chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of eighter VAQTA 25/0.5 ml injection (lot # L042838, expiration date 26-MAY-2017; dose, and route of administration were not provided), or RECOMBIVAX HB injection (lot# M013639, expiration date 15-SEP-2017; L036466, expiration date 25-JUN-2017; L030609, expiration date: 26-JUN-2017; dose and route of administration were not provided), or PNEUMOVAX23 injection (lot# M022947, expiration date: 12-NOV-2017; dose and route of administration were not provided). Nurse reported that at least one dose was definitely administered to the patient, but she could not determine which of the three products might have been administered at the time of the report. There was no adverse effect reported. The vaccines experienced the temperature excursion of >46 degrees Fahrenheit but <77 degrees Fahrenheit for 72 hours. There was no previous temperature excursions. Digital data logger was not involved. Additional information has been requested.
Vial was initially stored in the refrigerator on 29 Jun 2023, beyond use date was 29 Jul 2023 and administered 31 Jul 2023; No adverse event; HCP stated they accidentally administered 1 dose beyond use date on 31JUL2023. BUD was 29JUL2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose beyond use date on 31JUL2023. BUD was 29JUL2023), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 29 Jun 2023, beyond use date was 29 Jul 2023 and administered 31 Jul 2023) and NO ADVERSE EVENT (No adverse event) in a 6-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     Patient was healthy.  Previously administered products included for Product used for unknown indication: pfizer (Dose 1) on 05-Mar-2022. Past adverse reactions to the above products included No adverse event with pfizer.    On 31-Jul-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 31-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose beyond use date on 31JUL2023. BUD was 29JUL2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 29 Jun 2023, beyond use date was 29 Jul 2023 and administered 31 Jul 2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose beyond use date on 31JUL2023. BUD was 29JUL2023), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 29 Jun 2023, beyond use date was 29 Jul 2023 and administered 31 Jul 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose beyond use date on 31JUL2023. BUD was 29JUL2023) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 29 Jun 2023, beyond use date was 29 Jul 2023 and administered 31 Jul 2023).    The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication not reported.   The vial did not undergo any temperature excursions.  Treatment medication not reported.
On the same day of vaccination I had sore throat later that day and pain at injection site. On Saturday was really intense all day joint pain  in the afternoon, I got severe diarrhea and nausea. Then I started coughing intermittently , it wasn't bad. Saturday night I actually slept better and the joint pain died down. On Sunday the cough was worse and it felt like I had sinus pressure and infection and fatigue. I broke out in a rash on my trunk front and back. Its typical for me when I get a significant illness, its an indicator that I have getting better.
p/2days a bump came to RT;29JAN96 it is about 1" circumference,not raised,was moveable;no red but had a few small reddish blotches;pt given APAP & put cold clothes on bumps
Arm soreness that evening.  Starting 1am post vaccination- fever, bone racking chills, vertigo, difficulty ambulating, nausea, fatigue, headache. Nasue took 2 days to resolve, fever took 3 days to resolve even with medications.
Tired, Lethargic, dizzy, headache, weak, fever, cough, nausea. Temp of 103F, pale/peaked. Note from Nursing Supervisor. Child was vaccinated on a Thursday and came to school on Friday. She was absent on Monday and Tuesday of the following week but returned to school on Wednesday. The school nurse did not see the child in the shcool health office. As far as the school nurse and public health know, the child was never taken in to see a doctor for any complaints that were listed by the reporter. History includes suspected Beckers Muscular Dystrophy. Father has it.
The next day Sun-started with some blisters on left ankle and as day went on more blisters on buttock and up back, chest and up head. Afebrile c/o itching. No res. problems. Took Benadryl x4 days then went to doctor that cleared rash up. Had rash x13 days.-Better with prednisone.
flu; Initial information received on 03-Dec-2020 regarding an unsolicited valid non-serious case from a patient via social media.  This case involves a patient of unknown demographics who got the flu (influenza), while the patient received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was reported.   On an unknown date, the patient received an unspecified dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (latency unknown) after starting the suspect vaccine therapy, the patient reported that last two times got a flu shot and got the flu (influenza). Not said it was the result of the shots, but every other year the patient had not got a flu shot and had not been sick. The patient stuck with no shot.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
The patient developed a 3x5cm area on her upper right arm that appeared to look like a blister after receiving a pneumococcal vaccine on 10/26/06.  It was debrided and diagnosed as a cellulitis and given an Rx for Augmentin 1000 mg bid x 10 days on 10/30/06. The wound did not improve much, so she was then given Rocephin 1 gm IM x 1 on 10/31/06. She was seen again on 11/01/06 and had improved somewhat, so no additional treatment was done at that visit.  She was then seen again on 11/09/06 and given an Rx for Augmentin 875 mg bid x 10 more days.  She was seen again on 11/21/06 for a follow up and there was not much improvement.  There was no redness or enduration but the area was a large open wound with crust down to the adipose tissue.  She was diagnosed with an open wound, diabetic ulcer and we were able to get her in that day to a general surgeon for evaluation and treatment.
