chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023; No adverse event; Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023) 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. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-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 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-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 (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 14 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case
Narrative: Symptoms:   SkinRash & rash not at site of injection Treatment:
Information has been received from a medical assistant referring to a 4 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K016153 with expiration date 24-SEP-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
At time of 2nd vaccination appointment, pt reported that she had experienced both stomach ache and diarrhea for one day post 1st vaccination; also her arm was sore proximal to the vaccination site. The pt did not state that she sought medical attention. When asked, she indicated that she had not notified anyone, not completed a report herself.
Symptoms began about 44 hours after getting the shot. Daily, from 1/4-1/8,  I experienced headaches, fatigue, and low grade fever. The fever never exceeded 100.0 F. Symptoms generally began to worsen between 3-5pm each day. On Thursday night, 1/7, the headache was severe. On Friday, 1/8, all symptoms were very mild. All symptoms ended on Saturday 1/8.
Expired Engerix-B administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 47-year-old male patient who received HBV (Engerix B) (batch number 2793Z, expiry date 5th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th December 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 16th December 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 19-Dec-2022 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The patient received an expired dose of Engerix-B, which led to expired vaccine used.
I had a weird sound in my right ear.  I went to my doctor and I was diagnosis tinnitus.  It is still ongoing.  I had a MRI done, normal results.
About 24 hours after DTaP + IPU given in left arm, it became swollen, red, hot, indurated approximately 13 x 13 cm.  No fever.
One day post vax, the pt experienced hives all over body.  The hives are improving without treatment. The most recent information received reports the condition of the pt as ongoing.
mom reports that on evening of 21MAY98 noticed a small area of redness on rt deltoid;this AM redness had enlarged to about 20x20mm;daycare called mom because of swelling @ site;to hlth dept w/redness, swelling & tenderness;
J & J vaccine 4/6, developed headache N & V 4/7, today 4/14 not any better - tried migraine med with no results. Testing 4/14. Isolate - PTO.  Discussed seeing provider due to H/A after J & J vaccine.
Swelling is spreading down my arm; Arm at the injection site is red; Arm at the injection site is swollen; Headache; Temperature on and off; Cold; Sweat; Achy; Chills; Nurse put the needle in my arm and the syringe broke; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (Nurse put the needle in my arm and the syringe broke), NASOPHARYNGITIS (Cold), PERIPHERAL SWELLING (Swelling is spreading down my arm), HYPERHIDROSIS (Sweat) and PAIN (Achy) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DEVICE CONNECTION ISSUE (Nurse put the needle in my arm and the syringe broke). On 09-Mar-2021, the patient experienced NASOPHARYNGITIS (Cold), HYPERHIDROSIS (Sweat), PAIN (Achy), CHILLS (Chills) and PYREXIA (Temperature on and off). On 10-Mar-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling is spreading down my arm), INJECTION SITE ERYTHEMA (Arm at the injection site is red) and VACCINATION SITE SWELLING (Arm at the injection site is swollen). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) at an unspecified dose and frequency. On 10-Mar-2021, PAIN (Achy) had resolved. At the time of the report, DEVICE CONNECTION ISSUE (Nurse put the needle in my arm and the syringe broke), NASOPHARYNGITIS (Cold), PERIPHERAL SWELLING (Swelling is spreading down my arm), HYPERHIDROSIS (Sweat), CHILLS (Chills), HEADACHE (Headache), INJECTION SITE ERYTHEMA (Arm at the injection site is red), VACCINATION SITE SWELLING (Arm at the injection site is swollen) and PYREXIA (Temperature on and off) outcome was unknown.            No concomitant medications were provided. The patient reported that when nurse put the needle in her arm, the syringe broke, and the vaccine dripped down her arm, but then, the nurse gave her another dose.   .
Upon vaccination patient was fine however when patient was leaving pharmacy at parking lot patient fainted due to vasovagal shock.
Soreness/pain in left arm at the injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 26Apr2021(at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Apr2021, the patient experienced Soreness/pain in left arm at the injection site. The clinical outcome of the event Soreness/pain in left arm at the injection site was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Vomiting, diarrhea, dehydration, metabolic acidosis requiring hospital admission for IV fluids/rehydration.
