chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine stored on 18-Oct-2021 and then administered on 26-Oct-2021; 601 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine stored on 18-Oct-2021 and then administered on 26-Oct-2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine stored on 18-Oct-2021 and then administered on 26-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine stored on 18-Oct-2021 and then administered on 26-Oct-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. Date the vial was placed in refrigerator was on 18-Oct-2021. Temperature excursion was not reported. The patient did not experience any adverse event. The reporter stated that initially there were 606 doses from expired lot and they found out later that some patients that were impacted had received the Janssen COVID-19 vaccine. Treatment information was not provided.
Felt only a little tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt only a little tired) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Felt only a little tired). At the time of the report, FATIGUE (Felt only a little tired) outcome was unknown.            No concomitant medication was provided by the reporter.  It was reported that patient received first, second and booster Moderna Covid-19 and stated she has no problems with the Moderna's Covid-19 vaccine but stated she felt only a little tired after receiving one of the doses but did not  did not clarify which one. Patient stated that she heard rumors and read information that stated that the Moderna's Covid-19 vaccine can weaken the immune natural system of patients who received it and they are more likely to get the flu, fever, etc after vaccinated.   No treatment medication was provided by the reporter.
Shortness of Breath; weird chest feeling; Muscle pain inside the chest; 2nd dose beyond the recommended interval; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath), CHEST DISCOMFORT (weird chest feeling), MYALGIA (Muscle pain inside the chest) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose beyond the recommended interval) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 091D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced DYSPNOEA (Shortness of Breath), CHEST DISCOMFORT (weird chest feeling) and MYALGIA (Muscle pain inside the chest). 21-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose beyond the recommended interval). At the time of the report, DYSPNOEA (Shortness of Breath), CHEST DISCOMFORT (weird chest feeling), MYALGIA (Muscle pain inside the chest) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose beyond the recommended interval) outcome was unknown.            Patient had reported that he was worried about Myocarditis and the pain he was experiencing.  Concomitant information was not reported. Treatment information was not reported.
small blisters versus pustules @ center cellulitis, rt arm site of inj;med given;
Local arm swelling. Seen at the emergency room and diagnosed with an allergic reaction and cellulitis. Treated and released.
Got vaccine approximately 4 pm on 5/16/2021.  Had (expected) injection site soreness the next day or so.   Woke up in a.m. on 5/21/2021 with itching hives on both lower arms (starting at elbows down to hands)   and both legs starting at mid thigh and going all the way to feet.  Used hydrocortisone cream topically which seemed to ease symptoms for about 1 hour  and now itching is  starting to return.
Fever; Dizzy/ Light-headed; Tired; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 16Apr2021 at 11:15 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, cholesterol, triglycerides and allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN), triamterene (MANUFACTURER UNKNOWN) and evolocumab (REPATHA); all for unknown indication from unknown date and unknown if ongoing. The patient previously received amoxicillin (MANUFACTURER UNKNOWN), ampicillin (MANUFACTURER UNKNOWN) and neomycin sulfate; polymyxin b sulfate; bacitracin (NEOSPORIN); all for unknown indication on unknown date and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 17Apr2021 at 11:30, the patient experienced fever, dizzy, light headed, tired and was not going away. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, dizzy, light-headed and tired was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Within a few minutes while sitting on the chair after injection, felt my heart suddenly race, a flushing sensation occurred, and I tasted something in my mouth (chemical or metallic taste).  I started to get dizzy and was sweating.  Called over the Fire Dept personnel who were administering the injections and they helped me (fluids, ECG, etc.).  During this time they stated that my blood pressure dropped to the low 40's (not sure the exact number) and my heart rate as well.  My complexion was pale to them and sweating a lot.  After administering IV fluids a few minutes later my BP and HR started to rise.  My SpO2 was good.  Transported to ER for evaluation and labwork.
D68.9 COAGULOPATHY, UNSPECIFIED TYPE 4/24/2023 RECTAL BLEEDING D68.9 COAGULOPATHY, UNSPECIFIED TYPE 4/24/2023 DM 2 W MIXED HYPERLIPIDEMIA
Chest pain developed early morning. Persistant and progressive. Seen in urgent care with diffuse ST elevation, elevated troponin. Diagnosis of myopericarditis.
Developed fever of 102  that lasted for nearly 36 hours with body aches, chills, feelings of generalized fatigue
Injection site pain, Injection site swelling, Injection site redness, tiredness after injection
Red Mark; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red Mark) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-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 INJECTION SITE ERYTHEMA (Red Mark). At the time of the report, INJECTION SITE ERYTHEMA (Red Mark) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt received immunizations on 03-18-2008. 3-4 hrs later pt developed hives on trunk and limbs.
Arm was swollen with a big bump where injection site was. Then a rash developed that lasted several days. The injection site was quite painful for several days. I also received a pneumonia vaccine in my other arm that day. Also my diverticulitis had not been diagnosed until 1 1/2 months later. After a round of antibiotics the diverticulitis cleared up but the pain never went away.
