chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was stored in the refrigerator on 04-Jun-2023 after expiry on 30-May-2023; No adverse event; Dose administered to patient on 5-Jun-2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired on 30-May-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-Jun-2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired on 30-May-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-Jun-2023 after expiry on 30-May-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. 019H22A) 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 administered to patient on 5-Jun-2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired on 30-May-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-Jun-2023 after expiry on 30-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-Jun-2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired on 30-May-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-Jun-2023 after expiry on 30-May-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 to patient on 5-Jun-2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired on 30-May-2023) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-Jun-2023 after expiry on 30-May-2023).    This case contains information for patient 44 out of 50 patients as described by the reporter.  No concomitant medication information was reported.   It was reported that no adverse reactions had been reported by any patients.  The vial was initially stored in the refrigerator on 4-Jun-2023 and did not undergo any temperature excursion.  No treatment information was reported.   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 (Patient 44)
torso rash again. Rash progressed anyway. Still red.; I suppressed fever; This spontaneous case was reported by a patient and describes the occurrence of RASH ERYTHEMATOUS (torso rash again. Rash progressed anyway. Still red.) and PYREXIA (I suppressed fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose Number: 1 Batch/Lot No: ER8732 Location of injection: Arm Left) on 24-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose Number: 2 Batch/Lot No: ER8729 Location of injection: Arm Left) on 14-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (Batch/lot number: FJ1620, in Arm Left, dose number 3) on 29-Nov-2021 and PFIZER BIONTECH COVID-19 VACCINE on 29-Nov-2021. Past adverse reactions to the above products included Itching with PFIZER BIONTECH COVID-19 VACCINE; No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE; and Red rash with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Seasonal allergy (pollens), Osteoporosis (no medicines yet) and Allergy (thimerosal).    On 28-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (torso rash again. Rash progressed anyway. Still red.) and PYREXIA (I suppressed fever). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Fever, at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (torso rash again. Rash progressed anyway. Still red.) had not resolved and PYREXIA (I suppressed fever) outcome was unknown.            The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Calcium and Vit D supplements within 2 weeks of vaccination.   The patient had a 4th shot (2nd booster) on May 28, 2022 (Moderna) - torso rash again even though patient suppressed fever with NSAIDs this time. Took Zyrtec. Rash progressed anyway. Still red. Even though not a serious effect, it can be serious because will lead to vaccine hesitancy or reluctance in the future for me.   Pharmacist advised for next time to start antihistamine a few days before vaccine to allow more time for antihistamine to work. Patient will not be going through this 4 times a year given that the 4th dose has debatable benefit anyway, patent want to known patient would get this rash again, patient would have skipped the 4th dose and waited until fall.   The patient did not diagnose with COVID-19 Prior to vaccination. The patient had been tested for COVID-19 Since the vaccination. Device Date: 31May2022
Patient received 1 dose of Janssen vaccine at pharmacy on 5/25/21. Patient visited hospital emergency department  on 5/28/21 after experiencing new a syncopal episode with abdominal pain and vomiting, then acute left-sided chest and arm pain after with new atrial fibrillation diagnosis which was managed. Patient revisited same ED later on 6/1/21 for significant fatigue/weakness and diagnosed with STEMI.
fever blisters in corner of mouth 3 times; This case was reported by a consumer via interactive digital media and described the occurrence of fever blister in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever blister. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the fever blister was recovered/resolved.   It was unknown if the reporter considered the fever blister to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. After receiving Shingrix, the patient had fever blisters in corner of mouth 3 times. The patient asked if he/she should take the 2nd dose and stated that Valacyclovir almost cleared blisters.
dizziness 15min p/vax;completed series & had same sx each time;since 7OCT95 has non-specific sx of h/a, tired, dizzy;just does not feel right;seen on 7OCT95 blood sugar 123;poss sinus &/or UTI;tx w/Bactrim & Pyridium;
BODY ACHES; FEVER; SORENESS; This spontaneous report received from a patient concerned a  male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: not reported) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced soreness. On 09-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and fever on 11-MAR-2021, and was recovering from soreness. This report was non-serious.
Patient received COVID-19 (Pfizer) vaccine per vaccine process. Denied received a previous COVID vaccine on pre-vaccination checklist.  After receiving vaccine and leaving the clinic, patient spoke to the clinic director to notify her she has previously received two doses of COVID-19 (Moderna). Patient denied side effect or symptoms.
ringing in ears, dizzy,  scattered headaches,  muscle cramps in arms.  Classic flu like symptoms 24 hours after injection. 99.9 fever for 10 hours, headache, fatigue.   They resolved 24 hours later.
