chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients "over 14 years of age" received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date of the administration of GARDASIL 9 for this male (age unknown) was reported to be 1) 31-AUG-2015. No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Unusual amount of crying about one hour after immunizations, crying and unconsolability lasted for several hours. Repeat exam about five hours after immunizations showed by a fussy but consolable infant with minor redness at injection site.
No adverse event reported. This is inform that patient received a first booster of the moderna bivalent after its beyond use date. Vial was moved to fridge on 4/3/2023 and patient received vaccine on 5/12/23
Pfizer-BioNTech COVID-19 Vaccine EUA: During post-observation period, vaccine recipient complained about anxiety. Their lip and tongue was cyanotic. They were monitored by EMS and the pulse ox was 98%. Symptoms resolved.
I WOKE UP SATURDAY MORNING WITH FLU LIKE SYMPTOMS (FREEZING ONE MOMENT THEN BURNING UP THE NEXT). THAT WENT ON UNTIL MONDAY AFTERNOON. SATURDAY MORNING I ALSO NOTICED MY LEFT LEG WAS SWOLLEN AND HAD A BLUEISH/REDDISH COLOR AND WAS THROBBING. FROM TIME TO TIME i WOULD EXPERIENCE A SHARP PAIN BEHIND MY KNEE AND THIGH. AFTER A WEEK THE SYMPTOMS DID NOT GO AWAY SO I WENT TO THE DOCTOR. HE ORDERED AN ULTRASOUND ON MY LEG. THAT SAME DAY I HAD THE ULTRASOUND WHERE THEY FOUND MULTIPLE BLOOD CLOTS IN MY LEFT LEG. DOCTOR IMMEDIATELY PUT ME ON ELIQUIS. THE DOSE FOR THE FIRST 2 WEEKS WAS 10MG TWICE A DAY (10 MG MORNING AROUND 8AM AND 10 MG AROUND 8 PM). AFTER 14 DAYS HE REDUCED MY DOSE TO 5 MG AM AND 5 MG PM.
The injection site for the vaccinations were swollen and hard for 4 days following the vaccine. The baby was exhausted the day after the vaccination and slept a lot. The baby began vomiting and had diarrhea beginning 2 days after the vaccination and it continued through day 4 after the vaccination.
pt recv vax 21AUG95 & 20FEB97 pt devel 20 lesions that were described as chickenpox;
is redness around shot normal 2nd shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (is redness around shot normal 2nd shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (is redness around shot normal 2nd shot). At the time of the report, VACCINATION SITE ERYTHEMA (is redness around shot normal 2nd shot) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported. Action taken with mRNA-1273 in response to the events were Not Applicable.
Patient was 12 years and 2 months old and accidentally given the Pfizer pediatric dose approved for 5-11 years old.
Narrative:  Patient 49yo male passed away on10/10/2022 at his home of unknown cause. Patient was found by his landlord in his apt. Pt with history of Alcohol dependence (SCT 66590003) & Amphetamine dependence (SCT 21647008) & homelessness (resolved issue). Patient had received a covid vaccine EUA (J&J) on 7/15/2021. No other medical problems in patient's medical chart. Likely covid vaccine is not related to this death given long length of time in between date of vaccine and date of death.
Chest pain began shortly afterwards with shortness of breath on exertion. Four days afterwards developed left sided numbness and weakness, admitted for stroke rule out and diagnosed with migraine variant. Continuing to have migratory pins and needles sensations, severe headaches, foggy thinking and less intense chest pain.
vomiting described as "projectile", acting "lethargic".  Seen in ER at 7:30pm, recovered to normal, discharged home.
Muscle and joint soreness over entire body beginning approximately within an hour after injection and lasting approximately 12-24 hours in total duration.
Huge red welt that is swollen and itchy.  My whole arm is very sore and hurts to move...each day it is getting worse, today it is darker in color than it was yesterday and the site is hard as a rock now.  I called the pharmacy yesterday to inform them of what has taken place and they let me know to ice it and take a Tylenol, but even with following the instructions to the point of sleeping with ice on it through the night, it is now itching immensely and really seems to be worse.  I continue to feel light headed, nausea and almost blacked out last night...no appetite whatsoever and have lost weight.  I am seeing a Dr. tomorrow and getting their professional opinion as to my symptoms.  I just wanted to do the right thing and let someone know that the site reaction where I received this injection is absolutely not conducive with other shot's or injections I receive.
