chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Dose administered >12 hours after initial vial puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours after initial vial puncture) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7180B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu shot on 30-Mar-2023. Past adverse reactions to the above products included No adverse event with Flu shot.    On 07-Apr-2023 at 8:45 AM, 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 07-Apr-2023 at 8:45 AM,  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 >12 hours after initial vial puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours after initial vial puncture) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours after initial vial puncture).    No concomitant medications was reported.  Vial was removed from the refrigerator and initially punctured at 8:30 AM on 6-APR-2023. Vaccine sat at room temperature up until administration after being initially punctured.  No treatment medications was reported.
Adverse event: inflammatory reaction in left arm. Extending from base of arm to top of neck. Unable to lift arm. Swollen, red, hot to the touch.- treatment: 6 day course of prednisone and antihistamines. Urgent care advised that second dose could cause anaphylaxis- advised not to receive. Outcome: took 7 days to get swelling to go down, range of motion, pain to go away.
presents with cough, chills, and SOA that started this AM. He reports doing well after that however this AM he started to feel chilled. He then began having a dry cough and feeling diaphoretic. He reports over the last day or so, as the weather has cooled down, his asthma has been acting up. In the ED his CT PE was negative but he was found to be COVID positive. In addition pts lactate was 4.7 so he was given 2L IV fluids. His O2 saturation is 91-93 while laying in bed however it drops into the 80s when he ambulates. Medicine was consulted for admission due to his hypoxic respiratory failure 2/2 COVID infection. Currently pt denies chest pain, abdominal pain, constipation, diarrhea or issues urinating. In the ED he received a breathing treatment which helped. He feels very chilled but also sweaty. He continues to have a dry cough that is causing him some back pain. He feels like he is wheezing and has been taking his albuterol inhaler frequently.   Hospital course:  presented on 8/15 with 1 day of cough, chills, and SOB. In the ED, he was maintaining O2 sats in the low 90s that dropped to the 80s with ambulation. Workup in the ED was significant for an elevated lactate, negative CT-PE (but did reveal a RUL airspace disease), and a positive COVID-19 test. He was admitted to hospital medicine for medical management of his acute hypoxic respiratory failure. He was originally put on remdesivir and dexamethasone; however, given his lack of oxygen requirement he does not qualify based on protocol. Therefore he was switched to Paxlovid on 8/16 and antibiotics were started due to concern for CAP.   During admission, patient tolerated the Paxlovid, ceftriaxone, and azithromycin well and with no complications. He was discharged on 8/18 after completing an ambulation test, maintaining good oxygen saturation on room air, and completing 3 days of Paxlovid, and 4 days of ceftriaxone/azithromycin. He was discharged to a hotel with a voucher and transportation organized by social work for the remainder of his COVID isolation.  He was discharged with antibiotics to complete 5 day course for CAP.    Discharge Disposition/Condition Disposition: Home, hotel to finish 10d quarantine Condition: Stable (s/sx potential problems absent or manageable)
Numbness; This case was reported by a pharmacist via call center representative and described the occurrence of numbness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced numbness. On an unknown date, the outcome of the numbness was unknown.   It was unknown if the reporter considered the numbness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be between 77 or 78 years. The reporter stated that the patient had numbness the following day after their first dose of Shingrix. The patient thought it was because the pharmacist gave it too hard. The reporter consented to follow up.
Headache, Myalgia, Arthralgia, Fever, Diarrhea,  Localized pain; chills, fatigue Narrative:  Other Relevant History:
Almost 12 hours after receiving the vaccine my legs felt very tingly and I passed out in the front yard
Probably the 8th of April I started to get bloody noses and couldn't get them to stop. I got blood blisters in my mouth. On April 11th I woke up with measles like bumps all up and down my legs, I went to the ER. I was kept in the hospital for 4 days. All of my symptoms were caused from a lack of blood platelets. I was given about 6 packets of blood platelets and about 6 vials of Ab Ig. Once given that I came out of the hospital and my blood platelets have been staying up.
2/6/03: Started with runny nose and increased fever of 104 degrees per mother. Immediately after shots were given starting with difficulty breathing that night with vomiting and cough. Returned to doctor on 02/7/03 with vomiting. Returned back to clinic 2/12/03. Home nebulizer ordered. 2/21/03 because difficulty breathing.  4/14/03 got Prevnar shot and got nosebleed. Remains being treated. Will send copy of medical records upon request.
