chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tinnitus; This is a spontaneous report from a contactable physician, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK57c3) via an unspecified route of administration in the left arm on 18Dec2020 at 12:00 (at the age of 43-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231) via an unspecified route of administration in the right arm on an unknown date (age at vaccination- unknown); as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) and indapamide (MANUFACTURER UNKNOWN) both for unknown indication and ethinylestradiol / levonorgestrel (ALESSE) as oral contraceptive; all from unknown date and unknown if ongoing. On 24Dec2020 at 16:00, the patient experienced tinnitus. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
On Saturday September 11th I had itching and a burning sensation on the left side toward my back around my waist. I though it was a spider bite, but when I felt it I didn't feel anything. At noon  I noticed a lot of little red bumps that extended towards my spine on my back. I went to urgent care and they told me I had shingles. I was prescribed an anti viral medication for it which I took immediately. The medication that was prescribed was Valacyclovir 1000mg 3xday for 10 days by mouth. On the 7th day everything started to clear up.  The day before I found out I had shingles, I had a venom shot against yellow jackets, wasp, and hornets. I get the venoms shots just incase if I ever get stung the reaction would be milder because of my mast cell activation that I have. I have been getting those venom shots for five months without any issues.
Information has been received from the authors of the spontaneous literature article concerning to a 71-year-old woman who underwent a posttherapy radioiodine scan after 131I administration for papillary thyroid carcinoma. On day 1 of the posttreatment hospital isolation, the patient received a PNEUMOVAX 23 injection in the left deltoid muscle. A localized hypersensitivity reaction ensued with development of soft tissue edema and erythema at the PNEUMOVAX 23 injection site. This localized reaction persisted up to the subsequent posttherapy radioiodine scan 5 days after injection. Increased activity at the left deltoid region suggests a false-positive finding related to radiotracer sequestration due to inflammation from a localized postvaccination hypersensitivity reaction. The authors considered that hypersensitivity reaction was related to vaccination with PNEUMOVAX 23.
The day after, recipient developed redness at the site of injection.  It was about 3 inches wide.  It became very "angry" so on Saturday, she went to urgent care and was diagnosed w cellulitis and received doxycycline.  She is starting to feel better now.
T/C from pt 2 hours after injection. Nausea, vomiting, chills. To urgent care. T/C from patient after visit to urgent care. Patient was advised by physician to continue Pepto Bismol for N/V advised no Hep B #3.
This spontaneous report was received from a pharmacist via Pfizer (manufacturer control number# 2018377061) regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route, frequency, lot# and expiry date unknown) for prophylaxis. On an unknown date, the patient experienced vaccination site pain and vaccination site swelling. The outcome of vaccination site pain and vaccination site swelling was unknown. Causality assessment was not provided.
12/21/2021 HIVES AT THIGHS WITH ITCHING AT SITE ITCHING -RT SAME DAY 01/12/2021 HIVES AND ITCHING TORSO AND THIGHS- SITE OF ARM- LT SAME DAY UP TO 4TH DAY-WORST OM 1/16/2021 WITH RESTLESS NIGHT WAKING UP EYE MATTED-WAKING UP ITCHYAT SITE/TORSO/THIGHS/LT EYE SWELLING AND RT EYE WITH WATERY LUNG FEELING SEEN AT THE ER AND ORAL STEROIDS CAUSE SOME SWELLING AT OTHER EYE BUT BETTER AFTER 30 MIN.AFTER A NAP RT EYE WAS SWELLING W/O ITCHING PRETTY BAD.AND ORAL MEDROL PACK LAST DOSE 1/19/2021 AND FORGOT THE DOSE ON 1/21/2021 AT WORK HAD EYE SWELLING LT EYE FIRST THEN WENT TOOK A DOSE THEN HAD ON THE RT EYE. SWELLING WITH TORSO AND SITE ITCHING TOO SO TOOK ANOTHER STEROID GETTING BETTER WITH PO  BENADRYL 50 MG- FATIGUE BUT PRETTY GOOD.YESTERDAY TIRED TOWARDS THE END OF SHIFT AND THIS AM AFTER 9 HRS WAS FEELING TIRED-FATIGUE- STARTED LATE AND THIS PM SWELLING ON THE LT AND THEN RT (SAW CHIROPRACTOR 1/23/2020). IM DEXAMETHASONE 8 mg IM NOW BETTER AFTER 30 MINUTES BETTER.
