INADVERTANTLY GAVE 2 SHOTS OF MODERNA BIVALENT. pt received one shot in each arm.Additionally, pt did receive the requested tdap in right arm
Fever the day following injection, sore arm, recovered. Woke up 3-4 days later (2/8/21) with left eye vision loss, pain with eye movements - 2/10/21 diagnosed retrobulbar optic neuritis on with vision 20/50. Vision continued to worsen to 20/150 over the next few days. After 6-8 weeks, vision recovered without intervention to 20/25 and with optic atrophy.
Within a day of the first dose, I have had a rapid heartrate and felt shaky. The shakiness has subsided, but I continue to have rapid heartrate. I used my at home stethoscope today to listen to my heart, and it periodically skipped a beat/was irregular which never happened before. Following the first dose, I also have had a headache 2-3 days a week which is not normal for me. I receive my second dose today and plan to see a doctor if this continues following the second dose.
Sunday morning, started with upset stomach and then diarrhea. Later, vomiting's and continuous diarrhea (like liquids) throughout the night. Fever up to 101.7, chills and fainted. Eventually after 48 hrs. since the booster shot, I finally took some Tylenol and helped brought down fever, which eventually made me feel better. Diarrhea started to slow down by Tuesday. Went back to work on Wednesday but stomach was still not all well.
I got the first vaccine and I noticed burning under my arm. Then, I noticed the burning sensation with dose 2 and it didn't seem to be going away. Then I noticed a bump was forming under my armpit and it grew as big as the palm of my hand. I went and got medical attention about one month later because it was getting bigger and the burning sensation was not going away. I had a ultrasound first and then a MRI in which the doctor confirmed that I would need to have surgery in order I have the mass tumor removed or it would increase in size. So I had surgery 12/10/2021 where I had the tumor was completely removed but I noticed that the area of my armpit has some sight swelling. I will be seeing my doctor soon to make sure the tumor is not coming back.
headache; tingling in my scalp; This is a spontaneous report from a contactable consumer reported that. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Aug2021 10:30 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization (Age at vaccination 45 years). The patient was not pregnant at the time of vaccination. The patient past Medical history included known allergies: sulfa from an unknown date and unknown if ongoing. Concomitant medication(s) included progesterone (PROMETRIUM [PROGESTERONE, strength 100mg) taken for an unspecified indication, and Multivitamin. 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 vaccine within 4 weeks prior to covid-19 vaccination. After the administration of vaccine, the patient developed a headache on day one which has persisted every day since coming and going and tingling in her scalp on 23Aug2021. The events result in Doctor or other healthcare professional office/clinic visit. No treatment was received. The event outcome was not recovered.     The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Swelling, pain , rash at injection site.   Severe pain under the left arm that is tender to the touch still ongoing.
The patient only slept a combined total of 12 hours in the 48 hours following the vaccination. The patient typically slept 28 hours in a 48 hour period.
My back was cramping I had seen a Doctor and was given flexril to help ease the cramping muscles. After my shot the injection sight and my back became extremely painful. I was not able to get comfortable standing, sitting, or lying down my muscle pain in my back went from a 5 to 10 (or off the chart) all in my back where I was currently hurting. No where else except my left arm at injection sight. This went on until Saturday at 6pm. Started about 6pm Dec10. I?m not real sure about exact tim it started on Dec 10 but I know it was in the evening  I took a flexril and went to bed. That morning I couldn?t stand the pain had to get help to make it to toilet.   Pain was a lot different from what I saw the doctor for. The pain was in my hips and back.  Kept drinking water and Gatorade and some pedialite.  Needed help to restroom.  Then Saturday night around 6pm  it all went away. Back pain at a 2 on scale of 1-10.  Which was reasonable considering I should have been improving with the flexril.
This spontaneous report was received from a nurse prescriber referring to a 13 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were unknown by reporter. On unknown dates, the patient had gotten her first two doses of GARDASIL 9 0.5 ml, for prophylaxis (strength, route, lots # and expiration dates were not reported) at a different practice. On unknown dates, each time, the patient developed a strange and bad rash. It was unknown if the patient sought medical attention, received any treatment for the condition or if any laboratory study was performed. At the reporting time, the patient had not received her third dose of GARDASIL 9 yet. The outcome of rash was unknown. The causality assessment between the event and vaccinations with GARDASIL 9 was not provided.