Severe arm soreness; This is a spontaneous report from a non-contactable other health professional A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. Vaccine location: Left arm, Dose number:1. The patient medical history and concomitant medications were not reported. The patient experienced severe arm soreness on an unspecified date with outcome of unknown.  The action taken was not applicable. No follow-up attempts are possible; information about lot/batch number cannot be obtained
This case was reported by a sales representative and described the occurrence of decreased therapeutic response in a subject of unspecified age and gender who was vaccinated with Hepatitis B vaccine (GlaxoSmithKline). On unspecified dates, the subject received unspecified dose of Hepatitis B vaccine (unknown). At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced decreased therapeutic response. The sales representative reported that she "heard through hearsay", at least one subject had a titer of 7,000 mIU when a protective titer is considered 10,000 mIU, after completing the hepatitis B vaccine series in the past. The timing of this subject's previous vaccine series was not known. The sales representative did not have any further subject data at this time. She did not know what brand of hepatitis B vaccine had been used in the subject in the past. The sales representative will attempt to get further information. Relevant test results included hepatitis B antibody titer of 7,000 mIU. At the time of reporting the outcome of the event was unspecified.
Flu-like symptoms/ "Don't feel good", "ear feels clogged", "tired and wants to rest".
stroke; couldn't walk; Breathing was shower; eye sight was been worse; bad headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 245A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product AMLODIPINE for an unknown indication.    The patient's past medical history included No adverse event (No medical history reported. ).   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started AMLODIPINE (unknown route) at an unspecified dose. On 25-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant), GAIT DISTURBANCE (couldn't walk), RESPIRATORY RATE DECREASED (Breathing was shower), VISUAL IMPAIRMENT (eye sight was been worse) and HEADACHE (bad headaches). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), GAIT DISTURBANCE (couldn't walk), RESPIRATORY RATE DECREASED (Breathing was shower), VISUAL IMPAIRMENT (eye sight was been worse) and HEADACHE (bad headaches) had not resolved. Not Provided          Treatment for the event included clonidine, aspirin (81mg) to try to thin the blood, losartan, atorvastatin and cyclobenzaprine.  Action taken with mRNA-1273 in response to the event was not applicable.  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.
Several weeks of nose bleeds.  Almost every other day.  Doctor said the capillaries in my nose were bleeding and he could cauterize if I wanted him too.  By the time I went to the doctor the bleeds were getting less and less so didn't have him cauterize the nose.  My stools were very dark during that time so I thought I might be bleeding elsewhere too.
sick in bed for 5 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick in bed for 5 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick in bed for 5 days). At the time of the report, ILLNESS (sick in bed for 5 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment was provided. No concomitants were provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: follow up received on 10-jun-2021, AE contact information updated.
Pt recvd vax & devel severe fever blisters 3-4 wks p/dose 2; events have not subsided;
Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 29-Oct-2020 and the estimated date of delivery was 05-Aug-2021. On 06-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  tenth week of the pregnancy.  On 06-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Nov-2020, Blood phosphorus: positive (Positive) Positive. On 23-Nov-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment information was not reported. Estimated due date Aug 2021.  This is a case of product exposure during pregnancy with no associated AEs for this female patient of an unknown age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient of an unknown age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Woke up at 4:00am the next morning with fever, muscle aches over whole body, soreness at injection site, headache, sore throat. Starved the fever for a few hours and took Tylenol. I had broken the fever by 7:30am that morning and only minor body aches persist.
Information has been received from a health professional concerning a patient (14 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F).  It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day.  Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a 59 year old female patient. No medical history or drug allergies were reported. On 01-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # H022152, expiry: 18-MAR-2014). Concomitant therapies included RESTASIS. On 03-AUG-2013, the patient experienced redness around the injection site after receiving ZOSTAVAX. Patient sought medical attention contacted pharmacist. No treatment was given. No laboratory diagnostics studies were performed. The outcome of redness around the injection site was reported as recovering. Additional information has been requested.