After receiving all of her vaccines, patient began to experience dizziness. Shortly after she reported shortness of breath and felt that her throat was constricting. Patient agreed to receive an administration of epinephrine 0.3mg and have pharmacy associates contact 911. Pharmacist administered 1 dose of 0.3mg into the right thigh. Paramedics arrived shortly after and patient was taken to hospital.
fainted; patient received a vaccine that was from the purple cap formula for the COVID-19 vaccine (approved for 12-years and older); This is a spontaneous report received from a contactable consumer from Medical information team. The reporter is the parent.  A 6 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: FH8030) 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: SYNCOPE (medically significant), outcome "unknown", described as "fainted"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "patient received a vaccine that was from the purple cap formula for the COVID-19 vaccine (approved for 12-years and older)". Additional information: The patient fainted at the pharmacy after the injection The patient had her 2nd dose. When the patient received her 2nd dose the pharmacy staff looked at the first dose lot number and told that this was an adult dose, not the 5-11 orange cap formula.  No follow-up attempts are needed. No further information is expected.
no additional adverse event reported; lots: U015689 and U010395 have been administered to patients since the excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.      On 28-SEP-2021, the patient was inadvertently administered with  an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose for prophylaxis (strength, route of administration, and anatomical location were not reported; lot number U015689 had been verified to be a valid number; expiration date 18-MAY-2023). The temperature  excursion was at -12.0 degree Celsius (C), for a time frame of 1 hour and 50 minutes. No had previous temperature excursion. No additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA007144:
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Anxiety-Severe, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Every joint hurts; light headed; diarrhea; feeling awful; throat feeling swollen; This is a spontaneous report from a non-contactable consumer (patient).  A 34-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 06Mar2021 08:00 (at the age of as 34-year-old) unknown, single dose for COVID-19 immunisation. Medical history included allergy to NSAIDS. The patient's concomitant medications were not reported. On 13Feb2021, patient received other vaccine was administered in Arm. Patient did not receive any other vaccine in 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. On 06Mar2021 at 13:00 (01:00 PM), patient experienced every joint hurts, light headed, diarrhea, feeling awful, throat feeling swollen. There was no treatment for the events. The clinical outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Engerix 2nd Dose; Initial Report Received on 03-Nov-2021  A pharmacist reported that a 30 year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then received Engerix-B as the second dose.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 19-Aug-2021, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported), through an unspecified route and site at another pharmacy.  On 03-Oct-2021, 46 days after having been vaccinated with HEPLISAV-B, the patient received Engerix-B (second dose) at the pharmacy.   No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
I was fully vaccinated the last dose dates Feb 20th 2021. My husband and I were in our home from June 30th until now. I got sick with the symptoms of a cold and my cheeks and jaw hurt in the middle of the night. So I woke up feeling congested and had a headache and fever.  I was surprised I might be getting a bad head cold. Then I thought maybe it is just allergies so I took allergy medicine that day. The second day I continued to have a headache, sinuses, and jaw hurting. And on and of fever and chills of about 100. Allergy medicine wasn't touching it. The third day I thought I should have a covid test since a friend of ours here (unvaccinated got COVID) So I got a rapid test three days later at urgent care and it was positive. They could not tell me if it was Delta but I assumed it was.  I was pretty shocked. The nurse told me to go home, treat it like a cold but if my oxygen levels were low or my chest hurt to go to the emergency room. My husband got it the next day.  For the first week, I had bad cold symptoms and was fatigued. Fever on and off, up to 101. Mostly laid around, could not work or do much of anything else. The second week I felt worse instead of better.  More fatigue, dry mouth, fever still, weird stomach pressure at night-not pain-just all my organs feeling the pressure. Once it was so bad I wanted to scream!  So I ended up going to the emergency room Thursday eve (a week later from first symptoms)  as I was feeling worse not better and I couldn't break my temp 102 with Tylenol anymore. And my chest hurt. After going home (4 hours in emergency) I got better on the steroids but just laid around, really incapable of extending much energy on household tasks or normal activities. Very fatigued, slept a lot. Lost my smell and taste for about 6 days. At times my mouth tasted metal.  I did eventually get both back, though I can't smell as well. My chest cleared up and I am back to walking 45 mins a day, being on a stair stepper, and swimming 20 laps morning and night. I do still seem to need a nap every day.
