chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and from vaccine coordinator and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 20-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T041687 expiration date 10-DEC-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA005066: US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006586: US-009507513-2109USA006587: US-009507513-2109USA006588: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006594: US-009507513-2109USA006595: US-009507513-2109USA006596: US-009507513-2109USA006597: US-009507513-2109USA006537:
Admission to Hospital on 8/23/21 for cough, decreased oxygen saturation, and acute respiratory failure.  Reported by hospital that she has cough, SOB,  difficulty breathing.  At this time, it is reported that she has not been admitted to the ICU and has not required mechanical ventilation.
Patient experienced a metallic taste in mouth and feelings of dizziness. Instructed patient to sit down in store.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. No pertinent medical history was reported. On 31-JUL-2015, the patient was vaccinated with VARIVAX (Merck) (lot # L004653 and expiration date 11-FEB-2017) (strength, dose and route were not reported) which was improperly stored. No adverse events were reported. This is one of the two reprots received from the same source. Additional information has been requested.
ACCIDENTLY RECEIVED JANSSEN VACCINE AFTER FEB DOSE OF MODERNA VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, and hypertension, and other pre-existing medical conditions included the patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) .5 ml, administered on 16-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included mrna 1273 for prophylactic vaccination. On 16-MAR-2021, the subject experienced accidently received janssen vaccine after feb dose of moderna vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of accidently received janssen vaccine after feb dose of moderna vaccine was not reported. This report was non-serious.  Version created to amend previously reported information on 16-MAR-2021. Upon review the following information was amended: Concomitant Product (moderna vaccine) added and vaccination site updated in narrative.  .
crying & swelling rt deltoid area occurred w/in 24 hrs from inject; rx DPH, warm compress;
This spontaneous report was received from a 66-year-old female patient reporting on herself. Her concurrent conditions included macular degeneration. More than 20 years ago, she had an unspecified reaction to sulfa drugs. On an unknown date in November 2017 (also reported as 31-NOV-2017), she received PREVNAR 13 in left arm. Concomitant therapies included vitamins (unspecified). On 04-DEC-2018, the patient was vaccinated with PNEUMOVAX 23, 1 injection, in the left arm (strength, route of administration, lot # and expiration date were not provided) as recommended by her clinician to avoid Pneumococcal disease. On approximately 04-DEC-2018, 5 hours after injection, the patient began to have regular discomfort such as injection site pain, soreness and muscle pain in the bicep of the arm that received the injection. She continued to have pain in the left arm that was not excruciating but made it difficult for her to lift her arm over her head or button her bra from the back. Even at the day of the report (reported as "today") she had pain, but it was joint pain in her left shoulder. The patient said that she moved her arm each day and exercised, but was surprised that she would still have pain 5 weeks after vaccination. The patient received treatment for the events. She sought medical attention: she called the physician. The outcome of the events was reported as not recovered at the time of the report. The causality assessment between the events and PNEUMOVAX 23 was not provided.
Pt recvd 1 doses of REcombivax & 2 doses of Engerix-B & did not respond;
Extreme pain throughout entire body such that I can?t eat or sleep. Even lying down is painful.
Started to have chest pain and left sided numbness after 10 mins of receiving the vaccine. Blood pressure was slightly elevated at 142/90 and heart rate of 90 bpm. EMT was called and was taken to the emergency deparment.
Hives. Received Influenza vaccine IM. Hives to (R) wrist noted approximately 20 minutes post injection. Received BENADRYL po & CELESTONE IM. Home on ORAPRED & ZYRTEC po.
This spontaneous report was received from a healthcare worker refers to a multiple unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patients received improperly stored doses of ROTATEQ (lot # K010222, exp. 12-MAY-2016, dose and route of administration not provided) (incorrect product storage). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information is not expected. No contact details were provided.
Fussiness for 1-2 days within 6 hours of the vaccine. Followed by a pinkish, mucousy stool.