Red very swollen sore arm; Red very swollen sore arm; Red very swollen sore arm; This is a spontaneous report from a contactable physician via Pfizer Sales Representative.  A 63-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at single dose on an unspecified date for immunisation.  Medical history included smoker. Concomitant medications were not reported. The patient experienced red very swollen sore arm on an unspecified date with outcome of recovering. Therapeutic measures were taken as a result of red very swollen sore arm included Benadryl. Two days later all symptoms had subsided and didn't need to be rechecked.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
FLU LIKE SYMPTOMS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu like symptoms was not reported. This report was non-serious.
Patient indicates when administering the third dose Moderna " his mouth got locked" also reports neck pain. The reaction lasted 7 days.
Pt received Covid 19 Moderna  While waiting afterward reports chest tight, heart racing feeling flushed. SOA relieve by removing face mask.  Reported this happened 2 wks ago & this happen prior to that & thought to be anxiety
persistant, inconsolable crying from 10AM until 5PM on day of vax;
Flu shot Tuesday @2pm. I had an egg allergy as a child but think I've grown out of it...I eat quiche, cake, etc. 30 hours after flu shot I got red legs and arms, itching, and very cold, hard to stay warm. Chills subsided in a few hours, remnants of rash lasted several days.
pt recvd DTP/OPV/HIB mom reported the following day that pt would not walk due to inject site pain; also, has been very irritable;
LOSS OF SOME HIGH FREQUENCY HEARING; TINNITUS; NAUSEOUS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 40 year old male. 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, and batch number were not reported) dose was not reported, administered on APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 40 years old. No concomitant medications were reported. On 2021, the patient experienced headache, fever, and nauseous. On an unspecified date, the patient experienced ear problem of a loss of some high frequency hearing, and tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and nauseous on 2021, and the outcome of headache, loss of some high frequency hearing and tinnitus was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Gave DTaP instead of Tdap.  Pt had stepped on nail day before injection.  No adverse effects reported.
No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jun-2023, 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. On 20-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date).    No concomitant medications were reported. Patient was over 18 years of age. Staff gave patients vaccines past the use date of 18 Jun 2023. On 20-Jun-2023, 5 doses were administered at administration site 2. Treatment medications were not reported.  This case is for 17th patient out of 47 patients reported by reporter.    This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live significant follow up received: vaccine administration date was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master Case (Patient 1)
Chronic coughing and sneezing, disturbing normal routine and eating, coughing and sneezing every 2-10 minutes. Persistent for 11 months without relief from OTC medication or Rx medication.
Hashimoto's disease; missed for second dose; This spontaneous report was received from a physician referring to a 20 years old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.  On an unknown date, the patient was vaccinated with 1 out of the 2 required doses of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, lot# and expiration date were not provided) 0.5 milliliter for prophylaxis.         On an unknown date, the patient was diagnosed with Hashimoto's disease and had never had her second dose of varicella virus vaccine live (oka/merck) (VARIVAX).  The outcome of Hashimoto's disease was not recovered. The causality between the event and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided.   Upon internal review, Hashimoto's disease was determined to be medically significant.
feel bad; tiredness; weakness; headache; his arms and feet are cramped; feel sick; feel pain in his arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administration date 09Aug2021 (Batch/Lot number: unknown) at the age of 42 years 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: PAIN IN EXTREMITY (non-serious) with onset 10Aug2021, outcome "unknown", described as "feel pain in his arm"; FEELING ABNORMAL (non-serious) with onset 20Aug2021, outcome "unknown", described as "feel bad"; FATIGUE (non-serious) with onset 20Aug2021, outcome "unknown", described as "tiredness"; ASTHENIA (non-serious) with onset 20Aug2021, outcome "unknown", described as "weakness"; HEADACHE (non-serious) with onset 20Aug2021, outcome "unknown", described as "headache"; MUSCLE SPASMS (non-serious) with onset 20Aug2021, outcome "unknown", described as "his arms and feet are cramped"; ILLNESS (non-serious) with onset 20Aug2021, outcome "unknown", described as "feel sick".  Additional Information: Caller received the first dose of the Pfizer Covid-19 vaccine on 09Aug2021, the next day he started to feel pain in his arm and on Friday 20Aug2021 began to feel bad, he has felt tiredness, weakness, headache and his arms and feet are cramped. He would like to know if this is normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.