chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initially stored in the refrigerator on 14-Jan-2023 and was administered on 16-Feb-2023; No Adverse event; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 14-Jan-2023 and was administered on 16-Feb-2023) and NO ADVERSE EVENT (No Adverse event) in a 36-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     The patient had no known allergies. Previous COVID-19 diagnosis was unknown.  Previously administered products included for Product used for unknown indication: Janssen COVID-19 vaccine (Dose 1) on 26-Dec-2021. Past adverse reactions to the above products included No adverse event with Janssen COVID-19 vaccine.    On 16-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 16-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 14-Jan-2023 and was administered on 16-Feb-2023) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) had not resolved and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 14-Jan-2023 and was administered on 16-Feb-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 administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 14-Jan-2023 and was administered on 16-Feb-2023).    No concomitant medications were reported.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient received the initial booster dose of Moderna COVID-19 vaccine, Bivalent. Pharmacist reported that they inadvertently gave some vaccines past the 30-day BUD date of 13-Feb-2023 and were administered on 16-Feb-2023. Individual vials of Bivalent of 2.5 mL vial was initially stored in the refrigerator on 14-Jan-2023. The vial did not undergo any temperature excursions.  No treatment medications were reported.
Has had a rash on right arm since receiving FLULAVAL vaccine. Rash is itchy and unfortunately this has happened to multi patients in our practice.
Headache, Nausea, fever, chills, flusing of face and upper torso. Edema and warth at injection site
fever x 3 days (102.5), rigors, diaphoresis, severe fatigue, contralateral side inguinal lymphadenopathy (right side), severe localized arm pain x 4 days, severe muscle and bone pain at site of NSCLC metastatic lesion (right pelvic bone) x 3 days. Left axillary lymph nodes remain unremarkable. Partially responsive to acetaminophen. Fever and pain resolved 4/5/21. Inguinal Lymphadenopathy, mild edema inner right thigh, presence of tortuous vessels right inguinal region with pain present on pressure, and mild left arm pain persist as of 4/7/2021.
Immediately after the vaccination she experienced chest pain, tachycardia, and throat tightness. She was given benedryl and epinephrine and EMS was called.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # reported as L040054, expiration date 26-DEC-2017, dose and route not reported). No adverse effects were reported. Additional information has been requested.
Cough, tightness in chest, eyes bright red and puffy, took Zyrtec. Spoke to ER nurse. 11:00PM feeling better. She believes it wass "occular respiratory syndrome".
PATIENT REPORTS REDNESS IN THE INJECTION SITE AND RASH ABOUT COUPLE INCHES ON HER ARM
patients that received a dose administered  more than 12 hours post puncture; patients that received a dose administered  more than 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (patients that received a dose administered  more than 12 hours post puncture) and EXPIRED PRODUCT ADMINISTERED (patients that received a dose administered  more than 12 hours post puncture) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 060A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jul-2022 at 7:25 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients that received a dose administered  more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patients that received a dose administered  more than 12 hours post puncture). At the time of the report, PRODUCT STORAGE ERROR (patients that received a dose administered  more than 12 hours post puncture) and EXPIRED PRODUCT ADMINISTERED (patients that received a dose administered  more than 12 hours post puncture) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was initially stored in the refrigerator was 29-Jun-2022 The vial was first punctured was 6-Jul-2022 7:49am EST The date of administration of vaccine was 7-Jul-2022 7:25am and 7:45am The vial stored in fridge post puncture. The vial was not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree Celsius to 25 degree Celsius = 46 degree to 77 degree F) was Less than 30/45 minutes The vial was not exposed to room temperature for more than 24 hours. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-614415 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-614415:2nd patient
headache; This is a spontaneous report from a contactable consumer (the patient) from a sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 02Mar2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a headache after the vaccine. She asked if she was able to take paracetamol (TYLENOL). The outcome of headache was unknown.   Information on the lot/batch number has been requested
Patient experienced burning in the mouth and throat, swelling of the face and lips, increased secretions from the mouth and eyes, as well as pain and swelling at the injection site.
I noticed a slight swelling of my palms near the wrists on the following morning of my first dose of the Covid vaccine.  I took a dose of pseudoephedrine and the swelling went down.  Other reactions were tiredness and injection site pain.