Suspected vaccination failure; have shingles on the average of twice a year; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient had shingles on the average of twice a year. The patient reported that, he/she was learning to live without taking medications. He/she reported that, it was not easy, but steroids were not good all the time either. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Pt arrived in urgent care with temp max 40.3 slight rash around injection sites on thighs, high pitch cry. Ibuprofen given. He slept a bit, had juice, temp at discharge 37.1. No breathing difficulty.
HA, joint pain, low grade fever, body aches 1/20 at 0600
Grandson reported that she passed out while getting dressed for the day and that her arm was extremely sore and painfully.   At the time of event it was reported that her BP was WML and she had not eaten since the night before.  She is not a diabetic.
Pt reports pain at site with bump reports night sweats x 2 days none last night denies nausea. Also c/o feeling "wiped out" x 3 days post injection feeling much better today.
Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with the first dose of GARDASIL (Lot number not provided). The registered nurse reported that the patient said the injection was very painful. At the time of the report the patient had recovered. The patient sought medical attention in the office. No further information is available.
Approximately two weeks after Moderna Bivalent Booster, I felt constipated.  I needed to take Dulcolax to have a bowel movement.  Started experiencing sharp stomach pains in upper stomach.  I went to a doctor within the same practice as my primary care doctor on November 17.  This doctor prescribed Dicyclomine 20 mg twice a day and I should take Miralax daily.  The doctor also ordered xrays and suggested I possibly should follow up with a GI doctor.  I went for the xrays on November 29.  My doctor called me and stated I need to take Miralax twice a day for the constipation diagnosis from the xrays.  She said hopefully my stomach pains will go away.
HEADACHE; BLURRED VISION; SWOLLEN ANKLES; BRUISED ARM/LEG/ANKLE; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 44 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 and  expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced abdominal pain. On 19-APR-2021, the subject experienced swollen ankles. On 19-APR-2021, the subject experienced bruised arm/leg/ankle. On 20-APR-2021, the subject experienced blurred vision. On 23-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision on 22-APR-2021, and abdominal pain on 15-APR-2021, and had not recovered from headache, swollen ankles, and bruised arm/leg/ankle. This report was non-serious.
N/V, dizziness, taken via wheelchari to isolation area. Laying BP 103/52, HR 76. Sitting BP 94/74; HR 69; Standing BP 105/81; HR 86. Given water & juice w/no emesis.  Pt had no breakfast prior & felt sleepy.  After 10 min rest on guerney pt fel better. D/C'd in stable condition. Recommended to f/u w/PCP
On 01/19/22 a first dose of Pfizer was administered to an 11 year old female instead of a Pediatric Pfizer vaccination. A full dose of 0.3 ml was given for the initiation of a Pfizer series as requested by the mother. It was determined the Pediatric Pfizer was supposed to be given since the patient was not 12 years old until another 2-3 weeks.  No adverse reactions occured.  The patient did wait the recommended 15 minutes after the vaccination and continued to have no adverse reaction.  A consult to medical contril advised a Vaer report be submitted.
About 1 AM the day following  the second shot I woke with  a fever, body aches and chills for about 5 hours. I developed mild hives about 8 AM that same  day and they progressively worsened as the day wore on. I took one Benadryl about 1 PM and needed to retake one every four hours; the hives lasted four days. I called a call-in nurse on day 3; she told me that as the Benadryl was controlling it to wait until day 5 and if I did not see improvement, to schedule a doctor?s appointment.   By day four I was able to go 6-8 hours before needing Benadryl;  the hives receded on day 5 and I did not need Benadryl any longer.  I was able to control the hives with one 25 mg. tablet.