Tinnitus, getting  worse each day. Starts mild in AM and is worse at night.
I had the 2nd Moderna Vaccine on 5/7/2021.   On 5/7/2021, I had my RA infusion, Actemra.   The evening of 5/7/2021, I broke out in severe hives.     I contacted the Dr in June when we got back from vacation.   I suffered with hives and a lot of body pain as the Actemradid not work.   Took a lot of ibuprofen.   He had me contact my primary dr.   I saw her nurse practitioner.    They did not know what to do.   Dr prescribed a regiment of Prednisone.     This helped relieve the hives and pain somewhat.    July 6th, I had another Actemra  infusion.   I broke out with hives again, just not as severe.     I saw Dr and he believes the Moderna  created an allergic reaction to something in Actemra.    He said the Moderna should not be active by then and my body is allergic now to Actemra
MODERNA LEFT ARM GIVEN ON 06/21/21. PRESENTS TO URGENT CARE ON 06/23/2021 WITH BODY ACHES, CHILLS AND HEADACHES AND LYMPH NODE IN LEFT AXILLARY INFLAMMED.
No additional AE reported; a dose of PROQUAD was administered after a temperature excursion; This spontaneous report was received from an "healthcare professional" and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-SEP-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human Albumin (rHA) (PROQUAD) lot #W017570, expiration date: 29-NOV-2023 (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis (product storage error).  The improperly stored vaccine dose underwent a temperature excursion of 5.7 degrees Fahrenheit (F) for 0 hours, 30 minutes and 0 seconds, with previous excursions of 6 F up to 14 F (9.1F) for 1 hour 6 minutes and 0 seconds, and an additional prior excursion of 6 F up to 14 F (10 F) for 1 hour, 8 minutes, 0 seconds on 18-JUL-2022. No adverse events were reported.
Fever, NauseaVomiting, FATIGUE, SWEATS Narrative: MISSED DAY OFF WORK DUE TO SYMPTOMS
About 30 min later, my arm was sore. About 4 hours later, I was feeling tired, but nothing severe. About 10 hours later, I had body aches, chills and fever, which got so severe that I couldn't sleep. I had a fever that went up to 101 and then 102, so I took Aleve. Muscle aches became more tolerable. I felt fatigued for the next couple of days. I also had swollen lymph nodes under my armpit on day 2. A few days later, I started having joint pain in my left hand to where it hurts to use it and it is still happening now--6 weeks later. I have an appt with my doctor in a few weeks to have it checked.
Day 7 evening after shot, small quarter size hard swollen tender and warm to touch spot on arm  (not at injection site). Next morning had grown to size of a tennis ball. Much redder, swollen, tender to touch and hot. Began itching on day 12 and is still warm to touch at day 13.
This spontaneous report was received from a pharmacy technician regarding a 62 year old female patient. Previously she had cancer. Patient had none drug allergies or reactions. On 25-AUG-2016, the patient was vaccinated with ZOSTAVAX, subcutaneous, lot # M0159826-28-JUN-2017, (reported as vaccine). Concomitant therapies included EVISTA. On 25-AUG-2016, immediately after administration liquid started to come out of the injection site and ran down the patients arm (accidental exposure to product). On an unknown date in August 2016, the patient experienced injection site started itching and swelling. No treatment was given for the adverse event and none laboratory diagnostics were performed. At the time of adverse events the patient was at the office to seek medical attention. No PQC (product quality complaint) was involved. The outcome of the events were unknown. Causality was unknown. Additional information has been requested.