Arm is very sore 7/10 painscale; Its all around injection site flat rash, not itchy/like a big well; Headache; Extremely tired; Tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is very sore 7/10 painscale), VACCINATION SITE RASH (Its all around injection site flat rash, not itchy/like a big well), HEADACHE (Headache), FATIGUE (Extremely tired) and VACCINATION SITE PAIN (Tender to touch) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 047B21A) for COVID-19 vaccination.     Concomitant products included VITAMIN B12 (CYANOCOBALAMIN AND ANALOGUES), ASCORBIC ACID (VITAMIN C FORMULA), FOLIC ACID (FOLATE) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced PAIN IN EXTREMITY (Arm is very sore 7/10 painscale), VACCINATION SITE RASH (Its all around injection site flat rash, not itchy/like a big well), HEADACHE (Headache), FATIGUE (Extremely tired) and VACCINATION SITE PAIN (Tender to touch). At the time of the report, PAIN IN EXTREMITY (Arm is very sore 7/10 painscale), VACCINATION SITE RASH (Its all around injection site flat rash, not itchy/like a big well), HEADACHE (Headache), FATIGUE (Extremely tired) and VACCINATION SITE PAIN (Tender to touch) outcome was unknown.            Treatment medication was  not reported.
I felt like I had the flu; hands don't hurt all the time; This is a spontaneous report received from a Pfizer-sponsored program, XELSOURCE. A contactable consumer (patient) reported that a 64-year-old female patient received the first dose of BNT162B2 via an unspecified route on an unspecified date as single dose for COVID-19 immunization; and tofacitinib citrate (XELJANZ XR 11 mg prolonged-release tablet) via an unspecified route of administration from an unspecified date at 11 mg of unspecified frequency for an unspecified indication. Medical history and concomitant medications were not reported. The patient stated that her hands didn't hurt all the time. She hasn't felt this good in years. She can walk down the stairs. She reacted to her first Pfizer vaccine, but not the second. She felt like she had the flu. The action taken in response to the event for tofacitinib citrate and the outcome of the events were unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
It started with arm soreness after about 9 hours, then about 4 hours later, there was more extreme arm soreness, sore and swollen lymph nodes under the right arm (arm that received vaccine), fever was rising incrementally, cold chills, body aches, joint pain, sleeplessness, nasal dryness (humidity level in house was 69%), nausea.  This was about 3am.  By early morning, I could not move my right arm.  Fever on the first day was 100.7 (my normal is 97.9).  I waited to take Tylenol (PM) until 3pm on 4/6 (the next day, so more than 24 hours after vaccination).  It did not seem to help.  The arm soreness was the first to resolve, about 12 hours later, but that was prior to the Tylenol.  The nausea, body aches and joint pain resolved within 48 hours as well.  I did not take any more Tylenol.  The swollen lymph nodes were the last symptom after 72 hours and remained a problem for over a week.  They were so bad, I had difficulty getting into a sleeping position because I could not put my arm down.  To help mitigate the swollen lymph nodes, I did take 1-2 Valtrex for several days which seemed to help reduce the swollen lymph nodes.  I did this because I already know Valtrex reduces swollen lymph nodes in the groin area.  I really think it lessened the symptom time.  It certainly lessened the severity of the swollenness.
Pharmacist gave a 12 year old female the Johnson and Johnson vaccine instead of the Pfizer vaccine.
This spontaneous report as received from a physician via company representative refers to a female teenage patient of unknown age. In approximately 2013 reported as few months ago, the patient was vaccinated with the first dose of GARDASIL injection (strength, dose, route, lot number and expiration date not provided). Concomitant therapy included hepatitis A vaccine (manufacturer unknown) (dose and route not specified). In 2013, after receiving her 1st dose of GARDASIL the patient experienced a temporary blindness for a few minutes. She sought medical attention. The physician had the patient lay down quietly for a few minutes and the patient fully recovered (date unspecified in 2013). The physician did not continue with GARDASIL series. The relatedness between vaccination with GARDASIL and temporary blindness was not reported. Upon internal review, temporary blindness was considered to be a medically significant event. Additional information has been requested.