Injection site warm; The redness and itching came back; The redness and itching came back; Little bit of redness at the injection site that itched; Little bit of redness at the injection site that itched; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (The redness and itching came back), VACCINATION SITE PRURITUS (Little bit of redness at the injection site that itched) and VACCINATION SITE ERYTHEMA (The redness and itching came back) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), METFORMIN, LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN and PROPRANOLOL for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Little bit of redness at the injection site that itched) and VACCINATION SITE ERYTHEMA (Little bit of redness at the injection site that itched). On 07-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (The redness and itching came back) and VACCINATION SITE ERYTHEMA (The redness and itching came back). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site warm). The patient was treated with BACITRACIN ongoing since an unknown date at an unspecified dose and frequency; CORTISONE ongoing since an unknown date at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. On 01-Mar-2021, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Little bit of redness at the injection site that itched) and VACCINATION SITE ERYTHEMA (Little bit of redness at the injection site that itched) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (The redness and itching came back) and VACCINATION SITE ERYTHEMA (The redness and itching came back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
numbing of right hand side of face/mouth and right arm.  symptoms subsided after about 10-15 minutes but continued to present every few days.   I advised when i presented for my 2nd shot and they told me they had other reports of that and that is was fine/safe for me to take the 2nd shot, but to wait in a holding area for 30 minutes after the shot.
red dots on her legs below her knee on her legs; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red dots on her legs below her knee on her legs) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included hypothyroidism.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red dots on her legs below her knee on her legs). The patient was treated with LEVOTHYROXINE ongoing since an unknown date at a dose of 50 mcg. At the time of the report, ERYTHEMA (red dots on her legs below her knee on her legs) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       50 mcg of levothyroxine is used as treatment medication.  No concomitant medications were reported.
Feeling terrible; Had a little temperature, basically 100.6; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Feeling terrible) and PYREXIA (Had a little temperature, basically 100.6) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced FEELING ABNORMAL (Feeling terrible) and PYREXIA (Had a little temperature, basically 100.6). At the time of the report, FEELING ABNORMAL (Feeling terrible) outcome was unknown and PYREXIA (Had a little temperature, basically 100.6) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.6. On an unknown date, Heart rate: 100.  No concomitant medications were provided. Patient took the bivalent vaccine on Thursday. Patient had a little temperature, basically 100.6 for the past four days and think that Patient was heading down to the E. R, hopefully they'll be able to give some information there. No treatment medication was provided.
6 days post vaccine while at shopping mall had severe pain right arm, neck and head; seen in ER; had EKG and other tests - NAD; also seen by family Dr - NAD - has been tired and had headache since incident.
This spontaneous report as received from a certified medical assistant refers to a multiple number of patients. The patients were vaccinated with doses of GARDASIL (Lot # not reported) on an unspecified dates that were off schedule between their first, second and third doses. No adverse symptoms were reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source. Additional information has been requested.
pt. is pregnant but not sure how far.  presents with nausea & vomiting after vaccination.   pt. states feels much better now.
Feeling of wanting to pass out, dizziness and fell at home, severe headache, body aches, scratchy throat  and SOB.
arm was a little sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 (Lot number: ER8729, Expiration Date: Jul2021) at the age of 60 years as dose 1, single for covid-19 immunisation. Family history included: "son is a diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Apr2021, outcome "recovered" (14Apr2021), described as "arm was a little sore". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated because her son was a diabetic and has underlying health issues and she has to fly next month. Reporter declined to complete report at this time wished to be transferred for her question.  No follow-up attempts are possible. No further information is expected.
Grandmother called 10/13/10 - patient had vaccine in right deltoid IM 10/12/10, resulting in pain, swelling, redness at site, fever. Taken to ER (10-13) given ABX - today area continues to be slightly reddened hot to touch. (10-22).
razor sharp pain at injection site delirious with fever chills whitening of skin  lasting 5 hours
3 days after this COVID vax injection, onset of a herpes lesion on lower back, above coccyx; took Rx acyclovir to lessen duration of lesion. (Note: patient has approx. 50-yr Hx of occasional herpes lesion outbreaks on lower back or buttocks, usually occurring after sun exposure or brought on by stressful situation or illness.) This was not serious and was initially thought to be coincidental, but it occurred again after first COVID booster dose and later after updated COVID booster.