This is a 2 month old boy. He got 1st set of shots. ROTATEQ po, no problem. PENTACEL right thigh, no problem. RECOMBIVAX HB left thigh. Right after the pt stopped breathing, stiffened. Pt pink after stimulation, started to cry, OK. This lasted about 1/2 minute.
pt devel serious flu requiring hosp p/vax;No further info was available @ the date of this report;
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case involves a 47 years old female patient who experienced developed a rash to the injection all over her hands, legs and face/rash looks like little dots multiform, while she received vaccine FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. The patient did not receive any other vaccine other than suspect. On 27-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6261KA, expiry date 30-Jun-2019 via intramuscular route in the right deltoid. On 28-Sep-2018, the patient developed a non-serious rash to the injection all over her hands, legs and face/rash looks like little dots multiform 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Lab data was not provided. Final diagnosis was developed a rash to the injection all over her hands, legs and face/rash looks like little dots multiform. As a corrective treatment, the patient was given DIPROLENE cream and will be starting MEDROL dose pack on 24-Oct-2018. The patient outcome is reported as Unknown for developed a rash to the injection all over her hands, legs and face/rash looks like little dots multiform. List of documents held by sender- none.
Date the vial was initially stored in the refrigerator on 22Sep2022 and administered on 26Oct2022; No adverse event; given bivalent dose which was beyond the 30 use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given bivalent dose which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22Sep2022 and administered on 26Oct2022) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 vaccination.     The patient had ever been diagnosed with/ tested positive for COVID-19 was unknown. Acute illnesses at the time of vaccination and up to one month before was unknown.  Concurrent medical conditions included Drug allergy.    On 26-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 26-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given bivalent dose which was beyond the 30 use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22Sep2022 and administered on 26Oct2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given bivalent dose which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22Sep2022 and administered on 26Oct2022) 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 EXPIRED PRODUCT ADMINISTERED (given bivalent dose which was beyond the 30 use by date) and NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22Sep2022 and administered on 26Oct2022).    Concomitant medications were not reported.  Patient received dose 1 on 30Jun2022 and dose 2 on 12Aug2022. The vial was initially stored in refrigerator on 22Sep2022 12pm. The vial size was 2.5 ml and vial did not undergo any temperature excursion. They inadvertently administered 3 doses of the bivalent vaccine which was beyond the 30 days use by date today on 260ct2022. There was no other potential causes and unknown whether any similar experience happened in the past. No treatment medications were required.   This case was linked to US-MODERNATX, INC.-MOD-2022-673503, US-MODERNATX, INC.-MOD-2022-664543 (Linked Report). This case was linked to MOD-2022-673509 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673503:Same reporter US-MODERNATX, INC.-MOD-2022-664543:Same reporter
Patient administered vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.  It was reported that vials had not undergone any temperature excursion.Total of 168 doses/vials were given for LOT 048C21A.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains Non significant information.
a 67-year-old male with past medical history hypertension, CVA on aspirin and Plavix, diabetes mellitus on Metformin who presented to ED 3?30?-30-2021 secondary to shortness of air.  Patient son is at bedside and states he has had complaints of cough, chest pain and shortness of air for the past 3 to 4 days.  He has associated subjective fevers at home.  Patient son states that his daughter checks the patient's blood sugar daily.  He has not missed any of his medications or had a change in medications.  His blood sugar was checked this morning and noted to be high and he thus presented to ED for further evaluation.  Patient was ill-appearing on arrival to ED with respirations in the 30's as well as tachycardia and mild hypoxia.  He was placed on 2 L with O2 stats stable.  He states he has some relief with IV fluids but continues to have chest pain and shortness of air.  He is tachypneic with Kussmaul respirations noted.  Pertinent ED labs: Elevated lactic 3.0, potassium 6.8, glucose 760, BUN 33, creatinine 1.8, WBC 16, D-dimer 2636, decreased GFR 38, sodium 124, bicarb 5 VBG with pH 6.97, CO2 25, bicarb 6 Patient started on insulin drip, 2 L IV fluids, IV antibiotics, calcium in ED.
Leg became swollen, pale, and also turned blue and purple. I had a DVT blood clot from the toes to the vena cava, and a few pieces of the blood clot was in my lungs. Had to have a thrombectomy twice to clean out the vein. All symptoms (some that I didn?t know were symptoms at the time) started about a week after the first Covid shot, the second shot, which was taken on 7/7/21, made the swelling worse. I am now in recovery with a few residual pieces of an old blood clot.
Started feeling severe body aches and chills about 15 hours after 2nd dose vaccine.  Symptoms improved and only lasted around 24 hours. Felt fatigue about 24 hours later and started having trouble breathing at around 48hours. Went to urgent care and was told to go back on my albuterol inhaler.  Felt better the next day. No other symptoms since then.