Sore arm, redness, swelling, hot to touch, itches when touched when the patient reported the symptoms on 4/17/21
Felt achy and trouble sleeping all night post 2 nd injection. Woke up at 3 am with fever 100.5. Headache, chills, sweating, low grade fever 99.5 all day until about 10:00 pm on 1/8/21.  80% better on 1/9/21 just lower back soreness and mild headache. 100% better on 1/10/21. This was my second vaccine.
Expired dose of Shingrix administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received Herpes zoster (Shingrix) (batch number LG3B4, expiry date 08-APR-2023) for prophylaxis.   In APR-2023, the patient received the 2nd dose of Shingrix. In APR-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Expired dose of Shingrix administered to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 25-APR-2023 The pharmacist called to inform that it was possible that earlier that day, an expired dose of Shingrix had been administered to a patient. The Vaccine Administration Facility was the same as primary reporter. Consented to follow up. The patient received expired dose of Shingrix vaccine, which led to expired vaccine used.
Patient came to the Walk in Vaccination clinic and stated he is an essential personal . After receiving his vaccine,  patient reported feeling  ?tingling in his throat? and feeling anxious. patient was taken by RN to our first aid area and asked to sit  down. Patient denied shortness of breath or any other symptoms except tingling in his throat. Patient reported that he has no allergies to medications or foods but has a history of anxiety and stopped taking his medication 1 month ago. B/P was elevated 181/90,   P 100 Pulse ox 100%, T 98.1. Patient refused an epi pen and asked to remain lying down so he could calm down .   LVN Rechecked patient vitals in 15 min . Results were 124/88 , pulse ox 100%, T WNL. Patient stated he no longer felt tingling in his throat and denied any  . Pt was advised to wait an additional 15 min before heading home .
four children including my son went in with this illness/DID NOT PROTECT HIM FROM BACTERIAL MENINGITIS; four children including my son went in with this illness/Suspected vaccination failure; This case was reported by a consumer via interactive digital media and described the occurrence of bacterial meningitis in a child patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced bacterial meningitis (serious criteria death and GSK medically significant) and vaccination failure (serious criteria GSK medically significant). On an unknown date, the outcome of the bacterial meningitis was fatal and the outcome of the vaccination failure was unknown. The reported cause of death was bacterial meningitis.   The reporter considered the bacterial meningitis and vaccination failure to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at the vaccination was not reported. The patient was given meningitis B vaccine and it did not protect from bacterial meningitis. The reporter reported children went in with this illness. The patient did not survive. This case was considered as suspected vaccination failure, since the details regarding dose number, time to onset and laboratory confirmation were not provided. This case is linked to the case US2020AMR232425, US2020AMR232426 and US2020AMR232267.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR232267:same reporter US-GLAXOSMITHKLINE-US2020AMR232425:same reporter US-GLAXOSMITHKLINE-US2020AMR232426:same reporter; Reported Cause(s) of Death: Bacterial meningitis
No additional AE's and no PQC's were reported; patient missed his third dose of GARDASIL 9 according to the dosage schedule; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On unknown dates, the patient was vaccinated with two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, pre-filled syringe, for prophylaxis (exact dose, route of administration, anatomical site, lot # and expiry date were not provided). On 01-MAR-2021, the patient missed his third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) according to the dosage schedule (product dose omission issue). No additional adverse event was reported (no adverse event).
no adverse event, patient was discovered to be under 18 after paperwork review after shot was administered. Will let them know that we cannot give dose 2 until the patient turns 18
Leukopenia, Severe sepsis. ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Light headed, felt feverish but body temperature was 97.4 F, felt like heart rate was elevated. Resolved after 20-30 minutes.
Patient experienced tingling in the left hand and arm for approximately 20 minutes after getting shot. He also had a numbing feeling along left side of face and jaw that lasted about an hour. No treatment needed.
I woke up at 1:30 and my entire body was aching, but like each spot had its own ache -- not a general overall ache.  Very hard to describe.  I don't mean a little ache here or there.  I mean I couldn't turn on either side or flip over.  Even the backs of my hands separately ached.  I'd never felt like this before.    After 15 minutes of trying to figure out what was going on, I got up and took 2 Advils.  About 20 minutes later, the aching had subsided.
Headache; Neck Swelling (Sore throat); Neck Swelling (Sore throat); This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), OROPHARYNGEAL PAIN (Neck Swelling (Sore throat)) and SWELLING (Neck Swelling (Sore throat)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     NO medical history reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), OROPHARYNGEAL PAIN (Neck Swelling (Sore throat)) and SWELLING (Neck Swelling (Sore throat)). At the time of the report, HEADACHE (Headache), OROPHARYNGEAL PAIN (Neck Swelling (Sore throat)) and SWELLING (Neck Swelling (Sore throat)) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  Treatment details included Advil.
Approximately 7 minutes after vaccines were administered, patient fainted from a standing position. No injury. Patient responsive but dizzy and pale. Patient's BP WNL. Full recovery after about 7-10 minutes of rest.