A day or 2 later, soreness, redness, pain, swelling from shoulder to elbow in upper muscle area, warmth and rash. Started home treatment ice packs, cortisone ointment. It bothered mostly at night so slept with ice pack. Had no fever or fatigue. Did not bother for exercise. On 10/28 went back to doctor who specified she was having a local reaction. to continue with home treatment and to take antihistamine (over the counter) which only took 1 or 2 because reaction was going away. Today doing well. By 11/2 reaction was gone.
Case number PHEH2014US019557 is an initial spontaneous report received from a pharmacist on 26 Sep 2014. This report refers to an adult female patient who was in her 20's. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 145404) intramuscularly on an unknown date in Sep 2014 (reported as 21 Sep 2014 or 22 Sep 2014). It was reported that after vaccination, on an unknown date in Sep 2014 she experienced heat and rash at the vaccination site. The pharmacist did not know if the rash persists or it has discontinued. The event outcome was unknown. The seriousness and causality were not reported.
This spontaneous report was received from a nurse practitioner refers to multiple unspecified patients of unknown gender and age. Information regarding their medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unspecified dates in 2016 (reported as between February 2016 and April 2016), the patients were vaccinated with improperly stored doses of GARDASIL (lot # K006960, expiry date: 19-FEB-2017). Nurse reported that the vaccine underwent a temperature excursion in a large refrigerator at an unspecified temperature for an unknown time frame. No adverse events were reported. This is one of the eight reports received from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable consumer. A 70-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: was not reported), via an unspecified route of administration, on an unspecified date (age at the time of vaccination 70-years-old) as a single dose for COVID-19 immunization. Patient previously received first dose of BNT162b2 vaccine, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache and body aches. The outcome for all the events was unknown. Information of Lot/ Batch number have been requested.Follow-up attempts are completed. No further information is expected.
MOC noticed right arm was hot to the touch and red with mild swelling. Pt diagnosed with cellulitis.
severe headache; Iintercranial bleed; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache) and HAEMORRHAGE INTRACRANIAL (Iintercranial bleed) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Blood transfusion.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.  On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced HEADACHE (severe headache) (seriousness criterion hospitalization) and HAEMORRHAGE INTRACRANIAL (Iintercranial bleed) (seriousness criterion hospitalization). At the time of the report, HEADACHE (severe headache) and HAEMORRHAGE INTRACRANIAL (Iintercranial bleed) outcome was unknown. Not Provided  Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Unspecified blood disorder may have been contributory.
Anaphylactic reaction; Dysphagia; Orbital swelling; Swelling face; Swollen tongue; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B2121A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), DYSPHAGIA (Dysphagia), ORBITAL SWELLING (Orbital swelling), SWELLING FACE (Swelling face) and SWOLLEN TONGUE (Swollen tongue). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction), DYSPHAGIA (Dysphagia), ORBITAL SWELLING (Orbital swelling), SWELLING FACE (Swelling face) and SWOLLEN TONGUE (Swollen tongue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that no treatment medication was taken.; 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.
Should have been SC, but given IM in error.  Pt was notified within 15-20 minutes of discovery of error (about 25-30 minutes after vaccination).
patient was given the Dtap/IPV portion of PENTACEL and did not get the ActHIB part, no AE; Initial information received on 14-Dec-2020 regarding an unsolicited valid non-serious case from a physician in the united States.  This case involves a 2 months old female patient who was given the first dose of dtap/ipv portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot number UJ336AAA and expiration date 05-Jul-2021) and did not get the ACT-HIB part, via intramuscular route in the right thigh for prophylactic vaccination on 10-Dec-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) ; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for prophylactic vaccination.  It was a case of actual medication error due to inappropriate reconstitution technique (product preparation issue, same day latency).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Severe Vertigo; Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Severe Vertigo) and TINNITUS (Tinnitus) 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 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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, the patient experienced VERTIGO (Severe Vertigo) and TINNITUS (Tinnitus). At the time of the report, VERTIGO (Severe Vertigo) and TINNITUS (Tinnitus) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up received on 14-MAR-2021 and reporter Information Updated.