small pox vaccine scar has become inflamed and slightly irritated; small pox vaccine scar has become inflamed and slightly irritated; Dose number=3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Dec2021 11:00 (Batch/Lot number: unknown) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; VITAMIN D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (dose number=2, product=COVID 19, brand=Pfizer, lot unknown=True, lot unknown reason=Unable to locate or read the details, administration date=21Apr2021, administration time=06:00 PM, vaccine location=Left arm), administration date: 21Apr2021, when the patient was 24 years old, for Covid-19 immunization; Bnt162b2 (dose number=1, product=COVID 19, brand=Pfizer, lot unknown=True, lot unknown reason=Unable to locate or read the details, administration date=31Mar2021, administration time=09:00 AM, vaccine location=Left arm), administration date: 31Mar2021, when the patient was 24 years old, for Covid-19 immunization; Small pox vaccine (I received a small pox vaccine when I, was younger (previously lived in, Belarus).), for immunization. The following information was reported: IMMUNISATION (non-serious) with onset 05Dec2021 11:00, outcome "unknown", described as "Dose number=3"; SCAR INFLAMMATION (non-serious), SKIN IRRITATION (non-serious) all with onset 05Dec2021 15:00, outcome "recovering" and all described as "small pox vaccine scar has become inflamed and slightly irritated". Therapeutic measures were not taken as a result of scar inflammation, skin irritation.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Birth control medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. Adverse Event resulted in none.  The lot number for bnt162b2 was not provided and will be requested during follow up.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported   No treatment information was provided   This case was linked to MOD-2021-365189 (Patient Link).
Have a small fluid filled blister half an inch from injection site, some redness around site.  Don't think its from the band-aid because no usual rash associated with adhesive sensitivity.  Arm still sore.  Not seeking treatment at this time.
1st dose 08Aug2022 and 2nd dose recieved on 09Sep2022.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 86-year-old male patient who received Herpes zoster (Shingrix) (batch number J9B25, expiry date 14th September 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 9th September 2022, the patient received the 2nd dose of Shingrix. On 9th September 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 19-SEP-2022 Reporter's comment: The Pharmacist reports patient received first dose of Shingrix on 8th August 2022, and second dose was administered on 9th September 2022.   The patient was not immunocompromised.   The reporter give consent to follow up. Additional Supportive Information: The patient received second dose earlier than the recommended interval, which lead to shortening of vaccination schedule.
3in by 3in red and warm area. Painful and itchy. Applied ice and took ibuprofen. Will take a Benadryl tonight.
Patient presented with redness, swelling, and pain surrounding the injection site. Father reported pain and swelling have decreased however redness has persisted.
fluzone high dose vaccine was given to a patient under the age of 65 with no reported adverse event; Initial information received on 23-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adult and unknown gender patient under the age of 65 who was given fluzone high dose vaccine (INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]) with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength: unknown) lot number not reported via intramuscular route in unknown administration site as prophylactic vaccination.  On an unknown date the fluzone high dose vaccine was given to a patient under the age of 65 with no reported adverse event (product administered to patient of inappropriate age) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was unknown if there were lab data/results available. The company suspect product was inappropriately used as per local Marketing authorization.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (fluzone high dose vaccine was given to a patient under the age of 65 with no reported adverse event).  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a health care worker referring to multiple unspecified patients. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with an improperly stored doses of VARIVAX which had lot # L043624, expiry date: 03-NOV-2017 and lot # M000761, 06-JAN-2018 (strength, dose and route not reported). No adverse effects reported. No product quality complaint (PQC) involved. No further information reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever of 104.8F.  Chills and fever began at 0830, Tylenol taken at 0930 with a temp of 102F.  By 1100 temp was 104.8F (infared forehead).  Unable to take Ibuprofen because of extreme nausea.  Chest/abdomen temp reading with infared thermometer was 107F.   Took 8mg Zofran at 1100 and was able to take 400mg of Ibuprofen at 1140.  By 1300 temp down to 103F (infared forehead).   Other side effects were normal body aches, migraine, fatigue, joint pain.  Only reporting due to the extremely high temp.