Pt returned to clinic with  her mother 10 minutes  post flu vaccination ( 10.55 AM on 10/31/2020 )with c/o dizziness and blurred vision while standing in the check-out lane - Mother noticed that pt looked pale and was slightly warm to touch and when child started to fall she hit her left posterior aspect of  her head on the plexi-glass barrier , mother got a hold of her hand as child fell backwards. Per  mother the head did not hit very hard on the floor . Child got up in 1-2 minutes and they walked to the clinic- Vitals -97.9 temp, 65 Pulse,18 Resp, 118/68 BP, and  98% Oxygen sat. Pt did not appear to be in distress; PEERLA,  no increased  work of breathing noted;breath sounds clear to auscultation, regular cardiac rate and rhythm;CN I-XII grossly intact, alert, judgement intact; No bruising , swelling, open wounds or tenderness noted to scalp- No inflammation or erythema noted around the injection site . Pt was observed in clinic for the next 15 minutes .Mother denies any prior reactions including vasovagal response to vaccines or other significant medical conditions - Pt had some water ? verbalized that she is feeling better before she left the clinic- Mother is advised to monitor the child very closely for the next 24 hours ? Consult and follow-up with PCP about the fall and possible head injury and possible need of CT . Mother in agreement with plan of care.  Mother is contacted the today 11/1/2020 at 9.15 am  and she reported that Pt is doing fine.
no adverse effects. off-label use. patient received Pfizer for first dose, wrong second dose as given Moderna
Irregular menses and postcoital bleeding. I have seen multiple providers and had lab work completed as well as pelvic exams, Pap smears, std testing, and abdominal/transvaginal ultrasounds all of which were unremarkable
Patient given vaccination on 10/16/07 at approximately 11 AM. Patient developed soreness in left arm immediately. Said unable to move arm at all without pain at 1:00 PM, patient felt feverish, didn't take her temperature at 4:00 PM patient developed severe headache. On 10/17 at 0300, emesis x 3 over 1-2 hours. All symptoms improved on 10/17, all sx resolved completely morning of 10/18/07.
This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness on face/Numbness on back of head/Numbness on fingers), FEELING ABNORMAL (Feeling foggy) and PARAESTHESIA (Tingling on the back of the shoulder) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. NO medical history information was reported. On 02-Mar-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness on face/Numbness on back of head/Numbness on fingers). On 03-Mar-2021, the patient experienced FEELING ABNORMAL (Feeling foggy) and PARAESTHESIA (Tingling on the back of the shoulder). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbness on face/Numbness on back of head/Numbness on fingers) was resolving and FEELING ABNORMAL (Feeling foggy) and PARAESTHESIA (Tingling on the back of the shoulder) 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. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2021 and was forwarded to Moderna on 03-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness on face/Numbness on back of head/Numbness on fingers), FEELING ABNORMAL (Feeling foggy) and PARAESTHESIA (Tingling on the back of the shoulder) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. NO medical history information was reported. On 02-Mar-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness on face/Numbness on back of head/Numbness on fingers). On 03-Mar-2021, the patient experienced FEELING ABNORMAL (Feeling foggy) and PARAESTHESIA (Tingling on the back of the shoulder). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbness on face/Numbness on back of head/Numbness on fingers) was resolving and FEELING ABNORMAL (Feeling foggy) and PARAESTHESIA (Tingling on the back of the shoulder) 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.
Facial spasm (left side, same as injection arm), warm sensation on left side of face, mild dropping of left side.
Patient was given Moderna Bivalent Booster  0.25mcg, was to be given 0.5mcg.  Wrong dosage given.
No adverse event noted. Vaccine given too early due to patient information. Monitored for 30 mins.
Sore throat, fever, severe  body aches and pains (felt like bones were being crushed), extreme lethargy and fatigue, ulcers on throat, cheeks, and tongue
Patient approached pharmacy staff during 15 minute observation to report feeling of overheating and anxiousness. He was brought into the consultation room where blood pressure was taken which was normal. Patient was given water and a dose of Benadryl as well as provided direct cooling with table fan. He mentioned getting a taste in his mouth prior to the flushing and anxiety as well as blurred vision. He was observed for an additional 45 minutes with symptoms subsiding and was advised to seek medical attention if symptoms reappear as he refused any further medical intervention. Patient was called several hours after vaccine at home where he said he was feeling improvement but was resting.
COVID 19 Treatment; COVID 19 Treatment; Dose 1: Pfizer/ Dose 2: Pfizer/ Dose 3: Pfizer/ Dose 4: Pfizer/ Dose 5: Pfizer/Dose 6: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 70 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 05Jan2021 as dose 1, single (Lot number: EL1284), on 25Jan2021 as dose 2, single (Lot number: EL9262), on 08Oct2021 as dose 3 (booster), single (Lot number: FF2590) and on 03Apr2022 as dose 4 (booster), single (Lot number: FK9894) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05May2023 as dose 6 (booster), single (Lot number: AS7184B) for covid-19 immunisation. The patient's relevant medical history included: "Moderate Immunodeficiency Syndrome" (unspecified if ongoing); "known allergies/ allergy to Ceftin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05May2023, outcome "unknown", described as "Dose 1: Pfizer/ Dose 2: Pfizer/ Dose 3: Pfizer/ Dose 4: Pfizer/ Dose 5: Pfizer/Dose 6: Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid from  21Sep2023 to 25Sep2023 as Treatment of COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300315889 same patient, different drug/event;
On May 9, I got the J&J/Janssen COVID vaccine at the local pharmacy in my neighborhood. On May 17, I got my period which was pretty much normal. Then on June 12, my period started as normal, however it didn't end until June 23. There was lots of heavy bleeding and tiredness.   I haven't had a period for the month of July. It should have started around the 7th, but it's over a week late. I'm experiencing the bloating and tiredness of a period, except I'm not bleeding.