Mental cycle has been irregular with frequent periods And spotting. Otherwise normal periods before this.  Second  vaccine  Was in March and this started in may.. Have  spoken  with many other females and realize it was happening to them as well after Vaccine .  all females are  Various ages and different brands. Moderna, Johnson and Pfizer.
This spontaneous report was received from a registered nurse and refers to  a 52 year old male patient. The patient's concurrent conditions, medical history and drug allergies were not reported. The stock of vaccine was received in April 2016. On 21-FEB-2017, the patient was vaccinated with an improperly stored ZOSTAVAX lot # L046899 with expiration date of 28-FEB-2017 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (DILUENT MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 147 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved. No further information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014052:
This non-valid spontaneous report was received from a medical assistant and refers to a unspecified amount of unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. From 12-NOV-2017 to 05-DEC--2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection ( strength, dose and route of administration were not reported) (lot # N004799 with expiration date on 15-NOV-2019) for prophylaxis. The temperature of excursion with GARDASIL 9 was from 0 to 1 degrees Celsius for 3 hours.There was no previous temperature excursion performed. The temperature of excursion was detected by a data logger. No adverse effects were reported.
Pfizer Monovalent 5 yrs - 11 yrs administered in error. Patient was due for Bivalent.
Heplisav-B (Hepatitis B Vaccine Recombinant, Adjuvanted- ADULT DOSE) was administered to patient by primary RN; Dynavax (vaccine manufacturer) contacted and adverse event reported with RN; awaiting follow up instructions; primary MD aware
Redness and swelling of injection site. 5 cm x 1 cm rectangular area of purple brusing on left thigh, felt slightly firm under bruising site. Minimally tender. About 10 scattered pinpoint petechiae on left thigh leg and ankle.
heart arrhythmia; Dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series completed, manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 3, unknown manufacturer), for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset 10Oct2022 at 22:00, outcome "not recovered", described as "Dizzy"; ARRHYTHMIA (medically significant) with onset 10Oct2022 at 22:00, outcome "not recovered", described as "heart arrhythmia". Therapeutic measures were not taken as a result of arrhythmia, dizziness.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Redness near injection site, 3 x 1 with a bit of heat.  Did not materialize until a week or more later, or I only noticed it later.  In having my routine mammogram earlier today the technician noticed it and felt the heat.  As I understand it I have a mild case I f Covid arm.  A non-issue to this happy recipient!
I was freezing with chills but had a fever. Muscle aches and a bad headache. It happened all night until about 4am. I only felt those side effects through the night.
Warm sensation in the chest and the body 10 minutes after the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Warm sensation in the chest and the body 10 minutes after the vaccine.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced FEELING HOT (Warm sensation in the chest and the body 10 minutes after the vaccine.). At the time of the report, FEELING HOT (Warm sensation in the chest and the body 10 minutes after the vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment details was not reported by the reporter.
fever 102 starting day after vaccination, and 12 days later diagnosed with Left lower lobe atypical pneumonia. Symptoms SOB, Fever, cough, hospitalized at medical center 5/16/21 to 5/17/21    Initially fever without sob or cough: with normal CXR but elevated ESR, CRP. Was treated with Solumedrol dose pack 2 days before he developed symptoms.
Around 9pm after vaccination, I got rashes on both wrists. The next morning, I woke to a high heart rate- resting heart rate was 138. When I lay down  my heart rate drops to 110. I went to the ER, Light headed, Brain fog, Fever, Chills, Left arm was cold and bluish in color while the rest of my body remained warm, swollen in my tonsils- its hard to swallow or drink.
No adverse event; HCP reports that the patient received a dose of VARIVAX that has suffered a TE.  Supported TE case is 02452082. AE cases 02452088 and 02452120 are from the same office and involve similar events with different patients. No Additional AE/PQC reported.; This spontaneous report has been received from a nurse, regarding 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 11-AUG-2023, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, at a dose of 0.5 milliliters as prophylaxis (lot number: w039292, which was determined to be valid, with an expiration date on 11-DEC-2024) (strength, scheme, route and anatomical location of administration were not reported) (Product storage error).   The administered dose underwent a temperature excursion of -14.3 degrees Celsius for 13 minutes, with a previous temperature excursion of -10.6 degrees Celsius for 38 minutes.   No additional adverse event was reported.  This is one of three cases form the same reporter.
Developed slight rash across chest while in observation room after 20 minutes, declined benadryl. No other symptoms reported. Instructed to wait for 1 hour before leaving. After the alloted time, presence of rash did not get worse. She said she felt fine and left facility. Attempted to contact patient to follow-up, patient did not answer.