Seasonal influenza vaccine administered to left shoulder resulting in moderately severe myalgia and limited ROM of the arm, worsening x2 days.  Unknown type of influenza vaccine, chose random one from the list in item 17 out of necessity.
Penicillin allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 12-Jul-2020 and the estimated date of delivery was 19-Apr-2021. On 13-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient was pregnant at first and second dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-sixth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Delivered NOS. she delivered baby and baby is 2 months. On 13-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Patient was pregnant at first and second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Glucose tolerance test: normal (normal) normal. On an unknown date, Ultrasound scan: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Genetic testing was abnormal before vaccination, however, at the time of report it was normal. The number of fetuses was reported as 1 and had established prenatal care. There was no complications and acute illness during this pregnancy to date. The patient gave full-term  live birth to baby on 09-Mar-2021 (at 39 weeks and 7 days). There was no maternal history of subfertility.  It was reported that mother and baby were doing good and had no adverse events.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Birth type and narrative was updated.
Swelling, firmness,  itching,  and rash at injection site Migraine headache Slight may without vomiting
Fevers, shortness of breath, chills, exhaustion, cough, headache. Arm soreness at injection site.
Cognitive fog; Ocular migraine; Dizziness; Injection site discomfort; Burning sensation behind the eyes; pruritus at injection site; erythema at injection site; Fever 101+; Chills; Arthralgia; Fatigue; Headache; Myalgia; Nausea; This spontaneous case was reported by a health care professional and describes the occurrence of COGNITIVE DISORDER (Cognitive fog), OPHTHALMIC MIGRAINE (Ocular migraine), DIZZINESS (Dizziness), INJECTION SITE DISCOMFORT (Injection site discomfort) and EYE IRRITATION (Burning sensation behind the eyes) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Drug allergy, Food allergy, Dust allergy and Seasonal allergy. Concomitant products included METOPROLOL SUCCINATE (TOPROL XL) and HYDROCHLOROTHIAZIDE for Hypertension, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Multiple allergies.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COGNITIVE DISORDER (Cognitive fog), OPHTHALMIC MIGRAINE (Ocular migraine), DIZZINESS (Dizziness), INJECTION SITE DISCOMFORT (Injection site discomfort), EYE IRRITATION (Burning sensation behind the eyes), VACCINATION SITE PRURITUS (pruritus at injection site), VACCINATION SITE ERYTHEMA (erythema at injection site), PYREXIA (Fever 101+), CHILLS (Chills), ARTHRALGIA (Arthralgia), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Myalgia) and NAUSEA (Nausea). At the time of the report, COGNITIVE DISORDER (Cognitive fog), OPHTHALMIC MIGRAINE (Ocular migraine), DIZZINESS (Dizziness), INJECTION SITE DISCOMFORT (Injection site discomfort), EYE IRRITATION (Burning sensation behind the eyes), VACCINATION SITE PRURITUS (pruritus at injection site), VACCINATION SITE ERYTHEMA (erythema at injection site), PYREXIA (Fever 101+), CHILLS (Chills), ARTHRALGIA (Arthralgia), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Myalgia) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reporting a delayed local reaction on days 12 and 13 after dose 1 of the Moderna COVID vaccine administration. Erythema and pruritus at injection site. Both began after patient stopped receiving the v-safe daily check-ins.   This case was linked to MOD-2021-075991 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: follow up was received on 19 Apr 2021, reporter information was updated, patient details were updated(age, height and weight), medical history was updated (hypertension and allergy), vaccine information was updated (start date, batch no., dosage text, route, anatomical site), concomitant drugs were updated.
Patient received vaccine while seated. Patient was then standing and using her phone. After five minutes patient fainted on their back. Patient was rolled over to side. Patient then regained consciousness and asked what happened. The ambulance was called to the scene and took the patient to the hospital for further testing. Blood pressure and blood sugar readings were taken by EMT. EMT asked patient how she felt and patient stated she felt light headed. EMT spoke with parent and parent stated to take daughter to hospital for further tests. Parent called back stated all tests were normal and daughter was fine.
throat started getting swollen; hard for me to swallow; face started getting flush and started to swell too; face started getting flush and started to swell too; tongue started to feel funny; This is a spontaneous report from a contactable other health care professional (patient). A 30-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 at 18:30 hours (Batch/Lot Number: EM9810) as DOSE 1, SINGLE (at the age of 30-years-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. On 09Feb2021, the patient's throat started getting swollen, it was hard for the patient to swallow. The patient's face started getting flush and started to swell too. The patient's tongue started to feel funny. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events. The patient received treatment for the events with Benadryl, steroids, and Pepcid. The patient did not have any other vaccine in four weeks and was on no other medications in two weeks. The patient had not had COVID prior to vaccination and was not COVID tested post vaccination. The patient was recovering from the events.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Fever 100.4 F, bad headache, substantial body aches/generalized pain, chills for approximately 15 hours in duration, onset 2 hours after vaccine administration. Marked weakness and exhaustion during recovery the following day.