Blood sugar sugar went up; Breathing got better; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugar sugar went up) and THERAPEUTIC RESPONSE UNEXPECTED (Breathing got better) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination.     Concomitant products included INSULIN LISPRO (HUMALOG) for Blood sugar increased.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar sugar went up) and THERAPEUTIC RESPONSE UNEXPECTED (Breathing got better). The patient was treated with INSULIN LISPRO (HUMALOG) for Blood sugar increased, at an unspecified dose and frequency. On 29-Mar-2021, BLOOD GLUCOSE INCREASED (Blood sugar sugar went up) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Breathing got better) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: Blood sugar went up.     The patient received both scheduled doses of mRNA-1273 prior to the events. Therefore, action taken with the drug in response to the event is not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up information received contains no new information. On 18-May-2021: Follow-up information received contains no new information On 26-Jun-2021: No specific follow-up information recorded. On 28-Jun-2021: Nonsignificant follow up
Patient received first Pfizer COVID vaccine with subsequent shortness of breath, subjective throat swelling and ear pain/itching. Patient was taken to the ED for ongoing evaluation and is taking 50 mg of Benadryl, IV fluids, 125 mg of methylprednisone, and 20 mg famotidine followed by reevaluation. Patient had no additional symptoms and discharged.
(L) axilla edema; (L) arm pain; chills, fever; (L) arm pain with movement;
Information has been received from a physician concerning a (breast fed) female who in April 2008, was vaccinated PO with her first dose of ROTATEQ.  In April 2008, the patient experienced diarrhea four hours after vaccination which continued with 10-12 episodes per day for more than a week.  On 21-APR-2008 the patient was seen in the physician's office and was still having diarrhea but had not had any blood in her stool.  The patient's diarrhea persisted.  The patient was referred to a gastroenterologist at a hospital.  No additional information at this time.  There was no product quality complaint.  Additional information has been requested.
redness began 24 hrs often vax-lateral bicep/tricep area red; 1cm nodular area @ shot site of lt arm;
Patient felt hot, fainted, and fell out of chair. He regained consciousness and was helped up while EMS arrived. The patient was assessed and given water and a snack. He informed the pharmacist on duty that his neck and head were a little sore from the fall but that he was feeling better.. After speaking to EMS he stayed for about 20 minutes then left.
After 10 minutes of receiving vaccine patient starting feeling nausea and vomiting X 2, he stating feeling week. Vital signs as follow: BP 114/67, HR 91, R 22, O2 sat. 98%, patient was put  in supine position and lights of for 30 minutes, after that he was sent home with instructions to come back, clinic or go to ER to be evaluated if symptoms return, patient and mother verbalized understanding.
This spontaneous report as received from a pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 03-APR-2014, the patient was vaccinated with VARIVAX (Merck) lot # J009165; expiration date: 24-JUL-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
I know of someone else who suddenly got shingles some time after getting vaccinated; I developed a rash with small blisters on my back, on the left shoulder blade close to the spine.; I developed a rash with small blisters on my back, on the left shoulder blade close to the spine.; It's itchy and has a slight burning sensation.; It's itchy and has a slight burning sensation.; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 38-years-old female patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 vaccine, solution for injection, Batch/Lot Number: EP0161), (at the age of 38-years-old) via an unspecified route of administration on 08Apr2021 14:45 left arm as single dose for COVID-19 immunisation. The patient's medical history had chicken pox as a child. She had no known allergies and no other medical history. Concomitant medications were not reported. Patient neither receive any other vaccines within 4 weeks prior to the COVID vaccine nor any other medications within 2 weeks of vaccination. The patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EP7534), via an unspecified route of administration on 18Mar2021 13:00 as historical vaccination on left arm as single dose for COVID-19 immunisation. On 30Apr2021, about a week ago (late Apr), the patient developed a rash with small blisters on my back, on the left shoulder blade close to the spine. It's itchy and has a slight burning sensation. From an online search I believe it's shingles. I'm 38 and never had shingles before. Now it seems that it started to dry out. If needed, I can provide photos of the rash from different stages. Of course, don't know if it is related to the vaccine, but I know of someone else who suddenly got shingles sometime after getting vaccinated, so I thought I'd report it just in case. The patient did not receive any treatment for adverse events. The patient did not test COVID prior to vaccination and post vaccination. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Systemic: Chills-Medium, Systemic: Exhaustion/Lethargy-Severe, Systemic: Headache-Medium.
Started noticing 2 big red dots/bumps on right cheek on Saturday 3/20.  Dots/bumps continued to appear - all along hairline by Saturday night - and more on cheeks under eyes & across nose - biggest one is on side next to right eye.  Did not change anything this week to include diet, meds, exercise routine - so only connection I can make is the vaccine.  This AM 3/22 dots/bumps are very noticeable, all over forehead now and a few more have appeared randomly on face - have not found elsewhere