This spontaneous report was received from a nurse via company representative refers to a child patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of VARIVAX (lot # not reported) dose and route not reported. No concomitant medications were reported. The reporter received the information form a nurse at physician's office. A small child presented to the physician's office on 08-NOV-2012 with a case of disseminated varicella. The patient may or may not have received VARIVAX (merck) in the past. The patient had not recovered from the event. The patient sought medical attention for the event. No further information is available. Additional information has been requested.
On 1/27 I started to get a sore throat and a little cough and a little feverish. The next day I had a headache, fever, fatigue and cough. On Saturday, I got a rapid test and tested positive for COVID. I called my doctor a week afterwards because I couldn't shake the cough and had congestion. He prescribed a Prednisone derivative.
On 8-15-10 I noticed swelling and redness going a couple of inches behind my arm and the next day got harder and I got some redness and hardness towards the front of my arm also the area of injection was getting larger.
Patient without oxygen requirement at present. No indications for COVID-19 specific therapy.  Saturating well on room air with SpO2 greater than 94%. Treated with Decadron 6 mg daily for mild wheezing/asthma, currently resolved
Patient did not have a reaction to the medication he responded to the immunization by fainting. He was slightly nauseous and was perspiring.
Severe Diarrhea at 36 hrs after 1st dose, continuing for 48 hrs Severe Diarrhea and muscle aches 20 hrs after second dose.
red 2 inch diameter area; soreness/body aches; hot at the site; low grade fever; headache; joint pain; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced erythema, pain, injection site warmth, low grade fever, headache and joint pain. On an unknown date, the outcome of the erythema, pain, injection site warmth, low grade fever, headache and joint pain were recovered/resolved.   It was unknown if the reporter considered the erythema, pain, injection site warmth, low grade fever, headache and joint pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had erythema, pain, injection site warmth, low grade fever, headache and joint pain. The was coming up on her second dose and scared to experience the side effects again.    The patient stated the above noted side effects lasted for a day but did resolve.   She had a red 2 inch diameter area with soreness that was hot at the site.     She has not notified her physician because the issues resolved. The reporter consented to follow up. This case linked with US2020003266, reported by same reporter.
Flu like symptoms; Achiness; General malaise; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6206) via an unspecified route of administration in the arm right on 11Mar2021 at 13:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The medical history included heart disease. 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. The concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN) and famotidine (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on 18Feb2021 at 11:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The patient also took cefalexin(KEFLEX) previously on an unknown date and experienced allergy. On 12Mar2021 at 16:00, the patient experienced flu like symptoms, achiness and general malaise. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events flu like symptoms, achiness and general malaise were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Left arm dominant, received injection in L deltoid on 9/30/2014.  On 10/6/2014 started experiencing intermittent fasciculation of L deltoid muscle; numbness/tingling down L arm and L hand; notes worsened hand writing.
woke up 12SEP95 w/rash on trunk, especially back, arms;no temp;pt uncomfortable & c/o itching;no other sxs;had been exposed to chicken pox about 1wk ago;45-50 papule w/1 large cluster;excoriated minimal erythema
Random pain in left arm at the injection site. Deep pain like it was in the bone at the site.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 11Mar2021 at 09:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa drugs (sulfonamide allergy). 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 buspirone (MANUFACTURER UNKNOWN) and atorvastatin calcium (LIPITOR) for unknown indication on unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 18Feb2021 at 10:30 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. On 11Mar2021 at 10:00 the patient experienced random pain in left arm at the injection site, deep pain like it was in the bone at the site. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event random pain in left arm at the injection site was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
PATIENT EXPERIENCED BRUISING THE FOLLOWING DAY, AT LEAST TWO INCHES BELOW THE INJECTION SITE (DELTOID MUSCLE). PATIENT DID NOT HAVE ANY PAIN. THERE WAS NO IRRITATION AT THE INJECTION SITE.
Additional information has been received pertaining to the addition of the serious criteria of hospitalization, age change for patient at receipt of third dose of vaccine and deletion of concomitant therapy medication. Information regarding PREVNAR was received from a healthcare professional regarding a 19-month-old male patient who experienced drug ineffective and pneumococcal bacteremia. At 6 months of age, the patient received the third dose on 23-Dec-2005. The second dose was received on 10-Oct-2005. The first dose was received on 11-Aug-2005. The patient's concurrent illness included asthma (diagnosed on Jan-2007), convulsion (diagnosed at 9 months) and ear infection (ear tubes due to recurrent ear infections). Product was administered on 23-Dec-2005. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant therapy was not reported. On 27-Jan-2007, the patient developed pneumococcal bacteremia (drug ineffective), after receiving, a series of three doses. The child did not receive the 12-month dose of PREVNAR. The patient was hospitalized for 4 days. On 28-Feb-2007, titer levels were drawn on 15 serotypes. On an unspecified date, the pneumococcal bacteremia resolved. Laboratory test (results: pneumococcal titers- for 15 serotypes all were less than 0.2 except for 19F Igg) was done on 28-Feb-2007. No additional information was available at the time of this report.
it was rpt fr HCP concerning a pt who was vax & the following day pt exp rash. no further info avail