Second moderna shot 18 hours ago burst blood vessel in eye/burst a blood in eye after my second moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (Second moderna shot 18 hours ago burst blood vessel in eye/burst a blood in eye after my second moderna shot) in a male patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EYE HAEMORRHAGE (Second moderna shot 18 hours ago burst blood vessel in eye/burst a blood in eye after my second moderna shot) (seriousness criterion medically significant). At the time of the report, EYE HAEMORRHAGE (Second moderna shot 18 hours ago burst blood vessel in eye/burst a blood in eye after my second moderna shot) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
PAINS/ACHES; CHILLS; HEADACHE; NOT FEELING REAL GOOD; This spontaneous report received from a consumer concerned a 59 year old female, race not reported.   The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date the patient received covid-19 vaccine ad26.cov2.s (manufacturer not specified) (suspension for injection, route of admin not reported, and batch number: unknown and expiry: unknown) dose was not reported for prophylactic vaccination (dose series 1).  The batch number was not reported and has been requested.  On an unspecified date after receiving  covid-19 vaccine ad26.cov2.s (manufacturer not specified),  the patient had pains/aches, chills and headache (dose series 1). No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pains/aches, chills and headache was not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 2) (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on an unspecified date in OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. On an unspecified date in  OCT-2021, the patient experienced not feeling real good, pains/aches, chills and headache (dose series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not feeling real good, pains/aches, chills and headache was not reported (dose series 2). This report was non-serious.
Difficulty breathing; joint pain; headache; chills; nausea; diarrhea; body ache; hives; my throat started to close down it was very hard to breathe; I could barely talk; This is a spontaneous report from a contactable consumer (patient). This 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EW0161) on 08Apr2021 at 13:00 (at the age of 41 years), as first single dose, in left arm, for COVID-19 immunization. Medical history included penicillin allergy, latex allergy and peach, papaya allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levocetirizine dihydrochloride (XYZAL) pro air inhaler. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09May2021 at 14:00 the patient experience difficulty breathing, joint pain, headache, chills, nausea, diarrhea, body ache, hives, her throat started to close down, it was very hard to breathe and she could barely talk. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received included allergy medication, another inhaler and epinephrine (EPIPEN). The events were resolving. Since the vaccination, the patient had not been tested for COVID-19.
This spontaneous report was received from a physician concerning to currently 62 years old male patient. On 17-NOV-2012, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and not not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that a patient stated he received PNEUMOVAX23 at an unspecified healthcare facility by an unspecified physician and developed redness, swelling and tenderness at the injection site area from his upper triceps down to his elbow. The outcomes of events were reported as not recovered/not resolved. The relatedness for the events was unknown for PNEUMOVAX23. Additional information is not expected.
Hacking Cough, Wheezing, runny nose, vomiting mucous. Dr. diagnosed my son with bronchiolitis. I refused the rest of the vaccination series. My son has been suffering with the wheezing and coughing for 2 months and is still ongoing. He has been on a nebulizer treatment (albuterol) for the wheezing which helps in the moment but it recurs about an hour later.
No adverse affects reported; improperly stored VARIVAX was administered to patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 08-MAY-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/ merck) (VARIVAX), lot #S012036, expiration date: 17-APR-2021 (exact dose, strength, route of administration and anatomical location were not reported), for prophylaxis. The data logger registered a temperature excursion of 48.2 (unit not provided) for the time frame of 4 hours. There was no previous temperature excursion. No information about the diluent was provided. There were no adverse effects reported.
Patient sat for approximately 2 minutes following injection. After standing for a short period of time, patient fell forward and hit chin/face on floor. She was unresponsive for several minutes. Pulse weak, shallow breathing. Skin pale and diaphoretic. Upon waking up, patient complained of chin and left upper arm tingling. She stated that she felt dizzy and weak before passing out and lost vision.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Pennicillan" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid treatment from 27Oct2023 to 01Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300360712 same patient, different drug/AE.;
mom stated pt started adverse reaction the following morning started w/an boil to lt knee approx 1 inch below, then running nose, & elevated temp; sx cont x 2-3 wks;
This case was reported by a nurse via call center representative and described the occurrence of rash in a 61-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included ENBREL. On 22nd August 2018, the patient received the 1st dose of SHINGRIX. On 25th August 2018, 3 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unchanged. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The patient developed a rash on their trunk and neck, according to the reporter. The rash seemed to be expanding. The reporter did not have lot number or expiration, as the vaccine was administered elsewhere.
Aprox 10 minutes after receiving the vaccine client started c/o stinging and tingling in her hands and they were red, she felt flushed. No medications given. She felt better shortly afterwards. She did not let her PCP know of this information.
Patient was dizzy, and pale and clammy. Had slight ringing in the ear . All symptoms lasted about 25 min.
17AUG93 in for physical local reaction to rt thigh noted; not abscessed, non tender told to observe & call if redness inc; 26AUG93 in for diaper rash-sterile abscess devel on rt lat thigh; 9SEP93 in for URI;