Information has been received from a registered pharmacist concerning a 60 year old male patient with not pertinent medical history who on 21-SEP was vaccinated with a dose of ZOSTAVAX (Lot# 665531/0698Z, Exp. date 28-APR-2011) (route not reported). The pharmacist reported that on 29-SEP-2010 the patient developed a rash with lesions, shingles. At the time of the report, the outcome of the patient was reported. The patient called the pharmacy for medical attention. It has been determined the case #1405USA006086 is duplicate of case # 1010USA00154. Therefore, case # 1405USA006086 is being deleted from our files and the cases are consolidated into case # 1010USA00154. Additional information is expected.
woke on 10/11/21 with swollen upper lip, puffy face, itching on gums and face,  patient has taken otc antihistamine and after two hours was feeling a little better
Seeing double; eye are puffy; high neutrophils; high sugar; Dizziness; Nausea; Dry heaves; The ER told them she had an allergic reaction; This is a spontaneous report from a contactable consumer (patient's husband).  This 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6206), via intramuscular in the right arm, on 09Mar2021 (at 14:00) as single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9266) administered in the left arm on 15Feb2021 (at 14:00) for COVID-19 immunisation. Relevant medical history included psoriatic arthritis, chronic obstructive pulmonary disease (COPD), emphysema, blood pressure abnormal, blood cholesterol abnormal, blood potassium abnormal, sleep apnea (she used C-Pap machine). Past drug history included allergy to penicillin. Relevant concomitant medications included hydroxychloroquine sulfate (PLAQUENIL SULFATE) for psoriatic arthropathy, ixekizumab (TALTZ) for psoriatic arthropathy, levothyroxine sodium (SYNTHROID), rosuvastatin for blood cholesterol abnormal, ranolazine (RANEXA), losartan for blood pressure abnormal, carvedilol (COREG), clopidogrel bisulfate (PLAVIX), potassium chloride (KLOR-CON) for blood potassium abnormal, escitalopram oxalate (LEXAPRO) for blood pressure abnormal, furosemide, tiotropium bromide (SPIRIVA) for COPD, fluticasone propionate, salmeterol xinafoate (ADVAIR) for COPD, acetylsalicylic acid (ASPIRIN (E.C.)), salbutamol (ALBUTEROL HFA) for emphysema and COPD and oxygen. On 11Mar2021, the patient became dizzy and nauseous and it just got worse and worse. She had also dry heaves. On 12Mar2021, she took meclozine hydrochloride (ANTIVERT, NDC 65162 0441 10) and ondansetron hydrochloride (ZOFRAN, NDC 65862 0187 30). Finally, on 13Mar2021 she had dry heaves and felt like she was going to pass out so they took her to the emergency room (ER). At ER, a computerized tomogram (CT) of head was done and resulted negative and blood work was normal except for high neutrophils and high sugar due to her drinking ginger ale for the nausea. The ER treated her with a shot of ANTIVERT and ZOFRAN and then lorazepam (ATIVAN). ATIVAN helped her so they sent her home with a prescription for ATIVAN. On 15Mar2021 (on Monday), she was no better. She was still dizzy and nauseous although the nausea was getting better as she could keep food down; she couldn't get off the couch without getting dizzy; under her eyes are so puffy and she was seeing double this morning when she woke up. The ER told them she had an allergic reaction. She was not sick at all when she got the shots; she was perfect. She used a C-Pap machine for sleep apnea and had oxygen that she used as needed. The patient had recovered from dry heaves on 14Mar2021, from seeing double on 15Mar2021; the patient had not recovered from dizziness and eye are puffy. The patient was recovering from nausea while the outcome of the remaining events was unknown.
This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 29-APR-2015 the patient was vaccinated with VARIVAX (Merck) (lot # K016131 with expiration date: 23-SEP-2016, dose: 0.5 ml, administered subcutaneously) which had undergone supported excursion. No adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Patient felt very severe generalized weakness 24 hours after 2nd COVID Vaccine and had to be transported to local ER via ambulance
Moderna COVID-19 Vaccine EUA  January 30, 2021--Received vaccine at 9:45 a.m.  Noticed soreness in arm at 1 p.m.   At 2 p.m. felt sluggish decided to take a nap (arm began to hurt);  5:30 p.m. noticed large red rash with egg size knot under skin.  Skin was hot to the touch and itching ensued.   January 31-- 2:03 p.m.  In pain and rash was itching terribly bad.  Called the pharmacist (since this was weekend).  Pharmacist suggested liquid Benadryl for itch, hydrocortisone cream, Tylenol, and a cold pack.     Took photo progression from January 30 thru today, February 1 -- rash is still visible and itching but thinning; knot is smaller but still there; arm is stiff--but better.
While in the observation area for his 15 minute post-vaccine observation period, participant developed left sided chest pain. He has a history of myocardial infarction, diabetes, and pacemaker. A 12 lead EKG demonstrated ST elevation. He was hemodynamically stable. He was transported to local hospital for definitive care. Please note, the age and birthday reported in previous screen were approximate.
Red little bumps all over back and stomach turned into blotches (Temp 99.8 (A) morning of 4-16). Called MD eve of 4-15 and applied Benadryl gel. 2nd time that was applied, it seemed to irritate it. Dr told then to give him liquid Benadryl. Gave it again AM of 4-16 and he vomited. Never was really fussy. AM of 4-17, rash very faded.