Information has been received from a certified medical assistant concerning a 19 month old patient, who on 25-JUN-2012 was vaccinated in error with a dose of RECOMBIVAX HB (Lot # not reported) IM. The patient had already received 3 doses of PEDIARIX on 25-JAN-2011, 21-MAR-2011 and on 23-MAY-2011. The patient had also received Hep B (manufacturer unknown) on 21-NOV-2010. Additional information received from medical assistant noted that on 25-JUN-2012, the 19 month old female patient had been vaccinated with RECOMBIVAX HB (lot # 669597/0294AA, expiration date 27-SEP-2013) in right thigh in error (4 previous doses: 21-NOV-2010, 25-JAN-2011, 21-MAR-2011, 23-MAY-2011), HAVRIX in left thigh (3 previous doses, dates not reported) and INFANRIX in right thigh (1 previous dose, date not reported). On 07-JUL-2012, the patient had been vaccinated with Hib (OMPC) in left thigh (lot # 668962/1744AA) (2 previous doses: 25-JAN-2011, 21-MAR-2011). No known adverse effects were reported. Additional information is not expected.
Got my period only one week after my regular period ended. I?ve never gotten an unscheduled period before in my life.  This unexpected period is very heavy.
Mother describes "red rash on face" at approximately 9am this morning.  At this time, 2:45pm, he has the same rash on face and now has rash on trunk and diaper area.  Mom reports having given the child Benadryl "around 8:30am, which seems to have helped some".
Flu like symptoms- body aches, fever ,chills Headache, extreme fatigue, pain at injection site
scaly and darker red armpit; scaly and darker red armpit; like a bruise; 16-year-old daughter accidentally received the Moderna vaccine; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old daughter accidentally received the Moderna vaccine), PAIN IN EXTREMITY (arm soreness), ERYTHEMA (scaly and darker red armpit), SKIN EXFOLIATION (scaly and darker red armpit) and CONTUSION (like a bruise) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old daughter accidentally received the Moderna vaccine) and PAIN IN EXTREMITY (arm soreness). On 01-May-2021, the patient experienced ERYTHEMA (scaly and darker red armpit), SKIN EXFOLIATION (scaly and darker red armpit) and CONTUSION (like a bruise). On 29-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old daughter accidentally received the Moderna vaccine) had resolved. At the time of the report, PAIN IN EXTREMITY (arm soreness), ERYTHEMA (scaly and darker red armpit), SKIN EXFOLIATION (scaly and darker red armpit) and CONTUSION (like a bruise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took acetaminophen.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD21-085288 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up information received on 03 May 2021. Date of birth was added, patient's age was updated, anatomical location for vaccine was added, 4 new events were added.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. MOD21-085288:significant follow up
Burning left side of face (Hot) (shot given (L) arm) Resolved 1 hr. History of Bell's Palsy 2/08 no treatment needed. No other neuralogia signs/symptoms.
Patient displayed symptoms of Type 1 diabetes for several weeks before we investigated.  He was diagnosed with Type 1 diabetes on March 21, 2016.  Bloodwork revealed patient's pancreas began to decline 6 months prior to diagnosis.  The vaccine was administered nearly 6 months to the day before diabetes was diagnosed.
Woke up on floor/ Past out; Anxiety; Fall; Little weak; Foggy head; Shiver; Headache; Nausea; Throw up; Concussion; Buzzing in ears; Did not eat; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Woke up on floor/ Past out) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced CONCUSSION (Concussion), TINNITUS (Buzzing in ears), EATING DISORDER (Did not eat), CHILLS (Shiver), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Throw up). On 02-Jun-2021, the patient experienced ASTHENIA (Little weak) and FEELING ABNORMAL (Foggy head). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Woke up on floor/ Past out) (seriousness criterion medically significant), ANXIETY (Anxiety) and FALL (Fall). At the time of the report, LOSS OF CONSCIOUSNESS (Woke up on floor/ Past out), CONCUSSION (Concussion), TINNITUS (Buzzing in ears), EATING DISORDER (Did not eat), ASTHENIA (Little weak), FEELING ABNORMAL (Foggy head), ANXIETY (Anxiety), FALL (Fall), CHILLS (Shiver), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Throw up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2021, Blood glucose abnormal: abnormal (abnormal) abnormal. On 01-Jun-2021, Blood pressure measurement: abnormal (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported .  Treatment information was not 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.; 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.