Moderna Covid-19 vaccine EUA. 0.5ml given instead of 0.25ml.
on April 2 nd i had to go to family walk in clinic over chest pains and contractions. The clinic ran vitals with EKG letting me know a ambulance had to be called cause i was having a heart attack. I was not aloud to leave . In the ambulance i was giving Asprin  ,Nitros and a blood clot remover with high blood pressure meds. Takin to hospital.
I started to have a sore arm 2 days after i received the first dose of the vaccine on Jan 5, 2021.  As of today, Jan. 14, my arm is still very sore.  I'm not sure how long this lasts but it is very sore.
Early menstruation. I should be ovulating today and instead I got my period 2 weeks early with all typical menstrual side effects, bleeding, cramps, body aches.
On 5/8 I felt like I just had a cold. I had a runny nose, I felt like my sinuses were swollen and I was talking in a bubble. I had all the signs of the beginning of a cold and I had an increased thirst. I took an at home Covid test which was positive. I called my doctor on 5/30 to inform them of my results, but since my symptoms were not sever and I had no fever, they advised that I just monitor my symptoms. My symptoms have been gradually improving.
weakness; blood pressure dropped significantly; light headedness; This is a spontaneous report from a contactable consumer (father). A 16-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on Jun2021 (Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced weakness, blood pressure dropped significantly and light headedness. The patient was hospitalized due to the reported events on an unspecified date in 2021. The father stated that his son had a severe reaction to the vaccine and went to the doctor twice and the hospital. He stated his son is feeling better now and wants to know if there is any evidence or data on the second dose and having another reaction. He stated when he first got the shot his blood pressure dropped significantly and they held him at the location for a while. His blood pressure returned to normal and he was good for about 2 weeks and then he started to experience light headedness and weakness that almost lasted two months. He states that his son is almost back to normal and is hesitant to get the second dose. The reported events resulted in physician office visit. Therapeutic measure was taken as a result of the events. The outcome of the events was recovering.    The lot number for BNT162B2 was not provided and will be requested during follow up.
26 yo Air force active duty female with hx of delayed hives following AVA #2 and #3. Hives cleared. Allergy w/u included positive skin testing in April and Oct 2003.
SLEEPING LOT; JOINT ACHES; CHILLS; HIVES; FEVER; EXTREME TIREDNESS; HEADACHE; MUSCLE ACHES; PAIN AT INJECTION SITE; ELEVATED HEART RATE; TIGHTNESS IN CHEST; TIGHTNESS IN JAW/TIGHTNESS IN BACK; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included thyroid issue, and chemical exposure, and concurrent conditions included no alcohol use, non smoker, penicillin allergy, and codeine allergy. The patient experienced drug allergy when treated with acetylsalicylic acid.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982 expiry: 07-AUG-2021) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-JUN-2021, the subject experienced elevated heart rate. On 24-JUN-2021, the subject experienced tightness in chest. On 24-JUN-2021, the subject experienced tightness in jaw/tightness in back. On 24-JUN-2021, the subject experienced joint aches. On 24-JUN-2021, the subject experienced chills. On 24-JUN-2021, the subject experienced hives. On 24-JUN-2021, the subject experienced fever. On 24-JUN-2021, the subject experienced extreme tiredness. On 24-JUN-2021, the subject experienced headache. On 24-JUN-2021, the subject experienced muscle aches. On 24-JUN-2021, the subject experienced pain at injection site. On an unspecified date, the subject experienced sleeping lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint aches, headache, and muscle aches on 26-JUN-2021, had not recovered from elevated heart rate, extreme tiredness, tightness in chest, and tightness in jaw/tightness in back, and the outcome of pain at injection site, fever, chills, hives and sleeping lot was not reported. This report was non-serious.
Neck pain; Back pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN (Neck pain) and BACK PAIN (Back pain) 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 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced NECK PAIN (Neck pain) and BACK PAIN (Back pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Back pain and Neck pain, at an unspecified dose and frequency. At the time of the report, NECK PAIN (Neck pain) and BACK PAIN (Back pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient went to her doctor on 17-Mar-2021 and she was prescribed pain medication but the pharmacy did not had the medication available. She had taken Advil (ibuprofen) but the pain was still present at the time of reporting. She said she cannot sleep on her side but had to sleep on her back. She was not on any medication.