No adverse event; Expired Moderna COVID-19 vaccine administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna COVID-19 vaccine administered to patient) and NO ADVERSE EVENT (No adverse event) in a 9-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna COVID-19 vaccine administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna COVID-19 vaccine administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired Moderna COVID-19 vaccine administered to patient).    No concomitant medication details was reported. It was reported that no adverse reactions have been reported by the patient. Unbroken carton was used and vial size was reported as 2.5ml. The vial was stored in freezer up until administration. The vial did not undergo any temperature excursions. No treatment medication details was reported.
pt says she got a soreness from the injection site down to her fingers as soon as she got the shot. She got a burning sensation in both eyes that are also watering.  She was dizzy and some swelling in the throat, but did not last very long.  Next day she still has watering and burning in both eyes.  She has been using cool compresses on them that seems to help.  Pt will reach out to the medical center where she got the vax to see if she can use eye drops.
Right cheek swelling (mild) 13 days after MMRV and KINRIX. Mildly painful to touch; Afebrile and otherwise asymptomatic.
27 minutes after receiving the Pfizer 1st dose vaccine the patient began to experience headache, eye discomfort, and dizziness. At 4:53 pm  vital signs were taken BP 125/60, O2 99%, RR 16, HR 69. At 4:55pm patient was lethargic , ammonia inhalant was used, with arousal. Emergency number was called at 4:55, 2nd set of VS  was taken at 5:10 HR 75, O2 99.4, BP 110/70. EMT arrived at 5:10pm. Sister stated no history of allergies, and reactions to vaccines, at 5:15pm patient care transferred over to EMT.
itching; half dollar size red rash appeared at the injection site on arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of PRURITUS (itching) and VACCINATION SITE RASH (half dollar size red rash appeared at the injection site on arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-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 PRURITUS (itching) and VACCINATION SITE RASH (half dollar size red rash appeared at the injection site on arm). At the time of the report, PRURITUS (itching) and VACCINATION SITE RASH (half dollar size red rash appeared at the injection site on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment for the event includes 10mg of Zyrtec x1 dose.
feeling sick; fever; chills; tired; headache; flu like symptoms; the friend had received the second shot which was 18 days apart.; This is a spontaneous report from a contactable consumer for male patient (friend). A 41-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 21Feb2021 (Batch/Lot number was not reported) as dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on Mar2021 (batch/lot number was not reported) as dose 2, single for COVID-19 immunization (age at vaccination was 41 years). The patient's medical history and concomitant medications were not reported. The facility where the most recent COVID-19 vaccine was administered was hospital group: not at actual hospital guesses a clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The friend of the patient reported that the patient has received first dose of vaccine on 21Feb2021 and has been sick for a week since had received the second shot which was 18 days apart in Mar2021. Reporter clarified that the sickness of his friend was experiencing fever, chills, tired, and headache and stated as just flu like symptoms on 11Mar2021. Fever has gone up and down and for this the patient was treated with Tylenol just over the counter medications. The adverse events did not result in emergency room or physician office visit. Reporter stated that he has been helping a few people get appointments such as friends, family, and neighbours and mentioned that one of the vaccine sites that offers vaccines are scheduling their patients 18 days apart from where his friend got the doses of vaccine 18 days apart. Reporter stated he did not put this timeframe together until someone else noticed it. Reporter mentioned that the facility changed it to the correct time apart but was reluctant to. The patient was not recovered from the events tiredness and headache and was recovering from the events of fever and chills and outcome was unknown for rest of the other events.   No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
RIGHT PEC SWELLING AND RIGHT LYMPH NODES SWOLLEN UNDER THE ARMPIT
difficulty breathing; tight feeling in chest; pain with regular/deep breathing; dizziness; This is a spontaneous report from a contactable consumer (patient) reported for himself. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. After first dose of Pfizer COVID 19 vaccine, on an unspecified date, the patient experienced tight feeling in chest, difficulty breathing, pain with regular/deep breathing and dizziness on first day. Noted that cardiologist was not confident if the patient should take the second dose. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Tingling in L arm, lightheaded, dizziness, evaluated by EMS-cleared
Arm pain that lasted 3 days, chills and diarrhea that lasted 24 hours, I didn't take any treatment.
After the booster the next day. He sleep a till the evening the next day. He was completely fatigued and was not talking well. He had a difficult time and his depression was very bad. It was 3 months he could not do anything to help his depression. His PCP upped his dosage on his medication for his depression. He made him terrible tired and frustrating. He was having mind problems, like he was out of life. It was difficult for him to sleep at night. He was having extreme sweats when he sleep, day or not. He lost his appetite. In January he started to ease away back to be being better on his supplement medication. But even now he is very weak and tired. Now his memory is not a great as it was before. He has kind of recovered but he is not the same.
Patient says injection site is warm to the touch and is red, and reaction has moved to the back of the arm, fever.
1st day - 0, day 2 slight fever, sore injection site, red lasted 3 days, March 11th itching, slightly sore, quite red 3 days so far itching
fever up to 104 24 hours after vaccine administered.  Also had runny nose and mild cough.  No rash.
Pt. states that after receiving the 2nd dose of Phizer 02/19/2021, started experiencing symptoms 02/25/2021 of chest pain.  Hospitalized (Internal Bleeding) 03/11/2021-03/18/2021 diagnosed with Pulmonary Embolism, located in Lung.