Musle pain at injection site-unresolved since injection admin. Throbbing pain at injection site upon strenuous use of muscle. Muscle pain at injection site when arm is lifted to head level.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot# J014855 with expiration date 16-APR-2016, and lot# K026666 with expiration date 22-OCT-2016 (dose and route of administration were not reported). No information on patients' concomitant medications was provided. No adverse symptoms were reported. This is one of the several reports from the same reporter. Additional information has been requested.
patient described waking up the morning after injection and her whole body was very stiff. As of 6pm patient states that it has lightened up just a bit. Patient will be seeking treatment if symptoms do not resolve.
Per mom, patient developed a low grade fever which progressed to diarrhea and projectile vomiting after a few days.  Per mom, patient taken to an emergency room where they tried to hydrate, but could not get an IV in place, patient given Zofran which helped control the vomiting.  Mom states today, 09/09/14, is the first day patient is able to keep food down and appears to be doing better.  She strongly feels like it is a reaction to the immunizations, specifically Rotavirus vaccine.
This case was reported by a healthcare professional and described the occurrence of pain in right upper arm in a 53-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 19 October 2009 the subject received a dose of FLULAVAL (.5 ml, unknown, right arm). On 19 October 2009, less than one day after vaccination with FLULAVAL, the subject experienced pain in right upper arm. At the time of reporting the pain in right upper arm was unresolved. This is one of three cases reported by the nurse; see case A0815869A and A0816150A for subjects who had pain in upper right arm following vaccination with FLULAVAL.
Patient experienced redness and swelling of right arm of injection site. Pneumovax 0.5ml was given at 1:30pm, on 11/3/04. Symptoms began 4.5-5 hours later on that same day. Spoke with patient 11/5/04 at 3:05pm and she's feeling much better.
High fever of 102.3 started on day 10 after MMRV vaccine, along with lethargy, loss of appetite, and not feeling well in general. Fever would break after dose of Tylenol and come back again 6 hours later
I had swollen lymph nodes in my arm pits and breast, resulting in diagnostic mammogram and ultrasound followed by a second mammogram one month later.  This was before this known side effect was largely publicized.
there has been a good side effect from your vaccine. I have not had a cold sore, (herpes simplex), since Mar2020; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (Pfizer-BioNTech COVID-19) (Batch/Lot number: unknown) as dose 1, single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "herpes simplex", stop date: Mar2020, notes: I have not had a cold sore, (herpes simplex), since Mar2020.; "Cold sore", stop date: Mar2020, notes: I have not had a cold sore, (herpes simplex), since Mar2020. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "there has been a good side effect from your vaccine. I have not had a cold sore, (herpes simplex), since Mar2020".  The lot number for bnt162b2 was not provided and will be requested during follow up.
DTap, Hep B, Hib, PCV13, Polio and Rotavirus  Soon after administration, patient became fussy, had decreased intake and became febrile. He then had 5 seizure like episodes of arm and leg jerking and eye rolling in the back of his head. He was admitted to the hospital with negative MRI, LP without bacterial meningitis (pending viral studies) and EEG that showed diffuse encephalopathy. Patient is now on Keppra 70mg BID for increased seizure potential. Per neurology, this has been seen with the pertussis portion of the DTap vaccine before and potentially could have been a reaction to it.
no adverse event; HCP calling to report AE for patient that received expired dose of PNEUMOVAX 23.  No adverse effects reported.  No additional AE.  No PQC.; This spontaneous report was received from a pharmacist, referring to a 17-year-old male patient.  The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not reported.  On 24-OCT-2023, the patient was vaccinated with a dose of expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, single dose, lot #W019533, expiration date: 30-SEP-2023, for prophylaxis (strength, dose and route of administration were not provided) (Expired product administered). No adverse effects and no additional adverse event (AE) were reported.
Patient came in to the pharmacy to start her initial Shingrix series.  We gave her the first dose.  When she came back for her second dose, we checked to make sure the 60 days had elapsed and noticed patient had actually gotten Dose 1 and 2 in 2020.  Patient received a third dose.
Moderna dose given to under 18 years old. Patient stayed for 15 min observation. No adverse events observed.